Maximizing Pharmaceutical Patent Life Cycles

The definitive Hatch-Waxman event for brand names, generics and biopharmas

Tuesday, June 13, 2006

About

Update your company's Hatch-Waxman strategies for small molecules.
Prepare for patent life cycle challenges for biologics.


The Medicare Modernization Act substantially curtailed the ability of brand name manufacturers to extend patents on their drugs, and quickened the pace of entry for generic pharmaceuticals into the marketplace. The courts are now in the process of determining whether the tactics and strategies that both sides have used (to either sustain or gain market share for their small molecule products) are fair or foul within the new law. Also being adjudicated are new challenges that finally may force the FDA to decide whether an abbreviated pathway for approval - similar to that for small molecules - now can be safely adopted for biologics. This would allow follow-on biologics (a.k.a. generic biologics) to enter the marketplace when the patents for their brand name counterparts expire. With the EU now adopting measures for the manufacture of biosimilars (i.e. follow-on biologics)… and the astronomical cost of the Medicare Drug Benefit… many industry insiders believe that the approval of generic biologics in the US is an impending reality.

Does your company, whether a brand name, a generic, or a biopharma, have the offensive moves and defensive plays it now needs to maximize its most lucrative – or potentially lucrative - small molecule products on the last day of patent life? Moreover, are you prepared to help your company meet the potential challenges or reap the potential benefits of follow-on biologics?

This clearly is a dynamic time for life sciences industries throughout the country, but one of particular significance to the West Coast vis-ŕ-vis its unique concentration of biopharmaceutical companies. As these companies develop small molecule and biological products, their counsel need a complete understanding of the latest legal developments in this area and the implications for their companies' life cycle strategies - just as counsel to traditional brand name or generic pharmaceutical companies have had for several years.

In response to an overwhelming industry demand, this West Coast Edition of the American Conference Institute's publication on Maximizing Pharmaceutical Patent Life Cycles will bring you thoughtful and targeted commentary and in-depth analysis from an outstanding faculty of leading in-house pharmaceutical counsel and expert attorneys for both brand names and generics, as well as government representatives. This publication will provide you with valuable information on:
  • The potential impact of pending Patent Reform Legislation on pharmaceutical patent life cycles
  • The economic and R&D impact of follow-on biologics on the industry
  • How the courts are interpreting the Hatch-Waxman reform provisions of the MMA, with respect to:
    • Orange Book listings and challenges
    • Exclusivity: 180-day exclusivity, orphan drug, pediatric and beyond
    • How Integra has impacted the Safe Harbor
    • Authorized generics: will the FTC take action?
    • The impact of Hatch-Waxman reform in the US on EU pharmaceutical patent practice

Contents & Contributors

About

Update your company's Hatch-Waxman strategies for small molecules.
Prepare for patent life cycle challenges for biologics.


The Medicare Modernization Act substantially curtailed the ability of brand name manufacturers to extend patents on their drugs, and quickened the pace of entry for generic pharmaceuticals into the marketplace. The courts are now in the process of determining whether the tactics and strategies that both sides have used (to either sustain or gain market share for their small molecule products) are fair or foul within the new law. Also being adjudicated are new challenges that finally may force the FDA to decide whether an abbreviated pathway for approval - similar to that for small molecules - now can be safely adopted for biologics. This would allow follow-on biologics (a.k.a. generic biologics) to enter the marketplace when the patents for their brand name counterparts expire. With the EU now adopting measures for the manufacture of biosimilars (i.e. follow-on biologics)… and the astronomical cost of the Medicare Drug Benefit… many industry insiders believe that the approval of generic biologics in the US is an impending reality.

Does your company, whether a brand name, a generic, or a biopharma, have the offensive moves and defensive plays it now needs to maximize its most lucrative – or potentially lucrative - small molecule products on the last day of patent life? Moreover, are you prepared to help your company meet the potential challenges or reap the potential benefits of follow-on biologics?

This clearly is a dynamic time for life sciences industries throughout the country, but one of particular significance to the West Coast vis-ŕ-vis its unique concentration of biopharmaceutical companies. As these companies develop small molecule and biological products, their counsel need a complete understanding of the latest legal developments in this area and the implications for their companies' life cycle strategies - just as counsel to traditional brand name or generic pharmaceutical companies have had for several years.

