About
The rules of the patent endgame are rapidly changing. Do you have the strategies and tactics you need to maximize and protect your revenues?
Big Pharma, already facing the challenges of an unprecedented wave of upcoming patent expirations, is now in the midst of a political windstorm with an uncertain outcome.
In the last few months alone, these developments - the FTC report on Generic Competition, the passage of S.812 by the Senate, President Bush's recent proposal for FDA rulemaking on the matter of generic entry and the FDA's announcement that it would accept comments on the proposed rulemaking - have all added to the complexity of preserving patent life and the profits which those patents generate.
Generic manufacturers have their own set of formidable challenges. It has yet to be seen whether they will be the victors or victims of the current reforms. And, while the attempt at reform unfolds, their ANDAs are still being challenged.
What course of action should your company take in this atmosphere of dynamic legal and regulatory, not to mention, political change? Does your company, whether brand name or generic, have the offensive moves and defensive plays it needs to maximize its most lucrative - or potentially lucrative products - on the last day of patent life?
As counsel to either Big Pharma or one of its generic counterparts, you need a complete understanding of the latest developments and their implications for your company's life cycle strategies. This
third and all new
American Conference Institute event presented 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. They provided insights from their own experiences on:
- Directing your life cycle management team when the rules of the game are in rewrite
- Which proposed legislative, administrative and political reforms are the most viable
- Strategies for solving end of patent life problems in this time of sweeping change
- The latest on proposed reforms to Orange Book listings and how they will impact exclusivity and the 30 month stay
- Where biological products and "biogenerics" fall in the Hatch-Waxman debate
- How Safe Harbor protections will be affected by the proposed reforms
- The effect of Festo and other key cases and pending actions on patent life cycles
- The threat that compulsory licensing in the international arena poses to US patents
Whether you attended
ACI's inaugural conference on
Legal Strategies for Maximizing Pharmaceutical Patent Life Cycles last May or its encore in September, these new and updated event materials will bring you the latest legal strategies and tactics for successfully maneuvering through this playing field of reform which is still under construction.
Take this opportunity to hear from those on the first string as they meet the new challenges affecting pharmaceutical patent life cycles.
About
The rules of the patent endgame are rapidly changing. Do you have the strategies and tactics you need to maximize and protect your revenues?
Big Pharma, already facing the challenges of an unprecedented wave of upcoming patent expirations, is now in the midst of a political windstorm with an uncertain outcome.
In the last few months alone, these developments - the FTC report on Generic Competition, the passage of S.812 by the Senate, President Bush's recent proposal for FDA rulemaking on the matter of generic entry and the FDA's announcement that it would accept comments on the proposed rulemaking - have all added to the complexity of preserving patent life and the profits which those patents generate.
Generic manufacturers have their own set of formidable challenges. It has yet to be seen whether they will be the victors or victims of the current reforms. And, while the attempt at reform unfolds, their ANDAs are still being challenged.
What course of action should your company take in this atmosphere of dynamic legal and regulatory, not to mention, political change? Does your company, whether brand name or generic, have the offensive moves and defensive plays it needs to maximize its most lucrative - or potentially lucrative products - on the last day of patent life?
As counsel to either Big Pharma or one of its generic counterparts, you need a complete understanding of the latest developments and their implications for your company's life cycle strategies. This
third and all new
American Conference Institute event presented 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. They provided insights from their own experiences on:
- Directing your life cycle management team when the rules of the game are in rewrite
- Which proposed legislative, administrative and political reforms are the most viable
- Strategies for solving end of patent life problems in this time of sweeping change
- The latest on proposed reforms to Orange Book listings and how they will impact exclusivity and the 30 month stay
- Where biological products and "biogenerics" fall in the Hatch-Waxman debate
- How Safe Harbor protections will be affected by the proposed reforms
- The effect of Festo and other key cases and pending actions on patent life cycles
- The threat that compulsory licensing in the international arena poses to US patents
Whether you attended
ACI's inaugural conference on
Legal Strategies for Maximizing Pharmaceutical Patent Life Cycles last May or its encore in September, these new and updated event materials will bring you the latest legal strategies and tactics for successfully maneuvering through this playing field of reform which is still under construction.
Take this opportunity to hear from those on the first string as they meet the new challenges affecting pharmaceutical patent life cycles.
Contents & Contributors
THE END GAME FOR BRAND-NAME & GENERICS: WHAT'S THE STRATEGY?
