Paragraph IV Disputes

Expert Insights on Hatch-Waxman Litigation Strategies for Brand Names and Generics
April 24-25, 2012 | New York Marriott Downtown | New York City
CLE ETHICS
Credits Earn

6th Annual

American Conference Institutes

ACIs

Conference Co-Chairs:
e s

HATCH-WAXMAN
s e r i

Guy Donatiello Vice President, Intellectual Property Endo Pharmaceuticals

Timothy X. Witkowski, M.S., J.D. Executive Director & Executive Counsel, Intellectual Property Boehringer Ingelheim

Judicial Insights from:

Honorable Garrett E. Brown, U.S.D.J. Chief Judge United States Federal District Court District of New Jersey (Trenton, NJ) Honorable Joel A. Pisano, U.S.D.J. United States Federal District Court District of New Jersey (Trenton, NJ) Honorable Tonianne Bongiovanni, U.S.M.J. United States Federal District Court District of New Jersey (Trenton, NJ)

Industry Insights from:

Actavis Alembic Ltd Boehringer Ingelheim Endo Pharmaceuticals Impax Laboratories, Inc. Medicis Merck & Co. Novartis Corporation Pfizer Inc Sandoz, Inc. Sanofi Pasteur Sunovion Inc.

FTC Keynote on Pay-For-Delay Settlements:

Markus H. Meier Assistant Director of the Health Care Division Bureau of Competition Federal Trade Commission

Preeminent patent litigators representing brand name and generic drug makers will provide insights on every facet of Paragraph IV litigation from pre-litigation concerns to commencement of suit through to final adjudication. They will discuss the latest legal challenges affecting parties on both sides and help you: ASSESS how Patent Reform will influence Orange Book Patent challenges and pre-suit considerations REFINE Markman hearing strategies in view of the Federal Circuit split on claim construction UNDERSTAND how the Supreme Courts pending ruling in Caraco will redefine the relationship between a drugs patent, label and use code COMPREHEND how Global Tech, Akamai and McKesson will influence inducement of infringement and divided infringement allegations relative to method of treatment claims for pharmaceutical patents EXPLORE new threats to 180-day exclusivity and the repercussions of a possible extension of NCE exclusivity EVALUATE the use of parallel proceedings before the ITC and/or PTO

Customized Working Groups, Workshops and Master Classes

April 23, 2012 - Hatch-Waxman and BPCIA 101 A Primer on IP Basics and Regulatory Fundamentals April 23, 2012 - Working Group Session: Assessing The Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation April 26, 2012 - The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Names and Generics A Hands-On, Practical Approach

Sponsored by:

Supporting Sponsors:

Cocktail Reception Host:

Luncheon Sponsor:

Associate Sponsor:

VIP Breakfast Sponsor:

VIP Dinner Sponsor:

Executive Sponsor:

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ADVISo ry B o A r D A n D FA C U LTy LIST

ACIs Hatch-Waxman Series Advisory Board:
Stephen R. Auten Vice President Sandoz, Inc. (Princeton, NJ) Matthew P. Blischak Vice President Intellectual Property & Associate General Counsel Sunovion Pharmaceuticals Inc. (Marlborough, MA) Guy Donatiello Vice President, Intellectual Property Endo Pharmaceuticals (Chadds Ford, PA) Lisa A. Jakob Legal Director, IP Litigation Merck & Company (Rahway, NJ) George W. Johnston Vice President & Chief Patent Counsel Hoffmann-La Roche (Nutley, NJ) James P. Leeds Assistant General Patent Counsel Eli Lilly & Company (Indianapolis, IN) Meg Snowden VP, Intellectual Property Impax Laboratories (Hayward, CA) Shashank Upadhye Former Vice President - Global Intellectual Property Apotex, Inc. (Toronto, ON) Timothy X. Witkowski, M.S., J.D. Executive Director & Executive Counsel Intellectual Property Boehringer Ingelheim (Ridgefield, CT) Sandra A. Bresnick Partner Quinn Emanuel Urquhart & Sullivan, LLP (New York, NY) Honorable Garrett E. Brown, U.S.D.J. Chief Judge, United States Federal District Court District of New Jersey (Trenton, NJ) Kenneth J. Burchfiel Partner Sughrue Mion, PLLC (Washington, DC) Vincent L. Capuano, Ph.D. Partner Duane Morris LLP (Boston, MA) Kathleen B. Carr Partner Edwards Angell Palmer & Dodge LLP (Boston, MA) William F. Cavanaugh, Jr. Partner Patterson Belknap Webb & Tyler LLP (New York, NY) Anjan Chatterji Business Valuations - Life Sciences Advisory Deloitte Financial Advisory Services LLP (New York, NY) Dominick A. Conde Partner Fitzpatrick, Cella, Harper & Scinto (New York, NY) Michael A. Davitz Partner Axinn, Veltrop & Harkrider LLP (New York, NY) Michael P. Dougherty Special Counsel Cadwalader, Wickersham & Taft LLP (New York, NY) David A. Dow Director, Senior Counsel Boehringer Ingelheim USA Corporation (Ridgefield, CT) Kelly J. Eberspecher Shareholder Brinks Hofer Gilson & Lione (Chicago, IL) Lisa M. Ferri Partner Mayer Brown LLP (New York, NY) Thomas J. Filarski Partner Steptoe & Johnson LLP (Chicago, IL) Jennifer L. Fox Counsel Brinks Hofer Gilson & Lione (Research Triangle Park, NC) David P. Frazier Ph.D. Partner Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC) Adda C. Gogoris Partner Merchant & Gould P.C. (New York, NY) Kelly Falconer Goldberg Senior Corporate Counsel, Regulatory Law Pfizer Inc (New York, NY) Keith J. Grady Shareholder & Chair of the Intellectual Property Litigation Group, Polsinelli Shughart PC (St. Louis, MO) Nicholas Groombridge Partner Paul, Weiss, Rifkind, Wharton & Garrison LLP (New York, NY) Jonathan A. Harris Partner Axinn, Veltrop & Harkrider LLP (Hartford, CT) Pablo D. Hendler Partner Ropes and Gray LLP (New York, NY) Gary E. Hood Shareholder Polsinelli Shughart PC (Chicago, IL) Timothy R. Howe, Ph.D., JD, CLP Vice President, Legal Affairs, General Counsel and Head, Acquisitions and Licensing Transactions Sanofi Pasteur (Swiftwater, PA) James F. Hurst Partner Winston Strawn LLP (Chicago, IL) Christopher J. Kelly Partner Mayer Brown LLP (Palo Alto, CA) Thomas J. Kowalski Shareholder Vedder Price (New York, NY) Steven J. Lee Partner Kenyon & Kenyon (New York, NY) Denise L. Loring Partner Ropes & Gray LLP (New York, NY) Deborah L. Lu, Ph.D. Shareholder Vedder Price (New York, NY) Steven A. Maddox Partner Knobbe Martens Olson & Bear LLP (Washington, DC) Jim Mahanna Director, Intellectual Property Law Actavis (Elizabeth, NJ) Terry G. Mahn Principal Fish & Richardson P.C. (Washington, DC) David A. Manspeizer Partner Wilmer Cutler Pickering Hale and Dorr LLP (New York, NY) Ryan L. Marshall Shareholder Brinks Hofer Gilson & Lione (Salt Lake City, UT) Kerry B. McTigue Partner Duane Morris LLP (Washington, DC) Markus H. Meier Assistant Director of the Health Care Division Bureau of Competition Federal Trade Commission (Washington, DC) Jeffrey N. Meyers VP and Assistant General Counsel, Intellectual Property Enforcement Pfizer Inc (New York, NY) Don J. Mizerk Partner Husch Blackwell LLP (Chicago, IL) Steven J. Moore Partner Kelley Drye & Warren LLP (Stamford, CT) Catherine Nyarady Partner Paul, Weiss, Rifkind, Wharton & Garrison LLP (New York, NY) D. Christopher Ohly Partner Schiff Hardin LLP (Washington, DC) Joseph M. OMalley, Jr. Partner and Global Co-Chair, Intellectual Property Practice Paul, Hastings LLP (New York, NY) Dr. Alpesh Pathak Head-API Patent Cell Alembic Pharmaceuticals (Vadodara Area, India) Martin B. Pavane Member Cozen OConnor (New York, NY) Mark A. Perry Partner Gibson, Dunn & Crutcher LLP (Washington, DC) Chad J. Peterman Partner Patterson Belknap Webb & Tyler, LLP (New York, NY) Honorable Joel A. Pisano, U.S.D.J. United States Federal District Court District of New Jersey (Trenton, NJ) Joseph M. Reisman, Ph.D. Partner Knobbe Martens Olson & Bear LLP (San Diego, CA) Richard T. Ruzich Partner Duane Morris LLP (Chicago, IL) Michael A. Sitzman Partner Gibson, Dunn & Crutcher LLP (San Francisco, CA) Len Smith Principal Intellectual Property Counsel Medicis (Scottsdale, AZ) Matthew A. Smith Senior Counsel Foley & Lardner LLP (Washington, DC) Sanya Sukduang Partner Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC) Tedd Van Buskirk Partner K & L Gates LLP (New York, NY) Anthony J. Viola Partner Edwards Angell Palmer & Dodge LLP (New York, NY) Mark E. Waddell Partner Loeb & Loeb LLP (New York, NY) Peter Waibel Head US Patent Litigation Novartis Pharmaceuticals Corporation (East Hanover, NJ) Bruce M. Wexler Partner Paul, Hastings LLP (New York, NY) Patrick C. Woolley Shareholder Polsinelli Shughart PC (Kansas City, MO)

