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World Development Vol. 38, No. 8, pp.

1082–1093, 2010
Ó 2010 Elsevier Ltd. All rights reserved
0305-750X/$ - see front matter
www.elsevier.com/locate/worlddev
doi:10.1016/j.worlddev.2009.12.013

Patent Incentives, Technology Markets, and Public–Private


Bio-Medical Innovation Networks in Brazil
MICHAEL P. RYAN *
The George Washington University Law School, DC, USA
Summary. — Contested is whether patent laws promote indigenous technology invention and innovation in developing countries. Brazil
reformed its patent laws in 1996 to permit pharmaceutical product patents. Study of five post-patent law reform bio-medical technology
invention and innovation projects in the state of Sao Paulo supports the propositions that patents provide incentives to Brazilian
bio-medical technology entrepreneurs to make risky investments into innovation and that patents facilitate technology markets among
public–private technology innovation networks, both Brazilian collaborations and North–South collaborations. Brazil enacted a tech-
nology law in 2005 that encourages public–private technology innovation through patent incentives and patent-facilitated technology
markets.
Ó 2010 Elsevier Ltd. All rights reserved.

Key words — technology innovation, technology networks, patents, intellectual property rights, bio-medical technology, Brazil

1. INTRODUCTION This is a study of invention and innovation in national tech-


nology development.
The 1994 World Trade Organization Agreement regarding
Trade-Related Intellectual Property Rights obliges all WTO “Invention is the first occurrence of an idea for a new product or pro-
members to meet certain minimum standards of intellectual cess, while innovation is the first attempt to carry it out into practice.
property law and enforcement and this means that scores of . . . While inventions may be carried out anywhere, for example in uni-
versities, innovations occur mostly in firms, though they may also oc-
developing countries must provide higher levels of protection cur in other types of organizations, such as public hospitals. To be able
than has been their policy and practice in the past. Contested to turn an invention into an innovation, a firm normally needs to com-
is whether patent laws promote indigenous technology innova- bine several different types of knowledge, capabilities, skills, and re-
tion in developing countries. Runge (2006) rejects enclosure sources” (Fagerberg, 2005, p. 4).
through intellectual property protections to promote technol-
ogy progress in the North and says that the countries of the Post-patent law reform bio-medical technology invention
South have even more to lose from patent-based enclosure. and innovation in Brazil is studied here. Brazil has a long-
Evans (2005) calls for an open science model for technology established pharmaceutical industry, but Brazilian bio-medical
progress in developing countries. The development model R&D traditionally meant that their public and private drug-
should be non-proprietary and non-intellectual property-ori- makers reverse-engineered international pharmaceuticals so
ented. A developing country-based scholar says that stronger that they could manufacture and market medicines and vac-
intellectual property rights in countries such as her Colombia cines innovated in the North to the Brazilian marketplace.
will inhibit scientific research (Forero-Pineda, 2006). She ar- Brazilian pharmaceutical makers were at liberty to reverse-
gues that developing country scientists should participate in engineer, manufacture, and market products under patent in
international professional networks to achieve science and the United States and Europe because pharmaceutical compo-
technology advancement. sitions were not patentable subject matter in Brazil. But, in
Though these scholars do not provide empirical evidence to 1996 the Cardoso administration led the Brazilian congress
support their arguments, they do ask important questions for to amend the patent laws with Law No. 9,279 to allow for
development studies. Research universities, scholarly journals, the patentability of pharmaceutical product patents so that,
and science conferences are the institutions that drive scientific subject to procedural processes and some restrictions, only
progress (Pyenson & Sheets-Pyenson, 1999), but are these patent-holders or their licensees would be permitted to market
institutions sufficient to drive national technology innovation under-patent medicines.
in developing countries (or developed countries, for that mat- Bio-medical technology invention and innovation in the state
ter)? Technology innovation drives long-run national eco- of Sao Paulo is the focus of study. The state of Sao Paulo is the
nomic growth (Romer, 1986, 1990). Technology stasis leads wealthiest state of Brazil, representing some 40% of the gross
to national economic stagnation; technology progress leads domestic product of the country, and is the main scientific and
to national economic growth (Grossman & Helpman, 1991), business center of the country. Federal research support and
so it is important to identify the institutional frameworks that “the strong support by the state government makes the state
best promote national technological innovation in developing
countries. Do patent laws provide incentives to entrepreneurs
in developing countries to make risky investments into tech- * The author gratefully acknowledges, without responsibility for argu-
nology innovation? Do patent laws facilitate the development ments, University of Sao Paulo Center for Science and Technology Policy
of technology markets among public–private technology inno- director Professor Ary Plonski and PhD student Juliano Froehner, this
vation networks? Do patent laws facilitate North–South tech- journal’s thoughtful reviewers, and George Washington University rese-
nology innovation collaborations? arch assistant Thomas Lee. Final revision accepted: December 7, 2009.
1082
PATENT INCENTIVES, TECHNOLOGY MARKETS, AND PUBLIC–PRIVATE BIO-MEDICAL INNOVATION NETWORKS 1083

