2007 West Coast Edition

Maximizing Pharmaceutical Patent Life Cycles

The Definitive Hatch-Waxman Event for Biopharmas, Brand Names and Generics

Tuesday, June 05, 2007

About

The biopharmaceutical industry sits uniquely positioned in the latest political debate concerning pharmaceutical patents. With the evolution of the Medicare drug benefit, it is clear that cost containment measures adopted through the Hatch-Waxman reforms of the MMA for the manufacture of small molecules is not enough. As such, the 110th Congress, now in its infancy, is exploring the adoption of an abbreviated pathway for approval – similar to that of small molecules – for biologics. The adoption of this measure would put the biopharma industry at the epicenter of controversy, as scientists, politicians and lawyers debate whether a Hatch-Waxman schematic can be adopted safely for biological entities. Yet, the measures this new congressional body is exploring relative to pharmaceutical patents do not stop with the concept of follow-ons. There is currently also proposed legislation that would outlaw patent settlements between brand name and generic drug makers. There also is no doubt that patent reform will be revisited. Finally, certain provisions in last year’s Deficit Reduction Act regarding authorized generics may just be used as a vehicle to re-open Hatch-Waxman yet again. While these measures may seem of more consequence to brand name and generic manufacturers of small molecule drug products, it still has profound implications for biopharma patent portfolios – especially if follow-on biologics are approved.

All these happenings are indicative of the dramatic changes affecting pharmaceutical patent life cycles. The biopharmaceutical industry – like its brand name and generic pharmaceutical industry cousins – can no longer afford to be left in the dark.

ACI has developed this publication from the 2nd West Coast edition of Maximizing Pharmaceutical Patent Life Cycles to bring the biopharmaceutical industry the critical information that it needs regarding the legal aspects of pharmaceutical patent life cycles. An esteemed faculty of biopharmaceutical industry and Hatch-Waxman experts will provide targeted information and commentary especially for biopharmas on:

  • How Hatch-Waxman reform has affected:
    • product development
    • Orange Book listing strategies
    • market exclusivities
    • Paragraph IV challenges
    • patent settlements between brand names and generics

Contents & Contributors

About

The biopharmaceutical industry sits uniquely positioned in the latest political debate concerning pharmaceutical patents. With the evolution of the Medicare drug benefit, it is clear that cost containment measures adopted through the Hatch-Waxman reforms of the MMA for the manufacture of small molecules is not enough. As such, the 110th Congress, now in its infancy, is exploring the adoption of an abbreviated pathway for approval – similar to that of small molecules – for biologics. The adoption of this measure would put the biopharma industry at the epicenter of controversy, as scientists, politicians and lawyers debate whether a Hatch-Waxman schematic can be adopted safely for biological entities. Yet, the measures this new congressional body is exploring relative to pharmaceutical patents do not stop with the concept of follow-ons. There is currently also proposed legislation that would outlaw patent settlements between brand name and generic drug makers. There also is no doubt that patent reform will be revisited. Finally, certain provisions in last year’s Deficit Reduction Act regarding authorized generics may just be used as a vehicle to re-open Hatch-Waxman yet again. While these measures may seem of more consequence to brand name and generic manufacturers of small molecule drug products, it still has profound implications for biopharma patent portfolios – especially if follow-on biologics are approved.

All these happenings are indicative of the dramatic changes affecting pharmaceutical patent life cycles. The biopharmaceutical industry – like its brand name and generic pharmaceutical industry cousins – can no longer afford to be left in the dark.

ACI has developed this publication from the 2nd West Coast edition of Maximizing Pharmaceutical Patent Life Cycles to bring the biopharmaceutical industry the critical information that it needs regarding the legal aspects of pharmaceutical patent life cycles. An esteemed faculty of biopharmaceutical industry and Hatch-Waxman experts will provide targeted information and commentary especially for biopharmas on:

  • How Hatch-Waxman reform has affected:
    • product development
    • Orange Book listing strategies
    • market exclusivities
    • Paragraph IV challenges
    • patent settlements between brand names and generics

Contents & Contributors

PATENTS & POLITICS: A REVIEW AND UPDATE ON LEGISLATION AFFECTING HATCH-WAXMAN
Daniel M. Becker, M.D., Dechert LLP (Palo Alto, CA)

FOLLOW-ON BIOLOGICS: ISSUES AND PROSPECTS
Elaine Tseng, King & Spalding LLP (Washington, DC) (in residence, San Francisco)

EXTENDING PATENT LIFE Nina Ashton, Elan Pharmaceuticals, Inc. (San Diego, CA)
Romy L. Celli, Townsend, Townsend and Crew LLP (San Francisco, CA)

PARAGRAPH IV DISPUTES: WATCHING THE FEDERAL CIRCUIT
James Hopenfeld, Fish & Neave IP Group of Ropes & Gray LLP (Washington, DC)

SAFE HARBOR UPDATE: THE SCOPE OF THE RESEARCH EXEMPTION POST-INTEGRA
Jessica R. Wolff, Heller Ehrman LLP (San Diego, CA)

RE-EXPLORING ORANGE BOOK LISTING AND DE-LISTING STRATEGIES
Ann M. Caviani Pease, Dechert LLP (Palo Alto, CA)

EXCLUSIVITY: PATENT AND NON-PATENT Christine Saunders Haskett, Heller Ehrman LLP (San Francisco)

TRADEMARK EXCLUSIVITY: DO YOU WANT TO LIVE FOREVER?
Gretchen Stroud, Cooley Godward LLP (Palo Alto, CA)

PRESENT CONTROVERSIES AND UNCERTAINTIES IN MARKETING EXCLUSIVITY
Kurt R. Karst, Hyman, Phelps & McNamara, P.C. (Washington, DC)

PATENT SETTLEMENTS: DOES ANTITRUST MATTER?
Jesse W. Markham, Jr., Morrison & Foerster LLP (San Francisco, CA)

PATENT LITIGATION SETTLEMENTS: “EXCLUSION PAYMENTS” - HOW DO YOU KNOW?
Margaret M. Snowden, Impax Laboratories, Inc. (Hayward, CA)

EUROPEAN ROCHE BOLAR: UNDERSTANDING ITS IMPACT ON US PHARMACEUTICAL PATENT LIFE CYCLES
Dr. Martin Chakraborty, Lovells (Dusseldorf, Germany)



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