Are Genomic and Proteomic Patents Hindering Drug Development? : Market Research Report

Are Genomic and Proteomic Patents Hindering Drug Development?

Published: Nov. 9, 2006 - 22 Pages

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Executive Summary: Strategic Considerations; Stakeholder Implications; Overview; National Academies 2006 Report; Genomic and Proteomic Patents; Sidebar: Medical Correlations Claimed in U.S. 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 U.S. Supreme Court; Outlook
Tables: 1. Numbers of U.S. and European Patents in Genomic and Proteomics 2. Complexity of Biomarker Patent Claims: An Example; Figures; 1. Numbers of DNA-Based U.S. Patents by Year of Issue, 1971-2006; 2. Entities Holding the Largest Numbers of DNA-Based U.S. Patents, September 28, 2006; 3. Chemical Structures of Homocysteine and Related Sulfhydryl Amino Acids; 4. Homocysteine Metabolism Requires B-Complex Cofactors

Abstract

Sequencing the human genome resulted in a surge of patents for biomarkers, disease correlations, and their commercial uses. Are these patents now forming a barrier to the development and uptake of diagnostic tests and disease therapies? Going forward, how can various players in this field accommodate confl icting business needs and forge mutually agreeable collaborations?

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Business strategies in the biotech, diagnostic, and pharma industries depend upon product development. How does the current intellectual property environment pose a barrier to product development? What role do patents on gene-disease correlations play in limiting companies' willingness (or ability) to create new products and treatment protocols?

The interpretation of patent law changes over time, as shown by the recent U.S. Supreme Court involvement in the LabCorp v. Metabolite case. What is the future trend in court opinion toward correlation patents? How can the law infl uence the growth of the diagnostic test industry? Will such decisions have further-reaching impact across other industries?

There is a natural tension between industry players who would discredit the validity of correlation patents and those whose business depends on such patents. What is the best way for these two groups to accommodate their confl icting business needs? What challenges will these industries face as they search for mutually agreeable collaborations?

For now, biomarker-disease correlations are patentable, and such patents will continue to be granted. Will it become more diffi cult for companies to defend their correlation patents? How will weakened patent law for disease correlations impact market exclusivity and the willingness of companies to pursue costly R&D?

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Are Genomic and Proteomic Patents Hindering Drug Development?

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Abstract