Abstract
Introduction
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 conflicting 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 influence 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 conflicting 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?
Scope
- Landmark DNA patent report: analysis of the U.S. government's report on the influence uence of IP rights on R&D for diagnostics and medicines.
- Stakeholder implications: what patent rights mean for discovery research companies,clinical labs, and Big Pharma.
- Multiplex testing technology: the impact of patent and licensing rights on multiplex tests for gene-disease associations.
- Correlation patents: examples of how correlation patents influence drug R&D.
- In the courts: litigation and court rulings surrounding a high-profile case regarding patentability in biotech.
- Market outlook: our projections for how future court rulings on patents could alter the diagnostics and biotech landscapes.
Mentioned in This Report
Companies
- Abbott
- Affymetrix
- Agilent
- Amgen
- Applera
- Aventis (now Sanofi - Aventis)
- Bayer
- Celera Genomics
- Chiron
- Chugai
- Competitive Technologies
- Dako
- deCode Genetics
- Diagnostic Products
- Corporation
- Genentech
- Gen-Probe
- GlaxoSmithKline
- Human Genome Sciences
- Immunex
- Incyte Genomics
- Laboratory Corporation of America Holdings (LabCorp)
- Lilly
- Merck
- Metabolite Laboratories
- Mohr, Davidow Ventures
- Nanogen
- Novartis
- Novo Nordisk
- Perlegen
- Pfi zer
- Roche
- Sequenom
- University Patents
- Wyeth
Universities
- Baylor College of Medicine
- Columbia University
- Cornell University
- General Hospital
- Georgetown University
- Harvard University
- Johns Hopkins University
- Massachusetts Institute of Technology
- Salk Institute
- Stanford University
- University of California
- University of Colorado
- Health Sciences Center
- University of Pennsylvania
- University of Texas
- University of Wisconsin
Courts
- U.S. Supreme Court
- U.S. Court of Appeals for the Federal Circuit
- U.S. District Court for the District of Colorado
Cases
- LabCorp v. Metabolite
- Diamond v. Chakrabarty
- Diamond v. Diehr
- State Street Bank & Trust Co.
- v. Signature Financial Group
Government Entities
- European Patent Office
- The National Academies
- National Human Genome
- Research Institute
- National Institute of Health
- U.S. Department of Health and Human Services
- U.S. Patent and Trademark Office
- U.S. Securities and Exchange Commission
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