of Sao Paulo the second largest investor in R&D in Latin Amer- kets. During the research period there was one other known
ica, ahead of Mexico and Argentina” (Brito Cruz & de Mello, Sao Paulo-based bio-medical technology invention and innova-
2006, p. 6) and behind only the federal government of Brazil. tion-directed organization—Eurofarma. Eurofarma is, like
The state of Sao Paulo has invested in basic life sciences research Ache and Biolab, a big generic manufacturer and, also like Ache
at its universities and governmental research centers for decades and Biolab, has initiated biodiversity-based technology inven-
through its Fundacao de Amparao a Pequisa do Estado de Sao tion, but it is not studied here.
Paulo (FAPESP), the State of Sao Paulo Research Foundation. Pele Nova Biotecnologia, Genoa Biotecnologia, and Recep-
It is thus a good laboratory to explore bio-medical technology ta Biopharma are start-up enterprises with extensive university
invention and innovation in a developing country. ties. Pele Nova, co-founded by Brazilian professors, patented
Interviews were carried out in Sao Paulo, Brazil, over the per- a biodiversity-based tissue regeneration technology with multi-
iod 2005–08 with presidents and research directors from local ple surgical, health, and cosmetology products under develop-
pharmaceutical companies, leading scientists and administra- ment. Patents facilitated their first technology innovation
tors from the public bio-medical research institutes and univer- collaboration with a French company and they intend for their
sities, and federal and state science and technology support patents to facilitate other collaborations. The Genoa project,
institutions. Interviewees were asked about bio-medical technol- also co-founded by Brazilian professors, seeks to develop
ogy invention and innovation-directed R&D in their state, who innovative cancer and HIV/AIDS vaccines based on patented
was doing it, how it was being done, and what issues—patent technology independently developed by the researchers com-
laws and policies, bio-medical technology regulations, institu- bined with patented technology licensed from the United
tional and human capacities, business strategies and prac- States. The Recepta project organizes some 40 Brazilian uni-
tices—encouraged and discouraged their efforts and why. versity scientists to develop breast and ovarian cancer thera-
Through this process, five cases of bio-medical technology pies based on exclusive rights to patented technology
R&D organizations were identified and are presented here. licensed from the United States. The Lula administration led
These five cases during the study period of 2005–08 were likely the Brazilian congress in 2005 to enact a technology innova-
one case short of the universe in Sao Paulo. There are several tion law that encourages public–private technology innovation
other invention and innovation-directed bio-medical technology through patent incentives and technology market facilitation.
initiatives in other parts of Brazil (Rezaie et al., 2008), but these
projects are not studied here. The case study research was de-
signed according to the method of structured, focused compar- 2. INSTITUTIONAL ECONOMICS AND STRATEGIC
ison (George & Bennett, 2005; see also Mohr, 1985; King, MANAGEMENT OF PATENT INCENTIVES
Keohane, & Verba, 1994). The comparative research questions
were designed to test the propositions suggested by theory and (a) Technology development strategy of Brazilian patent law
empirical research findings concerning the institutional econom- reform
ics of patent incentives and the strategic management of tech-
nology markets and technology innovation networks. An international relations scholar recalls that developing
Case information is provided from five Sao Paulo bio-medical countries, including Brazil, were calling in the United Nations
technology invention and innovation-directed R&D projects. In in the 1980s for lower, not higher, patent law standards of intel-
summary, Ache Laboratorios Farmaceuticos is a long-estab- lectual property protection as part of their New International
lished Brazilian maker of generic pharmaceuticals. Ache man- Economic Order agenda; points out that Brazil in particular
agers waited some 15 years, until after the 1996 patent pursued vigorous diplomacy during the 1980s within the World
reforms, to organize an innovation process with some 100 uni- Trade Organization against a TRIPS agreement; contends that
versity specialists so that they could patent a biodiversity-based intellectual property reforms that did take place in developing
anti-inflammatory technology. Acheflan is the first example of a countries such as Brazil during the 1990s owed to coercion from
successful Brazilian bio-medical technology innovation intro- the United States (Sell,1995, 1998). The US government was, to
duced to their marketplace and is the subject of safety and effi- be sure, in the late 1980s and early 1990s—the TRIPS negotia-
cacy trials in the United States with the goal of securing tion period—harassing and threatening developing countries,
American market approval as well. The Institute Butantan Cen- including Brazil, for weak intellectual property laws and poor
ter for Applied Toxinology and the COINFAR consortium enforcement. Brazil’s ambassador in Washington recalls bit-
established public–private bio-medical technology innovation terly that “notwithstanding Brazil’s solid legal position, retalia-
collaboration. COINFAR was originally composed of Brazilian tions were imposed in the second half of 1988 on products from
generic pharmaceutical companies Biolab, Biosintetica, and Brazil in two areas—pulp and paper and electronic appliances—
Uniao Quimica, but Biolab and Uniao Quimica share the same whose potential for expansion in the US market is considerable
owners and Biolab between the two takes the invention and due to our relative competitive advantages in those sectors”
innovation lead. Ache later acquired Biosintetica and, thus, (Moreira, 1990, p. 258). Ambassador Moreira (1990, pp. 259–
took over the position in the COINFAR consortium. They filed 260) explained that “a peculiarly perverse convergence” in the
for patent protection on their biodiversity-based analgesic so 1980s of the second oil shock, extraordinarily high international
that they could put the technology into safety and efficacy trials interest rates, global recession, and non-oil commodity price
in the United States, but Institute Butantan disputes ownership collapses” had a “devastating effect” on his country’s economy,
of the patent rights. The planned clinical research studies will so the “threats, crowbars, and sanctions” carried out by the US
not start until the patent dispute is settled. Thus, patents facili- government did “not square with respect for the symmetry of
tate the local Brazilian bio-medical technology innovation net- rights, fairness in trade, and the spirit of multilateralism” and
works organized by Ache; dispute over patent rights brought the called it a “matter of regret.”
CAT/COINFAR public-private R&D collaboration to a stand- Brazilian diplomats in Geneva, to be sure, opposed placing
still. After completion of safety and efficacy product develop- intellectual property on to the Uruguay Round multilateral
ment in the United States by Ache and the CAT/COINFAR trade negotiation agenda and consistently opposed a TRIPS
consortium, patents are planned to facilitate manufacture and agreement during the trade negotiations (Ryan, 1995). The
distribution agreements for the American and European mar- Brazilian government nevertheless reformed its patent laws
1084 WORLD DEVELOPMENT

in 1996 despite that the TRIPS agreement obligated develop- edge and developing new techniques requires some degree of
ing countries such as Brazil to implement reforms within five property rights over ideas and innovation. In their absence
years from a starting date of 1995. The 1996 patent law re- the new technology may not be forthcoming.” Patent rights,
forms were carried out not in the Brazilian crisis atmosphere according to this theory of how laws and economic interact,
of the 1980s but in the Brazilian reform era of the mid-1990s. provide incentives to innovators to invest their know-how,
Import substitution industrialization under President Getu- time, and money into the creation of inventions under circum-
lio Vargas and a succession of military governments from the stances of the knowledge appropriability problem associated
pre-war years to the 1970s created high economic growth in with intangible assets (Dam, 1994). Without marketplace
Brazil. But, by the 1980s trade, foreign direct investment, intervention by the government through patent law, the invest-
and portfolio investment restrictions within a world economy ment into knowledge-based innovation may be unjustifiable
buffeted by oil shock, high interest rates, and recession, cumu- because the risk is great that a competitor will appropriate
lated to produce hyper-inflation that de-legitimized military the invention with less risky investment. However, just like
governance and challenged their civilian leader–successors to prospectors staking real property claims when searching for
defeat. Fernando Henrique Cardoso, first as finance minister gold, inventors stake their intellectual property claims with
under President Itamar Franco then as president himself, suc- no guarantee that gold will be their reward (Kitch, 1977).
ceeded with his Real Plan stabilization strategy when previous With the patent right, government confers to an inventor the
attempts failed, explains a comparative political economist exclusive right to make, manufacture, distribute, and license to
(Treisman, 2004, p. 406): “What made the Real Plan different distribute the invention. To receive a patent the invention
was not more effective fiscal adjustment or stricter monetary must be new or novel or show an inventive step, must not
policy, but rather a more credible political strategy. This strat- be obvious to one skilled in the art, and must have utility in
egy involved tactics for co-opting or neutralizing each of the the marketplace, decisions made through a formal examina-
main stakeholders [public sector employees, congressional pol- tion process conducted by public administrators. The patent
iticians, state governors, and the business community].” right term of protection, according to the obligation of Article
Macroeconomic stabilization, achieved in 1993, however, 33 of the WTO TRIPS agreement, “shall not end before the
was only the beginning for President Cardoso and other expiration of a period of 20 years counted from the filing
Brazilian opinion leaders; they wanted nothing less than a date.” Douglass North, who identified the knowledge-asset
new economic development model. A comparative political incentive and appropriability problem by studying the pre-
economist (Kingstone, 2001, p. 1001) explains, modern to modern history of the Western economies, argues
that the same institutional economic logic should apply to
The growing debate about future development within and among the
business community, the bureaucracy, and the political system led to a developing countries in the contemporary era, but he does
widely held belief that commercial liberalization represented an impor- not provide evidence to support his conclusion (North, 1989).
tant element in that “new model.” . . . Leading industrialists and techno- Strategic management scholars take great interest in patent
crats expressed similar concerns about the need to reduce the role of the laws. Firm managers make their investment and business
state and to integrate the Brazilian economy with the global economy on strategy decisions within particular knowledge appropriability
a competitive basis. Both groups were aware that changes in technology, regimes governed in large measure by intellectual property
and in the character of production and global competition were causing laws and their relative enforcement (Teece, 1987). The knowl-
Brazil to fall further behind the developing world.
edge appropriability regime ranges from “tight” or “strong” to
Brazilian technocrats in science and technology funding agen- “loose” or “weak” with implications for firm decisions about
cies and research universities recall that in the 1990s they real- how to manage their intellectual capital: “[Intangible] assets
ized that Brazil had great science but little technology can be the source of competitive advantage only if they are
innovation. A World Bank study of Brazil in the early 1990s ex- supported by a regime of strong appropriability or are non-
plained that the country had been one of the fastest growing tradeable or ‘sticky’” (Teece, 2000, p. 20). That is, either the
economies in the world in the 1970s but faltered thereafter not strong appropriability regime protects the firm’s intellectual
only because of macroeconomic instability but because of debil- capital or the firm figures out some business strategy of protec-
itating problems with its technology innovation system (Dahl- tion, such as a software program customized to the needs of a
man & Frischtak, 1993, p. 414). They identified public sector particular customer, or they do not take the technology into
commitment to investment into university and public labora- that marketplace at all. The knowledge appropriability logic
tory research as the key strength of the Brazilian system. How- explains the finding by industrial organization economists
ever, they explained that the lack of private sector R&D (Mansfield, 1986) that patent protection matters a great deal
capability and investment and lack of public–private linkages to decision-making in certain industry sectors, especially phar-
prevented technology from becoming commercialized into the maceuticals, fine chemicals, and information technology prod-
marketplace. Thus, they focused on the nature of the technology ucts, but matters comparatively less to decision-making in
institutions and thereby identified why the Brazilians were technology sectors such as automobiles, machine tools, and
poised for technological take-off but were not actually doing customized software.
it. Brazilian technocrats were aware that Professor Douglass The US Trade Representative (USTR), who works for the
North of the United States had co-won the Nobel Prize in Eco- President and holds cabinet rank, designated Brazil a “priority
nomic Science in 1993 and familiar with his arguments, in par- foreign country” in 1993 and initiated an investigation of Bra-
ticular regarding institutions, technology innovation, and zil’s intellectual property laws (USTR, 1995). However, USTR
economic growth. They sought to place science and technology revoked the “priority” status and terminated the investigation
commercialization at the core of the Brazilian development a year later because its bilateral discussions with the Cardoso
strategy. government showed that they had submitted to their congress
computer software intellectual property reform law and that
(b) Patent incentives they were drafting legislative reforms regarding patent law.
In its 1996 annual report, which appears early in the year,
A founder of institutional economics, North (1981, pp. 8, USTR (1996, pp. 2, 12) praised the Brazilian government for
10) argues that “the profitability of investing in new knowl- enacting patent law reforms that permit pharmaceutical
PATENT INCENTIVES, TECHNOLOGY MARKETS, AND PUBLIC–PRIVATE BIO-MEDICAL INNOVATION NETWORKS 1085