In response to an overwhelming industry demand, this West Coast Edition of the American Conference Institute's publication on Maximizing Pharmaceutical Patent Life Cycles will bring you thoughtful and targeted commentary and in-depth analysis from an outstanding faculty of leading in-house pharmaceutical counsel and expert attorneys for both brand names and generics, as well as government representatives. This publication will provide you with valuable information on:
  • The potential impact of pending Patent Reform Legislation on pharmaceutical patent life cycles
  • The economic and R&D impact of follow-on biologics on the industry
  • How the courts are interpreting the Hatch-Waxman reform provisions of the MMA, with respect to:
    • Orange Book listings and challenges
    • Exclusivity: 180-day exclusivity, orphan drug, pediatric and beyond
    • How Integra has impacted the Safe Harbor
    • Authorized generics: will the FTC take action?
    • The impact of Hatch-Waxman reform in the US on EU pharmaceutical patent practice

Contents & Contributors


ESSENTIALS OF PHARMA/BIO PRODUCT LIFE-CYCLE ENHANCEMENT
Martin A. Voet, Allergan Inc.

HATCH-WAXMAN OVERVIEW: FROM POLITICS TO PATENTS TO PRODUCTS
Nicole Fortune, Patent Attorney

HATCH-WAXMAN OVERVIEW: FROM POLITICS TO PATENTS TO PRODUCTS
Ann M. Caviani Pease, Dechert LLP

THE TIMES, THEY ARE A'CHANGING: LEGISLATIVE PROPOSALS ON PATENT REFORM AND ADMINISTRATIVE LAW CHANGES: PROPOSED PTO RULES
Charles Berkman, Ligand Pharmaceuticals Inc.
Robin M. Silva, Dorsey & Whitney LLP

WHAT'S GOING ON WITH "BIOSIMILARS"?
Robin M. Silva, Dorsey & Whitney LLP

BIOEQUIVALENCE TESTING
Charles Raubicheck, Frommer Lawrence & Haug LLP

THE FDA'S ROLE IN PHARMACEUTICAL PATENT LIFE CYCLES
Donald O. Beers, Arnold & Porter LLP

ORANGE BOOK LISTING STRATEGIES: CONSIDERATIONS AND CHALLENGES
Barry S. White, Frommer Lawrence & Haug LLP

180-DAY EXCLUSIVITY
Margaret M. Snowden, Impax Laboratories, Inc.
Jessica R. Wolff, Heller Ehrman LLP

"EXCLUSIVITY" BY OTHER MEANS
Peter J. Gluck, Greenberg Traurig LLP

THE INEQUITABLE CONDUCT DEFENSE IN PATENT LITIGATION: CURRENT ISSUES
Robert J. Goldman, The Fish & Neave Intellectual Property Group of Ropes & Gray, LLP

RESEARCH TOOLS/PLATFORM TECHNOLOGIES AND 271(E)(1) PROTECTED? IF NOT, WHAT THEN?
Elizabeth Howard, Orrick Herrington & Sutcliffe LLP

HOW BROAD IS THE "SAFE HARBOR"? MERCK V. INTEGRA
Gladys H. Monroy, Morrison & Foerster

FTC INITIATIVES TO PROMOTE COMPETITION IN THE PHARMACEUTICAL INDUSTRY
Seth Silber, U.S. Federal Trade Commission

AUTHORIZED GENERICS: THE INDUSTRY CONUNDRUM
Robert C. Funsten, Stradling Yocca Carlson & Rauth
Kevin D. McDonald, Jones Day
Christopher Stomberg, Bates White LLP

AUTHORIZED GENERICS: A NEW SHERMAN ACT FOR DRUG COMPANIES?
Kevin D. McDonald, Jones Day

THE INTERPLAY BEWTWEEN EU PATENT PRACTICE AND US HATCH-WAXMAN REFORM
Dr. Andreas von Falck, Lovells

NEW PRE-COMMERCIALIZATION CONCERNS FOR SMALL MOLECULES AND BILOGICS
Greg Brooks, Allergan Inc.

DRUGS AND BIOLOGICS: THE REGULATORY APPROVAL PROCESS
Charles Raubicheck, Frommer Lawrence & Haug LLP

HATCH-WAXMAN, GENERIC BIOLOGICS, AND THE PATENT-REGULATORY INTERFACE
Dale L. Rieger, Jones Day

NEW STRATEGIES FOR OBTAINING PHARMACEUTICAL PATENT EXTENSIONS
Daniel M. Becker, Dechert LLP



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