Dynamics of Hatch-Waxman Generic Challenges and Impact of the Courts, the FTC, States, and Congress

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Multiple Dynamics in Generics Challenges
• At-Risk Launch of Generics
  • Twenty Years of Change
  • Apotex Challenges Sanofi-Aventis/Bristol-Myers Squibb over Generic Plavix
  • Hyperbole About Treble Damages
    • Wanton and Willful Infringement or Bad Faith Litigation
    • Empirical Studies in Willful Patent Infringement
• Can the Innovator Stop Generic Market Entry with a Preliminary Injunction?
  • Changing Law Regarding Injunctions
    • eBay v. MercExchange
    • Abbott Labs v. Andrx Pharms and Teva (Abbott Case)
  • An Easier Obviousness Standard
• FTC Challenges to the Settlement of Patent Litigation
  • The Role of the FTC
  • The Schering Case
    • Courts Uphold the Right to Settle
    • Redistribution of Relative Risk
    • Crux of the Issue
  • The Tamoxifen Case
    • Scope of the Patent
    • Prior Holding of Patent Invalidity
    • Is the "Reverse Payment" Excessive?
    • Status of Third-Party Payers and Activists
  • In re Ciprofloxacin
  • The Warner Chilcott Case
• Proactive Role of the States
• Proposed Federal Legislation
  • Prohibiting Reverse Payments
  • Banning Authorized Generic Drugs
  • Citizen Petitions
  • Patent Reform
• Outlook
  • Health Care Costs
  • Generics Strategies
  • Hatch-Waxman' s Future

Tables

• 1. Select At-Risk Launches by Generics Companies, 2002-2006
• 2. Infrequency of Treble Damages Awards in Patent Infringement
• 3. Select Patent Litigation Settlement Agreements, 1993-2006
• 4. Select Bills Before the 109th U.S. Congress

Figures

• 1. Hatch-Waxman Framework for Litigation
• 2. Top 1984 Pharmaceutical Companies Compared with Top 2004 Generics Companies
• 3. Federal Trade Commission' s Pharmaceutical Competition Activities
• 4. U.S. Expenditures for Personal Health Care, 2004 .............................................................