product patents. However, later that year the Cardoso admin- engineer and sell the medicine themselves despite that they had
istration and Brazilian congress also took countervailing pat- not made the investment into the product discovery, refine-
ent law action with respect to AIDS medicines. President ment, and safety and efficacy testing. Thus, Ache did some
Cardoso (2006, p. 215) recalls in his memoirs: “In 1996, we exploratory research into the active ingredient but did not pur-
passed a new law guaranteeing Brazilians free access to anti- sue the project further.
retroviral AIDS drugs. . . . This was truly a revolutionary ini- When the Brazilian government reformed the patent law in
tiative, the first of its kind in any developing country. We 1996, permitting patents on pharmaceutical products, Ache
would have to deal with enormously complex issues of cost, managers took up the project again. The implication of the
ethics, and trade and business practices. Doing so meant a patent law reform for Ache managers was that they could fi-
confrontation with foreign pharmaceutical companies and nally invest in innovative medicinal product development,
governments, notably the United States.” He says that the such as the cordia anti-inflammatory project, because of the
US government complained to the World Trade Organization intellectual property ownership rights incentives provided by
that the Brazilian policy violated its TRIPS obligations. Pres- the new patent law. In 1998, lacking the internal capacity to
ident Cardoso (2006, p. 216) recalls, conduct the research, Ache established a research partnership
with a professor at one of the universities to re-new study of
With regard to the issue of patents, I simply believed that the unique
magnitude of the AIDS crisis justified our actions. Human lives took the plant and its chemistry. The agreement with the local uni-
precedence over profits. It was clear that the free-market system would versity was difficult to negotiate, in the words of an Ache se-
not be able to provide a solution by itself, so the government was nior manager, because there is “no patent culture” in Brazil.
needed as a mediator. We tried to reach a compromise, offering to Neither the researchers nor their university administrators at
pay the foreign companies what we could. It was less than they wanted, the university were familiar with patent rights, license agree-
but it was better than nothing—which is what they would have re- ments, or royalty rates.
ceived if there had been no program at all. In one sense we were cre- When isolation of the active chemical was achieved, lacking
ating customers rather than taking them away.
internal capacity, Ache hired an outside research organization
Thus, President Cardoso, showing again the deft hand of a to design and carry out the toxicology, safety, and efficacy
shrewd politician-policymaker, passed in the same year patent studies in order to gain market-release approval from Brazil-
legislation that removed a major trade policy dispute with the ian pharmaceutical regulators. Ache managers estimate that
United States, placed his country into compliance with a key some 100 university agronomists, biochemists, pharmacolo-
WTO TRIPS obligation, and provided patent incentives to po- gists, and medical doctors at a number of universities partici-
tential domestic bio-medical technology entrepreneurs, yet pated in the 1998–2004 product development process.
dramatically declared that patent law would not stand in the Agreements regarding intellectual property rights, confidenti-
way of AIDS public health policy, winning him domestic sup- ality, and compensation were negotiated with all these outside
port and international acclaim. He took a step in the direction specialists. They report that these agreements proved difficult
of a technology development strategy while maintaining com- to negotiate because of university inexperience with intellec-
mitment to an enduring principle of Brazilian health policy. tual property rights. Nevertheless, the issues were resolved
In short, theory from institutional economics and strategic and the investment with all this Brazilian S&T talent paid-
management suggests the following possible economic out- off, for cream-form Acheflan was introduced as a prescription
come in post-1996 patent law reform Brazil: medicine in summer 2005. Acheflan is the first medicine to be
innovated and introduced into the marketplace by Brazilians.
Proposition 1. Patent incentives encourage Brazilian entrepre- By 2006 Acheflan achieved a 30% share of the anti-inflamma-
neurs to make risky investments into bio-medical technology tory market and by the end of 2007 its market share exceeded
invention and innovation. 40%, despite that its competitors included products from
Aventis, Novartis, and Pfizer. The company initiated develop-
(c) The biodiversity-based bio-medical technology pioneer ment of a cream-form Acheflan for the American and Euro-
pean marketplaces, development of an aerosol-form Acheflan
The plant cordia verbenacea is endemic to Brazil. It grows to for Brazilian and international markets, and development of
2 m in height and is found along most of the coast of Brazil, an oral-form Acheflan for Brazilian and international markets.
but especially thrives in the areas between the states of Santa The aerosol version was released in 2007 in Brazil and clinical
Catarina and São Paulo. Local fishermen in the coastal cities research is being carried out in Europe and the United States
of Ubatuba and Caraguatatuba, in the state of São Paulo, on both forms of Acheflan so that regulatory authorities will
had long ago mashed the plant into an oil rub and used it di- approve Acheflan for market entry. Ache plans to license dis-
rectly on sprains and cuts as an anti-inflammatory and an anti- tribution rights to American and European pharmaceutical
scarring medicine to aid healing. People in the region passed marketers.
the practice down from generation-to-generation. Managers Ache’s attorneys submitted patent applications to the Bra-
at Ache Laboratorios Farmaceuticos, established in 1966 zilian National Institute of Industrial Property (INPI) that
and the biggest local manufacturer and marketer of branded indicated the inventiveness of the product and indicated how
generics in Brazil, came to know of the medicinal potential their anti-inflammatory would contribute a valuable new ther-
for the plant in the early 1980s. In order to attempt to develop apy to the betterment of the Brazilian health system. Their
a product from the plant, Ache managers recall that they attorneys also submitted patent applications for Acheflan,
would need to isolate the active ingredient and take it through both the cream form and the aerosol form, to the Patent
laboratory toxicology studies, animal testing, and human clin- Cooperation Treaty administrative unit of the World Intellec-
ical trials to demonstrate safety and efficacy in order to intro- tual Property Organization in Geneva in order to seek patent
duce the innovation to the marketplace. But, Brazilian patent protections in the United States and Europe and some other
law forbade pharmaceutical product patents and, thus, Ache countries.
would only be permitted to file for a process patent regarding The Ache story supports the proposition of institutional
the method of manufacture of the medicine. Should the prod- economics and strategic management about the utility of pat-
uct prove popular, Ache’s competitors would be free to reverse ent incentives to solve the bio-medical technology appropri-
1086 WORLD DEVELOPMENT

