About
Branded and generic pharmaceutical companies are in a mission critical phase where every decision has terrific consequences.
What kind of language should the parties include in a settlement agreement to avoid FTC rejection? How can pharma companies prepare a viable covenant not to sue in a post-Medimmune world? What actions will set off forfeiture of 180-day generic market exclusivity?
Increasing competition requires innovators to constantly reevaluate strategies for fully realizing a patented drug’s value during the life cycle. In turn, generics trigger formidable competition upon patent expiration.
The tasks on both sides of this complex equation are easy to identify, intricate to analyze, and difficult to execute.
FTC enforcement, FDA rulings, and differing court decisions add to the innovators’ already extensive demands of competition in the pharmaceutical industry. Pharmaceutical patent counsel at innovators are entrusted with the massive obligation of looking beyond the patent term and mastering these other complex factors in defining, strengthening, and extending a pharmaceutical patent’s life cycle. Generic pharma must incorporate the same factors in measuring their risk, developing a business plan, and mounting a competitive campaign against a patented drug already emboldened with years of exclusivity, name recognition, and success.
Branded and generic pharma companies must continually sharpen, refine, and evolve their patent life cycle strategies in the wake of constant, challenging, and sometimes volatile change – economic, political, and legal.
ACI is proud to present this timely publication from the hallmark event for the pharmaceutical industry – 9th Annual Maximizing Pharmaceutical Patent Life Cycles Conference. This definitive Hatch-Waxman event provided the crucial information for pharmaceutical patent counsel to cultivate, modify, and enhance a foundation for their life cycle strategies. Industry leaders offer insight on analyzing the complex issues, evaluating options, and benchmarking strategies against competitors on either side of the progressively heated branded-generic battle.
About
Branded and generic pharmaceutical companies are in a mission critical phase where every decision has terrific consequences.
What kind of language should the parties include in a settlement agreement to avoid FTC rejection? How can pharma companies prepare a viable covenant not to sue in a post-Medimmune world? What actions will set off forfeiture of 180-day generic market exclusivity?
Increasing competition requires innovators to constantly reevaluate strategies for fully realizing a patented drug’s value during the life cycle. In turn, generics trigger formidable competition upon patent expiration.
The tasks on both sides of this complex equation are easy to identify, intricate to analyze, and difficult to execute.
FTC enforcement, FDA rulings, and differing court decisions add to the innovators’ already extensive demands of competition in the pharmaceutical industry. Pharmaceutical patent counsel at innovators are entrusted with the massive obligation of looking beyond the patent term and mastering these other complex factors in defining, strengthening, and extending a pharmaceutical patent’s life cycle. Generic pharma must incorporate the same factors in measuring their risk, developing a business plan, and mounting a competitive campaign against a patented drug already emboldened with years of exclusivity, name recognition, and success.
Branded and generic pharma companies must continually sharpen, refine, and evolve their patent life cycle strategies in the wake of constant, challenging, and sometimes volatile change – economic, political, and legal.
ACI is proud to present this timely publication from the hallmark event for the pharmaceutical industry – 9th Annual Maximizing Pharmaceutical Patent Life Cycles Conference. This definitive Hatch-Waxman event provided the crucial information for pharmaceutical patent counsel to cultivate, modify, and enhance a foundation for their life cycle strategies. Industry leaders offer insight on analyzing the complex issues, evaluating options, and benchmarking strategies against competitors on either side of the progressively heated branded-generic battle.
Contents & Contributors
EVOLVING LIFECYCLE GAME PLAN: WHAT ARE THE DRIVERS?
WHAT’S THE STRATEGY?
John C. Vassil, Morgan & Finnegan LLP (New York, NY)
PATENT FILING STRATEGIES FOR THE PHARMASEUTICAL INDUSTRY:
WHAT, WHEN AND WHERE?
