3rd Annual In-House Counsel Forum on

Pharmaceutical Antitrust

Responding to New Legislation and Increased Enforcement Activity - Maximizing the Value of Deals and Products While Minimizing Risk

Tuesday, May 15, 2007

About

Antitrust liabilities and risks for brand name and generic pharmaceutical manufacturers have never been more real. Drug makers in both camps must have strategies in place to recognize and resolve today’s vital issues. They must be able to assess the impact of reverse payment legislation and circuit splits on patent settlements, weigh the role of authorized generics in the market and the impact of the FTC study, determine when bundled discounts and exclusive contracts are illegal, and know which antitrust pitfalls to avoid when entering into licenses and consolidations. If all this were not enough, recent case law concerning product innovation and reformulation present new dangers — and yet another thing to think about — for unsuspecting companies.

Recognizing and resolving these clear and present antitrust dangers are key to ensuring that a company does not endure time consuming and expensive repercussions down the road.

There is one place that in-house counsel and executives from brand name and generic pharmaceutical companies, and outside counsel to pharmaceutical companies, can come to resolve these and other complex antitrust matters affecting the protection and exploitation of their products. American Conference Institute’s timely publication from our 3rd Annual In-House Counsel Forum on Pharmaceutical Antitrust has been designed to call attention to the industry’s latest antitrust dilemmas and provide real solutions in the current environment. A leading faculty of pharmaceutical in-house counsel, government regulators, and expert antitrust attorneys will provide insights on the development of practical defensive and offensive strategies in this critical time.

Contents & Contributors

About

Antitrust liabilities and risks for brand name and generic pharmaceutical manufacturers have never been more real. Drug makers in both camps must have strategies in place to recognize and resolve today’s vital issues. They must be able to assess the impact of reverse payment legislation and circuit splits on patent settlements, weigh the role of authorized generics in the market and the impact of the FTC study, determine when bundled discounts and exclusive contracts are illegal, and know which antitrust pitfalls to avoid when entering into licenses and consolidations. If all this were not enough, recent case law concerning product innovation and reformulation present new dangers — and yet another thing to think about — for unsuspecting companies.

Recognizing and resolving these clear and present antitrust dangers are key to ensuring that a company does not endure time consuming and expensive repercussions down the road.

There is one place that in-house counsel and executives from brand name and generic pharmaceutical companies, and outside counsel to pharmaceutical companies, can come to resolve these and other complex antitrust matters affecting the protection and exploitation of their products. American Conference Institute’s timely publication from our 3rd Annual In-House Counsel Forum on Pharmaceutical Antitrust has been designed to call attention to the industry’s latest antitrust dilemmas and provide real solutions in the current environment. A leading faculty of pharmaceutical in-house counsel, government regulators, and expert antitrust attorneys will provide insights on the development of practical defensive and offensive strategies in this critical time.

Contents & Contributors

THE ANTITRUST ANALYSIS OF PHARMACEUTICAL PATENT SETTLEMENTS
Suzanne T. Michel, Federal Trade Commission (Washington, DC)

DIVERGENCE AT HOME: COMMENTS ON THE DIFFERENCES BETWEEN THE FEDERAL ANTITRUST ENFORCEMENT AGENCIES ON HOW TO SUGGEST THE LEGALITY OF REVERSE PAYMENTS
Mark J. Botti, Akin Gump Strauss Hauer & Feld LLP (Washington, DC)

“REVERSE PAYMENT” PROPOSED LEGISLATION 110TH CONGRESS
Ann Rappleye, Wyeth (Madison, NJ)

PATENT SETTLEMENTS CURRENT STATUS OF ANTI-TRUST ACTIONS
Mark S. Robbins, Upsher-Smith Laboratories (Maple Grove, MN)

AUTHORIZED GENERICS
Markus Meier, Federal Trade Commission (Washington, DC)

ASSESSING THE IMPACT OF AUTHORIZED GENERICS
Seth Silber, Wilson Sonsini Goodrich & Rosati (Washington DC)