ability problem. Ache organized and compensated a hundred with a trade secret and that much information asymmetry typ-
scientists to refine, test, demonstrate safety and efficacy, and ically is not conducive to finding a partner. Thus, a weak
manufacture to scale their innovative product, but, absent appropriability regime means weak technology markets and
pharmaceutical product patents, potential competitors would that means that in practice technology innovators have either
reverse-engineer, manufacture, and market a competing prod- to possess, acquire, or build the complementary assets them-
uct with considerably less investment and risk. However, the selves—or fail in the marketplace with the new technology.
case study also introduces the extensive and decisive role of The transactional rationale for the law of patents and intellec-
university researchers to the success of the project. Ache man- tual property rights supplements the knowledge appropriabil-
agers found it necessary to establish a public–private bio-med- ity problem rationale and has become ever more conceptually
ical technology innovation network to take Acheflan to important to the analysis of contemporary technology innova-
market. tion and competition (Merges, 2005).
Study of contemporary industrial technology innovation
finds that stronger patent rights matter more to smaller enter-
3. STRATEGIC MANAGEMENT OF PUBLIC–PRIVATE prises than to bigger enterprises, a finding the authors describe
INNOVATION NETWORKS as “sensible, even obvious” but unexplored empirically (Arora,
Ceccagnoli, & Cohen, 2007, p. 392). Economic historians find
(a) Technology markets that 19th century US technology innovation was characterized
by the presence of technology markets involving lone inventors
The economics of technological innovation are a lot like who licensed their patents to enterprises that would then man-
gambling or a lottery because most inventions are of modest ufacture it or integrate it into their systems (Lamoreaux &
value or even worthless—and that applies to many patents— Sokoloff, 1999). There is some evidence, then, that if it is true
and that economic reality has some big implications for inno- that “the most successful economies are those that have a mix
vators and policy-makers (Scherer & Harhoff, 2000). Ideally, of innovative entrepreneurs and larger, more established
some success, even great success, emerges from technology firms. . . that refine and mass produce the innovations that
innovation efforts. However, prospective technology entrepre- entrepreneurs. . . bring to market” (Baumol, Litan, & Sch-
neurs and their policymakers must accept the fact that tech- ramm, 2007, p. 4), then patent rights may be especially impor-
nology innovation is fraught with the risk of failure. The tant for the efficient technology markets that enable
obvious risk is that the new technology product may not be entrepreneurship. This finding about small firms and their pat-
embraced by the marketplace. As it turned out, Ache inno- ents may apply to some or even all the Sao Paulo firms studied
vated a product that people in Brazil wanted. Another risk here, for three are small start-up enterprises while two are “big”
is that a product that might be valued in the marketplace never Brazilian companies that are not so big in global market terms.
reaches the marketplace because the entrepreneur may not Thus, in short, strategic management studies propose the
manage the process of technology innovation. Ache managers following proposition:
did manage the process of technology innovation successfully;
Ache managers organized a considerable range of people with Proposition 2. Brazilian bio-medical technology inventors will
diverse know-how and skill sets—and most of the people were partner with outside organizations to achieve complementary
outside their organization. assets for technology innovation through patent-facilitated
Successful technology commercialization entails product/ technology markets.
service invention, production, and marketing. A useful inven-
tion prototype should be the yield from such investments, but
it must also be manufactured at a quality level and cost appro- (b) Public–private technology innovation networks
priate to the marketplace and must be marketed and distrib-
uted to customers and against competitors. The Ache managers had the vision for a final product, a capacity
technological innovator, however, need not possess all these to produce it, and the marketing and distribution capabilities
capabilities—complementary assets—within the organization. to sell it to Brazilian customers, but their organization lacked
Some of the essential questions of strategic management of the internal capacities to actually invent and innovate Ache-
technology concern which capabilities to possess, which to ac- flan. Ache managers looked to their university community
quire, or which to build inside the organization and which for partners who could bring their know-how and skills to
capabilities to leave to a partner. When these capabilities the Acheflan R&D project and a network of some 100 univer-
can be gained through partnership, then strategic management sity specialists ultimately participated in the project. Strategic
studies explain that efficient technology markets play vital management studies increasingly focus on R&D networks
facilitating roles (Arora, Fosfuri, & Gambardella, 2001). among public research organizations and private pharmaceu-
Sufficiently strong appropriability regimes establish the tical development enterprises as the key organizational mech-
institutional conditions for technology markets (Arora, 1995, anisms of innovation in pharmaceuticals, biotechnology, and
1996, 1997). From a managerial perspective, technology leak- the life sciences (Powell, Doput, & Smith-Doerr, 1996).
age should be minimized. Technology holders should be able R&D networks characterized by dense “knowledge integra-
to share technology with a partner or partners with the expec- tion” appear to substantially explain the trend for some two
tation that the appropriability regime encourages the partner decades of growing American preeminence in pharmaceutical
to protect the technology from third parties. That is, suffi- innovation in all therapeutic categories, as measured by R&D
ciently strong appropriability regimes facilitate licensing and expenditures, patents, production, and ratio of exports to
cross-licensing business partnerships. The parties to a licensing imports, so explains a huge European research project
or cross-licensing of technology relationship look to patent (McKelvey, Orsenigo, & Pammolli, 2004; Montobbio, 2004).
rights so that the nature of the knowledge to be transferred Universities in Europe “transfer” life sciences knowledge to
and the terms of its use can be specified through contract big private sector pharmaceutical firms through arms-length
(Grindley & Teece, 1997). A weak appropriability regime relationships; universities in the United States “integrate” life
means that the technology holder would attempt to negotiate sciences knowledge through the hosting of research seminars
PATENT INCENTIVES, TECHNOLOGY MARKETS, AND PUBLIC–PRIVATE BIO-MEDICAL INNOVATION NETWORKS 1087

