Irina Haracoglou-Competition Law and Patents - A Follow-On Innovation Perspective in The Biopharmaceutical Industry (New Horizons in Competition Law and Economics) - Edward Elgar Pub (2009) PDF

Competition Law and Patents
NEW HORIZONS IN COMPETITION LAW AND ECONOMICS
Series Editors: Steven D. Anderman, Department of Law, University of Essex,

UK and Rudolph J.R. Peritz, New York Law School, USA
This series has been created to provide research based analysis and discussion
of the appropriate role for economic thinking in the formulation of competition
law and policy. The books in the series will move beyond studies of the
traditional role of economics – that of helping to define markets and assess
market power – to explore the extent to which economic thinking can play a
role in the formulation of legal norms, such as abuse of a dominant position,
restriction of competition and substantial impediments to or lessening of
competition. This in many ways is the new horizon of competition law policy.
US antitrust policy, influenced in its formative years by the Chicago School, has
already experienced an expansion of the role of economic thinking in its
competition rules. Now the EU is committed to a greater role for economic
thinking in its Block Exemption Regulations and Modernisation package as
well as possibly in its reform of Article 82. Yet these developments still raise
the issue of the extent to which economics should be adopted in defining the
public interest in competition policy and what role economists should play in
legal arguments. The series will provide a forum for research perspectives that
are critical of an unduly-expanded role for economics as well as those that
support its greater use.
Titles in the series include:
Antitrust, Patents and Copyright

EU and US Perspectives
Edited by François Lévêque and Howard Shelanski
Innovation Markets and Competition Analysis

EU Competition Law and US Antitrust Law
Marcus Glader
Competition Law and Patents

A Follow-on Innovation Perspective in the Biopharmaceutical Industry
Irina Haracoglou
Competition Law and
Patents
A Follow-on Innovation Perspective in the
Biopharmaceutical Industry
Irina Haracoglou
Attorney at Law, Independent Researcher/Consultant
NEW HORIZONS IN COMPETITION LAW AND ECONOMICS
Edward Elgar
Cheltenham, UK • Northampton, MA, USA
© Irina Haracoglou 2008
All rights reserved. No part of this publication may be reproduced, stored in a retrieval
system or transmitted in any form or by any means, electronic, mechanical or
photocopying, recording, or otherwise without the prior permission of the publisher.
Published by
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A catalogue record for this book

is available from the British Library
Library of Congress Cataloguing in Publication Data

Haracoglou, Irina, 1981–
Competition law and patents : a follow-on innovation perspective in the
biopharmaceutical industry / by Irina Haracoglou.
p. cm. — (New horizons in competition law and economics series)
Includes bibliographical references and index.
1. Patent laws and legislation. 2. Pharmaceutical biotechnology—Patents.
3. Pharmaceutical biotechnology—Law and legislation. 4. Competition,
Unfair. I. Title.
K1575.H37 2008
346.04'86—dc22
2007038609
ISBN 978 1 84720 599 5
Typeset by Manton Typesetters, Louth, Lincolnshire, UK

Printed and bound in Great Britain by MPG Books Ltd, Bodmin, Cornwall
To Mum for her love & patience
To Dad for his persistence & perfectionism
To Dimitris (my stepfather) for his kindness & generosity
Contents
List of abbreviations xii

Preface xiv
Acknowledgements xv
Table of cases xvi
Part I: The problem – Access as a necessary element

of follow-on innovation?
1. Biopharmaceutical R&D: the increased importance of cumulative

innovation and related concerns 3
1.1 Introduction 3
1.2 The case of research tools 7
1.2.1 Defining research tools 7
1.2.2 The patent experience in biotechnology: biomedical
research tools 9
1.2.3 The effect of patent trends on the patent balance for
research tools 12
1.3 Conclusion 16
Part II: The Patent Balance and Working Solutions

in the Patent System
2. The patent system as a system of balancing 21

2.1 The Patent Balance 21
2.2 The particular importance of the patent balance in the
biopharmaceutical industry 25
2.2.1 The patent system and the biopharmaceutical industry 25
2.2.1.1 Biopharmaceutical innovation and patenting 28
2.2.1.2 Has the importance of patents been
overstated? 31
2.3 Conclusion 34
3. The patent system and some potential safety nets 36

3.1 Introduction to the patent safety nets 36
vii
viii Contents
3.2 The patent safety nets 37

3.2.1 Experimental use exemption 39
3.2.1.1 The experimental use exemption: a viable
and effective working solution? 39
3.2.1.2 The US experience: a helpful paradigm? 44
3.2.1.3 Conclusion on the EUE 46
3.2.2 The reverse doctrine of equivalents and blocking
patents 48
3.2.3 Patent pools 51
3.2.4 Compulsory licensing in the patent provisions 54
3.2.4.1 Introduction to compulsory licensing 54
(a) Definition and history 54
(b) Support and opposition for CL 54
(c) Grounds for granting a compulsory
licence 57
3.2.4.2 Analysis of the role of CL 58
(a) The role of CL in balancing
commensurability 58
(i) CL as a mechanism to induce
broad licensing 58
(ii) CL for non-use 59
(iii) CL for significant technological
advances 59
(iv) CL to address health
emergencies 61
(v) CL as a remedy for anti-
competitive conduct 63
(b) Conclusions on CL 63
4. The right to health as an interpretive principle of patent law 70

4.1 Introduction 70
4.2 The right to health as a human right and its status in
European law 71
4.2.1 Introduction to the right to health 71
4.2.2 Sources of the right to health 74
4.2.3 Implications of the right to health 76
4.2.3.1 Elements of the right to health 77
4.2.3.2 Obligation to respect, protect and fulfil 79
4.2.4 International Efforts to Strengthen the Right to Health 80
4.3 The right to health and patent law: The fundamental nature of
health concerns and the move towards a right to health as an
interpretive principle in patent law 82
Contents ix
4.3.1 The link between the right to health and patent law 82
4.3.1.1 The effect of patent law on the right to
health 82
4.3.1.2 The effect of the right to health on patent
law 83
4.3.2 The right to property and IP: IP as a human right 84
4.3.2.1 Striking the balance: limitations in the
public interest 86
4.3.3 Patenting and the right to health 87
4.3.3.1 Direct effect 87
4.3.3.2 The indirect effect of the right to health 88
4.3.4 The right to health as an interpretive principle in
patent law 90
4.3.4.1 Effect on specific patent provisions 91
4.3.4.2 Case-law on public health 93
4.3.4.3 European cases on IP and fundamental
rights analysis 94
4.4 Conclusions 96
PART III: Antitrust as a Complement to the Patent

System
5. Unilateral conduct, intellectual property rights and Competition

Law: a systems’ interaction 101
5.1 Introduction 101
5.2 The practice of the courts 103
5.2.1 The existence/exercise distinction 103
5.3 IPRs and competition: A systems’ interaction 107
5.3.1 IPRs – public goods, exclusivity and information
goods 107
5.3.1.1 Public goods and market failure 107
5.3.1.2 Patronage, procurement and property 109
5.3.2 Implications for competition 112
5.3.2.1 IP like other property rights for the purposes
of competition 112
5.3.2.2 Competition embedded in the IP system 114
5.3.2.3 The transition from separate to unified fields 114
5.3.2.4 How antitrust control affects incentives to
innovate 116
5.3.3 Recent recognition of antitrust control 119
5.4 Conclusions 121
Contents
6. The Duty to Deal under Art. 82 EC 122

6.1 Introduction 122
6.1.1 What is a refusal to deal and what is the rationale
behind its prohibition? 122
6.1.2 Concerns relating to a refusal to deal: Potential harm
to competition 123
6.2 The state of the law 126
6.2.1 Cutting off existing customers: The dependence cases 128
6.2.2 ‘Reservation of an ancillary activity’ and leverage
economics 130
6.2.3 The indispensability requirement and the essential
facilities doctrine (EFD) 133
6.2.3.1 Indispensability 135
6.2.3.2 Two-market requirement 138
6.2.3.3 Objective justification 139
6.2.4 New product innovation 141
6.3 Conclusions 143
Appendix The refusal to deal cases under Art. 82 145
PART IV: A MORE INNOVATION SENSITIVE APPROACH TO THE

INTERFACE OF COMPETITION LAW AND PATENTS?
7. The duty to deal as applied to address technology access problems

in the biopharmaceutical industry 177
7.1 Conclusions on the patent system in the case of research
tools 177
7.1.1 The particularity of research tools: pre-commercial
stage patents 177
7.1.2 A gap in the patent system? 179
7.1.3 The more the better? Optimal market structure for
innovation 179
7.2 Two possible avenues for increased access to essential
research tools 181
7.2.1 Patent law 181
7.2.2 A role for Art. 82? 185
7.2.2.1 Indispensability 186
7.2.2.2 Preventing the emergence of a new product
for which there is potential consumer
demand 187
7.2.2.3 Elimination of competition on a downstream
or neighbouring market/two-market
requirement 187
Contents xi
7.2.2.4 The absence of an objective justification 188

7.2.3.1 The impact of Art. 82 duty to deal with case-
law on the patent system 189
7.2.3.2 An innovation sensitive approach:
innovation markets in Art. 82? 191
7.2.3.3 Conclusions on compulsory licensing as a
safety net 195
7.2.4 Conclusion: A human rights approach to competition
law? 196
Bibliography 200
Legislation and Guidelines 200
Reports and Studies 204
Authors 210
Index 239
Abbreviations
ACIP Advisory Council on Intellectual Property

AIPLA American Intellectual Property Law Association
Am. Bus. L. J. American Business Law Journal
Am. J. L. and Med. American Journal of Law and Medicine
Antitr. L. J. Antitrust Law Journal
Berk. Tech. L. J. Berkeley Technology Law Journal
Buff. Hum. Rts. L. Rev. Buffalo Human Rights Law Review
CAFC Court of Appeals for the Federal Circuit
CFI Court of First Instance
Chi. Kent L. Rev. Chicago Kent Law Review
Chi. Trib. Chicago Tribunal
CL Compulsory licensing
CML Rev Common Market Law Review
Col. L. Rev. Columbia Law Review
Community European Community
Community Courts CFI and ECJ
CPC Community Patent Convention
CPTech Consumer Project on Technology
DOJ Department of Justice
EC Treaty Treaty Establishing the European Community
ECJ European Court of Justice
ECLR European Competition Law Review
ECR European Court Reports
EEA European Economic Area
EFD Essential Facilities Doctrine
EGE European Group of Ethics
EIPR European Intellectual Property Review
ELR European Law Review
EMEA European Medicines Evaluation Agency
EPC European Patent Convention
EPO European Patent Office
ESCRC Economics, Social and Cultural Rights Committee
EU European Union
EUE Experimental use exemption
FDA Food and Drug Administration
xii
Abbreviations xiii
Ford. Corp. L. Inst.

Fordham Corporate Law Institute
Ford. Int. L. J. Fordham International Law Journal
FTC Federal Trade Commission
GATS General Agreement on Trade in Services
IACHR Inter-American Court on Human Rights
IIC International Review of Industrial Property and
Copyright Law
IMA Innovation Markets Approach
IP Intellectual property
IPR Intellectual property right
J.L. and Econ. Journal of Law and Economics
JPE Journal of Political Economy
JPTOS Journal of the Patent and Trademark Office Society
LQR Law Quarterly Review
Mich. L. Rev. Michigan Law Review
NYU Law Review New York University Law Review
OECD Organisation for Economic Co-operation and
Development
OFT Office of Fair Trading
OJ Official Journal
OJ Objective justification
OUP Oxford University Press
R&D Research and Development
RJE Rand Journal of Economics
SME Small and medium-sized enterprise
SPC Supplementary Protection Certificate
SSM Specific Subject Matter
Stan. L. Rev. Stanford Law Review
TTBER Technology Transfer Block Exemption Regulation
TRIPS Agreement on Trade-Related Aspects of Intellectual
Property Rights
U. Chi. L. Rev. University Of Chicago Law Review
U. Ill. L. Rev University Of Illinois Law Review
USA United States of America
USPTO Patent and Trademark Office, USA
Va. J. Trans. L. Vanderbuilt Journal of Transnational Law
Va. L. Rev. Vanderbuilt Law Review
VI Vertical Integration
WIPO World Intellectual Property Organization
WTO World Trade Organization
Note: Other abbreviations that have been used are either defined in the text or can be found in the
bibliography.
Preface
In June 2005 the European Commission announced that it had fined AstraZeneca
€60 million for misusing the patent system to delay entry of competitors thereby
abusing its dominant position in contravention of Art. 82 EC. In October 2005
a complaint by six phone manufacturers was reported against Qualcomm, a chip
manufacturer that owns patents over technology used in 3G handsets, alleging
that Qualcomm refused to license essential patents on fair terms, and charged
excessive royalties for its essential patents thereby acting anti-competitively.
In December 2005 the Commission published a Discussion Paper on the Ap-
plication of Art. 82 to Exclusionary Abuses. In February 2007 the Commission
opened an investigation into Boehringer’s best selling drug last year, Spiriva, in
relation to possible misuses of the patent system to exclude competition from
the market.
These initiatives have as their backdrop two central questions, inter alia: first,
the relationship between competition law and intellectual property rights; and
secondly, the duty of dominant undertakings to deal/license/supply other
undertakings.
Against this background and in view of the increased significance these ques-
tions are likely to assume in the future, this book deals broadly with the
relationship between competition law and intellectual property rights, and more
specifically, with the interface between patent law and competition abuses – by
virtue of refusal to deal – in the biopharmaceutical industry. It focuses on a
paramount element for competition: ‘access’. It addresses the following ques-
tion: how do we strike the balance between initial and follow-on innovation so
as to ensure that access to ‘essential’ research tools (or other fundamental ele-
ments for follow-on innovation) is not impeded?

Commission press release IP/05/737. AstraZeneca abused its dominance by mak-
ing misrepresentations to national patent offices with a view to obtaining supplementary
protection certificates, as well as by misusing rules and procedures of medicines agencies
to block entry of generic products or parallel traders.

N. Gohring, Qualcomm accused of anticompetitive conduct in EU, 28 October
2005, available at www.infoworld.com.

December 2005, available at http://ec.europa.eu/competition/antitrust/others/ar-
ticle_82_review.html.

Case COMP/B2/39246.
xiv
Acknowledgements
This book started from a series of coincidences, evolved into a test of persistence
and patience, and culminated in a series of good fortunes the most significant
of which was to see one’s long-awaited aspiration realised.
It has certainly not been a smooth ride throughout as there have been many
moments of frustration, questioning and disbelief, together with many moments
of challenge, excitement and great fulfilment.
The various stages of the manuscript travelled with me across countries, and
have certainly filled me with many experiences that I have grown with and for
which I am most grateful.
I owe my most profound and sincere gratitude to my supervisor, Prof. Ullrich,
who has provided me with great support, understanding and words of
wisdom.
I am also deeply grateful to the following people who have helped me with
their support and useful comments: Prof. Shelanski, Prof. Joerges, Prof. Lemley,
Prof. Blackburn, Prof. Barton, Prof. Lévêque, Luk Peepercorn, Sandro Paollichi,
Dimitrios Giotakos, Dr Alan Riley, Dr Barry Rodger, Emanuela Lecchi, Andreas
Avgousti, Katherine Llorca and many more.
My warmest thanks are due to the European University Institute for the sup-
port and funding they granted me over the years as well as my funding body,
the Department of Education and Skills. I would also like to thank the University
of California, Berkeley and European Commission, DG COMP who, during my
stay there, were instrumental in helping my research. I am also grateful to the
members of CLASF for listening to drafts of my papers and providing me with
comments, Charles Russell LLP as well as to the TRA (Bahrain).
I am, of course, most grateful to my publisher, Edward Elgar and the people
therein who gave me their support, particularly Luke Adams, Jo Betteridge and
Kate Pearce.
Most of all, I would like to thank my friends and family without whose sup-
port this experience would not have been so remarkable: Mum and Alexia thanks
for listening during my many hours of frustration; Yianni and Eleni thanks for
providing me with immeasurable entertainment; Manoli thanks for supporting
me in the finish!
xv
Cases
European Courts’ Decisions

Case 402/85 Basset v SACEM [1987] ECR 1747 196
Case 77/77 Benzine en Petroleum Handelsmaatschappik BV and others v Com-
mission [1978] ECR 1513 129, 146
Case 311/84 Centre Belge d’Etudes du Marché-Télémarketing SA (CBEM) v
Companie Luxembourgeoise de Télédiffusion [1985] ECR 3261 127, 130,
151–2, 171, 173
Case T-201/04 Competition Microsoft v Commission, Order of the President of
the CFI, 22 December 2004 (Proceedings for interim relief – Art. 82 EC)
144, 169, 173, 179, 187, 188, 190
Case 78/70 Deutsche Grammophon [1974] ECR 1147 104
Case 56 and 58/64 Etablissements Consten SA and Grundig-Verkaufs-GmbH v
Commission [1966] ECR 299 104
Case T-374/94 European Night Services [1998] ECR II-3141 165
Case C 418/01, IMS, not yet reported, judgment of 29 April 2004 123, 126,
127, 136–7, 139, 141, 142, 143, 144,
165–9, 172, 173, 186, 187, 188, 198
Case 6/73 Istituto Chemioterapico Italiano and Commercial Solvents v Com-
mission [1974] ECR 223 126, 127, 128, 130, 145–7, 171, 173
Case C-200/96, Metronome Music v Music Camp, Judgment of the Court of 28
April 1998, ECR I-01953 95
Case 322/81 Michelin v Commission [1983] ECR 3461 148
Case C-377/98 Netherlands v Council, [2001] ECR I-07079 94–5
Case C-7/97 Oscar Bronner v Mediaprint [1998] ECR I-7791 103, 123, 127,
133, 136, 141, 143, 162–5, 172, 173
Cases C-241/91 P and C-242/91 P, Radio Telefis Eireann (RTE) and Independent
Television Publications (ITP) v Commission (‘Magill’), [1995] ECR I-743
103, 105–6, 121, 123, 126, 127, 128,
130, 133, 141, 159–61, 172, 173, 190
Case C-53/03 Synetairismos Farmakopoion Aitolias & Akarnanias (Syfait) and
Others v Glaxosmithkline AEVE, Opinion of the A-G Jacobs, reference 28
October 2004, not yet reported 124, 128, 140, 143, 170, 173
Case 88/501 Tetra Pak I (BTG license) [1988] OJ L272/27 190, 191
xvi
Cases xvii
Case C-333/94 Tetra Pak v Commission [1996] ECR I-5951 148–9

Case T-504/93 Tierce Ladbroke v Commission [1997] ECR II 923 126, 127,
128, 141–2, 161–2, 172, 173
Case 27/76 United Brands Co. and United Brands Continental BV v Commis-
sion [1978] ECR 207 124–5, 127, 128, 130, 147–9, 157, 171, 173
Case 238/87 Volvo v Veng (UK) Ltd [1988] ECR 6211 105, 123, 128, 153–4,
171, 173
Community Commission Decisions

Case COMP/B2/39246 Boehringer [2007], not yet reported 63, 197
Commission Decision M.877 Boeing-McDonnell-Douglas, OJ 1997 C.59/877
192
Commission Decision Boosey & Hawkes, OJ 1987 L. 286/36 146, 157
Commission Decision British Midland/Aer Lingus, OJ 1992 L. 96/34 127,
130, 156–7, 172
Commission Decision Ciba-GeigySandoz, OJ 1996 C.102/737 197
Commission Decision Crown Cork, OJ 1995 L. 75/39 192
Commission Decision Decca Navigator System, OJ 1989 L. 43/27 126, 127,
155–6, 172, 173
Commission Decision DSD and others, OJ 2001 L. 319/1 104, 106
Commission Decision M.984 DuPont-ICI, OJ 1997 L. 2985 192
Commission Decision M.555 Glaxo-Wellcome and others, OJ 1995 L. 2985
192
Commission Decision IGR Stereo Television EC, in Comm XI Competition
Policy Report, 1982, p. 63 150, 173
Commission Decision Info-Lab/Ricoh, in 1999 Competition Policy News
letter 165
Commission Decision Konsortium, OJ 1990 L. 228/31 192
Commission Decision London European-Sabena, OJ 1988 L. 317/47 126,
127, 154, 171, 173
Commission Decision in Case COMP/C-3/37.792 Microsoft [2004], not yet
reported 121, 137, 140, 142, 143, 169, 173
Commission Decision M.468 MSG-Media Services, OJ 1994 L. 364/01 192
Commission Decision Sea Containers v Stena Sealink, OJ 1994 L. 15/08
126, 127, 135, 143–4, 158, 172, 173
Commission Decisions Shell-Montedison, OJ 1994 L. 332/49 192
Commission Press release IP/05/737, AstraZeneca 173, 188
xviii Cases
International Case-law
Alejandro Moreno Alvarez v Estado Colombiano, SU.819/99, Corte
Constitucional de Colombia 1999, available at http://bob.minjusticia.gov.vo/
jurisprudencia/CorteConstitucional/1999/Tutela/su819-99.htm 81
Alvarez v Caja Costarricense de Seguro Social, Exp. 5778-V-97, No. 5934-97,
Sala Constitucional de la Corte Suprema de Justicia de Costa Rica 70, 81
Ceballos v Instituto de Seguros Sociales, T-484 Corte Constitucional de Colom-
bia 1992, available at http://bib.minjusticia.gov.co/jurisprudencia/Corte
Constitucional/1992/Tutela/T-48492.htm 80–81
Glenda Lopez v Instituto Venezolano de Seguros Sociales, 487-060401 Supreme
Court of Venezuela, Constitutional Chamber 1997, available at www.tsj.gov.
ve/decisiones/scon/Abril/487-060401-001343.htm 81
Minister of Health v Treatment Action Campaign, CCT 8/02 Constitutional
Court of South Africa, July 2002, available at www.tac.org.za/Documents
80
In The Matter Between Mpho Makhathnini, Nelislwe Mthethwa, Musa Msomi,
Elijah Paul Musoke, Tom Myers, AIDS Healthcare Foundation Limited, and
GlaxoSmithKline (Pty) Ltd, Glaxo Group Limited, Case Number 34/CR/
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Odir Miranda v El Salvador Case 12.249, Report No. 29/01, Inter-Am. CHR,
Annual Report 2000, OEA/Ser./L/V/II.111, Doc. 20 Rev. 2001 available at
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Pharmaceutical Wholesalers and Glaxo Wellcome, case 68/IR/Jun00, 18 June
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Protection Writ. Judgment of Fabio Moron Diaz, Magistrado Ponente, T-328/98
Corte Constitucional de Colombia 1998, available at http://bib.minjusticia.
gov.vo/jurisprudencia/CorteConstitucional/1998/Tutela/T-328-98.htm 81
Social and Economic Rights Action Center v Nigeria, Communication 155/96
(African Commission on Human and People’s Rights, Oct. 2001), available
at www.achpr.org/DECISIONS_30th_Session-_Oct.2001_eng.pdf 80
Street Children Case (Morales v Guatemala), Joint Concurring Opinion of
Judges A.A. Cancado Trinidade and A. Abreu-Burelli, Inter-Am. Ct H.R.
(Ser. C) No. 63, available at www.corteidh.or.cr/seriecing/Votocancadoabreu-
Serie_c_63_ing.doc 80
Cases xix
US case-law
Akro Agate Co. v Master Marble Co. No. 119, District Court, N.D. West Vir-
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and reversed en banc on other grounds, 999 F.2d 1436 (11th Cir. 1993), cert.
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Ciba-Geigy/Sandoz, Ciba-Geigy Ltd, 123 FTC 842 (1997) 191
Consolidated Gas Co. of Florida v City Gas Co. of Florida, 880 F.2d 297 (11th
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Embrex Inc. v Service Engineering Corp 99-1064, US CAFC, 216 F.3d 1343;
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Fishman v Wirtz, 807 F.2d 520 (7th Cir. 1986) 133
Glaxo/Burroughs Wellcome, Glaxo Inc., 119 FTC 815 (1995) 191
Graver Tank case 339 US 605 (1950) 48
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Hoechst/Rhone-Poulenc, Hoechst AG, FTC Docket No. C-3929 (2000) 191
Howard Hughes case 366 F. 2d 303 (2nd Cir. 1966) 92
Madey v Duke 01-1567 US CA for Fed. Circ. 307 F.3d 1351 44
MCI Communications Group and MCI Telecommunications Corp. v American
Telephone and Telegraph 708 F.2d 1-81 (7th Cir. 1983) 133, 134
Pfizer/Warner-Lambert, Pfizer Inc., FTC Docket No. C-3957 (2000) 191
Roche/Genentech, Roche Holding Ltd, 113 FTC 1086 (1990) 191
Roche Products v Bolar Pharmaceutical Company 733 F.2d 858 (CA Fed.),
cert. denied, 469 US 856 (1984) 45
Sawin v Guild 21 F.Cas 554 (C.C.D. 1813) (No. 12,391) 44
Scripps Clinic and Research Found. v Genentech, 666 F. Supp. 1379 (N.D. Cal.
1987); 927 F.2d 1565 (Fed. Cir. 1991) 11, 48
Sensormatic/Knogo, Sensormatic Elec. Corp., FTC Docket No. C-3572
(1995) 191
Texas Inst. v ITC, 6 USPQ 2d 1886 (Fed. Cir. 1988) 34
xx Cases
Time Inc. v Bernard Geis Associates NYLR, 21 January 1994, p. 5 (CD Cal. 11
June 1993) 92
Upjohn/Pharmacia, The Upjohn Co. 121 FTC 44 (1996) 191
US v General Motors Corp., No. 93-530 (D. Del. Filed 23 March 1998) 191
US v Griffith 334 US 100 (1948) 133
US v Lockheed Martin and Northrop Grumman (DDC filed 23 March 1998)
191
US v Terminal Railroad Association of St. Louis, 224 US 383 (1912) 133
Westinghouse v Boyden Power Brake Co. 170 US 537 (1898) 48
Whittemore v Cutter 29 F. Cas 1120 (C.C.D. 1813) 44, 45
Wilson Sporting Goods v David Geoffrey and Associations, 904 F.2d 677 (Fed.
Cir. 1991) 48
EU national case-law
Ethofumesate Case, (1991) 22 IIC 541, 546 (Germany) 40
Frearson v Loe (1878) Ch.D. 48 (UK) 40, 43
‘Hollow plastic profiles II’ BGJ GRUR 1982, 301 (Germany) 16
Inhale Therapeutic Systems Inc v Quadrant Healthcare Plc [2002] RPC 21
(UK) 43
‘Klinische Versuche’ Federal Supreme Court (BGH), 11 July 1995, GRUR 1996,
109; 1997 IIC 103 (Germany) 42
LG Berlin (Photographs of Ulrike Meinhof) [1978] GRUR 108 (Germany) 92
Lili Marleen BGH, 7 March 1985 [1987] GRUR 34 (Germany) 92
Medicopharma N.V. et al. v ICI plc, 14 Rechtspraak van de week 79–89 (1993),
(the Netherlands) 40
Monsanto v Stauffer [1985] RPC 515 CA (UK) 43
Sandisk Corporation v Koninklijke Phillips Electronics NV and Others [2007]
EWHC 332 Ch. (UK) 188
Scientology decision [2003] Mediaforum 337, note Visser; (2003) 6 AMI 217,
note Hugenholtz; (2003) 6 IER 352, note Grosheide. Appeal to the Supreme
Court pending (the Netherlands) 92
Smith Kline and French Laboratories Ltd v Evans Medical Ltd [1989] FSR 513
(UK) 43
Telegraaf case; Decision of director-general Dutch Competition Authority 10
September 1998, 1/501.o119 (Telegraaf v NOS/HMG); Trade and Industry
Appeals Tribunal 15 July 2004, www.rechtspraak.nl, LJN-nummer: AQ1727
(Netherlands) 140, 142
Zwangslizenz, Federal Supreme Court (BGH), 5 December 1995, GRUR [1996]
190; 24 IIC 397 (1993) (Germany) 42–3, 61
Part I
The problem – access as a necessary element of

follow-on innovation?
1. Biopharmaceutical R&D: the
increased importance of cumulative
innovation and related concerns
We often talk about how important patents are to promote innovation, because without
patents, people don’t appropriate the returns to their innovation activity, and I cer-
tainly very strongly subscribe to that … On the other hand, some people jump from
that to the conclusion that the broader the patent rights are, the better it is for innova-
tion, and that isn’t always correct, because we have an innovation system in which
one innovation builds on another. If you get monopoly rights down at the bottom you
may stifle competition that uses those patents later on, and so … the breadth and uti-
lization of patent rights can be used not only to stifle competition, but also [can] have
adverse effects in the long run in innovation. We have to strike a balance.
1.1 Introduction
Recent changes in the nature of research in the biopharmaceutical industry have
given rise to new concerns regarding innovation. In the US, in particular, the
industry has become fragmented into a two-tier system, in which small biotech
firms carry out all of the innovative research, which the large pharmaceutical
companies then further develop, produce, prepare and market.
Much of the research carried out by small biotech firms involves upstream
innovative research that is fundamental to the development of downstream re-
search on products and processes. Hence, research has increasingly become
dependent on access to other fundamental upstream research.

J.E. Stiglitz before the FTC Hearings on Global and Innovation-Based Competi-
tion, 12 October 1995; also quoted in D.A. Valentine, Abuse of Dominance in Relation
to Intellectual Property: US Perspectives and the Intel Cases, at the Israel International
Antitrust Law Conference, 15 November, 1999 at http://www.ftc.gov/speeches/other/
dvisraelin.htm.

J. Walsh and J. Cohen, Research Tool Patenting and Licensing and Biomedical
Innovation, in Cohen and SMerill (eds), Patents in the Knowledge-Based Society, Wash-
ington DC, National Academies Press (2003), p. 285; A. Gambardella et al. Global
Competitiveness in Pharmaceutical Industry (2002).

Ibid. See OECD, The Pharmaceutical Industry, Paris (2001).

Access as a necessary element of follow-on innovation?
Unlike most industries where innovation involves improving upon a first

product, in the biopharmaceutical industry, most cumulative innovation occurs
in the pre-commercial stage, before the initial marketable product is produced.
Once a marketable product has been developed, it is usually only subject to
competition by me-too drugs or generics, and not subject to significant improve-
ments in the end-product market. It is important, for this reason, to ensure that
cumulative innovation in the pre-commercial stage is not impeded. This is sig-
nificant as it may otherwise lead to a limitation in the paths to biomedical
research.
The recent increase in patenting in the biotechnological field has raised
several concerns regarding the potential implications for healthcare. For ex-
ample, the grant of a patent over the BRCA1 gene raised concerns that the
patent would hamper innovation and the identification of new tests and diag-
nostic methods, impairing equitable access to testing and the public health
approach.
Related to this, was the concern that patents are sometimes granted in cases
too broadly to even cover unanticipated utilities, which may hamper further re-
search. Hence, the CCR5 Receptor gene used in research for HIV/AIDS drugs
spurred concerns regarding the reasonableness of rewarding estimations of util-

R.K. Rai, Fostering Cumulative Innovation in the Biopharmaceutical Industry:
The Role of Patents and Antitrust, 16 Berkeley Tech Law Journal 813 (2001).

Ibid. The author notes that an exception to this is where the patented drug is not
a traditional small molecule chemical, but rather, a biologic (e.g. protein or macromole-
cule) and the improver has come up with a method to produce the biologic that is
drastically different.

Ibid. p. 813. Competition is perceived to be a driving force and to allow multiple
independent research paths that are important for creative development.

Biotechnology Industry Organization: Editors’ & Reporters’ Guide to Biotechnol-
ogy (Feb. 2000), available at www.bio.org/aboutbio/guide2000/facts.html shows, for
example, that in the USA biotechnology patenting escalated from 2,000 patents issued
in 1985 to more than 9,000 patents issued in 1998. See also Report of the National In-
stitutes of Health NIH, Working Group on Research Tools, presented to the Advisory
Committee to the Director, 4 June 1998, referring to an ‘increasing use of the patent
system to obtain proprietary rights in research tools’.

The BRCA1 gene indicates susceptibility to breast cancer. Its discovery was re-
ported by Myriad Genetics and Utah University in 1994, and ever since the gene and its
mutations have been part of numerous patent applications. See Nuffield Council on
Bioethics, The Ethics of Patenting DNA, 2001– Case Studies, pp. 39–40.

This led to a Resolution from the European Parliament in October 2001 opposing
the patenting of the BRCA1 gene. Resolutions B5-0633, 0641, 0651 and 0663/2001– on
the patenting of BRCA1 and BRCA2 (‘breast cancer’) genes OJ 2002 C 87/265. R. Dalpé,
L. Bouchard, A-J. Houle, L. Bédard, Watching the race to find the breast cancer genes,
28(2) Science, Technology, and Human Values 187–216 (2002); Nuffield (2001) op. cit.
pp. 39–40.
Biopharmaceutical R&D
ity, and the effect that such patents may have on research if they are not licensed
extensively.10
While in the 1980s upstream innovative research was mainly government-
sponsored research, with the rise in privatisation this came into the hands of
private firms who were able to exclude others from their findings. As more
stages, actors and inter-connectiveness complemented the drug development
process, patenting made commercial sense where before there was nothing to
patent.11
These two trends immediately raised fears that patents would deter innova-
tion. In an article published in Science magazine, Heller and Eisenberg
postulated a theory that too many patents on upstream innovation could lead to
two eventualities.12
First, the granting of too many fragmented patents may lead to a situation
identified as the ‘tragedy of the anti-commons’, whereby too many people have
the right to exclude and no one has an effective right to use; this means that one
can impede others from using his technology but is also impeded from using
the technology himself by the rights of exclusion of others. The creation of too
many fragmented and overlapping patent rights could lead to high transaction
costs, which, coupled with the heterogeneous interests of owners and the cogni-
tive biases of researchers,13 could make bargaining unlikely in most cases,
leading to the creation of fewer products and to less innovation.
The second eventuality postulated is that the granting of patents for funda-
mental upstream research could lead to a situation whereby patent owners stack
licenses on top of future discoveries of downstream users, and/or impede the
creation of downstream-dependent inventions.14
Heller and Eisenberg did not present scientific data to support their theory.
The degree to which research is fragmented and dependent on too many other
patents depends on many other factors including the breadth of the grant of the
patent, the nature of the research and the extent to which it is cumulative or
10
Ibid. p. 41.
11
While inventions were made, patents were not taken out.
12
M.A. Heller and R. Eisenberg, Can Patents Deter Innovation? Anti-commons in
Biomedical Research, 280 Science 698, 1 May 1998.
13
This refers to a situation whereby every patent holder over-estimates his position
and the value of his patents, therefore, it is difficult to reach an agreement on licences.
14
R. Eisenberg Bargaining Over the Transfer of Proprietary Research Tools, in R.
Dreyfuss et al., Expanding the Boundaries of Intellectual Property, Oxford, Oxford
University Press (2001). op. cit. See also R. Eisenberg, Technology Transfer and the
Genome Project: Problems with Patenting of Research Tools, 5 RISK 163 (1994), p. 168,
which states that: ‘the stacking of intellectual property obligations as successive tools
are used in the course of an extended research project has the potential to impede or even
preclude the development of new and better diagnostic and therapeutic products’.
discrete, and the bargaining power of the players. However, no evidence was
given in support of these factors.
Thereafter, Walsh and Cohen15 attempted to test these hypotheses against
more scientific data. They found that while there is an increase in the patents
on inputs to the discovery of the drug, the discovery was not substantially im-
peded except in the case of patented genetic diagnostics.
With regard to the ‘anti-commons’, more specifically, they found that while
there may be some delays in negotiating access and that negotiations could be
costly, there was no evidence of bargaining breakdowns or of a real threat of
royalty stacking or a failure to undertake projects on this basis. However, the
approximately 33 per cent increase in the transaction costs for filing, enforcing
and contracting for patents may make a difference between entering or not en-
tering such negotiations, depending on the size of the firm. They also found that
working solutions such as licensing, inventing around the patents, challenging
patents and relying on the goodwill and information sharing between companies,
nonetheless, constitute important tools for advancing research.16
Walsh and Cohen were less conclusive, however, on the issue of restricted
access to upstream discoveries and its effects on innovation. They found that
access to foundational discoveries can be restricted, and that patents over targets
may limit access in certain cases.17 Depending on the breadth of the interpreta-
tion and the capacity of a firm to market in a timely fashion, the lack of access
might lead to less innovation. In particular, in the case of targets, this might be
problematic depending on the breadth and degree of restriction compared to the
incentive necessary to invest in the first place. The effect of control upon such
discoveries will depend, first, on how essential it is for subsequent innovation,
and secondly, on the degree of rivalness in use of the first and subsequent prod-
ucts as this will, in turn, determine the motives for refusing access or not.18
Although such concerns have arisen, there is not much scientific evidence to
support one finding over another.19 Does the existence of many patents hinder
15
J. Walsh and J. Cohen (2003) op. cit.
16
Ibid. See also J. Holzapfel et al. (2002) op. cit.; E.G. Campbell et al. (2002) op.
cit.; C. Lawson, (2002) op. cit.
17
Ibid.
18
Ibid.
19
D. Nicol and J. Nielsen, Patents and Medical Biotechnology: An Empirical Analy-
sis of Issues Facing Australian Industry, Centre for Law and Generics Occasional Paper
No. 6 (2003). It is stated that it is quite difficult to obtain quantitative data on the number
of projects abandoned. ‘It may be that this will occur because of patent thickets and
perceived future negotiating difficulties (i.e. anti-commons issues). However, we do ac-
knowledge that projects will be abandoned or redirected for a whole host of reasons, and
these may often be more to do with the intrinsic value and likelihood of success of the
technology than the level of encumbrance.’
the development of products related to health care? Do upstream patents deter

further innovation and is exclusion really a problem? This concern has been
heightened in the case of research tools.20
1.2 The case of research tools

1.2.1 Defining Research Tools
The term ‘research tools’ has many meanings depending on the perspective.
Researchers who use them in the laboratory may view them as tools, whereas
firms who primarily manufacture and sell these resources may consider them
‘end products’.21
In their broadest sense, research tools embrace ‘the full range of resources
that scientists use in the laboratory’22 including ‘cell lines, monoclonal antibod-
ies, reagents, animal models, growth factors, combinatorial chemistry libraries,
drugs and drug targets, clones and cloning tools, methods, laboratory equipment
and machines, databases and computer software’.23
Hence, they can be sequences used in research with no immediate therapeutic
or diagnostic value. In this sense, they are a means to develop a commercial
product such as a medicine or a vaccine, but not an end product sold directly to
consumers. Research tools are licensed for particular sequences or applied to
discover drugs or other research, and in this way, may realise a commercial
value. They are a typical example of upstream innovation required to develop
downstream innovation. For example, the EST approach involving the rapid
sequencing of the coding parts of genes was used as a means to locate entire
genes.
A high percentage of the basic research tools of biotechnology are subject to
proprietary restraints (such as patents) or material transfer agreements. 24 Patent
20
Though focus is on the case of research tools, it may be that they are only an il-
lustration of a more general concern also present in other cases. See Chapter 7 for
discussion of Pharmacy Benefits Management (PBM) networks.
21
NIH Report on Research Tools (1998) op. cit. and J.M. Mueller, No Dilettante
Affair: Rethinking the Experimental Use Exception to Patent Infringement for Biomedical
Research Tools, 76 Wash. L. Rev. 1 (2001), p. 10.
22
NIH Report on Research Tools (1998) op. cit. p. 3.
23
Ibid. See also G. Cullem, Panning for Biotechnology Gold: Reach-Through Roy-
alty Damage Awards for Infringing Uses of Patented Molecular Sleeves, 29 IDEA 533
(1999).
24
J.M. Mueller (2001) op. cit. p. 11. A material transfer agreement (MTA) is a ne-
gotiated contract between the owner of a material and a party that seeks to use it for
research.
protection is deemed necessary for such tools to recover the high cost of their
development.25 The biotechnological research environment is complicated by
the fact that researchers need access to several research tools to conduct their
research.26
Some of the most important research tools include:27
l
The Cohen-Boyer Patents covering the basic method and plasmids for
gene cloning.28
l Polymerase chain reaction technology (PCR), a basic method of amplify-
ing DNA sequences and its key reagent, the enzyme Taq DNA
polymerase.29 The PCR selectively multiplies a region of DNA so that it
can be experimented on and analysed.
l The Harvard ‘oncomouse’ useful in cancer research.30
l Expressed sequence tags (ESTs) identified in decoding the human ge-
nome. These are a fragment of complementary DNA (cDNA) and are
useful in finding the full-length gene.31
25
S.A. Chambers, Comments on the Patentability of Certain Inventions Associated
with the Identification of Partical CDNA Sequences, 23 AIPLA Q.J. 53 (1995); M.A.
Flores, Taking the Profits out of Biomedical Research Tools, 17 Nature Biotechnology
819 (1999).
26
See S. Junnarkar, ‘GeneChip’ Encodes DNA on Silicon, N.Y. Times, 15 March
1997, describing DNA chips that offer a myriad of potential applications for studying
genes and diagnosing genetic mutations. On these chips more than 40,000 sequences
may be attached, and if each of these is covered by a patent, licensing will prove to be
exceedingly difficult.
27
J.M. Mueller (2001) op. cit. pp. 12–14.
28
This research tool has been extensively licensed. See R.K. Seide and J.M. McLeod,
Response to Policy Commentary, SCIENCE at www.sciencemag.org/feature/data/980465/
seide.shl.
29
This was initially owned by the Cetus Corporation.
30
The patent was assigned by Leder-Stewart to Harvard University who exclusively
licensed it to E.I. du Pont de Nemours. See J.M. Mueller (2001) op. cit. p. 13.
31
Ibid. pp. 13–14. See also R.S. Eisenberg and R.P. Merges, Opinion Letter as to
the Patentability of Certain Inventions Associated with the Identification of Partical
cDNA Sequences, 23 AIPLA Q.J. 1 (1995). There has been some debate on whether
ESTs are truly research tools. See R. Blackburn, Chief Patent Counsel, Chiron Corpora-
tion, remarks at the National Academies Board of Science, Technology and Economic
Policy’s Conference on Intellectual Property Rights: How Far Should They Be Extended?
Washington DC, 3 February (2000).
1.2.2 The Patent Experience in Biotechnology: Biomedical Research

Tools
The thermostable enzyme Thermus aquaticus YTI DNA polymerase (Taq) is a

basic and widely used biotechnology tool.32 In 1995, Hoffman-La-Roche ac-
cused more than 40 US universities and research institutes and more than 200
scientists of infringing its patents.33 The alleged wrongdoing involved the pur-
chase of Taq for use in the PCR process34 from a company which, according to
Roche, was not licensed to sell Taq for such use.35 Roche’s attempts to restrict
the use of Taq and PCR provoked great alarm, which were described as ‘violat-
ing practices and principles basic to the advancement of knowledge for the
public welfare’.36
The possibility that this large number of actors would be found guilty of in-
fringement triggered a whole debate on the patenting of research tools and the
implications for technological and medical progress.37 Coupled with the increase
in patenting in recent years,38 the use of these biomedical tools to advance R&D
for new drugs and therapies, diagnostic methods and other therapeutic products
and the heightened difficulties in their access and dissemination have continued
to trouble the research community.
In essence, the dispute involves the broad rights stemming from patents on
such tools, but is also complicated by other factors and determinants such as
the definition of infringement, transaction costs, proliferation complications and
licensing practices.39 According to the Nuffield Report:
32
J.M. Mueller (2001) op. cit. p. 2.
33
M.C. Aguilera, Local Institutes Named in Lawsuit, San Diego Daily Transcript,
25 May (1995); M. Barinaga, Scientists Named in PCR Suit, 268 Science 1273 (1995).
34
PCR refers to the polymerase chain reaction, the revolutionary DNA amplification
process using Taq. Taq allows the PCR process to be automated. The latter consists of
multiplying a specific region of DNA, producing quantities of DNA sufficient for ex-
perimentation and analysis. See J.M. Mueller (2001) op. cit. p. 3. See also K. Drlica,
Understanding DNA and Gene Cloning: A Guide for the Curious, New York: Wiley edn,
3rd edn (1997), pp. 153–7, (4th edn 2003); P. Rabinow, Making PCR: A story of Biotech-
nology, Chicago, University of Chicago Press (1996), pp. 128–32.
35
J.M. Mueller (2001) op. cit.
36
Hoffman-La-Roche Challenges Freedom of Researcher; List of ‘Infringers’ In-
cludes Hundreds of Researchers and Dozens of Government-Supported Laboratories,
Bus. Wire, 24 May (1995).
37
J.M. Mueller (2001) op. cit.; B. Rubenstein, La Roche and Promega in Tug of War
Over Enzyme; DNA-Testing Tool Patent at Issue, Corp. Legal Times, Jan. 1996, at 15.
38
Nuffield Report (2001) op. cit.
39
In addition, the narrow interpretation of some of the working solutions such as
the experimental use exemption, aggravates the situation. See Chapter 3.
10 Access as a necessary element of follow-on innovation?
There are various ways in which patents on DNA sequences which have a primary
use as research tools may inhibit innovation and development: the cost of research
may increase, as the grant of increasing numbers of patents will mean that ever more
licenses are required before research can be conducted; research may, as a matter of
practice, be made more difficult if researchers are required first to negotiate the use
of patented genes and sequences; a patent owner may withhold a license to gain
maximum financial benefits, or license it exclusively to one or a limited number of
licensees; companies that wish to acquire the rights to several DNA sequences may
decide not to develop a therapeutic protein or diagnostic test because of the number
of royalty payments that would be required (this is sometimes referred to as
royalty-stacking).40
Hence, there is a concern regarding the breadth of the patent on such tools. The
Nuffield Institute of Biotechnology concluded that the law is generous in grant-
ing patents to DNA sequences, as they are broad in scope (covering all of the
uses of DNA obtained and sometimes protein DNA produces) and/or are granted
when the criteria for inventiveness and utility are weakly applied. ‘This is be-
cause the patent system provides that in the case of patents directed to novel
and inventive DNA and other chemical entities, inventors are entitled to property
rights not only over the uses of their invention that they anticipated or predicted,
but also over new uses that are developed. The case studies also reveal that some
patent offices have been willing to adopt low thresholds for inventiveness and
utility.’41
In the case of diagnostic tests, the problem has been highlighted as the fact
that ‘excessively broad patents containing a claim to all conceivable diagnostic
tests create a monopoly such that there is little incentive to develop improved
tests’.42 A study has shown that almost half of the research laboratories surveyed
ceased to pursue research on genetic testing because of the patents on DNA se-
quences.43 Another study is also quoted, which proved that 30 per cent of the
laboratories discontinued or did not develop genetic testing for haemochroma-
tosis because of exclusive licensing of patents that asserted rights over the most
common mutation in gene involved.44
40
Nuffield Report (2001) op. cit.
41
Ibid. p. 47.
42
Ibid. para. 5.14.
43
See M.K. Cho, Ethical and Legal Issues in the 21st Century, in Preparing for the
Millennium: Laboratory Medicine in the 21st century, Washington DC, AACC Press,
2nd edn, 1998, pp. 47–63.
44
See J.F. Metz, et al., Diagnostic testing fails the test, 415 Nature 577–9, (2002).
Metz produces some evidence that individual researchers may have terminated individual
research projects as a consequence of property disputes. On the other hand, L. Bendekgey
and D. Hamlet-Cox, Gene Patents and Innovation, 77 Academic Medicine 1373 (2002),
argue that the evidence does not indicate any aggregate reduction in biological research
as a consequence of gene patenting.
Biopharmaceutical R&D 11
Other patents, it is felt, are granted without being warranted. Genetic informa-
tion was initially found to be patentable as it was thought that by isolating it or
producing it through a technological process, the required threshold of not exist-
ing in nature had been satisfied. This, however, is now being questioned as there
may no longer be a need for cloning in order to identify a DNA sequence and
that identification may be achieved by computer databases.45
In addition, patents confer broad rights to the owner as he can prevent others
from using the patented invention without distinction as to the nature or the
purpose of the use. Products developed through the use of the invention may
be found infringing even though they do not involve the sale of the patented
invention.46 The interpretation of the breadth of the patent as regards infringing
activity can be determinative, and can shift the balance one way or the
other.47
Hence, the broad interpretation of infringing activity by the courts may ag-
gravate the perceived broad nature (relative to disclosure) of such patent rights.
The lax application of the patentability requirements may lead to unjustified
45
See Nuffield Report (2001) op. cit. para. 6.4. ‘We have considered the question
of whether DNA sequences should be eligible for patenting. Even though we think that
the judgment that isolated DNA sequences are eligible for patenting is based on a ques-
tionable extrapolation to the case of genetic information from the case of the isolation
of chemical compounds, we accept that a limited number of the early patents granted on
the basis need not now be called into question, in view of the inventiveness required to
isolate the DNA sequences. Since the early days of the pioneering experiments using
positional cloning techniques, patents have been filed on many DNA sequences which
were mass produced by a mixture of computational and cloning techniques. Even if it
can be convincingly argued that these sequences were eligible for patenting, the patents
should be examined in the light of the criteria for inventiveness and utility. We note that
as techniques have advanced, and in particular as the use of computers to identify genes
has become more widespread, the eligibility of DNA sequences for patenting should
have diminished.’
46
J.M. Mueller (2001) op. cit. p. 5. ‘Use liability arises under the patent laws even
though the researcher has not physically incorporated the patented tool into the new
product that is ultimately marketed.’ The ‘selling’ prohibition has not been violated be-
cause the research tool is not incorporated in the commercial product.
47
In the USA, in Scripps Clinic and Research Foundation v Genentech, 666 F. Supp.
1379 (N.D. Cal. 1987) the Federal Circuit found a patent infringement by virtue of the
production of the same protein by recombinant means, refusing to construe product
claims to include inherent process limitations. It found that product by process claims
are not limited to products prepared by the process set forth in the claims. ‘The decision
reflects two antagonistic results, creating possible process-related exceptions to infringe-
ment of a product claim that on its face, makes no reference to any process parameters,
while reading process limitations out of a claim that expressly recites them.’ Y. Ko, An
Economic Analysis of Biotechnology Patent Protection, 102 Yale Law Journal 777
(1992).
grants or extensions in scope which heighten the risk of restricted research tool
access when coupled with a wide interpretation of infringement.48 Accordingly,
Art. 9 and Recital 25 of the Biotechnology Directive recognise that in determin-
ing the scope of protection of corresponding claims, there may be an overlap in
an essential part of the invention.49
1.2.3 The Effect of Patent Trends on the Patent Balance for Research
Tools
The effect of the issues raised above on the research community and more gen-
erally on innovation, however, is unclear. While the existing case studies have
not shown a recognisable problem with access to upstream research tools,50
some commentators believe that this is becoming a growing concern.51
48
In a joint article of the President of the US National Academy of Sciences and the
President of the Royal Society of London, both EU and US researchers admonish that
‘those who patent DNA sequences without real knowledge of their utility are stacking
claims not only to what little they know at present but also to everything that might later
be discovered about genes and protein associated with the sequence. They are in effect
laying claim to a function that is not yet known or a use that does not yet exist. This may
be in current shareholders’ interests, but it does not always serve society well.’ D. Gitter,
International Conflicts over Patenting Human DNA Sequences in the US and the EU:
An Argument for Compulsory Licensing and the Fair Use Exemption, 76 NYUL Rev.
1623 (2001), p. 1642.
49
Recital 25 provides: ‘Whereas, for the purposes of interpreting rights conferred
by a patent, when sequences overlap only in parts which are not essential to the invention,
each sequence will be considered as an independent sequence in patent law terms.’ Bio-
tech Directive (1998) op. cit.
See also Vossiues and Partner, The Patenting and Enforcement of Inventions Relating
to Research Tools: Chances and Problems, at www.vossiusandpartner.com/eng/publica-
tion/pub-patenting_and_enforcement.html. ‘As regards ESTs and SNPs, they might be
considered essential as a whole. However, for partial DNA sequences it may become
relevant to distinguish between coding and non-coding sequences.’
50
See, for example, the case of recombinant DNA, in which the patented research
tool was non-exclusively licensed with low fees, the case of PCR and TAQ Polymerase,
in which licensing arrangements were controversial, and the case of protein and DNA
sequencing instruments, in which strong patent protection promoted broad access, in R.
Eisenberg, Patenting Research Tools and the Law, in IPRs and Research Tools in Mo-
lecular Biology, Summary of Workshop Held at the National Academies of Sciences,
15–16 February 1996.
51
See I.N. Feit, Biotechnology Research and the Experimental Use Exception to
Patent Infringement, 71 J. Pat. & Trademark Off. Soc’y 819 (1989) p. 821, predicting
that ‘as commercial products of biotechnology become available, the infringement of
patents covering the basic research methods that led to the product will become an in-
creasingly difficult problem’. See also L. Nelsen, The Rise of Intellectual Property
Protection in the American University, 279 Science 1460 (1998). Nelsen describes the
Opinion differs in the pharmaceutical industry as to the effect of this on the discovery
of new medicines. Some companies take the view that the additional costs incurred
through the need to take out large numbers of licenses on DNA sequences for use in
research are not significant. Others consider that the costs incurred are already having
a significant impact on profit markets. These differences of view most likely reflect
the extent to which individual companies own patents that assert rights over DNA
sequences. Access to research tools based on DNA sequences may indeed prove to
be difficult and expensive unless the patents that protect them are licensed easily and
widely.52
In the least grave of cases, evidence has shown that such patents may lead to
more costly negotiations, which might make the difference for small firms be-
tween being on and off the market.53 The increasingly high transaction costs are
becoming a real problem and might pose a barrier to researchers and hence act
as an effective lack of access. ‘The stacking of intellectual property obligations
as successive tools are used in the course of an extended research project has
the potential to impede or even preclude the development of new and better di-
agnostic and therapeutic products’.54 This situation also results in increases in
secrecy and delays in research.55
Altogether this leads to a heightened concern among scientists regarding the
high prices and burdensome licensing conditions associated with research
tools.56 Numerous upstream patents must be practised to make a new down-
‘restricted availability or delays in exchange of “research tools” (such as vectors or

transgenic mice in biological research’ as one of the problems that universities face,
pp. 1460–61.
52
Nuffield Report (2001) op. cit. pp. 59–60. See also R. Eisenberg (2001) op. cit.
p. 223 who claims that one of the difficulties in the biopharmaceutical industry in con-
cluding transactions is the heterogeneity among the institutions. The universities,
pharmaceutical firms and biotechnology firms each have different expectations. For ex-
ample, in biotechnology, the emergence of commercial biotechnology firms in market
niches can be seen. These firms lie somewhere in between fundamental academic re-
search and end product development. They are also most likely to depend on the
commercialisation and the financial value of the research tools as they lack end products
for sale to non-research consumers.
Even within a single institution the interests may be different between the scientists,
lawyers and business people involved in the negotiations.
53
See Should Congress Liberate Gene Data? Chi. Trib., 16 September, 1999, ‘Hold-
ers of genetic patents have been charging steep licensing fees for use of their information
and sending “cease and desist” notices to competing companies, academic medical
centres and clinical laboratories that use it without permission’.
54
NIH Report on Research Tools (1998) op. cit. p. 22.
55
OECD, Genetic Inventions, IPRs and Licensing Practices: Evidence and Policies,
Paris (2002).
56
J.M. Mueller (2001) op. cit. p. 8. See also E. Marshall, A Deluge of Patents Creates
Legal Hassles for Research, 288 Science 255 (2000), pp. 255–7.
stream product, thus leading to a problem of ‘royalty stacking’.57 Patents on

research tools can ‘create obstacles to subsequent research and development
and add to a thicket of rights that firms must negotiate their way past before
they can get their products on the market’.58
In the case of clinical use, protection appears to have impeded access to in-
formation and therefore concern has been raised over the high costs and limited
access to genetic testing. In 1999, a survey showed that almost all patents were
licensed exclusively. This could mean, in practice, that they are offered at pro-
hibitive costs, thus impeding the provision of genetic testing services.59 Genetic
testing for a predisposition to diseases and early diagnosis is an issue of great
importance and restrictions on its availability may raise ethical concerns. Hence,
it has often been said that patents have a negative impact on access, the costs
and quality of testing and on information sharing between researchers.60
It is difficult to assess the frequency of access issues and their effect on R&D
and so whether the problem is occasional or systematic is unclear. An empirical
study of German inventions and the patent system concluded that there is a
proliferation of DNA patents and unduly broad patents causing a situation in
which patents are dependent on earlier inventions, which may cause a reluctance
to enter certain fields in which genes have already been patented and that royalty
stacking and higher transaction costs are present, leading to an explosion of legal
disputes and potential delays in innovation.61 Hence, the existence of patents
may lead to a redirection of research in other fields if it is perceived that depend-
ency might be avoided.
It should be clarified, however, that research tool patents are not viewed in
all cases as an obstacle to research. In some cases, research tools have been
treated as staple goods that can be easily purchased, even without disclosure of
57
R. Eisenberg (2001) op. cit. Reach-through licensing terms attempt to govern
rights to potential future inventions made by the user of the research tool. In this way,
the tool owners try to leverage their proprietary rights in early innovations in order to
have a share in the profits of future innovations. However, if there are too many pre-com-
mitments to future products, this may cause difficulties and complicate the situation by
virtue of the licence of several research tools.
58
R.S. Eisenberg (1994) op. cit. p. 168.
59
Ibid.
60
Nuffield Report (2001) op. cit. p. 69; However, in genetic tests, it was also found
that exclusive licensing might be necessary to the additional investment needed to de-
velop and test the potential economic viability of the product.
61
J. Strauss, Genetic Inventions and Patent Law, at OECD Workshop on Genetic
Inventions, IPRs and Licensing Practices: Evidence and Policies, Paris, 2002. See also
Should Congress Liberate Gene Data? (1999) op. cit. which states that ‘rather than risk
a lawsuit or pay fees they consider exorbitant, some researchers have stopped exploring
diseases whose genetic profiles already have been licensed’.
intended use. ‘Some proprietary research tools have been widely distributed
under license agreements that permit subsequent research to go forward while
preserving a return for the patent owner’.62 In such cases, for example in the
case of the Cohen-Boyer patent on recombinant DNA technology,63 there has
been no problem with regard to access.
In addition, practical considerations may be used to allay the concerns raised
by research tool patenting. First, pre-issuance use of the patent between the time
of publication and the time of the granting might be possible, although damages
might be available for this purpose.64 Policing is also quite difficult, therefore it
has been suggested that, in view of the difficulty in negotiating something specu-
lative, some firms could use the patented research tools without a licence,
assuming that they can settle the matter once, and if, they discover something
meaningful.65 In addition, while it constitutes an infringement to import a product
made by a patented process in the USA as long as the product made abroad has
not been materially changed, it is unclear whether a process claim which covers
the screening of a drug would be infringed by the importation of the data resulting
from the screening process.66 As the detection of the use of a research tool may
not occur until a commercialised product has been developed, it may even be
possible to escape any liability whatsoever due to the statute of limitations.67
62
R. Eisenberg (2001) op. cit. p. 229.
63
This was owned jointly by Stanford University and the University of California
and constituted a fundamental technology which was useful for research into a range of
problems. The terms of its licence permitted its wide dissemination and use. See Intel-
lectual Property Rights and the Dissemination of Research Tools in Molecular Biology,
Summary of a Workshop held at the National Academies of Sciences, 15–16 February,
1996 (1997), pp. 40–42.
64
J.A. Goldstein, Patenting the Tools of Drug Discovery, Drug Discovery World,
Summer 2001, p. 9. See also Art. 67 EPC which states that ‘from the date of publication
of a European patent application, the applicant can claim compensation reasonable in
the circumstances from any person who has used the invention in the said State in cir-
cumstances where that person would be liable under national law for infringement of a
national patent’.
65
R. Eisenberg (2001) op. cit. p. 233. Though this may be becoming increasingly
difficult in view of the recent US decision that allows for the initiation of litigation based
on a previous request for information from the potential defendant. J.A. Goldstein (2001)
op. cit. p. 9.
66
J.A. Goldstein (2001) op. cit. p. 9. In addition, in the US and now in the EU there
is immunity for infringement when it is done in pursuit of regulatory approval for the drug.
‘Yet it is not clear whether a patented receptor of software used in the pursuit of regulatory
approval for a drug would be immune under the clinical research exemption. The issue in
such a case would be that the material for which approval is sought (the drug) is not the
patented invention for which the immunity is sought (the target or the software).’
67
In Germany section 141 PatG provides that claims for infringement lapse after
three years from the time when the claimant obtains knowledge of the infringement and
1.3 Conclusion
In conclusion, in view of the increasingly cumulative nature of innovation, a
concern has been raised regarding the proliferation of patents, which may im-
pede access to essential technology and, as a result, hinder innovation.
More specifically, the case of research tools was examined as it captures the
essence of the concern in relation to follow-on/downstream innovation in the
biopharmaceutical industry and striking the patent balance. Research tools have
been at the centre of these discussions, although the problems in this area might
simply represent an instance of what might be a more general problem.
Practical evidence confirms that patents have been extended both in subject
matter and in scope, and this may often be seen as unjustified by the research
community. As patents, by definition, involve a degree of exclusivity, their very
grant is bound to affect access to the patented technology. Where their grant is
unjustified or overbroad, lack of access is bound to be seen as unwarranted.
While it is felt that this may in turn lead to the hindering of innovation, there
has been no evidence to date produced which unambiguously establishes a clear
negative effect on innovation.
The main concern relates to the increased transaction costs68 and the difficulty
in reaching licensing agreements.69 More specifically, regarding the issue of
exclusion, current practice shows broad licensing patterns in most cases. Nev-
ertheless, there is still some concern in the industry that access to essential
of the identity of the infringer. Bearing in mind that damages are only high enough to
merit instituting legal proceedings after a new pharmaceutical compound is successfully
put on the market, this is unlikely as it normally takes more than three years to get ap-
proval for a pharmaceutical compound. (It might, however, be possible to claim damages
in license analogy for unjustified enrichment, whose limitation period is 30 years, al-
though the Federal Supreme Court held that, in this case, damages can only amount to
a reasonable royalty. BGH GRUR 1982, 301 ‘Hollow plastic profiles II’).
See also the UK statute of limitations barring infringement actions after six years and
the equitable doctrine of ‘laches’ which might estop the patent proprietor from bringing
an action in the first place.
68
This may stem from the proliferation of patents, the need to negotiate with a wide
range of people or from other factors associated with the need to negotiate access to up-
stream patents such as exclusion or high prices.
69
See R. Eisenberg (2001) op. cit. pp. 232–47. Eisenberg attributes this to the fol-
lowing four factors: (1) the fact that transaction costs are a greater obstacle in low-value
exchanges and might be inhibited; (2) the heterogeneity among institutions leading to
complications in reaching agreeable terms of exchange; (3) the differences amongst
agents in institutions such as between scientists and lawyers and business people; and
(4) the fact that the evaluation of research tools involves an estimation of their contribu-
tion to potential future discoveries which is a highly speculative and subjective
process.
upstream technology may be refused and it is felt that this may impact negatively
on innovation.70 Whether this should be seen as a systematic failure in the patent
system, or simply as individual instances of restricted access, is not clear.
The industry also attributes the lack of evidence of a discernible impact on
innovation to the existence of working solutions, however, it is not clear what
these solutions involve or how the situation would differ in their absence.71 In
addition, as one of the working solutions is infringement, it could be questioned
whether it is sensible to have a system that relies on encouraging infringement.
Despite the ambiguous nature of the evidence on the purported lack of access
and its impact on innovation, industry participants still feel that this is a problem
that needs to be addressed. ‘Burgeoning research and development will require
ever-greater numbers of proprietary tools, giving rise to transaction costs associ-
ated with acquiring the right to use each such tool. In some cases, the patentee
may refuse to license the research tool altogether. The sum total of the transac-
tion costs involved with acquisition of all necessary research tools may be so
severe as to impede, postpone, or stop the development of important new
products’.72
The Nuffield Committee has admonished:
There is insufficient evidence to judge the extent to which the granting of patents that
assert rights over DNA sequences based on a primary use as research tools is produc-
ing the potentially deleterious effects set out above. However, we take the view that
the exercise of a monopoly over what are now essentially discoveries of genetic in-
formation accessible by routine methods is, in principle, highly undesirable. We
consider that the development of a culture among those who carry out scientific re-
search, whereby claims are made to naturally-occurring material which can be
isolated by routine procedures and to which a weakly demonstrated or hypothetical
utility may be ascribed to secure some possible future value, if endorsed by the patent
offices, amounts to a misapplication of the patent system. We consider, therefore, that
in general, the granting of patents which assert rights over DNA sequences as research
tools should be discouraged.
This report also recommended that wide licences should be encouraged.