Distinguished Faculty:
Co-Chairs Guy Donatiello Vice President, Intellectual Property Endo Pharmaceuticals (Chadds Ford, PA) Timothy X. Witkowski, M.S., J.D. Executive Director & Executive Counsel Intellectual Property Boehringer Ingelheim (Ridgefield, CT) Immediate Past Co-Chairs Brian P. Murphy Partner Edwards Wildman Palmer LLP (New York, NY) Barry S. White Partner Frommer Lawrence & Haug LLP (New York, NY) Speakers Yogesh Bahl Partner Deloitte Financial Advisory Services LLP (New York, NY) Aaron F. Barkoff, Ph.D Partner McAndrews, Held & Malloy, Ltd. (Chicago, IL) Richard J. Berman Partner Arent Fox LLP (Washington, DC) Asim M. Bhansali Partner Keker and VanNest (San Francisco, CA) Honorable Tonianne Bongiovanni, U.S.M.J. United States Federal District Court District of New Jersey (Trenton, NJ)

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over 80% of drug manufacturers are unprepared to meet the legal challenges of more than $60 billion in pharmaceutical patent losses.1 Is your company one of them? Avoid being caught off guard by attending the only event dedicated to providing brand name and generic legal professionals like you with the tools needed to master the strategies, standards and tactics of Paragraph IV litigation. Brand name and generic pharmaceutical companies are beginning to feel the initial impact of the patent cliff: the pecuniary perils of patent loss and the economic consequences associated with the decline of Hatch-Waxman market exclusivity. As a result, the industry has entered an era of extreme Paragraph IV litigation where the monetary ante has never been higher. To help you respond to the challenges of this new era, ACIs 6th Annual Paragraph IV Disputes conference will guarantee your access to the leading legal minds in this area. A whos who of Hatch-Waxman litigators for both brand names and generics will help you conquer the patent crisis of 2012 by addressing such industry shaping topics as: The impact of the AIA on Hatch Waxman litigation Carve-outs, use codes and labeling Claim construction Prior art obviousness and obvious-type double patenting Inducement of infringement and divided infringement Inequitable conduct Damages Hear also from renowned federal jurists and a key official from the Federal Trade Commission. Learn firsthand how the bench analyzes the theories of your case and what the FTC deems as fair and foul in the settlement of pharmaceutical patent disputes.
1 InPharm, A new survey shows pharma is not prepared to deal with the tough year ahead as many blockbuster drugs begin to go off patent, 1-12-12.

Complete your professional training by attending one or more of these customized Working Groups, Workshops and Master Classes: Hatch-Waxman and BPCIA 101 A Primer on IP Basics and Regulatory Fundamentals which will provide the patent and regulatory backdrop for the more in-depth Hatch-Waxman litigation controversies discussed in the main conference; A Working Group Session on Assessing The Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation which will address how new pre- and post issuance procedures may alter certain components of Paragraph IV litigation and parallel proceedings between the Federal Courts and PTO; and The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Names and Generics which will give practical and hands-on strategies for drafting and negotiating settlement agreements that will pass muster with the FTC. In this costly and ruthless endgame, not a moment can be lost. Register now by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563 or logging on to www.AmericanConference.com/PIVDisputesNYC.