on their campuses to discuss “works-in-progress” that turn number of patents earned, the number of technologies that get
into close-working technology innovation collaborations and to the marketplace, and the number of students and faculty
professor-led or professor-participating start-up enterprises who start-up enterprises, patenting still represents a very small
(Owen-Smith, Riccaboni, Pammolli, & Powell, 2002). Thus, percentage of research activity at the university (Agarwal &
Brazilian bio-medical technology innovation aspirants should Henderson, 2002). Most patents do not contribute much if
be studied for how they organize their efforts. any royalty revenues; only a few patents bring home substan-
Universities in the United States have become important tial royalties and only one or two patents prove to be block-
participants in technology markets (Branscomb, Kodama, & busters (Feldman, Feller, Bercovitz, & Burton, 2002). The
Florida, 1999). The traditional means used by universities to economics of university patenting, hence, look like the eco-
disseminate their knowledge has included presentations at nomics of technology innovation more generally—i.e., most
scholarly research conferences attended by specialists in par- inventions do not reach the marketplace as successful
ticular disciplines and fields; publication in peer-reviewed innovations. These findings say to the Bayh–Dole critics that
scholarly research journals; and helping their students find university patents are a big waste of time. To adherents of
jobs in academic, government, and industry research settings. the patent-technology market thesis, these findings say that
Some American policymakers came to believe in the late 1970s university technology transfer offices are challenged to manage
that this generally effective research system was nevertheless their (typically modest) resources with shrewdness and pru-
not as effective as it could be at encouraging the commercial- dence: Many technologies do not merit the expense of the pat-
ization of research findings with potential market applications: ent process; those that do depend on technology transfer
Too many promising technologies remained shelved rather officers who identify the appropriate licensee(s) and that is
than commercialized. not an easy thing to do (Mowery et al., 2002).
The United States congress with the 1980 Bayh–Dole Act Adherents of the patent-technology market thesis point to
gave universities and government research laboratories the an industry survey carried out with the assistance of the Asso-
authority to apply for patents for research findings that re- ciation of University Technology Managers that finds that
sulted from public funding so that rights to the research could 85% of university research still needs more development re-
be formally licensed to the private sector for further develop- search to be useful and that 45% of university research needs
ment and commercialization (Scherer, 2009). The 1980 Steven- a great deal more development research to be useful (Thursby
son-Wydler Act required key government research agencies to & Thursby, 2002). Bayh–Dole proponents argue that private
set up technology transfer offices. The 1986 Cooperative Re- sector licensees of university research prefer exclusive intellec-
search and Development Act (CRADA) permitted public–pri- tual property rights because they expect to put take on sub-
vate cooperative R&D agreements in which the industry stantial additional R&D costs and risks. A strategic
partner retained the patent rights, though with royalty obliga- management scholar (Schane, 2002) asks, when a university
tions to the government laboratory. The policy rationale was (MIT) does patent, does it more often lead to commercializa-
that property rights would provide incentives to individual tion success? Yes, for he finds that “inventions are more likely
university researchers to consider market applications in their to be licensed when patents are an effective mechanism for
research, to the administrators at universities to organize for appropriating the returns to innovation because the patent
technology exchange, and to private industry to invest in fur- system reduces the transaction costs of technology transfer.”
ther commercial development of basic technologies (Mowery, Effective university patents allow “commercialization to be
2007). undertaken by economic actors who possess a comparative
These policy reforms were controversial at the time and have advantage in that activity” (Schane, 2002, p. 133). When the
become perhaps more controversial as the number of patents patents are ineffective, the technology is either developed by
earned by universities has increased. The effects of Bayh–Dole the inventor him or herself, often unsuccessfully, or goes
on university research include the establishment of technology undeveloped. He explains, “Technology commercialization in-
transfer offices at many research universities, a substantial in- volves a set of skills—including identifying customer needs,
crease in the number of patents earned by universities and developing product concepts, designing products and pro-
their researchers, yet only a few examples of universities with cesses, prototyping, and manufacturing—that university
substantial royalty revenues (Mowery, Nelson, Sampat, & Zie- inventors rarely possess” (Schane, 2002, p. 123). This finding
donis, 1999; Mowery, Sampat, & Ziedonis, 2002). Critics of suggests that, though perhaps many university patents prove
the Bayh–Dole public–private technology innovation system not to be worth much, some university patents may be decisive
wonder whether all the time and financial expense of patents to successful technology innovation.
is worth it, especially given the big cost of mission conflict: Thus, in short, some scholars doubt the utility of patents to
Is the mission of the university to create and disseminate facilitate university-private R&D collaboration, but some stra-
knowledge and, if so, why establish barriers to access (Sampat, tegic management scholars propose the following:
2006)? “[I]f the findings of publicly-funded university research
are placed in the public domain, or are inexpensively licensed Proposition 3. Brazilian public–private bio-medical technology
to anyone who wants to use them, competition alone may innovation networks are facilitated by patent rights-based
stimulate their widespread application” says one critic (Mow- agreements.
ery et al., 1999, p. 268). According to this perspective, patents
and tech transfer offices divert university resources away from (c) The public–private biodiversity-based bio-medical technology
the primary mission of basic research and public dissemination collaboration
of research; open dissemination of science and technology best
facilitates not just scientific progress but technology innova- Studies of university–industry linkages in Asia find that they
tion, contends a legal scholar (Eisenberg, 1987, 1989, 1996). are informal in Japan and weak in India, Korea, Singapore,
The Bayh–Dole critics inspired some in strategic manage- and Thailand but proliferating toward a US model in Taiwan
ment studies to gather evidence and assess the merits of the cri- and China (Hershberg, Nabeshima, & Yusuf, 2007, p. 935).
tique. Study of MIT’s TTO, an operation that long pre-dates Technology commercialization in Asia remains a private sec-
the Bayh–Dole Act, shows, even at a university famous for the tor-dominated activity (Yusuf & Nabeshima, 2007). A recent
1088 WORLD DEVELOPMENT

