Hatch-Waxman Actの動向

Abstract

Introduction:

Multiple forces can affect the U.S. pharmaceutical market. Understanding their potential impact is critically important for effectively positioning products for market. In 2006, companies, the courts, the Federal Trade Commission, states, and Congress all struggled with how to respond to generics challenges. These entities' agendas are often at odds with one another, and pharmaceutical companies must continuously devise new strategies to remain competitive

Get the Answers You Need to Shape Your Strategy:

• In 1984, when the Hatch-Waxman Act was enacted, the largest pharmaceutical companies had annual worldwide sales of $1.5-2.6 billion. In comparison, generics companies were quite small and struggled to bring products to market. How has Hatch-Waxman changed this scenario over the last 20 years?
• The suggestion that a generics manufacturer that launches a drug before the drug' s patent has expired could be liable for treble damages is exaggerated. What steps can and do generics manufacturers take to avoid such damages?
• One operative procedure for preventing a competing generics product from reaching the market is a motion for a preliminary injunction. What two court decisions will make it more difficult for an innovator company to obtain such an injunction?
• The most politically charged and publicly prominent area of dispute in Hatch-Waxman litigations is pretrial settlement agreements between innovator and generics companies. How has the FTC tried to challenge pretrial settlement agreements?
• Several bills are before the 109th Congress that will affect the pharmaceutical industry if they become law. Which bills are they, and what will their impact be?

Scope:

The Hatch-Waxman Act of 1984: its initial intent, its impact, and its future

Preliminary injunctions: their weakening power

The FTC: its attempts to weaken patent law

States: states' actions through their attorneys general to make drugs more affordable

Federal legislation that could affect the pharmaceutical industry: bills in Congress relating to reverse payments in settlement agreements, authorized generics, citizen petitions, and patent reform

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 .............................................................