Are Genomic and Proteomic Patents Hindering Drug Development

Table of Contents

• Executive Summary
• Strategic Considerations
• Stakeholder Implications
• Overview
• National Academies 2006 Report
• Genomic and Proteomic Patents
• Sidebar: Medical Correlations Claimed in US Patents and Patent Applications
• Genomic and Proteomic Technologies
• Pending Patent Applications
• The National Academies' Recommendations
• Implications for Stakeholders
• Discovery Research Companies
• Clinical Labs
• Big Pharma
• Conflicting Stakeholder Interests
• Multiplex Testing Patent Pools
• Casting Doubt on Correlation Patents
• Patentable Subject Matter
• Total Homocysteine (tHcy) Correlation Patent
• The Invention
• Disease Correlation
• LabCorp and Metabolite Litigation
• Glimpses into the Thinking of the US Supreme Court
• Outlook

Tables

• 1. Numbers of US and European Patents in Genomic and Proteomics
• 2. Complexity of Biomarker Patent Claims: An Example

Figures

• 1. Numbers of DNA-Based US Patents by Year of Issue, 1971-2006
• 2. Entities Holding the Largest Numbers of DNA-Based US Patents, September 28, 2006
• 3. Chemical Structures of Homocysteine and Related Sulfhydryl Amino Acids
• 4. Homocysteine Metabolism Requires B-Complex Cofactors