study of science and technology in Brazil (Rodriguez, Dahl- ence Foundation with these programs and, thus, FAPESP
man, & Salmi, 2008, p. 5), by contrast, explains that the situ- does not carry out a “targeting” industrial policy. They fund
ation there is exactly the opposite of that common in Asia: projects because proposals are submitted and reviewers deter-
“Two factors—a bias toward overly ‘theoretical’ research in mine them to have comparatively more merit than proposals
publicly funded universities and significant under-investment that go unfunded. They say that this public investment made
[in R&D and human resource capacities] by a shielded private by FAPESP ameliorates the decisive problem of capital short-
sector that is spared the need to compete—lie at the heart of age confronted by industrial R&D aspirants in Brazil. Years
Brazil’s current relative under-performance in innovation.” of macro-economic instability and other factors have discour-
The Ache case illustrates their second generalization, but also aged risk-taking capital markets.
suggests that the know-how for technology innovation exists In 1999 FAPESP articulated a strategy for R&D in their
in Brazilian universities. state that set the introduction of technology innovations in
The state of Sao Paulo, especially through its Fundacao de the marketplace as the goal. FAPESP announced a plan to
Amparao a Pequisa do Estado de Sao Paulo (FAPESP), the establish a number of research centers that would focus on ap-
State of Sao Paulo Research Foundation, has led public plied R&D in partnership with the private sector. After field
investment into basic science and technology. For some 50 research in the United States regarding the National Science
years FAPESP has funded basic scientific research and gradu- Foundation and national laboratory technology commerciali-
ate education at universities in the State of Sao Paulo, such as zation policies and practices, FAPESP called on university and
the University of Sao Paulo, the University of Campinas, and public research institutes to compete to establish ten centers
Paulista State University. In addition to the universities, the seeded with 11 years of funding of US$1 million per year. Pro-
bio-medical research base in Sao Paulo includes the publicly- posed centers could concern any field of S&T but had to in-
supported Institute Bhutantan. Institute Butantan is a re- clude both a public research center and a private sector
search institute of the Ministry of Health and thus has been collaborator. Institute Butantan and a consortium of pharma-
organized to create bio-medical S&T capacity and pharmaceu- ceutical firms known as COINFAR jointly submitted a win-
tical medicine and vaccine production capability. The S&T ning proposal to FAPESP that resulted in the creation in
capacity long focused on reverse-engineering of international 2000 of a center for research, innovation, and knowledge dis-
medicines, especially vaccines, and, thus, Brazilian govern- semination in toxinology—the Center for Applied Toxinology
ment facilities produce some 200 different drugs and vaccines. (CAT).
The research institute, however, traditionally did not carry out CAT’s director, who left a university faculty position to lead
research aimed at new pharmaceutical innovation, either the new center, designed his laboratories to isolate, identify,
through independent efforts or through public–private part- and synthesize the active compounds in the toxins from
nership. snakes, frogs, and other fauna and flora. He went to the Uni-
Leaders at FAPESP say that they believe that technology ted States to seek medical science advice at MIT and technol-
commercialization opportunities created by their public ogy transfer advice at Cornell. What he learned was that he
investments into basic S&T had largely gone unrealized in had to provide “proof of concept” to the private sector to
the marketplace because, in general, their private sector invests maximize the likelihood of commercialization initiative. An
little into R&D. Two-thirds of R&D spending is invested by American patent attorney was invited to Sao Paulo during
the government; only one-third is invested by the private sec- the first months of the Center’s life in 2000 to give several days
tor. Seventy-five percent of scientists and technologists work of lectures to the scientists regarding patents, technology
in the universities; only 18% of scientists and technologists transfer, trade secrets, and confidentiality agreements.
work in the private sector (FAPESP, 2005). Most industrial Previous research suggested to the CAT director that the ve-
R&D carried out in the Brazilian private sector is conducted nom of a rattlesnake, Crotalus terrificus, was an especially
in the agriculture, aircraft, and energy sectors. Pharmaceutical good target for innovative medicines. The CAT-COINFAR
companies do not themselves possess research laboratories or- (i.e., essentially the two big Brazilian generic makers Ache
ganized for the purpose of new product invention and innova- and Biolab) joint venture determined that the project regard-
tion. There were thus few private sector jobs for bio-medical ing rattlesnake venom appeared the most promising, so it
graduates and thus modest incentives to pursue higher educa- was the priority project. It was a scientifically complex task
tion in the bio-medical sciences in Brazil for any reason other that required new equipment, including a mass spectroscopy
than university and public institute employment. facility, and new scientific skills about which he and his col-
For these reasons, during the Cardoso reform era, FAPESP leagues in toxinology research had previously been unfamiliar.
initiated a number of institutional innovations in how it went With the help of a Japanese chemist who worked with the
about supporting S&T in the state of Sao Paulo. In 1994 FA- CAT team for three years on a scholarship from FAPESP
PESP’s Governing Board reformed its mission to include “the and COINFAR, the CAT research team identified a molecule
transformation of knowledge into wealth” (FAPESP, 2005, p. in late 2004. Animal tests showed effects similar to morphine,
4). FAPESP would henceforth devote substantial financial re- but more potent and lasting, and apparently without the
sources to technology commercialization by funding public– dependency side effects of morphine. CAT and the COINFAR
private R&D projects. Since 1995 FAPESP’s Partnership for team worked with attorneys to draft a patent application,
Technological Innovation Program has invested R$90 million which they submitted to the patent offices in Brazil and the
(about US$37.5 million) by funding 90-some specific projects United States in 2005.
through peer-reviewed competitive bid processes. Since 1997 But the CAT–COINFAR partnership faced some of the
FAPESP’s Technological Innovation in Small Businesses pro- same problems that Ache and its university partners faced.
gram has invested another R$71 million (about US$29.5 mil- Both the CAT and COINFAR principals agree that, when
lion) to support R&D projects carried out by small enterprises. they put their relationship together, neither side knew enough
The projects have concerned agriculture, health and life sci- about patents and intellectual property rights. What informa-
ences, engineering, and earth sciences. However, the two suc- tion is kept secret as proprietary information? What informa-
cessive scientific directors who managed this process both say tion is patented? What information is published and when?
that they have used the peer-review model of the National Sci- Who, CAT or COINFAR, submits a patent application?
PATENT INCENTIVES, TECHNOLOGY MARKETS, AND PUBLIC–PRIVATE BIO-MEDICAL INNOVATION NETWORKS 1089

Who decides? Who pays for the legal fees and patent mainte- distribution company. The Pele Nova strategy calls for addi-
nance fees over time? Who owns the intellectual property? tional such collaboration agreements directed toward medical
How are the intellectual property issues defined in the con- product applications, so patents are for the company’s manag-
tracts that govern the relations among all concerned? Who ers and inventors both incentives for R&D and facilitators of
controls the international development and marketing strat- technology markets.
egy? If COINFAR owns the patents, how are royalties divided
among Institute Butantan, CAT, and individual researchers? (e) The cancer and HIV/AIDS biotechnology innovation
Regarding their potential analgesic, COINFAR member- ventures
company managers decided that the lack of R&D capacity
regarding laboratory and clinical research, not only in their The Genoa Biotecnologia and Recepta Biopharma pro-
companies, but also in Brazil at-large, the weak capacities of jects fundamentally differ from the Ache, CAT–COINFAR,
their regulators regarding laboratory and clinical research and Pele Nova projects, for they both are biotechnology-
practices, and their concerns about the lack of innovation based rather than biodiversity-based pharmaceutical R&D
incentives built into their national pharmaceutical price con- projects.
trol system meant that this potential drug needed to go the Genoa Biotecnologia is a private enterprise started up in
United States for development. So, the COINFAR consor- 1999 by professors on the faculty of a medical school in Sao
tium hired an American patent attorney to study their 2005 Paulo. Genoa leaders have assembled a research team of spe-
US patent application. Their new attorney identified some cialists in molecular biology, genetics, and bioinformatics. The
mistakes and re-filed their application. They expect to com- venture seeks to develop vaccines for the treatment of cancers
plete the US laboratory and animal studies in 2008 and and for HIV positive people who have not yet developed the
planned to start Phase I clinical trials in the United States in symptoms of AIDS. The Genoa vaccines apply a dendritic
2009. However, Institute Butantan disputes ownership of the cell-tumor cell fusion technique, which they invented, to stim-
patent rights. They learned clinical research studies say the ulate the defense cells to attack the tumor while sparing the
COINFAR partners will not start until the patent dispute is healthy tissue. Genoa is conducting animal and human trials
settled. with an array of local university and hospital partners on can-
cer patients who suffer from renal cell melanoma, carcinoma,
(d) The university-private start-up biodiversity-based venture pancreatic cancer, acute myeloid leukemia, and small-cell lym-
phoma. Genoa researchers are carrying out human and animal
A Brazilian surgeon and a Brazilian biochemist at a univer- trials with an array of local university and hospital partners.
sity in the northwest of the state of Sao Paulo came upon a They are further developing the technology as a high-precision
natural rubber-based material that with which they experi- diagnostic tool aimed at pharmaco-genetic tests capable of
mented in an esophageal tissue replacement in a dog. To their evaluating the efficacy and toxicity of chemotherapy drugs
astonishment, 10 days after the surgery, the dog processed for particular patients prior to treatment.
food normally and defecated the membrane remains. Three Genoa is also developing the technology for use against the
years of subsequent study showed that the rubber membrane HIV virus. In 2007 they entered into a collaborative research
stimulated the blood vessels to regenerate tissue significantly agreement with an American company that had been started
faster than normal. In 1998 university testing was initiated up to develop technology based on science carried out at an
in humans with a variety of chronic wounds. In 2002 the pro- American university. The collaboration combines the Genoa
ject was taken to the Brazilian Academy of Advanced Studies, dendritic cell-tumor cell fusion technique with the American
where a mix of public and private funding was secured company’s Lysosomal Membrane Associated Protein technol-
through angels and venture capital. An experienced business ogy and sets the terms for collaboration among the research-
leader was recruited to design a business plan to start-up a pri- ers. The goal is to produce a vaccine not to prevent HIV but
vate company, with the inventors as technology officers and to prevent HIV from becoming AIDS. Thus, their vaccine
share-holders, and Pele Nova Biotecnologia S/A was estab- would substitute for the anti-retroviral therapies commonly
lished in 2003. deployed to treat AIDS. Genoa researchers had submitted
Pele Nova seeks to develop products that assist skin and tis- 11 patent applications, most related to cancer, to take effect
sue re-generation for uses ranging from repair of diabetic ul- in the United States, Europe, and other countries and in Bra-
cers, surgical wounds, and skin burns to dermatological and zil. Thus, patents are for Genoa an incentive to conduct vac-
cosmetic applications. The several competing products, which cine and diagnostic tool development and also a source of
are produced by companies such as Johnson & Johnson and leverage for their HIV/AIDS vaccine development collabora-
Novartis, are synthetic, expensive, and used therapeutically tion with the American company.
when the expense can be justified. The Pele Nova technology Recepta Biopharma in Sao Paulo is developing new phar-
is natural rather than synthetic and supplies of the natural maceutical therapies for ovarian and breast cancers. Existing
material in Brazil are plentiful and not expensive. Their busi- pharmaceutical therapies for these cancers are effective only
ness strategy focuses on identifying for the technology as many in a small percentage of patients. Thus, if their R&D efforts
uses as possible, filing for patent protection on these many succeed, they will revolutionize medical treatment for women
applications, and developing products both in-house and afflicted with these cancers. A New York research center iden-
through license to R&D, manufacturing, and distribution col- tified antibodies with potential, but wanted to conduct drug
laborators. Pele Nova submitted patent applications in 2005 development work in Brazil because the quality of Brazilian
through the Patent Cooperation Treaty process of the World science was known to them through a New York–Sao Paulo
Intellectual Property Organization in Geneva and received bio-medical S&T network. In 2003 Recepta’s founding presi-
notification from the European Patent Office in Munich in late dent organized a network of some 40 scientists and clinical
2007 that their patent applications were granted and applied in researchers from universities and research hospitals in Sao
60 countries around the world. Pele Nova managers subse- Paulo, Rio de Janeiro, and Belo Horizonte to carry out the re-
quently negotiated a product R&D, marketing, and distribu- search. The team successfully carried out Phase I laboratory
tion collaboration agreement with a French innovation and tests for efficacy and safety of the candidate pharmaceutical
1090 WORLD DEVELOPMENT