In view of the above discussion, the next chapter considers the significance
that ‘striking the balance correctly’ assumes in the biopharmaceutical industry,
70
See NIH Report on Research Tools (1998) op. cit. which lists refusal to license
as one of the key concerns in the area of research tools. The definition of obstacles in-
cludes: ‘refusals to license, onerous royalty obligations, restrictions on the dissemination
of materials and information restrictions on the ability to collaborate with commercial
firms, and advance commitments regarding intellectual property rights in future discover-
ies’, p. 4.
71
J. Walsh and J. Cohen (2003) op. cit. p. 290.
72
and the mechanisms available within the patent system to encourage wide li-
cences and to reduce the problem of transaction costs in the area of research
tools.
Part II
The patent balance and working solutions in the

patent system
2. The patent system as a system of
balancing
2.1 The Patent Balance

The patent system is an integrated means of addressing public policy concerns.
It is concerned with encouraging the R&D of new intellectual products that
would otherwise remain undeveloped or under-developed due to the ease of
appropriability of knowledge and the difficulty in excluding others. While its
main objective is to encourage innovation, it also has competing interests to
address.
Box 2.1: Main rationales of patent

system
1. Invention motivation. The patent system provides incentives for

investment in innovation by granting a limited monopoly that
allows the inventor the opportunity to make a profit on the in-
vention. This is the most common rationale for the patent
system and its justification is usually based on the market fail-
ure rationale. In the absence of the government grant of
property rights, it is argued that the competitive market would
not give a sufficient incentive to induce the optimal amount of
innovation. This is because knowledge could be described as
a durable, indivisible, and non-rival commodity. While the costs
of production are high, the costs of imitation and reproduction
are low and there is ease of appropriability. Hence, it is argued

ABA, The Economics of Innovation: A Survey, ABA, July 2002 available at http://
www.ftc.gov/opp/intellect/0207salabasrvy.pdf; F. Machlup, An Economic Review of the
Patent System, Study No. 15 of the Subcomm. on Patents, Trademarks and Copyrights of
the Senate Comm. on the Judiciary, 85th Cong., 2nd Sess. (1958); E.W. Kitch, The Nature
and Function of the Patent System, 20 Journal of Law and Economics 265 (1977).

P.A. David, Intellectual Property Institutions and Panda’s Thumb: Patents, Copy-
rights and Trade Secrets in Economic Theory and History, in M. Wallerstein, M. Mogee
21
22 The patent balance
that in the absence of patents people would fail to or would

under-invest as they would lose on their investment. This ra-
tionale is based on the assumption that the inventor cannot
reap the full benefits by relying solely on secrecy measures to
prevent imitation. It generally views inventions as one-off events
and not as a cumulative process. Hence, the costs are related
to static ones of reduced access and the possible exercise of
market power. There may, however, also be dynamic costs as-
sociated with the deterrence of other innovation, and waste
due to ‘patent races’. The latter is associated with duplicative
investment by entering races or by over-investment. It also
raises the possibility that investment could be made at a faster
rate than the social optimum.
2. Invention dissemination. The patent system encourages dis-
semination by requiring the disclosure and publication of the
invention and details on how it works. This may in turn lead to
a wider use of the inventions, particularly where the inventor
cannot exploit the potential of the invention himself and where
secrecy would allow the inventor to reap some of the returns
effectively. This is often the case for process innovations. Pat-
ent publications may also improve the free flow of information.
Disclosure, in turn, may be beneficial to rivals. A study of the
spillover value of patents in the biotechnology sector showed
that core technology patents valued between $13 and $21
million may have knowledge spillovers generating economic
values of $3 to $6 million per rival firm, although some high-
profile patents are viewed as harmful to rivals and most patents
do not generate significant market effects.
3. Invention commercialisation. The commercialisation of an in-
vention often requires a large investment. Patents allow for the
development of inventions that may have little value in the initial
stages and need further development in order to be commer-
cially valuable. In some cases, a head-start might assist in
and R. Schoen (eds), Global Dimensions of IPRs in Science and Technology, National
Research Council, Washington, National Academy Press (1993).

ABA (2002) op. cit.

Process innovations refer to changes in the production process to reduce the costs
related to producing a product, while product innovations refer to changes in the product
itself to improve quality.

D. Austin, Patents, Spillovers and Competition in Biotechnology, Discussion Paper
00-53, November 2000, at http://www.rff.org.
The patent system as a system of balancing 23
regard to this objective, although the role of head-start is not

particularly important in the pharmaceutical industry.
4. Orderly cumulative development of innovation. Broad patents
may facilitate follow-on inventions by controlling the licensing
terms and avoiding duplicative efforts. However, they may also
hinder it if the transaction costs are high or if there is an over-
arching threat of infringement.
One of the central goals of the patent system is ensuring that follow-on re-
search building on previous inventions is not impeded by the granting of an
overly restrictive legal monopoly. The function of the patented invention as an
output has to be balanced against its function as an input for further develop-
ment. This is the vertical dilemma which the patent provisions seek to
address.
The patent system, however, also seeks to address issues associated with the
dissemination of the patented invention, as it would be counter-productive if
one could simply monopolise a particular invention and then not utilise it, for
example. In this way, ensuring that an invention is adequately disseminated is
the horizontal dilemma that the patent system addresses.10
In the non-cumulative model, patents involve a trade-off between incentives
and static efficiency loss associated with market power.11 In order to encourage
innovation in the long term, exclusive property rights are granted allowing pro-
ducers to restrict output and raise prices in the short term leading to static
losses.
In the cumulative framework, however, patents are concerned not only with
providing the best incentives for the primary invention, but also to ensure incen-

H. Grabowski, Patents and New Product Development in the Pharmaceutical and
Biotechnology Industries, in Science and Cents, April (2002), Federal Reserve Bank of
Dallas.

S. Scotchmer, Cumulative Innovation in Theory and Practice, Goldman School
of Public Policy Working Paper 240, University of California (Berkeley), February
(1999), p. 1.

H. Ullrich, Legal Protection of Innovative Technologies: Property or Policy? in
O. Grandstrand, The Swedish Intellectual Property Symposium (2001), p. 5; Y. Benkler,
Free as the Air to Common Use: A Political Economy of the Public Domain, in R. Drey-
fuss et al. (ed.), Expanding the Boundaries of Intellectual Property, Oxford, Oxford
University Press (2001).

The issue of whether and when such a motive might be present is not addressed
here.
10
H. Ullrich (2001) op. cit. p. 5; P. A. David (1993) op. cit. pp. 19, 32.
11
E.W. Kitch (1977) op. cit.
tives for follow-on inventions.12 Adjusting patent length and breadth might give
effect to some of these considerations. The problem is, however, that it is not
clear how much incentives are necessary.13 The dilemma in the area of sequential
innovation reflects the clash between monopoly and competition theorists, the
former arguing that monopolies eliminate duplicative efforts and ensure that
invention takes place,14 and the latter arguing that innovation incentives are often
smaller in monopolistic conditions and that competition may yield different
results in the race.15
The optimal length of patents is sensitive to price elasticity of demand in the
product market, and the responsiveness of the costs of the production process
to the amount of R&D resources devoted to its invention.16 In cases where the
demand is more elastic, the patent length should be shorter. This is because if
prices are higher, the quantity will be lower and there will be more deadweight
losses.
On the other hand, a wider breadth would provide strong incentives for the
breakthrough inventions and weaken incentives for the follow-on inventors.
Scotchmer and Green have shown that a broad scope puts followers at a dis-
advantage in negotiating the terms of licences for complementary elements
that they seek to patent, and results in additional costs in attempting to ‘invent
around’ the blocking first generation patent.17 Innovation is often cumulative
so that the patent could interfere with further discovery; inhibition of progress
as opposed to discouraging inventions.18 Weak and narrow patents encourage
firms to cross-license and disseminate, however, this may discourage funda-
mental inventions.19
12
S. Scotchmer (1999) op. cit.
13
F.M. Scherer, Nordhaus’ Theory of Optimal Patent Life: A Geometric Reinterpreta-
tion, 62(3) American Economic Review 422 (1972); R. Gilbert and C. Shapiro, Optimal
Patent Protection and Breadth, 21 Rand J. of Econ’cs 106 (1990); P. Klemperer, How
Broad Should the Scope of Patent Protection Be? 21 Rand J. of Econ’cs 113 (1990); P.A.
David (1993) op. cit.; F. Machlup (1958) op. cit.
14
See, for example, E.W. Kitch (1977) op. cit.; J. Schumpeter, Capitalism, Socialism
and Democracy, New York, NY Harper (1942) .
15
R. Merges and R. Nelson, On the Complex Economics of Patent Scope, 90 Colum
L Rev 839 (1990); G.C. Loury, Market Structure and Innovation, 93 Quarterly J. of
Econ’cs 345 (1979); M. Lemley, The Economics of Improvements in Intellectual Property
Law, 75 Texas L. Rev. 993 (1997).
16
P.A. David (1993) op. cit.
17
J. Green and S. Scotchmer, On the Division of Profit between Sequential Innova-
tors, 26 Rand J. of Econ’cs 20–33 (1995); S. Scotchmer, Standing on the Shoulders of
Giants: Cumulative Research and the Patent Law, 1 J. of Econ. Pers’s 29 (1991).
18
Ibid. J. Ordover, A Patent System for Both Diffusion and Exclusion, 5 J. of Econ.
Pers’s 212–29 (1991).
19
Ibid.
There is no clear dividing line and it is difficult to determine how much incen-
tives are necessary in view of the various and often competing policy objectives.
The balancing process necessarily involves certain trade-offs. For example,
where initial innovation ought to be encouraged the patent breadth will tend to
be wider, whereas to account for follow-on innovation, the exclusivity will have
to be restricted.
Table 2.1 The existing EU patent systems and sources determining their
applicability and implementation
Patent systems in Patentability Infringement and

the EU: validity
National patent To be determined by To be determined by

Member States, but de Member States, but de
facto harmonisation in facto harmonisation in
view of TRIPS, EPC view of TRIPS and CPC
and CPC
European patent EPC To be determined by
Member States, but de
facto harmonisation in
view of TRIPS and CPC
Community patent EPC Community Patent
Regulation

2.2 The particular importance of the patent

balance in the biopharmaceutical
industry
2.2.1 The Patent System and the Biopharmaceutical Industry
The patent balance assumes a particular significance in the biopharmaceutical

industry. First, it is an industry that affects public policy as it improves health
and the standard of living. These goods are not ordinary ones, and therefore
optimising innovation and striking the balance between short-term and long-
term innovation and ensuring access becomes fundamental.
Secondly, the patent system is perceived as being vital to the industry. In
contrast with many others, this industry relies heavily on the patent system to
appropriate returns and much of the innovation is based on the patent system
as an incentive mechanism. It hence becomes important to preserve this incen-

tive. On the other hand, consumers expect to gain access to new and effective
drugs at an affordable cost, not only in the short term but also in the long
term.
Box 2.2: The nature of biopharmaceutical

innovation
Innovation is the main source of competitiveness in the biophar-

maceutical industry.20 However, the dynamics of innovation are far
from clear.21 Research is a costly and risky business. There are in-
creasingly stringent requirements for approval, and research has
become orientated towards complex drug discovery, leading to a
sharp increase in the resources needed to develop new drugs.22 A
20
The nature of competition in the industry is such that a premium is based on re-
search and innovation in a dynamic sense. E. Halm and A. Gelijns, An Introduction to
the Changing Economics of Technology Innovation in Medicine, in A.C. Gelijns and
E.A. Halm (eds), The Changing Economics of Medical Technology, Institute of Medicine,
Medical Innovation at the Crossroads Vol. II, Washington, National Academies Press
(1991).
The biopharmaceutical is a highly research-based industry. The primary operations
of the industry are linked to: innovation, which is a risky and costly business; production,
which requires specialised methods; marketing, which aims at persuading the choice of
one product over another and is aimed at physicians who usually make the decisions re-
lating to which drug to prescribe; and distribution, which is usually done through
specialised wholesalers who in turn sell to retail pharmacists. EUROPE, Pharmaceutical
Products, Single Market Review (1996).
21
ABA (2002) op. cit. Much economic research has concentrated on whether com-
petition and potential competition can increase innovative activity. Whether concentration
or competition is more conducive to innovation is not clear. F.M. Scherer, Firm Size,
Market Structure, Opportunity and the Output of Patented Inventions, 55 American
Economic Review 1097–125 (1965); F.M. Scherer, D. Harhoff, J. Kukies, Uncertainty
and the Size of Distribution of Rewards from Innovation, 10 J. of Evol’y Econ’cs 175-200
(2000).
22
A. Gambardella, L. Orsengo, F. Pammoli, Global Competitiveness in Pharmaceuti-
cal Industry. A European Perspective, for DG Enterprise of European Commission, 2002.
In the EU the pharmaceutical industry is a highly regulated industry with provisions
controlling reward and safety, the quantity and quality of expenditures and, in some
cases, price controls. However, while there is a Community system for granting market-
ing authorisation, the market for medicines is still quite fragmented by national controls
especially over price. There are two means by which companies may receive authorisa-
tion to market a drug in the EU: the first is through an application to the European
Medicines Evaluation Agency (EMEA) which cooperates with the competent national
authority to scientifically assess the product and then sends its advisory opinion to the
study undertaken in 1985 concluded that the average annual ex-

penditure on R&D represented 8–10 per cent of sales, although it
was even higher for some firms.23
Basic research is an on-going process,24 but once a new sub-
stance is discovered, its development follows three stages: the
synthesis of active materials and determinations of their biological
effects; extensive biological testing on animals and then on humans
to establish its pharmacological activity and to detect adverse ef-
fects; and finally, product development.25 This process is lengthy,
costly and uncertain.
The growth rate of discovery and pre-clinical development costs
have increased substantially due to the need for a detailed under-
standing of the mechanisms involved, including highly specialised
medical, biological and biochemical skills, and the clinical costs
which have grown at a rapid rate.26 The rise in costs and length of
drug development is partly due to the more extensive clinical re-
search required prior to marketing and the nature of the disease
areas of research. Attention is focused on treating chronic clinical
conditions requiring greater overall resources prior to commercial
European Commission, which prepares a draft decision that becomes law if it is not op-
posed. This procedure is mandatory for biotechnological products and optional for
high-tech medicines. The second route is based on mutual recognition, where a licence
to enter the market is given after an investigation into the efficacy and quality of the
process. Quality and quantity control is achieved by direct or indirect means on the pre-
scribing/consumption practices, and price regulation is a national affair in the EU.
See also Directives 92/26, 92/28, 92/27, 92/23 on the rational use of medicines, OJ
1992 L113/13, which have harmonised the classification of medicines for prescription
and non-prescription products, the advertising of medicines, the information to be pro-
vided to patients and pharmaceutical wholesaling. See also Directive 98/44/EC on the
Legal Protection of Biotechnology Inventions, OJ 1998 L213/13 that provides a common
set of principles regarding the grant of patents, but only four Member States have adopted
the necessary legislation so far.
23
OECD, The Pharmaceutical Industry, Paris (1985).
24
The industry is made up of different types of firms. There are small companies
that specialise in sales of non-R&D intensive drugs which are mainly involved in the
manufacturing and commercial activities. There are also the New Biotechnology Firms
(NBFs) that specialise in biotechnology and who are mostly concerned with the discovery
and development of new drug compounds and the development of research tools which
pharmaceutical companies may subsequently develop and commercialise. A. Gam-
bardella et al. (2002) op. cit.
25
Ibid.
26
H. Grabowski, Patents and New Product Development in the Pharmaceutical and
Biotechnology Industries, in Science and Cents (April, 2002) (Federal Reserve Bank of
Dallas).
sale.27 However, the physiological effects of compounds can now

be predicted with greater ease.
It takes approximately 10 to 15 years to develop a new drug, and
most of these do not survive the development process. In the USA,
it has been found that only 20 out of every 5000 compounds
screened, enter the pre-clinical testing stage, and only one out of
every five drugs entering the clinical trials has been approved by
the FDA as fulfilling the safety and efficacy requirements. Clinical
trial requirements have increased, and hence the costs have risen,
while the average returns from marketing a new drug have de-
creased.28 It has been estimated that, on average, the development
of a new drug costs $802 million.29 In addition, most of the market-
ed drugs fail to cover their R&D costs, and so the development of
blockbuster drugs every two to three years is necessary for a com-
pany to be able to survive the R&D process.30
It has, however, been found that there is a positive correlation
between R&D intensity and the probability of discovering a new
drug,31 although the causal relationship is not clear, in other words
whether R&D expenditure leads to patents that provide lucrative
earnings or vice versa.32
2.2.1.1 Biopharmaceutical innovation and patenting

In view of the complexity and the cost of the innovation process, patents are per-
ceived to be of primary significance. Several researchers have commented that
27
H. Grabowski, The Changing Economics of Pharmaceutical R&D, in A.C. Gelijns
and E.A. Halm, (Eds), The Changing Economics of Medical Technology, Institute of
Medicine, Medical Innovation at the Crossroads Vol. II, Washington, National Academies
Press (1991).
28
G. Glover, Competition in the Pharmaceutical Marketplace before the FTC, Pro-
ceedings on Competition and IPRS: A. Diverse perspectives on patents. B. Business
perspectives on patents. Biotechnology and pharmaceuticals, 19 March 2002; A Congres-
sional Report 1998 showed that there was a 12% decline since 1984.
29
Ibid. See also H. Grabowski (1991) op. cit., for the best estimate of the average
cost of drug development as being $231 million in 1991. He estimated the R&D costs
per approved drug amounted to $400 million.
30
G. Glover (2002) op. cit. Out of every 10 drugs on the market, only three cover
their average development costs and this was prior to the facilitation of generic drug
competition.
31
E. Jensen, Research Expenditures and the Discovery of New Drugs, 36 Journal of
Industrial Economics 83 (1987).
32
M. Baily, R&D Costs and Returns: the US Pharmaceutical Industry, 80 Journal
of Political Economy 70 (1972).
the industry would not exist but for the patent system.33 Innovators would be re-
luctant to invest as they would be unable to make a reasonable return, and in this
way there would not be any products to be copied for the generic brands.34
The market would only afford two types of benefits to innovators: de facto
exclusivity from being the first mover, and a sizeable segment of consumers
which prefers branded products over generic ones. In the less serious cases, it
is thought that without patent protection, R&D would fall by almost 60 per
cent.35 This is also consistent with Mansfield, who reports that 65 per cent of
innovations generated from 1981 to 1983 would not have been marketed and
60 per cent would not have been developed if there had not been patent
protection.36
By comparing the four factors for appropriating the benefits from product
inventions, one study has concluded that patents are the most effective mecha-
nism. On a scale of one to seven, seven connoting very effective, patents had a
marking of 6.53 compared to learning by doing 4.24, lead time 5.47 and sales
and services 5.59. In other industries, these variations were very different, for
example in the computer industry patents were effective in a scale of 3.43 com-
pared to lead time that was 6.33.37 The importance of the patent system is
attributed to four main factors: the high costs of R&D; the low costs of imita-
tion; the fact that claims may be defined precisely for new chemical molecules,
making it easier to prove infringement; and the long life-span of pharmaceutical
inventions rendering lead time less important.38
Only one out of every eight patents has a significant economic value, there-
fore, apart from a few cases, the market does not seem to treat patents as
winner-take-all prizes.39 In addition, evidence shows that newer drugs reduce
33
See DOJ/FTC Proceedings on the pharmaceutical industry: Business perspectives
on the use and the role of patents in the biotech industry, 26 February 2002.
34
G. Glover (2002) op. cit.
35
Snyder in FTC/DOJ Proceedings on Competition and IPRs: A. Diverse perspec-
tives on patents. B. Business perspectives on patents. Biotechnology and pharmaceuticals,
19 March 2002. See also OECD Report, Competition and Regulation Issues in the
Pharmaceutical Industry, Paris (2001); where it is estimated that 65% of drugs would
not have been introduced without patent protection.
36
S.A. Singham, Competition Policy and the Stimulation of Innovation: TRIPS and
the Interface Between Competition and Patent Protection in the Pharmaceutical Industry,
26 Brooklyn J Int’l L 363 (2000).
37
H. Grabowski (2002) op. cit.
38
F.M. Scherer, D. Harhoff, J. Kukies, Policy Implications of a World Skew-Distrib-
uted Returns on Innovation, 29 Research Policy 559 (2000); F.M. Scherer et al.
Uncertainty and Size Distribution of Returns from Technological Innovation 10 J. Evol’n
Econ’cs 17 (2000); WTO, WTO Agreements and Public Health, A Joint Study by WHO
and the WTO Secretariat (2002); pp. 92–3.
39
Ibid.
non-drug expenditures 7.2 times as much as they increase drug expenditure.40

Dynamic efficiency evidence further supports the effectiveness and preservation
of the patent system; ‘While providing greater access to the current stock of
prescription drugs would yield large benefits to consumers in absolute terms,
realizing those benefits has yet greater costs in terms of lost consumer surplus
from reduction in flow of new prescription drugs. The ratio of harm to benefit
is three to one.’41 Moreover, patents do not render entry impossible or even un-
likely. Within four years of their introduction, a study has shown that 60 per
cent of patented successful innovations had been imitated.42 However, the patent
system generally increases the costs of imitations by about 30 per cent in the
industry.43
In addition, in view of the tight regulatory requirements, a substantial amount
of patent time is lost during clinical development and regulatory approval peri-
ods. Effective patent life in the pharmaceutical industry was usually around
seven years. In order to address this problem, the Supplementary Protection
Certificate44 was created, which allows for an additional protection of five years
on top of the 20 years from the filing period, with a cap of 15 years protection
in total, rendering the average effective patent life 10 to 12 years in which
companies must recover their expenses.
The patent system, however, does not address all of the public policy concerns
in the industry. While patents may be important for investing in R&D, pharma-
ceutical companies mainly focus on the diseases likely to yield high returns for
the shareholders, therefore diseases suffered by the poor or afflicting a small
number of people are neglected.45 Only 10 per cent of global R&D is directed
40
F. Lichtenberg, Benefits and Costs of Newer Drugs: An Update, 2002 at http://
www.nber.org/papers/w8996.
41
E.A. Snyder (2002) op. cit.
42
E. Mansfield, Unauthorized Use of IP: Effects on Investment, Technology Transfer
and Innovation, in Global Dimensions of IPRs in Science and Technology, National Re-
search Council, edited by M. Wallerstein, M. Mogee, R. Schoen, Washington, National
Academy Press (1993).
43
Ibid.
44
Regulation 1768/92 EEC, concerning the creation of a Supplementary Protection
Certificate for medicinal products, OJ 1992 L182.
45
It is for this reason that different mechanisms to stimulate innovation in diseases
afflicting a small proportion of the population have been created, such as the Orphans
Drugs Act. Regulation 141/2000/EC, on Orphan Medicinal Product OJ 2000 L 18/1.
See D.M. Richardson, The Orphan Drug Tax Credit: An Inadequate Response to An Ill-
Defined Problem, 6 The American Journal of Tax Policy 135 (1987). See also, P.J.
Kenney, The Orphan Drug Act – Is it a Barrier to Innovation? Does it Create Unintended
Windfalls? 43 Food Drug Cosmetic Law Journal 667–79 (1988). See also in the USA
the Orphan Drug Act that provides incentives to undertake orphan drug indications in-
cluding tax credits, clinical research grants programme, accelerated review by the FDA,
towards illnesses that account for 90 per cent of the worldwide diseases. ‘The
problem is rooted in poverty, not in industrial incentive structures’.46 In addition,
WHO estimates that one-third of the world’s population currently lacks access
to essential drugs and over 50 per cent of people in poor countries in Africa and
Asia do not even have access to the most basic drugs.47
2.2.1.2 Has the importance of patents been overstated?

While patenting is vital for the biopharmaceutical industry, its importance
should not be overstated.48 Many pharmaceutical patents are awarded to second-
ary and often trivial inventions rather than authentic ones, which attempt to use
patents strategically to extend their monopoly by restricting competition, creat-
ing large areas of exclusion around their inventions, thus preventing other
companies from exploiting their own patents and enhancing their bargaining
power in cross-licensing deals.49
For example, while the industry claims that it is a risky industry relying on
the few blockbuster drugs developed, the Public Citizen study has concluded
and guaranteed market exclusivity for seven years from the date of FDA approval. The
effects have been impressive as more than 200 drugs and biologicals for rare diseases
were developed between 1983 and 1999.
46
Oxfam, Patent Injustice: How the World Trade Rules Threaten the Health of Poor
People; at www.oxfam.org.uk p. 7. In such cases supplementary mechanisms need to be
embedded in the system, in the form of push mechanisms involving financial contribu-
tions towards R&D, and pull mechanisms aimed at ensuring the existence of an attractive
level of demand in the event that successful drugs or vaccines are generated.
47
WTO (2002) op. cit. p. 16. Access to essential drugs depends on four critical ele-
ments: rational selection and use, sustainable financing, reliable supply systems and
affordable prices. Access to drugs requires availability and affordability, and is condi-
tioned on many factors including price controls, medical insurance, import duties and
tariffs, local taxes, limited competition mark-ups for wholesaling, distribution and dis-
pensing. Cullet, Patents Bill, TRIPS and the Right to Health, XXXVI/43 Economic and
Political Weekly, 27 Oct. 2001.
48
The industry will want to lobby for the highest level of protection as it directly
affects its stock prices. For example ‘when the US court granted pharmaceutical con-
glomerate Eli Lilly an extension on its patent for Prozac that was two years shorter than
it had requested, its share fell by almost one third, wiping out $38bn of its market capi-
talization’. For this reason, pharmaceutical companies spend a huge amount on lobbying.
‘PhRMA’s political influence comes at a price. Between 1997 and 1999, PhRMA’s
members spent US$236m lobbying Congress and the executive branch of the govern-
ment. Another US$14m was provided to political parties in 1999 alone. Approximately
two-thirds of corporate investment in political lobbying in the USA is directed towards
the Republican Party, raising doubts about corporate influence over the new Administra-
tion.’ Oxfam, on patents op. cit. p. 7.
49
G. Dutfield, IPRs and the Life Science Industries, A 20th Century History, Alder-
shot, Ashgate (2003).
that pharmaceutical R&D is not particularly risky, as most new drugs are ‘me-
too’ drugs, (in other words close substitutes for successful drugs), and that the
initial R&D costs of many important drugs comes from public funds.50 It has
been shown that pharmaceutical companies have recently been found guilty of
paying generic producers to delay selling their versions of the drugs.51
In addition, the link between an increase in profits and an increase in R&D
in the industry is also not clear-cut, although a recent study has shown that as
profits increase, firms will compete to exploit them by increasing R&D invest-
ments.52 The lack of a direct correlation between research expenditure and
patent-based income renders it difficult to determine if the patent system is fair.
The price of drugs does not always correlate with the costs of R&D and produc-
tion as marketing costs, profit margins, subsidies, tariffs and tax are added to
those. Pharmaceutical firms spend more on advertising and promotion than on
R&D and this cannot be justified by the need for patent exclusivity. ‘There is
no apparent justification for allowing patent-based pricing to generate income
for advertisements.’53 This is particularly evident in the case of essential drugs
that are not dependent on advertising.54
It is also argued that companies exploit incremental innovations and patent
improvements or minor changes in order to extend the effective term of protec-
tion for the original invention.55 Therefore, it is claimed that the patent system
often rewards not only inventions which constitute ‘a moral triumph’, but also
those of predictable outcome.56
The patent system has also been accused of creating a situation in which
patents are used to stifle small firms that may be a prime source of innovation
in areas of new technology.57 The evidence is ambiguous, however, as other
studies have suggested that patent protection may be the key to commercial
50
WTO (2002) op. cit. pp. 92–3.
51
FTC, FTC Antitrust Actions in Pharmaceutical Services and Products, October
2003. See also the Commission announcement that it had fined AstraZeneca €60 million
for abusing its dominance by misusing the patent system. Commission Press Release
IP/05/737.
52
F.M. Scherer, New Perspectives on Economic Growth and Technological Innova-
tion, Washington, DC, Brookings Institution Press (1999).
53
See F.M. Abbott (2001) op. cit.
54
In such cases, other means may be warranted to allow for the recovery of research
costs such as tax credits, subsidies and prizes.
55
C. Correa, Internalization of the Patent System and New Technology in WIPO
Conference on the International Patent System, Geneva, 25–27 March (2002).
56
Ibid.
57
J. Barton, Adapting IP System to New Technology, in Global Dimensions of IPRs
in Science and Technology, National Research Council, edited by M. Wallerstein, M.
Mogee, R. Schoen, Washington, National Academy Press (1993).
success for medium-sized firms with the research capacity to produce innovative
new products but lacking the capital to fully exploit and commercialise their
inventions.58
Finally, it should be remembered that major breakthroughs are usually made
in universities, and companies are more likely to encourage research with obvi-
ous commercial applications in the interest of increasing profits. Pharmaceutical
companies have often been reproached for investing in lifestyle drugs treating
trivial conditions that need to be treated on a continuous basis (as opposed to
cured), such as baldness, rather than in lifesaving drugs.
A comparative analysis of the experience of several countries raises further
doubts as to the role of patents in ensuring a commitment to expensive R&D.
For Britain and France, the product patent regime was largely ineffective, while
in Switzerland, despite the absence of chemical industry patents, the industry
has evolved rapidly. Italy is also representative of the fact that the introduction
of product patent protection does not necessarily lead to increased innovative
R&D among domestic firms,59 though another study has shown that multina-
tional corporations limited their involvement in the Indian drug market after the
adoption of the weak patent system in 1970.60 None the less, stronger patent
protection does not necessarily result in more innovation and less patent protec-
tion does not necessarily mean less innovation. Therefore, caution should be
exercised in introducing overly-restrictive patent protection when there are other
discernible negative effects.
The above considerations should not lead us to conclude that the patent sys-
tem should be abolished, nor to undermine the importance of the patent system
in the biopharmaceutical industry. Rather, they seek to clarify the underlying
objectives of the industry in their quest for an absolute and unqualified patent
protection. Exclusivity involves a full scale of degree ranging from absolute
exclusivity to the complete lack of it.61 The level of patent protection is, there-
fore, a matter of degree and involves the careful balancing of competing
objectives.
58
See the case of Pliva which patented azythromycin worldwide, and then reached
a licensing agreement with Pfizer Inc. in which both companies and the public could
benefit from the commercialisation of the antibiotic. See WIPO, Azythromocin: A world
best-selling antibiotic – Pliva, at www.wipo.int.
59
F.M Scherer and S. Weisburst, Economic Effects of Strengthening Pharmaceutical
Patent Protection in Italy, 26 IIC 1009 (1995), p. 1023. G. Dutfield (2003) op. cit.
p. 241.
60
R. Garg et al., Four Opportunities in India’s Pharmaceutical Market, 4 MCKIN-
SEY Q. 132 (1996); S. A. Singham (2000) op. cit.
61
This depends, amongst other things, on how one determines an infringement, how
extensively compulsory licensing is used and how moral considerations affect the patent
grant or its invalidation.
2.3 Conclusion
Despite the significance of patent protection for the biopharmaceutical industry
and the centrality of the right to exclude in this respect, one should view with
caution requests for unlimited patent protection, as a balance is envisaged within
the system itself. Patent protection has various objectives to address and exclu-
sivity therefore is a matter of degree.
The continuous progress of innovation and production of improvements is a
central part of the patent balance, particularly in the biopharmaceutical industry.
To this end, it aims to encourage not only pioneer inventions,62 involving a dis-
tinct step in the progress of the art, but also technological improvements
resulting from independent discoveries or intentional efforts to design around
and therefore avoid infringing the patent.63
The patent system aims to achieve a balance between competing interests and
the incremental nature of innovation. As a result, patent rights may interact and
overlap in different ways, with different consequences in each case. In cases of
technological improvements, patents may block each other. In cases where dif-
ferent inventors patent different components of a larger invention independently,
patents are complementary and thus ineffective without a licence to each of the
patented products. In other cases, patents may be substitutes or inventions
around other patents and so may compete. Yet the categorisation amongst such
different types of patents and relations is not perfect and so, for example, com-
plementary patents may also compete.64
The patents system attempts to distinguish and cater for such competing and
often conflicting interests through limitations, exemptions from scope or other
provisions. For example, in the case of improvements, the patent system treats
them differently according to their significance and value in relation to the pio-
neer invention.65
62
A pioneer invention is defined as a ‘distinct step in the progress of art, distin-
guished from a mere improvement or perfection of what had gone before’. Texas Inst. v
ITC, 6 USPQ 2d 1886 (Fed. Cir. 1988).
63
M. J. Conigliaro, A.C. Greenberg and M.A. Lemley, Foreseeability in Patent Law,
16 Berkeley Tech L.J. 1045 (2001).
64
S.C. Carlson, Patent Pools and the Antitrust Dilemma, 6 Yale J. on Reg. 369
(1999).
65
M.A. Lemley (1997) op. cit. This is also consistent with the inventive step deter-
mination in case of pharmaceuticals. The greater the structural distance and the better
the technical effect of the invention as compared with the state of the art, the greater the
likelihood that inventive step will be found. See B. Domeij, Pharmaceutical Patents in
Europe, Deventer, Kluwer Law International (2000).
At the bottom of the scale are minor improvers for which the law offers no protection
and who may appropriate their findings only by trade secrets or first mover advantages.
It is therefore in no way inconsistent with the patent system to state that there
are limitations and ‘safety nets’ within the system itself that may address com-
peting interests, including follow-on innovation considerations.
The law, however, does not make allowance for an infringement of the pioneer invention.
Higher up the scale are significant improvers that exceed the minimum social value
threshold for patentability and are thus able to get an improvement patent. While they
may not use the pioneer invention without the permission of the patent holder, they may
prevent the patent holder (and any other unlicensed party), from using their improvement.
This often leads to the case of blocking patents which, according to the transactional
view of IPRs, is conducive to levelling the playing field and to minimising the chances
of a bargaining breakdown. In the EU, there is also a provision for compulsory licensing
in cases where the improvement patent involves an ‘important technological advance of
considerable economic interest’ Art. 53 EPC 1973 (Convention for the grant of European
Patents, which came into force in 1977, also known as the Munich Convention).
At the top of the scale there are radical improvements that depart from prior patents
and are afforded independent protection. In such cases, they may be found to depart from
prior patents even though they fall within the literal language of the claim. This is done
in the USA through the reverse doctrine of equivalence. As will be seen, where efficient
licensing will not occur, the law allows the improver to use the pioneer idea without that
being infringement, avoiding the hold up problem. This is done, as will be shown, by
interpreting the improvement as being sufficiently radical to escape the scope of the pio-
neer patent.
3. The patent system and some potential
safety nets
3.1 Introduction to the patent safety nets

Recent developments in biopharmaceutical R&D have raised concerns regarding
the basic assumption of most patent systems that society benefits more from
innovation than it is harmed by the grant of a legal monopoly. This chapter ex-
amines the safeguards in the system to ensure that follow-on innovation is not
unduly impeded in the case of research tools.
Before examining the means available within the patent system to ensure
access to such research tools, it should be clarified that the analysis is limited
to the patented tools used to develop biopharmaceutical products that do not
physically incorporate the tool. In addition, the analysis is limited to the situa-
tions in which access to the patented tool is problematic. As it was shown, access
has not proven to be problematic in most cases. None the less, access to re-
search tools remains problematic in some cases. This may be due to the
hesitation on the part of researchers to disclose the nature of their research in
the course of obtaining a licence, to a refusal on the part of the tool holder to li-
cense it, or to placement of significant limitations on the licences, or to
demanding a price amounting to an effective refusal to license.
The analysis will centre largely on the mechanisms available in patent law to
deal with a refusal to license. The mechanisms examined only involve potential
remedies once a patent has been granted. Therefore, for example, considerations
leading up to the grant of the patent such as whether certain types of inventions
should be patentable or not are outside the scope of the present examination.

The distinction has been highlighted by J.M. Mueller (2001) op. cit. p. 14 as it
does not trigger infringement liability for selling or offering to sell the patented products,
but rather only for use.

See Chapter 2.

J.M. Mueller (2001) op. cit.

Article 53 EPC provides for certain exceptions from patentability for ordre public,
under which research tools could arguably fall. The Guidelines for Examination in the
EPO provide that a fair test to determine what should be excluded from patentability on
this ground is if it is something which the public at large would consider so abhorrent
36
The patent system and some potential safety nets 37
The patent working solutions will be examined with reference to the research
tool experience, though their application may be equally applicable (or non-
applicable) in other cases involving similar issues. It should be stressed,
however, that the particularity of the case of research tools lies in the fact that
it is concerned with access to some technology for research purposes at a pre-
commercial stage (as distinct from product supply).
3.2 The patent safety nets

The following safety nets/limitations to patents are examined:
l experimental use exemption;

l reverse doctrine of equivalents and blocking patents;
l patent pools;
l compulsory licensing.
as to render a patent inconceivable. It is contemplated that this provision will be used

only in rare and extreme cases where an invention is likely to ‘induce riot or public dis-
order, or lead to criminal or generally offensive behavior’. None the less the possibility
of such an exclusion from patenting is not considered as it is assumed that patents in this
context are more desirable than not.
It also bears noting, however, that in the EU there is a group of advisers on the ethical
implications of biotechnology serving the interests of European society and respecting
the fundamental rights of every European citizen. The Group submits reports amongst
others on the compatibility of policies including patent policies with fundamental rights
such as the dignity of the human person. The Group gives its advisory opinion on ethical
aspects of patenting inventions involving, for example, elements of human origin, cloning
techniques, health care in the information society and gene therapy. So, for example, in
the EU we have a Biotech Directive (1998) op. cit. excluding the patenting of inventions
which would be contrary to public order of morality, and a Directive 98/79/EC, on In-
Vitro Diagnostic Medical Devices, OJ 1998 L331/1 referring to the protection of the
integrity of human persons. See the Report of the European Group on Ethics in Science
and New Technologies on the Charter on Fundamental Rights Related to Technological
Innovation, as requested by President Prodi, on 3 February 2000. The Group also decided
that the recourse to compulsory licensing should be encouraged when the access to di-
agnostic and treatments is blocked by a misuse of patent rights and stressed that it is the
responsibility of the states to establish a legal procedure for compulsory licensing where
that is justified by fair access to health care. In addition to the European Group, there
are also National Ethics Committees such as the Hellenic National Bioethics Commission
and the Nuffield Council on Bioethics considering issues of ethics and patenting and that
could potentially consider the issue of patenting when a life-saving drug is in issue, or
as otherwise required by the right to health.
Table 3.1 Community patent provisions for the grant and extent of patent
protection
Source Rule Requirements Exceptions/ Exclusions/ Article

Limitations
European Patentability Inventions: Exclusions: Art. 52

Patent – concrete – artistic works
Convention – technical – scientific theories and
(EPC) character mathematical methods
– presentation of
information
– business methods
Exceptions to Art. 53
patentability:
– against ‘ordre public’
– plant or animal
varieties
Industrial Exception: Art. 57
application – methods of medical
treatment or methods
of diagnosis
Novelty Art. 54
Inventive step Art. 56
Community Infringement – direct use Limits of exclusive rights: Art. 7, 8,
Patent – indirect use – acts done privately and 9, 10, 11,
Regulation for non-commercial 12
(CPR) purposes
– acts done for
experimental purposes
– preparation of
medicine in pharmacy
according to medical
prescription
– exhaustion
– prior use
Compulsory licensing: Art. 21
– non-use for 3 yrs from
grant and 4 yrs from
application
– to use second
otherwise infringing
patent where
important technical
advance of
considerable economic
significance
– cases of extreme
urgency

3.2.1 Experimental Use Exemption
3.2.1.1 The experimental use exemption: a viable and effective working

solution?
The experimental use doctrine is a very narrow exception that excuses the in-
fringement of a patent. To the extent that the experimental use exemption is
present in Europe, it is governed by national law. Article 54(1) of the European
Patent Convention (EPC) provides that the rights conferred by a European patent
shall be the same as those conferred by a national patent for each of the desig-
nated states. Article 64(3) of the EPC provides that any infringement of a
European patent shall be dealt with under national law.
Patent legislation in EPC countries contains limitations of the rights of pat-
entees. Article 69 EPC specifies that the scope of the patent right is determined
by the claim, but the infringement exceptions can be found in the Community
Patent Convention (CPC) Arts 25–28. Article 27(b) provides that the ‘Com-
munity Patent shall not extend to acts done for experimental purposes relating
to the subject matter of the patented invention’. The national patent systems
have generally accepted this exemption from patent infringement.
The general opinion is that the experimental use of a patented invention in
order to check the accuracy of the patent specification, or to carry out experi-
ments with no commercial impact or profit motive, does not amount to patent
infringement.10 An important rationale behind the experimental use exemption

The experimental use exemption at its current state is viewed as only useful in
exceptional cases. See M. Kern, Recent Federal Supreme Court Decision on Experimen-
tal Use and Compulsory Licensing, 3(2) CASRIP Newsletter 2, Summer (1996).

See IPR Helpdesk, at http://www.ipr-helpdesk.org/ on Patenting and the Research
Exemption.

A similar provisions was also found in Art. 9 of the Draft Council Regulation on
the Community Patent COMM (2000) 412 final (that has now been modified by Doc
7119/04 PI 18, Revised Proposal for Council Regulation on the Community Patent, 8
March 2004, COM(2004) 7119).

All EU states except for Austria have introduced such a general exception.

See W.R. Cornish, Experimental Use of Patented Inventions in European Com-
munity States, 29(7) IIC 736 (1998).
See French Patent Law Including Modifications of 1978, Art. 29 providing that ‘acts
accomplished for personal or domestic purposes or for the purpose of testing the object
of the patented invention shall not be considered as affecting the patentee’s rights’. Ger-
man Patent Act of 16 December 1980, § 11.2 ‘effects of the patent shall not extend to
… acts done for experimental purposes relating to the subject matter of the patented in-
vention’. UK Patent Act 1977 § 60(5) exempting acts ‘done privately and for purposes
which are not commercial’ as well as those acts ‘done for experimental purposes relating
to the subject matter of the invention’.
10
D. Gilat, Experimental Use and Patents, 16 IIC 1 (1995).
(EUE) is to prevent technical and scientific progress from becoming

paralysed.11
The EUE relates to two types of experiments: market-oriented and research-
oriented.12 Market-oriented experiments include generic drug manufacturers
who seek to make the drugs during the patent life in order to obtain marketing
authorisation and sell the generic products as soon as the patent lapses. The
position regarding these types of experiments has been more or less settled fol-
lowing the introduction of the Drug Price Competition and Patent Term
Restoration Act 198413 in the USA, and the recent adoption of the Bolar excep-
tion in the EU.14
In the context of research tools, however, the issue is different. Typical liti-
gants do not involve a research and a generic drugs company, but rather it
involves two research companies which have invested a large amount of finan-
cial resources and time in R&D. In such cases, the issue before the courts
involves the question of ‘which policy would better serve the promotion of
progress: an ex ante incentive to invest, disclose and innovate or the ex post le-
gitimation of research and development efforts which have contributed to
advancing technology one step forward’.15
This distinction has been recognised in several European cases. For example,
the German Supreme Court in the Ethofumesate case stated that ‘experimental
activities are considered permissible to the extent that they serve the purpose of
technically perfecting and further developing the patented subject matter.’16
11
See ibid. and British case Frearson v Loe (1878) Ch.D. 48, 66, where Jessel MR
said that if a man merely makes a bona fide experiment with the aim of ‘improving upon
the invention the subject matter of the patent, or with the view of seeing whether an im-
provement can be made or not, that is not an invasion of the exclusive rights granted by
the patent. Patents were never granted to prevent persons of ingenuity exercising their
talents in a fair way’.
12
Ibid.
13
Drug Price Competition and Patent Term Restoration Act 1984, Public Law
98-417.
14
See 11 March 2004 when the Council of Ministers adopted a new European
Pharmaceutical regulatory package including a provision allowing pre-patent expiry
development work and registration and generic approval. Directive 2004/27/EC of the
European Parliament and of the Council amending Directive 2001/83/EC, on the Com-
munity code relating to medicinal products for human use O.J 2004 L 36/34.
15
D. Gilat (1995) op. cit. p. 9.
16
Ethofumesate Case 22 IIC 541 (1991), p. 546. The Supreme Court distinguished
experiments aimed at developing the subject matter of the patent and experiments aimed
at gaining an advantage in the market once the patent expires.
A similar distinction can be found in the British Case Frearson v Loe (1878) 9 Ch.D.
48, and in the Dutch case Medicopharma N.V. et al. v ICI plc, 14 Rechtspraak van de
week 79–89 (1993).
The application of the EUE remains a highly contentious matter with different
authors arguing for different applications.17 It seems that one of the guiding
principles in its application involves checking whether consensual licensing
would take place so that the exemption covers the other cases.18
The EUE is linked, to a large extent, to the problem of high transaction costs
which hinder the carrying out of experiments. From a policy perspective, it is
desirable that competitors should be able to experiment and improve on an in-
vention, especially in fields such as the biopharmaceutical industry where
therapeutic advances are of great significance.
It is unlikely that a licence would be negotiated as the parties usually have
different views on the value, validity and scope of protection of the patent and
the experiment, and therefore the transaction costs for such negotiations are
likely to be significant. In addition, if a product patent is framed in a way that
includes all therapeutic indications and the exemption cannot be invoked, it is
impossible for someone to search for new indications as the patent holder would
view him as a possible future producer and would be reluctant to negotiate a li-
cence. This situation would impede competition and innovation within the scope
of the patents already granted. ‘If research can result in a product with added
value, the experimental use exception should probably be applicable, as it is not
likely that this research would happen without it. The transaction costs would
prevent the negotiation of a license.’19 In such cases, experiments using the in-
vention as an object and not as a tool are exempt.
Therefore, if a competitor seeks to use the invention, as there is a danger that
the inventor’s profits will decrease when the experimenter commercially exploits
his results, it is unlikely that a licensing arrangement will be made. If the ex-
perimenter seeks to invent around the patent, denying the exemption might result
in the ‘paralysation’ of progress, whereas invoking it would undermine incen-
17
See R.D. Hantman, Experimental Use as an Exception to Patent Infringement,
67 JPTOS 617 (1985) basing the distinction on monetary profit or lack of it and distin-
guishing experimenting on and for experimental purposes. See also N.A. Israelsen,
Making, Using and Selling Without Infringement: An Examination of 35 U.S.C.Sec.271(e)
and the Experimental Use Exception to Patent Infringement, 16 AIPLA Q.J. 457
(1988–89); R.S. Eisenberg, Patents and the Progress of Science: Exclusive Rights and
Experimental Use, 56 Univ. Chi. Law Rev. 1017 (1989); L.T. Welch, The Experimental
Use Exception to Patent Infringement in the USA, 19 Patent & Licensing 17 (1989); D.E.
Tuffery, Experimental Use as a Defense to Infringement in New Zealand, Patent World,
Oct. (1992), p. 22.
18
D. Gilat (1995) op. cit. pp. 19 and 29 ‘According to the thesis suggested in this
study, where there is no barrier to a consensual license or an assignment transaction be-
tween the patentee and the user of the invention an exemption from patent infringement
is not required.’
19
B. Domeij (2000) op. cit.
tives to invent. The conclusion was that the patent policy of encouraging
‘inventing around’ should prevail over the incentives policy.20
Hence, a distinction was drawn between experimenting on and experiment-
ing with the patented invention. The former refers to use in order to study its
underlying technology and to invent around the patent which is considered
exempted, while the latter refers to use in order to study something else that
is not covered by the exemption. Hence, for example, a research tool that is
used for conducting work will require permission from the patent holder,
whereas people that study the research tools themselves will be considered
exempted.21
As regards the interpretation of the provision in the different European coun-
tries, it appears that Germany is the most liberal in its interpretation. German
courts generally find that the use of the patented invention to obtain further in-
formation about the product falls within the exception.22 During the mid-1990s,
the German Supreme Court in two cases known as Clinical Trials I and II,23
ruled that experiments or trials on a patented substance such as pharmaceutical
products were permitted, both in order to test the claimed properties and for
new indications, as long as they were directed on the substance itself. The
Constitutional Court of Germany affirmed these decisions in the interest of the
development of the state of the art and the public interest.24
20
See D. Gilat (1995) op. cit. p. 53 referring to a distinction as to mere improvement
and delineation of substitute and alternative.
21
One may question whether this is a sensible approach as it is exactly in the case
of improvements and competing products that the patent exclusivity may be advanta-
geous. None the less, it is thought that this amounts to research in the technology field
and that the inventions are used for a different purpose than that for which they were
originally created. Hence, this only represents a small loss of revenue to the patentee as
his main market resides in their non-experimental uses. The fact that such research may
lead to improvements or new competing products that are patentable does not change
the analysis. On the other hand, it is felt that experimentation with a patented invention
does not advance the field of technology or contribute to innovation as they leave the in-
vention unchanged, hence this is not exempted.
See P. Ducor, Research Tool Patents and the Experimental Use Exemption – A no-win
situation? 17 Nature Biotechnology 1027 (1999).
22
C. Laherty and Y. Shibata, Harmonization of Patent Term Extension and Experi-
mental Use Laws Related to Drug Development and Testing, Comparative Patent law
Seminar, Spring 2001 at http://www.law.washington.edu/casrip/Harmonization/PDF/Ex-
perimentalUse.pdf.
23
Klinische Versuche I (BGH, 11 July 1995); Klinische Versuche (BGH, 17 April
1997); 1997 IIC 103
24
See Cases Federal Supreme Court (BGH) 11 July 1995, GRUG 1996, 109 ‘Kli-
nische Verusche’ and 5 December 1995 GRUG 1996, 190 ‘Zwanglizenz’ concerning the
protein, interferon. The Düsseldorf Court of Appeals held that experiments undertaken
that neither establish the characteristics of the substance nor the feasibility of its produc-
On the other hand, the exception has been construed more narrowly in the
UK.25 For example, in the case Smith Kline & French Laboratories Ltd v Evans
Medical Ltd [1989] FSR 513, experimental purposes relating to the subject
matter of the invention was interpreted to mean ‘in the sense of having a real
and direct connection with that subject matter’.26
tion fall outside the scope of s.11(2) as otherwise it would be inconsistent with the
principle of product patents extending to all possible uses of its subject matter. The Court
stressed that what was important was not the activity itself but the purpose of the activity,
but that ‘experiment’ was limited to those directed to the ‘subject matter of the patented
invention’.
25
See Frearson v Loe [1878] 9 Ch.D. 48, where the Court held that experimentation
with a patented product with no intention to sell or use but just to improve upon the in-
vention or to see whether an improvement can be made does not amount to infringement.
See also Monsanto v Stauffer [1985] RPC 515 CA, where the Court stated ‘trials carried
out in order to discover something unknown or to test an hypothesis or even in order to
find out something which is known to work in specific conditions would work in different
conditions or even perhaps to see if the experimenter could manufacture commercially
in accordance with the patent. These can fairly be regarded as experiments, but trials
carried out in order to demonstrate to a third party [such as a regulatory body] that a
product works, or in order to amass information to satisfy a third party, whether a cus-
tomer or body that the product works as its maker claims are not to be regarded as acts
done for “experimental purposes”’. Of course the recent European Directive referred to
above has to some extent changed and harmonised the position as regards regulatory
bodies.
See also Smith Kline & French Laboratories Ltd v Evans Medical Ltd [1989] FSR
513, observing ‘what is or not an experiment must depend on the facts of each case but
can include experiments designed with a commercial end view’.
In Inhale Therapeutic Systems Inc v Quadrant Healthcare Plc [2002] RPC 21, the
Patents County Court observed ‘it is said that there is a defence of experimental use.
This fails on the facts. None of the exploitation of the products or technology complained
of was conducted by Quadrant for its own experimental purposes. In all cases Quadrant
was trying to exploit and sell its technology to third parties. This is not experimental
use’. To the extent this viewpoint is endorsed it seems that the UK is moving away from
the liberal stance of Germany towards the more narrow view of the exemption of the
USA.
26
See M. Fysh, Supplementary Certificate Legal Issues in Exploiting Drug Patents
in Europe, LES-Italy Conference, Milan, 2002, ‘I believe that the exception may there-
fore have a very narrow effect under UK/Irish law. The qualification may cover such acts
as verifications of various kinds (such as seeing whether a compound can be made as
proposed or will work in a particular climate), assessment of validity, and in-house ex-
periment for the purpose of improvement and modification etc. But the exception would
not in my view exclude the use of a patented process in experiments specifically to test
some other product or process with the view to the direct use of the results thereof for a
commercial purpose.’
3.2.1.2 The US experience: a helpful paradigm?

