Maximizing Pharmaceutical Patent Life Cycles

The Up-to-Date Playbook for Brand Names and Generics

Monday, October 04, 2004

About

There's a new pharmaceutical patent endgame - with new rules. Do you have the strategies and tactics that you need to maximize and protect your revenues?

The rules of the patent endgame have dramatically changed in the last year. The introduction of the Final FDA Rule in June 2003 set the tone for change through its provisions on patent listings and stays. Yet, it was not until the passage of the Medicare Modernization Act ("MMA") this past November that the game was officially re-invented. Title XI of the MMA, like the provisions of the Final FDA Rule "The Final Rule"* that it superseded, substantially curtails the ability of the brand names to extend patent life and quickens the pace of the entry of generic pharmaceuticals into the marketplace.

However, the heightening political controversy over generic biologics, importation, re-importation and counterfeiting may force the re-invention of the game yet again. What course of action should your company take in the midst of these dynamic legal, regulatory, and political changes? 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?

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 updated publication will give you the latest legal strategies and tactics for successful maneuvering in the new patent endgame.

Contents & Contributors

About

There's a new pharmaceutical patent endgame - with new rules. Do you have the strategies and tactics that you need to maximize and protect your revenues?

The rules of the patent endgame have dramatically changed in the last year. The introduction of the Final FDA Rule in June 2003 set the tone for change through its provisions on patent listings and stays. Yet, it was not until the passage of the Medicare Modernization Act ("MMA") this past November that the game was officially re-invented. Title XI of the MMA, like the provisions of the Final FDA Rule "The Final Rule"* that it superseded, substantially curtails the ability of the brand names to extend patent life and quickens the pace of the entry of generic pharmaceuticals into the marketplace.

However, the heightening political controversy over generic biologics, importation, re-importation and counterfeiting may force the re-invention of the game yet again. What course of action should your company take in the midst of these dynamic legal, regulatory, and political changes? 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?

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 updated publication will give you the latest legal strategies and tactics for successful maneuvering in the new patent endgame.

Contents & Contributors

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

INSIGHTS ON KEY LEGISLATIVE AND REGULATORY CHANGES TO THE HATCH-WAXMAN ACT
Patrick Morrisey, Sidley Austin Brown & Wood LLP

THE HATCH-WAXMAN ADENDMENTS IN TITLE XI OF THE MEDICARE MODERNIZATION ACT OF 2003
Brian P. Murphy, Morgan Lewis & Bockius

NEW FDA RULE: A GENERIC PERSPECTIVE
Brendan Magrab, Alpharma, Inc.

FDA'S NEW ORANGE BOOK RULE: OLD AND NEW CLAIMS UNDER THE NEW RULES
Bruce A. Pokras, Pfizer

FDA FINAL RULE: POLYMORPHS
Louis J. Wille, Bristol-Myers Squibb Company

IN THE UNITED STATES COURT OF APPEALS FOR THE ELEVENTH CIRCUITSCHERING-PLOUGH CORP., UPSHER-SMITH LABORATORIES, INC. V. FEDERAL TRADE COMMISSION
Michael S. Wroblewski, U.S. Federal Trade Commission

ORANGE BOOK LISTING STRATEGIES: NEW CONSIDERATIONS AND CHALLENGES: ANTITRUST CONSIDERATIONS AND LISTING CONTROVERSIES
Gregory J. Glover, J.D., M.D., Ropes & Gray

OPPORTUNITIES TO CHALLENGE IMPROPER ORANGE BOOK LISTING
Mark Waddell, Chadbourne & Parke

THE HATCH-WAXMAN ACT: PATENT LISTING AND ENFORCEMENT QUESTIONS
Robert Baechtold, Fitzpatrick, Cella, Harper & Scinto

INVOKING A PATENT CHALLENGE: PARAGRAPH IV CERTIFICATIONS AND BEYOND DECLARATORY JUDGMENTS IN WAXMAN-HATCH LITIGATION
Steven J. Lee, Kenyon & Kenyon

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

A BRIEF OVERVIEW OF THE CURRENT STATE OF 180-DAY GENERIC EXCLUSIVITY
Christopher N. Sipes, Covington & Burling

BEYOND PATENT PROTECTION: EXCLUSIVITY BY OTHER MEANS
Donald O. Beers, Arnold & Porter

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

EXCLUSIVITY BY OTHER MEANS
Edward T. Lentz, Patent Attorney

THE SCOPE OF PROTECTION UNDER THE "SAFE HARBOR" PROVISION OF THE HATCH-WAXMAN ACT AND THAT OF FOREIGN COUNTERPARTS; APPLICABILITY OF THE "SAFE HARBOR" PROVISION TO RESEARCH TOOL PATENTS; AND SECTION 271(e) AND THE IMPORTATION OF DATA
Brian D. Coggio, Orrick, Herrington & Sutcliffe LLP

COMPULSORY LICENSING & RE-IMPORTATION
Edward T. Lentz, Patent Attorney

PATENT TERM ADJUSTMENT: PURSUANT TO THE AMERICAN INVENTORS PROTECTION ACT
Natalie M. Derzko, Covington & Burling (Washington, DC)

SECOND GENERATION PATENTS
Denise L. Loring, Fish & Neave

PATENT TERM RESTORATION IN THE UNITED STATES 35 USC 156
Richard S. Parr, Merck & Co., Inc.

GETTING AN EXTENSION ON YOUR PHARMACEUTICAL PATENTS
Anthony D. Sabatelli, PhD, JD, Rib-X Pharmaceuticals, Inc.

PREPARATION AND SUBMISSION OF PARAGRAPH IV CERTIFICATIONS AND NOTICE LETTERS
Barry S. White, Frommer Lawrence & Haug
Charles J. Raubicheck, Frommer Lawrence & Haug LLP
Phanesh B. Koneru, PhD, LLM, Formerly with Watson Pharmaceuticals



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