therapies. Phase II study, which uses human patient and which  development agencies should provide financial and
started in June 2008, will indicate to the team whether their human resource assistance in support of private sector
optimism owing to the laboratory research is warranted. R&D.
The patent strategy at Recepta starts with the risky nature This law shares some key features with the US Bayh–Dole and
of cancer therapy development. Because, despite their best ef- CRADA laws of the 1980s, but Brazilians intend that the law
forts, they may not produce a pharmaceutical therapy that can confronts their experience with institutional problems regard-
be approved by drug regulators for use with cancer patients, ing technology innovation incentives and technology markets.
Recepta obtained exclusive license rights to use the patents
of its New York collaborator. Recepta’s president explains
that their angel investors thereby know that, if their R&D ef- 4. RESEARCH CONTRIBUTION AND LIMITATIONS
forts do succeed and if their judgment about the unmet cancer
need is correct, they will be rewarded for their financial contri- There is a school of thought that says, while the logic of pat-
bution to making the R&D effort possible. However, because ents as incentives is basically sound, though arguments in sup-
of the inexperience with patents and lack of patent policies at port of the superiority of cash reward systems are made
Brazilian research universities, Recepta is not conducting pat- (Shavell & Van Ypersele, 2001), the present global, especially
ent-oriented research in Brazil. Thus, patents facilitated inter- United States, patent system has established a bio-medical
national R&D collaborations between American inventors anti-commons with too many patents in general and excessively
and Brazilian developers in the Recepta as well as the Genoa broad patents with respect to research tools in particular (Heller
cases. Patents on Genoa’s new inventions are intended to facil- & Eisenberg, 1998). Heller and Eisenberg did not offer an empir-
itate future technology commercialization through license to a ical study or any real examples of the phenomena they imagine,
private sector innovator. but their thesis has encouraged a good deal of theoretical and
empirical debate. Too many patents lead to patent litigation
(f) Brazilian technology innovation law of 2005 that negatively impacts firm R&D investment decisions (Lerner,
1995), especially in pharmaceuticals, biotechnology, and the life
Brazilian generic pharmaceutical firms did not possess the sciences because the economic stakes are high (Lanjouw &
internal capacities for innovative R&D and all the Sao Paulo Schankerman, 2001), and small firms may be especially at risk
bio-medical technology innovation cases illustrate the exam- (Lanjouw & Schankerman, 2004). Patent litigation has in the re-
ples of public–private technology innovation networks rather cent years “exploded” so that the costs to litigants outweigh the
than go-it-alone private development enterprises, a finding benefits of their patent rights (Bessen & Meurer, 2006) and
that is consistent with the prediction of strategic management threaten the global technology innovation system (Bessen &
scholarship. The Sao Paulo bio-medical technology innova- Meurer, 2008; Jaffe & Lerner, 2004).
tion cases vividly illustrate patent-facilitated technology mar- Nevertheless, other scholars (Epstein & Kuhlik, 2004) reject
kets with external R&D networks. But these early projects the Heller and Eisenberg thesis as inconsistent with both
proved not so easy for the participants to negotiate. Leaders economic theory and marketplace experience: Contesting
at FAPESP, the research universities, and innovation-prospec- bio-medical patent holders “work through” their technology
tive firms identified problems and “the key elements of Brazil’s business problems through licensing, cross-licensing, and
innovation policy are spelled out in the 2002 White Book on other business strategies (Walsh, Arora, & Cohen, 2003). A
Innovation. The current policy framework, known as PITCE survey of university and industry bio-medical technology man-
(Politica Industrial, Tecnologica e de Comercio Exterior), agers finds that pharmaceutical R&D projects stop 62% of the
launched in late 2003, focuses on the promotion of R&D activ- time because of lack of funding, 60% of the time because of
ities in the business sector aiming at better integrating innova- lack of time, 29% of the time because of competition concerns,
tion into the government’s industrial and foreign trade and 1% of the time because of patent litigation threats (Cohen
policies” (Brito Cruz & de Mello, 2006, p. 5). This Brazilian & Walsh, 2007; Walsh, Cohen, & Cho, 2007).
technology innovation community encouraged the Lula Thus, there are two views about bio-medical patents and lit-
administration to lead the Brazilian congress to enact an intel- igation and there is evidence to support both views: Litigation
lectual property-oriented technology law, Law No. 10,973, in is expensive, time-consuming, and debilitating, especially for
2005. The technology innovation law “introduces provisions small technology start-ups, but litigation often results in pat-
on incentives for innovation and scientific and technological ent-licensing, cross-licensing, and strategic alliances among
research in the production environment . . .” The law encour- competitors. In every case studied here the Brazilian bio-med-
ages public–private R&D cooperation by stating explicitly ical innovator aims to invent a wholly new medicine. Brazilian
that bio-medical innovators do not express concerns about the
 public research institutes may agree to share their labora- existing bio-medical patents. Indeed, bio-medical innovator
tory facilities with private-sector enterprises; firms in developing countries such as Brazil that are pursuing
 public research institutes and private sector enterprises bio-prospecting-based R&D strategies should not run afoul of
may enter into capital relationships for the purpose of the existing product patents. It is conceivable that they could
R&D partnerships; become entangled in biotechnology research tool patents,
 the public and private partners may specify by contract but they do not say that is a problem for them at this time.
intellectual property rights ownership; In short, there is no evidence of bio-medical technology patent
 the public research institute and its employees must pro- anti-commons for Brazilians. However, their radical innova-
tect trade secrets associated with their research; tion strategies may not make their experiences the best tests
 the public research institute may license a technology to a for the issue. For better tests of the anti-commons thesis,
private enterprise; incremental pharmaceutical innovators in Brazil or some-
 individual researchers may share in the economic returns where else in the developing world should be examined.
associated with successful commercialization; None of the scholars who contribute papers to Intellectual
 public researchers may take leave from their public posi- Property, Trade, and Development (Gervais, 2007) provides
tion in order to work for a private enterprise; any evidence regarding indigenous technology innovation in a
PATENT INCENTIVES, TECHNOLOGY MARKETS, AND PUBLIC–PRIVATE BIO-MEDICAL INNOVATION NETWORKS 1091