The experimental use doctrine originated in the USA as a narrow judge-made
exemption to patent infringement for anyone who makes, uses or sells a patented
invention purely to satisfy scientific curiosity, or philosophical reasons. It was
initially expounded by J. Story in a dictum in Whittemore v Cutter27 in 1813, in
which he stated that ‘it could never have been the intention of the legislature to
punish a man who constructed a patented machine merely for philosophical
experiments, or for the purpose of ascertaining the sufficiency of the machine
to produce its described effects’. In Sawin v Guild,28 J. Story further elaborated
on the exceptions to infringement. In order to constitute an infringement, it must
involve ‘the making with intent to use for profit, not for the mere purpose of
philosophical experiment, or to ascertain the verity and exactness of the
specification’.
The defence reflects an understanding that the interests of the patent holder
are not harmed, and this is dependent to a large extent on whether the alleged
infringer derives profit from the patented article. However, in most cases, the
defence has failed, and whilst the recent US decision of Madey v Duke29 affirms
the existence of the doctrine, it defined its applicability in a very narrow sense. 30
The scope of the exemption remains unclear both in terms of applicability and
policy.
The breadth of the exemption relies on how one defines ‘curiosity, amusement
and philosophical experiment’. Arguably, the latter is prone to different inter-
pretations that would have different implications on the applicability of the
exemption. Could ‘philosophical’ include the acts of designing around an inven-
tion as this arguably leads to the creation of new knowledge?
The exemption shifts the importance to the intention behind the use of the
patent, and directs an evaluation into whether the use is commercial or not. ‘The
making must be with an intent to infringe the patent rights, and deprive the
owner of the lawful rewards of his discovery’.31 Damages will only be available
where there is some commercial use involved, yet damages cannot be used alone
as the benchmark of its application as there might also be non-infringing uses
that result in a loss of revenue to the patent holder, which he would not be justi-
fied in claiming. In addition, while infringement consists of use, inter alia,
27
Whittemore v Cutter 29 F.Cas 1120 (C.C.D. 1813).
28
Sawin v Guild 21 F.Cas 554 (C.C.D. 1813) (No. 12,391).
29
Madey v Duke 01-1567 US CA for Fed. Circ. 307 F.3d 1351.
30
Ibid. See also Embrex Inc. v Service Engineering Corp 99-1064, USCA for Fed.
Cir., 216 F.3d 1343; 2000 U.S. App. LEXIS 15036; 55 U.S.P.Q.2D (BNA) 1161, June
28, 2000, Decided; where the Federal Commission commented that the experimental
use exemption is construed very narrowly.
31
Sawin v Guild, 21 F.Cas 554 (C.C.D. 1813) (No. 12,391) and J. Story dicta.
irrespective of the purpose of the use, under patent law, the exemption imports
a subjective evaluation into the motives underlying the use. The extent to which
this is sound is contentious. Can intent and purpose make something exempt
from infringement when it is irrelevant to establishing an infringement in the
first place?
In the case of corporations, there is an unspoken assumption that these ac-
tivities are motivated by a commercial intent. Hence, a distinction was initially
made in the case of universities, where it was thought that there was no com-
mercial intent. This assumption, however, has been called into question in
recent times with the increasing commercialisation of activities on the part of
universities, especially in the USA.32 However, when does a use become com-
mercial? Even while researching or upon the development of a commercial
product? Under the current status of the exemption it seems that even use for
the purpose of testing will be infringing if it also has a proximate commercial
purpose.
Hence, the practical utility of such an exemption can be questioned. It is
thought that an infringement action is unlikely to occur in the first place in cases
where an invention is used for commercially insignificant purposes, and while
the exemption may exist in theory, it is hard to sustain it in practice. It seems to
be applicable only in cases of use to assess the commercial viability and appli-
cability of the results where that does not lead to commercial gain for the user
and a loss of interest for the patentee.33
With regard to the specific case of pharmaceuticals, in the USA, in the case
of Roche Products v Bolar Pharmaceutical Company,34 the CAFC in 1984 re-
jected the argument that a generic drug manufacturer should be able to use a
patented drug to conduct clinical trials during the term of the patent, with a view
to commercialisation immediately after the expiration of the patent. It was held
that the defence is truly narrow and cannot permit experiments conducted with
a view to commercial exploitation.
The US Congress has, however, reconsidered the effects of this ruling as it
was felt it, in fact, extended the term of effective patent protection to include
32
R. Eisenberg (2001) op. cit.
33
In US common law the defence has seldom succeeded. In Whittemore v Cutter
29 F.Cas. 1120 (C.C.D. 1813) the use of a product to assess its applicability to a com-
mercial process was exempted. Similarly, in Akro Agate Co. v Master Marble Co. No.
119, District Court, N.D. West Virginia, 18 F. Supp. 305; 1937 US Dist. LEXIS 2087,
16 January 1937; the use of a machine merely to assess its usefulness that was then
abandoned voluntarily was also found exempted. But these represent very specific and
limited instances of philosophic inquiry.
34
Roche Products v Bolar Pharmaceutical Company 733 F.2d 858 (CA Fed.), cert.
denied, 469 US 856 (1984).
the period required for generic companies to obtain marketing authorisation

once the patent had expired, in other words, for another one to two years. It also
noted that there was no economic effect on the patent holders by virtue of such
conduct. In view of the significant impact it might have on public health, it
amended the statute to permit the use of inventions for the purpose of developing
and submitting information under laws regulating the manufacture, use or sale
of drugs.
The Drug Price Competition and Patent Terms Restoration Act 1984 § 202,
later codified as 35 USC § 271(e)(1)(2001),35 permits clinical trials for the pur-
pose of providing data to official regulatory authorities for market clearance of
a medicine developed by a non-licensed third party covered by a patent that is
due to expire. It protects drug manufacturers whose use of products is necessary
to satisfy the pre-market testing requirements of the FDA: ‘the patented drugs
should be used solely for purposes reasonably related to testing requirements
under federal law’.36 Furthermore, ‘reasonably related’ is an objective test of
acts deemed to constitute an infringement except for § 271.
Therefore, although Bolar was overruled, the judgment still presents a valu-
able insight into the notion of infringement, as the patent cannot be permitted
under the ‘guise of scientific inquiry when the inquiry has definite, cognizable
and not insubstantial commercial purposes’.37
While the US experience has proved useful in encouraging Europe to also
endorse a Bolar-type exemption, the dilemmas facing research tools and the
problem with the applicability of the experimental use exemption is the same
and might even be more heightened in view of their more limited interpretation
of the doctrine.
3.2.1.3 Conclusion on the EUE

‘The purpose of the experimental use doctrine is not to subsidize new research
at the expense of the patentee, but rather to allow such research when market
forces prevent it.’38 In the case of research tools used by other researchers for
the purpose for which they were created, it was traditionally believed that no
barrier to licensing exists as they are the ordinary consumers, and therefore the
exception should not be invoked.39 The distinction between experimenting on
35
Public Law 98-417.
36
G.N. Pate, Analysis of the Experimental Use Exception, 3(2) North Carolina
Journal of Law and Technology 253 (2002).
37
For an analysis of the Bolar exemption see J. Love, Bolar Exemption, 1998 at
http://lists.essential.org/1998/pharm-policy/msg00004.html.
38
D. Gilat (1995) op. cit. p. 41.
39
Ibid. p. 44. See also R.S. Eisenberg, Proprietary Rights and the Norms of Science
in Biotechnology Research, 97 Yale L. J. 177 (1987) p. 225.
and experimenting with would not provide access in cases of downstream re-
search, as it would be inapplicable. ‘The problem is that researchers are ordinary
consumers of patented research tools, and that if these consumers were exempt
from infringement liability, the patent holder would have nowhere else to turn
to collect patent royalties.’40
In light of the increasing difficulties in reaching an agreement or securing a
licence, however, this assumption may be called into question. The Working
Group on research tools has concluded that an EUE should not be available to
those ‘working with’ a patented invention as such workers are truly ‘ordinary
consumers’ of the tool.41 This is only reasonable, however, if the research tools
to these people can be freely acquired in the ‘marketplace at a reasonable cost
via anonymous purchasing without the need for licensing transactions. The
growing incidence of high transaction costs associated with accessing multiple
patented research tools contravenes the ordinary consumer assumption, however.
When research tool transaction costs are severe enough to impede or stop the
development of new biomedical products, line-drawing between “experimenting
on” and “experimenting with” may no longer be justified’.42
In addition, there may be further complications with maintaining this distinc-
tion, as the Australian Department of Health and Ageing has stated:
It should also be noted that there are also practical problems in some fields of
technology in making this distinction … including biotechnology, with its tendency
towards broad patents … research using knowledge of the structure of a gene, di-
rected towards identifying treatment for disease associated with abnormal forms
of the gene may be regarded as research with the gene. Research intended to identify
variation within the gene may be regarded as research on the invention. However,
clinical diagnostic testing, which can be regarded as technology subject to com-
mercial application, could in principle be thought of as research on the invention.
This is in the sense that it is research directed towards identifying the exact structure
or property of the ‘invention’ in the specific individual being tested. The distinction
between research genetic testing and clinical diagnosis is also clouded by the fact
that, although the objectives may differ, the processes generally remain identical.
This problem seems inherent in the patenting of ‘inventions’ which are also a form
of discovery.43
40
R. Eisenberg (1996) op. cit.
41
42
Ibid. p. 40.
43
ACIP, Patents and Experimental Use, Options Paper, Advisory Council on Intel-
lectual Property, December 2004.
3.2.2 The Reverse Doctrine of Equivalents and Blocking Patents
The reverse doctrine of equivalents is an equitable doctrine devised by the courts

in the USA to excuse infringement even though it may be within the scope of
the patent claim, by taking the importance of the improvement in question into
consideration. Although falling within the literal words of the claim, it refers to
a situation in which the improvement performs the same or similar function in
a substantially different way, and in this way, the reverse doctrine of equivalents
is used to bring it outside the scope of patent protection.44
While the US Supreme Court has made reference to this doctrine on several
occasions,45 the Federal Circuit has viewed it with some scepticism although it
has been validated in theory.46 None the less, the doctrine has rarely been in-
voked and even more rarely applied, therefore, its practical effectiveness remains
a contested issue.
In the EU no provision is made as to the reverse doctrine of equivalents, al-
though a proposal for a similar measure has been made. Domeij has proposed
that the reverse doctrine of equivalents should be used in Europe so as to facili-
tate the entry of new products into the market that are of high value to consumers
in cases that would otherwise encroach on the scope of the patent granted.47
However, it appears that the indirect use of the principle may be made upon in-
terpreting the scope of the patent.
It has been argued that the doctrine is a judicial response to the likelihood of
breakdown in bargaining between the pioneer and the improvers.48 This break-
down is likely to occur, first, due to the difficulty in setting the value on the
relative contributions and, secondly, the uncertainty over the future development
of the technology, as well as its profitability.49 Strategic bargaining may aggra-
vate the situations and lead to a failure in reaching an agreement, despite the
existence of a cooperative surplus.
44
L.A. Handley, Refining the Graver Tank Analysis with Hypothetical Claims: A
Biotechnology Exemplar, 5 Harvard J. Law & Tech 31 (1991).
45
See Westinghouse v Boyden Power Brake Co. 170 US 537 (1898), and Graver
Tank case 339 US 605 (1950).
46
Wilson Sporting Goods v David Geoffrey & Associations, 904 F.2d 677 (Fed. Cir.
1991). See also Amgen Inc. v Chugai Pharmaceutical Co. 927 F.2d 1200 (Fed. Cir. 2000),
and Scripps Clinic and Research Foundation v Genetech Inc. 927 F.2d 1565 (Fed. Cir.
1991), where the Federal Circuit limited the scope of the inventor’s claims of purified
natural products and applied the reverse doctrine of equivalents.
47
B. Domeij (2000) op. cit.
48
R. Merges, IPRs and Bargaining Breakdown: The Case of Blocking Patents, 62
Tenn. L. Rev. 75, (1994).
49
Ibid.
In such cases, the reverse doctrine of equivalents promotes the voluntary li-
censing between parties by creating a threat to the pioneer patentee, encouraging
them to reach a socially productive agreement without recourse to statutory
compulsory licensing. In the USA, it allows the radical improver to use the pio-
neer inventor’s idea in certain cases in which the latter would otherwise have
held the radical improver hostage.50 In such cases, it is not necessary to have
recourse to compulsory licensing as the improvement falls outside the scope of
protection. The radical improver is exempt from liability regardless of whether
it lies within the literal scope of the claim, so as to encourage its creation and
ensure it reaches the market.51
According to this, the improvement is treated as a function of its value and
significance in relation to the original invention. A minor improvement is not
eligible for a patent and in order to reach an agreement with the patent holder,
it must overcome Arrow’s paradox of information.52 The latter refers to the situ-
ation in which the improver is unable to protect the information once it has been
disclosed, yet needs to disclose it in some way in order to reach an agreement
with the patentee. The improver cannot stop the pioneer from using the improve-
ment and it is unlikely that an agreement will be reached. The minor improver
is also likely to infringe, whether literally or by virtue of the doctrine of
equivalents.
In the case of a significant improvement, however, a property right is given
to the improver in the form of a patent, although his unauthorised use of the
original patent would still be infringing. This creates a mutually blocking situ-
ation which levels the bargaining power of parties and creates an incentive for
both parties to reach an agreement and to push technology forward.53
The rationale of the blocking patents doctrine in US patent law reflects the
statutory provision in EU law and in TRIPS regarding dependent patents. Under
European patent law, it is possible to get a compulsory licence in cases of a
secondary dependent patent that involves an important technological advance
of considerable economic interest.54 Hence, while there is no provision for
compulsory licensing (CL) of dependent patents in US law, as it exists in the
EU, the blocking patents doctrine attempts to have the same effect by maximis-
ing the situations in which licensing can occur. 55
50
M.A. Lemley (1997) op. cit.
51
Ibid.
52
Ibid.
53
R. Merges (1994) op. cit. The author elaborates on a transactional view of
IPRs.
54
See further down at 3.2.4.2(a).
55
R. Merges (1994) op. cit. Delineating the scope of the patent according to the
value of the improvement relative to the pioneer patent also overcomes the incentive ac-
The transactional view of patents permeates doctrines such as the doctrine of

equivalents and the reverse doctrine of equivalents. Consideration is paid to
when parties are likely to reach an agreement and how to maximise the cases
of important agreements for follow-on innovation, so as to ensure that com-
mercially value-added innovation reaches the market.
Despite the lack of certainty, in many respects, on the law relating to improve-
ments and the delineation of the relationship between the initial and subsequent
patents, the extent to which the current provisions or doctrines would cater for
the problem of research tools is not clear. This is because, first, the reverse
doctrine of equivalents only applies to radically different inventions, and sec-
ondly, and most significantly, research tools do not usually fall within the
category of improvements.
As explained, access to research tools is mostly needed to research down-
stream pharmaceutical products. In such cases, the reverse doctrine of
equivalents would not remedy the problem relating to access. The doctrine could
only have a small role to play in cases dealing with improvements on the re-
search tools as such, and even here it would be limited as it would only cover
radical improvements (involving inventing around) and would also fail to justify
‘of itself’ experimentations on the invention until such time as the improvement
has been developed.56 The doctrine would be of little use in cases in which ac-
cess is needed to the research tool for downstream research. It therefore becomes
necessary to examine what other provisions may be used to give effect to such
concerns.
cess paradox of compelling access in cases where the incentive for the pioneer work is
most significant. This is because the improvement’s value is measured relative to the
original patent. Practical evidence, however, is equivocal on the role of commercially
added value as the most significant factor in determining the scope of patent protection.
It is feared that this will lead to uncertainty from a technical point of view as the scope
of protection will effectively depend on the value of the improvement. See the author’s
proposal that the portion of the scope of protection devised by the courts be mainly
thought of as an ex post facto adjustment taking into account the value of the attacked
embodiment, and that the doctrine of equivalents be seen as an economic test not a
technical one. He argues that patent claims define the invention but do not conclusively
define the scope of protection since it is impossible at the time of the grant to foresee all
possibly infringing products that add something of importance and therefore should be
encouraged by the courts.
56
In fact, as regards access to the patented technology it provides no means of en-
suring that and only seems to operate ex post to excuse infringement by taking the
improvement out of the pioneer’s scope. To that end see the experimental use exemption
analysed next.
3.2.3 Patent Pools
The creation of patent pools provides another working solution to the problem
of blocking patents and stacking licences. Patent pools are predominantly used
in situations where patent thickets57 arise, so that the commercialisation of new
technologies is not impeded by an overlapping set of patent rights. They refer
to the ‘aggregation of IPRs which are subject to cross licensing, whether they
are transferred directly by the patentee to the licensee or through some medium
such as a joint venture set up specifically to administer the patent pool’.58 Patent
pools have been described as ‘private liability rule’ organisations that function
in a similar way to compulsory licences except that they have been devised by
an organisation.59
Typically, a single entity licenses the patents of two or more companies to
third parties as a package, and this offers the convenience of a ‘one-stop shop’.
In cases of standardisation any patents necessary to comply with the standard
become really essential and, in such cases, patent pools may be particularly ef-
fective. Hence patent pools mostly arise in cases of standards, in cases where
essentiality is not readily defined or in cases where there are blocking patents
from different companies that are not part of a standard.60 Where a patent is es-
sential to the practice of the relevant technology field then the blocking situation
is present.
Patent pools are typically created in industries in which parties have a long-
standing relationship and form a homogenous group, where there are repeat-play
transactions and they hold mutually blocking patents.61
While the object is to ensure that access to essential inputs is not impeded, it
refers predominantly to a situation of complementary and multiple patent rights
that are interdependent and potentially inter-blocking in the absence of coordi-
nation. Hence, they are more a solution to the balkanisation of rights that may
lead to higher prices than a single package price, high licence fees and may also
57
For an explanation of the term ‘patent thicket’, see C. Shapiro, Navigating the
Patent Thicket: Cross Licenses, Patent Pools and Standard-Setting, UCLA Department
of Economics in its series Levine’s Working Paper Archive no. 122247000000000539,
2004.
58
J. Clark, J. Piccolo, B. Stanton, K. Tyson, Patent Pools: A Solution to the Problem
of Access in Biotechnology Patents? US PTO, 5 December (2000) at http://www.uspto.
gov/web/offices/pac/dapp/opla/patentpool.pdf.
59
See R.P. Merges, Institutions for Intellectual Property Transactions: The Case
of Patent Pools, in R. Dreyfuss et al., Expanding the Boundaries of Intellectual Property,
Oxford, Oxford University Press (2001).
60
J. Kubalski, Comments on Patent Pools and Standards, for the FTC Hearings on
IP and Antitrust, January 2002.
61
ACIP (2004) op. cit.
dynamically be a drag on innovation, than access to a single essential input

technology.62 Patent pools are particularly effective in cases of complementary
as opposed to substitute patents, minimising transaction costs in negotiating
individual licences and reducing the possibilities of a hold-up problem.63
Patent pools are perceived as particularly beneficial in the biotechnology in-
dustry as they may assist in integrating technology, reduce the often high
transaction costs, prevent blocking positions, avoid costly litigation and promote
the dissemination of technology. The biotech landscape, it is often felt, is such
that the ‘vast amount of genetic information and its significance as a fundamen-
tal research tool even absent functional knowledge can give rise to an almost
overwhelming number of patents, the true value of which may be unascertain-
able without the cooperative efforts of other companies’.64
Hence one-stop shopping may be particularly effective in this industry to save
time, money and resources that can be directed instead to further innovation.65
It also leads to the distribution of risk benefit as the members share the risks as-
sociated with R&D and each member may receive a set of income based on the
percentage of the royalty earned from the pool. It can also be advantageous as
it provides a mechanism for the free sharing of technical information relating to
the patented technology and provides an incentive for avoiding overlapping ef-
forts, leading to a more effective and efficient allocation of limited resources.
However, these perceived benefits have not gone unchallenged. First, it is
questionable whether the genetic inventions market is amenable to patent pools.
While there is a significant degree of interdependence and high transaction costs,
some have argued that unlike the electronic industry, the definition of standards
and need to ensure interoperability is not essential in the pharmaceutical indus-
try, especially in the development of therapeutics.66 It is also often found that
the number of patents to which access is effectively required is usually
manageable.
Patent pools have also been criticised as potentially ineffective in view of the
likely disagreement over the value of the patents. In addition, as the industry is
made up of diverse, heterogeneous players and parties who are often involved
in one-off transactions, the usefulness of pools may be limited.67 Criticism is
62
C. Shapiro (2004) op. cit.
63
Ibid. See also R.P. Merges (2001) op. cit. describing the need for ‘strict compli-
mentarity’ of patent pools, i.e. that none of the parties be able to have any return in the
absence of an agreement to pool.
64
L. Sung, Greater predictability may result in patent pools, 8 February 2002 in
CPTech on Collective Management of IPRS: Patent Pools at www.cptech.org.
65
J. Clark et al. (2000) op. cit.
66
OECD (2002) op. cit.
67
ACIP (2004) op. cit. p. 59.
also made regarding the fact that they may inflate the costs of competitively
priced goods (although this could be remedied if truly blocking patents are
identified), shield invalid patents and encourage collusion and price fixing.68
The latter, however, would seem to be amenable to control if an independent
expert were charged with evaluating the patents, and if a field of application
could be defined and the essential patents identified. In this case, the patent
pools may be deemed worthy of consideration.
Empirical evidence has shown that some patent pools have been created in
the biotech industry such as the SNP Consortium and the Genebank pool.69
These have been viewed as particularly effective pools. On the other hand, em-
pirical evidence from Germany has shown that patent pools were not deemed
to be effective in increasing access to genetic inventions due to the difficulty in
assessing contributions.70 Furthermore, in some cases, pools have been found
to be inefficient. For example, the patent pool between VISX and Summit
Technology, of the only two FDA-approved manufacturers of lasers used in
photo refractive keratoctomy, was condemned as it was perceived to act as a
tool for fixing prices and eliminating horizontal competition between the com-
panies, in view of the ability of both companies to enter the market
independently.71 The careful examination of the true complementarity and de-
pendency therefore seems to be paramount.72
In conclusion, while patent pools may prove particularly advantageous in
certain cases, it would seem that they have been directed more towards the
problem of the proliferation of patent rights and the creation of patent thickets,
than to the problem of access to a single essential upstream technology as in
the case of research tools.73 In order for patent pools to function, a symmetrical
structure is required in which everyone owns patents. This is not usually the
case for upstream biotechnological research and downstream pharmaceutical
developments. Patent pools are also usually dependent on the voluntary decision
to pool the patents, which is not likely to arise in the absence of interdependence
in cases of access to essential inputs.
68
J. Clark et al. (2000) op. cit.
69
This is analysed in CPTech on Collective Management of IPRS: Patent Pools at
www.cptech.org.
70
J. Strauss (2002) op. cit.
71
CPTech on Collective Management of IPRS: Patent Pools at www.cptech.org.
72
See though R.P. Merges (2001) op. cit. who argues that the most important factors
are open membership to the pool and non-exclusive licensing.
73
See the submissions on p. 59 ACIP (2004) op. cit. ‘It should be remembered that
patent pools are promoted as a solution to patent thickets, or anti-commons issues, so
they do not assist where blocking patents are used in an exclusionary manner.’
3.2.4 Compulsory Licensing in the Patent Provisions
3.2.4.1 Introduction to compulsory licensing
(a) Definition and History

A compulsory licence enables a government to license a third party to use the
patented invention without the patent holder’s consent. The competent authority
will grant the licence to a designated body or person that usually compensates
the patent holder by providing him with reasonable remuneration. Contrary to
other balancing mechanisms in the patent system, compulsory licences do not
arise automatically but instead only after a decision has been made by the com-
petent body.
Historically, compulsory licensing (CL) arose to ameliorate the risk of forfeit-
ing the patent, which was used to encourage the development of national
industry by requiring a domestic patentee to work his invention, directly or in-
directly in the relevant country.74 Patentees are generally required to work their
invention in nearly every country in which a patent has been obtained.75 Forfei-
ture of the patent, however, as a sanction for failing to work it, had social costs,
especially in instances where investment and/or know-how was not sufficient
to encourage competitors to produce the invention themselves. CL developed
against this background, marking a shift of the sanction from forfeiture to
CL.76
(b) Support and Opposition for CL

CL has been met with support but also with opposition. There are several factors
that point to the desirability of CL when certain conditions are met.77 CL might
be considered desirable, first, where the demand for the product has not been
met.
According to economic theory, a monopolist will intentionally under-supply
goods (to sell at higher prices) in order to maximise profit. In such circum-
stances, CL may facilitate entry into the market leading to enhanced consumer
74
J. Reichman, C. Hasenzahl, Non-Voluntary Licensing of Patenting Inventions:
Historical Perspective, Legal Framework under TRIPS, and an Overview of the Practice
in Canada and the USA, UNCTAD (2002), p. 5.
75
See survey of patent laws in Table 3.2.
76
See Art. 5 of the Paris Convention for the Protection of Industrial Property of 20
March 1883 as revised at Brussels on 14 December 1900, at Washington on 2 June 1911,
at the Hague on 6 November 1925, at London on 2 June 1934, at Lisbon on 31 October
1958, and at Stockholm on 14 July 1967, and as amended on 2 October, 1979.
77
See also ACIP (2004) op. cit. p. 58 confirming the perception of the compulsory
licensing as desirable as a tool in certain cases.
choice and lower prices. There is a risk, however, of eliminating the monopoly
position of the intellectual property (IP) holder, although this may be justified
to ‘assure a more complete utilization and commercialization of innovative
products’.78
Compulsory licences may also be desirable in certain cases as they may fa-
cilitate further innovations, especially the case of improvements or patents
building upon previous ones. Proponents of this view also argue that IP rights
can reinforce market power in the areas of network industries. CL may also be
desirable for products which are vital to the public, such as those relating to
public health, welfare and national defence.79
CL is also supported under patent law by virtue of deadweight loss concerns.
According to the deadweight loss argument, wasteful levels of research activity
can be invested in the race to be the first to innovate and reap the first-mover
profits. The reason is that social utility is a function of the overall likelihood of
innovation which is a function of the absolute level of research activity.80 There-
fore, in line with this argument, there may be some benefits in weakening IP
protection through CL as it results in a reduction in wasteful activity.
Indeed, in certain cases, considerations of explicit costs and opportunity costs
could militate against the provision of a particular product or service at a higher
rather than a lower level.
The socially optimal level of a particular good is the level at which the marginal
benefit of providing another unit is equal to the marginal cost of providing an addi-
tional unit. Pointing to the fact that CL will lead to a less-than marginal level of R&D
is not dispositive as the social cost of providing those additional units of research
may outweigh their social utility.81
78
C.M. Fauver, Compulsory Patent Licensing in the US: An Idea Whose Time Has
Come, 8 J Intl. L Bus. 666 (1988).
79
Ibid.
80
T.C. Bailey, Innovation and Access: The Role of Compulsory Licensing in the
Development and Distribution of the HIV Drug, U. Ill. J. L. Tech. & Pol’y 193, 2001.
The author refers to the work of P. Tandon. The author explains that competing firms
will engage in absolute levels of research that exceed the point at which such activity
contributes positively to social utility, as it may contribute to the firm’s individual utility
by increasing the likelihood that it will invent first and reap the profits. In a dynamic
model, relaxation of patent protection may lead a firm to refrain from competition, and
although that may reduce research activity at an absolute level, the level may be socially
optimal avoiding wasteful activity. A firm will have an incentive to invest in a particular
industry as long as the profits earned in that industry are more than the average profit
rate of industry as a whole, assuming there are no barriers to entry. Hence, in such in-
dustries, weakening patent protection may not actually decrease innovation, or at least
may reduce it to an optimal level. P. Tandon, Optimal Patents with Compulsory Licensing
90(3) J. of Polit’l Econ’y 470–86 (1982).
81
Ibid.
The social costs include the potential consumers who would be able to afford
a product or service in a competitive market but who cannot afford it at
monopoly prices. ‘This is the deadweight loss associated with monopoly
pricing’.82
CL has also been severely criticised, however, as it is feared that it reduces
incentives for the original innovation.83 This rests on the assumption that a re-
duction in incentives would dramatically reduce the level of investment. It is
also argued that a compulsory licence would discourage the IP owner to engage
in further research as he would have normally used the profits from the IPRs
for this purpose. Empirical evidence is ambiguous on this matter. For example,
an analysis of patenting activity from 1954 to 1956 has shown that patent owners
subject to CL significantly reduced their patenting activity.84 By contrast, a 1975
study did not find any evidence that CL adversely affected corporate R&D ex-
penditure.85 It would seem, therefore, that the effect of CL is also dependent on
other factors, such as first-mover advantages and royalty rates.86
82
Ibid. Hence, the concept of deadweight loss considers the consumers who are
not able to afford the monopoly product, and the wasteful levels of research activity in
the race to reap the first-mover profits.
It should be noted, however, that this is part of a general problem and used as an argu-
ment on behalf of those advocating a liability system. See, for example, C.T. Taylor and
Z.A. Silberston, The Economic Impact of the Patent System, Cambridge, Cambridge
University Press (1973), pp. 198–9.
83
V. Korah, Compulsory Licenses and Incentives to Invest in Innovation and Com-
pulsory Licenses, OECD (1998).
84
F.M. Scherer, The Economic Effects of Compulsory Patent Licensing, New York,
New York University Monograph Series in Finance and Economics (1977), pp. 43–50.
See also C.T. Taylor and Z.A. Silberston (1973) op. cit. pp. 198–9 which shows that
British pharmaceutical executives believed that some forms of licensing could harm
innovation.
85
H. Hovenkamp, J. Mark, M. Lemley, Intellectual Property and Antitrust: An
Analysis of Antitrust Principles Applied to Intellectual Property law, New York: Aspen
Law & Business, c. 2002, 2003 Supplement. See also F.M. Scherer (1977) op. cit.
pp. 43–50. He concludes that the licensing had no long-term negative impact on licensors’
innovation, even for industries like pharmaceuticals. Indeed, companies subjected to
compulsory licensing actually spent more, on average, on R&D than similar firms in
their industry that had not been subjected to compulsory licensing. A study of Canada’s
compulsory licensing programmes found similar results, i.e. that there was no negative
impact on pharmaceutical innovation. D.G. McFetridge, Intellectual Property, Technol-
ogy Diffusion, and Growth in the Canadian Economy, in Competition Policy and
Intellectual Property Rights in the Knowledge Based Economy, R.D. Anderson and N.T.
Gallini (eds) (1998), p. 65.
86
See, for example, C.V. Chien, Cheap Drugs at What Price to Innovation: Does
the Compulsory Licensing of Pharmaceuticals Hurt Innovation? 18 Berkeley Technology
Law Journal 853 (2003), pp. 21–2 who analyses the effects of compulsory licensing and
states that it is likely to depend not only on the price that will be set but also two other
(c) Grounds for Granting a Compulsory Licence

A survey of European and international IP law reveals that there are three pri-
mary grounds for CL: where a dependent patent is blocked; where a patent is
not being worked; or where the public interest so dictates whether because it
relates to food or medicine, to an antitrust remedy, to national defence or to the
sovereign.87
Accordingly, the TRIPS Agreement provides for three main cases in which
CL may arise. These include:
l
the non-use of a patent for three years from its grant or four years from
its application;
l when necessary to use a second otherwise infringing patent that consti-
tutes an important technical advance of considerable economic
significance; and
l in cases of extreme urgency, crisis, or to remedy anti-competitive
behaviour.88
While the provisions relating to CL are sufficiently broad to cater for different
interpretations, the Agreement on Trade-Related Aspects of Property Rights
(TRIPS Agreement) lays down some procedural safeguards that should be
followed in exercising the discretion to grant a CL. They stipulate that govern-
ments should consider the cases on their individual merits, that prior to the
authorisation of third party use there should be an effort to negotiate a volun-
tary licence on reasonable commercial terms, and that the government
provides adequate remuneration taking into account the economic value of
significant factors, namely, ‘market significance’ and ‘predictability’. Market significance

refers to the extent to which a licensee actually threatens the patentee’s market, while
predictability refers to the extent to which a licensor anticipates a compulsory licence.
‘Unpredictable licenses that cover only existing technologies are more limited in scope
than those that are predictable and cover future inventions. Although unanticipated loss
of exclusivity that accompanies an unpredictable compulsory license may influence a
company’s decisions about investing in follow-on innovation, development and com-
mercialization, the licensing event may come at a point that is too late for the company
to change course. This is not the case with an order that requires licensing of future pat-
ents. The licensor may choose to redirect R&D investment, put off inventive activity
until the license has expired, or choose trade secret over patent protection.’ See also
Chapter 5 at 5.3.2.4 on harm to incentives.
87
The survey shows that some states merely refer to a broad notion of public interest
that could potentially include these more specific considerations, whereas others refer
more particularly to these three grounds. See survey of patent laws in Table 3.2. See also
G. Julian-Arnold, International Compulsory Licensing: The Rationales and the Reality,
1993 IDEA 349.
88
TRIPS Agreement (1994) op. cit.
the authorisation.89 Article 32(f) of TRIPS also requires that use should be
authorised predominantly for the supply of the domestic market.90
3.2.4.2 Analysis of the role of CL
(a) The Role of CL in Balancing Commensurability

As was shown above, it would seem that neither the EUE nor the patent pools
solutions are adequate in addressing the potential blocking of access to upstream
innovation. In such a technological environment, it would seem that the CL
provisions could serve many functions. On the one hand, it might work as a
factor to induce voluntary licensing, and on the other hand, it could be used as
a safety net to address substantive concerns.91
The usefulness of the CL provisions in the context of research tools depends
on both the substantive and the practical aspect. Substantively most countries
contemplate licences where the public interest so dictates. This diverts the ques-
tion to the interpretation of ‘public interest’. Other countries refer more
specifically to the specific cases of non-use, dependent patents and emergency
or anti-competitive situations.92
(i) CL as a mechanism to induce broad licensing CL may be used as a means

to encourage and induce broad licensing techniques. Evidence has shown that
89
It should also be noted that some of these requirements may be waived in cases
of national emergency.
90
Related to this provision is the issue of the extent to which a country that has no
manufacturing capacity of its own could use CL to compel manufacturers in another
country to export to it. This issue is particularly relevant to developing countries, as the
South Africa and Brazilian experiences have shown. However, this issue is not addressed
in the present paper. In such cases, however, CL works to reduce the adverse effects that
patents may have on prices and availability. For developing countries, the issue which
needs to be resolved centres on how to overcome limitations on prospective importing
states as to the sources of the products, and of exporting states in their capacity to estab-
lish economies of scale. See F. Abbott, Compulsory Licensing for Pubic Health Needs:
The TRIPS Agenda and the WTO after the Doha Declaration on Public Health, Quaker
UN Office, February 2002, p. 16. See also the recent developments with the Proposal for
a Regulation of the European Parliament and of the Council on Compulsory Licensing
of patents relating to the manufacture of pharmaceutical products for export to countries
with public health problems, COM/2004/0737 COD 2004/0258.
See also the Netherlands Policy rules on issuing compulsory licenses pursuant to the
WTO decision WT/L/540 on the implementation of paragraph 6 of the Doha Declaration
on the TRIPS Agreement and public health, under s.57(1) of the Kingdom Act on Patents
of 1995 available at www.cptech.org/ip/health/cl/netherlands-export-rules.html.
91
With regard to the latter, see H. Hovenkamp, J. Mark, M. Lemley (2003) op. cit.
para. 6-53, who state that: ‘compulsory licensing should be used as ‘a last resort’.
92
See survey of patent laws in Table 3.2.
even the threat of CL is effective in exerting power on firms to reach a consen-

sual agreement on licensing. Hence in cases where the upstream patentee would
have otherwise refused to deal with a downstream competitor, the possibility of
a compulsory licence might be effective in obtaining a voluntary licence.
The Brazilian experience is illuminating in this respect.93 The government of
Brazil threatened to produce pegylated interferon locally, which is a medicine
used to cure Hepatitis C, unless the branded producers reduced their price. This
led to an agreement between the government and the patent-holder, Roche, who
offered to sell the drug in Brazil at an additional 40 per cent discount in order
for Brazil to refrain from issuing a compulsory licence. The practical value of
CL, therefore, is not only its use, but also ‘that the threat of it usually induces
the grant of contractual licences on reasonable terms, and thus the objective of
actually working the invention is accomplished’.94
(ii) CL for non-use It is in the interest of every state to promote the working
of the patents as this assures the supply of new and better goods.95 Non-use
provisions are therefore implemented in order to promote local working of the
inventions and to forward the public interest in having access to novel and de-
sired subject matter.96
It is argued that this type of CL would not serve as a possible safety net in
the context of research tools as they address different issues. The research tool
problem is grounded on lack of access rather than a lack of any kind of working
of the patented invention.
(iii) CL for significant technological advances It is also possible to have

recourse to a provision allowing for the granting of a licence in cases in which
a product or process would otherwise be infringing a first patent, and which
represents an important technological improvement of considerable economic
significance.97
93
J. Reichman and C. Hasenzahl (2002) op. cit. p. 97.
94
Ibid. See also Roche’s bid for a compulsory licence in May 2001 of Chiron’s
blood screening patents in Germany, which led to a licensing agreement between the
parties. See www.cptech.org/ip/health/cl/cl-eu.html.
95
Bhatnager, GATT Intellectual Property Protection Proposals in Context with
Developing Countries and the Paris Convention, 40 Patent World 33 (1992).
96
G. Julian-Arnold (1993) op. cit. p. 349. See also S.P Ladas, Patents, Trademarks
and Related Rights: National and International Protection, Cambridge: Harvard Uni-
versity Press (1975), §§ 245–9, pp. 423–36.
97
This provision existed in Art. 21 of the 2000 version of the Proposal for a Council
Regulation, however, it was not included in the 2004 version. EC Commission Proposal
for a Council Regulation on Community Patent, 1 August 2000, COM (2000) 412 final
This is broadly referred to as the dependent patent, as it cannot be worked

without infringing the earlier issued patent.98 If a licence agreement has not
been reached, the dependent patent cannot be used. The ramifications of this
depend on the value of the second patent in relation to the first patent. Hence,
the hold-up problem could be significant where the improvement is of much
larger value than the original patent. In some countries, the delay in introducing
the improvement is perceived as being contrary to the public interest in having
the unencumbered working of all patented inventions.99 To this end, CL provi-
sions seek to remedy this situation.
For example, Art. 36 of the Swiss Patent Law provides that: ‘If a patented
invention cannot be used without violating the prior patent, the owner of the
more recent patent shall have the right to the grant of a licence to the extent re-
quired for such use of his invention, provided that that invention serves a purpose
entirely different from that of the prior patent, or that it involves a considerable
technical advance’. The rationale is to provide incentives for the promotion of
technical and economic development.
Industry-specific similar provisions have also been created such as the Euro-
pean Directive on Biotechnological Inventions that allows breeders to request
a CL if it has not been possible to acquire or exploit a plant variety without in-
fringing a prior patent.100 It also allows for CL where the patent holder cannot
use a protected variety without infringing third party rights.101
While these provisions may be desirable, it is questionable whether they are
sufficient as they have been narrowly interpreted and so only applied in excep-
tional cases.102 For example, the provision on substantial improvements was
Doc. 7119/04 PI 18, Revised Proposal for Council Regulation on the Community Patent,
8 March 2004.
See also UK section 48 Patents Act 1977; France Art. L 613.15 Industrial Property
Code 1992; Netherlands, section 57 Patent Act 1995. For example, in the UK
s.48(3)(d)(ii) provides that three years after the date of patent grant a compulsory li-
cence may be granted where the working of another patented invention is being
prevented or hindered by the refusal to grant licences on reasonable terms. This is
subject to the condition that the compulsory licensee is prepared to cross-license its
own dependent patent on reasonable terms. (section 48(7) PA 1977). None the less,
this case of compulsory licensing has not been the subject of litigation in the UK. See
M. Kern (1996) op. cit.
98
See G. Julian-Arnold (1993) op. cit p. 349.
99
Ibid. See survey in Table 3.2.
100
Biotech Directive (1998) op. cit. See also UK SI 2002/247 on Patents and Plant
Variety Rights (Compulsory Licensing) Regulations 2002 that envisage compulsory li-
censing in cases constituting ‘significant technical progress of considerable economic
interest in relation to the invention protected by the patent’.
101
Ibid.
102
M. Kern (1996) op. cit.
applied by the German Federal Patent Court on 7 June 1991, in favour of the
granting of a CL.103 In this case, Bioferon owned a patent for a pharmaceutical
product, polyferon, for the treatment of chronic polyarthritis and it also held
dependent patents on specific uses of human immune interferon. The Court
found that there was a public interest in the medical use of polyferon which was
dependent on the dominant substance patent, however, in December 1995, the
Federal Supreme Court ruled that a CL would not be granted if the public inter-
est could be satisfied with an alternative mechanism of equivalent effect. On the
facts, it found that the substantially improved therapeutic properties had not
been established.104
It is noteworthy that a study published in 1990 has shown that the last depend-
ent compulsory licence in Japan had been granted more than 20 years before,
and that the Federal Court in Switzerland had not dealt with such a case since
the law had come into force in 1956.105
In cases involving a significant technological advance impeded by another
patent and raising public health concerns, one could potentially envisage the
use of CL under this provision to remedy the blocking effect, however, the use-
fulness of this approach has not been tested thus far.106
It should also be noted that it is unclear whether this provision can only be
used for improvements or if it can also be used for dependent downstream
technology. The wording of the Community Patent Regulation only provides
for a second infringing patent, therefore it, prima facie, covers both cases.
However, it seems that this provision would be inadequate to deal with cases
raising similar issues such as research tools, as use is required prior to any po-
tential patent. Hence, it would seem that this provision could not be used in
cases of blocked access to an upstream innovation for downstream research, as
opposed to patents that have already been granted.107
(iv) CL to address health emergencies Most countries have provisions in

their patent laws relating to the grant of CL in situations involving a national
103
‘Zwangslizenz’ Federal Supreme Court (BGH), 5 December 1995, GRUR 1996,
190; 24 IIC 397 (1993). See also Grounds for Granting Compulsory Licensing, at www.
southecentre.org.
104
See Grounds for Granting Compulsory Licensing, at www.southecentre.org, p. 4.
For a critique of the strict interpretation of the notion of ‘public interest’ by the Court,
see M. Kern (1996) op. cit.
105
W.G. Walter, Compulsory Licenses and Dependent Patents, 21 IIC 532 (1990).
106
See IPR Helpdesk, Some Basic Issues Surrounding Improvements Made to Pat-
ented Invention and to Dependent Patents, at http://www.ipr-helpdesk.org/.
107
As it was shown earlier, downstream research to potentially obtain a second patent
would not be exempted under the experimental use exemption, as it would constitute
commercial use and experimenting with as opposed to on the invention.
emergency108 which may include health emergencies.109 Some countries, such

as the USA, have even enacted more sector-specific legislation to cater for the
particular interests affected by pharmaceutical patenting.
In this way, the Public Health Emergencies Act110 gives the US Secretary of
Health and Human Services broad discretion to issue CL to address public health
emergencies.111 It also provides that, in the determination of reasonable remu-
neration, account should be taken of the following factors: the risks and costs
associated with the invention; the efficacy and innovative nature and the impor-
tance of the invention or of products using the invention to public health; the
degree to which the invention has benefited from publicly funded research; the
need for adequate incentives for the creation and commercialisation of new in-
ventions; the public interest in health care services; the public health benefits
of wider access to inventions; the benefits of making inventions available to
working families and retired persons; and the need to correct anti-competitive
practices or other public interest considerations. The USA has also enacted the
Affordable Prescription Drugs Act,112 that seeks to use competition to bring
108
See section 24(1) of the German Patent Act which states that ‘If the applicant or
patentee refuses to permit the exploitation of the invention by another person offering
to pay reasonable compensation and to furnish security therefore, that person shall be
given authority to exploit the invention if permission is indispensable in the public
interest.’
See also Art. L.613-16 of the French Code on Intellectual Property which provides
for compulsory licensing of patents ‘if required in the interest of public health’. Accord-
ing to WHO’s publication, Globalization and Access to Drugs, Implications of the
WTO/TRIPS Agreement, WHO, November 1997, this law authorised this procedure when
patented drugs ‘are only made available to the public in insufficient quantity or at ab-
normally high prices’.
See also according to G. Julian-Arnold (1993) op. cit. p. 349 who states that in Greece
‘for imperative reasons of public health, if the invention has been insufficiently exploited
to satisfy local needs a license may be granted’.
On health emergencies, see Proposal for Regulation of the European Parliament and
Council on Compulsory Licensing of patents relating to the manufacture of pharmaceuti-
cal products for export to countries with public health problems, COM (2004) 737.
109
See Doha Declaration, WT/MIN(01)/DEC/1 November 2001 5(c) providing
‘Each member has the right to determine what constitutes a national emergency or other
circumstances of extreme urgency it being understood that public health crises … can
represent a national emergency, or other circumstances of extreme urgency.’
110
Public Health Emergencies Act HR 3235, 6 November 2001.
111
The anthrax scare in 2001 led the DHHS Secretary Thomson to seek a large
stockpile of ciprofloxacin (Cipro) that would be sufficient to treat 10 million people.
However, as the quantity was greater than Bayer was able to produce in a timely manner,
Thomson was asked to issue compulsory licences to generic manufacturers on 16 Octo-
ber. For more information see www.cptech.org/ip/health/cl/recent-example.html.
112
Affordable Prescription Drugs Act HR 1708, 27 April 2001.
down the cost of the prescription drugs. If the patent privilege is misused at the
expense of consumers, generic competition is seen as having an important role
in ensuring broader access and reasonable prices. HR 2927 also provides for
the CL of certain patented medical inventions.113
The Competition Commission in South Africa found that GlaxoSmithKline
and Boehringer Ingelheim had contravened the Competition Act of 1998 and
abused their dominant positions in the anti-retroviral markets by virtue of exces-
sive pricing in respect of ritonavir, lamivudine, ritonavir+lamivudine and
nevirapine.114 Therefore, this may provide another avenue to give effect to the
predominance of health concerns.
(v) CL as a remedy for anti-competitive conduct The final ground for grant-
ing a compulsory licence is to remedy practices found to be anti-competitive.115
In this context, it is possible to contemplate a situation in which a compulsory
licence could be imposed if a dominant firm refuses to grant access to its up-
stream innovation, thereby impeding innovation on downstream research or
follow-on innovation. This might represent a threshold that is lower than the
dependency provisions within the patent system as it does not necessitate the
existence of a significant technological advance of considerable economic inter-
est. In this respect, it may be broader and more effective than the dependency
provision. On the other hand, it should be remembered that liability for a uni-
lateral refusal to deal is only imposed in anti-trust law on dominant undertakings
and not on a general level. The implications of this type of CL are not dependent
on the internal patent provisions but rather on the external anti-trust
determination.
(b) Conclusions on CL
CL is envisaged to take many different forms in order to cater for the potential
problems relating to research tools. The outcome largely depends on the inter-
pretation and the recourse made of the provisions relating to public interest/health
emergency, dependent patents and anti-competitive practices.
In view of the uncertainty of pharmaceutical patent protection regarding its
effect on prices, profitability and innovation, it is difficult to evaluate the desir-
113
Affordable Prescription Drugs Act, HR 2927, 23 September 1999.
114
For an extensive discussion see www.cptech.org/ip/health/cl/recent-examples.
html.
115
While this has not been found to be a ground justifying CL in most European
national patent laws, it is within the scope of lawful CL under TRIPS, and could find its
way into national law if it is deemed desirable through the interpretation of ‘public inter-
est’ which is present in most national systems. See survey of CL provisions in Table
3.2.
ability of compulsory licences. A study which analysed the effects of CL on the

R&D expenditure of firms and sought to establish whether the incentives to in-
vest were hampered by such licences, found that in relation to the 70 companies
surveyed, a negative effect on R&D could not be established, and that there was
even a discernible rise in comparison to similar companies that were not subject
to such licences.116
As was shown, however, much depends on the interpretation and application
of the patent provisions as an overly narrow interpretation could render them
useless.117 Julian Arnold has found that compulsory licences have rarely been
applied in cases where dependent patents were blocked.118 This is due to the
practical problems associated with the fact that an improvement on the inven-
tion must be made prior to an application, a patent must have been granted,
the improvement patent must survive the possible length of the opposition
proceedings, and an attempt to voluntarily reach an agreement must have been
made. The dependency provisions might prove to be even less helpful in the
context of research tools as they apply to secondary patents and not research
as such.
CL may also prove to be problematic due to the costs associated with patent
litigation. ‘The costs of the litigation in the AZT patent case were estimated at
$100,000 per day, and it is common in the US for parties to spend more than
$1million to litigate a patent dispute.’119 In cases where access is needed to
simply carry out research with the research tool which is at a stage where it is
unclear whether it will be successful, these practical obstacles might be decisive
and might render CL inefficient.
Empirical evidence from other European countries confirms that although
some form of compulsory licence scheme exists, it is rarely exercised in prac-
tice.120 For example, statistical data for the German Federal Patents Court, which
116
See F.M Scherer, The Patent System and Innovation in Pharmaceuticals, Cam-
bridge, Harvard University Press (1998), pp. 107–8; Grounds for Granting Compulsory
Licensing, www.southcentre.org, p. 6. It is also known that pharmaceutical companies
spend more on advertising and promotion than on R&D which is hard to justify in the
case of life-saving drugs such as antiretrovirals, that are essential and do not require ad-
vertising. See F. Abbott (2001) op. cit. p. 41.
117
See, for example, in Australia where only one application has been made to the
Federal Court for a CL on the grounds that ‘the reasonable requirements of the public
with respect to the patented invention have not been satisfied’. This claim was rejected.
See ACIP (2004) op. cit.
118
G. Julian-Arnold (1993) op. cit.
119
J. Love, Implementing TRIPS safeguards with particular attention to administra-
tive models for compulsory licensing of patents, WHO meeting in Harare, Zimbabwe,
21 August 2001.
120
See M. Kern (1996) op. cit. p. 2.
was founded in 1961, shows that until the end of 1991 there had been only 12
cases in which parties had instituted proceedings for compulsory licences.121
In practice, compulsory licensing is not greatly used. Between 1991 and 1993, the
Patent Office did not receive any applications for compulsory licenses, although be-
tween 1988 and 1990 it received eight. As Jeremy Phillips has pointed out however,
these figures do not necessarily tell the whole story. The licensing provisions also act
as a form of deterrent against abuse – or to look at it another way, of encouragement
to grant licenses voluntarily. Actual applications under s. 48 may therefore be re-
garded as instances where the compulsory license provisions have failed, while on
many other occasions they may have been successful in encouraging voluntary
agreements.122
Despite this, some governments might even be unwilling to impose a com-

pulsory licence in cases of national emergency due to the uncertainty over the
potential compensation. It has been suggested that the reluctance of the Bush
administration to act in a way that would ‘override’ the patent, could be attrib-
uted to the concern over what the Treasury might thereafter charge for lost
revenues. ‘As a consequence of concerns about uncontrolled or unpredictable
costs, public health officials will act conservatively and expose the public to
higher risks.’123
In conclusion, while CL might be associated with different contexts, the most
relevant patent law situation relates to dependent patents. The interpretation and
practical use of this provision has thus far been quite limited, therefore in its
current form it is doubtful whether it would be helpful in the context of research
tools. Apart from internal licensing, there are only two other instances that might
be helpful in the research tool context, which include cases of ‘extreme urgency’
including public health and CL as a remedy to anti-competitive conduct. How-
ever, as these involve licences outside the patent system, they need to be
analysed externally, in line with their own system. The application and inter-
pretation of both of these cases as an effective means to address follow-on
innovation concerns are discussed in the following section. In this regard, it will
be endeavoured to ascertain the implications of the right to health on the duty
to deal and how this may potentially cater for situations of blocked access to
essential research inputs.
121
Ibid.
122
R. Battcock, IPRs, software copyright and competition law: restricting the rights
of intellectual property owners in the wider public interest, available at www.cptech.
org/ip/health/cl/cl-eu.html.
123
CPTech comments on H.R. 3235, the ‘Public Health Emergency Medicines Act’,
7 November 2001, http://lists.essential.org, p. 1.
Table 3.2 European national provisions for compulsory licensing and on the
experimental use exemption
Country Applicable statute Compulsory licensing Patent infringement

provisions limitations-
experimental use
exemption
Austria Austrian Patent Law § 36. CL for

(Patentgesetz 1970) as – non working
last amended by the – dependent patents
Law No. 234 of where of
23 May 1984 ‘considerable
commercial or
industrial
significance’
– public interest
Denmark The Consolidate CL for Art. 3(3) excuses non-
Patents Act – non working (s.45) commercial use and
Patents Act No. 479 – dependent patents if use for experimental
1967 as last amended reasonable in view purposes relating to the
by Act No. 733, of its importance subject matter of the
27 Nov. 1989 (s.46) invention
– if required by
important public
interests (s.47)
Finland Finnish Patents Act CL for Section 3: exclusive
Patent Law – non working (s.45) right does not apply to
(Patenttilaki) No. 550 – dependent patents if ‘use of experiments
1967 as last amended ‘reasonable’ (s.23) relating to the
by Act No. 243, – where ‘considerable inventions as such’
21 Mar. 1997 public interest’
(s.47)
France Intellectual Property CL for non-working L. 613-6 ‘acts
Code and for dependent performed on an
French Patent Act patents experimental basis and
Law No. 92-597 (as Art. L 613-16 in the which relate to the
last amended by Law interests of public object of the patented
No. 96-1106 1996) health, patents granted invention’
for medicines …
See also Use of
Inventions for Service
of State Section 78 (for
the maintenance of
supplies essential to
life, for promoting
productivity…)
Table 3.2 continued

experimental use
exemption
Germany German Patent Act Section 24(1) where Section 11 No.2 ‘acts
Patent Law of 16 Dec. the public interest so done for experimental
1980 as last amended commands purposes which are
by Law of 25 Oct. 1994 related to the subject
matter of the patented
invention’
No.1 excuses private
uses for non-
commercial purposes
Greece Technology Transfer, §§ 13, 14 CL for Art. 10 (2) a. non-
Inventions and – non-working professional or research
Technological – dependent patents if purposes
Innovation Law ‘significant progress
1733/1987 as last in comparison with
amended by Law No. invention of prior
17/39 1987 and patent’,
Presidential Decrees – imperative reasons
No. 54/1992 of public health or
national defence
(Art. 14)
Italy Law on Patents for §54 CL for non Art. 1(3) exclusive
Inventions; Royal working, dependent rights do not extend to
Decree No. 1127 1939 patents ‘important non-commercial use/
as last amended by technological experimental use/
Legislative Decree No. improvement’ private use
198 1996
Netherlands Dutch Patent Act 1910 – Section 34(1) Section 30(3) ‘acts
as last amended by the compulsory license exclusively done for
Act of the Kingdom of based on ‘public experimental purposes
29 May, 1987 interest’ relating to the subject
– Section 34(2) and matter of the invention,
(3) for non-use including the product
– Section 34(4) to obtained directly as a
enable use of result of applying the
younger patent patented process’
Table 3.2 continued

experimental use
exemption
Norway Patents Act No. 9 1967 §§43 50 CL for Art. 3 excuses

as amended by Act No. – non-working experiments outside
104, 20 Dec. 1996 – dependent patent professional activities
‘important – or experiments relating
technological to the subject-matter of
advance of the invention
considerable
economic
significance’,
– ‘important public
interests’
Portugal Industrial Property CL for Art. 98 on experimental
Code Decree Law No. – non-working (art. purposes
16/95 1995 103)
– dependency when
considerable
technological
advance (art. 107)
– public interest incl.
public health or
national defence
(Art. 102)
Spain Spanish Law on §86 CL for Art. 52 patent rights
Patents No. 11 (20 – non-working not extend to ‘acts
March 1986) as last – dependent patents carried out for
amended by Law 50, so long as the experimental purposes
1998 invention has which relate to the
‘distinctive subject matter of the
industrial objectives patented invention.’
or represents Also exemption as to
considerable private and non-
technical progress’ commercial use.
– ‘reasons of public
interest’ where
paramount for
public health or
national defence
Also special provisions
for cases of medicines
and public health.
Table 3.2 concluded

experimental use
exemption
Sweden Swedish Patents Act CL when Section 3: excludes use

No. 837 1967 as last – non working (s.45) from exclusive right
amended by Act No. – dependent patents that is not commercial,
1406 of 1998 where reasonable use for experiments
(Patentlag) (s.46) which relate to the
– required by public invention …
interests of extreme
importance (s.47)
Switzerland Federal Law on Patents CL for Implicit support for
for Inventions 1954 (as – Art. 40(1) ‘public EUE via Art. 26(1) No.
last amended on interest’ 3 – disclosure not
24 March 1995) – Non-working Art. sufficiently clear and
Swiss Patent Act 37 complete is a nullity
– dependent patents and Art. 36
Art. 36 when acknowledging
important dependent inventions
technological or patents.
advance of
significant
importance
UK UK Patents Act 1977 Section 48(3) Section 60(5) ‘acts
as last amended by the – Non working done privately and for
Copyright, Designs and – dependent patent ‘if purposes that are not
patents Act 1988 the working of an commercial’ ‘for
invention which experimental purposes
makes a substantial relating to the subject
contribution to the matter of the invention’
art is hindered’
– demand not met …
Section 51 CL in
consequence of report
of Monopolies and
Mergers Commission
where would be in
public interest
Sections 55–57 on
Crown Use for public
interest
European Directive 98/44/EC on Art. 12 ‘significant See recent endorsement
Communities legal protection of technical progress of of Bolar exemption
biotechnological considerable economic See EPC Art. 27(b) for
inventions interest’ EUE
4. The right to health as an interpretive
principle of patent law
In a state of law, the right to life, and in consequence the right to health, receives
particular attention. Any economic criterion that pretends to annul the exercise of
such rights must cede in importance … because without the right to life all of the
other rights are useless … Of what use are all other rights and guarantees, the institu-
tions and programs, the advantages and benefits of our system of liberties, if even
one person cannot count on having the rights to health and life guaranteed? (Alvarez
v Caja Costarricense de Seguro Social, Exp. 5778-V-97, No. 5934-97, Sala Constitu-
cional de la Corte Suprema de Justicia de Costa Rica)
4.1 Introduction
One of the particularities of the biopharmaceutical industry is that human rights
and specifically the right to health may have implications on policy making.
This is due to the nature of the goods produced as any unintended impact on
the balance may lead to an increased social cost.
The implications that the right to health might have on the patent balance
cannot therefore be overlooked. The objective of this chapter is to enquire into
the extent to which patent law could be affected by the existence of the right to
health, whether directly or indirectly.
As shown in the previous chapter, patent law does not contain specific pro-
visions for cases where the right to health might be in issue, however, it does
envisage the possibility of granting a compulsory licence in the interest of
public health. It also allows for exceptions and exclusions to be created in
the interest of ordre public, which may include health concerns in certain
cases.

See Chapter 3 and Art. 8 of the TRIPS Agreement, Principles. The reference to
‘public health’ does not directly incorporate the right to health, although one might as-
sume that the latter is included in it.

In the EU, the European Group on Ethics in Science and Technology is an inde-
pendent pluralist multidisciplinary body, which was set up in 1992 by the Commission
to advise on the ethical aspects of new technologies envisaged in Community policies
or proposed legislation.
70
The right to health 71
In order to examine the potential implications of the right to health on the

patent system and, more specifically, on the duty to deal in the pharmaceutical
industry, the following elements will be assessed:
1. Does a right to health exist and what obligations does it create?

2. Does a right to intellectual property law exist and can it be described as a
human right?
3. How does the right to health impact on patent law? How does the right to
health affect patent statutes, either through interpretation or as a means of
invalidation?
4.2 The right to health as a human right and

its status in European law
4.2.1 Introduction to the Right to Health
The right to health as a human right has its roots in the public health movement
of the nineteenth century when the first health legislation was adopted. Due to
the development of commerce and transportation, the creation of a mechanism
was sought to prevent transmittable diseases at the international level, as it was
believed that diseases would hinder international trade. Gradually, the founda-
tions for the recognition of health as a human right were laid both at national
and international level. It was quickly understood that in order to improve health,
issues such as poverty and sanitary conditions would have to be tackled.
The starting point for the protection of health can be found in the WHO
Constitution, which states that the enjoyment of the highest attainable standard
of health is one of the fundamental rights of every human being without dis-
crimination as to race, religion, political belief, economic or social condition.
The promotion and protection of health is fundamental to the individual’s well-
being and dignity and, therefore, health services became an important social
good. States have responsibilities in relation to public health, which crystallise

C.A. Toebes, The Right to Health as A Human Right In International Law, Oxford,
Intersentia- Hart 1999, pp. 15–17; P. Farmer, Pathologies of Power. Health, human rights
and the new war on the poor, Berkeley, University of California Press (2003); N. Birdsall
and E. James, Health, government and the poor: The case for the private sector, in J.N.
Gribble and S.H. Preston (eds), The Epidemiological Transition Policy and Planning
Implications for Developing Countries, Washington DC, National Academy Press (1993),
pp. 229–51.

Article 1 of the WHO Constitution, 1945 available at http://www.who.int/rare-
books/official_records/constitution.pdf.
in the obligation to create some basic conditions to protect and enhance public
health; however, this does not extend to an obligation to guarantee the well-be-
ing of every individual.
In view of its paramount importance in society, health has been recognised
as a human right in several international, regional or national human rights
treaties. There is much controversy surrounding the existence of this right, even
in the use of the term.

At the international level, it is set out in myriad international treaties including
the ICESCR GA Res. 2200, UN GAOR, Supp. No. 16, UN Doc. A/6316 (1966), 999
UNTS 171 (entered into force 23 March 1976) (see further down), Art. 24 of the Chil-
dren’s Convention (Convention on the Rights of the Child, No. 20 1989 GA Res. 44/25,
UN GAOR 44th Sess., Supp. No. 49, at 167, UN Doc. A/44/49 1989) stating ‘State par-
ties recognize the right of the child to the enjoyment of the highest attainable standard
of health …’, the International Convention on the Elimination of All Forms of Racial
Discrimination of 1965, UN GAOR Res. 2106 A(XX), and the Convention on the Elimi-
nation of All Forms of Discrimination against Women of 1979, GA Res. 34/180 UN
GAOR 34th Sess., Supp/No. 44 at 193, UN Doc A/34/36 91980 (entered into force 3
September 1981) at Art. 12.
At the regional level, there are also several instruments setting out the right to health
care and the obligation to undertake public health measures, such as Art 16 of the Banjul
Charter (African [Banjul] Charter on Human and People’s Rights, adopted 27 June 1981,
OAU Doc. CAB/LEG/67/3 rev. 5, 21 I.L.M. 58 (1982) entered into force 1986) securing
the right to the ‘best attainable state of physical and mental health’, and the European
Social Charter, ETS 35 – Social Charter, 18.X.1961, 18 October 1961 (available at www.
conventions.coe.int/Treaty/en/treaties/hetml/035.htm) Art. 11(3) referring to the obliga-
tion to take appropriate measures to ‘prevent as far as possible epidemic, endemic and
other diseases’ and Art. 13(1) to ‘ensure that any person who is without adequate re-
sources and who is unable to secure such resources … be granted adequate assistance,
and in case of sickness, the care necessitated by his condition.’
At the domestic level, the right to health has been enshrined in more than 60 national
constitutions. See The Right of Everyone to the Highest Attainable Standard of Physical
and Mental Health, Report of the Special Rapporteur, Paul Hunt, submitted in accord-
ance with Commission Resolution 2002/31, UN ESCOR, 59th Sess., Agenda Item 23,
¶ 20, UN Doc. E/CN.4/2003/58 (2003).

