4th National

MAXIMIZING PHARMACEUTICAL PATENT LIFE CYCLES

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

Monday, January 26, 2004

About

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

The rules of the patent endgame have dramatically changed. The introduction of the FDA's Final Rule has - at least for the moment - re-invented the game. The Final Rule has severely curtailed the ability of the brand names to extend patent life and has quickened the pace of the entry of generic pharmaceuticals into the marketplace.

However, before time is called, the rules may change again. Presently, there are certain provisions in both the House and Senate versions of the proposed Medicare legislation which would dramatically change portions of the Hatch Waxman Act. There is also concern over the impact of the pending re-importation bill.

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 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 fourth and all new American Conference Institute 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 the brand names and generics, as well as government representatives. The publication will provide insights on:

  • How the Final Rule and proposed legislation will affect: - Orange Book listings and challenges - Paragraph IV Certifications - Exclusivity: 180 day exclusivity, orphan drug, pediatric and beyond
  • The effects of the Integra and Housey decisions on the Safe Harbor
  • The threat of compulsory licensing to US patents
  • The potential effects of re-importation on the patent endgame

Contents & Contributors

About

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

The rules of the patent endgame have dramatically changed. The introduction of the FDA's Final Rule has - at least for the moment - re-invented the game. The Final Rule has severely curtailed the ability of the brand names to extend patent life and has quickened the pace of the entry of generic pharmaceuticals into the marketplace.

However, before time is called, the rules may change again. Presently, there are certain provisions in both the House and Senate versions of the proposed Medicare legislation which would dramatically change portions of the Hatch Waxman Act. There is also concern over the impact of the pending re-importation bill.

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 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 fourth and all new American Conference Institute 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 the brand names and generics, as well as government representatives. The publication will provide insights on:

  • How the Final Rule and proposed legislation will affect: - Orange Book listings and challenges - Paragraph IV Certifications - Exclusivity: 180 day exclusivity, orphan drug, pediatric and beyond
  • The effects of the Integra and Housey decisions on the Safe Harbor
  • The threat of compulsory licensing to US patents
  • The potential effects of re-importation on the patent endgame

Contents & Contributors

RETHINKING A LIFECYCLE GAME PLAN: WHAT ARE THE DRIVERS? WHAT'S THE STRATEGY?
George W. Johnston, Hoffmann LaRoche

MANAGING EXPECTATIONS RELATED TO LIFECYCLE STRATEGIES
Bryan Zielinski, Pfizer Inc.

IMPLEMENTING THE FINAL RULE: WITHER THE 30-MONTH STAY?
Jeffrey B. Chasnow, Pfizer Inc.

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

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

FDA FINAL RULE: POLYMORPHS
Louis J. Wille, Aventis Pharmaceuticals

IN THE MATTER OF SCHERING-PLOUGH CORPORATION, et al. DOCKET NO. 9297 OPINION OF THE COMMISSION
Submitted by: Michael S. Wroblewski, U.S. Federal Trade Commission

THE FTC AND ORANGE BOOK LISTINGS
Gregory J. Glover, JD, MD, Ropes & Gray

FDA/JUDICIAL GUIDANCE ON LISTING MATTERS: THE EFFECT OF FDA'S FINAL RULE
David Korn, Arnold & Porter

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, Ph.D., Kenyon & Kenyon

EXCLUSIVITY: MODES AND METHODS - PART I
Patricia Carson, Kaye Scholer LLP

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

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 SECTION 271(e)(1) TO RESEARCH TOOL PATENTS; AND SECTION 271(g) AND THE IMPORTATION OF DATA
Brian D. Coggio, Orrick, Herrington & Sutcliffe LLP



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