Reserve your place now at ACI's 6th annual:

Maximizing Pharmaceutical Patent Lifecycles

The Definitive Hatch-Waxman Event for Brand Names and Generics

Monday, October 17, 2005

About

Are Your Company's Hatch-Waxman Strategies and Tactics In Line With The New Patent End-Game?

Nearly two years ago, the Medicare Modernization Act ("MMA") officially re-invented the patent end game established by the Hatch-Waxman Act. Title XI of the MMA was intended to substantially curtail the ability of brand name manufacturers to extend patent life and quicken the pace of entry of generic pharmaceuticals in the marketplace. The courts are now in the process of determining whether the tactics and strategies which both sides employ in their efforts to either sustain or gain market share are fair or foul within the new law. However, before time is called, new controversies arising from reimportation, patent reform, and "generic" biologics may force the re-invention of the game once again.

Does your company, whether brand name or generic, have the offensive moves and defensive plays it now needs to maximize its most lucrative - or potentially lucrative products ---- on the last day of patent life?

As counsel to either a brand name or generic pharmaceutical company, you need a complete understanding of the latest legal developments and their implications for your company's life cycle strategies. This sixth American Conference Institute publication on Maximizing Pharmaceutical Patent Life Cycles will give you in-depth analysis from an outstanding faculty of leading in-house pharmaceutical counsel and expert attorneys for both the brand-names and generics, as well as government representatives. They will provide insights on:

    The potential impact of pending Patent Reform Legislation on pharmaceutical patent life cycles
    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
      - The current status of Paragraph IV challenges

        - In re Petering
        - Apotex
        - Teva


    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

Are Your Company's Hatch-Waxman Strategies and Tactics In Line With The New Patent End-Game?

Nearly two years ago, the Medicare Modernization Act ("MMA") officially re-invented the patent end game established by the Hatch-Waxman Act. Title XI of the MMA was intended to substantially curtail the ability of brand name manufacturers to extend patent life and quicken the pace of entry of generic pharmaceuticals in the marketplace. The courts are now in the process of determining whether the tactics and strategies which both sides employ in their efforts to either sustain or gain market share are fair or foul within the new law. However, before time is called, new controversies arising from reimportation, patent reform, and "generic" biologics may force the re-invention of the game once again.

Does your company, whether brand name or generic, have the offensive moves and defensive plays it now needs to maximize its most lucrative - or potentially lucrative products ---- on the last day of patent life?

As counsel to either a brand name or generic pharmaceutical company, you need a complete understanding of the latest legal developments and their implications for your company's life cycle strategies. This sixth American Conference Institute publication on Maximizing Pharmaceutical Patent Life Cycles will give you in-depth analysis from an outstanding faculty of leading in-house pharmaceutical counsel and expert attorneys for both the brand-names and generics, as well as government representatives. They will provide insights on:

    The potential impact of pending Patent Reform Legislation on pharmaceutical patent life cycles
    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
      - The current status of Paragraph IV challenges

        - In re Petering
        - Apotex
        - Teva


    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


RETHINKING A LIFE CYCLE GAME PLAN: WHAT ARE THE DRIVERS? WHAT'S THE STRATEGY?
George W. Johnston, Hoffmann-La Roche
John C. Vassil, Morgan & Finnegan

H.R. 2795 REFORMS TO THE U.S. PATENT LAWS
Amy Hamilton, Eli Lilly & Co.

OVERVIEW OF HATCH-WAXMAN REFORMS
Thomas D. Hoffman, Novartis

REFORM AT THE CROSSROADS: HOW WILL PATENT REFORM LEGISLATION IMPACT PHARMACEUTICAL PATENT LIFE CYCLES?
Edward T. Lentz, Patent Attorney

HATCH-WAXMAN REFORMS: LITIGATION SETTLEMENTS
Suzanne E. Babajko, Bristol Myers Squibb Co.

HOW HAVE HATCH-WAXMAN REFORMS CHANGED THE PATENT END GAME?
Brian P. Murphy, Morgan Lewis & Bockius

PROPOSALS TO RESTRICT "AUTHORIZED GENERICS": SOLUTIONS SEARCHING FOR A PROBLEM
Jeffrey B. Chasnow, Pfizer

AUTHORIZED GENERICS: THE INDUSTRY DEBATE
Scott Tarriff, Par Pharmaceuticals

SCOPE OF THE SAFE HARBOR EXEMPTION OF THE HATCH WAXMAN ACT AFTER MERCK V. INTEGRA LIFESCIENCES, 125 S.CT. 2372 (2005)
Brian D. Coggio, Greenberg Traurig

SKB V. APOTEX REVISITED A NEW STANDARD FOR INHERENT ANTICIPATION
Steven J. Lee, Kenyon & Kenyon

HATCH-WAXMAN UPDATE: (I) DECLARATORY JUDGMENT ACTIONS, AND (II) IN RE PETERING
Brian V. Slater, Fitzpatrick, Cella, Harper & Scinto

DOWSING FOR DEVICE PATENTS
Bruce A. Pokras, Pfizer

ORANGE BOOK LISTING: CHALLENGES
Mark Waddell, Chadbourne & Parke

180-DAY EXCLUSIVITY AFTER HATCH-WAXMAN REFORM
Sandra A. Bresnick, Weil, Gotshal & Manges LLP

180-DAY GENERIC MARKET EXCLUSIVITY
Charles Raubicheck, Frommer Lawrence & Haug LLP

"EXCLUSIVITY" BY OTHER MEANS: UPDATE OF CURRENT ISSUES
Matthew B. Van Hook, Engel & Novitt, LLP

FOLLOW-ON BIOLOGICS: WHY THE PROPOSED 505(B)(2) ROUTE TO APPROVAL SHOULD NOT WORK
Donald O. Beers, Arnold & Porter

TRADE DRESS PROTECTION FOR PHARMACEUTICAL PRODUCTS
Dickerson M. Downing, Morgan & Finnegan

FOLLOW-ON BIOLOGICS AND MARKETING EXCLUSIVITY
William D. Hare, Ranbaxy Pharmaceuticals Inc.

EXCLUSIVITY BY OTHER MEANS
Edward T. Lentz, Patent Attorney

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

REGULATORY EXCLUSIVITIES AND LIFE CYCLE MANAGEMENT
Denise L. Loring The Fish & Neave IP Group of Ropes & Gray

PATENT TERM RESTORATION - 35 USC 156 - 37 CFR 1.710 1.791
Richard S. Parr, Merck & Co., Inc.

MAXIMIZING PATENT TERM UNDER 35 U.S.C. 154
Jane T. Gunnison, The Fish & Neave IP Group of Ropes & Gray



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