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Monday, april 23, 2012 9:00 AM 12:30 PM (registration opens at 8:30 am) Continental Breakfast will be served
A
Hatch-Waxman and BPCIA 101 A Primer on IP Basics and regulatory Fundamentals
David A. Dow Director and Senior Counsel Boehringer Ingelheim USA Corporation (Ridgefield, CT) Kelly Falconer Goldberg Senior Corporate Counsel, Regulatory Law Pfizer Inc (New York, NY) Ryan L. Marshall Shareholder Brinks Hofer Gilson & Lione (Salt Lake City, Utah) Kerry B. McTigue Partner Duane Morris LLP (Washington, DC) Mark A. Perry Partner Gibson, Dunn & Crutcher LLP (Washington, DC) This hands-on workshop will provide you with an in-depth review of the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as well as other IP and regulatory basics relative to small molecules and biologics. The workshop leaders will lay the necessary foundation for you to comprehend thoroughly the dynamics of the IP and regulatory backdrop underlying each Paragraph IV dispute. They will help you fully appreciate the complexities of the Hatch-Waxman litigation challenges presented during the main conference as well as anticipated conundrums under the biosimilar schematic. Points of discussion will include: Regulatory Essentials Relative to Hatch-Waxman Understanding the link between the FDA approval process and the patenting of drugs and biologics Rx Drugs (new drugs) Identifying the application process for the approval of a new drug, i.e., small molecule, new chemical entities, etc. NDA (New Drug Application) - what information does it contain? - labeling, patent information, trade name
- filing requirements - the FDA review process INDA (Investigational New Drug Application) aka IND - how does it differ from an NDA? - filing requirements - what does it entitle you to do? Accelerated approvals - defining eligibility criteria for accelerated approval and priority reviews - what portions of approval submissions might FDA release and when? Using advisory committees in the approval process ANDA: what does it require? Paragraph IV Certifications and Notice Letters Bioequivalence defined The Orange Book: what is it and why is it Orange? - listings and de-listings

Biologics Understanding the approval process for a biologic - how does the approval process for a biologic differ from that of a drug? BLA (Biological Licensing Application) - how does a biologic differ from a drug? - what application needs to be filed and with whom is it filed? - which products require BLAs instead of NDAs? - what does a BLA look like? Why is it a license, rather than an approved application? What does the approval process for a biosimilar under BPCIA entail and how is it different from the BLA approval process? IP Protection for Drugs and Biologics Analyzing the patenting process for drugs and biologics Seeking patent protection during the preapproval process IP and regulatory redress for time lost during the pre-approval process Distinguishing the patenting process for drugs from that of biologics - which biologics are treated as drugs and why? Identifying the respective roles of the FDA and the PTO in the patenting of drugs and biological products Drugs Exploring the differences between a NDA and an ANDA (Abbreviated New Drug Application)

Biologics Identifying biologics that fall within the purview of Hatch-Waxman - why are other biologics outside of the Hatch-Waxman rubric? Overview of the biosimilar (FOB) law - Title VII of the Patient Protection and Affordable Care Act (PPACA, P.L. 111-148), i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA) The rationale for safety and efficacy concerns surrounding second generation biologics The Pharmaceutical Patent Endgame: Hatch-Waxman Explained Overview of Hatch-Waxman and reforms under the Medicare Modernization Act (MMA) The role of Orange Book under Hatch-Waxman vis--vis the MMA Exploring different concepts in exclusivity - exclusivity (180 day market exclusivity) - regulatory exclusivity - NCE (new chemical entity) - 5 years marketing exclusivity - 5 years data exclusivity - indication (new indication or use) - 3 years marketing exclusivity - NDF (new dosage formulation) - ODE (orphan drug exclusivity) - PED (pediatric exclusivity) 30-month stay Patent extensions The safe harbor FD&C 505b2 (an alternate pathway to an ANDA) Trademark and Trade Dress Issues Identifying the PTO and FDA clearances necessary for trade name/trademark approval on your product

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Monday, april 23, 2012 2:00 PM 5:30 PM (Registration opens at 1:15 pm)
B
Working Group Session: Assessing The Impact of new PTo Procedures Under the AIA on Paragraph IV Litigation
Kenneth J. Burchfiel Partner Sughrue Mion, PLLC (Washington, DC) Adda C. Gogoris Partner Merchant & Gould P.C. (New York, NY) Deborah L. Lu, Ph.D. Shareholder Vedder Price (New York, NY) Matthew A. Smith Senior Counsel Foley & Lardner LLP (Washington, DC) Patrick C. Woolley Shareholder Polsinelli Shughart (Kansas City, MO) Through its creation of new and amending of existing PTO Procedures, the America Invents Act (AIA) has opened the door to parallel and/or alternate administrative avenues to Paragraph IV proceedings in the District Courts. These PTO Procedures go directly to the heart of an invalidity challenge and also provide administrative mechanisms which in some instances could cure errors in the file history. There are also mechanisms that could stop the issuance of a patent during the pendency of its application. However, the use of these mechanisms may carry unintended consequences and bring about the opposite of their intended purpose. The workshop leaders will address ` these procedures as well as specific concerns for brands and generics. Points of discussion will include: Third Party Pre-Issuance Submissions Understanding when the pre-issuance submission of prior art to the PTO by a third party challenger as outlined by this procedure would be used in a Hatch-Waxman scenario Examining scenarios in which the application of a pending pharmaceutical patent might actually be strengthened as opposed to diminished by the invocation of this procedure Supplemental Proceedings Exploring Paragraph IV scenarios in which it makes sense for a patent holder to pursue supplemental reexamination Protocols and procedures for supplemental proceedings Defining a substantial new question of patentability (SNQP) - question of prior art Exploring relationship between supplemental proceedings and inequitable conduct - circumstances in which supplemental reexam can be used as a means to circumvent questions of inequitable conduct - failure to disclose - presence of mind - intent v. mistake does it make a difference in the findings? - findings of fraud in aftermath of proceedings and possibility of criminal prosecution - materiality Post Grant Review Weighing considerations for when a challenge should be brought under post grant review (PGR) in a Hatch-Waxman setting Exploring start dates, timing and basis of the application questions to ask - is the challenge brought within nine months of patent issuance? - what is the basis of the invalidity challenge - prior art - 112 deficiency under written description - lack of enablement - obviousness - inherent anticipation - fate of best mode Estoppel considerations relative to Paragraph IV litigation - have you raised all bases for invalidity lest you be precluded from raising them in other PTO or district court proceedings? Examining the mechanics, protocols and procedures for PGR - filing of petition - analogous nature of proceeding to district court litigation
- discovery - hearings; motions; settlement - appearing before the Patent Trial and Appeals Board (PTAB) Analyzing the petitioners burden of proof - proving that it is more likely than not that one of the claims challenged in the petition is unpatentable Procedures for appeal

Inter Partes Review Comparing current inter partes reexamination protocols to inter partes review protocols under AIA Examining how current inter partes reexamination procedures are being employed by both patent challengers and patent holders in Hatch Waxman scenarios - questions of economics, efficiencies and risk - what can we glean from these current behaviors relative to the future utilization of inter partes review? Understanding the fine points of the new inter partes review procedure - considerations for choosing this forum - timing, cost, speed of resolution Revisions to patent challengers burden of proof under current inter partes reexamination and new inter partes review procedures - substantial new question of patentability vs. reasonable likelihood that the petitioner will prevail on claim - understanding the immediate repercussions of this shift on inter partes reexam and strategies for inter partes review for pharmaceutical patent litigation Exploring the scope of review for current and new procedures under 102 and 103 - patents (prior art) and publications - comprehending the relationship between scope of review and estoppel Transition and phase out - examining the interplay between the timing for post grant review and inter partes review - transition in presiding forums - Central Reexam Unit (CRU) vs. Patent Trial and Appeal Board (PTAB) - appeal to CAFC

