非專利藥品之問題解決及降低藥品風險的前端策略

Abstract

Introduction

Any company with a drug worthy of launch in the U.S. market is vulnerable to patent litigation. Even the mere announcement of litigation against an innovator can drastically dampen sales and share prices. As the risk and complexity of litigation continues to increase, the battle between generics companies and pharmaceutical innovators intensifi es. Both sides are ratcheting up their efforts to gain advantage under various statutory and regulatory provisions of both patent and drug law

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The Hatch-Waxman Act of 1984 attempted to balance the interests of innovator and generic pharmaceutical companies and caused a surge in patent litigation. More than 20 years later, the pharmaceutical market has grown far more complex. How have innovator and generics companies used provisions under the Hatch-Waxman Act, and how have their strategies changed over the years? High-profi le cases are questioning the standards by which patents are enforceable. What pivotal court decisions are shaping patent and drug laws and forcing innovators to analyze their patent development processes? The life spans of pharmaceutical patents are shrinking, and proposed legislation threatens to weaken patents even further. Generics companies can begin the process of challenging a patent when a drug is still in early development. How are innovator companies protecting their patents? What are some additional tactics they can adopt? What lessons can be learned regarding how to respond to a generics challenge without mishandling a billion-dollar drug, as happened with Bristol-Myers Squibb and Sanofi -Aventis over Plavix?

Decision Resources, Inc. 12-2

Scope

• Hatch-Waxman Act and Procedure: new drug application (NDA); abbreviated new drug application (ANDA); paragraph I, II, III, and IV certifi cations; authorized generics; and the 180-day incentive
• The changing landscape of patent litigation: interaction of patent and drug law, sameness requirements, petitioning the FDA, citizen petition, 505(b)(2) NDA application, "carve-out"and "section viii statement."
• Front-end litigation strategies: patent and FDA procedures, positioning for advantage, judicial decisions, launching at risk, and authorized generics
• Outlook: future implications for generic and innovator pharmaceutical manufacturers, regulators, legislators, and enforcement agencies

Table of Contents

• Executive Summary
• Strategic Implications
• Stakeholder Implications
• Generic Pharmaceuticals
• The Changing Landscape of Pharmaceutical Patent Litigation Risk
• Hatch-Waxman Act
• Strategic Use of the Hatch-Waxman Procedure
• Hatch-Waxman Procedure
• Authorized Generics and the 180-Day "Incentive"
• The Growing Challenge to Patents-Interaction of Patent and Drug Law
• Coordinating Patent and NDA Submissions
• Sameness Requirements
• Petitioning the FDA
• The Citizen Petition
• The Zocor Case-Merck Declines to Sue, then De-Lists Its Patents
• "Carve-Out" and "Section viii Statement"
• 505(b)(2) NDA Application
• Biogenerics-"Follow-On" Biologicals
• Patent Litigation
• Outlook

Tables

• 1. Select Authorized Generic Launches, 2005-2007
• 2. Coordination of Patent and Regulatory Strategies
• 3. Select Generics Company Mergers and Acquisitions, 1996-2006

Figures

• 1. Dollar Value of Brand Drugs Going Off-Patent, 1995-2010
• 2. Receipts of Original Abbreviated New Drug Applications (ANDAs), 2001-2006
• 3. Approvals and Tentative Approvals of ANDAs, 2000-2006
• 4. Hatch-Waxman Framework for Litigation
• 5. Abbreviated New Drug Applications (ANDAs) Filed With Paragraph IV Certifications,2003-2006
• 6. Sales of Drugs Challenged With a Paragraph IV Patent Certification, 2005
• 7. Pharmaceutical Risk Management and Coordinated Patent and Drug Analysis