ANTITRUST, INTELLECTUAL PROPERTY & AUTHORIZED GENERICS
Dara Diomande, Pfizer Inc. (New York, NY)

THE ANTICOMPETITIVE THREAT OF AUTHORIZED GENERICS
Brian S. Roman, Mylan Pharmaceuticals Inc. (Canonsburg, PA)

UPDATE ON THE NEW CONGRESS: RESPONDING TO THE VARIETY OF LEGISLATIVE PROPOSALS
Makan Delrahim, Brownstein Hyatt Farber Schreck, P.C (Washington, DC)

FINDING SMART SOLUTIONS AND ESTABLISHING COMMON GROUND
Tim Gilbert, Gilbert's Washington Inc. (Washington, DC)

ANTI-COMPETITIVE INNOVATION: IS THERE A ROLE FOR ANTITRUST IN EVALUATING PRODUCT LINE EXTENSIONS?
Jay Himes, Office of the Attorney General of New York (New York, NY)

ANTITRUST RISKS OF LIFESTYLE MANAGEMENT
Bruce A. Pokras, Pfizer Inc (New York, NY)

UBIQUITOUS LIFECYCLE MANAGEMENT STRATEGIES THAT WITHSTAND ANTITRUST ATTACK
Michael F. Brockmeyer, Frommer Lawrence & Haug LLP (Washington, DC)

TRICOR: HOW ABBOTT AND FOURNIER MAINTAINED THEIR MONOPOLY IN THE FENOFIBRATE MARKET THROUGH SHAM INNOVATION OR “DRUG HOPPING”
David A. Balto, Law Office of David Balto (Washington, DC)

“MARKET SWITCHES” AND MARKET POWER
Jeffrey W. Brennan, Dechert LLP (Washington, DC)

ANTITRUST CONSIDERATIONS IN PRICING AND DISTRIBUTION
LaDonna L. Steiner, Purdue Pharma L.P. (Stamford, CT)

ECONOMIC CONSIDERATIONS IN BUNDLING
Christopher Stomberg, Ph.D., Bates White, LLC (Washington, DC)

ANTITRUST CONSIDERATIONS IN PRICING AND DISTRIBUTION - TYING, EXCLUSIVE DEALING, BUNDLING
John W. Treece, Sidley Austin LLP (Chicago, IL)

PHARMACEUTICAL PRODUCT MARKET DEFINITION: COUNSELING THE COMMERCIAL CLIENT
Stephen J. Cipolla, Merck & Co., Inc. (North Wales, PA)

MARKET DEFINITION IN PHARMACEUTICAL ANTITRUST PROCEEDING: SOME BASICS
Robert Hickok, Pepper Hamilton LLP (Philadelphia, PA)

DEFINING MARKETS AND DETERMINING MARKET POWER IN THE PHARMACEUTICAL INDUSTRY: WHAT ROLE DOES INNOVATION PLAY?
Joanne C. Lewers, Attorney, Drinker Biddle & Reath LLP (Philadelphia, PA)

MERGERS IN THE PHARMACEUTICAL AND MEDICAL DEVICE INDUSTRIES: HOW TO GET YOUR DEAL THROUGH THE ANTITRUST REVIEW PROCESS
Matthew J. Reilly, Federal Trade Commission (Washington, DC)

AVOIDING ANTITRUST DILEMMAS IN PHARMACEUTICAL MERGERS AND ACQUISITIONS: AN FTC APPROACH
Susan A. Creighton, Wilson Sonsini Goodrich & Rosati (Washington, DC)
Robert W. Doyle, Jr., Doyle, Barlow & Mazard PLLC (Washington, DC)
Kent K. Matsumoto, Counsel (Allendale, NJ)

DRAFTING AND EXECUTING COLLABORATIVE AGREEMENTS
Melissa S. Barnes, Eli Lilly and Company (Indianapolis, IN)
Stephen A. Stack, Dechert LLP (Philadelphia, PA)



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