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Main Conference Day 1 Tuesday, April 24, 2012

7:15 8:00

Registration and Continental Breakfast Co-Chairs Opening Remarks

Guy Donatiello Vice President, Intellectual Property Endo Pharmaceuticals (Chadds Ford, PA ) Timothy X. Witkowski, M.S., J.D. Executive Director & Executive Counsel, Intellectual Property Boehringer Ingelheim (Ridgefield, CT) Immediate Past Co-Chairs Brian P. Murphy Partner Edwards Wildman Palmer LLP (New York, NY) Barry S. White Partner Frommer Lawrence & Haug LLP (New York, NY)

8:30

Anticipating and Reassessing Paragraph IV Challenges in the Era of the Patent Cliff
Anjan Chatterji Business Valuations - Life Sciences Advisory Deloitte Financial Advisory Services LLP (New York, NY) Jennifer L. Fox Counsel Brinks Hofer Gilson & Lione (Research Triangle Park, NC) Pablo D. Hendler Partner Ropes and Gray LLP (New York, NY) Len Smith Principal Intellectual Property Counsel Medicis (Scottsdale, AZ)
Understanding how the arrival of the patent cliff has changed a patent holders Paragraph IV due diligence strategies

Evaluating the strength of the patents in your current portfolio in light of the new industry dynamics created by the patent cliff - Orange Book and non-Orange Book eligible patents Examining the Orange Book to list or not list dilemma - which types of patents should you list? - alternatives to compound patents - methods - employment of use codes - polymorphs - special listing considerations for small proteins filed through an NDA as opposed to a BLA in light BPCIA biosimilar provisions - what is the proteins method of manufacture - is it chemically derived or made through a biotechnological process? Gauging when to reasonably expect a Paragraph IV filing by a generic competitor in the era of the patent cliff Learning to look beyond the blockbuster patents ` - understanding why patents on smaller products may be more vulnerable to challenge in some instances Exploring brand name exclusivities and their correlation to the start of a Paragraph IV challenge - NCE - possible extension of NCE exclusivity from 5 to 12 years? - new use or indication - new formulation - orphan drug - pediatric Preparing for litigation - developing discovery check-lists - implementation of document retention policy - when is a litigation hold put on all documents which may be discoverable - e-discovery - possible e-discovery restraints in various jurisdictions - call back rule for inadvertent disclosure Preventing a Paragraph IV challenge - entering an authorized generics agreement

- claiming the label - filing a citizens petition - OTC switches Understanding how changes in the US Patent System under the AIA may influence Orange Book listing strategies - first to file - third party pre-issuance submissions - file early, file often - provisional applications - prior user rights 9:30

Invalidity and Non-Infringement Post-Microsoft: Reaffirmation of The ANDA Applicants Pre-Litigation Obligations and Assertions
Stephen R. Auten Vice President, Head of IP, North America Sandoz, Inc. (Princeton, NJ) Richard J. Berman Partner Arent Fox LLP (Washington, DC) Dr. Alpesh Pathak Head-API Patent Cell Alembic Pharmaceuticals (Vadodara Area, India) Joseph M. Reisman, Ph.D. Partner Knobbe Martens Olson & Bear LLP (San Diego, CA)
Reexamining the initial obligations of the ANDA applicant under Paragraph IV in light of the Supreme Courts ruling in Microsoft v. i4i - when is there clear and convincing evidence that patent is invalid and therefore not infringed - assessing the consequences of not meeting this burden of proof Weighing your options in light of the burden: should you file a Paragraph IV certification or choose another ANDA route? Choosing which Orange Book patents to challenge - compounds - formulations - process

Brand Name Side

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Generic Side

- methods of use - polymorphs - factoring forfeiture into your Orange Book strategy - skinny labeling and carve-out considerations via Caraco - obviousness assessments How Patent Reform may impact Orange Book patent challenges - elimination of Best Mode defense - prior user rights - exploring new Post Grant Review and Inter Partes Review as another mechanism for invalidating an Orange Book patent Understanding the role of non-Orange Book patents in your PIV ANDA strategies - innovator / non-innovator - API Procuring legal opinions on invalidity and non-infringement - assessing when opinions are needed - opinion of in-house v. outside counsel - questions of privilege - Rule 26 (b) (4) revisions regarding expert opinions Filing the ANDA - fulfilling requirements for FDA approval: - pharmaceutically equivalent - bioequivalent - identifying triggers which may necessitate new bioequivalence studies Contents of the Paragraph IV certification

For the Generic Side: Shashank Upadhye Former Vice President - Global Intellectual Property Apotex, Inc. (Toronto, ON) Tedd Van Buskirk Partner K & L Gates LLP (New York, NY) Moderator: Dominick A. Conde Partner Fitzpatrick, Cella, Harper & Scinto (New York, NY) Generic Side
Procedural requirements Perfecting the Paragraph IV Certification Contents of the Notice letter Delivery/service of Notice Letter Making necessary amendments to the ANDA Substantive requirements Identifying the proposed product covered by the ANDA Identifying the patent of the corresponding branded product which is the subject of the Paragraph IV letter Legal and factual basis Examining the detailed statement and questions of confidentiality - Nycomed v. Tolmar Civ. No. 10-2635, 2011 (D.N.J. Apr. 28, 2011) Exploring the use of opinion letters in relation to notice letters - are they still needed in view of Patent Reform - how detailed do they need to be to avoid sanctions vis- - vis Takeda

- scope of information that can reasonably expected - negotiations Extending the 45 day period - 21 CFR 314.95 (f ) When should a patent owner file suit? - other options to explore - license - authorized generic Strategies to consider with multiple ANDA filers Questions for both sides to consider: Options to explore if suit is not commenced in 45 days - pros, cons and consequences of: - forfeiture of 30 month stay - suing for damages - declaratory judgment actions - no contest letter 12:00 Networking Luncheon
Sponsored by:

1:15

New Claim Construction Considerations in Paragraph IV Litigation

Lisa M. Ferri Partner Mayer Brown LLP (New York, NY) Jonathan A. Harris Partner Axinn, Veltrop & Harkrider LLP (Hartford, CT) Martin B. Pavane Member Cozen OConnor (New York, NY) Moderator: Catherine Nyarady Partner Paul, Weiss, Rifkind, Wharton & Garrison LLP (New York, NY)

10:30 Morning Coffee Break 10:45 The Throwing of the Gauntlet:

The Paragraph IV Notice Letter

For the Brand Name Side: Denise L. Loring Partner Ropes & Gray LLP (New York, NY) Peter Waibel Head US Patent Litigation Novartis Pharmaceuticals Corporation (East Hanover, NJ)

Branded Side
The response Making productive use of the 45 day period Information gathering techniques strategies - confidentiality agreements and document requests - obtaining the ANDA - terms

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 How the split in Federal Circuit on claim construction may impact Paragraph IV challenges - more narrow reading of claims vs. broader reading - Cybor and Phillips The significance of dissent in Retractable Technologies, Inc. v. Becton, Dickinson and Company (Fed. Cir. 2011) - viewing claim construction as the most important event in the course of a patent litigation in contrast to the ill defined and inconsistent rules in the Federal Circuit Revisiting 112 written description and enablement distinction requirements vis--vis Ariad v. Lilly and Centacor relative to clarity of claims - reviewing specification requirements - understandability - inventorship Strategies for working around these inconsistencies at Paragraph IV Markman hearings 2:00

Moderator Richard T. Ruzich Partner Duane Morris LLP (Chicago, IL) Legal Analysis
Prior Art Obviousness Exploring the reaffirmation of KSR through In Re Kao (Fed. Cir. 2011) - examining secondary considerations before the PTO under current procedures - under new AIA Post Grant Review procedure Understanding the impact of KSR and its progeny on primary compound and composition claims vis--vis a Paragraph IV challenge - impact on secondary patents - enantiomers - isomers - polymorphs - new formulations - new indications - crystallizations - salts Examining questions of secret prior art and inherent anticipation - Teva Pharmaceutical Industries Ltd. v. AstraZeneca Pharmaceuticals LP (Crestor) Assessing the impact of the AIAs prior art provisions in Paragraph IV related obvious challenges - pre/post 2013 Obviousness-Type Double Patenting Analyzing the evolving state of the law on obviousness-type double patenting and its impact on Paragraph IV litigation - Sun Pharm. Indus. v. Eli Lilly & Co., No. 2010-1105 (Fed. Cir. 2010) - Boehringer Ingleheim Intl, et al. v. Barr Labs, Inc., et al., 592 F.3d 1340 (Fed. Cir. 2010) Brand-name and generic strategies for navigating the new double patenting landscape

Practical Applications Strategies for invoking and responding to an obviousness challenge in concurrence with current law - brand name and generic tactics for addressing prior art and double patenting controversies - PTO and District Court redress Summary judgment assessments Discovery approaches - considerations regarding the deposing of primary reference authors Experts - should the same expert be used for both infringement and invalidity opinions? - new expert report provisions under Rule 26 (b) (4)
3:00

Afternoon Refreshment Break

Sponsored by:

Prior Art Obviousness and ObviousType Double Patenting: Legal Analysis and Practical Applications for Brand Names and Generics
Michael A. Davitz Partner Axinn, Veltrop & Harkrider LLP (New York, NY) Steven J. Lee Partner Kenyon & Kenyon (New York, NY) Joseph M. OMalley, Jr. Partner and Global Co-Chair, Intellectual Property Practice Paul Hastings LLP (New York, NY) Sanya Sukduang Partner Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC)

3:15

And Theyre Off: The Start of the Paragraph IV Law Suit - Pleadings and Other Initial Considerations and Analyses
For the Brand Name Side: Chad J. Peterman Partner Patterson Belknap Webb & Tyler, LLP (New York, NY) For the Generic Side: Gary E. Hood Shareholder Polsinelli Shughart PC (Chicago, IL) Jim Mahanna Director, Intellectual Property Law Actavis (Elizabeth, NJ) Moderator: Kathleen B. Carr Partner Edwards Wildman Palmer LLP (Boston, MA)

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Judicial Roundtable
6:00 6:00

Initial considerations Where should suit be filed? - attempts by the generic to influence where and when the suit will occur - exploring transfer motions and writs of mandamus relative to venue/jurisdiction - In Re Link - examining joinder provisions and HatchWaxman exceptions under AIA relative to venue Assessing subject matter jurisdiction - Sunovion v. Sandoz (2011) - Cephalon v. Sebelius (2011) Questions of standing - considerations for multinationals and subsidiaries - weighing probability for motions to dismiss Handicapping of judges and jurisdictions Surveying local patent rules - knowing which district rules favor patent holders and patent challengers - New Jersey - E.D. Texas - Delaware Question of jury trial: exploring circumstances that may put you in front of a jury Exploring possible parallel proceedings before the PTO in view of Patent Reform Crafting the initial pleadings The complaint - challenging the Paragraph IV certification: alleging the patent is valid and infringed - what claims are made in the ANDA? - avoiding Rule 11 sanctions - assessing whether attorneys fees can be properly sought? The answer and counterclaims - de-listing improperly listed patents - antitrust and unfair competition claims - counterclaims relative to the label under MMA - Caraco - assertions of inequitable conduct - the generic point of view: - attorneys fees - Rule 11

Considerations with Multiple ANDA Filers Branded Side Choosing who to sue - ANDA filers; others? - when does it make sense to only sue the first filer or a few as opposed to all ANDA filers? - what are the consequences of not suing all ANDA filers? Special forum selection considerations for multiples Amending pleadings for later ANDA filers Generic Side The generics position in the queue - general considerations for first to file - thoughts for second and later filers Consolidation vs. separate cases The Changing Dynamics of Branded and Generic Pharma How the blurring of the lines between branded and generic companies are influencing initial considerations in the course of Paragraph IV litigation Generic Generic Law Suits - exploring circumstances in which the generic on the pleadings behaves as an innovator - pleading protection of market exclusivity Declaratory Judgments Understanding the MMA declaratory judgment provisions and the CAFCs interpretation of these provisions - two prong test When is it appropriate to move for a DJ Circumstances when a DJ will be granted? Should DJ be sought on all patents listed and not listed? Factoring - in the 30 month stay Commencement of the statutory 30 month stay - understanding the scope and limits of the 30 month stay under the MMA The 30-month stay in the course of litigation - options and strategies for the patent holder if the stay expires during the course of litigation - early termination of the stay

4:45

A View From the Bench

Honorable Garrett E. Brown, U.S.D.J. Chief Judge, United States Federal District Court District of New Jersey (Trenton, NJ) Honorable Joel A. Pisano, U.S.D.J. United States Federal District Court District of New Jersey (Trenton, NJ) Honorable Tonianne Bongiovanni, U.S.M.J. United States Federal District Court District of New Jersey (Trenton, NJ) Moderators: Brian P. Murphy Partner Edwards Wildman Palmer LLP (New York, NY) Barry S. White Partner Frommer Lawrence & Haug LLP (New York, NY)
Renowned jurists with some of the most active Paragraph IV litigation dockets in the country will share their thought and insights on some of the most pressing issues facing both patent holders and patent challengers. Come prepared with your most pressing questions.