While the term, right to health, is most often used in international law, reference
is made in some cases to the right to health care, or to health protection. Some even al-
lege that there is no such right at all as it makes no sense to confer a right unless someone
else has the ability to meet that need. ‘So any ‘right’ to medical care imposes on someone
the obligation to provide care to those who cannot provide it for themselves.’ See D.
Kelley, Is there a right to health care, The Objectivist Centre (1993), http://www.objec-
tivistcenter.org/articles/delley_right-to-health-care.asp.
Others have described the right to health as misleading by arguing that it should be
converted to the right to health protection including the right to health care and a right
to healthy conditions. H.L. Fuenzalida-Puelma/S.S. Connor, The Right to Health in the
Americas, Pan-American Health Organization, Scientific Publication No. 509, Washing-
ton, D.C., 1989. V.A. Leary, The Right to Health in International Human Rights Law,
1(1) Health and Human Rights: An International Journal 1, (1994).
The right to health is used in the international human rights context, first, to
refer to the more lengthy detailed provisions relating to health in the WHO
Constitution and in legally binding human rights treaties, and secondly, to
emphasise the social and ethical aspects of health care and status. The concept
of a right to health implies that fundamental human rights principles such as
dignity, non-discrimination, participation and justice are relevant to issues of
health care and health status. ‘Three aspects of the right to health have been
enshrined in the international instruments on human rights: the declaration on
the right to health as a basic human right; the prescription of standards aimed
at meeting the health needs of specific groups of persons; and the prescription
of ways and means for implementing the right to health.’
Conceptualising health issues as a right emphasises their exceptional impor-
tance as social or public goals and not merely as medical, technical or economic
problems.10 It focuses on the dignity of persons as recognised in the Preamble
to the Universal Declaration of Human Rights (UDHR),11 which provides for
The right to health, however, is probably the most desirable term as it recognises a
right not only to health care, but also to underlying preconditions for health such as oc-
cupational health and environmental health. C.A. Toebes (1999) op. cit. p. 17.
See also R.K. Lie, Health, human rights and mobilization of resources for health, 4
BMC International Health and Human Rights 4 (2004).

See The Committee on Economic Social and Cultural Rights which monitors
compliance with the International Covenant on Economic, Social and Cultural Rights,
G.A. Res. 2200 (XXI), UN GAOR, Supp. (No. 16) 49, UN Doc. A(6316) 1966. This
Committee held a ‘Day of General Discussion on the Right to Health’ on 6 Dec. 1993
(the right to the enjoyment of the highest attainable standard of physical and mental
health) UN Information Service, Press Release HR/3604, 6 December 1993; R.J. Cook,
Human Rights in Relation to Women’s Health, The Promotion and Protection of Women’s
Health through International Human Rights Law, WHO/DGH/93.l; Fuenzalida-Puelma
and Connor (1989) op. cit.

V.A. Leary (1994) op. cit. p. 2.

T.C. Van Boven, The Right to Health, pp. 54–72, in R-J. Dupuy (ed.), The Right
to Health as a Human Right, Workshop, The Hague Academy of International Law and
the United Nations University, Sijthoff & Noordhoff, Alphen aan den Rijn, The Nether-
lands (1979), pp. 54–55.
10
V.A. Leary (1994) op. cit. p. 8. A. Chetley, A Healthy Business? World Health and
the Pharmaceutical Industry, London, Zed Books (1990), p. 206; R-J Dupuy (1979) The
Right to Health and Human Rights, Alphen aan den Rijn, The Netherlands: Sijthoff &
Noordhoff, 1979.
11
‘Recognition of the inherent dignity and of the equal and inalienable rights of all
members of the human family is the foundation of freedom, justice and peace in the
world.’ UDHR, GA Res. 217 A(III), UN Doc. A/810 (1948) Preamble. In the health
context, this stresses that the dignity of each person must be central in all aspects of
health, including health care, experiments etc. The focus is on the good of the individual
not the collective good.
equality or non-discrimination,12 the participation of individuals and groups in

issues affecting them,13 implies an entitlement14 and interdependence with other
rights, and that limitations should be subject to strict scrutiny.15
However, as a socio-economic right, the precise content of the right to health
is unclear. Contrary to civil and political rights which are frequently invoked in
national judicial proceedings and which are enshrined in many international
complaint mechanisms, economic, social and cultural rights are often regarded
non-justiciable at the national level, and viewed as ineffective due to the lack
of effective complaint systems at the international level. This is often due to the
reluctance of states to accept the high costs associated with ensuring entitle-
ments to health or housing or food and education.16
4.2.2 Sources of the Right to Health
Within EC law, the most relevant provisions on the right to health can be found
in the Charter on Fundamental Rights.17 The European Charter on Fundamental
Rights18 was drawn up in order to ‘strengthen the protection of fundamental
rights in the light of changes in society, social progress and scientific and tech-
nological developments by making those rights more visible in a Charter’.19
Article 35 of the Charter provides for the right of access to preventive health
care and the right to benefit from medical treatment under the conditions estab-
lished by national law and practice. It is not considered as a right to individual
12
See Art. 2 of the Universal Declaration on Human Rights GA Res. 217 A(III), UN
Doc. A/810 (1948) recognising the fundamental nature of non-discrimination in the hu-
man rights context: ‘Everyone is entitled to all the rights and freedoms set forth in this
Declaration, without distinction of any kind such as race, colour, sex, language, religion,
political or other opinion, national or social origin.’
13
The Declaration of Alma-Ata on Primary Health Care states: ‘The people have
the right and duty to participate individually and collectively in the planning and imple-
mentation of their health care.’ Declaration of Alma-Ata, adopted at the International
Conference on Primary Health Care, 12th September 1978, World Health Organization,
Geneva.
14
This means that governments have a duty to provide for individuals, not just to
society in general.
15
According to the International Covenant on Civil and Political Right, UNGA
Resolution 2200A [XX1], 16 December 1966, limitations are permitted on the rights to
liberty of movement, freedom of religion, freedom of expression and the right to freedom
of association, in the interest of protecting public health (e.g. Art. 18(3)).
16
B.C.A. Toebes (1999) op. cit.
17
Other national, regional or international relevant provisions were mentioned above.
op. cit.
18
Charter of Fundamental Rights of the European Union OJ 2000 C 364/01.
19
Ibid. Preamble.
health, but rather, a right to conditions that may lead to it. The extent and level
of protection is left to the discretion of individual states, although it stipulates
that a ‘high level of human health protection’ should be ensured.20
The right to health has been recognised on several occasions at the interna-
tional level, the most important of which include: first, the Universal Declaration
of Human Rights,21 which affirms in Art. 25(1) that: ‘Everyone has the right to
a standard of living adequate for the health and well-being of himself and of
his family, including food, clothing, housing and medical care and necessary
social services, and the right to security in the event of unemployment, sickness,
disability, widowhood, old age or other lack of livelihood in circumstances be-
yond his control.’
In addition, the International Covenant on Economic, Social and Cultural
Rights contains the following provisions:22 Art. 11(1) states that ‘The States
Parties to the present Covenant recognise the right of everyone to an adequate
20
The rights recognised in the Charter are addressed to the institutions and bodies
of the EU and to the Member States in the implementation of Union law, and therefore,
they are not building on individual pharmaceutical companies (Art. 51). Limitations on
such rights may be provided for by law if they respect the essence of these rights and
freedoms and are proportional, necessary and meet the objectives of the general interest
recognised by the Union or are necessary to protect the rights and freedoms of others
(Art. 52). Hence, it would seem that the Charter seeks to balance potentially competing
interests in particular through the proportionality and necessity principle.
Important safeguards and provisions regarding the right to health can also be found
in the European Charter of Patients’ Rights. The latter is directed to active citizenship
organisations working on patients’ rights at the national level, yet it also addresses health
care professionals, managers, governments, legislatures and administrative bodies. The
dissemination and application of the contents of the Charter is carried out on many levels,
particularly at European, national and local levels. The supremacy of the rights of patients
over financial constraints is underlined, and an attempt is made to harmonise respect for
the patients’ rights throughout the Union. It complements the Charter of Fundamental
Rights in affirming the inalienable and universal nature of these individual rights. It ex-
plains that the protection of the right to health as provided for in Art. 35 is both an
individual and a social good. The Charter proposes 14 patients’ rights which would be
concrete, applicable and appropriate to the transitory nature of the health services. The
latter includes: the right to preventive measures, access, information, consent, free choice,
privacy and confidentiality, respect of patients’ time, observance of quality standards,
safety, innovation, avoidance of unnecessary suffering and pain and personalised treat-
ment, and the right to complain and to receive compensation. The Charter effectively
stresses the need to ensure that ‘the criteria of economic sustainability do not prevail
over the right to health care’. Article 12 Active Citizenship Network. European Charter
of Patients’ Rights, 2002, available at http://www.activecitizenship.net/health/europe-
an_charter.pdf.
21
GA Res. 217 A(III), UN Doc. A/810 (1948).
22
GA Res. 2200, UN GAOR, Supp. No. 16, UN Doc. A/6316 (1966), 999 UNTS
171 (entered into force 23 March, 1976).
standard of living for himself and his family, including adequate food, clothing
and housing and to the continuous improvement of living conditions.’ According
to Art. 12(1): ‘The State Parties to the present Covenant recognise the right of
everyone to the enjoyment of the highest attainable standard of physical and
mental health.’ Article 12(2) states:
The steps to be taken by the States Parties to the present Covenant to achieve the full
realisation of this right shall include those necessary for:
(a) The provision for the reduction of stillbirth-rate and of infant mortality and for
the healthy development of the child;
(b) The improvement of all aspects of environmental and industrial hygiene;
(c) The prevention, treatment and control of epidemic, occupational and other
diseases;
(d) The creation of conditions which would assure to all medical service and medi-
cal attention in the event of sickness.
The latter is the most comprehensive provision on the right to health in in-
ternational human rights law.23 General Comment 14 of 2000 analyses the
implications of Art. 12 and its recognition of the right to the highest attainable
standard of health.24
4.2.3 Implications of the Right to Health
The right to health is dependent on and related to respect for human dignity and
the realisation of other human rights including the rights to food, life, non-dis-
crimination, equality and privacy. Within the preamble to the Constitution of
WHO, health is defined as ‘a state of complete physical, mental and social well-
being and not merely the absence of disease or infirmity’.25 However, as the
General Comment highlights, the right to health does not refer exclusively to
the right to health care but also embraces a range of socio-economic factors that
promote conditions for a healthy life, and extend to other aspects such as food,
nutrition, housing and a healthy environment.26
23
Other international provisions affirming the right to health can be found in: Art.
5(e)(iv) of the International Convention on the Elimination of All Forms of Racial Dis-
crimination, 1965; Arts 11.1(f) and 12 of the Convention on the Elimination of All forms
of Discrimination against Women, 1979; and Art. 24 of the Convention of the Rights of
the Child, 1989 op. cit.
24
E/C.12/2000/4, The Right to the Highest Attainable Standard of Health, CESCR
General Comment 14, 11 August 2000.
25
WHO Constitution (1945) op. cit.
26
See General Comment No. 14 (2000) op. cit. See also R-J Dupuy (1979) op. cit.;
International Institute for Human Rights Studies. Le médecin face aux droits de l’ homme.
Health care is therefore simply a part of the right to health, which encom-
passes broader factors as shown above. Access to medication is a critical
component of the right to health, both for epidemic and endemic diseases.27 The
right to health does not, however, guarantee the right to be healthy, as health is
a very subjective matter:
Health is a state of being, not something that can be given, and only in indirect ways
something that can be taken away or undermined by other human beings. It no more
makes sense to claim a right to health than a right to wisdom or courage. These excel-
lences of soul and of body require natural gift, attention, effort, and discipline on the
part of each person who desires them. To make my health someone else’s duty is not
only unfair; it is to impose a duty impossible to fulfil.28
4.2.3.1 Elements of the right to health

The right to health consists primarily of the right to health care and the precon-
ditions for health. It also involves two levels of obligations: those which can be
realised progressively and those which can be realised irrespective of the finan-
cial resources of a state; the scope and core content of the right to health
respectively.29
Padova: CEDAM, 1990. p. 1485; J. Montgomery, Rights to Health and Health Care, in
A. Coote (ed.), The Welfare of Citizens, Developing New Social Rights, London, Institute
for Public Policy Research/Rivers Oram Press (1992).
27
See Art. 12(2)(c) and (d) ICESCR. See A.E. Yamin, Not Just A Tragedy: Access
to Medications as a Right under International Law, 21 Boston University International
Law Journal 178 (2003).
28
L.R. Kass, Regarding the End of Medicine and the Pursuit of Health, 40 The
Public Interest 11 (1975). The right to health does not signify a right to be healthy, but
instead it contains freedoms such as the right to control one’s health and body, and enti-
tlements such as the right to a system of health protection that provides an equal
opportunity for people to enjoy the highest attainable standard of life. The latter refers
not only to the individual’s biological and socio-economic conditions, but also to the
state’s available resources and so is bound to vary. The state may not ensure good health
services, therefore ‘the right to health must be understood as a right to the enjoyment of
a variety of facilities, goods, services and conditions necessary for the realisation of the
highest attainable standard of health.’ Hence, the right to health includes not only ap-
propriate health care but also the determinants of health, and the right of individual
participation in health-related decision-making at all levels including national, commu-
nity and international levels.
29
While there are several elements which impact on health, they should not be in-
cluded in the scope of the right if they are not referred to in the treaties or protected
through other human rights, as in the case of torture and protection against compulsory
medical treatment or experimentation. M. Whitehead, The Concepts and Principles of
Equity and Health. WHO Regional Office for Europe: Copenhagen, 1990. World Health
Organization. Indicators to Measure the Realization of the Right to Health, Background
Paper for Seminar on Appropriate Indicators to Measure Achievements in the Progressive
The core content of the right to health is comprised of the following aspects:
maternal and child health care; immunisation against major infectious diseases;
appropriate treatment of common diseases and injuries; the provision of essen-
tial drugs; and an adequate supply of safe water and basic sanitation and freedom
from serious environmental health threats.30
The General Comment clarifies that the right to health depends on four ele-
ments that may be applied at the discretion of the State in line with the
availability of resources. These include:
1. Availability: public health, health-care facilities, goods and services should

be made available in a sufficient quantity at the national level.
2. Accessibility: health facilities, goods and services should be accessible to
all without discrimination. This involves non-discrimination, physical
accessibility (within safe physical reach), economic accessibility (afforda-
bility), and information accessibility (the right to seek, receive and impart
information and ideas concerning health issues though also preserving
confidentiality of personal health data). Accessibility requires that the vul-
nerable and marginalised groups are not prejudiced in any way.
3. Acceptability: this refers to the fact that facilities, goods and services must
respect medical ethics and should be sensitive to cultural needs.
4. Quality: facilities, goods and services must be of the appropriate standards
and quality.
While the right to the highest attainable standard of health is a progressively

realisable right due to resource limitations, some obligations are immediate,
such as those relating to non-discrimination and the provision of deliberate,
concrete and targeted steps.
Realization of Economic, Cultural and Social Rights. Geneva, 25–29 January 1993,
HR/Geneva/1993/Sem/BP.
30
In addition, it is believed that the services should be ‘geographically, culturally
and functionally within easy reach of the whole community’. It has also been suggested
that additional health services should be available, subject to equal access, give extra
protection to vulnerable groups and that the quality of those services should be taken
into account. Toebes (1999) op. cit., pp 287–8. See also A.E. Yamin (2003) op. cit.; P.
Carl, et al., AIDS and Human Rights in the European Communities, Utrecht, Netherlands
Institute of Human Rights (1991); L. Gostin and J. Mann, Towards the Development of
a Human Rights Impact Assessment for the Formulation and Evaluation of Health Poli-
cies, 1(6) Health and Human Rights: An International Journal 58 (1994).
4.2.3.2 Obligation to respect, protect and fulfil

As with all human rights, states have a three-fold obligation; namely, the obliga-
tions to respect, protect and fulfil.31 The obligation to respect requires that the
State should not interfere directly or indirectly with the enjoyment of the right
to health, and to refrain from denying or limiting equal access for all persons.
The obligation to protect requires the state to take measures to prevent third
parties from interfering in the attainment of the right to health,32 while the ob-
ligation to fulfil requires the adoption of appropriate legislative, administrative,
budgetary, judicial, promotional and other measures for the full realisation of
the right to health.33
The right to health could be violated in the following ways: the suspension
of legislation or the adoption of laws or policies that interfere with the enjoy-
ment of any of the components of the right to health; the failure of the state to
take its legal obligations regarding the right to health into account when entering
into bilateral or multilateral agreements with other states, international organisa-
tions and other entities such as multinational corporations; the failure to regulate
the activities of individuals, groups or corporations so as to prevent them from
violating the right to health of others and the failure to take measures to reduce
the inequitable distribution of health facilities, food and basic services.34
31
A.E. Yamin (2003) op. cit.; WHO, Indicators to Measure the Realization of the
Right to Health, (1993) op. cit.; J. Montgomery (1992) op. cit.; R-J. Dupuy (1979) op.
cit.
32
Failure to take action to restrict the harmful conduct of pharmaceutical companies
might potentially be such a breach of obligations.
33
Despite the above core and scope obligations, however, it cannot be concluded
that the right to health is justiciable as such at the international level. The term ‘recognise’
in contrast with to ‘ensure’ or ‘guarantee’, reflects its non-binding character. None the
less, some elements of the Article are justiciable such as the obligation of non-discrimi-
nation and the obligation to realise the core content.
The core content of the right to health consists of both negative (freedom from serious
health infringements) and positive (access to basic health services) obligations. When
translated into the core obligations, the obligation to respect the right to health means
that states have to respect the equal access to basic health services, and refrain from acts
that seriously encroach upon people’s health. The obligation to protect consists of the
obligation to take legislative and other measures to assure that people have equal access
to basic health services if provided by third parties, and to take legislative and/or other
measures to protect people from serious health infringements by third parties. Finally,
the obligation to fulfil requires states to adopt a national health policy and devote a suf-
ficient amount of their budget to health, and to provide the basic health services or create
conditions under which individuals have adequate and sufficient access to health
services.
34
See also E/CN.4/Sub.2/2002/9, Economic, Social and Cultural Rights, Liberaliza-
tion of trade in services and human rights, Report of the High Commissioner, 25 June
2002.
4.2.4 International Efforts to Strengthen the Right to Health
There have been some steps taken to strengthen the obligations imposed by the
right to health or its related provisions at the international level.35 The Nigerian
government was recently found to have violated the right to life, to health and
to housing, amongst other things, due to pollution and environmental degrada-
tion.36 The obligation of states is not simply a negative duty to refrain from
interfering arbitrarily with people’s rights, but also the positive obligation to
‘take all measures necessary’ to ensure that basic rights are not violated, either
by public or private entities.37
In the specific case of access to pharmaceutical products, it seems that do-
mestic courts are increasingly willing to find that the denial of access to certain
medication may constitute a violation of the constitutional right to life.38 The
35
Attempts have been made at the international level to make the right to health
more concrete. In 2002, the main UN policy-making body on human rights, the Com-
mission on Human Rights, adopted a resolution on the right to health to appoint a special
rapporteur (an independent expert) to report annually to the Commission on the extent
to which governments are fulfilling the right to health. Press release WHO/61 24 July
2002, New WHO publication explores important links between health and human rights
an area drawing increased attention. A new mechanism to create a means for individuals
to petition their governments at the international level for failure to respect, protect, or
fulfil human rights obligations is also being examined.
See also, for example, the right to life, ‘There has been a tendency to move towards
a broader and more comprehensive concept of the right to life which characterizes the
right to life not only as the legal foundation for all other rights, but also as an integral
part of all the rights that are essential to guarantee the access of every human being to
all the goods … required for the development of his/her material, moral, and spiritual
existence.’ IACHR, Status of Human Rights in Several Countries: Nicaragua, Annual
report of the Inter-American Commission on Human Rights 1993, OEA/Ser.L/V/II.85,
Doc. 9 Rev. (1994) at 465, available at www.cidh.org/annualrep/93span/cap.IVe.htm
(quoting The Right of Everyone to Own Property Alone as well as in Association with
Others, UN Commission on Human Rights, 49th Sess., Provisional Agenda Item 7, at
25, UN Doc. E/CN.4/1993/15).
36
Social and Economic Rights Action Center v Nigeria, Communication 155/96
(African Commission on Human and People’s Rights, Oct. 2001), available at www.
achpr.org/DECISIONS_30th_Session-_Oct.2001_eng.pdf.
37
See Street Children Case (Morales v Guatemala), Joint Concurring Opinion of
Judges A.A. Cancado Trinidade and A. Abreu-Burelli, Inter-Am. Ct H.R. (Ser. C) No.
63, ¶¶ 2–4, available at www.corteidh.or.cr/seriecing/VotocancadoabreuSerie_c_63_ing.
doc.
38
Costa Rica, India, Venezuela, Colombia, Argentina and South Africa are among
the many countries in which national courts have recognised an obligation on states to
provide medication in HIV/AIDS cases and for other diseases. See Minister of Health v
Treatment Action Campaign, CCT 8/02 Constitutional Court of South Africa, July 2002,
at www.tac.org.za/Documents; Ceballos v Instituto de Seguros Sociales, T-484 Corte
Constitutional Court of Colombia set out a four-pronged test in order to deter-

mine the situations in which the right to health services might be justiciable.
The health issues must implicate ‘fundamental’ rights such as life, work or edu-
cation. There must be a ‘grave and imminent threat to human life or health’
presented by the failure of the state to provide services. The claimant must be
in extreme financial and physical need of the services and there must be a pos-
sibility of providing the service.39 In this way, the right to health has been
increasingly found to be justiciable,40 and this may have implications for pat-
ented products which impact upon access to essential drugs.
In addition, with regard to private entities, the ESCR Committee clarified that
the obligation of states to protect includes, inter alia, ‘ensuring that privatization
of the health sector does not constitute a threat to the availability, accessibility,
acceptability and quality of health services; controlling the marketing of medical
equipment and medicines by third parties; and States ensuring that third parties
do not limit people’s access to health-related information and services’.41
Constitucional de Colombia 1992, available at http://bib.minjusticia.gov.co/jurispruden-

cia/CorteConstitucional/1992/Tutela/T-48492.htm; Alvarez v Caja Costarricense de
Seguro Social, Exp. 5778-V-97, No. 5934-97, Sala Constitucional de la Corte Suprema
de Justicia de Costa Rica.
See Glenda Lopez v Instituto Venezolano de Seguros Sociales, 487-060401 Supreme
Court of Venezuela, Constitutional Chamber 1997 available at www.tsj.gov.ve/deci-
siones/scon/Abril/487-060401-001343.htm. (This Court found a violation of the right
to life on the part of the social security institute by virtue of failing to provide antiretro-
viral treatment on a regular basis that could lead to an inexorable deterioration of the
immune system in addition to viral resistance, leading to opportunistic infections and
death.) See also Protection Writ. Judgment of Fabio Moron Diaz, Magistrado Ponente,
T-328/98 Corte Constitucional de Colombia 1998, available at http://bib.minjusticia.gov.
vo/jurisprudencia/CorteConstitucional/1998/Tutela/T-328-98.htm.
See also S. Shah, Illuminating the Possible in the Developing World: Guaranteeing
the Human Right to Health in India, 32 VAND. J. TRANSNAT’L L. 435 (1999).
39
Alejandro Moreno Alvarez v Estado Colombiano, SU.819/99, Corte Constitucional
de Colombia 1999, available at http://bob.minjusticia.gov.vo/jurisprudencia/Corte
Constitucional/1999/Tutela/su819-99.htm.
40
A.E. Yamin (2003) op. cit.; P. Carl (1991) op. cit.; R-J Dupuy (1979) op. cit.
41
General Comment 14 (2000) op. cit. ¶ 35.
4.3 The right to health and patent law: The

fundamental nature of health concerns
and the move towards a right to health
as an interpretive principle in patent law
4.3.1 The Link Between the Right to Health and Patent Law
4.3.1.1 The effect of patent law on the right to health

The patent system may affect health considerations, on the one hand, by leading
to reduced access to pharmaceutical products,42 and on the other hand, by re-
stricting access to products or processes that are necessary for downstream
innovation or the creation of improvements.
The increasing justiciability of the right to health coupled with the implica-
tions of the obligation to ‘protect’ highlight increased attention regarding the
duties of private entities (namely pharmaceutical companies) as regards the right
to health and specifically, in access to essential medications.
The obligation to protect the right to health also requires states to ensure that
threats by third parties are restricted. This requires the creation of institutions
to prevent and monitor the violation of fundamental rights by private actors.
The right to health may, therefore, influence the way adjudicative and legislative
bodies make decisions relating to health. It creates legal obligations and ac-
42
Generic products may have an impact on drug prices, for example, as shown in
the case of HIV drugs. The UNDP Human Development Report 2000 notes that generic
production of the HIV treatment fluconazole, a treatment for AIDS-related meningitis
in India has remained at $55 for 150 mg compared to $697 in Malaysia, $703 in Indo-
nesia and $817 in the Philippines. According to Medecins Sans Frontiéres, generic drugs
are approximately 70–90% cheaper than branded drugs. In some cases, they can be
200–300% cheaper than the branded equivalent made in the West. In Thailand, flucona-
zole, which treats cryptococcal meningitis—an infection affecting one in five of AIDS
sufferers—was supplied exclusively by US company, Pfizer, until 1998. Since local al-
ternatives have become available, the cost of a daily dosage of 400mg has fallen from
US$14 to 5% of the price. Thus, it costs only US$0.30 a day in Thailand. However, this
same drug costs US$18.00 a day in Kenya where it is patent protected. U. Ally Mwalimu,
Implications of WTO/TRIPS in East Africa-With Special Emphasis on Pharmaceutical
Patents, Economics and Social Research Foundation, Workshop on Globalization and
East Africa, 15–16 April 2002.
None the less, access to drugs is conditioned by many factors including price controls,
medical insurance, import duties and tariffs, local taxes, limited competition mark-up
for wholesale, distribution and dispensing, and hence, not solely on prices and the avail-
ability of generics. See WHO, More equitable pricing for essential drugs: What do we
mean and what are the issues? Background paper for the WHO-WTO Secretariat Work-
shop on Differential Pricing and Financing of Essential Drugs, Hosbjor, Norway, 8–11
April 2001, p. 9.
countability, not only with regard to the organisation of the health system, but
also, inter alia, in competition, pricing, licensing and other laws.43 Hence, the
right to health provisions may work as an external enforcement mechanism
imposing concrete obligations, and also have an internal impact, guiding the
interpretation and application of other laws in order to ensure consistency with
its provisions.44
4.3.1.2 The effect of the right to health on patent law

The impact of the right to health on patent law depends largely on the link be-
tween the right to health and intellectual property rights (IPRs).
The relationship between fundamental rights and IP, in general, can be viewed
in two simplistic ways.45 On the one hand, IP could be seen as a human right
and the property character of IPRs could be overemphasised at the expense of
other fundamental rights. Accordingly, the appropriate balance should be created
by the legislator and, therefore, any interference would not only hinder the dy-
namics of the system, but would also be undemocratic. At the other extreme
there can be the view that IP is merely an institution which infringes on funda-
mental rights. The reality, it is argued, lies somewhere in between these polarised
views.
Therefore, in order to establish the potential impact of health concerns and
the right to health on patent law, either externally or internally, the following
elements need to be established:
1. Is IP a human right and would this make a difference?

2. Is there an inherent conflict between IP and human rights, or more specifi-
cally, the right to health (since IP may also be a human right)?
3. How can patent laws be interpreted to fulfil the spirit of the right to health?
Does this obligation exist?
43
Therefore, the enforcement of competition rules in cases where patent holders
refuse to grant licences and charge excessive prices for their products, or issue a com-
pulsory licence in the interest of public health should be considered to support the right
to health objectives. See A.E. Yamin (2003) op. cit.
44
M.G. Bloche, WTO Deference to National Health Policy: Toward an Interpretive
Principle, 5(4) Journal of International Economic Law 825 (2002).
See also T. Mully, Intellectual Property, Fundamental Rights (and Competition Law):
Do They Interoperate? International Conference, Intellectual Property Beyond Rights,
25–26 October 2004, Hanasaari Cultural Centre, Finland. Mully argues that fundamental
rights have the greatest impact through interpretation and systematisation.
45
T. Mully (2004) op. cit.
4.3.2 The Right to Property and IP: IP as a Human Right
The right to property and more specifically IP can be found in several European
and international human right treaties. Article 1 of Protocol 1 of the European
Convention on Human Rights46 provides that:
Every natural person or legal person is entitled to the peaceful enjoyment of his pos-
session. No-one shall be deprived of his possessions except in the public interest and
subject to the conditions provided for by law and by the general principles of inter-
national law.
The preceding provisions shall not, however, in any way impair the right of a State
to enforce such laws as it deems necessary to control the use of property in accord-
ance with the general interest or to secure the payment of taxes or other contributions
or penalties.
In line with the above provisions, Art. 17 of the European Charter on Funda-
mental Rights47 provides for the right to property, however, this is subject to the
limitations, deprivations and regulation as required in the public interest and
conditions provided for in law, the general interest and subject to fair
compensation.
At the international level, the UDHR48 recognises the right of authors to the
moral and material interests resulting from their scientific, literary and artistic
productions.49 Similarly, Art. 15 of the International Covenant on Economic,
Social and Cultural Rights (ICESCR)50 provides: ‘The State Parties to the
present Covenant recognise the right of everyone: to take part in cultural life;
to enjoy the benefits of scientific progress and its applications; to benefit from
the protection of the moral and material interests resulting from any scientific,
literary or artistic production of which he is the author.’
This provision implies the recognition of the legitimate interest of the public
in intellectual productions. IPRs should contribute to the scientific, cultural and
economic enrichment of society, however, as an author, the individual also has
a right to benefit from these works.
While the provisions require states to protect the interests of authors and in-
ventors, they are in vague and general terms in order to leave a broad margin of
discretion to states regarding implementation. Therefore, exclusive property
46
213 UNTS 221 (1953).
47
C-2000 OJ 2000 364/01.
48
GA Res. 217 A(III), UN Doc. A/810 (1948).
49
See Art. 27(2): ‘Everyone has the right to the protection of the moral and material
interests resulting from any scientific, literary or artistic production of which he is the
author.’
50
GA Res. 2200, UN GAOR, Supp. No. 16, UN Doc. A/6316 (1966), 999 UNTS
171 (entered into force 23 March 1976).
rights are not the only possible means of protection, nor is the instrument itself
transformed into a human right, although the interest itself may constitute a
fundamental right. ‘Neither the Universal Declaration nor the ICESCR creates
an obligation on the part of the states to establish (and certainly not an individual
right to) exclusive rights, as the latter is only one alternative way of safeguarding
the individuals’ interests protected … This does not exclude the idea that intel-
lectual property rights may protect individual interests of fundamental rights
nature.’51
In addition, there is no minimum level of protection required, therefore, the
level of protection found in international IP instruments such as the TRIPS
Agreement easily satisfies and exceeds the requirements laid down in the human
rights instruments. Against this background of IP protection, the UDHR and
ICESCR are of little significance as protective provisions have already been put
in place.
It is problematic to consider IPRs exclusively as human rights if one considers
the nature of human rights.
Human rights are inalienable and universal claims belonging to individuals, and in
some situations to communities but never to corporations. Human rights are under-
stood to exist independently of recognition or implementation while IPRs are granted
by the State according to criteria by national legislation. In contrast with human rights
which establish permanent and irrevocable entitlements, IPRs are temporary; they
exist for a limited period and can be revoked, licensed or assigned to someone
else.52
In addition, the history of the drafting of the international human rights con-
ventions affirms the weakness inherent in the claims of IP as a human right
which was only accepted after considerable discussion and controversy.53 In
both cases, it was supported mainly because it is instrumental in the realisation
of other rights of a stronger moral basis.
What the phraseology of intellectual property as a human right does is to convert a

question of legislative policy to be addressed with fundamental rights analysis into
something changing the analytical premises of this effort: in this metamorphosis intel-
lectual property protection transforms from the object of fundamental rights analysis
(legislative policy) into its very subject, namely a fundamental right in itself not to
be interfered with even by the legislator, less to the extent required by other funda-
51
T. Mully (2004) op. cit. p. 10.
52
Report on Science and Human Rights, AAAS Science and Human Rights Program,
Winter 2002 Vol. XXII, No. 1, at http://shr.aaas.org/report/xxii/ip.htm.
53
A.R. Chapman, Approaching IP as a Human Right, Obligations related to Art.
15(1)(c), Copyright Bulleting, Vol. XXXV No. 3, 2001, UNESCO Publishing, E/C.12/
2000/12.
mental rights and sufficiently serious policy reasons necessary and proportionate in
a democratic society. As a corollary, institutional alternatives for the protection of the
interests mentioned in the human rights instruments, such as liability rules and direct
protection of creativity and innovation, are precluded as being in irreconcilable con-
flict with the intellectual property fundamental rights.54
4.3.2.1 Striking the balance: limitations in the public interest

The EU Charter and the European Convention on Human Rights (ECHR) envis-
age limitations on property rights which are necessary in the public interest.
Article 15 of the International Covenant on Economic, Social and Cultural
Rights, requires states parties to respect, protect and fulfil individual’s cultural
rights, and achieve a balance between the protection of public and private in-
terests in intellectual property.55 This balance refers, on the one hand, to the
right of everyone to take part in cultural life and enjoy the benefits of scientific
progress, and on the other hand, to the right of authors of scientific, literary or
artistic work to benefit from the protection of their moral and material
interests.
This balance is recognised in IP instruments. A balance of rights and obliga-
tions is also an objective of TRIPS,56 and limitations have been put in place to
reflect certain public interest concerns.57
This means that IP is subordinated to the general public interest. Exclusive
property rights may be overridden if it is required by important concerns such
as public health, and this is not incompatible with the right to property even if
it is considered to be a human right. Indeed, limitations have even been accepted
in the context of other human rights in the interest of public health. Under the
International Covenant on Civil and Political Rights, limitations are permitted
on the rights to liberty of movement, freedom of religion, freedom of expression
and the right to freedom of association, for the protection of public health.58
54
T. Mully (2004) op. cit. p. 11.
55
See E/CN.4/Sub.2/2001/27, on the impact of the Agreement on Trade-Related
Aspects of Intellectual Property Rights on Human Rights, Report of the High Commis-
sioner, 27 June 2001.
56
See Art. 7 TRIPS.
57
Article 8 TRIPS allows for measures to be taken that are necessary to protect
public health and to promote the public interest in sectors of vital importance to their
socio-economic and technological development. Patent protection excludes the patenting
of inventions that might be contrary to the ordre public or morality, including the protec-
tion of human, animal or plant life or health. See Chapter 3.
58
U.N.T.S. No. 14668, vol. 999 (1976), p. 171. e.g. Art. 18(3).
4.3.3 Patenting and the Right to Health
4.3.3.1 Direct effect

Patent law impacts most significantly on the right to health as it may lead to
higher drug prices in the short term and, hence, it may result in restricted ac-
cess.59 In addition, patent law encourages a specific type of research that is not
always in the public interest.60 Furthermore, patent law may affect the creation
of improvements or downstream innovation with potential implications on the
development of medical products.61
Although patent law may affect health, it is not incompatible with the right
to health. It promotes long-term health interests by encouraging research and
also by providing for the balancing of instruments in the short term, such as
compulsory licensing or exclusions in the interest of ordre public.62
For this reason, it is unlikely the right to health would have a direct impact
on patent law in general, as it would rarely be found to be unconstitutional for
infringing the right to health. Patent laws would not be created in such a way
as to overly infringe the right to health. Nevertheless, it is possible to envisage
that a state might be found to have violated the obligation to protect the right to
health, for example by failing to grant a compulsory licence in a case in which
59
There are several other factors which affect access to drugs such as rational se-
lection and the use of drugs, sustainable financing and reliable health and supply
systems. Similarly, the price of drugs is affected by factors other than just patents, such
as import duties, taxes and local market approval costs. See WHO (2001a) op. cit.
p. 9.
60
See, for example, the Orphan Drug Act created to stimulate research into diseases
that affect a small number of people, for which pharmaceutical companies would other-
wise not invest a significant amount of resources. The US Orphan Drug Regulations (57
FR 62076) 29 Dec. 1992 and CFR Part 316 et seq. In the EU Orphan Medicinal Product
Regulation (2000) op. cit. See D.M. Richardson (1987) op. cit.. See also P.J. Kenney
(1988) op. cit. S. Boseley, EU loophole sends drug prices soaring, Guardian Weekly, 24
June 2002. See also http://www.cptech.org/ip/health/orphan/.
61
See Chapter 2.
62
op. cit. As already noted, there is a group of advisers in the EU on the ethical im-
plication of biotechnology serving the interests of European society and respecting the
fundamental rights of every European citizen. The Group submits reports amongst other
on the compatibility of policies including patent policies with fundamental rights such
as the dignity of the human person. The Group gives its advisory opinion on ethical as-
pects of patenting inventions involving, for example, elements of human origin, cloning
techniques, health care in the information society and gene therapy. So, for example, in
the EU we have a Directive 98/44/EC on the Legal Protection of Biotechnology Inven-
tions OJ 1998 L213/13, excluding the patenting of inventions which would be contrary
to public order or morality, and a Directive 98/79/EC, on In-Vitro Diagnostic Medical
Devices 1998 OJ No. L 331/1 referring to the protection of the integrity of human per-
sons. See also Chapter 3.
private commercial pricing practices are ‘shown to be probabilistically related

to impaired or reduced access to medication’.63
4.3.3.2 The indirect effect of the right to health

The right to health may have indirect effects in such cases through its internal
effects on the patent system itself. ‘The obligations to respect, to protect and to
fulfil obviously overlap to some extent and indeed, the manner in which a state
enforces and interprets its legislation, including competition, patent, and intel-
lectual property legislation, in cases involving access to medicines involves
important “administrative … and other measures” needed to fulfil the right to
health.’64 Hence the objectives of the right to health may need to be read in the
patent provisions so as to guide their interpretation and application.
In the case of Odir Miranda v El Salvador,65 the refusal of El Salvador to
purchase the triple therapy and other medication to improve the quality of life
of people suffering from HIV/AIDS and to prevent deaths, was found to be a
violation of the right to life and health. The Inter-American Court of Human
Rights (IACHT) concluded that while it did not have the competence to deter-
mine violations of Art. 10 of the Protocol of San Salvador, it would take the
provisions relating to the right to health into account in analysing the merits of
the case.66 Following this reasoning, it should be possible for the provisions re-
lating to the right to health to be taken into account when applying patent law.
The Recent WTO Ministerial Declaration on the TRIPS Agreement and
Public Health recognised the gravity of health problems and stressed the need
for TRIPS to be part of the wider national and international activities to address
these problems. In this regard, it was stated that the TRIPS Agreement ‘does
not and should not prevent Members from taking measures to protect public
63
A.E. Yamin (2003) op. cit. p. 207; P. Drahos, Biotechnology Patents, Markets and
Morality, 21(9) EIPR 441 (1999); B. Cornish, M. Llewelyn, M. Adcock, Intellectual
Property Rights and Genetics. A study into the impact and management of intellectual
property rights within the healthcare sector, 2003 at http://www.phgu.org.uk/about_
phgu/resources/word/s-ipr1.doc; C. Pekari, Intellectual Property and Human Rights:
Where to after the first WSIS? at http://www.eumap.org/journal/features/2004/infohr1/
infohr/ipandhr/.
64
A.E. Yamin (2003) op. cit.; H. Hogerzeil, Access to Essential Medicines as a Hu-
man Right, 33 Essential Drugs Monitor 25, 2003 at http://www.who.int/medicines/
library/monitor/33/EDM33_25-26_Access_e.pdf; R-J Dupuy (1979) op. cit; M. White-
head, The Concepts and Principles of Equity and Health, Copenhagen, WHO Regional
Office for Europe (1990).
65
Odir Miranda v El Salvador Case 12.249, Report No. 29/01, Inter-Am. CHR,
Annual Report 2000, OEA/Ser./L/V/II.111, Doc. 20 Rev. 2001 available at www.cidh.
oas.org/annualrep/2000eng/ChapterIII/Admissible/ElSalvador12.249.htm.
66
Ibid. ¶ 36.
health’.67 It also affirmed that the TRIPS Agreement should be interpreted and
implemented in a manner supportive of WTO Members’ right to protect public
health.
Furthermore, in 2000 the Sub-Commission on Human Rights affirmed the
primacy of human rights obligations over economic policies and agreements.68
Therefore, international human rights law addresses the need to ensure that the
TRIPS Agreement, and hence, the Community IP provisions which are consist-
ent with the former, should not be implemented in a way that negatively impacts
on the enjoyment of human rights as provided for in international human rights
instruments.69 States parties must take action that is conducive to realising the
right to health, and as recognised in Doha, the TRIPS Agreement ‘can and
should’ be interpreted in a manner that supports their obligations with regard
to the right to health.
67
In the main Doha Declaration, it was stated that: ‘We recognize that under WTO
rules no country should be prevented from taking measures for the protection of human,
animal or plant life or health, or of the environment at the levels it considers appropriate,
subject to the requirement that they are not applied in a manner which would constitute
a means of arbitrary or unjustifiable discrimination between countries where the same
conditions would prevail, or a disguised restriction on international trade, and are other-
wise in accordance with the provisions of the WTO Agreements’ (para 6) Doha
Declaration (2001) op. cit.
See also R. Elliott, Realizing the right to health: access to HIV/AIDS-related medica-
tion, 3 April 2002 at http://www.aidslaw.ca/Maincontent/issues/cts/righttohealth.doc.
As clarified by the Doha Declaration, the TRIPS Agreement must be interpreted in
accordance with the rules of public international law found in the Vienna Convention on
the Law of Treaties, which requires that the interpretation of a Treaty must take subse-
quent agreements on the interpretation of the Treaty, subsequent practice, and any
relevant rules of international law into account. As the Doha Declaration is an example
of a ‘subsequent agreement’, the TRIPS Agreement can and should be interpreted and
implemented in a manner supportive of the right to protect public health and promote
access to medicines for all. Hence, the TRIPS Agreement must be interpreted in this way
in order to be consistent with the obligation to protect, respect and fulfil human rights,
including the right to health.
68
E/CN.4/SUB.2/RES.2000/7, United Nations High Commissioner for Human
Rights, Intellectual Property and Human Rights, Sub-Commission on Human Rights.
This was reiterated in the UN Resolution of the Sub-Commission on Human Rights
2001/21. See also E/C.12/2001/15, Human Rights and Intellectual Property Issues,
Statement by the Committee on Economic, Social and Cultural Rights, 26 November
2001, Intellectual Property and Human Rights (Geneva: World Intellectual Property
Organization and the Office of the United Nations High Commissioner for Human
Rights, 1999), WIPO Publication No. 762(E).
69
Ibid.
4.3.4 The Right to Health as an Interpretive Principle in Patent Law
The Report of the High Commissioner on the Impact of the TRIPS Agreement
on Human Rights70 stresses the importance of a human rights approach to IP.
This approach relies upon striking a balance with the primary objective of pro-
moting and protecting human rights without causing a negative impact on any
other rights in the Covenant. ‘Human rights are the first responsibility of
Governments.’71
A human rights approach to IP differs in some ways from commercial IP
rights. A human rights approach to IP highlights the often implicit balance be-
tween the interests of the public and the right holder, and makes it more explicit.
‘The human rights approach is predicated on the centrality of protecting and
nurturing human dignity and the common good. The goal is to improve human
welfare and not to maximize the economic benefit. From a human rights per-
spective IP protection is understood more as a social product with a social
function and not primarily as an economic relationship.’72
A similar approach has been advocated in the context of trade liberalisation.
In 2002, the need for the WTO to endorse a human rights approach to trade and
promote and protect human rights was recognised in the Report of the High
Commissioner on the liberalisation of trade.73
This approach, amongst other things, involves setting the promotion and
protection of human rights among the objectives of trade liberalisation, taking
the rights of individuals into account in determining the effects of trade liber-
alisation, and promoting international cooperation for the realisation of human
rights and freedoms in the context of trade liberalisation. Hence consideration
must be paid to the protection of human rights in negotiating, implementing
70
E/CN.4/Sub.2/2001/27, The Impact of the Agreement on Trade-Related Aspects
of Intellectual Property Rights on Human Rights, Report of the High Commissioner, 27
June 2001.
71
Vienna Declaration and Program of Action, World Conference on Human rights,
25 June 1993.
The TRIPS agreement envisages human rights as exceptions to the rule rather than as
an explicit guiding principle.
72
A.R. Chapman, The Human Rights Implications of Intellectual Property Protec-
tion, in 5 Journal of International Economic Law 861 (2002). See also D. Weissbrod and
K. Schoff, Human Rights Approach to Intellectual Property Protection: The Genesis and
Application of Sub-Commission Resolution 2000/7, 5(1) Minnesota Intellectual Property
Review 1-46 (2003); T.A. Lipinski and J.C. Pekari, J Britz, Rethinking the ownership of
information in the twenty first century: Ethical implications, 2 Ethics and Information
Technology 49–71 (2000).
73
E/CN.4/Sub.2/2002/9, Report of the High Commissioner, Economic, Social and
Cultural Rights, Liberalization of trade in services and human rights, 25 June 2002.
and interpreting the scope of GATS and in assessing the limitations of trade
practices.
In addition to this interpretive requirement, GATS also includes general ex-
ceptions to protect public morals as well as human, animal and plant life and
the protection of certain aspects of individual privacy.74 The report lists some
types of action to promote a human rights approach to the liberalisation of trade
in services, including: the guarantee of equal access for basic services; the
preservation of states parties’ right and duty to regulate; encouraging compatibil-
ity with human rights in the interpretation of GATS; undertaking human rights
assessments of trade policies; the provision of international cooperation and
assistance and increasing dialogue between human rights and trade.
4.3.4.1 Effect on specific patent provisions

It would therefore seem that a human rights approach to IP would require that
the limitation provisions and those relating to compulsory licensing (CL) should
be given a broader interpretation, and that health issues should be considered
in the application of standards relating to patentability.75 This would require a
more explicit consideration of the public’s interests to the detriment of the eco-
nomic interests of individual right holders.76 A human rights (or at least a right
to health) approach would differ from the approach of IP law, as it would place
greater emphasis on the interests of the public in the short term, as well as in
the long term.
For example, if the application of a law could potentially impact on the right
to health, a right to health standard should be applied as a guiding principle.
This could be seen in the case of patent law, subverting issues such as compul-
sory licensing to address health concerns and exceptions to patentability to the
right to health body of law. In this way, patent law could incorporate the right
to health standards in its decision-making process.
The use of human rights as an interpretive principle in the patent CL provi-
sions would not only require that the provision referring to ‘extreme urgency’
including public health, would be judged from a human rights perspective, but
74
Ibid.
75
See, for example, the interpretation of ordre public as involving something ‘abhor-
rent to the overwhelming majority of the public or a contravention of the totality of
accepted norms’ op. cit.
76
See, for example, A.R. Chapman (2002) op. cit. who contends that many factors
indicate that IP rights are inconsistent with the human rights approach, and perhaps even
human rights law in general. These include: the fact that IP does not necessarily protect
the rights of the inventors, especially in the case of employment; the lack of democratic
control and participation; and the often inadequate protection of the human interest or
ethical concerns.
Patent scope
Public health, including

the right to health as
determined by human
rights law and public
policy; not IP law.
Figure 4.1 What the CL provisions show in relation to IP and public health
it would also potentially affect the interpretation of the CL provisions relating

to significant technological advances. In such cases, it might lead to a more leni-
ent application of the provisions and, also, to a lower threshold for CL. If the
impact of the improvement on public health is deemed to be significant, it will
be easier to prove that a technological advance has taken place.77 In addition,
77
Apart from the interpretive principle to be used in cases of CL or to exclude spe-
cific cases from patentability, it might also be possible for the principle to become a
defence to patent infringement. Cases of a similar nature have been brought in the USA,
in which the question has been posed in terms of the First Amendment guarantee of
freedom of speech, and the extent to which it may be used as a defence to copyright in-
fringement. See Howard Hughes case 366 F.2d 303 (2nd Cir. 1966). See Time Inc. v
Bernard Geis Associates NYLR, 21 January, 1994, p. 5 (CD Cal. June 11, 1993). In
Germany see LG Berlin (Photographs of Ulrike Meinhof) [1978] GRUR 108 and BGH,
7 March 1985 (Lili Marleen) [1987] GRUR 34. See also Pinto, The Influence of the Eu-
ropean Convention on Human Rights [2002] EIPR 217; P. Loughlan, Looking at the
Matrix: Intellectual Property and Expressive Freedom [2002] EIPR 30; Dutch Scientol-
ogy decision [2003] Mediaforum 337, note Visser; (2003) 6 AMI 217, note Hugenholtz;
(2003) 6 IER 352, note Grosheide. An appeal to the Supreme Court is pending. In this
case, while an infringement of the copyright was found, it was argued that it was dispro-
portional in comparison to the general interest in freedom of information of Art. 10, para.
1 of the ECHR and therefore the publication was allowed. It should also be noted that
the Dutch Civil Code provides for cases of abuse of copyright including cases where
there is a disproportionate balance between the interest protected and those harmed by
the exclusive right. ((Civil Code Art. 3:13): ‘Instances of abuse of right are (1) the exer-
cise of a right with the sole intention of harming another or (2) for a purpose other than
that for which it was granted or (3) the exercise of a right where its holder could not rea-
sonably have decided to exercise it, given the disproportion between the interest to
exercise the right and the harm caused thereby.’) See also H.C. Jehoram, Copyright and
in considering exclusions on the grounds of ordre public, the right to health

would also need to be considered.
4.3.4.2 Case-law on public health

Health emergencies provide sufficient ground for derogating from the rules laid
down in TRIPS, which on the one hand reflects the potential supremacy of hu-
man right concerns such as the right to health, and on the other hand, it
demonstrates the flexibility granted by the TRIPS Agreement allowing for the
consideration and implementation of fundamental concerns, such as those relat-
ing to the right to health.78 The experience of both Brazil and South Africa reflect
these considerations.
In South Africa, the debate centred on the 1997 Medicines and Related Sub-
stances Control Amendment Act, which represented a response to the HIV/AIDS
crisis and the lack of access to affordable drugs. This Act authorises the govern-
ment to determine the extent to which a specific drug patent may apply, and to
authorise parallel imports from other countries where the same medicine is also
manufactured.79
The pharmaceutical companies challenged the first provision of this Act, al-
leging that it was unconstitutional in granting too much discretion to the
government in determining the circumstances in which patents could be cur-
tailed. The upholding of the right to curtail patent rights would appear to confirm
the supremacy of health concerns. The Act could either be seen as compatible
with the limitations provided for in the patent system itself and thereby consti-
tutional, or it could be found that the right to property did not allow for such
interventions in the exclusivity and was unaffected by the right to health, and
therefore be found to be unconstitutional.
The petition was abandoned in April 2001 in the face of strong public opposi-
tion. While we can only speculate on the outcome of the case, the abandoning
Freedom of Expression, Abuse of Rights and Standard Chicanery: American and Dutch
Approaches, 26(7) EIPR 275, 2004.
In such instances, use of the defence is rare, although IP statutes are increasingly being
openly read and narrowly construed in order to take the requirements of freedom of ex-
pression into consideration. Hence, it might be that one could legitimately raise the
defence of the right to health in a patent infringement case, although it is more likely
that the latter would work as a ground for the granting of a CL rather than a right to in-
fringe it. Otherwise, this would lead to private companies being found to have infringed
the right to health by restricting access to drugs, despite acting in line with patent law.
However, it is difficult to imagine that the right to health would ever be entrenched to
such a degree.
78
Cullet (2001) op. cit.
79
Section 15C of the Medicines and Related Substances Control Amendment Act
1997 (Republic of South Africa, Government Gazette, 12 December 1997).
of the case could be interpreted as support for the predominance of health

concerns.
The Brazilian experience could also be seen as a reflection of the flexibility
envisaged in TRIPS in order to give effect to human rights. In this case, the
government made a decision to facilitate access to drugs in the face of the
HIV/AIDS crisis by implementing a strong CL regime. It was stipulated that
unless it was economically unfeasible, inventors had a duty to manufacture the
products in Brazil. The US government objected to this requirement and initiated
WTO complaint proceedings, on the grounds that the ‘local working’ require-
ment constituted a protective industrial policy measure inconsistent with the
provisions of the TRIPS Agreement. Following some bilateral negotiations, the
case was withdrawn after a few months.
Brazil has gone further than TRIPS in recognising the possibility for CL
for national emergencies and public interest, as well as establishing the rules
for the granting of these licences and defining the public interest to include
public health, nutrition, the protection of the environment, and elements of
primordial importance for technological, social or economic development.80
The fact that the case was dropped could be read as the acceptance of the
subordination of patent policy to the public interest or at least it could be in-
terpreted as reflecting the flexibility of patent protection in addressing health
emergencies.
In line with the TRIPS Agreement, the parties are permitted to address na-
tional emergencies and public health issues without infringing patent laws, by
interpreting the flexibility in a manner that is conducive to the public interest
and health. This would be consistent with the right to health as an interpretive
principle in patent protection.81
4.3.4.3 European cases on IP and fundamental rights analysis

Within the EU framework, the ECJ has handed down two judgments on IPRs
involving fundamental rights, although it should be noted that neither of these
cases involved the right to health.
In Netherlands v Council and Parliament, the ECJ analysed the Biotechnol-
ogy Directive.82 In this case, the ECJ stated that the granting of a patent does
not preclude legal limitations from applying to research into or the exploitation
of patented products. It further held that the purpose of the Directive was not to
80
See WTO, WTO Agreements and Public Health, A Joint Study by WHO and the
WTO Secretariat, 2002, pp. 104–6.
81
M.G. Bloche (2002) op. cit.
82
Case C-377/98 Netherlands v Council, Judgment of the Court of 9 October 2001,
ECR I-07079.
place restrictive provisions guaranteeing compliance with certain ethical rules

outside the scope of the Directive.83
The ECJ adopted a narrow reading of fundamental rights by finding that they
are ‘misplaced as against a directive which concerns only the grant of patents’.84
The ECJ thereby insulated ethical and fundamental rights considerations from
the granting of the patent and, in this way, it could be argued that its approach
differs significantly from the idea of a human rights interpretive principle. ‘The
potential existence of restrictive provisions outside patent law does not exclude
the need to take fundamental rights into account also within patent law. When
the exclusion from patentability is related to the protection of a fundamental
right, the patent law principle of narrow interpretation of exclusions from pat-
entability becomes very problematic.’85
In Metronome Music v Music Point Hokamp the ECJ considered whether the
Directive on rental and lending rights was consistent with the freedom to pursue
a trade or a profession and also with the right to property.86 The Advocate Gen-
eral Tesauro had contended that Art. 27(2) recognises copyright as a human
right and the Court found that the granting of an exclusive right ‘certainly con-
stitutes the most effective form of protection …’. 87 The Court also found that
the freedom to pursue trade or profession cannot be interpreted in isolation from
the general principles relating to IPRs.
Insofar as the Court omitted any reference to the ‘collective good’ provided
for in the human rights treaties and in the public interest, the reasoning is insuf-
ficient. In addition, the view that the exclusive property regime is the least
restrictive and most effective regime, can be criticised as the right to IP does
not precipitate exclusive rights and a liability system could also be put in place
to safeguard these interests.88
In both cases, the ECJ did not attribute any particular importance to the fun-
damental rights in interpreting IP and, to this extent, it appeared to be in favour
of stronger IP protection.89 This is regrettable as it is set against the background
83
Ibid. para. 79–80. See also M. MacLaren, Patently Unsatisfactory?: Community
Legislative Competence and the ECJ Biotech Decision, 2 German Law Journal 18
(2002).
84
Ibid. para. 79.
85
86
Case C-200/96, Metronome Music v Music Camp, Judgement of the Court of 28
April 1998, ECR I-01953.
87
Ibid, para. 24.
88
See Chapter 5 at 5.3.1.2. However, the Court also referred to the right to property
(in addition to the freedom to pursue trade or profession) as not being absolute but rather
should be viewed ‘in relation to their [its] social function’ which could be used in future
cases in such way as to support the public interest.
89
of the proliferation of IPRs and the increasing concerns in the biopharmaceutical

industry,90 although arguably, if the right to health had been at stake, the ECJ
might have ruled otherwise.
To the extent fundamental rights analysis does not form part of the balancing
instruments within IP laws, a right to health interpretive principle should be
endorsed where applicable.
4.4 Conclusions
In this chapter it was shown that the right to health constitutes a central concern
and continues to be one of the primary obligations of governments. It assumes
a particular significance in relation to the biopharmaceutical industry, as goods
are used to enhance the quality of life.
The right to health has become increasingly justiciable, particularly in coun-
tries where access to medication has become a national emergency. In this
context, the relationship between the right to health and patent law has become
critical.
In general, the right to health and the right to IP (whether this is regarded as
a human right or not) are not incompatible.91 It is, therefore, unlikely that the
right to health would have a direct impact on patent law in the sense of finding
the latter unconstitutional. None the less, the subordination of the analysis of
IP rights to the public interest plays a pivotal role, and in light of these condi-
tions the right to health could be decisive as an interpretive principle to patent
law.
The Doha Declaration clarified that TRIPS should not prevent members from
taking action to protect public health and that the flexibility provided for in
TRIPS could be used for this purpose. It also highlights that the TRIPS Agree-
ment should be interpreted and implemented in line with the right to protect
health and promote access to medicine for all and highlights the importance of
the reference to the ‘balance’ of interests within the objectives and principles
of TRIPS.
The right to health as an interpretive principle would most likely have the
greatest impact in the interpretation of the CL provisions and the provisions
relating to exclusions in the interest of the ordre public. In the case of CL, it
would direct the determination of ‘extreme urgency’, ‘public health’ and
90
See Chapter 2.
91
Patent law deals with long-term health considerations by providing the incentive
for the development of pharmaceutical products. In addition, patent law contains a provi-
sion allowing for CL in cases that are warranted by public health and other similar
provisions such as the interest of ordre public.
‘public interest’ to the health provisions and related considerations. It could

also serve to lower the threshold of CL in cases involving secondary dependent
patents of significant economic advantage. In such cases, an invention would
be more likely to warrant a licence if it has clear relevance to public health
concerns.
The international trends demonstrate a wider application of fundamental
rights analysis and the increased justiciability of the right to health. On the
other hand, the ECJ has considered fundamental rights in relation to IP on two
occasions, and in both cases that analysis worked to strengthen IP protection,
making no reference to the ‘public interest’. While it is true that there has not
been a case in which the right to health has been explicitly violated in the EU,
the health interpretive principle to patent law, where applicable, would appear
to be consistent with its obligations and with the international trends in this
domain.
None the less, the health interpretive principle does not resolve the problem-
atic issues in the biopharmaceutical industry. The principle is directed more to
end product accessibility and dissemination rather than access to research inputs,
therefore, in the absence of a patent mechanism, a right to health interpretation
would not be helpful. Imposing a direct obligation in cases involving access to
inputs to carry out downstream research to ensure consistency with the right to
health would be too far-fetched, as it involves potential innovation with only
potential effects on health.92
In the absence of more general IP provisions, competition may have a role
to play in this instance of restricted access to necessary inputs to downstream
innovation.93 This would also be consistent with the obligations of states to
protect the right to health, and ensure compliance in their interpretation of
competition laws.94 In a situation of alleged conflict between patent law and the
potential health and right to health implications, the human rights approach
could require more flexibility in analysing competition law provisions.95 Indeed
92
See also the attempt of families of children afflicted with Canavan disease, a rare
genetic disorder of the brain, to sue the research scientists who had patented the gene in
an effort to ensure broader and improved licensing terms. P. Gorner, Parents Suing Over
Patenting of Genetic Test, Chi. Trib., 19 November 2000, p. 1.
93
See Chapter 7.
94
‘Strong enforcement of anti-competition rules where patent holders refuse to grant
licenses to generic producers and excessively price their products is therefore a measure
that can and should be taken ‘to reduce the inequitable distribution of health facilities,
goods and services’ in contemplation of the ESCR Committee’s General Comment No.
14.’ Statement by consumer project on technology, concerning an alleged prohibited
practice in terms of section 49B(2)(a) of the Competition Act 89 of 1998, Feb. 2003 at
http://www.cptech.org/ip/health/cl-cases/rsa-tac/cptech-statement-3feb2003.doc, p. 12.
95
H. Hogerzeil (2003) op. cit.; B. Cornish et al. (2003) op. cit.
the recent South African judgment which found an abuse of a dominant position
by virtue of excessive pricing could be seen as a move in this direction.96
96
Elijah Paul Musoke, Tom Myers, AIDS Healthcare Foundation Limited, and GlaxoSmith-
Kline (Pty) Ltd, Glaxo Group Limited, Case Number 34/CR/Apr04, in which the South
African courts found GlaxoSmithKlyne to have abused its dominant position by virtue
of the excessive price of drugs. See also the South African Competition Tribunal’s deci-
sion and order in Pharmaceutical Wholesalers and Glaxo Wellcome, Case 68/IR/Jun00,
18 June 2003 at www.comptrib.co.za/decidedcases/pdf/68IRJUN00kinesis.pdf, and Case
No. 15/CAC/Feb02. See Chapter 7.
PART III
Antitrust as a complement to the patent system

5. Unilateral conduct, intellectual
property rights and competition law: a
systems’ interaction
5.1 Introduction
The relationship between intellectual property (IP) and competition is a contro-
versial subject. Whilst both share a common objective, namely, the enhancement
of consumer welfare and promoting innovation, some problems arise as they
operate in different ways.
Antitrust seeks to achieve the object of maximising allocative and productive
efficiency by preventing monopolistic output reduction and unlawful restric-
tions on competition, whilst intellectual property rights (IPRs) endeavour to
achieve the same result by providing a legal monopoly as an incentive for in-
novation and for the manufacture of new and cheaper products. ‘In the short run
consumers are supplied with an additional choice, albeit at a monopoly price;
and in the long run when the patent expires, the industry as a whole can produce
more and at lower cost.’
Hence, while the relationship between IP and competition is no longer
perceived as inherently conflictual, and the possible pro-competitive role of
IPRs has been recognised, at least for long-term competition, there are still
cases where EC competition law will intervene if it is perceived that the short-
term impact on competition outweighs the long-term efficiencies. This is
usually the case where the patent holder is able to extend his legal monopoly
beyond the statutory grant, often to overlap with an economic monopoly, or
to pursue aims against the letter and the spirit of the EU competition
provisions.