developing country. In that volume Argentine legal scholar Cor- ness with respect to the behavior of bio-medical technology
rea (2007, p. 258) says, “In Latin America the relationship be- innovation entrepreneurs in a developing country setting. Bra-
tween intellectual property and development remains as zilian generic pharmaceutical reverse-engineering R&D had a
nebulous as elsewhere.” Four papers contributed to Interna- long tradition in both the private sector and government labo-
tional Public Goods and Transfer of Technology Under a Global- ratories, but bio-medical invention and innovation had been nil
ized Intellectual Property Regime (Maskus & Reichman, 2005) before the 1996 patent law reforms. Nevertheless, Brazil’s ac-
appear in the section “Stimulating Local Innovation” but, tive generic pharmaceutical companies and a deep bio-medical
though all the papers speculate about intellectual property science research base in universities and public research insti-
and developing country indigenous technology innovation, only tutes created potential inventors and innovators. A study of
one paper provides evidence and the evidence comes from Japan biotechnologists in the United States finds that “star” scien-
(Branstetter, 2005). In the World Bank collection Intellectual tists, measured by journal articles, produce more patented
Property and Development: Lessons from Recent Economic Re- inventions and contribute to better firm performance (Zucker,
search (Fink & Maskus, 2005) only one paper (Maskus, 2005) Darby, & Armstrong, 2002), a finding that prompts the
takes up the question of what the domestic economic impacts question here: What are the characteristics of these Brazilian
might be to the strengthening of intellectual property rights in innovation leaders? Ache had been led for decades by a law-
a developing country (Lebanon), but provides static analysis yer-by-training who rolled up his sleeves and got into the labo-
predicting increased royalty payments, employment losses, ratory because he loved pharmaceutical science. Success with
and firm exits in the pharmaceutical, software, and creative Acheflan proved the promise of his vision to develop Brazil’s
industries. Two economists who do provide evidence do so by flora and fauna into new medicines, so he recruited a Brazilian
studying developing country-based patents to the US Patent bio-chemist who was teaching biodiversity-based pharmaceuti-
and Trademark Office from 1985 to 1995 (Chen & Puttitanun, cal technology innovation at a Swiss university to return to
2005). They find that local innovation effect dominates local imi- Brazilia to lead Ache’s biodiversity technology innovation pro-
tation effect, i.e., the possible trade-off between innovation and gram. He is leading projects with university collaborators in
imitation, as development level rises, beginning at about $850 therapeutic areas such as antifungals, anxiety, cognitive dys-
per capita. Research findings here in comparatively rich state function, diabetes, and metabolic dysfunction. Biolab’s re-
of Sao Paulo are consistent with their aggregate analysis. search director has two decades of experience working in the
Some scholars who doubt the value of patents and intellectual United States for pharmaceutical innovators and he is passion-
property rights to bio-medical technology innovation often ate about turning his company into an innovator. The director
point to a study that addressed the incentive role of patents by of the Center for Applied Toxinology is a university scientist
studying the effect of patent reform in the early 1980s on phar- who is similarly passionately pursuing the goal of new drug
maceutical R&D and innovation in Italy, a country with no his- development. The three entrepreneurial ventures were all
torical record as a pharmaceutical innovator. They found that started up by scientists, though in one case they lured the leg-
the effect of patent reform for pharmaceutical innovation had endary founder of the only globally competitive Brazilian tech-
been modest (Scherer & Weisburst, 1995). But, the investigators nology company (commercial aircraft) out of retirement to lead
cautioned that the Italian government had enforced the most their company. The scientists are all very much aware that they
stringent pharmaceutical price controls in Europe during the are breaking new ground in their country; the one who did
post-reform era, which may have “overwhelmed the stimulative break new ground in his country contends that getting people
incentive effects of drug product patent protection” (Scherer & to believe that they could innovate commercial aircraft at
Weisburst, 1995, p. 1023). Specific to developing country phar- world-class levels was the biggest challenge of all in building
maceutical R&D, Forero-Pineda (2006) refers to a Mexican the company. The characteristics of risk-taking technology
study that finds no evidence of local bio-medical technology innovation leaders in developing countries merit more study.
innovation after their 1994 patent reforms. However, both Mex- Early private-sector entrants discovered that their reverse-
ico and Brazil pursue aggressive pharmaceutical price control engineering skills did not help them with new product invention
health policies and managerial economists have identified Euro- and innovation, so they sought partnerships with university sci-
pean and global price controls as significant factors with respect entists. The State of Sao Paulo Research Foundation spurred
to pharmaceutical innovation (Grabowski & Vernon, 1990; public–private bio-medical technology invention and innova-
Grabowski & Vernon, 2002; Lichtenberg, 2006) and global tion initiative by issuing a competitive request-for-proposal pro-
pharmaceutical market entry decisions (Danzon, Wang, and cess and funding the CAT–COINFAR consortium, bringing
Wang; 2005; Kyle, 2007). Brazilian interviewees in this study together a major public research center and private generic-ma-
say that Brazilian price controls strongly negatively influence ker pharmaceutical companies. Three private start-ups emerged
their innovation decision-making and their behavior—patent from the university and public research community. It is thus
protection and clinical research in the United States and Eur- not argued here that patent reforms alone are sufficient condi-
ope—as documented here supports their words. Regulatory tions for biodiversity-based and/or biotechnology-based inno-
environments regarding laboratory, clinical, and ethical prac- vation to happen in a developing country. Other necessary
tices, safety and efficacy, and prices and demand strongly influ- institutional and competitive conditions exist in Brazil and
ence bio-medical technology innovation in the United States likely must exist or be built in other developing country settings.
and Europe (McKelvey et al., 2004). Technology innovation Nevertheless, Brazilian bio-medical technology entrepreneurs
promotion policy is often trumped by health cost containment knew intimately the reverse-engineering capacities within their
policy, so future research in Brazil should focus on the regula- generic industry, so the 1996 patent law reform fundamentally
tory environment for bio-medical technology innovation. These changed the knowledge appropriability regime. Further study
value and policy conflicts may be especially acute in developing of the incentive and technology market effects of patent reforms
countries. President Cardoso’s 1996 policy decisions to grant is needed for their interactions with institutional and competi-
pharmaceutical product patents yet threaten AIDS drug com- tive environments in other developing country settings, espe-
pulsory licenses are cases in point. cially with respect not only to innovation in bio-medical
The study findings from the state of Sao Paulo, the largest technology, but also in innovative fields such as agricultural
science center in Latin America, are significant for their rich- technology, information technology, and green technologies.
1092 WORLD DEVELOPMENT

Developing countries played little role in bio-medical tech- can operate in a developing country. Rich discussion of the
nology innovation during the 20th century. But, the need for Sao Paulo’s public research support organization shows that
bio-medical innovations to meet the global health burden they added promotion of public–private technology commer-
grows and the opportunities for developing countries owing cialization collaboration to their pure science investment mis-
to biodiversity and biotechnology are considerable, so how sion in 1994, showing that some S&T leaders believed that
people in developing countries can best design the institutions good, or even great, science in Brazil had not and would not
for successful bio-medical technology innovation challenge in itself lead to technology innovation in the marketplace.
development studies. Rich case studies of Sao Paulo bio-med- They have been pursuing a deliberate policy toward a technol-
ical innovation projects put propositions of institutional eco- ogy development strategy for some 15 years, encouraging two
nomics and strategic management to test and support the very different presidents of Brazil to go their way.
propositions that patent incentives and technology markets

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