Conference adjourns to Day 2 Cocktail Reception

Hosted by:

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Main Conference Day 2 Wednesday, April 25, 2012

7:15 8:00 8:15

Registration and Continental Breakfast Co-Chairs Opening Remarks and Recap of Day One Of Labels, Patents and Use Codes: The Significance and Possible Repercussions of Novo Nordisk v. Caraco to Hatch-Waxman Challenges
Aaron F. Barkoff, Ph.D. Partner McAndrews, Held & Malloy Ltd. (Chicago, IL) James F. Hurst Partner Winston Strawn LLP (Chicago, IL) Michael A. Sitzman Partner Gibson, Dunn & Crutcher LLP (San Francisco, CA) Anthony J. Viola Partner Edwards Wildman Palmer LLP (New York, NY) Moderator: Terry G. Mahn Principal Fish & Richardson P.C. (Washington, DC)
Exploring the relationship between a drugs label, patents, use codes and Orange Book listings relative to Hatch-Waxman litigation Deciphering therapeutic equivalence evaluation codes - what are the roles of AB ratings and OB use codes in the Orange Book Defining Section viii carveouts and understanding their significance to Orange Book listings and Paragraph IV challenges - skinny labeling - off-label uses Examining how the Supreme Courts pending ruling in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. may alter the landscape in this area with respect to:

- the interpretation of the counterclaim provision challenging method of use patents per the MMA amendments - delisting strategies based on use codes and labeling controversies - when can use codes be altered? - seeking permission from the FDA to carve-out patent protected language to allow for generic entry - possible consequences of narrowing vs. expanding the use code narrative Understanding the significance of Solicitor Generals /U.S. governments position and arguments in this matter 9:15

Reassessing Paragraph IV Strategies for Method Treatment Patents in View of Recent and Pending Decisions Regarding Inducement and Divided Infringement
David P. Frazier Ph.D. Partner Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC) Keith J. Grady Shareholder Polsinelli Shughart LLP (St. Louis, MO) Lisa A. Jakob Legal Director, IP Litigation Merck & Company (Rahway, NJ) Meg Snowden VP, Intellectual Property Impax Laboratories, Inc. (Haywood, CA) Moderator: Sandra A. Bresnick Partner Quinn Emanuel Urquhart & Sullivan, LLP (New York, NY)
Defining inducement of infringement and divided infringement under current law - how the Supreme Courts ruling in Global Tech v. SEB has altered the standard for inducement findings

- mens rea requirements - willful blindness vs. deliberate indifference - indirect vs. direct infringement - the concept of divided and joint infringement vis--vis Akamai Technologies, Inc. v. Limelight Networks, Inc. (Fed. Cir. 2011) and McKesson Technologies Inc. v. Epic Systems Corp. (Fed. Cir. 2011) Exploring the relationship between inducement actions and divided infringement allegations and how they apply to methods of treatment claims in pharmaceutical patents Examining inducement and divided infringement challenges to methods of treatment claims listed in the Orange Book - AstraZeneca LP v. Apotex, Inc.: exploring the role of Section viii carve-outs and the inducement controversy How may the Federal Circuits en banc rulings in Akamai and McKesson influence Paragraph IV challenge of these types of Orange Book listed patents going forward? 10:15 Morning Coffee Break 10:30 Exclusivities and Forfeitures:

New Developments, Controversies and Concerns Relative to Paragraph IV Litigation

Michael P. Dougherty Special Counsel Cadwalader, Wickersham & Taft LLP (New York, NY) Kelly J. Eberspecher Shareholder Brinks Hofer Gilson & Lione (Chicago, IL) D. Christopher Ohly Partner Schiff Hardin LLP (Washington, DC) Moderator: Thomas J. Filarski Partner Steptoe & Johnson LLP (Chicago, IL)

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 Assessing the possible impact of the proposed FAIR Generics Act on 180 day exclusivity - evisceration of 180 day market exclusivity? - sharing of exclusivities among competitors - proposed extension of NCE exclusivity and related impact on 180-day market exclusivity Deciphering the FDAs stance on pre and postMMA 180-day exclusivity When can the 180-day exclusivity period be transferred to another ANDA applicant? Evaluating when the 180-day exclusivity period can be relinquished, and exploring the consequences When can a brand park a generics exclusivity? Defining shared exclusivity How have authorized generics changed the playing field relative to 180-day exclusivity? Exploring regulatory bars to exclusivity - GMP violations - SEC Forfeiture provisions: circumstances under which exclusivity is forfeited - identifying circumstances under which forfeiture of anothers exclusivity may occur? Interpreting the earlier of , later of language in making a forfeiture determination Evaluating the strength of the failure to market provision post-Lipitor Exploring simultaneous qualification for and forfeiture of exclusivity for failure to obtain tentative approval Evaluating the impact of delisting on forfeiture Forfeiture relative to patent expiration Understanding the relationship between forfeiture and the increase in generic/generic litigation Revisiting the relationship between exclusivity, forfeiture and the 30 month stay - circumstances under which a second stay may be granted impact on grant of exclusivity 11:15

The FTC continues to vigorously use its enforcement and policy tools to prevent anticompetitive business practices in the pharmaceutical industry. Over the last several years, the Commission has used much of this arsenal on the matter of reverse settlement or pay-fordelay agreements which it views as a very anticompetitive practice. The FTC is not alone in this view, as the DOJ and some members of Congress have also come to the conclusion that these agreements are in restraint of trade and cause great harm to the consumer. Markus Meier, Assistant Director of the FTCs Bureau of Competitions Health Care Division will discuss the current status of the FTCs efforts to end pay-for-delay settlements and address such matters as: The status of pending FTC litigation concerning patent settlements The status of pending legislation regarding pay-for-delay settlements The enforcement of the MMA reporting requirements The findings of the FTCs authorized generics study

Moderator: Mark E. Waddell Partner Loeb & Loeb LLP (New York, NY)
Examining the Federal Circuits tightening of the of the inequitable conduct standard in Therasense - intent to deceive - single most reasonable inference - materiality - but for test - possible Supreme Court review? Exploring the application of Therasense in a Paragraph IV scenario - Pfizer v. Teva - awarding sanctions for asserting unsubstantiated claims of inequitable conduct - repercussions of this ruling and its impact for future inequitable conduct filings Re-examining the relationship between inequitable conduct and corporate fraud - future question of corporate intent in a Hatch-Waxman setting Inequitable conduct and Patent Reform - supplemental proceedings under the AIA: an opportunity to cure inequitable conduct? Afternoon Refreshment Break
Sponsored by:

FTC Keynote

12:00 Networking Luncheon

Sponsored by:

1:15

New Standards in Inequitable Conduct Post-Therasense: Ethical Considerations for Paragraph IV Cases
Matthew P. Blischak Vice President, Intellectual Property & Associate General Counsel Sunovion Pharmaceuticals Inc. (Marlborough, MA) Vincent L. Capuano, Ph.D. Partner Duane Morris LLP (Boston, MA) Stephen J. Moore Partner Kelley Drye & Warren LLP (Stanford, CT) Bruce M. Wexler Partner Paul Hastings LLP (New York, NY)

2:15

Ethics
2:30

New Controversies Surrounding Damages and Injunctions Relative to At Risk Launches

William F. Cavanaugh, Jr. Partner Patterson Belknap Webb & Tyler LLP (New York, NY) Nicholas Groombridge Partner Paul, Weiss, Rifkind, Wharton & Garrison LLP (New York, NY)

Pay-for- Delay Update

Markus H. Meier Assistant Director of the Health Care Division Bureau of Competition Federal Trade Commission (Washington, DC)

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11

David A. Manspeizer Partner Wilmer Cutler Pickering Hale and Dorr LLP (New York, NY) Don J. Mizerk Partner Husch Blackwell LLP (Chicago, IL)
Launching at risk during litigation or the appeal period - benefits and risks analysis Injunctions Examining the inconsistencies between the Federal Circuit and the Supreme Court relative to the granting of a preliminary injunction - intra-Circuit split - Kimberly-Clark Worldwide, Inc. v. First Quality Baby Products, LLC, Case No. 10-1382 (Fed. Cir., Sept. 29, 2011) - eBay Inc. v. MercExchange, LLC, 547 U.S. 388 (2006) - considerations by the District Courts in light of this inconsistency Practical strategies for brand names and generics in dealing with this discord before the District Courts and Federal Circuit Seeking a preliminary injunction in the event that the stay ends in the course of the litigation - posting of bond by the branded side Exploring the possibility of a stipulated injunction - why a stipulated injunction may be of benefit to both sides Damages Analysis

provisions on stipulated damages. Now, the industry is carefully watching the Protonix litigation to see how damages may be assessed in an at risk launch in the absence of such stipulation. This panel will explore these matters as well as: The quantification of damages - brandname vs. generic point of view - small v. large generic company concerns Lost profits: - assessment of profit as a true measure of damages - is the drug profitable? - a question of sales - when is it the only thing that you can seek? Reasonable royalties: - basis for royalty - looking at market share - the point where infringement began Mitigating factors impacting damage award 4:00

Parallel Proceedings in Paragraph IV Disputes: Strategies for Balancing and Streamlining Proceedings Before the Federal Courts, PTO and ITC
Asim M. Bhansali Partner Keker and VanNest (San Francisco, CA) Timothy R. Howe, Ph.D., JD, CLP Vice President, Legal Affairs General Counsel and Head, Acquisitions and Licensing Transactions Sanofi Pasteur (Swiftwater, PA) Thomas J. Kowalski Shareholder Vedder Price (New York, NY)
The passage of the America Invents Act and the recent acceptance of a Paragraph IV case by the ITC have brought the matter of parallel proceedings in HatchWaxman litigation into greater focus. This panel will examine the different forums and proceedings before which Paragraph IV litigants may seek simultaneous redress. Points of discussion will include: Forums in which parallel Paragraph IV challenges may be brought - PTO 5:00

Yogesh Bahl Partner Deloitte Financial Advisory Services LLP (New York, NY) Jeffrey N. Meyers VP and Assistant General Counsel, Intellectual Property Enforcement Pfizer Inc (New York, NY) The question of damages in at risk launch has caused considerable concern of late. Not too long ago, all eyes were on Sanofi v. Apotex (Plavix) and its

- Federal District Court - ITC Evaluating the types of proceedings which may run parallel to a Paragraph IV Dispute - traditional District Court litigation - new PTO proceedings - post grant review - inter partes review - existing ex partes reexam mechanism - ITC investigatory actions under section 337 of the Tariff Act of 1930 Analyzing whether parallel proceedings make sense in view of the particular circumstances of your Paragraph IV challenge Cost and time comparisons - which proceedings make the most economic sense in terms of time and money? Specific concerns for joinder relative to District Court and PTO Procedures under the AIA Exploring circumstances in which a 337 Complaint can be brought before the ITC in a Paragraph IV matter - In the Matter of Certain Gemcitabine and Products Containing the Same (Eli Lilly Section 337 Complaint) Stays of District Court and ITC proceedings in view of pending decisions from the PTO Federal Circuit appeals during the pendency of parallel proceedings Factoring in new rules relating to: - how each type of proceeding will be conducted - e.g., what types of validity attacks can be raised in each proceeding - scope of proceeding - scope of discovery in each type of proceeding - legal standards of review Estoppel effects

Conference Ends

WHo yoU WILL MEET

Patent attorneys and litigators (in-house & law firm) who represent: Brand name pharmaceutical companies Generic pharmaceutical companies Biopharmaceutical companies

12

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ThUrSday, april 26, 2012 9:00 aM - 12:30 pM (registration opens at 8:30 am) ConTInEnTAL BrEAKFAST WILL BE SErVED

C C

The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Names and Generic A Hands-On, Practical Approach
Christopher J. Kelly Partner Mayer Brown LLP (Palo Alto, CA) Steven A. Maddox Partner Knobbe Martens Olson & Bear LLP (Washington, DC)
The MMA mandated that pharmaceutical companies provide the FTC with advance notice of proposed settlements of pharmaceutical patent disputes. The FTC and state attorneys general and private plaintiffs have challenged a number of settlements on antitrust grounds. The DOJ has also lent its support to the FTC in also challenging the legality of these settlements. Both brand names and generic drug companies have expressed their frustration with the FTC in attempting to come to an agreeable resolution in this matter. There is also fear in the pharmaceutical industry over proposed legislation introduced term after term- which may, in certain circumstances deem these types of settlements to be per se illegal and eviscerate 180-day exclusivity. This hands-on, interactive workshop will examine how in the current environment, parties to a Paragraph IV dispute can resolve their differences and receive the governments blessing. The workshop leaders will explore best practices to reach and finalize successful and sound settlements. Through the use of a hypothetical, they will help you: Draft and structure an agreement that will receive FTC approval Identify and avoid red flags that may lead to FTC scrutiny Anticipate possible requirements regarding patent settlements under proposed legislation - Preserve Access to Affordable Generics Act - The Fair Generics Act Understand the role of authorized generics in these agreements and the FTCs view on this topic Incorporate elements in the agreement that emphasize the preservation of competition Devise strategies to employ pending completion of the FTCs review

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Continuing Legal Education Credits