Allocative efficiency presupposes that the price mechanism will ensure that pro-
ducers produce what the consumers want, and productive efficiency presupposes that
competition from other producers will produce at near optimum costs. See S. Anderman,
EC Competition Law and IPRs: The Regulation of Innovation, Oxford University Press
(1998), p. 17.

R. Merkin, The Interface between Antitrust and Intellectual Property [1985] ECLR
377.
101
102 Antitrust as a complement to the patent system
Table 5.1 EC Treaty relevant provisions
EC Treaty Wording
Provisions
Art. 3 For the purposes set out in Art. 2, the activities of the
Community shall include…
(c) an internal market characterised by the abolition, as
between Member States, of obstacles to the free
movement of goods, persons, services and capital…
(g) a system ensuring that competition in the internal market
is not distorted…
Art. 28 Quantitative restrictions on imports and all measures having
equivalent effect shall be prohibited between Member States.
Art. 29 Quantitative restrictions on exports and all measures having
equivalent effect shall be prohibited between Member States.
Art. 30 The provisions of Arts 28 and 29 shall not preclude
prohibitions or restrictions on imports, exports or goods in
transit justified on grounds of … the protection of industrial
and commercial property. Such prohibitions or restrictions shall
not, however, constitute a means of arbitrary discrimination or
a disguised restriction on trade between Member States.
Art. 82 Any abuse by one or more undertakings of a dominant position
within the common market or in a substantial part of it shall be
prohibited as incompatible with the common market in so far
as it may affect trade between Member States. Such abuse may,
in particular consist of:
(a) directly or indirectly imposing unfair purchase or selling
prices or other unfair trading conditions;
(b) limiting production, markets or technical development to
the prejudice of consumers;
(c) applying dissimilar conditions to equivalent transactions
with other trading parties, thereby placing them at a
competitive disadvantage;
(d) making the conclusion of contracts subject to acceptance
by the other parties of supplementary obligations which,
by their nature or according to commercial usage, have no
connection with the subject of such contracts.
Art. 295 This Treaty shall in no way prejudice the rules in Member States
governing the system of property ownership.

Unilateral conduct, intellectual property rights and competition law 103
Whilst it has been repeatedly recognised that the grant and scope of IPRs is
a matter for national law, in the absence of harmonisation, the ECJ and the
Commission have also repeatedly confirmed that the exercise of IPRs can be
subject to competition control and, in certain cases, the unilateral refusal of an
IP holder may even be found to constitute an abuse.
This chapter examines the relationship between the two bodies of law as ap-
plied to unilateral conduct. The approach of the European Courts is examined
against the economic theory and the conclusions are drawn in the final section.
5.2 The practice of the courts

Article 82 of the EC Treaty prohibits the abuse of a position by dominant un-
dertakings. However, the precise content of an abuse in the case of IPRs is a
contentious issue. The Commission and Courts have struggled to draw a clear
distinction between a lawful exercise of exclusivity and an unlawful one, under
Art. 82.
The whole debate on how competition should deal with IPRs and whether it
is able to trump national IP laws, can be traced back to Art. 295, which provides
that the Treaty ‘shall in no way prejudice the rules in Member States governing
the system of property ownership’. In an attempt to uphold Art. 295, the Courts
and Commission came up with several doctrines seeking to balance the national
character and independent status of property rights with the Community laws
and policy objectives.
In general, the Courts and Commission have followed an approach that dis-
tinguishes IP from other cases, thus, a more favourable stance is taken whereby
the exercise of exclusivity will only constitute an abuse in exceptional cases.
5.2.1 The Existence/Exercise Distinction
The tensions that have been traditionally perceived between national IPRs and
EC competition law has led the Commission and Courts to try to achieve a bal-
ance between the two bodies of law, most significantly, distinguishing between

Case 89/205 Magill [1995] ECR I-743.

See case-law analysed in 5.2.

A-G Jacobs in Oscar Bronner (Case C-7/97 [1998] ECR I-7791) referred to the
essential facilities doctrine in relation to IPRs: ‘Where such exclusive rights are granted
for a limited period, that in itself involves a balancing of the interest in free competition
with that of providing an incentive for R&D and for creativity. It is therefore with good
reason that the Court has held that the refusal to license does not of itself, in the absence
of other factors, constitute an abuse.’
the existence and exercise of IPRs. According to this doctrine, the existence of
an IPR would be unaffected by competition law, while competition law could
control the way these rights were exercised in certain cases.
The origin of this distinction can be found in the competition law case of
Consten and Grundig, in which the Court stated that the Commission’s decision
did not affect the grant of the rights but only limited their exercise in order to
avoid a presumed violation of Art. 222 of the Treaty of Rome (now Art. 295)
(providing that the ‘Treaty shall in no way prejudice the rules in Member States
governing the system of property ownership’).
Following this judgment, the doctrine was criticised as being incoherent and
unnecessary. ‘The existence/exercise distinction appears to have arisen from a
hasty response by the Court to Consten’s and Grundig’s argument regarding
Art. 222 (now Art. 295).’ Marenco and Banks note that ‘the Court could have
given a wholly different answer by pointing out that Art. 222 (now Art. 295) is
not a guarantee of property (as is Art. 36) (now Art. 30) but a provision ensuring
that the Treaty does not detract from the freedom of Member States (MS) to
determine the private or public ownership of enterprises’.
In the context of the free movement (specifically Arts 30 and 36) (now Arts
28 and 30) the doctrine was believed to be necessary at a time when IP laws
were only national in nature. It was felt that a balance had to be struck between
the need to respect national IP laws while also ensuring that they were not used
in a way to impede the free movement within the Community. In this way, the
doctrine was used to justify a de facto harmonisation of IPRs.
In an attempt to distinguish between the existence and exercise of IPRs in line
with the principle of free movement, the court then developed the specific subject
matter concept (SSM),10 referred to elsewhere also as the ‘essential function’.11
‘The exercise of IPRs in a manner inconsistent with Art. 30 is only permitted
under Art. 36 if such exercise is in the course of protecting the SSM.’ 12

Case 56 and 58/64 Etablissements Consten SA and Grundig-Verkaufs-GmbH v
Commission [1966] ECR 299.

T.C. Vinje, Magill: Its Impact on the IT industry [1992] EIPR 397.

Marenco and Bancs, IP and the Community Rules on Free Movement: Discrimina-
tion Unearthed, 15 ELR 224 (1990).

When IPRs are reviewed under Art. 36, the Court ‘strikes out one part of national
IP law’. IPRs are ‘interpreted’ and applied in order to ensure compatibility with Com-
munity law. See Myrick, Will IP on Technology still be Viable in a Unitary Market [1992]
EIPR 9.
10
Case 78/70 Deutsche Grammophon [1974] ECR 1147.
11
See Commission Decision DSD and others, OJ 2001 L 319/1, in which it was
stated that the crucial question concerns the essential function.
12
S. Smith, The Changing Approach of the European Court to Intellectual Property,
at www.solent.ac.uk/law/ssmith2.html, p 8. See also M. Van Der Wal, Art 86: The Limits
In the competition law context, however, it is questionable whether these

concepts are applicable.13 Control is not directed to state measures but rather
individual entities. Article 36 requires that the restrictions on imports should be
‘justified’ by the protection of IPRs. Article 295, which is applicable to the
competition rules, does not include this requirement. ‘Arts 85 and 86 (now Arts
81 and 82) should not be invoked to limit the substance of IPRs under national
laws. The ECJ, at least in competition cases, will not attempt to second guess
the national legislature’s wisdom in granting an author or inventor a particular
right.’14
In addition, the existence/exercise distinction is not particularly helpful in
distinguishing a permissible use from an abuse of IPRs. ‘An obligation upon
the proprietor of a protected design to grant third parties, even in return for a
reasonable royalty, a licence for the supply of products incorporating the design
would lead to the proprietor thereof being deprived of the substance of his ex-
clusive right.’15 In cases where national law grants an IPR, its existence cannot
generally be divorced from its availability in each particular case.
The SSM doctrine did not assist in clarifying the demarcation of unlawful
conduct.16 ‘Abusive exercise requires certain additional features over and above
the mere refusal to allow others to use the protected rights.’17 Similarly, in
Magill, it was stated that the aims of Art. 86 should be respected, thus rendering
the attempt to make this distinction largely redundant.18 The abusive element
of Compulsory Licensing [1994] ECLR 231; Reindl, The Magic of Magill: TV Program
Guides as a Limit of Copyright Law? [1993] IIC 60; A. Robertson, Compulsory Licensing
Under EC Law? [1992] LQR 39.
13
S. Smith op. cit. p 8. ‘The distinction between the inviolability of the exercise of
IPRs (per Art. 222, now 295) and the vulnerability of their exercise under Treaty provi-
sions is illogical, since a prohibition on the exercise of rights means that an essential part
of the relevant law is unenforceable, and thus is an attack on the very existence of such
laws.’ Beier, Industrial Property and Internal Market, 2 IIC 131, 1990.
14
Myrick (1992) op. cit.
15
Case 238/87 Volvo v Veng (UK) Ltd [1988] ECR 6211.
16
See Case C-241 and 242/91P Magill [1995] ECR I-743. In this case the CFI stated
that ‘while it is plain that the exercise of the exclusive right to reproduce a protected
work is not in itself an abuse, that does not apply where in the light of the details of each
individual case, it is apparent that that right is exercised in such ways as in fact to pursue
an aim manifestly contrary to the objectives of Art. 86. In that event, the copyright is no
longer exercised in a manner which corresponds to its essential function which is …
while respecting the aims of, in particular, Art 86.’ While the Court made reference to
the essential function, it also stated that the objectives of Art. 86 should be taken into
account in determining this function.
17
Ibid.
18
See also C.G. Miller, Magill: Time to Abandon the Specific Subject-Matter Con-
cept [1994] EIPR 415, who argues for the abandonment of the SSM because it is
‘illogical, causes confusion, leads to inconsistent results and is wrong’. He describes the
related to the provisions of Art. 82 and it was the objectives that were subject
to control, rather than an exercise beyond the SSM.
Since the Magill case, the ECJ has not made reference to the existence/exer-
cise doctrine and it is hoped that it is silently pronouncing its death.19 Instead,
the ‘circumstance-based’ approach was upheld as a means of determining
whether a particular conduct constitutes an abuse. While the ‘circumstance’
approach represents a positive step as it is not reliant on an all-encompassing
rule, and allows each case to be judged according to the circumstances, it is be-
lieved that the ECJ should have provided more details on what constitutes
exceptional circumstances, and IP differs from other cases.20 Economic theory
supports the view that there is no reason to treat IP differently from other prop-
erty rights.
distinction between the exercise of IPRs and the abusive exercise of market dominance
as the source of the confusion. He draws the distinction between the copyright itself, and
the ancillary freedoms stemming from this right. He explains that abuses are exercises
of ancillary freedoms and not of copyright, which are possible because of its dominance.
It is thus unnecessary to identify the core rights as they are already set out in legislation.
Further, he argues that abuses of dominance involving IPRs are committed without the
exercise of an IPR. The author makes an analogy with real property: ‘an undertaking
that has become dominant, in part because it has built up the largest, or one of the few
largest, and most efficient manufacturing facilities in Europe. Any exercise of its rights
of property ownership over the land, buildings and machinery, to prevent competitors
coming on to his property to use his facility to compete, could prevent or restrict com-
petition. However, such an exercise can never be an abuse of market dominance. It is
plainly and simply and obviously an exercise of property rights conferred by law. This
is not an exercise of market power in order to prevent others competing. The SSM and
essential function of such rights are simply not an issue.’
19
However, see also the Commission Decision in DSD (2001) op. cit. in which it is
stated that the crucial question concerns the essential function. Some have argued that
this does not mean that IPRs have no special status, as they do not constitute per se an
abuse or require exceptional circumstances. S. Anderman, The Aftermath of Magill [1996]
Yearbook of Media and Entertainment Law 235. However, do the other refusal to license
cases constitute an abuse per se? The response would appear to be negative according
to the latest trends. And as to exceptional circumstances, it is also not clear if this alludes
to a different threshold than the general situations of a duty to deal.
20
T. Vinje, The final word on Magill [1995] EIPR 297.
5.3 IPRs and competition: A systems’

interaction
5.3.1 IPRs – Public Goods, Exclusivity and Information Goods
5.3.1.1 Public goods and market failure

IPRs are an instrument used to further public policy objectives. In an informa-
tion-based economy, policy objectives broadly refer to the desire to maximise
the net social benefits arising from new information assets, and to ensure the
equal social net rate of return on investments. More specifically, the aim is to
ensure the optimal flow of improvements and development of scientific and
technological knowledge in order to ensure that the information created is used
efficiently for the maximum social benefit of producers and consumers and that
knowledge is diffused to a desirable extent, and to ensure that the creative condi-
tions are such that the social costs of productions are minimised with regard to
the social costs of producing new knowledge and the use of existing
knowledge.21
Knowledge is an unusual commodity with many distinct characteristics aris-
ing from its intangible nature. It is difficult to define knowledge precisely or to
clearly demarcate its boundaries or specific attributes and measurements. It can
function both as a pure consumption good and as a capital good having an in-
trinsic value when combined with another asset. Therefore, for example,
information relating to a cost-reducing process has value of itself. As with clas-
sical public goods, knowledge is indivisible and durable. This means that once
it has been obtained, it can last forever, and can be used repeatedly with no need
to recreate it. Its multiple and simultaneous use will not deplete it, therefore, in
terms of consumption, it is a non-rival good.22 While someone might be impov-
erished by sharing a fish that he has caught with someone, he does not lose
anything if he teaches him how to fish, except to the extent that too many are
educated in such a way as to depend on the same embodiments of the intangible
knowledge, namely here, the fish. As with traditional public goods, information
is also non-excludable. In addition, while the cost of producing information is
21
P.A. David, IP Institutions and Panda’s Thumb: Patents, Copyrights, and Trade
Secrets in Economic Theory and History, in Global Dimensions of IPRs in Science and
Technology, Washington, National Academy Press (1993), pp. 24–45.
22
However, knowledge can often be a positional good in the sense that its value may
depend on how many other people possess it. Hence in many cases the value of informa-
tion depends on whether it is also available to other people and to how many people. It
works similar to the case of information about a shortcut to a place, that is not crowded
with cars. This might be very valuable information to a taxi driver, but if too many people
know about it then its value would be diminished.
high, the cost of transmitting knowledge is negligible in most cases. Hence, had
it not been for the incentives to create it, it should in most cases have been left
free.23
Due to these characteristics, information resembles traditional public goods
like a lighthouse, in that it can be used to the benefit of many without any deple-
tion in use, and it is non-excludable in nature. Its utility is based on its exchange
and propagation. However, contrary to other public goods, knowledge has two
additional characteristics. First, the attributes, characteristics and value of the
commodity are not known beforehand, therefore there is some asymmetry in
the distribution of information. The complete contents of information are not
known beforehand, often even by the interested parties. This renders the conclu-
sion of contracts for the production and use of new information particularly
difficult.24 Secondly, knowledge is cumulative, therefore it builds on prior
knowledge, interacts with other knowledge and involves a recombinant
process.
The problem with public goods is that because they are indivisible, not easily-
appropriable and non-rival by nature, the competitive market fails to give
sufficient incentives to induce the optimal amount of innovation. This is because
the competitive market leads prices near the marginal cost of production and
thereby even fails to cover the high fixed production costs. Every consumer is
a potential producer, supplying only at the cost of copying. This implies that in
order to protect oneself against imitation, whether by means of secrecy or oth-
erwise, the inventor will have to incur high transaction costs, thus rendering the
production and sale of the products inefficient.25 In addition, a single unit may
satisfy an infinite number of users at zero or almost zero marginal cost.26 Hence,
without intervention, as in the case of other public goods, a market failure would
result, as witnessed in the form of under-investment in information goods.27
23
For a more extensive discussion of public goods, see H. Perritt, Property and In-
novation in the Global Information Infrastructure, 1996 U. Chi. Legal Forum 261; P.A.
David (1993) op. cit. pp. 24–45; J. Boyle, Law and Economic of IPRs: Cruel, Mean, or
Lavish? Economic Analysis, Price Discrimination and Digital Intellectual Property, 53
Vand. L. Rev. 2007, 2000; Europe Economics, Global Public Goods in Health, May
2001, at www.europe-economics.com/. The costs are not only high for production, but
also to ensure that information is assimilated that learning takes place.
24
P.A. David (1993) op. cit. pp. 24–45, 28.
25
H. Perritt (1996) op. cit.
26
J. Boyle (2000) op. cit.
27
This proposition, however, is subject to the qualification that it may be time-con-
suming or impossible to copy information in certain cases, therefore, property rights may
not be required to overcome under-investment. This is apparently the case with Coca
Cola which has not been copied in the past 100 years even though it is not subject to
patent protection. See S. Shavell, Economic Analysis of Property Law, Harvard Law and
While the fact that there will otherwise be a market failure does not precipitate
the creation of private rights, due to certain characteristics of information, that
are analysed below, it would seem that it is the most desirable.
5.3.1.2 Patronage, procurement and property

There are three solutions traditionally associated with the problem of public
goods: patronage/subsidies, procurement/direct government production and
property/regulated monopoly.28 The first solution, patronage, refers to publicly
financed subsidies, while the second, procurement, refers to state taxes to finance
contracting with private parties.
Both schemes involve the supply of information without charge, although
patronage is more conducive to the speedy disclosure of information based on
reputation.29 The major drawback of both schemes is that it is almost impossible
to lay down efficient terms for the contract due to the uncertainty surrounding
the nature of the information as well as its value, due to the problem of asym-
metry. Hence, there would be very high transaction costs coupled with a huge
administrative burden, which would only lead to imperfect agreements.30
The third option, property, refers to a publicly regulated private monopoly,
which operates for a normal rate of profit, however this is not guaranteed. This
consists of granting exclusive property rights which allow for the formation of
a market, which will, in turn, provide an opportunity for the right holder to
benefit from the profits. The advantage of this approach lies in the fact that there
is no need to predetermine the economic benefits as these are left to the market.
It is the only system that allows for individuals to respond to market opportuni-
ties and in this way it also grants economic freedom to the individuals
concerned.31
Property rights are devised to allow for the efficient exploitation of scarce
resources. Right holders must choose the most efficient type of conduct, avoid-
ing problems relating to the overuse of common property, also known as the
Economics Discussion Paper No. 399, Dec. 2002, chapter 12. Indeed, without some form
of protection for information, there would be some degree of creation, reflected also in
the fact that some highly industrialised countries, such as Switzerland, did not adopt
patent legislation until recently, however, it is thought the level of creation would fall
short of the optimal.
28
P.A. David (1993) op. cit. pp. 24–45, 29.
29
Ibid. pp. 29–31.
30
See, however, S. Shavell (2002) op. cit. chapter 12, who discusses the reward
system and concludes that ‘For a variety of reasons, apparently more political than based
on consensus about the intellectual appeal of the patent system, the latter system won
out’. p. 20.
31
It is clear that not all individuals will be able to make choices to respond to the
market, as many will be excluded.
‘tragedy of the commons’.32 With regard to information, while not scarce of it-
self, its specialisation is, in the sense that its creation requires special incentives
to ensure that the creator devotes time to this task. The exclusive right turns a
public good into a private one. As a means of managing scarcity, property rights
assign the responsibility of working with the scarce resource to one individual,
as well as the benefits and losses of that decision. If property rights are transfer-
able, a market may operate and a price can be set. However, the viability of
these rights rests on the need to ensure a sufficient level of exclusivity.33
Different information goods have different public and private good charac-
teristics so that in certain cases there are sources of excludability and rivalness
negating the need for a property right. Lead time, costly copying, less than per-
fect copies, inability to use copies without the assistance of the inventor and
reputational advantages may be present in such a way in certain types of infor-
mation, that the public goods justification is obviated.34 The intellectual property
system has to strike a balance between the free knowledge, the knowledge that
is appropriable but not transferable, and the transferable exclusive rights – name-
ly the cases where protection is granted.35 Hence, the two basic questions that
IP protection faces are, first, when information deserves protection under prop-
erty rights, and secondly, the length and breadth of those rights.
Like in all systems, trade-offs are involved in the production of knowledge
and in the grant of property rights. The priority system, for example, on which
the patent system is built, allows for the speedy disclosure of inventions. This
reflects the objective of constant innovation, and rapid development. However,
32
R. Hardin, Valuing Intellectual Property, 68 Chi. Kent L. Rev. 659 (1993); M.A.
Heller, The Tragedy of the Anti-commons: Property in the Transition from Marx to
Markets, 111 Harv. L. Rev. 621 (1998).
33
E. Mackaay, Economic View of Information Law in E.J. Dommering, P.B. Hugen-
holtz, J.J. Kabel, Information Law towards the 21st century, Deventer/Boston: Kluwer
Law and Taxation Publishers (1992).
See also H. Perritt (1996) op. cit. Perritt justifies the grant of property rights based on
the transaction costs of public goods stemming from their characteristics of non-rivalness
and non-excludability. Every consumer is a potential source of supply at only the cost
of copying and that increases transaction costs. Property rights mitigate free riding by
increasing the pirate’s costs so that he not only incurs the marginal cost of copying, but
also the legal costs of expected liability. As with all property rights, they are limited in
some way by the needs of the public. See also R. Merges, IPRs and Bargaining Break-
down: The Case of Blocking Patents, 62 Tenn. L. Rev. 75 (1994), where the property
basis of IPRs is defended as it grants the remedy of an injunction that is desirable in view
of the difficulty of calculating the losses resulting from copying.
34
H. Perritt (1996) op. cit. p. 269.
35
This is also reflected in the different forms of protection for information according
to its perceived merit. Some information may be protected by trade secret law and tort
and contract law, while other might warrant strong property rights.
it also leads to a rush to innovate and rivalries amongst inventors based on a

winner-take-all solution. Too many inventors in the race to innovate and to be
the first to discover or file a particular invention are likely to lead to common
pool problems associated with the fact that people will be individually minded
without consideration of their effects on other competitors.36 It may also lead to
allocative inefficiencies. In addition, as the IP systems like the patent system,
being built on the race-to-innovate, make coordination impossible, they might
lead to wasteful duplication that may be an even larger problem than the common
pool problem. Problems, however, associated with excess or under-investment
are sought to be resolved by the adjustment of the patent length and breadth, so
as to induce optimal innovation.37
However, another disadvantage of the property system relates to the with-
holding of access to the new knowledge, hindering the creation of similar
knowledge of a superior quality at a possible lower price. This can be witnessed
both by reduced dissemination of the invention in question, and also in the re-
duced development of improvements or dependent products or services which
depend on the initial invention. The difference between the benefit offered by
the information under property rights and the benefit that would accrue if ex-
ploitation had been made on a competitive basis, is the ‘deadweight burden’ of
the patent monopoly.38
As mentioned above, the implications of the trade-off between the incentives
for new knowledge and its efficient dissemination and exploitation may change
by varying the length and breadth of the endowed property rights. In this way,
it has been shown, for example, that weak and narrow patents may encourage
cross-licences and hence allow for dissemination and improvements, while
strong broad patents may encourage more fundamental, initial breakthrough
inventions.39 The optimal length and breadth, however, is far from clear due to
all of these uncertain and competing interests that need to be addressed in the
patent system. The problems are aggravated by the fact the desirable level and
type of innovation is also unclear.
36
P.A. David (1993) op. cit. pp. 24–45.
37
Awarding the property rights early, namely, as soon as it is known that a party has
worked out the essentials of an invention, may mitigate this wasteful effect, but may also
lead to the control of a whole market, or to the suppression of improvements on technol-
ogy. It is difficult to achieve this balance.
38
P.A. David (1993) op. cit. p. 34.
39
R. Merges and R.R. Nelson, On the Complex Economics of Patent Scope, 90
Colum. L. Rev. 839 (1990). The scope of protection includes different aspects, such as
the type of behaviour which constitutes an infringement. It is generally believed that
conduct will be judged to be an infringement if it produces benefits to the right holder
at a low social cost, and vice versa. See S. Shavell (2002) op. cit. chapter 12.
In conclusion, IP is viewed as an effort to cure a form of market failure arising

in the case of public goods. While it is not the only means of overcoming the
problem of public goods, it is the most desirable solution due to the asymmetry
of information, and the difficulty of placing a value on knowledge prior to its
creation. The advantage of property rights is that they are granted at a time when
the desirability of an invention is not known.40 IP itself, however, involves trade-
offs usually addressed through changes in the length and breadth of the patent.
The trade-offs involved in IP have broadly been described as the vertical and
the horizontal dilemma. The latter involves a compromise between the right to
exclude as an incentive for new technology, and competition for the optimal
exploitation and dissemination of the new technology. The former addresses the
clash between the interests of new technology as an output, and its use as an
input for further research and development of a dependent or similar technology.
Hence, in the definition and demarcation of IPRs it is endeavoured to achieve
the optimal balance between incentives and use and accessibility, and pioneering
works and improvement. These competing considerations reflect the difficulty
and the clashing interests involved in IP as a system.
5.3.2 Implications for competition
5.3.2.1 IP like other property rights for the purposes of competition

IP statutes allow for a market to operate in four ways: they create property rights,
lower transaction costs, provide valuable information, and contain a mechanism
for enforcement.41 Hence, IPRs are devised to create a market for information
goods that would not be established otherwise, or at least not at an optimal level:
‘IP is conceived to bring informational subject-matter into the realm of market
rules to optimize their creation’.42 Private parties are left to internalise the deci-
sion of whether to create a type of knowledge whose value is not known
beforehand, and are given the opportunity to respond to the market created, that
will in turn set the price of the information created. The rationale is similar to
the rationale behind real property: ‘There appears then to be some truth in the
conservative dictum that everybody’s property is nobody’s property. Wealth that
is free for all is valued by no one because he that is fool enough to wait for its
40
N. Siebrasse, A Property Rights Theory and the Limits of Copyright, 51 U. of To-
ronto L. J. 1 (2001).
41
H. Ullrich, Intellectual Property, Access to Information and Antitrust: Harmony,
Disharmony and International Harmonization, in Expanding the Boundaries of Intel-
lectual Property: Innovation Policy for the Knowledge Society, Oxford University Press
(2001); H. Ullrich, Legal Protection of Innovative Technologies: Property or Policy?
(2001) in O. Grandstrand, The Swedish Intellectual Property Symposium.
42
Ibid.
proper time of use will only find that it has been taken by another … The fish
in the sea are valueless to the fisherman, because there is no assurance that they
will be there for him tomorrow if they are left behind today’.43 Efficient exploi-
tation is therefore attained by privatisation.
Hence, IPRs are not exemptions from the competition provisions, but rather,
the IP system depends on the proper functioning of competition, and has only
been devised to allow for the response to the opportunities and conditions of
the market.44 Hence, the IP system is not conceived as protection from competi-
tion, but rather protection for competition in the market of intangible products,
whose tangible embodiments are set against and valued according to the com-
petitive market conditions which competition protects. IP does not guarantee a
reward, and as with any other property right, it merely grants the opportunity
for a reward on the market. Therefore, IP can only require equal treatment by
virtue of the competition provisions. In a similar way to other property rights,
the exclusivity allows for the autonomous determination of conduct and does
not modify antitrust rules.45
IP sets out the regulatory framework, under which it provides for the grant
of individual property. The exclusivity of rights turns the public good into an
economic good, for which competition alone can determine the value, providing
incentives and rewards in line with demand.46 In such cases, it depends on the
proper functioning of competition within the market. As a piece of individual
property, however, it provides for the autonomy of decision-making and freedom
of contracting, as with any other property, which must conform with competition
rules.47 In this case, IP does not constitute a justification for the infringement
of competition, nor does it grant the right to restrain or impair residual competi-
tion. ‘The exclusivity is granted to allow to respond to the opportunities in the
market not to control it.’48 It is the competition provisions which determine
when it controls the market, whether an IP or any other case is concerned, in
the same way. Therefore, there is no economic justification for treating IP
differently.
43
H.S. Gordon, The Economic Theory of a Common-Property Research: The Fish-
ery, 62 Journal of Political Economy 124 (1954).
44
The IP system, indeed, is a constitutive element of the market.
45
H. Ullrich, Legal Protection of Innovative Technologies: Property or Policy? in
O. Grandstand, The Swedish Intellectual Property Symposium (2001).
46
As the price is set by the market, this was the basic reason underlying the prefer-
ence of property rights over the other schemes.
47
Related to this issue is the question of whether IPRs are a right to do something
suboptimal but useful, or merely a basic right to optimise that can be overridden. The
analysis of this issue is beyond the scope of the present inquiry.
48
H. Ullrich, Legal Protection of Innovative Technologies (2001).
5.3.2.2 Competition embedded in the IP system

IP, however, is not neutral to the competition rules. By changing a non-market
into a market place, the terms and conditions for autonomy of exploitation are
provided, along with a framework regulation of the market. It modifies the
conditions of competition and thereby creates new markets. While in one sense
it excludes competitors from the technology market, this does not mean that it
is also exempted from competition liability arising from anti-competitive
conduct.
The paradox only seems to arise in cases where the exclusion (as such) be-
comes the reason for anti-trust liability, such as in the refusal to deal cases. It
is feared that imposing competition law liability for conduct consisting solely
of a refusal to deal negates the grant of property rights whose essence is the
right to exclude. However, even here, liability does not arise solely by virtue of
the exclusion, but as set against the market conditions and structure. It is no
more different than the case with real property and the right to exclude, only
that in the case of intangible goods the exclusivity might be less efficient and
may entail a far larger amount of monopoly power.49
In addition, as IP addresses competing objectives, and seeks to achieve a
balance between incentives and dissemination and exploitation, competition
considerations are built-in in the IP provisions. This is reflected in the limitations
in the length and the breadth of the property rights, and in exceptions, such as
CL for non-use of patents, and the fair use and experimental use doctrine. How-
ever, it is not clear what kind of competition system should be embedded in the
IP system in order for it to achieve its objectives. None the less IP is a ‘constitu-
tive element’ of competition allowing for a market to operate, and not a
restriction of it.50
5.3.2.3 The transition from separate to unified fields

The traditional confusion with regard to IP and its consideration as exempt from
or requiring a different threshold from competition, springs from the assumption
that there must be complete exclusivity, which allows the IP, inter alia, holder
to charge any price, and so IP is allowed to exclude competition in the short
term, as it will enhance dynamic competition in the long term.
The problem with this approach is that, by an equation of the protected intangible
subject-matter with its tangible embodiments, it creates a confusion between the
49
E. Mackaay (1992) op. cit. Although, there may be other problems in the case of
real property also, mostly associated with physical and economic constraints preventing
duplication, and also with capacity to supply, that are, in most cases, not an issue with
regard to information.
50
H. Ullrich, Legal Protection of Innovative Technologies (2001).
reasons justifying the exclusivity (on the technology market) and an alleged right to
restrain competition (on the product market). Therefore it assumes an antagonism
where there is none. … The reason for protecting technologies … is that by their very
nature, they cannot be exposed to competition, unless they are protected against imita-
tion, in one way or the other.51
Hence, the traditional approach viewed antitrust and IP as two competing and
separate fields, where IP granted a monopoly within which the property rights
were absolute. In viewing these fields as separate spheres involving an inherent
tension required the determination of the precise scope of the property rights,
so that anything within was lawful whereas anything beyond, constituted an
antitrust violation. It is in this context that the European Courts and Commission
resorted to the doctrines of existence/exercise, the specific subject matter and
the essential function. These doctrines attempted to determine what was in the
scope of the property right in question, and to set the boundaries for anti-com-
petitiveness. The result was an artificial and incoherent demarcation of the scope
of property rights.
While such a formalistic approach may have the advantage of creating clear
rules that are predictable and transparent, and can be efficiently administered,
it is undesirable as it shifts the emphasis in the determination on the precise
scope envisioned in IP statutes, which may lead, as indeed did, to artificial re-
sults and distinctions and effects that may prevent certain types of transactions
that foster innovation, or lead to a false determination of illegality.52
The transition from the perception of antitrust and IP as two separate and
competing fields, to a unified field, in the sense of working towards the common
goal of maximising wealth by producing what consumers want at the lowest
cost, introduces the benefits of treating IP in the same way as any other property
right. While this might impose a burden of analysis of the market conditions,
and might result in a slow, resource-intensive and less predictable system, con-
sideration of the effects allows for a more accurate determination of what
constitutes pro- and anti-competitive activity, without resorting to artificial
doctrines.
IP and competition policy address the same dilemma through different means,
namely, the balance of the ‘monopoly privilege’, and its dissemination—the
vertical and horizontal dilemma. IP addresses these questions through the defini-
tion of exclusivity and outlining its limitations. Competition addresses these
questions by maintaining competition in the face of exclusivity as defined by IP.
This is also reflected in the fact that claims of patent infringement and the abuse
51
Ibid. p. 7.
52
W.K. Tom and J.A. Newberg, Antitrust and IP: From Separate Fields to a Unified
Field, 66 Antitrust L. J. 167 (1997).
of a dominant position based on refusal to grant access address the same prob-
lem: the definition of degree of exclusivity permitted and patent breadth. While
both respond to a series of social, economic and political considerations, and
therefore may point to different conclusions depending on their different poli-
cies, IP and competition policy are interdependent and mutually determining.
In conclusion, IP and competition law are interdependent and inter-determin-
ing. IP changes a non-market to a market, sets out a regulatory framework
embodying competition concerns, and by granting exclusive rights it limits
competitors in certain respects, as with any other type of property. However, as
a piece of individual property, it is open to abuse, both exploitatively or structur-
ally as any other case, as provided for in competition law. It is in this sense that
IP can be said to be a constitutive element of competition, and indeed a protec-
tion for competition, but is not a restriction or exemption from competition
law.53
5.3.2.4 How antitrust control affects incentives to innovate

The idea that antitrust law would hamper incentives to innovate is the most
common and strong argument against using antitrust law as a means to control
conduct that is condoned under IP laws, and in favour of immunising it from
liability.
While there is very little empirical evidence on the effects of this control in
general, and compulsory licensing in particular,54 it is none the less argued that
such a concern is based on a series of erroneous assumptions.55 First, it assumes
that IP laws grant holders an economic monopoly. Secondly, it assumes that the
53
Hence, economically there is no reason for treating IP differently from other
property. IP confers a property right as in the case of tangible property, however, that is
not unlimited and unqualified. Restrictions may be built into the system granting these
rights, but they may also come externally from other sources, such as competition laws.
While IPR legislation can change the market conditions and has built-in safeguards to
restrict the scope of the exclusivity granted, it cannot be expected to assume the respon-
sibilities of competition law and ensure the proper functioning of market forces. See
Anderman (1998) op. cit. Hence, for example, just as a port owner might be required to
grant access to competing ferry services, in a similar situation the IP owner might be re-
quired to grant access to products or services covered by the IPR, especially where a
monopolisation of derivative markets might otherwise have been permitted.
With regard to competition, IP grants a legal monopoly that does not necessarily co-
incide with the economic monopoly, therefore, if the latter is present, competition law
assumes its usual role. While IP restricts competitors and affects the competitive market,
competition controls the IP-holder and the way in which he uses his property rights as
in any other case. It is the exclusivity as exercised against the market conditions that is
controlled and not exclusively by virtue of the exclusivity.
54
F.M. Scherer (1977) op. cit.
55
S. Genevaz (2004) op. cit.
acquisition of monopoly power is the only way to appropriate revenues from

inventions, and thirdly, it assumes that antitrust liability would necessarily have
overall adverse effects on incentives to innovate.
IP rights in general, and patents in particular, do not necessarily and automati-
cally confer monopoly power on their owners.56 ‘The intellectual property laws
do not purport to confer any monopoly, however, but only the right to exclude
others from producing the good, expression or symbol covered by the intellec-
tual property interest. This right is a property right that is not different in
principle from other property rights.’57 The law encourages the creation of sub-
stitutes, of inventing around inventions and therefore substitutes may exist in
the market. Hence, the legal monopoly granted by a patent does not coincide
with an economic monopoly in the marketplace in most cases.
As regards the appropriation of revenues which provides an incentive to in-
novate, it is clear that IPRs are not the most significant factor in most cases in
ensuring returns in most industries. Factors such as lead time, reputation and
costly copying may present greater sources of excludability and profit.58 While
it is true that patents are the most significant factors in appropriating returns in
the pharmaceutical industry, in this specific case, ‘economic analyses dispute
the idea that the concentration of market power is the best way to ensure an op-
timal appropriation’.59 Kenneth Arrow suggests that a monopolist has less
incentive to innovate than a firm in a competitive industry, as the latter has a
higher incentive to reduce the cost of its product.60 Hence, anti-trust liability
does not necessarily lead to an overall reduction in incentives to innovate in the
relevant industry.
In addition, as antitrust control is limited to exceptional cases, it would only
rarely impose a constraint on the courses of action available to IP owners.61
Ayres and Klemperer suggest that the loss of incentive is negligible in compari-
son to the increase in social welfare stemming from limited restrictions on the
patentees’ market power.62 However, the latter’s suggestion applies only in cases
56
Ibid.
57
H. Hovenkamp et al. (2003) op. cit.
58
See H. Perritt (1996) op. cit.
59
S. Genevaz (2004) op. cit. p. 750.
60
Ibid. See also K.J. Arrow, Economic Welfare and the Allocation of Resources for
Invention, in Essays in the Theory of Risk-Bearing, Chicago, Markham Publishing Co.
(1971).
61
Ibid. p. 10.
62
I. Ayres and P. Klemperer, Limiting Patentees’ Market Power Without Reducing
Innovation Incentives: The Perverse Benefits of Uncertainty and Non-Injunctive Reme-
dies, 97 Mich. L. Rev. 985, (1999), p. 990: ‘Because the last bit of monopoly overcharging
is so disproportionately damaging, restricting the patentee’s monopoly power a small
amount is likely to increase social welfare. The benefit of reducing the deadweight loss
where there is high price elasticity in the market so that every price reduction
results in an increase in demand.63 In industries such as the biopharmaceutical
industry, where demand for the end product is not elastic as consumers need
access to medicine (as opposed to luxury products), a reduction in the monopoly
price may have few consequences on the deadweight loss and can greatly dimin-
ish incentives to innovate. Nevertheless, this may not be the case in the
pre-commercial stage of research where demand for research tools by competing
firms takes place on different levels of the market, as distinct from end product
situations.
In addition, Scherer concluded that CL had little effect on incentives to inno-
vate in industries in which the parties had to maintain a high level of R&D to
remain competitive or where the ability of competitors to invent around patents
reduced the value of patent protection.64 Even testimonies of industry operators
themselves seem to take for granted that antitrust liability might arise as in any
other case, and this is not perceived to impact negatively on incentives.65
Finally, it would also make little sense, in practice, to have different rules for
immunity for refusals to deal by patent holders as that would encourage the ar-
bitrary incorporation of protected components in designs simply to escape
of supra-competitive pricing is likely to outweigh the costs of a slightly lower incentive

to innovate.’
See also S. Semerano, The Efficiency and Fairness of Enforced Sharing: An Examina-
tion of the Essence of Antitrust, 52 Kansas Law Rev. 57 (2003), p. 25: ‘All things being
equal, forced sharing may discourage both the innovator and the sharer from investing
in improvements. But all things are not equal. Shared property may enable more vigorous
competition than would otherwise occur, and that competition may stimulate investment
to a greater extent than forced sharing may reduce it. A firm not faced with competition
will only consider innovation’s demand-expanding and entry-delaying effects. A firm
faced with competition, however, will have an incentive to innovate not only to expand
the existing market and deter entry, but also because of the fear of losing market share
to, and the desire to gain it from, a competitor.’
63
S. Genevaz (2004) op. cit. p. 752.
64
F.M. Scherer (1977) op. cit.; F.M. Scherer and D. Ross, Industrial Market Struc-
ture and Economic Performance, 3rd edn, Boston, Houghton Mifflin Co. (1990): ‘all in
all the substantial amount of evidence now available suggest that compulsory patent li-
censing, judiciously confined to cases in which patent-based monopoly power has been
abused … would have little or no adverse impact on the rate of technological progress
…’, pp. 456–7
See also C.V. Chien (2003) who compares inventive activity with compulsory licenses
to conclude that no decline in innovation can be seen. Hence the author argues against
a blanket exclusion to CL, although also stresses the importance of two factors, ‘predict-
ability’ and ‘importance’ that may be decisive in the impact of CL.
65
FTC/DOJ Proceedings on Competition and IPRS: A. Diverse perspectives on
patents. B. Business perspectives on patents. Biotechnology and Pharmaceuticals, 19th
March 2002.
liability. Hence, it is submitted that the solution cannot be found in immunising

IP, but rather in determining the cases in which antitrust liability should be im-
posed for a refusal to deal.
5.3.3 Recent Recognition of Antitrust Control
This approach has come to be recognised in recent IP legislation, in which it is

stipulated that an abuse of the property rights conferred is possible, and thus
IPRs are not unlimited rights. Furthermore, no provision is made for a different
threshold.66
Article 8 of TRIPS provides that ‘appropriate measures … may be needed to
prevent the abuses of intellectual property rights …’ This reflects the fact that
IPRs are not immune from the competition provisions and that it is possible for
patent holders to abuse their position.
The EC Database Directive 96/9/EC also envisages the possibility of abuse
by a copyright holder: ‘protection by the sui generis right must not be afforded
in such a way as to facilitate abuses of a dominant position. … Whereas the
provisions of this Directive are without prejudice to the application of Com-
munity or national competition rules’. The Directive can be interpreted as
reflecting the idea that IP is not exempt and that it is subject to the application
of competition rules, just as with any other property rights.
Hence, in accordance with TRIPS, the patent system could provide for the
compulsory licensing of patents if it would be judged anti-competitive by com-
petition law and not IP.67 This could be seen as a reflection of the fact that, in
66
In the USA, this is explicitly recognised in the US FTC/DOJ Antitrust Guidelines
for the Licensing of Intellectual Property (6th April 1995), reprinted in 4 Trade Reg. Rep.
(CCH) ¶ 13, 132, available at http://www.usdoj.gov/atr/public/guidelines/ipguide.
htm#back1 which provide that liability IP will be treated like any other kind of property
for the purposes of antitrust, that there should be no presumption of market power, and that
licensing may allow complementary factors of production and hence be pro-competitive.
See also UK Patent Act s. 51 on powers exercisable following the report of the Com-
petition Commission, in which action may be taken in situations that are likely to operate
against the public interest either because of a refusal to license or of the licensing
conditions.
See also Berne Convention for the Protection of Literary and Artistic Works of 9
September 1886, as last amended on 28 September 1979, and by Council Directive
91/250/EEC of 14 May 1991, on the legal protection of computer programs, OJ 1991 L
122/ 42. In the 27th recital, that Directive states that its provisions are without prejudice
to the application of the competition rules under Art. 82 EC ‘if a dominant supplier
refuses to make information available which is necessary for interoperability as defined
in this Directive’.
67
See the Draft Proposal for a Council Regulation on the Community Patent (2000)
op. cit. and the explanatory Memorandum.
accordance with economic theory, the patent is the same as any other property
right for the purposes of competition law, and that the incentives and need for
innovation do not justify an immunity, first, because it is not clear how much
incentive is required, and therefore it may not be sensitive to these limited in-
stances of control, and secondly, because there may be static distortions
outweighing the dynamic benefits or other concerns regarding follow-on
inventions.
Patents grant a legal monopoly that cannot necessarily be equated with an
economic monopoly. For example, in the pharmaceutical industry, patents do
not award a legal monopoly over the treatment of a specific disease, but only
over a specific product or process. Hence, there is often some potential for strong
competition between products in a therapeutic class. The fact that a legal mo-
nopoly does not coincide with an economic monopoly operates on two levels.
On the one hand, it should not be assumed that patents create market power.68
Equally, however, when the legal monopoly that patents confer, coincide with
an economic monopoly, they will not be exempt from competition control.
Competition control operates ex post according to the market conditions, while
patent protection operates ex ante irrespective of the market conditions.
The provisions of TRIPS are important in recognising that IP and competition
are no longer understood as separate spheres, so that the metes and bounds must
be sought within which IP is absolute, but IP remains subject to competition
law liability as provided for by the latter for any case according to its effects.
Indeed TRIPS may be read as the legitimation (on the part of IP instruments)
of such competition control.
With regard to competition law, it is clear that IP is subject to competition
law rules as shown in the practice of the EC Commission and Courts. While the
Courts and Commission have abandoned the insistence on defining the scope
of IP protection under the existence/exercise and specific subject matter doc-
trines, in their latest decisions they still nevertheless continue to reflect a
theoretical understanding that IP warrants a different threshold of general im-
munity except in ‘exceptional circumstances’.69 As has been shown, this
difference cannot be justified. The circumstances should be regarded as more
exceptional than in other cases.
There is no defining-line in IP determining when an act will be deemed anti-
competitive. Rather, the latter will be determined according to the impact of
specific practice under a rule of reason analysis. The scope of a patent is not
something concrete that exists in isolation, but is also dependent on external
68
This is recognised in the US FTC/DOJ IP Licensing Guidelines (1995) op. cit.
69
I insist on theoretical understanding, as in practice, it would seem that the circum-
stances are not any different from the other cases.
factors such as antitrust control. In this way, antitrust law should be seen as
simply another factor in determining patent scope.
5.4 Conclusions
In this chapter, a case has been made for the lack of economic justification in
treating IP differently from other property rights for the purposes of competition
law. Whilst different doctrines were created by the EC Courts to distinguish
IPRs in theory, this control has been applied in practice as exceptionally as in
other cases, thus according to the facts of the case. The EU Commission seems
to be more willing recently to recognise this approach, and indeed in its recent
Microsoft decision, it resorted to the Magill case to argue that ‘intellectual
property rights are not in a different category to property rights as such’.70
The next chapter addresses the antitrust duty to deal under Art. 82 and its
application in the biopharmaceutical industry.
70
See C-3/37 Microsoft Case 792, 2004, para. 550: ‘The Court of Justice stated that
“the refusal by the owner of an exclusive right [copyright] to grant a license, even if it
is the act of an undertaking holding a dominant position, cannot in itself constitute abuse
of a dominant position”. It pointed out, however, that “the exercise of an exclusive right
by the proprietor may, in exceptional circumstances, involve abusive conduct” thereby
clarifying that intellectual property rights are not in a different category to property rights
as such.’
6. The duty to deal under Art. 82 EC
6.1 Introduction
This chapter considers the duty of a dominant firm to deal with competitors/
customers and the cases in which it is lawful under Art. 82 EC to refuse or cease
to deal. The chapter does not address the general objections and rationale behind
compulsory licensing as these have already been addressed. Furthermore, it does
not consider the role of contract law as this is beyond the scope of enquiry for
the purposes of this chapter. In contrast, this chapter undertakes a pragmatic
examination of the case law and seeks to propose a specific interpretation of the
state of the law.
There is no consistent rationale behind the case law in this area and therefore
the state of the law is far from clear. Many questions remain unanswered, nev-
ertheless, as will be shown in the next chapter, it is still possible to use Art. 82
in its current form to address concerns relating to access in the biopharmaceuti-
cal industry.
The chapter proceeds on the basis of the categorisation of the Advocate
General in Oscar Bronner, which identifies the three main factors leading to a
duty to deal under EC competition law. These involve the ‘dependence’ cases,
the leverage cases and/or the essential facilities cases. Based on these factors,
it examines the rationale behind the duty to deal, and what each of these cir-
cumstances involves.
6.1.1 What is a Refusal to Deal and What is the Rationale Behind its
Prohibition?
Clear guidance on the refusal to deal is difficult to find as the existing case law
is scarce and rather inconsistent. While it is clear that there is no general obliga-
tion under EC competition law to deal with somebody (whether a competitor
or a customer), none the less in certain ‘exceptional circumstances’, a duty to

Case C-7/97 [1998] ECR I-7791.
122
The duty to deal under Art. 82 EC 123
deal will be imposed. The duty is exceptional regardless of whether an intel-

lectual or other property right is involved.
In this context, a refusal to deal refers to a situation in which the licensor
refuses to give a licence, leaving potential licensees with no option but to seek
a compulsory licence. However, a refusal to license is not limited to cases of
outright refusal but may also include situations in which there is a delay in ne-
gotiations or cases in which the acceptance of the licensing terms proves to be
so difficult that they amount to an effective refusal to deal.
In general, even dominant undertakings have the right to refuse to license and
to unilaterally decide which third party they wish to deal with. In the absence
of other special circumstances, Art. 82(c), which requires the application of
similar conditions to equivalent transactions, cannot be invoked to challenge a
refusal to license or to order a licence on the same terms. However, if a certain
‘abusive conduct’ or ‘exceptional circumstances’ are deemed to exist, a duty
will be imposed.
6.1.2 Concerns Relating to a Refusal to Deal: Potential Harm to

Competition
The main economic consideration behind the striking down of certain refusals
to deal relates to the potential of harm to competition, as opposed to individual
competitors.

ECJ, Cases C-241/91 P and C-242/91 P, Radio Telefis Eireann (RTE) and Independ-
ent Television Publications (ITP) v Commission (‘Magill’), [1995] ECR I-743, para 50.

See Chapter 5.

Delays in negotiations are only abusive if there is a duty to deal. Hence, when
negotiations are delayed it should first be examined whether there is a duty to negotiate
and reach an agreement in the first place.

With regard to the licensing terms, while they may in themselves on many occa-
sions amount to an abuse of a dominant position (e.g. tying, non-compete obligations
etc) there may also be cases where this is not the case, such as high royalty rates. Where
the terms are such that any licensee is prevented from making an economically viable
use of the license, then the offer to deal may amount to a refusal.

Once access is given to one licensee, there should not be an automatic obligation
to grant identical access to everybody else, as this would inhibit the first license, and
may not be reasonable.

Case 238/87 Volvo v Veng [1988] ECR 6211 (para 9).