George W. Johnston, Hoffmann LaRoche
John C. Vassil, Morgan & Finnegan LLP
HATCH-WAXMAN REFORM: FDA'S PROPOSED RULEMAKING AND
LEGISLATIVE UPDATE
Brian P. Murphy, Morgan Lewis & Bockius
Philip C. Canelli, Morgan Lewis & Bockius
LEGISLATIVE UPDATE – THE FDA'S PERSONAL USE EXCEPTION FOR
THE IMPORTATION OF DRUGS AND 6 MOTH PATENT EXTENSIONS FOR
PEDIATRIC TESTING
Patricia Carson, Clifford Chance
Thomas F. Fleming, Clifford Chance
PHARMACEUTICAL PATENT PRACTICE – A RECOMMENDATION FOR
LIFE CYCLE MANAGEMENT (3): THE CLEAR ZONE
Monte R. Browder, IVAX Corporation
THE EFFECT OF PROPOSED LEGISLATIVE REFORMS ON THE PATENT
ENDGAME
Clifford M. Davidson, Davidson Davidson & Kappel
PROTECTING INNOVATION IN THE PHARMACEUTICAL INDUSTRY
Edward T. Lentz, Law Offices of Edward T. Lentz
WHO CAN LIST WHAT - WHO CAN COMPLAIN HOW: TWO CASES
Steven J. Lee, Kenyon & Kenyon
POLYMORPHS, METABOLITES, INTERMEDIATES, AND PRODUCT-BY-
PROCESS PATENTS: THE STATE OF PLAY
Elizabeth Stotland Weiswasser, Covington & Burling
BIOLOGICAL PATENTS AND THE RISE OF "BIOGENERICS": REGULATORY
AND INTELLECTUAL PROPERTY ISSUES
Gregory J. Glover, M.D., J.D., Ropes and Gray
BIOLOGICAL PATENTS AND THE RISE OF "BIOGENERICS": REGULATORY
AND INTELLECTUAL PROPERTY ISSUES
Roger L. Williams, M.D., United States Pharmacopeia
PHARMACEUTICAL COMPETITION ISSUES
Michael Wroblewski, U.S. Federal Trade Commission
THE SCOPE OF PROTECTION UNDER THE "SAFE HARBOR" PROVISION
OF THE HATCH-WAXMAN ACT AND PROTECTION PROVIDED BY FOREIGN
COUNTERPARTS; APPLICABILITY OF SECTION 271 (e) (1) TO RESEARCH
TOOL PATENTS; AND APPLICABILITY OF SECTION 271 (g) TO TECHNICAL
DATA
Brian D. Coggio, Orrick, Herrington & Sutcliffe LLP
EXCLUSIVITY: WHO CAN STAY AND WHO CAN PLAY?
Charles J. Raubicheck, Frommer Lawrence & Haug LLP
GENERIC MARKETING EXCLUSIVITY UNDER HATCH-WAXMAN:
THE "WHO, WHAT, WHERE AND WHEN"
Henry J. Renk, Fitzpatrick, Cella, Harper & Scinto
Charles J. Raubicheck, Frommer Lawrence & Haug LLP
GENERIC MARKETING EXCLUSIVITY UNDER HATCH-WAXMAN:
THE WHAT, WHO, HOW AND WHEN
Scott K. Reed, Fitzpatrick, Cella, Harper & Scinto
Tara A. Byrne, Fitzpatrick, Cella, Harper & Scinto
PATENTING A DRUG'S BIOLOGICAL MODE OF ACTION
Richard J. Berman, Arent Fox Kintner Plotkin & Kahn
SURVEY OF ORANGE BOOK LISTING CASES AFFECTING
PHARMACEUTICAL PRODUCT LIFE CYCLES
Maxine Y. Graham, Kirkland & Ellis
LIMITATION ON RIGHT TO EXCLUDE DURING THE 156 EXTENSION
PERIOD: AMLODIPINE CASE STUDY
Mark Waddell, Chadbourne & Parke
DEVELOPING A COHERENT CLAIM CONSTRUCTION STRATEGY THAT
WILL BE SUCCESSFUL IN THE DISTRICT COURT AND ON APPEAL
Kelsey I. Nix, Fish & Neave
Bryan J. Vogel, Fish & Neave
THE EFFECT OF FESTO ON PHARMACEUTICAL PATENTS; CLAIM
CONSTRUCTION AND THE DOCTRINE OF EQUIVALENTS: THREE
SUMMARY JUDGEMENTS AND A DENIAL
Steven J. Lee, Kenyon & Kenyon
INTERNATIONAL CONCERNS IN COMPULSORY LICENSING
Stanley L. Amberg, Law Offices of Stanley L. Amberg
Publication Details