CLE Credits

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With more than 500 conferences in the United States, Europe, Asia Pacific, and Latin America, American Conference Institute (ACI) provides a diverse portfolio devoted to providing business intelligence to senior decision makers who need to respond to challenges spanning various industries in the US and around the world. As a member of our sponsorship faculty, your organization will be deemed as a partner. We will work closely with your organization to create the perfect business development solution catered exclusively to the needs of your practice group, business line or corporation. For more information about this program or our global portfolio of events, please contact: Wendy Tyler Head of Sales, American Conference Institute Tel: 212-352-3220 x5242 | Fax: 212-220-4281 w.tyler@AmericanConference.com

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

ACI certifies that the activity has been approved for CLE credit by the New York State Continuing Legal Education Board in the amount of 15.0 hours of which 1.0 will apply to ethics. An additional 4.0 credit hours will workshop A-C participation ACI certifies that this activity has been approved for CLE credit by the State Bar of California in the amount of 12.75 hours of which 1.0 will apply to ethics. An additional 3.5 credit hours will apply to workshop A-C participation. You are required to bring your state bar number to complete the appropriate state forms during the conference. CLE credits are processed in 4-8 weeks after a conference is held. ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request. Questions about CLE credits for your state? Visit our online CLE Help Center at www.americanconference.com/CLE

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Visit www.americanconference.com/blog and navigate to the ACI Expert Jobs link. Its quick, easy and free for you, your in-house recruiters, or anyone in your firm to post current open positions and take advantage of our exclusive community of experts. The newly posted jobs will appear on the relevant sections of www.americanconference.com and our partner sites, ensuring that your free job listing is visible to a large number of targeted individuals.

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SPonSorS AnD EXHIBITorS

Brinks Hofer Gilson & Lione has over 140 attorneys, scientific advisors and patent agents who specialize in intellectual property, making it one of the largest intellectual property law firms in the U.S. Clients around the world use Brinks to help them identify, protect, manage and enforce their intellectual property. Brinks lawyers provide expertise in all aspects of patent, trademark, unfair competition, trade secret and copyright law. The Brinks team includes lawyers with bachelors and advanced degrees in all fields of technology and science. Brinks has offices in Chicago, Washington, D.C., Research Triangle Park, Salt Lake City, Ann Arbor and Indianapolis. More information is available at www.usebrinks.com

Deloitte Financial Advisory Services LLP (Deloitte FAS) advises clients on managing business controversy and conflict, executing deals, and maintaining regulatory compliance. We provide services to companies throughout their lifecycle - from purchasing a company to investigating potential fraud. Specifically, we help clients address serious business concerns involving fraud, forensic investigations, litigation and reorganization. Through Deloitte Corporate Finance LLC, our wholly owned securities brokerage subsidiary, we assist clients with originating and executing transactions and strategic investments for mergers and acquisitions, divestitures, and capital planning. We also advise businesses on valuation issues and other matters to help them remain compliant in today's rigorous regulatory environment. Our dedicated Deloitte FAS professionals bring vast experience, specialized skill sets and deep industry knowledge to our Health Sciences clients.

Duane Morris' ANDA lawyers represent worldwide generic pharmaceutical companies in their quest to enter the U.S. market with new products, with significant experience in litigation related to ANDAs filed under the Hatch-Waxman law. www.duanemorris.com

Edwards Wildman attorneys have represented several of the worlds largest brand pharmaceutical companies in Hatch-Waxman Paragraph IV patent litigation against many major generic drug companies. These cases have protected billions of dollars worth of small molecule pharmaceutical sales for our clients. Our pharmaceutical patent litigation experience is characterized by effective lead trial counsel well-versed in Hatch-Waxman issues. Teams are based in New York and Boston and have enforced patents covering NCEs, polymorphs, solid and liquid dosage forms, salts, treatment methods, stabilizers, and sustained release formulations. We are also seasoned and successful appellate advocates at the Court of Appeals for the Federal Circuit. More information can be found at ip.edwardswildman.com.

With more than 375 intellectual property lawyers, Finnegan is one of the largest IP law firms in the world. From offices in the United States, Europe, and Asia, we handle all aspects of patent, trademark, copyright, and trade secret law, including counseling, prosecution, licensing, and litigation. www.finnegan.com

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Knobbe Martens is an agent of innovation, providing clients worldwide with forward-focused Intellectual Property law service and representation. We are one of the largest and fastest-growing IP law firms, with more than 275 attorneys and scientists representing the complete spectrum of technologies and IP practice areas. We combine unmatched technical and litigation expertise to deliver superior results in both transactional and contested matters, for both cutting edge start-ups and established Fortune 500 companies. Our work spans fields ranging from physics to pharmaceuticals and entertainment to engineering. But perhaps more impressive than our scope is our skill. We are established experts in our fieldsscientists, engineers and thinkers who blend deep educational and technical knowledge with a strategic focus gleaned from our real-world business experience. We know your issues. Your pressures. And should the need arise, we know how to aggressively protect the assets that give your business its competitive edgewith extensive experience and intimate knowledge of domestic and international judicial systems. Whatever our role, our goal is simple: to advance and protect those whose innovations propel the world forward.

Patterson Belknap Webb & Tyler LLP, is based in New York City with approximately 200 lawyers delivering a full range of services across more than 20 practice groups in both litigation and commercial law. More than half of the attorneys at Patterson Belknap are devoted to litigation. Our litigating partners have tried hundreds of cases, including many of the most complex in their fields. Our attorneys secured a settlement of $1.725 billion, the largest settlement ever of a patent infringement case in the United States on behalf of a Fortune 50 client.

The Paul Weiss patent litigation group has extensive experience in the life sciences field, including ANDA litigation as well as patent disputes on biologics, medical devices and diagnostics. The group is currently handling significant matters for BiogenIdec, Edwards Life Sciences, Genentech, Life Technologies, Medicis and Yeda, among others.

Polsinelli Shughart has a national presence in the pharmaceutical and life sciences industries. Our work includes Hatch-Waxman Act litigation, intellectual property litigation and enforcement, patent prosecution, opinion work, and advice regarding transactional matters. We work with manufacturers of generic pharmaceuticals and biologics, along with start-up and entrepreneurial clients.

American Conference Institute, 2012

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15

American Conference Institutes

th
HATCH-WAXMAN
s e r i e s

ACIs

Annual

Customized Working Groups, Workshops and Master Classes for all your Hatch-Waxman needs

Paragraph IV Disputes
Expert Insights on Hatch-Waxman Litigation Strategies for Brand Names and Generics
April 24-25, 2012 | New York Marriott Downtown | New York City

April 23, 2012 - Hatch-Waxman and BPCIA 101 A Primer on IP Basics and Regulatory Fundamentals April 23, 2012 - Working Group Session: Assessing The Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation April 26, 2012 - The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Names and Generics A Hands-On, Practical Approach
Registration fee
the fee includes the conference all program materials continental breakfasts lunches and refreshments.

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