D. W. Carlton, Antitrust at the millennium: A general analysis of exclusionary
conduct and refusal to deal, 68 Antitrust L J 659, (2001).
See also the ECJ in Case C 418/01, IMS, judgement of 29 April 2004, para. 145 refer-
ring to the requirement that it should be ‘impossible or at least unreasonably difficult for
any undertaking seeking to operate in the market to create’ an alternative, confirming
that harm to competition should not be equated with harm to a particular competitor.
The refusal to license will not in itself constitute an abuse in all cases. Hence,
the refusal to license can be seen as the means, and harm to competition as the
end, prohibited in Art. 82. Accordingly, in GlaxoSmithKline the Advocate-
General made a distinction between the negative consequences for competition
of a refusal to supply that may be abusive, and the refusal to supply with the
object/effect of restricting parallel trade, which was found on the facts to be
non-abusive.10
A refusal which seriously disrupts competition on a market may constitute
an abuse. On the other hand, a refusal that merely restricts the supply and dis-
tribution of an end product so as to restrain parallel trade is not abusive if there
is no harm to competition.11
The concerns relating to the potential harm to competition consider the direct
impact on end consumers, who may have to pay higher costs, with a more re-
stricted choice or lower product quality by virtue of the refusal, resulting in a
loss in consumer welfare.12 In essence, four categories of refusals have been
identified in the literature:13
1. A refusal to take part in a joint venture: in such a situation, it is found that

if the parties do not wish to take part in such a venture there is no harm to
competition as it means that the joint venture would not have been efficient
for them.
2. Where an enterprise in a dominant position refuses to deal with any cus-
tomer who deals with his competitor. This echoes the situation in United
Brands14 in so far as United Brand’s (UB’s) refusal was based on Olesen’s
promotion of a competing firm. In such a case, economic theory provides
that exclusive dealing may be pro-competitive insofar as it creates incen-
tives for UB to incur expenses that might otherwise have been avoided due
to the possibility of free riding by the competitors. This case may, however,
also raise competitive concerns as if economies of scale are present, exclu-

Others v Glaxosmithkline AEVE, Opinion of the AG Jacobs, 28 October 2004.
10
Ibid para. 104. As stated by AG Jacobs, ‘I would note that the above analysis
does not preclude the possibility that a restriction of supply by a dominant pharmaceutical
undertaking might fall foul of the Court’s established case-law on refusal to supply if it
had negative consequences for competition arising other than as a consequence of its
restriction of parallel trade.’
11
Ibid para. 104. This was, however, based on the particularities of the pharmaceuti-
cal industry.
12
J.K. Mackie-Mason, What about Unilateral Refusal to Deal? In FTC/DOJ Hear-
ings on IP and Competition Policy 2002.
13
D. W. Carlton (2001) op. cit.
14
Case 27/76 United Brands [1978] ECR 207.
sive dealing might inhibit the second firm (Olesen) from achieving
efficiency. Hence, a rule of reason is required, in order to inquire into the
possibility of economies of scale and offsetting efficiencies.
3. Where there are two markets, in which firm one (F1) is present, and the
product of market A is a necessary input for market B, in which firm two
(F2) is also present, and F1 refuses to license F2. Economic theory suggests
that F1 will only refuse F2 if the latter does not allow him to price discrimi-
nate, as in other cases, F1 will wish to keep F2 in the market if he is more
efficient as he can receive profits from his supply of product A. This is not
the case, however, if products A and B are not complements for some con-
sumers and economies of scale are present. In such a case, F1 may refuse
to deal in order to preserve its power on market B. If F1 refuses to supply
product A to any customer consuming B from F2, F2’s scales will drop,
forcing him to leave the market. In this case, customers only want product
B and will be faced with a monopoly and thereby suffer as a result of the
reduced competition.
4. Finally, the dynamic model, in which F1 is present on market A and both
firms are present on market B, but there is a possibility of competition in
A and economies of scale in B. In this case, F1 will seek to limit the power
of F2 in market B so that it preserves its power in market A. By keeping F2
small in market B so that it is not an effective supplier of market B to com-
petitors, F1 protects its position in market A. This will also allow F1 to
transfer his monopoly over time from one product to another.
Economics clearly cautions us about the possible net harm to competition if

there is a significant foreclosure of the distribution system, thus preventing a
competitor from achieving economies of scale, or if the monopolist excludes a
competitor by depriving it of customers who also need the first product of the
monopolist.15
In economics, the optimal balance is empirical, however, this is complicated
due to the potential global effects and the fact that the decision should not only
take ex post rewards for investments into account, but also, how the latter will
affect ex ante future decisions to invest. The optimal balance will depend on the
static allocative inefficiency resulting across firms, industries, time, the amount
of additional innovative effort it is likely to induce and the amount of future
consumer welfare induced by the incremental investment.16
15
It should also be remembered that economics takes not only the local effects of
the case at issue into account, but also its global effects, as this affects the expected re-
turns from innovation.
16
J.K. Mackie-Mason (2002) op. cit.
The risk of harm to competition is also dependent on the type of market

structure put in place and the extent to which it is conducive to innovation.17 To
some extent, this is reflected in the clash between the monopolist18 and competi-
tion theorists.19 The conclusions in this regard are ambiguous: ‘Permitting
greater consolidation of market power in a market may increase or decrease in-
novative activity in that market’.20 A clear economic formula which would
differentiate between desirable and undesirable refusals to deal has not yet been
devised.21
6.2 The State of the law

A duty to deal has been imposed in the following EC competition law cases:22
1. Cases involving two markets:

(a) Refusal to supply an input to downstream competitors in vertically
related markets to preserve market power in market B: Commercial
Solvents,23 Magill,24 Ladbroke.25
(b) Denial of access to a facility necessary to compete with a downstream
competitor, to preserve market power in market B: Sabena,26 Decca
Navigation Systems,27 Sea Containers,28 IMS.29
17
See ABA (2002) op. cit. See also chapter 7.
18
F. Parisi, B. Depoorter, The Market for Intellectual Property: The Case for Com-
plementary Oligopoly, in The Economics of Copyright: Developments in Research and
Analysis, W. Gordon and R. Watt, eds., Cheltenham, UK and Northampton, MA, USA,
Edward Elgar (2003); J. Schumpeter, Capitalism, Socialism and Democracy, New York,
NY, Harper (1942).
19
S. Yi, Market Structure and Incentives to Innovate: The Case of Cournot Oli-
gopoly, 65 Economics Letters 379–388 (1999). J. Boone, Intensity of Competition and
Incentives to Innovate, 19 Inter’l J. Ind. Org’n 705, (2001).
20
J.K. Mackie-Mason (2002) op. cit.
21
See also the Commission discussion paper on possible principles for the applica-
tion of Article 82 to exclusionary abuses, published on the Commission website for
consultation in December 2005.
22
See end of chapter for a closer analysis of the cases.
23
Case 7/73 Commercial Solvents [1974] ECR 223.
24
Case C-241 & 242/91P Magill [1995] ECR I-743.
25
Case T-504/93 Tierce Ladrbroke [1997] ECR 927.
26
Commission Decision London European-Sabena, OJ 1988 L 317/47.
27
Commission Decision Decca Navigator System, OJ 1989 L 43/27.
28
Commission Decision Sea Containers v Stena Sealink, OJ 1994 L15/08.
29
Case C-418/01 IMS [2004] ECR I-05039.
(c) Refusal to grant access to the distribution system to an upstream

competitor or a refusal to share methods in reaching customers to
preserve market power in market A: Bronner.30
(d) Essential facilities: Sabena, Decca Navigation, Sea Containers,
Magill, Ladbroke, Bronner, IMS.
(e) Refusal to share spare parts with independent providers of aftermarket
support/complementary markets: Volvo.31
2. Cases involving one market:
(a) Refusal to deal with distributors promoting a competing brand to
preserve market power in market A: United Brands.32
(b) Refusal to deal with suppliers dealing with competitors to preserve
market power in market B: Telemarketing.33
(c) Refusal to join or continue a joint venture with competitors/
(disproportional sanction?) Aer Lingus.34
(d) No competitive relationship between parties in any market: Ladbroke.
The relationship between these categories, however, is unclear and some

may indeed overlap to some degree. There are three common denominators in
the cases in the sense that they may involve the cutting off of previous relation-
ships as a response to the conduct of the dependent firm, the possibility of using
power on one market to create or preserve market power on another market,
and the indispensable nature of facilities for the operation of a firm on another
market.
These main considerations are also reflected in the categorisation of the Ad-
vocate-General in Oscar Bronner,35 who outlined the situations in which a duty
to deal will arise under EC competition law:
l
Cases involving the cutting off of supplies to existing customers: Com-
mercial Solvent, United Brands.
l Cases in which an undertaking holding a dominant position on a particular
market reserves to itself an ancillary activity without objective necessity
which might be carried out by another undertaking as part of its activities
on a neighbouring but separate market, with the possibility of eliminating
all competition from such undertakings: Telemarketing.
30
Case C-7/97 Oscar Bronner [1998] ECR I-7791.
31
Case 238/87 Volvo v Veng [1988] ECR 6211.
32
Case 27/76 United Brands [1978] ECR 207.
33
Companie Luxembourgeoise de Télédiffusion [1985] ECR 3261.
34
Commission Decision British Midland/ Aer Lingus, OJ 1992 L 96/34.
35
Case C-7/97 [1998] ECR I-7791 para 33-53.
l Cases in which the refusal concerned a product or service that was either
essential to the exercise of the activity in question, in the sense that there
was no actual or potential substitute, or a new product whose entry might
have been prevented despite the constant, specific and regular potential
demand by consumers: Volvo, Magill, Tierce Ladbroke.36
Any obligation to deal, however, will only be imposed after ‘close scrutiny
of the factual and economic context’ and even then within narrow limits.37
6.2.1 Cutting Off Existing Customers: The Dependence Cases
The case-law demonstrates that an obligation to deal has been imposed in situ-
ations where a dominant firm cuts off supplies to existing customers.
In Commercial Solvents38 the party was compelled to continue supplying Zoja
with the raw materials necessary for the production of a derivative, despite its
decision to vertically integrate and also become operative on the downstream
market for the supply of the derivative. The Court held that a refusal to license
in such cases constitutes an abuse of a dominant position where it thereby ‘risks
eliminating all competition on the part of this customer’.39
Similarly, in the United Brands case40 the Court considered that an undertak-
ing in a dominant position ‘cannot stop supplying a long standing customer who
abides by regular commercial practice, if the orders placed by that customer are
in no way out of the ordinary’.41 Such conduct would be incompatible with Art.
82 as it would ‘limit markets to the prejudice of consumers and would amount
to discrimination which might in the end eliminate a trading party from the rel-
evant market’.42 The Court also held that a dominant undertaking has the right
36
He concludes that ‘a dominant undertaking commits an abuse where without
justification it cuts off supplies of goods and services to an existing customer or elimi-
nates competition in a related market by tying separate goods and services. However, it
also seems that an abuse may consist in mere refusal to license where that prevents a
new product from coming on a neighbouring market in competition with the dominant
undertaking’s own product on that market’ para. 43. It seems that the Advocate-General
is looking for an additional element to find an abuse, such as tying sales, or discriminat-
ing vis-à-vis independent competitors.
37
Others v Glaxosmithkline AEVE, Opinion of the AG Jacobs, 28 October 2004 at para.
53.
38
Case 6/73 Istituto Chemioterapico Italiano and Commercial Solvents v Commis-
sion [1974] ECR 223.
39
Para. 25 of the judgment.
40
Case 27/76 [1978] ECR 207.
41
42
to take reasonable steps to protect its commercial interests, provided its behav-
iour is proportionate to the threat and not aimed at strengthening or abusing a
dominant position.43
Hence, in the BP case, the restriction of supply by a dominant petroleum
company during an oil shortage in a manner which was reasonable to the par-
ticularities of the commercial situation and relations between different
customers, was not found to constitute an abuse of a dominant position.44
There is a three-fold rationale behind the relevance of previous dealing.45
First, previous dealing proves that dealing is feasible and consistent with invest-
ment and creation. Secondly, it is possible to use the previous terms as a
benchmark, and thirdly, people may have relied on the expectation of a deal.46
However, flexibility should also be preserved, as the conditions of the licence
may have changed, or the party may reasonably seek to change the terms and
cost of the licence.47
An obligation to deal can, thus, be imposed in circumstances where the retali-
ation to a behaviour of the customer/competitor is not proportional to the
behaviour that it aims to sanction.48 This may be seen as an extension of the
abuse of market power to cases of relational market power.
Furthermore, in Germany for example, the concept of economic dependence
has been introduced.49 Nacke also contemplates that a partenaire obligatoire
may also be found in the Community law, under which ‘a company may be
43
Paras. 189 and 190 of the judgment.
44
Case 77/77 BP [1978] ECR 1513 paras. 28, 29, 30, 32, 33, and 42 of the
judgement.
45
C. Shapiro, Competition and IP Law and Policy in the Knowledge-Based Society:
Is there a Cause for Concern about Unilateral refusals to Deal? in DOJ/FTC Hearing
on IP and Competition Law, May 1 2002.
46
The latter argument echoes the estoppel argument present in UK common law.
The rationale for estoppel is based on the idea that if somebody makes a representation
on which the other party relies to his detriment, then he should be held to the representa-
tion that he made.
47
Courts must be careful not to penalise people for making bad licensing choices
which cannot be reviewed or altered as this might create an incentive to refrain from li-
censing in the future. J. Glenken, Competition and IP Law and Policy in the
Knowledge-Based Society: Is there a Cause for Concern about Unilateral refusals to
Deal? in DOJ/FTC Hearings on IP and Competition Law, 1 May 2002.
See also C. Shapiro (2002) op. cit.; who states ‘shouldn’t private parties if they are
going to make reliance on investments seek their own assurances that a standard will be
open or something will be licensed on an ongoing basis, rather than some sort of broad
antitrust regime that would require ongoing dealing?’
48
See also analysis of S. Anderman (1998) op. cit. Chapter 14.
49
See s 26(2) of German Act Against Restraints of Competition: ‘relative domi-
nance’ for dependent customers/competitors.
found guilty of an abuse if those dependent on it cannot substitute, if the abuse

is unlikely to encourage new competitors and if the company is not constrained
in its behaviour by competition in wider “downstream” markets’.50
These dependence considerations are also consistent with the proportionality
principle contained in Art. 82, which requires that the action taken by the domi-
nant firm to attain a legitimate objective should take the form of the least
restrictive means available.51
While one may question the extent to which the concept of ‘dependence’
makes sense from a competition law perspective, as it seems to be more similar
to a contractual notion, none the less, it could be considered to be legitimate if
it is limited according to the proportionality principle of EC law since the lever-
age and/or essential facilities rationale is also present in most cases.52
Indeed, one could even argue that following the Telemarketing case,53 claim-
ants will also have to establish the presence of the other considerations. In this
case, despite the existence of previous dealing, the Court focused on the essential
nature of the facility and the leverage possibility.
The Court held that where an undertaking holding a dominant position ‘re-
serves to itself or its subsidiary another activity’ on a neighbouring but separate
market, without any objective necessity, with the possibility of eliminating all
competition from such undertaking, it constitutes an abuse of its dominance. It
also noted that the input withheld should be indispensable for the activities.54
6.2.2 ‘Reservation of an Ancillary Activity’ and Leverage Economics
In line with the Telemarketing case, in Magill the Court considered the fact that
the broadcasters, by their conduct, ‘reserved themselves the secondary market
of weekly television guides by excluding all competition on that market’, was
relevant in determining an abuse of a dominant position.55
50
T. Nacke, Abuse of Dominant Positions, 1995 at http://europa.eu.int/comm/com-
petition/speeches/text/sp1995_025_en.html, p. 6.
51
Ibid.
52
In Commercial Solvents (1974) op. cit. for example consideration was also paid
to the possibility of leverage by virtue of vertical integration, and there might even have
been a case for arguing that the raw materials were essential facilities. Similarly, in
Telemarketing (1985) op. cit. the focus was on the essentiality of access for the secondary
market to operate, and on the possibility of leverage.
On the other hand, in United Brands (1978) op. cit. and British Midland/ Aer Lingus
(1993) op. cit. these considerations were present, but the focus was on the hardship suf-
fered by the customer/competitor.
53
Case 311/84 [1985] ECR 3261.
54
Ibid. para. 25 to 27.
55
Magill (1995) op. cit. para. 56 of the judgment.
This was based on the concern that the dominant firm would limit access to
the upstream product to gain power in the downstream market.56 The rationale
behind this can be found in the idea of the economics of leverage which claims
that a firm with market power on one market may use that market power to gain
additional power in a related but independent market.
This theory has been criticised as it is argued that a firm cannot obtain two
monopoly rents, and that there is no gain from leveraging as one can extract
all monopoly rents on the first market.57 The Chicago school has argued that
if product A is used as an input, the monopolist could simply charge a high
price for it.58 If it is used on a stand-alone basis, the monopolist would wel-
come competition in the complementary segment as this would increase the
value of the good and the consumer could still be charged the monopoly
price.59 The ‘chain link’ model thus concludes that refusals are generally effi-
cient as monopolists do not need to refuse to deal in order to extract monopoly
profits.60
It cannot be assumed that efficiency can be found in cases in which the mo-
nopolist is unable to make monopoly profits.61 If the monopolist is unable to
obtain monopoly rents, then it might refuse to deal in order to eliminate com-
petition on lower levels and receive a monopoly price.62 This would arise in the
following cases: if the nature of the product and business relationship renders
the transaction costs of metering prohibitive; if a variable fee for use would lead
56
In the case that the firm is present in the downstream market (hence, vertically
integrated) it can do this by refusing to deal, charging high wholesale prices or by making
the upstream product incompatible with the downstream ones, amongst other. If such
vertical integration is not present, he may do so by favouring a particular downstream
competitor by exclusive dealing or by discriminatory treatment.
57
M. Whitener, Competition and IP Law and Policy in the Knowledge-Based So-
ciety: Is there a Cause for Concern about Unilateral refusals to Deal? in DOJ/FTC
Hearings on IP and Competition Law, May 1 2002. The theory has also been criticised
for failing to capture the essence of patents, which are capable of having more than one
end use and therefore it is believed that the number of markets that the patent can be di-
vided into, should be irrelevant for antitrust purposes.
58
D.G. Gerber, Rethinking the Monopolist’s Duty to Deal: A Legal and Economic
Critique of the Doctrine of Essential Facilities, 74 VA L Rev 1069 (1988).
59
See for example D.G. Gerber (1988) op. cit. pp. 1069–1085. ‘The presumption
that vertically integrated plaintiffs seek to decrease competition in downstream markets
contradicts the widely held view that vertical arrangements generally cannot augment
monopoly power.’ See also D.W. Carlton, (2001) op. cit.
60
Ibid. This is because the profits of the licensee firm can be extracted through the
pricing of the product on the upstream market, to which access is required in order to
produce in the downstream market.
61
Ibid.
62
Ibid.
to resource under-utilisation and thereby sub-optimal profits for the competitor;

or where the monopolist seeks to eliminate risk sharing.63
An anti-competitive refusal to deal therefore arises either in situations involv-
ing a regulated industry in which the monopolist vertically integrates in order
to avoid regulation, or in cases where the link between charging user fees on
market A and creating a monopoly price on market B has been disrupted – as
in the public goods case.64
In order for a leveraging claim to be valid, however, there must be a monopoly
in the primary market (as there is nothing to leverage otherwise), and the sec-
ondary market must be concentrated and protected by barriers to entry. Hence,
certain structural preconditions must exist before vertical integration can become
harmful competition, and, in fact, it can also lead to efficiencies.65
It becomes clear that vertical integration is not necessarily a negative develop-
ment and must be reviewed through a rule of reason approach in order to
establish if the structural preconditions exist for a possible harm to competition
and whether other offsetting efficiencies are also present. Even in such cases,
leverage will only be profitable if the monopolist controls an input that can be
used in variable proportions with other inputs so that the monopolist induces
63
Ibid. If the upstream and downstream products are not complementary for some
consumers, and there are economies of scale in the production of the downstream prod-
uct, there may be a risk to competition arising from the refusal to supply, In addition,
there may be instances of dynamic models in which there will be the possibility of
competition for the upstream product in the future periods and scale economies for the
downstream product, in which case the dominant firm will wish to ensure that the de-
pendant firm remains limited in its production of the downstream product so that it does
not become an effective supplier of competitors in the upstream product.
64
Ibid.
65
Ibid. Efficiencies can result from the elimination of the double marginalisation
problem associated with successive monopolies. The latter relates to the fact that all
parties wish to maximise profit by increasing prices. By vertically integrating, there are
no longer several companies seeking to make a profit but rather one and this may lead
to lower prices. Vertical integration can also lead to efficiencies arising from the reduction
of transaction costs. This is because it reduces the friction in the organisation of the en-
terprises, internalizes certain transactions and avoids the necessity of having to protect
oneself against opportunistic behaviour such as hold up and free riding. See however
N.W. Hawker, Open Windows: The Essential Facilities Doctrine and Microsoft, 25 Ohio
NUL Rev. 115 (1999); P. Rey, Competition and IP Law and Policy in the Knowledge-
Based Society: Is there a Cause for Concern about Unilateral Refusals to Deal? in
DOJ/FTC Hearings on IP and Competition Law, 1 May 2002, which suggests that vertical
integration by a monopolist may also increase the difficulty of entering either market,
by requiring competitors to enter both markets simultaneously.
customers to deviate from the most efficient input mix, or where the monopolist
is subject to rate regulation and integrates in order to avoid it.66
In this way, the economic theories on leveraging and foreclosure have hence
largely been discredited and, even if they still have some support, they depend
on structural preconditions underlying the exceptional nature of a duty to deal.
In Magill the Court reasoned that the reservation of the secondary market of
weekly TV guides was abusive as it excluded competition from the market by
denying access to the ‘basic information which was the raw material indispen-
sable for the compilation of such a guide’.67
6.2.3 The Indispensability Requirement and the Essential Facilities

Doctrine (EFD)
In Oscar Bronner68 the Court, in line with Magill, observed that in order to find
an abuse, it is necessary to establish not only that the refusal of the service would
most probably lead to the elimination of all competition in the market and that
such a refusal would be incapable of being objectively justified, but also that
the service itself must be indispensable for the running of the individual’s busi-
ness, as ‘there is no actual or potential substitute’ for this scheme.69
The indispensability requirement alludes to the essential facilities doctrine
(EFD). The EFD has its origins in US antitrust cases and it describes instances
in which access to something is mandated for those who would not have access
otherwise.70 It specifies the situations in which the owner of an essential facility
(EF) is required to provide access to this facility to competitors at a reasonable
price. It traditionally requires the existence of two markets, the upstream market
66
C.S. Yoo, Vertical Integration and Media Regulation in the New Economy, 19
Yale Journal on Regulation 171 (2002).
67
Case C-241 & 242/91P [1995] ECR I-743, para. 56.
68
Case 7/97 [1998] ECR I-7791.
69
Ibid. para. 38, 41, 42 and 44.
70
See United States v Terminal Railroad Ass’n of St. Louis, 224 U.S. 383 (1912);
United States v Griffith 334 U.S. 100 (1948). Aspen Highlands Skiing Corp. v Aspen
Skiing Co., 738 F.2d 1509 (10th Cir. 1984) aff’d on other grounds, 472 U.S. 585 (1985);
Fishman v Wirtz, 807 F.2d 520 (7th Cir. 1986); Hecht v Pro-Football, Inc., 570 F.2d 982
(D.C. Cir. 1977), cert. denied, 436 U.S. 956 (1978); Consolidated Gas Co. of Florida v
City Gas Co. of Florida , 880 F.2d 297 (11th Cir. 1989); BellSouth Advertising & Pub-
lishing Corp. v Donnelly Information Publishing, Inc., 933 F.2d 952 (11th Cir. 1991) ,
vacated, 977 F.2d 1435 (11th Cir. 1992), and reversed en banc on other grounds, 999
F.2d 1436 (11th Cir. 1993), cert. denied, 114 S. Ct. 943 (1994). MCI Communications
Group and MCI Telecommunications Corp v American Telephone & Telegraph 708 F.2d
1-81 (7th Cir. 1983).
and the downstream market.71 The dominant firm will usually be active on both
markets, and the other firm will be active or wish to become active in the down-
stream market. The latter normally seeks access to an input of the integrated
firm that has been denied.72
The usual elements quoted as necessary for the establishment of mandatory
access are found in the US case MCI.73 They include: the control of an essential
facility by a monopolist; the competitors’ inability to practically or reasonably
duplicate the EF (requiring more than being more economical than alternatives,
or mere inconvenience or economic loss); the denial of the facility to the com-
petitor (including the charging of unreasonable prices); and the ability to provide
the facility.74
71
Whether the existence of two markets is a prerequisite is a matter of debate, and
this is evident from the conflicting arguments of the parties in IMS.
72
While the EFD may arise in purely private circumstances, it is often raised in
situations involving regulation or involving some state-related or state-owned facility.
This explains why it is often a public policy choice. OECD, Essential Facilities Doctrine,
Paris (1996).
73
P. Areeda, Essential Facilities: An Epithet In Need of Limiting Principles, 58
Antitrust Law Jnl 841, (1989).
74
However, there are significant variations in the definitions of the doctrine. It has
even been described as follows: ‘It is less a doctrine than an epithet, indicating some
exception to the right to keep one’s creations to oneself, but not telling us what those
exceptions are.’ Ibid. A. Kezsborn and A.V. Goldman, No Shortcut to Antitrust Analysis:
The Twisted Journey of the Essential Facilities Doctrine, 1996 Colum Bus L Rev 1. See,
for example, the issue of whether the doctrine should be limited to natural monopolies.
This is based on the argument that as these markets are particularly vulnerable to tipping,
the tendency will be for a monopoly. In such cases, the key to maintaining a monopoly
the key is to create a large installed base, as it tends to become self-perpetuating after-
wards as users will become locked-in because of high switching costs. A monopolist can
use the monopoly base to tip the downstream market creating a ‘bandwagon effect’, by
creating technological links between the two products. M.H. Harz, Dominance and Duty
in the EU: A Look through Microsoft Windows at the Essential Facilities Doctrine, 11
Emory Int’l Rev 189 (1997). Harz explains that, in natural monopolies, free market forces
do not gravitate toward an equilibrium point, the maximum production and most efficient
resource allocation, and there are many equilibrium points. Tipping may move the market
off its equilibrium point towards a new point that favours a competitor or a particular
product. J.S. Venit, J.J. Kallaugher, Essential Facilities: A Comparative Law Approach,
in Hawk ed, 1994 Fordham Corp. L. Institute, pp. 245-344.
Others argue that as antitrust cannot change the structural characteristics of natural
monopolies, its applicability in these industries will depend on the specific costs and
benefits of an EFD and whether it is likely to do more good than harm. See A. B. Lipsky
and J.G. Sidak, Essential Facilities, 51 Stan Law Rev 1187, (1999); See also C.O. Rob-
inson, On Refusing to Deal with Rivals, 87 Cornell L. Rev. 1177 (2002); Troy, Unclogging
the Bottleneck: A New Essential Facilities Doctrine, 83 Colum L Rev 441 (1983).
The essential facilities doctrine requires that the facility should at least be
indispensable to viably compete on the market and that there should be clear
anti-competitive effects in the product or technology market. This, in effect,
requires that there would not be any workable alternative technology available,
and that there would be a potential effect to eliminate competition by the re-
questing party or from any third party.75 The facility, whether physical or
technological, must be indispensable to enter or stay on the market. Once a fa-
cility is deemed essential and unless there is a legitimate justification, the denial
of access will amount to an abuse of dominance.
The application of the indispensability requirement (similar to essentiality in
the EFD) raises three fundamental questions on its application: first, what con-
stitutes indispensable/essential, secondly, whether there is a need for two
markets, and thirdly, what classifies as an objective justification.
6.2.3.1 Indispensability
Different definitions have been proposed as regards the issue of essentiality/in-
dispensability.76 In Sealink,77 the Court defined an essential facility as ‘a facility
or infrastructure, without access to which one cannot provide services to their
customers’.
75
Commercial Solvents (1974), Telemarketing (1985), Bronner (1998) op. cit.
76
Areeda understands that to meet the threshold of essential the following require-
ments must be met: the competitor must be essential to competition in the market place;
it must be essential to the individual competitor, (in the sense of being critical to its
competitive vitality); and that duplication of the facility and practical alternatives must
not be available. P. Areeda (1989) op. cit.; see also D.E. Troy (1983) op. cit., who pro-
poses that a facility should not be deemed essential unless the facility is necessary for
entry into the market, duplication of the facility is beyond the standard cost of entry into
the foreclosed market and the plaintiff cannot commercially exist without access to this.
The test advocated by the author is objective, focusing solely on the effects of the mo-
nopolist’s decision.
Other commentators claim that a facility is essential only when ‘public necessity justi-
fies treating the facility as essential’, so that consumer preferences, analysis of the market
and the needs of competitors are irrelevant in a determination of essentiality. C.M. Seelen,
The Essential Facilities Doctrine: What does it mean to be Essential?, 8 Marq L Rev
117 (1997). Others have defined essentiality according to whether it is required by a
competitor in order to compete effectively. N. W. Hawker (1999) op. cit.
See D. J. Gerber (1988) op. cit. who offers a legal and economic definition of essential-
ity. Economically, it involves facilities that can impede the users’ production or access
to a market. It requires the presence of four characteristics: a. the facility must be unique
in that there are no similar and competing facilities and duplication is precluded; b.
preservation of uniqueness; c. the facility must be centrally located, and the flow of pro-
duction and distribution must flow from there; and d. the monopolist must be able to
regulate his facility- functional control. The legal definition as established in Hecht v
Pro-Football No. 2815-66, US Dist, Ct for Dist. Of Columbia, 312 F. Supp. 472; 1970
77
It would seem difficult to justify a test of essentiality or practicability of du-
plication that was in any way less stringent than the tests of market power.78 It
would also be wrong to have a test that focuses on the survival of a particular
competitor as opposed to whether it was generally economically viable for any
competitor to survive without access to the ‘facility’. The test can only be
objective.79
Accordingly, as clarified in Bronner,80 any alternative technology must be
assessed on the assumption that comparable assets would be invested for its
development, even if they are less advantageous for competitors.81
In addition, certain factors may be taken into account in the determination of
essentiality. For example, whether the facility has become an industry standard,82
U.S. Dist. LEXIS 12049; 1970 Trade Cas. (CCH) P73,170, 16th April, 1970, would seem
to be that duplication of the facility would be economically infeasible and the denial of
use inflicts severe handicap on potential entrants in the market. See also A.B. Lipsky,
J.G. Sidak, (1999) op. cit. who believe that inherent in the notion of essentiality lies the
premise that the owner of the facility possesses monopoly power. They identify three
requirements: a. some uniqueness and market control; b. the lack of feasible alternative
or ability to reproduce; and c. the ‘facility connotes an integrated physical structure or
large capital asset with the unique character that usually confers monopoly power and
control by virtue of the superiority of its intended purpose.’ They also believe that the
EFD is inappropriate in the following situations: where there is no monopoly power; the
facility is not an indivisible unit; an IPR is involved; and it is necessary to expand the
capacity of the facility to accommodate for the new user.
See M.A. Bergman, The Bronner Case – A Turning Point for the Essential Facilities
Doctrine? [2000] 2 ECLR 59, who believes that the requirement of a market share
equivalent to the dominant firm in Oscar Bronner is too strict. However, the EFD should
not be applied simply if a firm finds it impossible to establish an EF. Ideally, it is argued,
that the criterion should be ‘able to distinguish between situations in which investments
and other desirable behaviour might be jeopardised by its application, and situations in
which such significant risk is at hand and the application of the doctrine can potentially
result in substantial efficiency gains.’
77
Stena Sealink (1994) op. cit.
78
Lipsky and Sidak (1999) op. cit.
79
In general, Art. 82 applies an objective concept of abuse. It is only in the context
of ‘dependence’ and cases that reflect the estoppel rationale that one may argue that
abuse has acquired a subjective character.
80
Case C-7/97 Bronner, [1998] ECR I-7791.
81
Ibid, paras. 43-45.
82
This has influenced the Commission in IMS in deciding that the product was in-
dispensable and in favour of granting a compulsory licensing order. It is believed that
once a service or product develops into a standard, then access should be available to all
competitors as it is impossible without it to compete. The Commission reasoned that as
the 1860 brick structure had developed into an industry standard, according to consumer
preferences, the dominant undertaking was not allowed to refuse access to it. Hence, in
this sense the industry standard consideration could militate in favour of finding of
indispensability.
or whether the intellectual property (IP) in question does not require or merit
any incentive might militate (whether expressly or impliedly) in favour of a
ruling of essentiality.83 On the other hand, the threshold of essentiality may be
higher, where there are significant sunk costs involved, or if the incentives to
innovate are very important.
In IMS84 the ECJ confirmed that the test for determining the indispensability
of a ‘facility’ or input relates to whether there are ‘products or services which
constitute alternative solutions, even if they are less advantageous, and whether
there are technical, legal or economic obstacles capable of making it impossible
or at least unreasonably difficult for any undertaking seeking to operate in the
market to create, possibly in cooperation with other operators, the alternative
products or services’.85
83
This is an unspoken consideration that seems to have influenced the EU Courts
and Commission in the Magill and IMS case. It is interesting that both cases involved a
national IP law that did not exist in the rest of the EU countries, and was viewed with
disbelief as failing to warrant IP protection. The dominant positions in both cases suc-
cessfully invoked the national copyright law to drive the complainant out or prevent him
from entering the business. The perception that the laws in question were of limited value,
may have been a consideration that influenced the Courts to find the refusals abusive.
Admittedly if an IP of no merit is concerned, this should be remedied in the IP provi-
sions, and competition law should not be seen as correcting perceived IP regulatory
failures.
If it was controlled by competition law, it would be seen as addressing IP failures and
not treating IP like other cases. If competition law did not control it, it would be seen as
exempting IP from something, unjustifiably, as argued in Chapter 5. However, if competi-
tion law merely controls it, then, because of the effect of these laws on the market as
they eliminate downstream competition, there would arguably be no objection.
Accordingly, the IP in question is not relevant in determining the effects of exclusion,
but may be relevant as a matter of fact in the determination of essentiality/indispensability
of the facility. The weaker the rationale for protecting the exclusivity of the facility,
stemming from IP or otherwise, the easier it may be for a facility to be deemed indis-
pensable. In this sense, the weak nature of the IP in question may be relevant after all.
This would also be consistent with the AG Jacobs’ opinion in Glaxosmithkline on taking
the regulatory context and other factors into account in the determination of abuse and
objective justification. See below.
However see also G. Lunney, Re-examining Copyright’s Incentive/ Access Paradigm,
49 Vanderbuilt L. Rev. 483 (1996), on the ‘incentive/access paradox’, who posits that
access is more likely to be precipitated in exactly those cases where the invention in-
volved is important and deserving of the incentives.
84
Case C-418/01 29 April 2004
85
Ibid. para 28. See however, the Commission Decision in Case COMP/C-3/37.792
Microsoft [2004] where a lower standard for indispensability was adopted. While it was
recognised that there may be less advantageous alternatives, it was argued that those
were not in reality alternatives.
6.2.3.2 Two-market requirement

Opinion is divided with regard to the question of whether there is a need for
two markets. Some argue against the need for two markets and focus instead on
the competitive relationship between parties,86 while others stress the necessity
of the existence of two markets arguing that there is no obligation to create
competition in one’s own market.87
It would appear that the effect of the denial of access is the same regardless
of whether the firm is vertically integrated or not.88 If a firm is vertically inte-
grated and unable to price discriminate, it would be inclined to deny access as
part of a predatory practice. If it is not vertically integrated it would again be
inclined to limit downstream competition in order to reap a downstream price.
Hence, the denial might be present in both cases, either to increase market power
or to maximise profits. The harmful effects on welfare are also present in this
case. Thus whether the dominant firm is present on the downstream market also
does not seem to be decisive for the purposes of the essential facilities doctrine,
86
R. Pitofsky, The Essential Facilities Doctrine under US Antitrust Law, Paper
submitted to the European Commission in support of National Data Corporation in its
essential facilities case against IMS. 2002; ‘The courts require only that the plaintiff
prove that the facility is indispensable for competition in a relevant product market, is
controlled by a monopolist who could practically make access available, and is not ca-
pable of duplication. The policy concern is simply to ensure competition in the market
where the two parties could compete but for the refusal to provide access to the essential
asset… the vital issue is whether a plaintiff has a competitive relationship with the al-
leged monopolist in the relevant product – not what the relationship is between the
plaintiff and the defendant with regard to the asset alleged to be essential.’ pp. 23–4. R.
Pitofsky, D. Patterson, J. Hooks, The Essential Facilities Doctrine under US Antitrust
Law, 70 Antitrust L. J. 443 (2002).
87
P. Marquandt, M. Leddy, The Essential Facilities Doctrine and Intellectual
Property Rights: A Response to Pitofsky, Patterson and Hooks, 70 Antitrust L. J. 847
(2002).
88
Given that the essential facilities doctrine refers to a situation where the users’
production or access to a market is impeded by the lack of access to the essential facil-
ity, it would appear that it refers to a factual situation in which the important
relationship is a vertical one between the monopolist and the user, and so emphasis
should not be placed on the horizontal relationship. Viewing the doctrine from this
perspective directs attention to the situations, irrespective of vertical integration, in
which it is either desirable to impose judicial regulation, as the facility concerns an
unregulated natural monopoly for which overly high returns are not warranted (as they
have not been achieved by merit or skill) and would lead to an inefficient allocation
of resources (as it would attract too much investment to the detriment of regulated
goods), or the refusal to deal would be anticompetitive from a dynamic point of view.
Accordingly, a competitive relationship would not be necessary and the issue of
whether two markets are necessary is avoided; the focus is placed on the essentiality
of the input. D.J. Gerber (1988) op. cit.
as it would lead to the same effect if there was another sole downstream
supplier.89
The conclusions drawn by the ECJ on the two market requirement in IMS
should be seen in light of these considerations. ‘It is determinative that two dif-
ferent stages of production may be identified and that they are interconnected,
the upstream is indispensable in as much as for supply of the downstream
product.’90
Therefore, it adopted a wider definition which does not require two markets
in the traditional antitrust sense: ‘it is sufficient that a potential market or even
hypothetical market can be identified. Such is the case where the products or
services are indispensable in order to carry on a particular activity…’.91 If the
criterion of a secondary market is the hypothetical one then effectively the
threshold has been significantly lowered and it will be met in all or almost all
cases.92
6.2.3.3 Objective justification

The third contentious issue relates to the scope of an objective justification. A
legitimate justification generally includes situations such as: the lack of capacity
to supply or grant access; inability to pay (the foreclosed party is unable or un-
willing to bear the monopolists’ costs of doing business that include not only
the actual expenses, but also a reasonable return for the investment); and cases
where access would interfere with the service of other customers.93
Furthermore, the analysis undertaken in the previous chapter supports the
conclusion that IP, in itself, would not constitute an objective justification as
this would amount to the exemption of IP from antitrust control.94
89
J. Ratner, Should there be an Essential Facilities Doctrine, 21 UC DAVIS L.
REV. 327 (1988) p. 382. In addition, it is sometimes impossible to characterise some
markets as separate markets in an antitrust sense, but nonetheless there is a dependence
situation as in the case of IMS, and also in the case for research tools.
90
IMS Case (2004) op. cit. para 45.
91
Ibid. para 44.
92
See J. Killick (2004) op. cit.
93
D.E. Troy (1983) op. cit.
94
See Chapter 5. As it was contended earlier, the existence of unwarranted IPRs
that lead to unreasonable monopolisations of the market may constitute an unspoken
consideration in the determination of essentiality. In cases where weak IP laws are in-
volved which grant an extra advantage in the market without justification, the
essentiality benchmark may effectively be lowered. This should not be seen as competi-
tion law adopting a different threshold for IP, but rather as similar to the case in which
an industry standard is involved as it will affect the application of the essentiality/ in-
dispensability requirement. This effectively involves taking the specific regulatory and
other contexts into account in determining indispensability. See also Dutch Telegraaf
case (Decision of director-general Dutch Competition Authority 10 September 1998,
The recent opinion of Advocate-General Jacobs in GlaxoSmithKline95 sheds

some light on the objective justification. First, he stated that the question of
abuse and justification should be dealt with together as a single issue.96 Sec-
ondly, and most importantly, he considered that the specific and regulatory
context can be taken into account in the determination of abuse and objective
justification.97
In this case, the Advocate-General took the pervasive regulation of price and
distribution in the pharmaceutical industry into account, as well as the likely
impact of unmoderated parallel trade upon pharmaceutical undertakings, and
the effect of such trade upon consumers and purchasers of pharmaceutical
products.98 Based on the particularities of these factors in the pharmaceutical
industry, he concluded that a refusal to license which was intended to restrict
parallel trade, did not constitute an abuse and was capable of ‘justification as a
reasonable and proportionate measure in defence of that undertaking’s com-
mercial interests’.99
The Advocate-General’s opinion is illuminating insofar as it takes considera-
tion of the broader context and specificities involved in line with the
characteristics of the industry. In addition, insofar as he considers abuse and
objective justification one question, consideration of the economic and regula-
1/501.o119 (Telegraaf v NOS/HMG); Trade and Industry Appeals Tribunal, 15th July,
2004, www.rechtspraak.nl, LJN-number: AQ1727) in which the Rotterdam District
Court decided that the existence of IPRs could not be used to establish an objective
justification.
See also Commission Decision in Case COMP/C-3/37.792 Microsoft [2004] ‘Micro-
soft’s refusal cannot be objectively justified merely by the fact that it constitutes a refusal
to license intellectual property’ (recital 712).
95
AG Opinion in Glaxosmithkline (2004) op. cit.
96
Ibid. para. 72.
97
Ibid. para. 68.
98
Ibid. para. 76.
99
Ibid. para. 100. The AG considered that this was the case due to the particularities
of the industry as well as the fact that the case dealt with: a. the pervasive and diverse
measures of State intervention in the pricing of pharmaceutical products, which is re-
sponsible for price differentials between the Member States; b. the regulation of the
distribution of products which establishes nationally demarcated obligations upon phar-
maceutical undertakings and wholesalers to ensure the availability of adequate stocks of
those products; c. the potentially negative consequences of parallel trade for competition,
the common market and incentives to innovate, given the economic characteristics of
the pharmaceutical industry; d. the fact that end consumers of pharmaceutical products
may not benefit in all cases from parallel trade and that public authorities in Member
States, as the main purchasers of such products, cannot be assumed to benefit from lower
prices, given that they are themselves responsible for fixing prices within their territories
(para. 105).
tory context should also be taken into account in determining abuse and its
individual elements, including indispensability.100
6.2.4 New Product Innovation
In the IMS case, the Court further referred to the circumstances in which a re-
fusal by a dominant undertaking to grant a licence (to use its IP) might constitute
an abuse under Art. 82 EC. Following Magill, the Court stated that in order for
the refusal to give access to an indispensable product or service to be treated as
abusive three cumulative conditions must be satisfied: the refusal prevents the
emergence of a new product for which there is potential consumer demand; it
is unjustified; and it amounts to the exclusion of any competition on a secondary
market.101
100
In the case of IP, this again does not amount to an exemption but rather to a con-
sideration of the regulatory context that may include IPRs. This is likely to be crucial in
finding in favour of a duty to deal where a weak IP is concerned.
101
IMS (2004) op. cit. para. 38 of judgment. See also Magill op. cit.
This differs from the Magill case, as although the product was not yet in existence
there was certitude as to its development and what it would involve. On the other hand,
it is only required here that there should be an ‘intention to produce a new product’ which
one may also argue negates the very requirement itself. In biotechnology and specifically
in the case of research tools, as it will be shown in Chapter 7 this is important in view
of the fact that access is sought at a stage where it is not known whether a new product
will be developed.
Other cases however have not made reference to the new product rule or found it not
to be decisive. The Bronner case made no reference to the new product rule in its inter-
pretation of the duty to deal. See Bronner (1998) op. cit. para 41:
Therefore even if that case-law on the exercise of an intellectual property right were
applicable to the exercise of any property right whatever, it would still be necessary,
for the Magill judgment to be effectively relied upon in order to plead the existence
of an abuse within the meaning of Article 86 of the Treaty in a situation such as that
which forms the subject-matter of the first question, not only that the refusal of the
service comprised in home delivery be likely to eliminate all competition in the daily
newspaper market on the part of the person requesting the service and that such re-
fusal be incapable of being objectively justified, but also that the service in itself be
indispensable to carrying on that person’s business, inasmuch as there is no actual or
potential substitute in existence for that home-delivery scheme.
Hence, while Magill identified the new product requirement, Bronner did not perceive
it as an essential element of the test. Similarly, the Commission Decision in Microsoft
(2004) op. cit. did not make any reference to the new product rule.
See also, however, Ladbroke (1997) op. cit. para. 131. The Court in Ladbroke inter-
preted the prohibition on the refusal to deal as applying either in cases where the product
or service is essential or in cases where a new product might be prevented despite ‘spe-
This new product rule alludes to both consumer preferences and also to in-
novation and the need to promote new and efficient products.
Therefore, the refusal by an undertaking in a dominant position to allow access to a

product protected by copyright, where that product is indispensable for operating on
a secondary market, may be regarded as abusive only where the undertaking which
requested the licence does not intend to limit itself essentially to duplicating the goods
or services already offered on the secondary market by the owner of the copyright,
but intends to produce new goods or services not offered by the owner of the right
and for which there is a potential consumer demand.102
There are two fundamental issues which should be noted with regard to the
new product rule. First, this may be seen as the departure from the essential fa-
cilities doctrine as this emphasis is not only placed on ‘indispensability’ but
also on the ‘new’ product. The EFD did not contain a requirement relating to
the new product. Hence, strict adherence to the requirement would imply that
the EFD is insufficient to capture the essence of the duty to deal under Art. 82;
the emphasis should not only be on the indispensability of the facility but also
on the creation of a new product.
Secondly, it should be noted that the ECJ adopted a liberal definition of the
new product, as it refers to ‘intention to produce new goods’ as distinct from
their actual production. There may be significant implications arising from this
broad definition, particularly in the biopharmaceutical industry, as there may
be a duty to deal where access to an input is required as a basis for further re-
search and development, to ‘enable’ further innovation, even if it is as yet
impossible to identify the new products that would be developed, or even to
state with certainty that new products would be developed.103 Taking this argu-
ment to the extreme, one could also argue that the reference to an intention to
produce actually negates the very requirement of a new product.
cific, constant and regular potential demand’ on the part of consumers. The new product
rule would accordingly be a sufficient ground for liability, but not a necessary one.
102
IMS (2004) op. cit. para. 51.
103
Unfortunately, the Commission did not address the issue of this requirement in
its Microsoft decision. See Commission Decision in Microsoft (2004) op. cit. para.
693–701, in which the Commission briefly discusses whether the refusal ‘limits technical
development to the prejudice of consumer’, without analysing the new product
requirement.
See however the Dutch Telegraaf case (1998) op. cit. in which the Trade and Industry
Appeals Tribunal found that a refusal to license did not amount to an abuse of a dominant
position as the television guide which Telegraaf sought to publish did not qualify as a
new product as required in EC case law, thus applying the considerations of the ECJ in
IMS.
6.3 Conclusions
As recently confirmed in EC case law, the duty to deal under Art. 82 remains
exceptional and only sanctioned within narrow limits.104 It is applicable where
the refusal to license leads to harm to competition, rather than to a specific
competitor105 or to the restriction of parallel trade.106
Determining whether there are exceptional circumstances which amount to
a risk of harm to competition requires a ‘comprehensive examination’.107 In
addition, the regulatory and economic context needs to be considered.108 This
is important, as industry-specific characteristics may be decisive in establishing
indispensability and objective justification.
The case law clarifies that the duty to deal remains limited to situations in
which:
1. the product or service is indispensable for carrying on a particular

business;
2. the refusal prevents the emergence of a new product with a potential con-
sumer demand;
3. the refusal is not objectively justified;
4. the refusal effectively excludes all competition on the secondary
market.109
The aftermath to the Sealink decision underlines the importance of considering

alternatives and avoiding an over-eagerness in finding something ‘essential’.110
It should be recalled that the decision provided that the defendant should make
the port available to the rival ferry service, Sea Containers. The events that fol-
lowed showed that the latter did not avail of this option and instead chose to
104
AG opinion in Glaxosmithkline (2004) op. cit. para. 53; IMS (2004) op. cit.
105
See Bronner (1998) op. cit.
106
See Glaxosmithkline (2004) op. cit.
107
Microsoft Commission decision (2004) op. cit. para. 555–558.
108
AG opinion Glaxosmithkline (2004) op. cit. para. 53 ‘any obligation to deal pur-
suant to Article 82 EC can be established only after a close scrutiny of the factual and
economic context.’
109
IMS case (2004) op. cit. It confirmed that ‘in order for the refusal by an undertak-
ing which owns copyright to give access to a product or service indispensable for carrying
on a particular business to be treated as abusive, it is sufficient that three cumulative
conditions be satisfied, namely that the refusal is preventing the emergence of a new
product for which there is a potential consumer demand, that it is unjustified and such
as to exclude any competition on a secondary market.’
110
N/e/r/a, Competition Brief, Oscar Bronner: Legitimate Refusal to Supply, 1999,
at www.nera.com, p. 3.
operate a service to Ireland from Liverpool rather than Holyhead. At the time,
the Commission had dismissed this as an alternative, being too readily persuaded
by the claimant claims as to the essentiality of the facility.111
It therefore becomes clear that in imposing any obligation to deal, it is im-
portant not to dismiss the alternatives too easily. It is likely that the essential
nature of a product is overstated and thereby found essential, even though it
might not have been more than an inconvenience to the competitor. It is also
important not to encourage competitors to rely on the dominant firm’s facilities
but rather to encourage them to develop new and innovative services
themselves.112
In conclusion, the introduction of the new product rule as a prerequisite for
liability113 leads to a reconsideration of the applicability of the EFD in this
context and the extent to which it is the appropriate term to capture to the es-
sence of the duty to deal under Art. 82. It would rather seem to be more
appropriate in this case to refer to a more generally phrased duty to deal in cases
of indispensable ‘facilities/inputs’ which also prevent potential ‘new’ products
from entering the market. It should be noted, however, that it is not yet clear
whether the conditions laid down by the Court in IMS are necessary or merely
sufficient to impose liability for refusal to deal. 114
111
Ibid. p. 4.
112
Ibid.
113
IMS Case (2004) op. cit.
114
This debate is reflected in the Order of the President of the CFI 22 December
2004 (1) (Proceedings for interim relief – Article 82 EC) Competition Microsoft v Com-
mission Case T-201/04 para. 206: ‘Clearly, that question cannot be resolved at the interim
relief stage. It should be pointed out, however, that the Court of Justice has held, in the
words of paragraph 38 of the judgment in IMS Health, that “it is sufficient”, in order for
“the refusal by an undertaking which owns a copyright to give access to a product or
service indispensable for carrying on a particular business to be treated as abusive”, “that
that refusal is preventing the emergence of a new product for which there is a potential
consumer demand, that it is unjustified and [that it is] likely to exclude all competition
on a secondary market.”’
Appendix The Refusal to Deal Cases under

Art. 82
Box 6.1 Commercial Solvents: Refusal

to supply input to downstream
competitor in vertically related
market/ to preserve power in
market B
The first case in which a refusal to supply was found to constitute

an abuse of a dominant position contrary to Art. 82 EC was Com-
mercial Solvents.115 The defendant, Commercial Solvents (CS),
was the world’s only producer of an industrial scale raw material
which was used to produce ethambutol, an important drug in the
treatment of tuberculosis, which required a high level of know-how
and for which barriers to entry were high. Zoja was one of the three
main manufacturers of ethambutol in the common market and had
asked to be released from the contract. However, when it became
impossible to buy the drug elsewhere, Zoja requested CS to begin
supplying the raw materials again.
The latter refused to supply Zoja with the raw material and in-
structed the other companies who received the supplies not to sell
it on to Zoja. Finally, CS took the decision to integrate down the
market vertically and produce the drug itself. Zoja complained to
the Commission, who ordered minimum quantities be supplied,
however, it was not clarified whether this order was made to protect
the interests of Zoja or the consumer.
The ECJ upheld the finding of abuse, as it was particularly con-
cerned about vertical integration. It held that the decision by a
dominant firm to vertically integrate did not justify the refusal to
supply a long-standing customer, even if he was a competitor, as
it would eliminate competition from one of the principal manufactur-
ers in the market.
Market A: Raw material D
Long-standing customer Vertical Integration

Market B: Ethambutol P D
115
Case 7/73 ICI and Commercial Solvents v Commission [1974] ECR 223.
The ruling in this case thus imposes an obligation to grant a li-

cence to existing customers, if the failure to supply would lead to
the elimination of a significant competitor in the market. The ECJ
seems to have been particularly wary of vertical integration, fearing
that dominant firms in the production of raw material would use
their power in an upstream market to gain power in a related down-
stream market, with the possibility of also monopolising that
market.
Therefore, it took an interventionist approach, shaping the market
in line with its structural objectives, beyond its mandate to protect
the interests of customers and competitors.116 The case supports
the view that consumer interests are served by having as much
competition as possible in the final market.117 The decision, how-
ever, makes a clear appeal to the need to protect the interests of
consumers so that conduct that may ‘directly or indirectly prejudice’
them by impairing the competitive structure will be found abusive.
How would the court have ruled if CS had not chosen to integrate
vertically, but had none the less refused to supply Zoja, in response
to the latter’s initial preference of another upstream supplier? It is
probable that, even in this case, CS would have been forced to
supply as it would have been found to have been a disproportionate
response to the conduct of Zoja, and an unreasonable means to
protect its own interests.118 If the conduct of CS were to be deemed
to be proportionate and reasonable, then it could have also quali-
fied as an objective justification for the refusal to supply. However,
what constitutes a legitimate objective justification and in what
cases is it proportionate?119
The Court did not provide any guidance on the latter questions,
as it was believed that CS would have refused to license, even
116
R. Grosvenor, To what Extent can Art 86 be used to compel dominant undertak-
ings to supply competitors? at www.jumper.demon.co.uk/comm8a.htm, p. 3.
117
Ibid.
118
See also Case 27/76 United Brands v Commission [1978] ECR 207, on the issue
of proportionality.
119
See BP, Case 77/77, Benzine en Petroleum Handelsmaatschappik BV and others
v Commission [1978] ECR 1513, in which the Court held that BP had not abused its
dominant position during the 1973 oil crisis, when it reduced supplies significantly more
to the complainant than to its regular customers. This conduct was justified as reductions
were relative to the oil shortage. See, however, also Boosey & Hawkes OJ [1987]
L286/36, where the Commission stated that ‘a dominant undertaking may always take
reasonable steps to protect its commercial interests, but such measures must be fair and
proportional to the threat’.
without the initial cancellation of Zoja and stressed that vertical in-
tegration cannot be used to justify the elimination of a principal
manufacturer.
Box 6.2 United Brands: Refusal to deal

with a distributor promoting a
competing brand to reserve
market power in A
The next case that arose involving a refusal to deal was United
Brands.120 The defendant had reduced supplies to Olesen, a long-
standing customer (distributor/ ripener) of bananas, because he
had taken part in an advertising campaign for a rival brand, Dole.
United Brands (UB) argued that the complainant was pushing Dole
bananas at the expense of Chiquita bananas.
The Commission was concerned that if such conduct were per-
mitted, it would discourage other distributors from advertising and
promoting other brands. ‘In this manner UBC succeeds in keeping
its principle distributor/ripeners within its own marketing network
and in preventing competitors from having access to them, thus
denying to such competitors the essential facilities which they may
require in order to ripen their bananas before sale.’
The ECJ advised that an undertaking in a dominant position
‘cannot stop supplying a long-standing customer who abides by
regular commercial practice, if the orders placed by this customer
are in no way out of the ordinary’.121
Market A: banana production D and Competitors
Long-standing customer
Market B: distributors/ripeners P
The argument that Olesen was selling a competitor’s product

and neglecting the sale of UB’s product did not justify a failure to
supply. The reduction of supplies was found to violate Art. 82. The
ECJ stressed that a dominant undertaking can only take reasona-
120
Case 27/76 United Brands v Commission [1978] ECR 207.
121
Ibid. para. 182.
ble steps to ensure that its produce is properly sold. Hence, the
Court seems to be raising proportionality requirements again in
this case, as the right to protect one’s own commercial interests is
only justified if the action taken is reasonable and appropriate. In
considering the proportionality of this type of sanction, the eco-
nomic strength of the undertakings at stake will be taken into
consideration. Any attempt to extend and abuse the dominance of
the firm will be found to have violated Art. 82.
This is also in line with the requirement that the justification must
be objective. It is unclear, however, what steps UB could have taken
in this instance to defend its legitimate interests. It is important to
distinguish between the requirement of equal treatment in relation
to a distributor’s sales policy,122 and the actual restriction of com-
petitors from access to the distributor’s marketing networks—the
so-called ‘essential facilities to ripen the bananas’. However, had
UB crossed this line?
It appears that the Court was also concerned about the inde-
pendence of SMEs, which allows them to preserve their business
interests and determine their own sales policy. A restriction upon
a firm’s right to participate in the advertising of a supplier would
effectively hamper the actual sales of other brands, as well as the
buyer’s freedom to decide its business interests. The arbitrary in-
terference in the management of Olesen’s business had resulted
in serious damage, and if the Court had found in favour of the be-
haviour of UB, it would have strengthened its bargaining position
even further and effectively allowed UB to indirectly discourage the
promotion of competing brands.
However, would this factor not exist in most cases? One might
argue that the Court chose to uphold the business interests of
Olesen, but denied UB the right to enforce its respective business
interests. Nevertheless, as it has been repeatedly recognised,
dominant undertakings are under more onerous obligations,123 as
they also have more potential for abuse, and more commercial
122
In effect, it could be argued that it was as if the Court was applauding the actions
of Dole leading to Olesen treating him favourably, but not those of UB wanting to be
treated equally.
123
See Case 322/81 Michelin v Commission [1983] ECR 3461 on special responsi-
bility. See also Case C-333/94 Tetra Pak v Commission [1997] 4 CMLR 602, where the
dominance in one market and the close links with another market gave the latter a ‘free-
dom of independence of conduct compared to the other economic operators such as to
impose on it a special responsibility under Art. 82 to maintain genuine and undistorted
bargaining power. In this light, the Court sought to encourage SMEs

to make their own commercial decisions, uninfluenced by threats
of large and more powerful companies, and to discourage the latter
companies from exerting this type of pressure in the first place. The
Commission and Court seem to have paid particular attention to
the fact that the market for bananas had many barriers to entry; as
UB was vertically integrated to a large degree, from plantation to
marketing, it controlled the sources of supply and was able to
guarantee regular supplies to competitors.
It is also worth noting, moreover, that by providing a requirement
to supply long-standing customers, the Court was in effect setting
a general rule prohibiting a refusal to supply unless justified, irre-
spective of the fact that competitors were not an issue and that
there was no possibility for leverage as in the Commercial Solvents
case.124
Hence, this case seems to provide a more general and broader
obligation not to go against a pattern of dealing, by refusing to li-
cense a long-standing customer, regardless of the rationale. Hence,
in the case of a refusal to supply, an objective justification would
seem to be necessary in order to escape liability, and while the
Court did not provide guidelines on what constitutes such a justifi-
cation, it appears that the requirements of reasonableness and
proportionality will be strictly applied.
It should be remembered, however, that the behaviour of UB was
also found abusive, as there was evidence of price discrimination
and a restriction on the resale of green bananas, resulting in the
segmentation of the market in practice. As integration was an im-
portant consideration at stake, the Court was determined not to
allow any possibility for discrimination along national boundaries,
and therefore its strict ruling against the refusal to supply may have
been influenced by its condemnation of price discrimination and its
desire to prevent any perceived barriers to integration.125
competition on those markets’. V. Korah, Competition Law of the European Communi-

ties, 2nd edn, Lexis Nexis (2001).
124
In this case, the parties only had a vertical relationship, and not a horizontal one
of competition as in the ICI and Commercial Solvents v Commission 7/73 [1974] ECR
223.
125
For a critique of the unclear economic rationale of the Court’s condemnation of
price discrimination, see L. Zanon di Valgiurate, Price Discrimination Under Art 86 of
the EEC Treaty: The United Brands Case [1982] Internat’l and Comparative Law Quar-
Box 6.3 Hugin: No effect on trade
The Hugin126 case involved Hugin’s refusal to supply spare parts

to its former exclusive distributor in the UK which were needed to
repair and maintain the large numbers of Hugin cash registers that
it rented out. The Commission ruled against Hugin, using a similar
rationale to the previous case, as it was concerned for the interests
of consumers and the preservation and independence of SMEs.
The Court, however, did not find any infringement of Art. 82, as the
firm only operated locally and therefore there was no effect on
trade.
Box 6.4 IGR: Refusal to license an

essential facility?
IGR Stereo-Television127 involved the refusal of a firm, IGR, the

proprietor of patents for stereo receivers which were necessary for
providing German television sets with stereo reception, to license
non-members (or the plans to license at a later stage along with
restrictions on quantity), and the use of the patent rights to prevent
a Finnish company, Salora, from supplying stereo TV sets which
required a patent licence.
The Commission found that the conduct constituted an abuse of
a dominant position that could not be justified on the basis of patent
rights. Compulsory licensing was not imposed, however, despite
the Commission’s willingness to impose it, as IGR agreed to grant
a licence to Salora without limitations after the initiation of
proceedings.
Market A: Patents for stereo receivers D
New entrant
Market B: TV manufacturing P
terly 37. The author states that that ‘the judgment appears more akin to those laws aiming
at the protection of existing competitors rather than of competition itself.’ p. 53.
126
Hugin v Commission Case 22/78 [1979] ECR 1869.
127
IGR Stereo Television EC, Comm XIth Competition Policy Report, 1982, p. 63.
In this case, the Commission was concerned with the control by

a firm in an upstream market of a downstream market, regardless
of the rationale behind this control, or whether it was due to an IPR
or otherwise. This case is similar to the previous cases, and again,
it concerned a vertical relationship. It differs, however, from the
previous cases as there was no previous relationship between the
parties, and therefore there was no consideration of the long-stand-
ing relationship or the pattern of behaviour. The refusal to license
the Finnish company effectively prevented a new entrant into the
German market of TV manufacturing. The obligation to license or
supply was hence extended by the Commission, to situations be-
yond those involving existing dealers, requiring dominant firms to
take affirmative action to ensure that competition is allowed to take
place in all markets on which they have an influence.128
Box 6.5 Telemarketing: Tying/ Refusal

to deal with suppliers dealing
with competitors/ to preserve
market power in B
In the Telemarketing case,129 a subsidiary of Radio and TV Luxem-

bourg refused to accept advertisements from advertisers who had
not used the telemarketing services of its associated phone-in
marketing company when it sought to enter the field.
The Commission treated this as a case of tying, and held that
‘there is an abuse of a dominant position where an undertaking
which occupies a DP on a market and which is thus able to control
the activities of other undertakings on a neighbouring market de-
cides to establish itself on the second market and for no good
reason refuses to supply the product or service in question on the
market where it already occupies a DP to the undertakings whose
activities are centred on the market which it is penetrating’.
The ECJ treated the case as a refusal to supply and found that
Art. 82 applies even where dominance is due to some legal provi-
128
R. Subbiotto, The Right to Deal with Whom One Pleases Under EC Competition
Law: A Small Contribution to a Necessary Debate, 9 ECLR 234 (1992).
129
Companie Luxembourgeoise de Télédiffusion [1985] ECR 3261.
sions providing for limited or no competition, as it refers to a factual

situation. An abuse is committed where an undertaking holding a
dominant position on a particular market reserves an ancillary ac-
tivity without objective necessity to itself or to an undertaking
belonging in the same group which might be carried out by another
undertaking as part of its activities on a neighbouring but separate
market, with the possibility of eliminating all competition from such
undertaking. It also stated that the same applies where an under-
taking has a dominant position on the market for a service that is
indispensable for another undertaking on another market.
The case might also be seen as a refusal to deal with suppliers
(for example advertising as in this case) which dealt with competi-
tors on a secondary market (such as answering services) to
preserve market power in the latter market.
Market A: TV D
Vertical integration
Market B: Answering services D Competitors
Market C: Telemarketing P
The judgment is significant for several reasons. First, it held that

Art. 82 applies even where dominance arises from provisions en-
shrined in law. While the case the Court referred to liberalised
companies by virtue of Art. 90(2), in the present case, this also
implies the same attitude for IPRs, which are also granted by law.
Secondly, it appears that in the present case, the Court and
Commission were particularly concerned about the existence of
related markets, and the possibility of extending market power from
an upstream to a downstream market with the possibility of elimi-
nating competition. The requirements for an abuse would hence,
thus far, seem to include: (a) the existence of a dominant position;
(b) the reservation of an ancillary activity; (c) with the possibility of
eliminating all competition from such undertaking; and (d) with no
objective necessity.
Box 6.6 Volvo: Refusal to share spare

parts with independent
providers of aftermarket
support
Another case which involved a refusal to supply was Volvo v
Veng.130 Volvo had used its design rights in the UK to restrain Veng
from importing wing panels of Volvo cars from another Member
State. It alleged that there had been an infringement of its regis-
tered design. Veng, in its defence, argued that Volvo’s refusal to
license spare parts for Volvo motor carts constituted an abuse of
a dominant position.
The ECJ refused to rule against the injunction imposed on Veng.
Advocate-General Mischo concluded that the right to restrain third
parties from exploiting the design constitutes the very subject mat-
ter of the exclusive right. Consequently, the ECJ held that an order
for the granting of a licence would deprive the right of the substance
of its exclusivity and that a refusal to license did not constitute an
abuse of that right. Nevertheless, it added that the exercise of a
holder’s exclusive right might be prohibited by Art. 82 if it involved
‘certain abusive conduct such as the arbitrary refusal to supply
spare parts to independent repairers, the fixing of prices for spare
parts at an unfair level or a decision no longer to produce spare
parts for a consumer model even though many cars of that model
are still in circulation’ provided that such conduct may affect trade
between Member States. Whilst the Court emphasised that, in the
absence of harmonisation ‘the determination of the conditions and
procedures under which protection of designs is granted is a matter
for national law’, it also clarified that their exercise could be limited
by Art. 82 in certain cases.
Market A: Car manufacturer and spare parts D
Registered design rights on replacement body panels

Market B: Repair of car/replacement parts P
The case highlighted that a dominant position does not arise only
by virtue of the existence of exclusive rights; rather, this would also
130
Volvo v Veng (UK) Ltd Case 238/87 [1988] ECR 6211.
depend on the absence of substitutes, clarifying that the existence

of an IPR is not concomitant with dominance. However, the Court’s
reference to ‘arbitrary refusal to supply spare parts’ does not ad-
dress the question of when such a refusal will be deemed
arbitrary.
Box 6.7 Sabena: Denial of access to a

facility to downstream
competitors which is necessary
to compete/ to preserve market
power in market B
In London European/Sabena,131 Sabena, as the dominant firm in

the market for computer reservation services (CRS) in Belgium,
refused access to its CRS to London European, as it sought to
enter the London–Brussels route, competing with it on the fare
rates. The refusal prevented London European from covering this
route, and it was therefore treated by the Commission as an abuse,
which consisted of refusing access to an essential service.
Market A: Computer reservation services D
Market B: Flights/London-Brussels route D P
The Commission was paving the way for the essential facilities
doctrine. It also took consideration of the fact that the refusal to
grant access was not based on a lack of capacity, but on a desire
to prevent the competitor from entering the market. Sabena’s op-
erations on both markets opened the possibility for leverage, in
particular as the CRS was essential for operating in the market and
its access would have to be granted on the basis of objective cri-
teria and of the competitive (or anti-competitive for this matter)
strategies of the controlling company.
131
Commission Decision London European-Sabena, OJ 1988 L 317/47.
Box 6.8 Decca: Essential Facilities?