Philip Datlow, Boehringer Ingelheim Pharmaceuticals, Inc. (Ridgefield, CT)
GUARDING AGAINST THE DANGER OF JUDGES MISREADING PATENTS
Renee Kosslak, Ph.D., PDL BioPharma, Inc. (Redwood City, CA)
ENSURING AN INTERNATIONAL PATENT PROSECUTION STRATEGY IS
IN PLACE
Andrew A. Paul, Procter & Gamble Company (Cincinnati, OH)
VIEW FROM THE FTC: PHARMACEUTICALS, PATENTS AND PROMOTING
COMPETITION
Saralisa Brau, Federal Trade Commission (Washington, DC)
NAVIGATING THE COMPLEXITY OF STRUCTURING PATENT SETTLEMENT OPTIONS BETWEEN BRAND NAME AND GENERIC PHARMACEUTICAL COMPANIES
Stephana E. Patton, Ph.D., Salix Pharmaceuticals, Inc. (Palo Alto, CA)
NAVIGATING PATENT SETTLEMENTS: REVIEW OF FTC COMPLAINT
IN RE CEPHALON
Shashank Upadhye, Apotex, Inc. (Toronto, Canada)
BRAND NAME AND GENERIC PHARMACEUTICAL PATENT SETTLEMENTS
Mark E. Waddell, Loeb & Loeb LLP (New York, NY)
DECLARATORY JUDGMENT ACTIONS AND COVENANTS NOT TO
SUE IN A POST-MEDIMMUNE WORLD
Denise L. Loring, Ropes & Gray LLP (New York, NY)
EYE ON THE BENCH: IDENTIFYING JUDICIAL TRENDS IN
PHARMACEUTICAL PATENT CASES
Hollie L. Baker, Wilmer Hale LLP (Boston, MA)
KSR 18 MONTHS LATER: RETHINKING PARAGRAPH IV CHALLENGES IN
VIEW OF SHIFTING OBVIOUSNESS STANDARDS
Duane-David Hough, Fish & Richardson P.C. (New York, NY)
THE 180-DAY EXCLUSIVITY: WAIVER AND RELINQUISHMENT
Mark I. Bowditch, Sandoz Inc. (Princeton, NJ)
MASTERING THE INTRICACIES OF THE 180-DAY GENERIC MARKET
EXCLUSIVITY
William D. Hare, Concentrx BioSciences, Inc. (Princton, NJ)
HATCH-WAXMAN FORFEITURE CASES 2003 MMA AMENDMENTS
Thomas D. Hoffman, Sandoz Inc. (East Hanover, NJ)
FDA EXCLUSIVITIES
Charles J. Raubicheck, Frommer Lawrence & Haug LLP (New York, NY)
RESEARCH TOOL PATENTS AND THEHATCH-WAXMAN SAFE HARBOR
Brian D. Coggio, Fish & Richarson P.C. (New York, NY)
INJUNCTIONS RELATED TO ACTIVITIES NOT WITHIN “SAFE HARBOR”
Eric Fischer, Schering-Plough Corporation (Kenilworth, NJ)
271(E)1 SAFE HARBOR, PROVERIS, AND ME?
Thomas S. Kim, VGX Pharmaceuticals, Inc. (Blue Bell, PA)
VIEW FROM THE FDA: PATENTS AND THE EXCLUSIVITY
PROVISIONS OF THE MMA
Elizabeth Dickinson U.S. Food and Drug Administration (Rockville, MD)
RECENT DEVELOPMENTS IN THE LAW OF DECLARATORY JUDGMENTS
IN PATENT CASES
Michael P. Dougherty, Cadawalder, Wickersham & Taft LLP (New York, NY)
SLICING THROUGH THE COMPLEX SPECTRUM OF DECLARATORY
JUDGMENT ACTIONS IN PHARMACEUTICAL PATENT CASES
Steven J. Lee, Ph.D., Kenyon & Kenyon LLP (New York, NY)
SLICING THROUGH THE COMPLEX SPECTRUM OF DECLARATORY
JUDGMENT ACTIONS IN PHARMACEUTICAL PATENT CASES
James P. Leeds, Eli Lilly and Company (Indianapolis, IN)
FACTORING THE ROLE, CHALLENGES, AND IMPACT OF ORANGE BOOK
LISTINGS AND DE-LISTINGS IN PATENT PORTFOLIO MANAGEMENT
Ann M. Caviani Pease, Ph.D., Dechert LLP (Silicon Valley, CA)
MINING THE ORANGE BOOK AND PATENT DELISTING: EFFECT ON
180-DAY GENERIC EXCLUSIVITY
Bruce A. Pokras, Pfizer Inc. (New York, NY)
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