Denial of access to a facility to
downstream competitors that is
necessary to compete/to
preserve market power in
market B
In Decca Navigation Systems,132 Decca refused to grant access to
its navigation signals that were protected by copyright to users of
non-Decca receivers. The Commission found that this constituted
an abuse of a dominant position, as navigation signals were es-
sential to all receivers, and hence Decca was under a positive duty
to grant access to other receivers. As in the case of IGR TV, the
emphasis seems to be on the exclusionary behaviour on a second-
ary market, regardless of whether dominance was due to or
associated with the IPR.
The recurring pattern seems to involve a firm which is dominant
on the upstream market and is also present on the downstream
market in which another firm seeks to enter or continue to operate;
access to the upstream product or service is necessary to compete
in the downstream market.
Market A: Navigation signals D©
Essential for operation on downstream market

Market B: Receivers D P
In this case, other considerations might also have influenced the

Commission, as Racal had entered into an agreement with com-
petitors to partition the market for commercial and pleasure boat
receivers. There was no potential competition on the market for the
signals, whereas with the agreement and the change of frequen-
cies in the signals, DNS-compatible receivers for commercial use
enjoyed a de facto monopoly. The Commission believed that such
action would lead to a negative impact on consumers as it would
limit their freedom of choice.
Abuse was therefore found on the basis of use of power on the
market for signals to foreclose and limit the access of third parties
132
Commission Decision Decca Navigator System, OJ 1989 L 43/27.
to the market for receivers, thereby also affecting consumer

interest.
The Commission also found that Racal (DNS) did not have any
legitimate property interests, as its patents on the receivers had
lapsed and there was no ‘legal property in the transmission of sig-
nals, which is the service supplied but only in the equipment
(chains)’.133 It seems that the Commission was also concerned
about the possibility of extending the legal monopoly (of the pat-
ents) after they had lapsed. Regarding the copyright in question
which aimed to partition the market, it was not found to justify ‘far-
reaching restrictions on competition’.
It also clarified that IPR do not enjoy immunity from the competi-
tion provisions: ‘The Community system of competition does not
allow the improper use of rights under national copyright laws which
frustrate Community competition law’.134
Hence, in its finding of abuse, the Commission seems to have
been influenced by the following factors: (a) there was an agree-
ment between competitors allocating the markets; (b) it impeded
competing receivers resulting in a de facto monopoly; (c) it was
acting against the interests of the consumers; and (d) there was
no justification for this conduct as it eliminated innovative competi-
tion and limited technological and economic progress, rather than
fostering innovation.
Box 6.9 Aer Lingus: Refusal to continue

joint venture with competitor. A
disproportionate sanction?
In British Midland/Aer Lingus,135 the two companies had an interlin-
ing agreement, which involved issuing tickets reciprocally on behalf
of the other airlines. When BM began to compete on a specific
route with AL (the Dublin–London route), the latter decided to end
the interlining agreement, which rendered BM flights less attractive.
The Commission found that such a withdrawal constituted an abuse
133
Ibid. para. 104.
134
Ibid. para. 104.
135
Commission Decision British Midland/ Aer Lingus, OJ 1992 L 96/34.
and fined AL.136 It stated that ‘refusing to interline is not normal

competition on the merits … the argument that interlining would
result in a loss of revenue would not of itself make the refusal le-
gitimate. Both the refusal to grant new interline facilities and the
withdrawal of existing interline facilities may, depending on the cir-
cumstances, hinder the maintenance of competition’.
The Commission also referred to ‘… objectively likely to have a
significant impact on the other airline’s ability to start a new service
or sustain an existing service in account of its effects on the other
airline’s costs and revenue…’. The Commission, however, recog-
nised that new entrants should not be allowed to operate on their
competitor’s networks forever, but instead should be encouraged
to develop their own and therefore only imposed the interlining
agreement for a period of two years.137
It has been suggested that it might be more ‘helpful to character-
ize Aer Lingus, Boosey & Hawkes and United Brands as cases of
dependence rather than essential facilities. They were all cases of
retaliation by dominant firms against customers who either entered
into, or joined with competitors to enter into competition with their
“supplier”. In such a situation Art. 86 can apply even if the degree
of dominance is such that there are some alternative sources of
supply and the legal test is one of objective justification and pro-
portionality for the dominant undertaking’s use of the sanction of
refusal to supply as a punishment’.138
136
See Commission Speeches on short-term benefits, in http://europa.eu.int/comm/
competition/speeches/text/sp1996_0542_en.html which refers to cooperation between
competitors that might be essential to carry out certain operations, specifically referring
to airlines’ interlining, where more participants is considered better as there is usually
only scope for one system. ‘Network externalities magnify disadvantages of exclusion,
and reduce the viability of otherwise essential competitors. Exclusion would be hard to
justify, as it would create a category of second-class competitors, unless admission would
reduce the efficiency of the network.’ p. 17.
137
R. Grosvenor, To what extent can Art 86 be used to compel dominant undertak-
ings to supply competitors? at www.jumper.demon.co.uk/comm8a.htm, pp. 4–5.
138
Anderman, EC Competition Law and IPRs: The Regulation of Innovation, 1998,
p. 202. See also T. Nacke Abuse of Dominant Positions, 1995 at http://europa.eu.int/
comm/competition/speeches/text/sp1995_025_en.html. He refers to the notion of eco-
nomic dependence of some Member States, in which a company has market power but
is not dominant. The author proposes that we should develop a concept of partenaire
obligatoire so that there is an abuse if the dependent company cannot substitute, if it is
likely to deter new competitors and if the company’s behaviour is not constrained by
competition in the wider downstream market.
Box 6.10 Sea Containers: Essential

facilities? Refusal to grant
access to a facility to a
competitor/to preserve market
power in B
Sea Containers v Stena Sealink139 also seems to follow the same
pattern of the previous cases. This involved a port owner who re-
fused to give access to a new ferry service, as it competed with its
own ferry service from Holyhead to Ireland. For the first time, the
Commission explicitly referred to the essential facilities doctrine,
holding that the port constituted an essential facility, and that the
denial of access was not based on an objective justification, and
that the owner had to offer access to competitors and customers
on a non-discriminatory basis.
Market A: Port owner D
Market B: Ferry service D P
In the present case, it appears that here the requirements for an

obligation to grant access on a non-discriminatory basis would in-
clude: (a) an essential facility controlled by a dominant undertaking;
(b) denial of it to a competitor or access on less favourable terms;
(c) no objective justification.
It would seem again that the rationale was the fear of extending
power from an upstream market in which the defendant is dominant
to the downstream market. The Commission imposed a strict duty
of non-discrimination as the owner of the facility had to satisfy the
dual role as administrator and operator of the facility. The Commis-
sion therefore imposed more onerous obligations on the owner of
the facility who had to negotiate as an independent standard opera-
tor, and not just on reasonable grounds.140
139
Commission Decision Sea Containers v Stena Sealink, OJ 1994 L15/08.
140
It should be noted, however, that the standard of an independent operator was
perhaps imposed here as the case involved a natural monopoly. There was indeed a double
monopoly as both the upstream and the downstream market were monopolised by the
defendant and not through his skill and merit, J.S. Venit and J.J. Kallaugher, Essential
Box 6.11 Magill: Essential facilities/

Refusal to supply input to
downstream competitor/to
preserve market power in
market B
The next case that led to significant debate on the dominant firm’s
obligations to deal with competitors and the compulsory licensing
of IPRs was the Magill case.141 The case involved the monopolisa-
tion of the weekly TV programme magazines. Three channels, RTE,
BBC and ITP, each published their respective weekly listings for
their TV programmes. These were sent to newspapers and maga-
zines free of charge who were allowed to publish daily TV
programmes one day in advance during the week and two days in
advance at weekends. The TV listings were protected by copyright
law. There was no comprehensive weekly guide published for all
channels and injunctions restrained Magill from publishing a com-
prehensive weekly TV magazine. As a result, a complaint was
made to the Commission.
In this case, the ECJ stated that although mere ownership of an
IPR cannot confer a dominant position, the broadcasters had a
factual monopoly over the basic information that was required by
a third party; they had complete control over the raw material for
weekly TV guides. Therefore, they were deemed to be in a domi-
nant position.
The ECJ also held that the exclusive rights of reproduction form
part of the rights of a copyright holder and that a refusal to grant a
Facilities: A Comparative Law Approach, in Hawk ed., 1994, Fordham Corp. L. Inst.
315 (1995).
Hence, it might reflect concerns about liberalised industries and the possibility for lever-
age and extension of power on secondary markets, with the possibility of eliminating
competition on such markets, or to evade regulation in the upstream market by extending
power in other unregulated markets. ‘In Europe important sectors of industry are being
deregulated or at least liberalized by the EU. These measures would be of little value if the
companies concerned, most of which are dominant in their own areas, were free to integrate
forward and to discriminate in favour of their own downstream operations. Regulated or
state-owned companies often own facilities that are essential for all or most of their down-
stream competitors. The essential facilities principle is in effect the follow-up of Art 90 of
the EEC Treaty.’ J.T. Lang, Defining Legitimate Competition: Companies’ Duties to Supply
Competitors and Access to Essential Services, 1994, Fordham Law Inst. 245.
141
Case C-241 and 242/91P Magill [1995] ECR I-743.
licence cannot in itself constitute an abuse. However, the exercise

of exclusive rights may amount to an abuse in exceptional circum-
stances. It was relevant that the refusal to supply the raw
information prevented the emergence of a new product for which
there was substantial demand. Secondly, the refusal was not justi-
fied and, thirdly, through their conduct, the broadcasters had
reserved to themselves a secondary market excluding all competi-
tion on that market, as they had denied access to the basic
information to the public, the raw material that was indispensable
for the creation of such a guide.
The Court also highlighted that the case was not concerned by
the differences in granting IPRs by Member States, but at the same
time it emphasised that it was wrong to assume that conduct con-
sisting of the exercise of copyright which is legitimate under national
law cannot be reviewed under Art. 82. It confirmed that the Com-
mission had the power to impose compulsory licensing (as it was
the only way to bring an end to infringement), and that for effect on
trade potential effect is enough.
Market A: TV listings/ programme information © D
Market B: Weekly programme listings and weekly D P

TV publications
(including non-listings material)
The impact of Magill largely depends on its interpretation. Two

interpretations may be made of the ECJ’s requirement of excep-
tional circumstances. The narrow requires both the prevention of a
new product for which there is significant demand, and that IPRs
are linked to essential inputs for a secondary market. The broad
interpretation states that the essential input in a secondary market
is sufficient, thus placing positive duties on IPR holders.142 Thus,
on the position regarding a refusal to license, the impact of Magill
depends on whether one views the exceptional circumstances as
consisting of two separate rules (the new product rule and the es-
sential facility rule) or as one cumulative one. Evidence of the fact
that it constitutes one rule can be found in para. 57 of the judgment
142
S. Anderman, EC Competition Law and IPRs: The Regulation of Innovation,
Oxford University Press (1998).
in which the Court found that ‘in the light of all those circumstances
the Court of First Instance (CFI) did not err in law in finding that the
appellant’s conduct was an abuse of a dominant position within the
meaning of Art. 86 of the Treaty’.143
Box 6.12 Ladbroke: The absence of a

competitive relationship/
Refusal to license input/
Essential facilities
In the case of Tierce Ladbroke v Commission,144 the CFI held that

the judgment in Magill did not apply to the refusal by the copyright
holders of French horse racing to grant Ladbroke a licence to show
the races in its Belgian betting shops.
The relevant market was defined as the sound and picture of
horse racing in general in Belgium. Ladbroke argued that the con-
duct of the copyright holders was discriminatory as it had licensed
the French horse racing to other countries. The CFI rejected this
argument, however, as the refusal could not have been discrimina-
tory in the absence of competition in the relevant market, notably
Belgium. It also believed that this did not result in the partitioning
of the common market as the pattern of demand showed that the
markets were divided along national lines and not as a result of the
right holders’ licensing policy. Furthermore, the latter did not oper-
ate nor had they granted a licence to other operators in Belgium.
Market A: Broadcasting coverage of horse racing © D
Market B: Operation of betting shops P
The Court also strictly distinguished the case from Magill, as in

the present case, Ladbroke was not even present on the market let
alone enjoyed a monopoly. The CFI explained that for a duty to deal
to arise the product must either be essential or it must involve a new
product. While the broadcasting was ‘an additional and suitable
143
Magill case, op. cit., Judgment of the Court, para. 57.
144
Case T-504/93 Tierce Ladbroke v Commission [1997] ECR II 923.
service for bettors’, it was not indispensable to the main activity, in

other words, to the taking of bets, nor did it constitute a new product.
Ladbroke showed other races on screen, and its betting activity was
very strong even without a licence to the French horse races.
The case is important as it offered a broad interpretation of Magill
in the wider way, holding that the new product rule and the leverage
rule were separate, rather than cumulative. However, it should be
noted that this is not an authoritative interpretation of Magill, as it
was discussed obiter dicta. The case also reflects how market
definition is crucial in deciding whether an IPR holder has abused
its dominant position by refusing to license a product.145
Box 6.13 Bronner: Refusal to grant

access to a distribution system
to an upstream competitor/
Refusal to share methods to
reach customers/Essential
facilities?/To preserve market
power in market A
Oscar Bronner v Mediaprint146 involved the obligations of a domi-

nant newspaper firm to grant access to its nation-wide home-delivery
service of daily newspapers to Mediaprint, a newspaper of smaller
circulation. It was held that the access to the home-delivery system
was not indispensable and, therefore, it was found that no abuse
had occurred. The case displays a narrow interpretation of the
doctrine of a refusal by a firm that was not in the public sector to
grant access to an essential facility.147
Market A: Newspapers D P
Market B: Home delivery service D
145
The CFI spoke in terms of ancillary markets that were not independent of the
main market and not of sub-markets as in Magill, but it is not clear what the term signi-
fies. See Fitzgerald, Magill Revisited EIPR 154, 1998.
146
Case C-7/97 [1998] ECR I-7791.
147
V. Korah, Competition Law of the European Communities, 2nd edn, Lexis Nexis
(2001).
The Advocate-General explained the doctrine applied in cases

where a dominant firm in the provision of facilities for the supply of
goods or services on another market abuses its dominant position
by refusing access to those facilities without objective justification.
This involves cases in which a dominant firm is obliged not merely
to refrain from anti-competitive activity, but also must actively pro-
mote competition by allowing potential competitors to have access
to the facilities that it has developed. He also acknowledged the
importance of the right to choose one’s trading partners, the need
to preserve the incentive for a dominant position to invest, and that
the primary purpose of Art. 82 is to prevent distortion of competition
and to safeguard the interests of the consumers rather than protect
the position of particular competitors. He observed that reserving
oneself to the downstream market ‘will not have an adverse impact
on consumers unless the dominant position is sufficiently insulated
from competition to give it market power’.148
With regard to IPRs, the Advocate-General stated that in the ab-
sence of other factors, the refusal to license does not in itself
constitute an abuse, and recognised that a wide duty to provide
access would have a harmful effect on the incentive to make the
original investment, particularly bearing in mind that duplication of
the facility was possible and the difficulty of the courts in establishing
the amount of compensation. There should be a real stranglehold
on a related market before a duty to license is imposed, for example
if ‘duplication of the facility is impossible or extremely difficult owing
to physical, geographical or legal constraints or is highly undesirable
for reasons of public policy. It is not sufficient that the undertaking’s
control over a facility gives it a competitive advantage.’149
He also noted that the test must be objective: ‘it must be ex-
tremely difficult not merely for the undertaking demanding access,
but for any other undertaking to compete’.150
The Court upheld the Advocate-General’s decision in the sense
that the refusal must be likely to eliminate all competition in the
market, it must be incapable of being objectively justified, and the
service in question must be indispensable to carrying on that per-
son’s business, inasmuch as there is no actual or potential
substitute in existence for that home-delivery scheme. ‘For such
148
C 7/97 Oscar Bronner, A-G Jacobs Opinion, ECR [1998] I-07791, para. 58.
149
Ibid. para. 65.
150
Ibid. para. 66.
access to be capable of being regarded as indispensable it would

be necessary at the very least that it is not economically viable to
create a second home-delivery scheme for the distribution of daily
newspapers with a circulation comparable to that of the daily news-
papers distributed by the existing scheme’.151 In this way, the facility
should not only be desirable, it must also be necessary.
On the facts of the case, the ECJ found that the home-delivery
system was not essential and access was not indispensable, even
if an alternative system would not be economically viable due its
small circulation. It viewed Magill as an exceptional case, in which
the information was indispensable to the publication as: Magill
could not publish a magazine for which there was consumer de-
mand at all without it; there was no objective justification for refusal;
and the refusal would result in the elimination of all competition in
the secondary market of TV guides. In the present case, however,
the facility was not indispensable, as the question of whether it
could be expected to establish a second such system was not
judged from the position of Bronner but that of an undertaking of
comparable position to Mediaprint.152
151
Oscar Bronner op. cit., Judgment of the Court, para. 46.
152
R. Whish, Recent Developments in Community Competition Law, 2000 E.L. Rev.
219.
For a criticism of this see M. Bergman, The Bronner Case—A turning point for the
Essential Facilities Doctrine? 21 ECLR 59 (2000) who believes that if such a high
standard is applied without consideration of the specific circumstances, only natural/in-
evitable monopolies will qualify as EF. The author also believes that although the strict
criterion encourages strong firms to take risks and invest, it hampers competition (at least
in the short run) and reduces incentives for small firms to invest. He also believes that
the ECJ replaced the ‘circumstance approach’ of economic analysis for legal certainty,
thus undermining the flexibility of the notion of abuse which is perceived by many com-
mentators to be its virtue. This case has also been criticised for confusing the issues of
dominance and abuse. See Stothers, Refusal to Supply as Abuse of a Dominant Position:
Essential Facilities in the EU, 7 ECLR 256 (2001). The author shows that two out of the
three requirements laid down by the Court for abuse involve dominance. He concludes
that in the end the traditional test of Commercial Solvents and the modern approach of
Magill and Oscar Bronner are the same. This test involved the question of whether there
was a dominant position on the market, and if there was, whether it had been abused.
The author further argues that the essential facilities doctrine involves the importation
of an unnecessary concept in EC law and that refusal to supply cases may be sufficiently
and better dealt with under Art. 82. Regarding the need to preserve incentives for invest-
ment, refusal to supply will only constitute abuse if it is determined that there is no
sufficient possibility of substitutes to prevent dominance. It is unnecessary to show
dominance in a downstream market as, if this is not the case, the dominant firm will not
be able to take monopoly rent at that level in any case. Finally, the author believes that
Therefore, the requirements for liability in this case appear to

include: (a) refusal to license; (b) likely to eliminate all competition
in market; (c) no objective justification; (d) service indispensable to
carrying business/no substitutes. The ECJ treated the obligation to
license as much narrower than in previous cases such as United
Brands and Commercial Solvents, as the service should be indis-
pensable, and a real stranglehold must exist before compulsory
licensing is imposed.
Box 6.14 IMS: Refusal to license input

(format) to competitors/
Essential facilities/To preserve
market power in market A
In the IMS case153 NDC complained to the Commission that IMS

had refused to license its ‘1860 brick structure’ for reporting German
sales data in the pharmaceutical industry. Within this structure,
Germany was divided into the maximum number of geographical
the transaction costs of enforcing this aspect of competition law would outweigh its
benefits. Hence the solution he proposes involves the use of Art. 82, but without readily
finding dominance. Once dominance is established, refusal to supply should be seen as
abusive unless an objective justification is given. IP should be considered as an objective
justification for all cases, apart from the most exceptional ones. Hence, it directs criticism
to the definition of dominance rather than abuse. It is submitted that such an approach
would then redirect attention in IP cases of which exceptional circumstances negate the
justification. Indeed the essential facilities doctrine may not be necessary to analyse re-
fusal to supply cases. It may, however, none the less be desirable, as limiting the
situations in which a dominant firm will be under a duty to supply/license. Furthermore,
this assumption of an obligation on dominant firms to license, at the very least imposes
an obligation on IPR holders, and any dominant firm in general, to give reasons for their
refusal to supply to avoid interference on the grounds that the refusal was arbitrary, and
therefore abusive. ‘Although jurisdictional requirements remain, any IP owner in more
than one EC Member State will be capable of satisfying them.’ See Robertson, Compul-
sory Licensing Under EC Law? 1992 LQR 39.
See also Case T-374/94 European Night Services [1998] ECR II-3141 in which the
Court took the view that train crews could not constitute an EF; and Info-Lab/Ricoh
(Competition Policy Newsletter (1999)) in which the Commission referred to the restric-
tive approach of Oscar Bronner and rejected a claim that Ricoh was under an obligation
to supply the complainant with new empty toner cartridges to enable him to compete
with Ricoh’s filled cartridges.
153
IMS Health Inc v Commission, 10 August 2001, Order of President of CFI, 26
October 2001, Order of President of CFI, 11 April 2002, Order of President of Court.
units permitting data collection, while not enabling users to match

the data to a specific pharmacy, as that would contravene German
data protection rules.154 IMS which collects and sells regional data
services for sales data collection and analysis, used its copyright
on the brick structure to prevent competitors from marketing data
services using the same or similar reporting formats. NDC argued
that the refusal to license the structure prevented it from effectively
competing, as an alternative structure would not serve the custom-
ers’ needs and would be unmarketable. In this instance, their
complaint was effectively based on the essential facilities doctrine.
Market? Brick structure standard?
Market A: Selling regional data services D (brick structure) P
Market B: Sales data collection and analysis
Wholesalers using input data of Service Provider
Service provider (IMS, NDC…) check and format using

brick structure
Regional Sales Report
The Commission found that the relevant market was the German
regional sales data service, and that there were exceptional cir-
cumstances in this instance, as it became clear that the brick
structure had developed into a de facto industry standard and that
an alternative standard would not be economically viable. It hence
ordered interim measures, consisting of a licence on a non-dis-
criminatory basis in return for a reasonable royalty.
In its decision, the Commission greatly expanded the ambit of
third party rights of access.155 It effectively did away with the re-
quirement of a new product, based on its reading of Ladbroke, and
it also neglected the requirement of a secondary market. It is also
argued that while access to the information was vital in Magill as
154
D. Hull, J. Atwood, J. Perrine, Intellectual Property Compulsory Licensing, 2002
European Antitrust Review 36, at www.Global-Competition.com.
155
Ibid.
there was no alternative and Magill could not invent or develop the
listings, nor could it publish the non-listings material without this
information. In the IMS case, access to medical data was not at is-
sue, but the ‘use of the format developed to present this information
to the pharmaceutical companies’.156
In reaching its conclusion on the indispensability of the structure
particular attention was paid to whether customers would buy data
formatted in other structures. This might be criticised, as although
consumers’ interests are an important consideration, it is only natu-
ral that they prefer a higher product developed with a significant
level of skill and merit. However, the Commission based its decision
on the fact that the brick structure had been developed by a working
group, and pharmaceutical companies had participated in this
process; the brick structure was therefore built to suit their interests
over a long period of time and there were many disincentives in
switching. It therefore found that it had evolved into a de facto in-
dustry standard.
The fact that the pharmaceutical companies were economically
dependent on the brick structure was also relevant in this decision,
as switching would be an unviable economic option in light of the
comparability and compatibility of data, the change of sales territo-
ries and the costs of modifying the software applications. In reaching
its conclusion on the indispensability of the brick structure, the Com-
mission was also concerned that it would not be likely for competitors
to create an alternative structure due to technological and legal
constraints.157 These included administrative boundaries, data pro-
tection constraints and uncertainty surrounding the sale of data and
whether it would infringe the copyright of the 1860 brick structure.
The Commission’s willingness to impose compulsory licensing
and to find that the brick structure constituted an essential facility
raises many questions regarding the need for two markets, along
with whether IP is treated or should be treated differently from other
cases.
The decision of the Commission was suspended by Order of the
President of the CFI on 10 August 2001, as IMS argued that the
156
Ibid. p. 37.
157
It might also have been relevant that there was a low margin of creativity in the
brick structure of 3–5%, which means that any alternative is bound to be similar and,
therefore, likely to lead to an infringement of the data. This was also confirmed by the
practice in other countries that showed that the brick structures were either similar, or
identical.
competitive advantage was the essence of copyright, and that

compulsory licensing was incompatible with Art. 295. On 26 Octo-
ber 2001, the President referred to the question at issue: whether
the application of German copyright law may be affected by Art. 82
EC. The arguments of the parties are important, as they illuminate,
first, when there is an obligation to deal is uncertain, and secondly,
that the position regarding IP is also a matter of debate.
IMS argued that a refusal to license an IPR can only constitute
an abuse if there is some additional behaviour that is in itself abu-
sive, or when an essential facility is at stake, which presupposes
the existence of two markets.158 The applicants further argued that
Magill was exceptional, as there was leverage from the upstream
to the downstream market and the copyright from broadcasting was
used to extend dominance in the weekly TV guides. In the present
case, IMS was not seeking to exploit market power in a separate
market.
On the other hand, the Commission argued there was no sepa-
rate product in Magill either, and that in both cases the supply of
service was indispensable. While there was no new product in IMS,
there was no such requirement, adopting the broad interpretation
of Magill. Hence, it argued that there is no precondition for two
markets. In accordance with Magill, it found that there were excep-
tional circumstances (such as that it had been developed in
cooperation with pharmaceutical companies and constituted an
industry standard with no likelihood of alternative), and in accord-
ance with Oscar Bronner, the refusal was likely to eliminate all
competition, access to it was necessary to compete and there was
no justification for such refusal.
The President of the CFI interpreted Magill as highlighting the
exceptional circumstances in which the exercise of exclusive rights
would constitute an abuse; when it is exercised in such ways and
circumstances as ‘in fact to pursue an aim manifestly contrary to
Art. 82’. He found, however, that the balance of interests weighed
in favour of the preservation of copyright and therefore suspended
the Commission decision until the CFI judgment had been given.
The ECJ gave its Art. 234 reference opinion relatively recently
in the IMS case.159 It adopted a cumulative reading of the Magill
158
IMS Health Inc v Commission, 10 August 2001, Order of President of CFI, 26
Oct 2001, Order of President of CFI, 11 April 2002, Order of President of Court. p. 15.
159
Case C-418/01, not yet reported, 29 April 2004.
requirements by stating that the refusal must prevent the emer-

gence of a new product. It adopted a broad definition of a ‘new
product’, however, as it referred to the ‘intention to produce new
goods’ as distinct from the actual production.
As regards the presence of two markets in an antitrust sense,
the Court concluded that ‘it is determinative that two different
stages of production may be identified and that they are intercon-
nected, the upstream is indispensable in as much as for supply of
the downstream product’.160 It hence adopted an expanded defini-
tion that did not require two markets in the traditional antitrust
sense: ‘it is sufficient that a potential market or even hypothetical
market can be identified. Such is the case where the products or
services are indispensable in order to carry on a particular
activity…’.161
Box 6.15 Microsoft162 – refusing to

provide interoperating
information
In March 2004 the Commission adopted a decision finding that

Microsoft had abused its quasi-monopoly in desktop operating
systems by, inter alia, refusing to provide interface information
necessary for competitors to create their own desktop operating
systems that could interoperate with Microsoft. The Commission
amongst other things imposed an obligation on Microsoft to license
the interface information to competitors on reasonable and non-
discriminatory terms and to provide an unbundled version of
Windows without the media player.
160
Ibid. para. 45.
161
Ibid. para. 44.
162
Commission Decision in Case COMP/C-3/37.792 Microsoft [2004], not yet
reported.
Box 6.16 GlaxoSmithKline, Syfait –

refusal to fully meet supply
requests to prevent parallel
imports163
The Greek Competition Commission made a preliminary reference
under Art. 234 EC in relation to the extent to which a dominant
company may refuse to fully meet orders placed by pharmaceutical
wholesalers with the intention of limiting parallel trade. The ECJ
found that it could not rule on the case as the Greek authority is
not a court or tribunal for the purposes of Art. 234, however, Advo-
cate-General Jacobs gave his opinion on the matters.
The Advocate-General found that due to the particular features
of the pharmaceutical sector, mostly relating to the high level of
regulation and sunk costs of R&D, pharmaceutical companies may
be objectively justified in refusing to fully supply wholesalers with
the intention of limiting parallel trade. He suggested that Courts
should take a flexible, economics-based approach in applying Art.
82 to the pharmaceutical sector, taking into account the whole
context (economic, regulatory and otherwise) and the particularities
of the industry.
In 2006 the Greek Competition Commission followed the Advo-
cate-General’s Opinion allowing GlaxoSmithKline to implement its
strategy to combat parallel imports.
163
Case C-53/03 Synetairismos Farmakopoion Aitolias and Akarnanias (Syfait) and
Others v Glaxosmithkline AEVE, Opinion of the A-G Jacobs, 28 October 2004.
Table 6.1 An overview of the main case law
Cases Principles Considerations
Commercial 1. existence of a long- Leverage. Vertical

Solvents: standing customer integration (VI)
2. elimination of proportionate sanction
important competitor
in market
United Brands: 1. long-standing SMEs, dependence
customer proportional sanction
2. regular commercial – Price discrimination
practice and market
segmentation
Hugin: No effect on trade
IGR Stereo-TV:* 1. new entrant Leverage. Vertical
COM 2. essential for down- integration
stream research Essential Facilities
Doctrine (EFD)?
same standard for IP
Telemarketing: 1. reservation of Leverage. Vertical
ancillary activity integration
2. possibility of elimi- long-standing customer
nating all competition
from such
undertaking
3. no objective
necessity
1. indispensable
2. for another market EFD
3. no objective
justification
Volvo v Veng:* additional abusive same for non IP cases
conduct also?
London European: 1. essential service Vertical integration,
COM New entrant Leverage
EFD?
Table 6.1 concluded
Cases Principles Considerations
Decca Navigation:* 1. essential Leverage. Vertical

COM New entrant integration, EFD?
same for IP and non-IP
British Midland: 1. long standing No leverage
COM 2. Significant impact on dependence?
firm even if new Proportionality of
entrant sanction
No indispensability—no
EF
Sea Containers: 1. essential facility Leverage, EFD
COM 2. denial New entrant
3. no objective
justification
Magill:* 1. new product New entrant
2. no objective Leverage
justification EF
3. indispensable for In practice same for
secondary market non-IP?
IPRs exceptional
circumstances
Tierce Ladbroke: not essential nor betting
shop new
Oscar Bronner: 1. indispensable No leverage?
2. likely to eliminate all Not EF
competition IP same as non-IP?
3. no objective
justification
IMS: 2 markets or one? – indispensable – no
EF? alternatives
– industry standard
dependence of
customers
Note: * and Italics for IP cases and considerations.

Table 6.2 The outcome of the main case law
Abuse No Abuse
IP Non IP IP Non IP
Decca Commercial Volvo (on Ladbroke

Navigation Solvents facts/in theory
can be abuse) Bronner
Magill United Brands
GlaxoSmith
IMS Telemarketing Kline
Microsoft Sabena
AstraZeneca Sea Containers

PART IV
A more innovation sensitive approach to the

interface of competition law and patents?
7. The duty to deal as applied to address
technology access problems in the
biopharmaceutical industry
Compulsory licensing is not an absence of patent protection but merely a lessening
of that protection. While compulsory licensing may weaken the incentives to invest
in pharmaceutical research the trend of rapid and significant increases in investment
in pharmaceutical research demonstrates that the present incentives to invest are so
strong that they would have to be weakened considerably before there would be any
reduction in the amount of pharmaceutical research.
7.1 Conclusions on the patent system in the

case of research tools
7.1.1 The Particularity of Research Tools: Pre-commercial Stage
Patents
The nature of biopharmaceutical research and of the industry in general is such

as to potentially give rise to concerns related to refusals to deal or lack access
in certain cases. The specific case of research tools was examined in this
context.

T.C. Bailey, Innovation and Access: The Role of Compulsory Licensing in the
Development and Distribution of HIV/AIDS Drugs, 2001 U. Ill. J. L. Tech. & Pol’y 193,
p. 207.

The latter consists of the full range of resources that scientists use in laboratories,
recognising that one institution’s research tool may be another’s end product. NIH Report
on Research Tools (1998) op. cit.. They are used to find, refine or design and identify
something else that is sold in the marketplace. R. Blackburn in DOJ/FTC Proceedings
on the Pharmaceutical Industry: Business Perspectives on the Use and the Role of Patents
in the Biotechnology Industry, 26 February 2002.
Many research tools are expensive to develop and have significant competitive value
to the companies that own them. If institutions wish to gain a competitive advantage
from their exploitation, they are likely to limit access and restrict their use and disclosure.
This trend is also accompanied by the increasing use of the patent system to obtain pro-
prietary rights for the research tools. There may be competing interests among those who
control the tools depending on whether they are scientists, university technology transfer
177
178 The interface of competition law and patents
While concerns relating to access are not new in the area of antitrust law, re-
search tools are more complicated as they are not only end products whose
dissemination/distribution effects can readily be measured or witnessed, but
they are also tools for research, which are important in the pre-commercial stage
when the impact of the restricted access cannot be easily determined.
The problem in the case of research tools does not relate to the restriction of
a product or technology market, but rather the hindering of the ‘innovation
process’. The concern is that the lack of access may lead to reduced research
which would, in turn, lead to less innovation. Therefore, we are not concerned
with something that may already crystallise in a product or technology market,
but rather with something in even earlier stages of research and development.
professionals or private firms, and whether they are importers or exporters. See Chapters
2 and 3.
However, research tools are merely an example of what might be a general problem.
For example there may be similar exclusionary concerns in cases involving Pharmacy
Benefits Management (PBM) networks. See R. Levy, The Pharmaceutical Industry: A
Discussion of Competition and Antitrust Issues in an Environment of Change, Bureau
of Economic Staff Report, FTC March 1999. While until recently the doctors’ prescrip-
tions were the most crucial factor in determining which drugs would be dispensed by
pharmacists, today pharmacies are usually part of PBM networks that administer the
drug benefits as part of health insurance plans to employers and others. This could give
rise to some concerns as drug companies now may acquire PBMs and the exchange of
information may allow for the monitoring of deviations of coordination in the prescrip-
tion drug markets. In addition, this could ‘raise the marginal costs of unintegrated drug
companies and lead to higher prices and lower level in prescription drug markets’. A re-
fusal to deal scenario may exist where C, an unintegrated pharmaceutical manufacturer,
has no substitutes for the marketing services of A and B’s downstream PBMs and A and
B have the incentive to coordinate to limit a company’s ability to undermine collusion.
Foreclosure effects might also occur with regard to the exclusion of unintegrated PBMs
from the market, depending on the availability of ways for the unintegrated company to
avoid the exclusion.

For more information on pre-commercial stage patents see R.A. Epstein, Steady
the Course: Property Rights in Genetic Material, The Law School of Uni of Chicago,
working paper no 152, 2003 at http://ssrn.com/abstract_id=317101.
See In The Matter Between Mpho Makhathnini, Nelislwe Mthethwa, Musa Msomi,
Kline (Pty) Ltd, Glaxo Group Limited, Case Number 34/CR/Apr04, where the South
of excessive prices of drugs. See also South African Competition Tribunal’s decision and
order in Pharmaceutical Wholesalers and Glaxo Wellcome, case 68/IR/Jun00, 18 June
2003 at www.comptrib.co.za/decidedcases/pdf/68IRJUN00kinesis.pdf, and Case No.
15/CAC/Feb02.
Technology access problems in the biopharmaceutical industry 179
7.1.2 A Gap in the Patent System?
As shown in Chapter 3, the patent laws do not adequately provide for this pos-
sibility. While there are provisions on compulsory licensing and other limitations
on the breadth of the patent permitting use, such as the experimental use exemp-
tion, these are rarely used and usually address other concerns.
Compulsory licensing provisions, for example, as it was demonstrated, are
drafted to deal with more developed stages of research that have already led
to the development of products or technology which already warrant a patent.
The experimental use exemption is again usually concerned with experiment-
ing on an invention in the sense of improvements, as opposed to experimenting
with.
In addition, while the right to health does have implications for patent law as
it affects access to drugs, it is unlikely that the right to health would be helpful
in the context of the innovation process as it is too far removed from the actual
results and overly speculative about the innovation process.
7.1.3 The More the Better? Optimal Market Structure for Innovation
It should also be noted that the desire to have broader access to fundamental
research tools is also based to some extent on the assumption that the more re-
search paths undertaken the better.
While the economics of innovation and whether concentration or competition
is more conducive to innovation is far from clear, it is assumed that access would
be more desirable in some cases where it has been refused. ‘When more risky
investment is required until there is a useful product, it may be socially desirable
to have many firms engaging in the next innovative step. Because this approach
involves some duplication of effort, it is not necessarily cost effective. However,
there may well be situations in which the patent owner would like to be the sole

See Chapter 3.

See Chapter 4.

See Commission Decision in Microsoft (2004) op. cit. para. 782 in which the
Commission stated that a refusal to supply would ‘have the consequence of stifling in-
novation in the impacted market and of diminishing consumer’s choices by locking them
into a homogeneous Microsoft solution. As such it is particularly inconsistent with the
provisions of Art. 82(b) of the Treaty’, hence, effectively endorsing a ‘view of innovation
which suggests that technical development in the IT industry is best promoted by a
number of different firms innovating rather than one.’ S. Anderman, Does the Microsoft
Case offer a New Paradigm for the ‘Exceptional Circumstances’ Test and Compulsory
Copyright Licenses under EC Competition Law? Presented at the Clasf Conference on
9 September 2004.
developer of the final product but society would be better off if this were not
the case.’
A significant amount of economic research has focused on the issue of
whether competition and potential competition are capable of increasing innova-
tive activity. The findings are ambiguous in this regard. Some commentators
have argued that firms which are insulated from competition may choose a quiet
life. Yi has found that in the case of process innovations, as long as they are
not drastic, their benefit decreases in line with the number of firms under certain
conditions.10 Boone has concluded that if competition is intense and innovations
lead to major technological changes then small increases in competition may
quicken innovation as they force the leading firm to innovate in order to refrain
from losing its competitive advantage.11
On the other hand, other economic studies seem to support innovation by
large firms in concentrated markets. Schumpeter found that large firms are more
innovative than smaller firms, which could mean that in concentrated markets
there was more innovation taking place. This may be due to two factors.12 First,
innovative activity may be less costly for large firms as there are significant
economies of scale in innovation. Large firms may have more specialised re-
sources undertaking many R&D projects which reduce the marginal costs of
innovation. As innovation involves significant fixed costs, these companies are
able to incur less average total costs, and they may have larger portfolios of
R&D, increasing the likelihood of success. Secondly, it might be the case that
firms obtain higher benefits from innovative effort as they diversify products,

R. Aoki and J. Small, Compulsory licensing of technology and the essential facili-
ties doctrine, 16 Information Economics and Policy 23 (2004).

W.M. Cohen and R.C. Levin, Empirical Studies on Innovation and Market Struc-
ture, in R. Schmalensee and R.D. Willig (eds), Handbook of Industrial Organization,
North-Holland, Amsterdam (1989), p. 1078; J. Lerner, An Empirical Exploration of a
Technology Rate, 28(2) Rand J. Econ’cs 228 (1997).

See K. Arrow, Economic Welfare and the Allocation of Resources for Innovation,
in pp. 609–26, R.R. Nelson (ed.), The Rate and Direction of Inventive Activity, New York:
New York, Princeton University Press (1962); S. De Santi and W. Cohen, Competition
to Innovate: Strategies for Proper Antitrust Assessments, in R. Dreyfuss et al. ed., Ex-
panding the Boundaries of Intellectual Property, Oxford, Oxford University Press (2001);
ABA (2002) op. cit.
10
S. Yi (1999) op. cit.
11
J. Boone (2001) op. cit.
12
Ibid. See also F. Parisi, B. Depoorter (2002) op. cit. on oligopoly in complemen-
tary as opposed to substitutable products. See also R.A. Epstein, Steady the Course:
Property Rights in Genetic Material, The Law School of Uni. of Chicago, Working Paper
No. 152 (2003) on the marginal cost and double marginalisation problem. R.C. Dreyfuss,
Varying the Course in Patenting Genetic Material: A Counter-Proposal to Richard Ep-
stein’s Steady Course, NYU Law School, Public Law Research Paper No. 59 (2003).
thus increasing the likelihood of discovery, and even the more effective market-
ing of new products.
Empirical evidence shows that large firms have developed a significant share
of innovation but in recent years small firms have also done so.13 Early studies
showed that R&D rose more than proportionately with firm size, however,
Scherer14 has shown that was up to some size level. Recent studies suggest that
large firms may actually be generating less innovation per dollar of R&D than
small firms.
7.2 Two possible avenues for increased

access to essential research tools
Increasing access to patented research tools could either be achieved through
patent law or through antitrust law.
7.2.1 Patent Law
Several proposals have been made as to how the patent system itself could be
changed to account for the problem of research tools.15 Professor Eisenberg had
13
ABA (2002) op. cit.
14
F.M. Scherer, Firm Size, Market Structure, Opportunity and the Output of Patented
Inventions, 55 American Economic Review 1097 (1965).
15
On open source proposals see R.X. Cringely, The True Believer: Can Mike Doyle
do to Microsoft what the rest of the computer industry and the Department of Justice
couldn’t do? The Pulpit, 7 November, 2002; D. Burk, Open Source Genomics, 8 Boston
University Journal of Science and Technology Law 254 (Symposium on Bioinformatics
and Intellectual Property Law, 27 April, 2001, Boston, Mass. (Winter 2002)). S. Maurer,
Promoting and disseminating knowledge: the public/private interface, Washington DC,
National Research Council (2002). See specifically in the case of agricultural biotechnol-
ogy: J.L. Kind, Concentration and Technology in Agricultural Input Industries, 2001,
US Department of Agriculture Economic Research Serve; Benkler, Coase’s Penguin, or,
Linux and The Nature of the Firm. 112 Yale L. J., Winter 2002–3; S. Maurer, New Institu-
tions for Doing Science: From Databases to Open Source Biology, conference paper,
European Policy for Intellectual Property, University of Maastricht, November 2003,
available at http://ist-socrates.berkeley.edu/~scotch/maurer.htm.
On the interpretation of the term ‘relating to’ in the experimental use exemption see
the European Commission’s proposed Council Regulation on the Community Patent, 1
August 2000 (exempting acts ‘done privately and for non-commercial purposes’ and
‘acts done for experimental purposes relating to the subject-matter of the patented inven-
tion’); J.M. Mueller (2001) op. cit. p. 38 refers to the possibility of interpreting the term
‘relating to’ broadly to include the ordinary use of patented research tools to research
downstream.
proposed the expansion of the experimental use doctrine based on a distinction

between three types of cases.16
First, in cases involving use of a patented invention to verify that the require-
ment of enabling disclosure has been satisfied, the use should be exempt. This
situation is the least contentious and most countries allow such use.17 This type
of use, however, is unrelated to the problem of access to essential research
tools.
Secondly, in cases involving use of an invention having a ‘primary or signifi-
cant market’ among research users who are ‘ordinary consumers’ of the
invention, the exemption should be inapplicable. In such cases, it was felt that
there should be a licence prior to use, as there should not normally be any access
problems.18
Finally, in cases where an improvement in the technological field of the patent
is concerned, there should not be a need for any licence in order to encourage
designing around patents. While the users would be infringers, there would be
limitations in the remedies available against them. The patent holder would not
be able to prevent use in such cases but would be entitled to a reasonable royalty
in some instances.
This situation is a variation of the compulsory licensing provisions as ap-
plicable to improvements and secondary dependent patents, although there is
usually no need for a licence or to petition for a compulsory licence in the
first place in the case of the experimental use exemption. From the start, the
remedies of the patentee are limited to a liability rather than a property
rule.19
This interpretation of the experimental use exemption, however, would still
not cover cases where access is needed to the research tool for research on
Others contend, however, that research tools should be excluded entirely from patent-
ing. See public comments received from USPTO in response to its first round of Interim
Written Description Guidelines, published in June 1998 asserting that ‘ESTs are genomic
research tools that should be available for unencumbered research to advance the public
good’. Department of Commerce, Patent and Trademark Office, Revised Utility Examina-
tion Guidelines, 64 Fed. Reg. 71 (1999) 440.
16
R.S. Eisenberg, Patents and the Progress of Science: Exclusive Rights and Ex-
perimental Use, 56 U. Chi. L. Rev. 1017 (1989), pp. 1074–78.
17
See Chapter 3.
18
It was believed that these tools could be readily licensed or bought on the open
market. The patentee ‘will want to sell to these users – they fall squarely within the
market for the patented invention’. Ibid. p. 1085.
19
On this distinction see G. Calabresi and D. Melamed, Property Rules, Liability
Rules and Inalienability: One View of the Cathedral, 85 Harv. L. Rev. 1089 (1972); I.
Ayres, E. Talley, Solomonic Bargaining: Dividing a Legal Entitlement to Facilitate
Coasean Trade, 104 Yale L. J. 1027, (1995).
downstream products. They would fall into the second category of Professor
Eisenberg’s model of the ‘ordinary consumers’.
The extension of the doctrine was also considered by the NIH Working Group,
who concluded that:
It is difficult to imagine how a broader research exemption could be formulated

without effectively eviscerating the value of patents on research tools. Researchers
are ordinary consumers of patented research tools, and if these consumers were ex-
empt from patent infringement liability, the patent holder would have nowhere else
to turn to collect patent royalties. An excessively broad research exemption could
eliminate incentives for private firms to develop and disseminate new research tools
which could on the balance do more harm than good to the research enterprise.20
The difficulty with such a view, however, is that the assumption that such
workers are truly ‘ordinary consumers’ of the tool is called into question. When
it becomes increasingly difficult for these ‘consumers’ of the tool to obtain ac-
cess, then to the extent the experimental use doctrine is based on that distinction,
it becomes questionable. ‘When research tool transaction costs are severe
enough to impede or stop the development of new biomedical products, line
drawing between “experimenting on” and “experimenting with” is no longer
justified. In such cases access to the experimental use doctrine should not turn
on the relatively fine distinction between experimenting on or experimenting
with the patented invention.’21
The arguments against an expanded experimental use exemption mirror to a
large extent the general arguments against a reduced patent scope. In this con-
text, it is felt that any reduction in patent protection would lead to a reduction
in innovation.22 As argued in Chapter 5, however, the optimal balance between
initial and follow-on innovation is not known to any degree of precision. Al-
though there may be some reduction in the development of new research tools
by forcing wider access, there may equally be more products developed by vir-
tue of the broader access to those tools. The trade-off ultimately is an empirical
one.23
20
NIH Report on Research Tools (1998) op. cit. App. D-8.
21
J.M. Mueller, No Dilettante Affair: Rethinking the Experimental Use Exception to
Patent Infringement for Biomedical Research Tools, 76 Wash. L. Rev. 1 (2001), p. 40.
22
See, for example, J.P. Karp, Experimental Use as Patent Infringement: The Im-
propriety of a Broad Exception, 100 Yale L. J. 2169 (1991), p. 2181. The author contends
that ‘an expansive experimental use exception, which threatens the patentee’s potential
for economic returns, would reduce inventive activity, particularly in those industries
that rely on patent protection’.
23
See R.S. Eisenberg (1989) op. cit. pp. 1030–31 who states that it is difficult to
determine the impact of a reduction in the breadth of patents on the incentives for invest-
ment, either through the research exemption or other limitations.
In response, Mueller proposes the endorsement of a development use rule

which makes no distinction as to the type of use that is contemplated for the
tool.24 The only limitation would be that it must relate to the use of the patented
research tool, rather than the sale of which products physically incorporate the
patented invention.25
In such cases, he suggests that a reach-through royalty scheme should be ap-
plied whereby the user would be allowed to infringe the patents but then would
have to pay a royalty according to the ultimate commercial value of the products
developed. ‘The research tool patent owner would acquire the right to a poten-
tially commercially significant future royalty stream, while the tool user would
avoid the burdens of pre-use license negotiations, up-front payments and
blocked access to the proprietary research tools’.26
According to Mueller, royalties should be paid for no longer than the total
period of the effective patent life, beginning on the first date of the sale of the
product developed.27 In addition, in cases where no product is developed, he
argues that a standardised schedule of royalty fees could be drawn up, similar
to the musical works model.28 He contends that calculating the royalty rate may
be more of a problem in theory than in practice.29
Similarly, Gilat claims that the experimental use doctrine may not be suffi-
cient in the area of biotechnology industry, and for this reason a liability rule
might be required.
Indeed the fact that patents are granted on biotech basic research inventions seems
to require a more liberal experimental use exemption than that provided by traditional
patent law, as the effect of enforcing a patent right against research competitors might
be detrimental to progress, and it therefore appears that, in addition to the exemption
from infringement liability provided by the experiment exception, a specific liability
rule in respect of research use of patented inventions may be appropriate.30
24
25
Ibid. p. 58. The author distinguishes between use and selling as the latter is not
exempted from liability.
26
Ibid. p. 58.
27
Ibid. p. 62.
28
See 17 USC § 115 (Supp. IV 1998) (‘Scope of exclusive rights in non-dramatic
musical works: Compulsory License for making and distributing phonorecords’). Once
the owner of a copyright for a non-dramatic musical work has sold the work to the public,
any other person has a compulsory license to record and sell the phonorecords of the
same work. See M. Leaffer, Understanding Copyright Law, New York, Bender, § 8.7
(2nd edn, 1995) 4th edn (2004). A monthly statutory ceiling price must be paid for each
record distributed under the licence.
29
30
D. Gilat (1995) op. cit. p. 81.
In this context, antitrust may be a desirable safety net. It imposes a liability

rule in certain cases, while not requiring any change of the law.
7.2.2 A Role for Art. 82?
As a policy matter, ‘antitrust limitations should be desirable unless they result

in a net decrease in innovation’.31 The problem lies in the fact that there is no
clear formula to decide how much innovation is due to patent law and how much
can be attributed to antitrust law.
In some ways, antitrust law addresses the same concerns as the patent system,
namely the breadth of the exclusivity only, in light of the market conditions. In
the case of a controlling upstream innovation that impairs the progress of the
downstream innovation by virtue of limited licensing practices or a refusal to
deal, it would seem that it is possible to use antitrust law to judge when access
to such upstream innovation should be granted, and to compel it.32
A blanket antitrust exemption for all unilateral refusals to license IP, including refusals
used to prevent competition in complementary markets, may discourage innovation,
not only in the unprotected complementary markets, but also in the patented market.
This is because it would require entry at two levels if there is no viable competition
in the complementary market.33
As shown in Chapter 3, the TRIPS Agreement provides that compulsory li-

censing (CL) may be used to remedy cases in which a practice has been
determined anti-competitive in a court of law. In accordance with economic
theory, this was interpreted to mean that there is no justification for applying a
different antitrust threshold for cases involving IPRs, and that the application
of the competition law provisions remains intact.34
31
M. Lao, Unilateral Refusals to Sell or License IP and the Antitrust Duty to Deal,
9 Cornell J. L. & Pub. Policy 193 (1999).
32
While it is true that antitrust law presumes that the market will fix failures, it is
contemplated here that antitrust should work as a safety valve if the market fails to fix
an imperfection and in the absence of a patent mechanism to correct it.
33
M. Lao (1999) op. cit. p. 201.
34
Whether one chooses to interpret this as the use of antitrust to address patent regu-
latory failures or merely to be a co-determinant of patent scope, makes little difference
in practice. See D.S. Karjala, Copyright Protection of Operating Software, Copyright
Misuse ad Antitrust, 9 Cornell J. L. & Pub. Pol’y 161 (1999), who states in the context
of copyright and the relation with antitrust: ‘Although the copyright courts have correctly
concluded that an antitrust violation is not a predicate of copyright misuse, there is no
reason in principle why the courts could not treat copyright misuse by someone with
market power as an antitrust violation … the courts tailor the scope of copyright protec-
tion all the time in an effort to further the underlying copyright policies. This is not
Article 82 has been used to condemn unilateral refusals to deal in several

cases, some even involving IPRs. There has not yet been any case before the
ECJ, however, regarding early pre-commercial biopharmaceutical patents.
Nevertheless, this provision may still be helpful.
In Chapter 6, the duty to deal under Art. 82 was analysed. CL was analysed
in terms of four factors: indispensability, the introduction of a new product, the
elimination of competition on a downstream market, and the absence of objec-
tive justification.
7.2.2.1 Indispensability
It was shown that the Court has placed particular emphasis on whether access
to the product or process is indispensable to carry on business.35 The test is
whether there are ‘products or services which constitute alternative solutions,
even if they are less advantageous, and whether there are technical, legal or
economic obstacles capable of making it impossible or at least unreasonably
difficult for any undertaking seeking to operate in the market to create, possibly
in cooperation with other operators, the alternative products or services’.36
In the specific case of research tools, the test will focus on whether access to
the former is truly indispensable/essential to conduct research on the down-
stream market.37 In addition, the high threshold should be preserved if the duty
to deal is to remain exceptional. The threshold should be set high enough to
ensure that the ‘resulting static gains are large enough to outweigh such dynamic
losses’.38
While indispensability ultimately is to be judged on the facts of the case, there
may be certain factors, as seen in Chapter 6, which will militate in favour or
against such a finding. The existence of high sunk costs and/or incentives to in-
novate may be two such factors.39 Furthermore, the good in question must really
be unique, central to the operation on the market and without any feasible
alternative.
necessarily easy but the only fundamentally new aspect suggested here is that antitrust
rather than copyright supplies the hook for devising remedies’ p. 189.
35
See Chapter 6.
36
Case C-418/01 IMS, 29 April 2004, para. 28.
37
There may be many instances in which IP products or technologies could be re-
garded as indispensable as traditionally judged under the essential facilities doctrine.
This is because it may not make economic sense to duplicate them and they may be of
national economic significance, similar in some ways to land facilities. R. Aoki and J.
Small (2004) op. cit. p. 27.
38
Ibid. p. 28.
39
See Chapter 6.
7.2.2.2 Preventing the emergence of a new product for which there is

potential consumer demand
In IMS, the liberal position adopted by the Court can be seen from the following
statement:
Therefore, the refusal by an undertaking in a dominant position to allow access to a

product protected by copyright, where that is indispensable for operating on a second-
ary market, may be regarded as abusive only where the undertaking which requested
the license does not intend to limit itself essentially to duplicating the goods or serv-
ices already offered on the secondary market by the owner of the copyright, but
intends to produce new goods or services not offered by the owner of the right and
for which there is a potential consumer demand.40
Following the broad interpretation of IMS, the new product requirement

would easily be met in cases where access to research tools is required to re-
search on the downstream market in an attempt to develop technology further.
The reference to the intention to produce new goods or services, as distinct from
their actual production, may hence be of particular significance to the biophar-
maceutical industry, where it is felt that access may be warranted in the
pre-commercial stage in some cases even if the research is in its early stages
and possibly even still in the pipeline.
This would allow for a CL to be ordered for certain indispensable research
tools while taking into account that a more extensive use would most likely lead
to more products but not necessarily so. Hence this will provide access to re-
search tools to be used for further research irrespective of what that later leads
to. This effectively involves endorsing a wider definition of ‘new product’ to
include potential innovation,41 and indispensability, which would be viewed
from the perspective of enabling further innovation. In addition, as clarified by
the Commission in Microsoft, demand for that potential new product also only
needs to be potential.42
7.2.2.3 Elimination of competition on a downstream or neighbouring

market/two-market requirement
As regards the two-market requirement, as shown in Chapter 6, the Court
adopted a wide interpretation: ‘it is sufficient that a potential market or even
40
IMS Case (2004) op. cit. para. 49.
41
This rests on the assumption that more research lines may be more conducive to
innovation. See section 7.1.3 on the relationship between market structure and
innovation.
42
See Commission reference to Ladbroke and the essential facilities doctrine in para.
552 where reference is made to ‘specific, constant and regular potential demand’.
hypothetical market can be identified. Such is the case where the products or
services are indispensable in order to carry on a particular activity …’.43
Hence, it would seem that this case can be used as a precedent that two mar-
kets in an antitrust sense are not required, and an obligation to deal will be based
on the essentiality of an input for the operation of a market. Therefore, it effec-
tively extended harm to competition to potential or hypothetical markets.
In the example of research tools which require access to potentially develop
some downstream product, the doctrine remains applicable, and if truly indis-
pensable the research tools could be the object of a CL. In IMS, the Court stated
that it is ‘determinative’ that ‘two different stages of production may be identi-
fied and that they are interconnected, the upstream product is indispensable in
as much as for supply of the downstream product’.
This is also consistent with the innovation markets approach, in the sense that
the court extended its interpretation of the elimination of competition not only
to existing or potential product or technology markets, but also to innovation
markets not yet in existence.44
7.2.2.4 The absence of an objective justification

In the Microsoft case, the Commission confirmed that ‘intellectual property
rights are not in a different category to property rights as such’45 and, therefore,
they could not amount to an objective justification. Hence, the fact that research
tools are protected by patents of itself would not negate the duty to deal if it
arose. This is in line with recent competition findings, whereby the fact that
something involves IPRs does not exempt conduct from competition control.46
43
IMS (2004) op. cit. para. 44.
44
See IMA at section 7.2.3.2. See also J.T. Lang, European Community Antitrust
Law: Innovation Markets and High Technology Industries, 20 Fordham International L.
J. 717 (1997).
45
Microsoft (2004) op. cit. para. 550.
46
See, for example, the recent Commission decision fining AstraZeneca (Commis-
sion press release IP/05/737) for abusing its dominance by misusing the patent system.
Patent misuse is a known defence in the USA according to which a patent holder might
be prevented from asserting its patent if such have been obtained by breaching antitrust
laws or illegally extending the term of the patent. AstraZeneca in this instance abused
its dominance by making misrepresentations to certain national patent offices with a
view to obtaining supplementary protection certificates, as well as strategically misusing
procedures to block the entry of generic products or parallel traders. Similarly, a UK
court judge stated that the enforcement of patent rights could constitute abusive conduct
in certain cases, where a dominant undertaking brings action which: cannot reasonably
be considered as an attempt to establish its rights and can only serve to harass the oppo-
site party, and is conceived to eliminate competition: Sandisk Corporation v Koninklijke
Phillips Electronics NV and Others [2007] EWHC 332 Ch.
7.2.3.1 The impact of Art. 82 duty to deal with case-law on the patent
system
Article 82 can effectively be used to grant access to an indispensable input for
further research where this has been refused. In this way, it can address problems
associated with the hindrance of potential technology and potentially restricted
access to necessary inputs. It involves recognition of the importance of potential
innovation, and bases the remedy on treating IP just as any other case, while
adopting a broader definition of a new product and of secondary markets.
Although the economics of cumulative innovation fail to provide a clear for-
mula, none the less, they affirm that concentration may not necessarily lead to
more innovation; the granting therefore of an unqualified exclusive right (and
thereby immunising IP) may not actually be conducive to innovation.47 In the
same way as the patent system attempts to balance initial innovation with fol-
low-on innovation through the patent length and breadth, competition law may
also be used to achieve this objective.
In this way, antitrust can be seen as interchangeable as a remedy with patent
CL provisions, only with a difference in threshold; one requiring a patent of
significant technological advance of considerable economic interest, and the
other requiring the existence and abuse of a dominant position by virtue of a
refusal to grant access to an indispensable/essential input as set against the
market conditions, respectively.
Noticeably, the new product rule imports in Art. 82 also the consideration of
ensuring some advantage from access. None the less, the definition of the new
product is much broader than the one in patent law, as it is not limited to patented
products or processes constituting a significant technological advance, and it
can even relate to potential goods. It is not restricted to dependent patents, but
may be applied to downstream innovation as distinct from improvements.48
It should be noted, however, that market definition will preserve its centrality
as it will in turn determine the availability of substitutes, the risk of elimination
of competition and hence also the indispensability of the product or process in
question. The application of antitrust control would be limited to cases in which
the monopoly is effectively over a variety of product lines and in which there
is a series of dependent inventions, without a real alternative in the market.
The advantage of the antitrust application of a duty to deal is that it is set
against the market conditions in order to ascertain: the extent to which access
to the input is indeed necessary in view of the alternatives and substitutes; the
47
See also the endorsement of this view with the introduction of the innovation
markets approach in the USA discussed below, at section 7.2.2.2.
48
See above at section 7.2.2 on the new product requirement and the IMS definition.
See also Chapter 3 on patent CL provisions.
extent to which the consumers will benefit by virtue of access; and the extent
to which the market has proven that the patent controls not only a specific
product or process but indeed a whole area of endeavour.
This approach effectively advocates a more explicit consideration of follow-
on innovation in the application of antitrust analysis and this may apply not only
for the application of the duty to deal provisions, but also for investigations of
cross-licences and patent pools, and potentially for mergers.49 Indeed, in the
EU, unilateral restraints on innovation have been condemned on several occa-
sions,50 either because they involved the acquisition of control over potentially
competitive innovations,51 the prevention of downstream innovation,52 or the
foreclosure of innovation by raising barriers to entry.53
In brief, the issue of research tools introduces a new element into the analysis
of refusals to deal or to grant access. The new element centres on the fact that
it is not concerned with the restriction of a downstream existing product or
technology market, either by virtue of distribution or otherwise, but rather it is
concerned with downstream research which may or may not lead to new prod-
ucts which could either be seen as future product markets or, in some cases, as
new innovation markets.
In the case of research tools, access is mandated for potential innovation and
this, similar to the traditional cases where access is mandated to a facility, con-
tains assumptions about the type of structure that is more conducive to market
developments (whether product, technological or innovation).54
49
See, for example, innovation markets approach in merger review and the consid-
eration paid to potential competition. J.H. Barton, Patents and Antitrust: A rethinking in
light of patent breadth and sequential innovation, 65 Antitrust L. J. 44 (1997), who pro-
poses that attention should also be paid to technology lines and not only product market
or technology or innovation markets. ‘Clearly there are antitrust issues when a license
or merger concentrates control over product lines or combines into one management
several patents covering complementary ways of manufacturing a specific product.’
50
See M. Dolmans, Antitrust and the Suppression of Technology in the US and Eu-
rope: Is there a Remedy? Restrictions on Innovation: An EU Antitrust Approach, 66
Antitrust L. J. 455 (1998).
51
Case 88/501 Tetra Pak I (BTG license) [1988] OJ I.272/27.
52
Magill (1995) op. cit.
53
Microsoft decision (2004) op. cit.
54
In conventional antitrust enforcement there is a broad consensus on the relation-
ship between market structure and market performance. In contrast, this is seen as more
contentious in innovation market enforcement and, for this reason, these structural as-
sumptions are seen as being more dangerous. In view of the role of technological change,
however, in today’s economy conventional enforcement may even ‘require judges to
predict the inherently unpredictable course of future technology’ and so the differences
between the two approaches should not be exaggerated. R.W. Davis, Innovation Markets
and Merger Enforcement: Current Practice in Perspective, 71 Ant. L. J. 677 (2003),
7.2.3.2 An innovation sensitive approach: innovation markets in

Art. 82?
A similar approach considering innovation and the type of structure that is more
conducive to it can be seen in the application of other antitrust provisions, spe-
cifically in the application of the Technology Transfer Block Exemption
Regulation (TTBER) and in merger analysis.55
p. 681. See also J. Kattan, Antitrust Considerations in Innovation-Driven Markets, 21

Can.-US L. J. 115 (1995), p. 117; D. McGowan, Innovation, Uncertainty, and the Stabil-
ity in Antitrust Law, 16 Berkeley Tech. L. J. 729 (2001); I. Knable Gotts and J.G. Kraus,
Antitrust Review of New Economy Acquisitions, Antitrust, Fall 2000, p. 59.
55
The innovation markets approach has been discussed most extensively in the USA
where it was formally recognised as an enforcement tool for the first time in the IP Li-
censing Guidelines (1995) op. cit. This was then extended to a broader variety of
competitor collaborations by the FTC/DOJ, Antitrust Guidelines for Collaborations
Among Competitors (2000), reprinted in 4 Trade Reg. Rep (CCH). Since then it has been
the subject of many enforcement actions of the Antitrust Division in conjunction with
the conventional potential competition analysis such as US v General Motors Corp. No.
93-530 (D. Del. Filed 23 March 1998), US v Lockheed Martin and Northrop Grumman
(D.D.C. filed 23 March, 1998). In addition, the innovation effects have been the key
factor of the decisions in several FTC enforcement records, especially concerning the
pharmaceutical industry in view of the FDA collaboration in assessing the likely effect
of each innovation effort. See J. Kattan, After the IP Guidelines: Trends in Intellectual
Property Antitrust Enforcement, Antitrust, Summer 1997, p. 26. See, for example, FTC
innovation markets enforcement actions Roche/Genentech, Roche Holding Ltd, 113 FTC
1086 (1990); American Home Products/American Cyanamid, American Home Prods.
Corp. FTC Docket No. C-3557 (1995); Sensormatic/Knogo, Sensormatic Elec. Corp.,
FTC Docket No. C- 3572 (1995); Glaxo/Burroughs Wellcome, Glaxo Inc., 119 FTC 815
(1995); Upjohn/Pharmacia, The Upjohn Co. 121 FTC 44 (1996); Ciba-Geigy/Sandoz,
Ciba-Geigy Ltd, 123 FTC 842 (1997); Baxter/Immuno, Baxter Int’l, Inc., 123 FTC 904
(1997); Pfizer/Warner-Lambert, Pfizer Inc., FTC Docket No. C-3957 (2000); Hoechst/
Rhone-Poulenc, Hoechst AG, FTC Docket No. C-3929 (2000).
In the EU, the European Commission has two main concerns in the area of innovation:
first, patents may pose considerable entry barriers to competitors on future markets; and
secondly, mergers between firms that are active in similar R&D projects must not become
dominant actors that are capable of eliminating future competition in related markets,
and thus slowing the innovation process itself. J. Pons, Innovation and Competition, A
View from the European Commission, speech for the 50th anniversary of the Japan Trade
Commission in Tokyo – 1st December 1997, published in the EC Competition Policy /
DGIV/speech/eight/en/sp980xx.htm February 1998.
Hence, Commission Regulation 772/2004, on the application of article 81(3) of the
Treaty to categories of technology transfer agreements, 2004 OJ L213/11, allows the
Commission to withdraw the benefit of block exemption where the licensed products are
not exposed to effective competition in the licensed territory. This principle was applied
in Case 88/501 Tetra Pak I (BTG license) [1988] OJ I.272/27 where the licensee was
found to have abused its dominant position and was forced to give up the exclusive rights
attached to its licence.
In the context of mergers, the innovation markets approach aims to assess the
effects of a merger on the incentive for R&D and innovation. It assesses the ex-
tent to which an output in the upstream R&D market may be restrained and
whether the latter may lead to adverse competitive effects on the downstream
product market at a later stage.
The approach is based on two factors:
First that antitrust ought to be concerned about agreements and transactions that are
likely to result in a reduction in resources devoted to research and development in
definable lines of research, or in the elimination of one or more parallel research
tracks, when such a reduction of resources, or elimination of a line of research, is
likely to have an adverse effect on price or non-price competition in a product mar-
ket at some time in the future (whether or not the product market in question exists
or does not exist at the time when enforcement action is taken); and second, that
the doctrine of potential competition does not suffice to address the adverse com-
petitive effects of many agreements and transactions that reduce competition in
innovation.56
The concerns of the innovation markets approach are similar to those found
in CL as it seeks to encourage multiple research paths by ensuring that essential
innovation tools remain de-concentrated even if this is only to protect innovation
on a research/pipeline level as distinct from commercialisable products.
This approach is contentious,57 as unlike traditional oligopoly theory applied
to markets for existing products, there is no firm basis in economics to support
the presumption that an anti-competitive reduction in innovation would result
from a reduction in the number of competitors attempting to innovate.58
Similarly, there have been several cases where mergers have raised concerns in the
field of R&D and innovation. Commission Decisions Shell-Montedison, OJ 1994 L.
332/49, M.555 Glaxo-Wellcome and others, OJ 1995 L. 2985, Crown Cork OJ 1995 L
75/39, Ciba-GeigySandoz OJ 1996 C.102/737, M.984 DuPont-ICI, OJ 1997 L. 2985,
M.468 MSG-Media Services OJ 1994 L. 364/01, M.877 Boeing-McDonnell-Douglas OJ
1997 C.59/877. In all of these cases, a divestiture or licence remedy was imposed. How-
ever, the Commission has also allowed collaborations where the agreements contained
some efficiencies, such as Konsortium OJ 1990 L. 228/31.
56
R.W. Davis, Innovation Markets and Merger Enforcement: Current Practice in
Perspective, 71 Ant. L. J. 677 (2003) pp. 677–8
57
Criticism and more extensive analysis of the use of the approach is beyond the
scope for present purposes. For alternative views on the approach see T.N. Dahdoud and
J.F. Mongoven, The Shape of Things to Come: Innovation Market Analysis in Merger
Cases, 64 Antitrust L. J. 405, 1996; M.H. Morse, The Limits of Innovation Markets, at
www.dbr.com; E. Kwoka, Non-Incumbent Competition: Mergers Involving Constraining
and Prospective Competitors, 52 Case W. Res. L. Rev. 173 (2001).
58
D.L. Wald and D. L. Feinstein, Merger Enforcement in Innovation Markets: The
Latest Chapter – Genzyme/Novazyme, The Antitrust Source, July 2004, p. 4. On a debate
between the optimal market structure for innovation see section 7.1.3. above. See also
The novelty of the approach, as confirmed in the recent Genzyme/Novazyme59

merger, lies in the fact that there may be an antitrust violation despite the absence
of an ‘existing’ goods market and the lack of clarity on the link between market
structure and innovation. In theory, it is possible that a merger may not injure
actual or potential competition in any relevant product market but nevertheless
it harms consumers by reducing competition in innovation.60 For example, this
may occur if the parties in the merger are among the few or only likely potential
entrants into a product market that does not exist at the time of the merger.61
However, the innovation markets approach should be subject to a strict factual
analysis to establish whether innovation is likely to be adversely affected or
R. Gilbert and W. Tom, Is Innovation King at the Antitrust Agencies? The Intellectual
Property Guidelines Five Years Later, 69 Antitrust L. J. 43 (2001), p. 83, who concludes
that there is only anecdotal evidence to support the view that competition enhances R&D
efforts. See also D. Carlton and R. Gertner, Intellectual Property, Antitrust and Strategic
Behaviour, University of Chicago, National Bureau of Economic Research, Working
Paper No. W8976, May 2002, p. 10 , reprinted in A. Jaffe and J. Lerner, Innovation Policy
and the Economy, Vol. 3, MIT Press (2003); ‘neither theory nor empirical work provides
any general justification for an antitrust merger policy aimed at preserving competition
in R&D markets’. R. Rapp, The Misapplication of the Innovation Market Approach to
Merger Analysis, 64 Antitrust L. J. 19 (1995); R.J. Gilbert and S.C. Sunshine, The Use
of Innovation Markets: A Reply to Hay, Rapp and Hoerner, 64 Antitrust L. J. 75 (1994);
who argue that the lack of clarity regarding the link between market structure and innova-
tion is not as important as Rapp contends; D. Mc Gowan, Innovation, Uncertainty, and
Stability in Antitrust Law, 16 Berkeley Tech. L. J. 729, (2001).
59
See FTC 13 January 2004 closing the investigation of Genzyme Corporation’s
acquisition of Novazyme Pharmaceuticals in 2001. FTC Press Release, FTC Closes its
Investigation of Genzyme Corporation’s 2001 Acquisition of Novazyme Pharmaceuticals,
Inc., at www.ftc.gov/opa/2004/01/genzyme.htm; Statement of Chairman T.J. Muris, in
the Matter of Genzyme Corporation/Novazyme Pharmaceuticals, Inc., at www.ftc.gov/
os/2004/01/murisgenzymestmt.pdf; Dissenting Statement of Commissioner M.W.
Thompson, Genzyme Corporation’s Acquisition of Novazyme Pharmaceuticals, at www.
ftc.gov/os/2004/01/thompsongenzymestmt.pdf; Commissioner P.J. Harbour Statement
available at www.ftc.gov/os/2004/01/harbourgenzymestmt.pdf. For an analysis, see D.
L. Wald and D.L. Feinstein, Merger Enforcement in Innovation Markets: The Latest
chapter – Genzyme/Novazyme, The Antitrust Source, July 2004; P. Balto and S. Sher,
Refining the Innovation Focus: The FTC’s Genzyme Decision, Antitrust magazine, 2004,
p. 28.
60
R.J. Gilbert and S.C. Sunshine, Incorporating Dynamic Efficiency Concerns in
Merger Analysis: The Use of Innovation Markets, 63 Antitrust L. J. 567 (1995); G.A.
Hay, Innovations in Antitrust Enforcement, 64 Antitrust L. J. 7 (1995).
61
This corresponds to the case of Genzyme/Novazyme, FTC Press Release, FTC
Closes its Investigation of Genzyme Corporation’s 2001 Acquisition of Novazyme Phar-
maceuticals, Inc., at www.ftc.gov/opa/2004/01/genzyme.htm. See also R.W. Davis
(2003) op. cit. For further examples, see also R. Gilbert, Should Antitrust Enforcers Rely
on Potential Analysis or the Concept of Innovation Markets? at www.ftc.gov/opp/glo-
bal/gilbert1.htm.
enhanced by consolidation. This involves recognising that collaborations are

often pro-competitive and that it is paramount in determining whether independ-
ent R&D efforts are close substitutes. In making this determination, attention
should be paid to ‘the nature, scope and magnitude of their R&D efforts; their
access to financial support; their access to intellectual property, skilled person-
nel, or other specialized assets; their timing; and their ability, either acting alone
or through others, to successfully commercialize innovations’.62
Merger control, in this case, is used as means to ensure that R&D is not overly
concentrated so that downstream potential markets may develop, and remedies
such as divestiture and CL are used to achieve this result. In a similar way, Art.
82 duty to deal case-law could be used to ensure that R&D is not suppressed
by the control of essential inputs in the R&D process by a few dominant firms
with the discretion and possible motive to deny or reduce access to such
inputs.
Antitrust law aims to promote not only price competition and output max-
imisation of existing products, but also ‘industrial progress’, therefore, practices
which limit such progress pose problems for antitrust, either in the application
of Arts 81 and 82 or in merger analysis.63 As in the case of mergers, the use of
innovation markets analysis assesses the likelihood of delay in or elimination
or reduction in quality or diversity of innovation as a result of decreased levels
of competition in innovation. A corollary of this is that unilateral practices with
the same effect will also be reviewed under Art. 82.64
In addition, this approach is particularly appealing in biopharmaceutical in-
dustry in view of the tight regulatory requirements. These permit competition
authorities in cooperation with the regulatory authorities, to forecast the effects
of exclusion or consolidation. For example in the USA the cooperation between
the FDA and the FTC provides extensive information on ‘the status, approach
and likely effect of each innovation effort … that might have been difficult to
obtain otherwise’.65 Therefore, it may be more feasible to determine on a factual
basis which research tools are truly ‘indispensable’.
62
FTC/DOJ Guidelines for Collaboration Among Competitors (2000) op. cit. § 4.3
These may also be the relative considerations in determining indispensability under Art.
82.
63
R.W. Davis (2003) op. cit., p. 682.
64
In the same way that a merger may lead to increased consolidation, similarly a
refusal to deal may lead to the elimination of all competition as prohibited in certain
cases by Art. 82. This application of Art. 82 may also be seen as the other side of the
TTBER (2004) op. cit., which exempts certain types of agreements between competitors
under Art. 81.
65
FTC, Office of Policy Planning, Anticipating the 21st Century: Competition Policy
in the New High-Tech Global Marketplace, 1996, available at www.ftc.fov/opp/hitech/
global.htm.
7.2.3.3 Conclusions on compulsory licensing as a safety net

While it would seem that much uncertainty surrounds fundamental questions
in this area, the importance of CL as a means of addressing follow-on innovation
considerations should not be underestimated. ‘To the extent that neither statutory
nor case law establishes clearly the legal scope of an IP grant, one should also
look to policy concerns in determining whether a unilateral refusal to license
should ever be considered an antirust violation.’66 As it is questionable whether
innovation incentives are sensitive to the narrow refusal to deal liability, the
benefits may far outweigh the cost.67
The recognition of the existence of CL under antitrust law to remedy a situa-
tion of blocked follow-on innovation as a last resort safety net (whether this is
seen as remedying a perceived patent failure or simply balancing the system as
initially contemplated) would seem to be a more feasible and indeed more desir-
able option. While competition law is not the only instrument to improve the
balance, it does provide a means of enhancing the innovation/access balance.68
A major disadvantage of this approach is the fact that it relies on courts to
determine what constitutes a ‘reasonable royalty’. None the less, it would seem
that this is more problematic in theory, rather than in practice, as the courts are
66
‘…There is no definitive test for dividing the optimal level of protection for IP.
Logically the law should not place antitrust constraints on a monopolist’s right to refuse
to license if such constraints would undermine the IP laws. Conversely, the law should
not give IP holders the carte blanche to refuse to license if that would result in frustrating
the very objectives that IP laws seek to achieve.’ M. Lao (1999) op. cit. p. 210.
67
See Chapter 5 on alleged harm to incentives to innovate. See also C. Springman,
Competition and IP Law and Policy in the Knowledge-Based Society: Is there a Cause
for Concern about Unilateral refusals to Deal? 1 May 2002, DOJ/FTC Hearings on IP
and Competition Law. The author questions whether innovation incentives are sensitive
to narrow refusal to deal liability, leading to a significant reduction in incentives across
industries. He also refers to Klemperer’s model (P. Klemperer, How Broad Should the
Scope of Patent Protection Be? 21 Rand J. Econ’cs 113 (1990)) that suggests that a small
reduction in the patent holder’s right to profit may reduce deadweight loss even more.
Hence, the assumption that the IP right to exclude is complete may prove to be incorrect.
A similar argument is levelled with regard to the commensurability and proportionality
of the incentive to innovate and the benefit form immunity. See A. Arora, Competition
and IP Law and Policy in the Knowledge-Based Society: Is there a Cause for Concern
about Unilateral Refusals to Deal? 1 May, 2002, DOJ/FTC Hearings on IP and Competi-
tion Law, and D.J. Gerber (1988) op. cit.
See also T.C. Bailey (2001) op. cit. p. 12 ‘Pointing to the fact that compulsory licensing
will lead to a less-than-maximum level of research and development is not dispositive
because the social cost of providing those additional units of research may outweigh
their social utility. … There is no reason to assume that the present level of research ac-
tivity is in fact the socially optimal level.’
68
An alternative may be a patent compulsory licensing provision in the case of
necessary inputs for follow-on or downstream innovation.
used to determining infringement damages on a regular basis.69 In general, it is

left up to the parties to reach an agreement within a specific period, however,
failing this, the royalty fee may be set by an expert.70
A reasonable royalty fee covers costs as well as a reasonable profit taking the
market value of the innovation into account amongst other things.71 It is believed
that royalty payments, particularly in the case of information goods, ‘allow
greater choice [than fixed fees] among profits and consumer welfare in the final
good market’72 and permit flexibility so as to prevent as far as possible ‘the po-
tential to cause unreasonable loss of income to the copyright owner’.73 So, for
example, in a case involving whether the level of royalties charged for an IP li-
cence were excessive, the Advocate-General indicated that the cost/price
analysis would not be appropriate in the context of copyright licensing as the
cost of creating a work ‘of the imagination’ is impossible to determine; the ECJ
simply compared the rates with those charged by other copyright management
societies in other Member States.74
The shortcoming of such an approach may be that the enforcement costs are
so high and the procedure so lengthy that it effectively discourages parties from
pursuing a compulsory licensing action, and instead diverts research to other
areas.75 If this proves to be the case in practice, then the alternative of enacting
a specific patent provision for research tools should be considered.76
7.2.4 Conclusion: A Human Rights Approach to Competition Law?
In conclusion, it should be noted, that the right to health not only affects patent
law but may also increasingly affect the interpretation and application of com-
petition law. For example, in South Africa, the Competition Commission found
69
J. H. Barton (1997) op. cit.
70
See Check List for Fast Track Compulsory Licensing, in J. Love, Implementing
TRIPS Safeguards with Particular Attention to Administrative Models for Compulsory
Licensing of Patents, WHO Meeting in Harare, Zimbabwe, 21 August 2001.
71
However, the royalty may not be at discriminatory rates that would violate Art.
82(c) prohibiting dissimilar conditions for equivalent transactions. None the less, in
considering which rates are discriminatory consideration is paid to, amongst other things,
the differences in the costs of licensing, lost profits, other business relations, and different
end-uses.
72
R. Aoki and J. Small (2004) op. cit. p. 28.
73
WTO, US – Section 110(5) of the US Copyright Act, Panel Report of 15 June 2000,
WT/DS160/R, para. 6.229.
74
Case 402/85 Basset v SACEM [1987] ECR 1747.
75
See, for example, in the USA where it is estimated that parties spend more than
$1 million to litigate a patent dispute. See J. Love (2001) op. cit.
76
An alternative to this may be the endorsement of a rebuttable presumption in fa-
vour of compulsory licensing.
GlaxoSmithKline and Boehringer Ingelheim to have abused their dominant

position by virtue of excessive pricing in respect of ritonavir, lamivudine,
ritonavir+lamivudine and neviparine.77
More specifically, the parties were found to have violated the provisions of
the Competition Act of 1998 which prohibit excessive pricing (s. 8(a)), refus-
ing access to essential facilities (s. 8(b)) and exclusionary acts that have an
anti-competitive effect that outweighs technological efficiency or other pro-
competitive gains (s. 8(c)).78 Hence, the abuse also consisted of refusal to
grant licences to generic manufacturers in return for a reasonable royalty. It
was found that this would have been feasible and also beneficial to consumers
as it would lead to lower prices.
The South African case shows that competition law may be interpreted in line
with the human rights obligations and, more specifically, with the goal of striv-
ing ‘towards the highest attainable standard of health’. Excessive pricing and
anti-competitive refusals to deal, amongst other things, should therefore be ex-
amined within the context of the health implications at stake. If access to drugs
is disproportionately restricted due to pricing measures, private companies may
be found to be in violation of the competition provisions.79
77
Kline (Pty) Ltd, Glaxo Group Limited, Case Number 34/CR/Apr04, in which the South
of the excessive pricing of drugs. See also South African Competition Tribunal’s decision
and order in Pharmaceutical Wholesalers and Glaxo Wellcome, case 68/IR/Jun00, 18
June 2003 at www.comptrib.co.za/decidedcases/pdf/68IRJUN00kinesis.pdf.
See Competition Commission finds pharmaceutical firms in contravention of the
Competition Act, 16 October 2003, available at http://www.cptech.org/ip/health/sa/
cc10162003.html and Competition Commission concludes an agreement with pharma-
ceutical firms, 10 December 2003, available at http://www.cptech.org/ip/health/sa/
cc12102003.html.
78
Ibid. The terms of the settlement included: (1) extend the voluntary licence granted
to Aspen Pharmacare in October 2001 in respect of the public sector to include the private
sector; (2) grant up to three more voluntary licences on terms no less favourable than
those granted to Aspen Pharmacare, based on reasonable criteria which include registra-
tion with the Medicines Control Council and the meeting of safety and efficacy
obligations; (3) permit the licensees to export the relevant antiretroviral drugs to sub-
Saharan African countries; (4) where the licensee does not have manufacturing capability
in South Africa, GSK will permit the importation of the drugs for distribution in South
Africa; (5) permit licensees to combine the relevant ARV with other antiretroviral medi-
cines; and (6) charge royalties of no more than 5 per cent of the net sales of the relevant
ARVs
79
See Statement by Consumer Project on Technology Concerning an alleged pro-
hibited practice in terms of section 49B(2)(a) of the Competition Act 89 of 1998, at www.
cptech/ip/health/cl/recent-examples.html.
In this way, specific health concerns associated with the effect of patents in
the biopharmaceutical industry may be ‘mitigated’ by competition law and the
obligations relating to the right to health.
This interpretation of competition law, however, is more likely in cases in-
volving dissemination concerns where the effect on health would be apparent,80
rather than in cases such as research tools where the effects on health are more
indirect and can only be speculated.81 None the less, they may affect the com-
pulsory licensing provisions in the sense of lowering the indispensability
threshold and may lead more easily to a finding that access to certain research
tools should be mandated.
In the IMS case, the interpretation of the new product requirement as extend-
ing to ‘intention to produce new goods’, and the interpretation of a market as
including a ‘potential or even hypothetical market’ could be seen as a step in
this direction. Adopting a more innovation sensitive approach to competition
law and the particularities of certain innovation-based industries such as biop-
harmaceuticals could in this sense also be seen as in line with the obligation of
states to strive ‘towards the highest attainable standard of health’.
Consistent with the above, in the Discussion Paper on the application of Art.
82 to exclusionary abuses it is stated that when it comes to refusal to deal with
IPR: a ‘refusal to licence an IPR protected technology which is indispensable
as a basis for follow-on innovation by competitors may be abusive even if the
80
See, for example, in 1973 when the Monopolies Commission in the UK required
Roche to lower the price of its patented Librium and Valium to the NHS. Chlordiazepox-
ide and Diazepam (H.C. 197, 1973). The Monopolies and Mergers Commission was the
forerunner of the present Competition Commission.
81
As explained above, the crucial element in the case of research tools is the indis-
pensability of the input for downstream innovation. Classical antitrust cases in the
biopharmaceutical industry, however, have rather been concerned with products which
were present on the market. In this context, the Commission has distinguished between
the markets for the production and sale of approved products, R&D into new therapeutic
compounds and wholesale distribution of medicines. Drug markets usually correspond
to the therapeutic classes, although reimbursement policies are also relevant. In the case
of research tools however, the novel element of the analysis is the future potential innova-
tion element. In addition, unlike traditional antitrust cases where markets are still quite
fragmented along national lines in this industry, with prices differing according to the
pricing policies of each Member State, in the case of research tools, the market may
consist of the global innovation market. See J. Gatti, Mergers, Mergers, Joint Ventures
and the Pharmaceutical Industry, 1996 EU Pharmaceutical Forum 1996 at http://europa.
eu.int. See also S.A. Singham, Competition Policy and the Stimulation of Innovation:
TRIPS and the Interface Between Competition and Patent Protection in the Pharmaceuti-
cal Industry, 26 Brooklyn J. Inte’l L 363, 2000; K. Maskus, Parallel Important in
Pharmaceuticals: Implications for Competition and Prices in Developing Countries,
Report to WIPO 2001, at http://www.wipo.org/about-ip/en/studies/pdf/ssa_maskus_pi.
pdf.
licence is not sought to directly incorporate the technology in clearly identifiable

new goods and services.’82
82
Commission Discussion Paper on the Application of Art. 82 to Exclusionary
Abuses, December 2005, para. 240.
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Hoffman-La-Roche Challenges Freedom of Researcher; List of ‘Infringers’ In-
cludes Hundreds of Researchers and Dozens of Government-Supported
Laboratories, Bus. Wire, 24 May, 1995.
S. Junnarkar, ‘GeneChip’ Encodes DNA on Silicon, New York Times, 15
March1997.
P. Rabinow, Making PCR: A Story of Biotechnology, Chicago, University of
Chicago Press, 1996.
‘Should Congress Liberate Gene Data?’, Chicago Tribune, 16 September
1999.
‘Striking a Balance on Patent Rights’, Herald Tribune, 30 October 2001.
Index
AAAS (American Academy of Arts and antitrust
Sciences) 85 aims 101
ABA (American Bar Association) 21, 22, compulsory licensing as interchange-
26, 126, 181 able remedy with 189
Abbott, F.M. 32, 58, 64 control
abuse of dominance effect on incentives to innovate,
compulsory licensing and 150, 159–61 IPRs and competition law
essential facilities doctrine and 167–8 116–19
proportionality and 147–8, 156–7 recent recognition of, IPRs and
refusal of access to essential services competition law 119–21
and 154–6, 158, 162–5 essential facilities doctrine and 133–4
refusal to license and 150–51, 153–4, intellectual property and, transition
163, 169 from separate to unified fields
refusal to supply and 147–9, 151–4 115
requirements for 152, 153–4, 156, 165 law see competition law; duty to deal
Treaty of Rome and 103 technology access problems and 185–6
vertical integration and 145–7, 149, Aoki, R. 180, 186, 196
151 Areeda, P. 134, 135
acceptability Arora, A. 195
right to health and 78 Arrow, K.J. 49, 117, 180
access Attwood, J. 166
essential services, to, refusal of 154–6, Austin, D. 22
158, 162–5 Australia
see also technology access compulsory licensing 64
accessibility experimental use exemption 47
right to health and 78 Australian Department of Health and
ACIP (Advisory Council on Intellectual Ageing 47
Property) 47, 51, 52, 53, 54 Austria
Adcock, M. 88 compulsory licensing and experimen-
agreement see MTA; TRIPS tal use exemption provisions 66
Aguilera, M.C. 9 see also EU
ancillary activity availability
reservation of, leverage cases and duty right to health and 78
to deal 130–33 Ayres, I. 117, 182
Anderman, S. 101, 106, 116, 129, 157,
160, 179 Bailey, T.C. 55, 56, 177, 195
anti-commons Baily, M. 28
property rights and 109–10 Balto, P. 193
research fragmentation and 5, 6 Banks, K. 104
anti-competitive conduct Barinaga, M. 9
remedy for, compulsory licensing as 63 Barton, J.H. 32, 190, 196
239
240 Index
Battcock, R. 65 refusal to supply input to preserve

Belgium power in market B 145–7,
duty to deal 154, 161–2 159–61
see also EU see also courts; dependence cases;
Bendekgey, L. 10 essential facilities doctrine;
Benkler, Y. 23, 181 leverage cases
Bergman, M.A. 135, 164 Chambers, S.A. 8
Bhatnager, 59 Chapman, A.R. 85, 90, 91
Biotechnology Industry Organization 4 Chetley, A. 73
Birdsall, N. 71 Chien, C.V. 56–7, 118
Blackburn, R. 8, 177 Cho, M.K. 10
Bloche, M.G. 83, 94 CL (compulsory licensing)
blocking patents doctrine abuse of dominance and 150, 159–61
patent protection and 37, 49 antitrust as interchangeable remedy
see also patent with 189
Boone, J. 126, 180 blocking patents doctrine and 49
Boyle, J. 108 incentives to innovate and 118
Brazil new product for which potential
compulsory licensing 59 consumer demand and, prevent-
right to health 94 ing emergence of 187
Britain see UK patent protection and 37, 63–5
Britz, J. 90 definition and history 54
EU Member State provisions for
Calabresi, G. 182 66–9
Campbell, E.G. 6 grounds for 57–8
Carl, P. 78, 81 role of 58–63
Carlson, S.C. 34 support and opposition for 54–6
Carlton, D.W. 123, 124, 131, 193 public health case law and 94
case law research tools and, access through
essential facilities doctrine cases, duty patent law 182, 184
to deal 122 right to health and 70, 87, 91–3, 96–7
intellectual property 94–6 safety net, as, technology access
patent system, technology access problems and 177, 195–6
problems impact on 189–90 two-market requirement and 188
public health 93–4 see also licensing
refusal to deal under Art 82 EC 147–9, Clark, J. 51, 52, 53
151–2, 171–3 Cohen, C. 3
denial of access 154–6, 158, 162–5 Cohen, J. 6, 17
no effect on trade 150 Cohen, W.M. 180
refusal to continue joint venture Cohen-Boyer Patents
with competitor 156–7 research tool, as 8
refusal to fully meet supply requests Colombia
to prevent parallel imports 170 right to health 80
refusal to license 150–51, 161–2, commensurability
165–9 compulsory licensing role in balancing
refusal to provide interoperating 58
information 169 competition
refusal to share spare parts with IPRs and see IPRs, competition law and
independent provider of potential harm to, refusal to deal and
aftermarket support 153–4 123–6
Index 241
Competition Commission (South Africa) Community Code Relating to Medici-

63, 196–7 nal Products for Human Use,
competition law amending 40
human rights approach to, technology Database 119
access problems and 196–9 In-Vitro Diagnostic Medical Devices
see also duty to deal; IPRs, competi- 37
tion law and Legal Protection of Biotechnology
Conigliaro, M.J. 34 Inventions 27
Connor, S.S. 72 Legal Protection of Computer
Cornish, B. 88, 97 Programs 119
Cornish, W.R. 39 Rational Use of Medicines 27
Correa, C. 32 Rental and Lending Rights 95
courts see also EU; legislation
practice, IPRs and competition law DNA sequences
103–6 biomedical research tools and 9–12
see also case law patent trends effect on patent
Cringely, R.X. 181 balance for 13, 14
Cullem, G. 7 see also genetic diagnostics
Cullet, P. 93 Dolmans, M. 190
cumulative innovation Domeij, B. 34, 41, 48
biopharmaceutical see R&D Drahos, P. 88
patent breadth and 24 Dreyfuss, R.C. 180
see also invention; patent Drlica, K. 9
Ducor, P. 42
Dahdoud, T.N. 192 Dupuy, R.-J. 73, 76, 79, 81
Dalpé, R. 4 Dutfield, G. 31, 33
David, P.A. 21–2, 24, 107, 108, 109, duties
111 right to health, under 79
Davis, R.W. 190, 192, 194 duty to deal (Art 82 EC)
De Santi, S. 180 refusal to deal under 122–3, 143–4
deadweight loss cases see case law, refusal to deal
compulsory licensing desirability and under Art 82 EC
55–6 competition and, potential harm to
property rights and 111 123–6
demand see product, demand state of law on 126–8
Denmark dependence cases 128–30
compulsory licensing and experimen- essential facilities doctrine (EFD)
tal use exemption provisions 66 cases, indispensability
see also EU requirement and 133–41
Department of Commerce, Patent and new product innovation 141–2
Trademark Office (USA) 182 leverage cases, ‘reservation of
dependence cases ancillary activity’ 130–33
characterization unhelpful 157 technology access problems and 185–6
duty to deal 122, 128–30 impact on patent system case-law
see also case law 189–90
Depoorter, B. 126, 180 indispensability 186
direct effect innovation markets in 191–4
patenting and right to health 87–8 new product for which potential
Directives consumer demand, preventing
Biotechnology 12, 37, 60, 94–5 emergence of 187
242 Index
objective justification, absence of see also individually named Member

188 States
two-market requirement 187–8 EUE (experimental use exemption)
patent protection and 37, 39–43, 46–7
EC Treaty see Treaty of Rome EU Member State provisions for
EFD (essential facilities doctrine) 66–9
abuse of dominance and 167–8 US experience 44–6
access refused to essential services and ‘relating to’ in, interpretation of 181
154, 158 research tools and, access through
antitrust and competition and 115 patent law 181–3, 184
cases, duty to deal 122 European Commission
exceptional circumstances and 166 antitrust and IP and 115
indispensability requirement and 133–5 antitrust control recognition and 120
indispensability 135–7 duty to deal and 144, 157
objective justification 139–41 existence/exercise distinction and 104
two-market requirement 138–9 experimental use exemption and 181
refusal to license and 165–9 innovation markets and 191
Eisenberg, R. S. IPRs and competition law and 103,
experimental use exemption and 45, 121
46, 47 technology access problems and
research fragmentation and 5–6 198–9
research tools and 8, 13, 14, 15 European Group on Ethics in Science
technology access problems and 16, and New Technologies 37, 70, 87
181–2, 183 exceptional circumstances
El Salvador essential facilities doctrine and 166
right to health 88 exclusive rights exercise and, interpre-
Elliott, R. 89 tation 160–61, 166
EMEA (European Medicines Evaluation exclusivity
Agency) 26–7 patronage, procurement and property
EPO (European Patent Office) 36–7 and, IPRs and competition law
Epstein, R.A. 178, 180 109–12
ESCRC (Committee on Economic Social existence/exercise distinction
and Cultural Rights) 73 antitrust and competition and 115
ESTs (expressed sequence tags) IPRs and competition law and 103–6
research tool, as 8, 182
EU (European Union) Fauver, C.M. 55
competition law 101, 103, 119, 121 Feinstein, D.L. 192, 193
compulsory licensing 60, 66–9 Feit, I.N. 12
experimental use exemption provisions Finland
66–9 compulsory licensing and experimen-
intellectual property cases 94–6 tal use exemption provisions 66
patent protection provisions 38 duty to deal 150–51
patent systems and sources 25 see also EU
reverse doctrine of equivalents 48, 49 Fitzgerald, D. 162
right to health 74–5, 94, 97 follow-on innovation
right to health as human right, status in compulsory licensing desirability and
law 71–4 55
right to property and IP 84, 86 patent protection and 36–7
Supplementary Protection Certificate blocking patents doctrine 37, 49
30 compulsory licensing see CL
Index 243
experimental use exemption see Gilbert, R.J. 24, 193

EUE Gitter, D. 12
patent pools 37, 51–3 Glenken, J. 129
reverse doctrine of equivalents 37, Glover, G. 28, 29
48–9, 50 Goldman, A.V. 134
see also invention; patent Goldstein, J.A. 15
France goods see information goods; public
compulsory licensing and experimen- goods
tal use exemption provisions 66 Gordon, H.S. 113
patents’ importance, overstating 33 Gorner, P. 97
see also EU Gostin, L. 78
FTC (Federal Trade Commission) (USA) Grabowski, H. 23, 27, 28, 29
32, 193, 194 Greece
FTC/DOJ compulsory licensing and experimen-
Antitrust Guidelines for Collaboration tal use exemption provisions 67
Among Competitors 191, 194 duty to deal 170
Antitrust Guidelines for the Licensing see also EU
of Intellectual Property 119, 120 Green, J. 24
Hearings on IP and Competition Law Greenberg, A.C. 34
195 Grosvenor, R. 146, 157
Proceedings on Competition and IPRs
29, 118 Hahn, E.A. 26
Proceedings on the Pharmaceutical Hamlet-Cox, D. 10
Industry 29 Handley, L.A. 48
Fuenzalida-Puelma, H.L. 72 Hantman, R.D. 41
Fysh, M. 43 Hardin, R. 110
Harhoff, D. 26, 29
Gambardella, A. 26, 27 Harvard ‘oncomouse’
Gwrg, R. 33 research tool, as 8
Gatti, J. 198 Harz, M.H. 134
Gelijns, A.C. 26 Hasenzahl, C. 54, 59
genetic diagnostics Hawker, N.W. 132, 135
biopharmaceutical R&D and cumula- health
tive innovation 4–5, 6 emergencies, compulsory licensing
research tools and 8, 9 role in addressing 61–3
patent pools and 52 see also public health; right to health
see also DNA sequences healthcare
Genevaz, S. 116 implications, biopharmaceutical R&D
Gerber, D.G. 131 and 4–5
Gerber D.J. 135, 138 Heller, M.A. 5
Germany Hogerzeil, H. 97
compulsory licensing 61, 64–5, 67 Holzapfel, J. 6
duty to deal 129, 150–51, 165–9 Hooks, J. 138
experimental use exemption 40, 42, 67 horizontal dilemma
patent pools 53 patent balance and 23
research tools, patent trends effect on Hovenkamp, H. 56, 58
patent balance for 14 Hull, D. 166
see also EU human rights
Gertner, R. 193 approach to competition law, technol-
Gilat, D. 39, 40, 41, 42, 46, 184 ogy access problems and 196–9
244 Index
right to life 80 invention

see also right to health; right to commercialization, as patent system
property rationale 22–3
dissemination
IACHR (Inter-American Commission on patent system goals and 23–4
Human Rights) 80 patent system rationale, as 22
ICESCR (International Covenant on motivation, as patent system rationale
Economic, Social and Cultural 21–2
Rights) orderly cumulative development of, as
property rights and, public interest patent system rationale 23
limitations 86 see also patent
right to health elements and 78 IP (intellectual property)
right to health sources and 75–6 European cases on, fundamental rights
right to health strengthening and 81 analysis and 94–6
right to property and IP as human right human right, as, right to property and
and 84, 85 84–6
see also legislation system, competition embedded in
incentive reduction 114
compulsory licensing desirability and see also property
56 IPRs (intellectual property rights)
India competition law and 101, 103, 121
generic products and drug prices 82 antitrust control 116–21
indirect effect competition embedded in IP system
patenting and right to health 88–9 114
indispensability courts’ practice 103–6
duty to deal and technology access EC Treaty provisions 102
problems and 186 exclusivity, patronage, procurement
essential facilities doctrine and and property and 109–12
133–7 information goods, patronage,
objective justification 139–41 procurement and property and
two-market requirement 138–9 109–12
information IPRs like other property rights for
access see technology access purposes of competition
goods, IPRs and competition law 112–13
109–12 public goods
see also knowledge market failure and 107–9
innovation patronage, procurement and
nature of biopharmaceutical 26–8 property and 109–12
new product, duty to deal 141–2 transition from separate to unified
patenting and 28–31 fields 114–16
see also cumulative innovation; see also rights
follow-on innovation; patent Ireland
innovation incentives duty to deal 156–7, 159–61
antitrust control effect on 116–19 see also EU
compulsory licensing and 118 Israelsen, N.A. 41
innovation markets Italy
duty to deal and technology access compulsory licensing and experimen-
problems and 191–4 tal use exemption provisions 67
optimal structure 179–81 see also EU
see also market
Index 245
James, E. 71 Berne Convention for the Protection of

Japan Literary and Artistic Works 119
compulsory licensing 61 Charter of Fundamental Rights of the
Jehoram, H.C. 92–3 European Union 74–5, 84, 86
Jensen, E. 28 Civil Code (Netherlands) 92
Julian-Arnold, G. 57, 59, 60, 62, 64 Community Patent Convention (CPC)
Junnarker, S. 8 39
Community Patent Regulation (CPR)
Kallaugher, J.J. 134, 158–9 38, 39, 61
Karjala, D.S. 185–6 Competition Act (South Africa) 63, 197
Karp, J.P. 183 Convention on the Elimination of All
Kass, L.R. 77 Forms of Discrimination Against
Kattan, J. 191 Women 72, 76
Kelley, D. 72 Convention on the Rights of the Child
Kenney, P.J. 87 72, 76
Kenya Intellectual Property Code (France) 62
generic products and drug prices 82 Drug Price Competition and Patent
Kern, M. 39, 60, 64–5 Term Restoration Act (USA) 40,
Kezsborn, A. 134 46
Killick, J. 139 European Charter of Patients’ Rights 75
Kind, J.L. 181 European Convention on Human Rights
Kitchm E.W. 21, 23, 24 (ECHR) 84, 86
Klemperer, P. 24, 117, 195 European Patent Convention (EPC) 15,
Knable Gotts, I. 191 35, 36, 38, 39
knowledge European Social Charter 72
public good, as 107–8 General Agreement on Trade and
see also information Services 91
Ko, Y. 11 International Convention on the
Korah, V. 56, 148–9, 162 Elimination of All Forms of
Kraus, J.G. 191 Racial Discrimination 72, 76
Kubalski, J. 51 International Covenant on Civil and
Kukies, J. 26, 29 Political Rights (ICCPR) 74, 86
Kwoka, E. 192 Medicines and Related Substances
Control Amendment Act (South
Ladas, S.P. 59 Africa) 93
Laherty, C. 42 Orphan Drugs Act (EU) 30
Lang, J.T. 159 Orphan Drug Act (USA) 30–31, 87
Lao, M. 185, 195 Paris Convention for the Protection of
Lawson, C. 6 Industrial Property 54
Leaffer, M. 184 Patent Act (Germany) 15–16, 39, 62
Leary, V.A. 72, 73 Patent Law (Switzerland) 60
Leddy, M. 138 Patent Law Including Modifications
legislation (France) 39
Act Against Restraint of Competition Patents Act (UK) 39, 60, 119
(Germany) 129 Patents and Plant Variety Rights
Affordable Prescription Drugs Act (Compulsory Licensing) Regula-
(USA) 62–3 tions 60
African Charter on Human and Public Health Emergencies Act (USA)
People’s Rights (Banjul Charter) 62
72 San Salvador Protocol 88
246 Index
Technology Transfer Block Exemption market

Regulation (TTBER) 191 failure, public goods and, IPRs and
Universal Declaration of Human competition law 107–9
Rights (UDHR) 73–4, 75, 84, 85 structure, optimal for innovation,
Vienna Convention on the Law of technology access problems and
Treaties 89 179–81
see also Directives; EPC; ICESCR; see also innovation markets; two-
Treaty of Rome; TRIPS market requirement
Lemley, M.A. 24, 34, 49, 56, 58 market-oriented experiments
Lerner, J. 180 experimental use exception and 40
leverage cases Marquandt, P. 138
duty to deal 122, 130–33 Marshall, E. 13
see also case law Maskus, K. 198
Levin, R.C. 180 Maurer, S. 181
Levy, R. 178 McFetridge, D.G. 56
license stacking McGowan, D. 191, 193
patent trends effect on patent balance McLeod, J.M. 8
for research tools and 13–14 Melamed, D. 182
technology access and innovation and Merges, R.
5–6 IPRs and competition law and 110, 111
licensing patent balance and 24
broad, compulsory licensing as patent protection and 48, 49–50, 51,
mechanism to induce 58–9 52, 53
compulsory see CL research tools and 8
refusal Merkin, R. 101
abuse of dominance and 150–51, Metz, J.F. 10
153–4, 163, 169 Miller, C.G. 105–6
essential facilities doctrine and Mongoven, J.F. 192
165–9 Montgomery, J. 77, 79
refusal to deal, as 124 Morse, M.H. 192
Lichtenberg, F. 30 MTA (material transfer agreement)
Lie, R.K. 73 research tools and 7
Lipinski, T.A. 90 Mueller, J.M.
Lipsky, A.B. 134, 135 duty to deal and technology access
Llewelyn, M. 88 problems and 181, 183, 184
Loury, G.C. 24 patent protection and 36, 47
Love, J. 46, 64, 196 research tools and 7, 8, 9, 11, 13, 17
Lunney, G. 137 Mully, T. 83, 85–6, 95
Luxembourg Mwalimu, U.A. 82
duty to deal 151–2 Myrick, M.E. 104, 105
see also EU
Nacke, T. 129–30, 157
Machlup, F. 21, 24 National Institutes of Health (NIH)
Mackaay, E. 110, 114 (USA) 13, 183
Mackie-Mason, J.K. 124, 125, 126 Nelson, L. 12–13
MacLaren, M. 95 Nelson, R.R. 24, 111
Mann, J. 78 Netherlands
Mansfield, E. 29, 30 compulsory licensing and experimen-
Marenco, G. 104 tal use exemption provisions 69
Mark, J. 56, 58 see also EU
Index 247
new product length, patent system goals and 24

innovation, duty to deal 141–2 pools, patent protection and 37, 51–3
potential consumer demand existing, pre-commercial stage 4, 177–8
preventing emergence of, duty to see also innovation; invention
deal and technology access patent balance
problems and 187 patent system as balancing system and
see also product 21, 23–5
Newberg, J.A. 115 research tools, for, patent trends effect
Nicol, D. 6 on 12–15
Nielsen, J. 6 right to health implications see right to
Nigeria health
right to health 80 patent law
NIH (National Institutes of Health) right to health and
(USA) 4, 7, 17, 177, 183 effect of patent law on right to
non-use health 82–3
compulsory licensing role for 59 effect of right to health on patent
Norway law 83
compulsory licensing and experimen- interpretive principle, as 70–71,
tal use exemption provisions 67 90–93, 96–8
Nuffield Institute of Biotechnology 4, 5, public-health case-law 93–4
9–10, 11, 13, 14, 17 technology access problems and 181–5
patent protection
objective justification compulsory licensing as, technology
absence of, duty to deal and technol- access problems and 177, 195–6
ogy access problems 188 European law provisions for 38
abuse of dominance and 148 follow-on innovation and 36–7
essential facilities doctrine and blocking patents doctrine 37, 49
indispensability requirement and compulsory licensing (CL) 37, 63–5
139–41 definition and history 54
parallel trade restrictions and 170 EU Member State provisions for
refusal to supply and 149 66–9
obligations see duties grounds for 57–8
OECD (Organisation for Economic role of 58–63
Cooperation and Development) 3, support and opposition for 54–6
13, 27, 29, 52, 134 experimental use exemption (EUE)
Ordover, J. 24 37, 39–43, 46–7
ordre public EU Member State provisions for
right to health and 70, 87, 96 66–9
Orsengo, L. 26, 27 US experience 44–6
Oxfam 31 patent pools 37, 51–3
reverse doctrine of equivalents 37,
Pammoli, F. 26, 27 48–9, 50
Parisi, F. 126, 180 impeding information access and
Pate, G.N. 46 14–15
patent patent system
blocking, doctrine, patent protection balancing system, as 34–5
and 37, 49 biopharmaceutical innovation
breadth, patent system goals and 24 nature of 26–8
dependent 49, 65 patenting and 28–31
importance, overstating 31–3 patent balance 21, 23–5
248 Index
patents’ importance, overstating property

31–3 public goods, exclusivity and informa-
biopharmaceutical industry and 25–6 tion goods and, IPRs and
case-law, technology access problems competition law 109–12
impact on 189–90 see also IP; right to property
EU existing 25 property rights
importance of, factors in 29–30 specific subject matter doctrine and
main rationales 21–3 115
research tools and, technology access see also IPRs; rights
problems 177–81 proportionality
safety nets see patent protection abuse of dominance and 147–8, 156–7
patenting public goods
biopharmaceutical innovation and market failure and, IPRs and competi-
28–31 tion law 107–9
increase in, healthcare implications patronage, procurement and property
4–5 and, IPRs and competition law
privatization and 5 109–12
right to health and 87–9 public health
patronage case law, patent law and right to health
public goods, exclusivity and informa- 93–4
tion goods and, IPRs and compulsory licensing and 70
competition law 109–12 see also health
Patterson, D. 138 public interest
PBM (Pharmacy Benefits Management) IP as human right and right to property
networks 84, 86
refusal to deal and 178
PCR (polymerase chain reaction) quality
technology right to health and 78
biomedical research tools and 9
research tool, as 8 R&D (research and development)
see also technology cumulative innovation and 3–7, 16–18
Pekari, J.C. 90 biomedical research tools 9–12
Perrine, J. 166 defining research tools 7–8
Perritt, H. 108, 110 patent trends effect on patent
Pitofsky, R. 138 balance for research tools
Pons, J. 191 12–15
Portugal see also research
compulsory licensing and experimen- Rabinow, P. 9
tal use exemption provisions 68 Rai, R.K. 4
see also EU Rapp, R. 193
privatization Ratner, J. 139
biopharmaceutical R&D and 5 Reichman, J. 54, 59
procurement remedy
public goods, exclusivity and informa- anti-competitive conduct, for, compul-
tion goods and, IPRs and sory licensing as 63, 185
competition law 109–12 interchangeable, compulsory licensing
product and antitrust 189
demand not met, compulsory licensing research
desirable where 54–5 fragmentation, biopharmaceutical
see also new product R&D and 5–7
Index 249
nature of, recent changes in 3 duty to deal and technology access

see also R&D problems and 181
research tools IPRs and competition law and 116,
biomedical, cumulative innovation and 118
R&D and 9–12 patent balance and 24, 26, 32, 33
compulsory licensing usefulness and patent protection and 56, 64
58 Schoff, K. 90
defining, cumulative innovation and Schumpeter, J. 24, 180
R&D and 7–8 Scotchmer, S. 23, 24
essential, technology access problems Seelen, C.M. 135
and 181–5 Seide, R.K. 8
experimental use exemption and 40, Semerano, S. 118
46–7 Shah, S. 81
patent pools and 53 Shapiro, C. 24, 51, 52, 129
patent system and, technology access Shavell, S. 108–9, 111
problems 177–81 Sher, S. 193
patent trends effect on patent balance Shibata, Y. 42
for, cumulative innovation and Sidak, J.G. 134, 135
R&D and 12–15 Siebrasse, N. 112
reverse doctrine of equivalents and 50 Silberston, Z.A. 56
reverse doctrine of equivalents Sing, L. 52
patent protection and 37, 48–9, 50 Singham, S.A. 29, 33
Rey, P. 132 Small, J. 180, 186, 196
Richardson, D.M. 87 SMEs (small- and medium-sized
right to heath enterprises)
elements 77–8 independence, abuse of dominance and
human right, as, status in European 148–9, 150
law and 71–4 Smith, S. 104–5
implications 76–7 Snyder, E.A. 30
obligation to respect, protect and fulfil South Africa
79 compulsory licensing 63
strengthening, international efforts for right to health 93–4, 98
80 technology access problems 196–7
sources 74–6 Spain
IP 84–6, 94–6 compulsory licensing and experimen-
patent law and 70–71, 82–3, 90–94, tal use exemption provisions 68
96–8 see also EU
patenting and 87–9 Springman, C. 195
right to property SSM (specific subject matter) doctrine
IP as human right and 84–6 existence/exercise distinction and 104,
rights 105–6
exclusive, exercise of and exceptional property rights and 115
circumstances interpretation see also access
160–61, 166 Stiglitz, J.E. 3
see also IPRs; property rights Stothers, C. 164–5
Robertson, A. 165 Strauss, J. 14, 53
Robinson, C.O. 134 Subbiotto, R. 151
Ross, D. 118 Sunshine, S.C. 193
supply
Scherer, F.M. refusal to 147–9, 151–4
250 Index
Sweden see also legislation

compulsory licensing and experimen- TRIPS (Trade-Related Aspects of
tal use exemption provisions 68 Intellectual Property Rights)
see also EU Agreement
Switzerland antitrust control and 119, 120
compulsory licensing 60, 61, 69 blocking patents doctrine and 49
experimental use exemption provisions compulsory licensing and 57, 58,
69 185
patents’ importance, overstating 33 property rights and, public interest
limitations 86
Talley, E. 182 right to health as interpretive principle
Tandon, P. 55 in patent law and 90, 93, 94
Taq (Thermus aquaticus YTI DNA right to health indirect effect and 88–9,
polymerase) 96
research tool, as 9 see also legislation
Taylor, C.T. 56 Troy, D.E. 134, 135, 139
technology two-market requirement
PCR 8, 9 duty to deal and technology access
significant advances, CL role in 59–61 problems and 187–8
technology access essential facilities doctrine and
competition law, human rights indispensability requirement and
approach to 196–9 138–9
compulsory licensing as safety net refusal to license and 169
177, 195–6 see also market
duty to deal (Art 82 EC) and see duty Tuffery, D.E. 41
to deal, technology access
problems and UK (United Kingdom)
impeded, patent protection and 14–15 compulsory licensing provisions 69
innovation and 16–17 duty to deal 150, 153–4, 159–61
license stacking and 5–6 experimental use exemption 43, 69
research tools and patent system, patents’ importance, overstating 33
conclusions see also EU
antitrust law see duty to deal Ullrich, H. 23, 112, 113, 114–15
innovation, optimal market structure UN (United Nations) 80, 89, 90
for 179–81 UNDP (United Nations Development
patent law 181–5 Programme) 82
patent system gap 179 USA (United States of America)
research tool particularity 177–8 antitrust control 119
see also access biopharmaceutical innovation in,
Thailand nature of 28
generic products and drug prices 82 Bolar exception 40
Toebes, C.A. 71, 73, 74 compulsory licensing 62–3, 64, 65
Tom, W.K. 115, 193 essential facilities doctrine 133, 134
Treaty of Rome (EC Treaty) experimental use exemption 44–6
abuse by dominant undertaking and 103 innovation markets and 191
Art 82 see duty to deal research tools, patent trends effect on
existence/exercise distinction and 104, patent balance for 15
105, 106 reverse doctrine of equivalents 35, 48,
IPRs and competition law and, 49
relevant provisions 102 right to health 94
Index 251
technology access problems 194 Whish, R. 164

two-tier R&D system, cumulative Whitehead, M. 77, 88
innovation and 3 Whitener, M. 131
use see EUE; non-use WHO (World Health Organization)
compulsory licensing and health
Van Boven, T.C. 73 emergencies and 62
Venit, J.S. 134, 158–9 Constitution 71, 73, 76
vertical dilemma Declaration of Alma-Ata on Primary
patent system goals and 23 Health Care 74
vertical integration innovation and patenting and 31
abuse of dominance and 145–7, 149, right to health and 77–8, 79, 82, 87
151 WIPO (World Intellectual Property
leverage cases and 131–2 Organization) 33
Vinje, T. 104, 106 WTO (World Trade Organization) 31–2,
Voissiues and Partner 12 88–9, 89, 90, 94, 96
Walsh, J. 3, 6, 17 Yamin, A.E. 77, 78, 79, 81, 83, 88

Walter, W.G. 61 Yi, S. 126, 180
Weissbrod, D. 90 Yoo, C.S. 133
Weisburst, S. 33
Welch, L.T. 41 Zanon di Valgiurate, L. 149–50

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Competition Law and Patents

NEW HORIZONS IN COMPETITION LAW AND ECONOMICS

Series Editors: Steven D. Anderman, Department of Law, University of Essex,

Titles in the series include:

Antitrust, Patents and Copyright

Innovation Markets and Competition Analysis

Competition Law and Patents

NEW HORIZONS IN COMPETITION LAW AND ECONOMICS

Edward Elgar Publishing, Inc.

A catalogue record for this book

Library of Congress Cataloguing in Publication Data

ISBN 978 1 84720 599 5

Typeset by Manton Typesetters, Louth, Lincolnshire, UK

List of abbreviations xii

Part I: The problem – Access as a necessary element

1. Biopharmaceutical R&D: the increased importance of cumulative

Part II: The Patent Balance and Working Solutions

2. The patent system as a system of balancing 21

3. The patent system and some potential safety nets 36

3.2 The patent safety nets 37

4. The right to health as an interpretive principle of patent law 70

PART III: Antitrust as a Complement to the Patent

5. Unilateral conduct, intellectual property rights and Competition

6. The Duty to Deal under Art. 82 EC 122

PART IV: A MORE INNOVATION SENSITIVE APPROACH TO THE

7. The duty to deal as applied to address technology access problems

7.2.2.4 The absence of an objective justification 188

ACIP Advisory Council on Intellectual Property

Ford. Corp. L. Inst.

European Courts’ Decisions

Case C-333/94 Tetra Pak v Commission [1996] ECR I-5951 148–9

Community Commission Decisions

The problem – access as a necessary element of

Unlike most industries where innovation involves improving upon a first

the development of products related to health care? Do upstream patents deter

1.2 The case of research tools

1.2.2 The Patent Experience in Biotechnology: Biomedical Research

The thermostable enzyme Thermus aquaticus YTI DNA polymerase (Taq) is a

‘restricted availability or delays in exchange of “research tools” (such as vectors or

stream product, thus leading to a problem of ‘royalty stacking’.57 Patents on

This report also recommended that wide licences should be encouraged.

The patent balance and working solutions in the

2.1 The Patent Balance

Box 2.1: Main rationales of patent

1. Invention motivation. The patent system provides incentives for

that in the absence of patents people would fail to or would

regard to this objective, although the role of head-start is not

Patent systems in Patentability Infringement and

National patent To be determined by To be determined by

2.2 The particular importance of the patent

The patent balance assumes a particular significance in the biopharmaceutical

as an incentive mechanism. It hence becomes important to preserve this incen-

Box 2.2: The nature of biopharmaceutical

Innovation is the main source of competitiveness in the biophar-

study undertaken in 1985 concluded that the average annual ex-

sale.27 However, the physiological effects of compounds can now

2.2.1.1 Biopharmaceutical innovation and patenting

non-drug expenditures 7.2 times as much as they increase drug expenditure.40

2.2.1.2 Has the importance of patents been overstated?

3.1 Introduction to the patent safety nets

3.2 The patent safety nets

l experimental use exemption;

as to render a patent inconceivable. It is contemplated that this provision will be used

Part I: The problem – Access as a necessary element

Part II: The Patent Balance and Working Solutions

PART III: Antitrust as a Complement to the Patent

PART IV: A MORE INNOVATION SENSITIVE APPROACH TO THE