This study highlights opportunities and risks in diagnostics/companion diagnostics sector from patenting perspective. It provides an overview of key intellectual property (IP) issues, recent cases for diagnostics and gene patenting in the United States and their business impact.
It also provides an overview of the patenting activity in the area of companion diagnostics and strategic recommendations for formulating an appropriate IP strategy.
2. Research Objectives and Background
2.1 Research Objectives
2.2 What Is Companion Diagnostics?
2.3 Why Is Companion Diagnostics so Important?
2.4 Expansive R&D Makes IP Protection a Key Issue in Diagnostics/Pharmaceutical Sector
3. Key IP Issues for CDx
3.1 Key IP Issues Relevant to CDx
3.2 TRIPS Agreement Provides Member States Flexibility to Notify Various Categories That Are Excluded from Patenting
3.3 Patentability Criteria for Diagnostics in Major Markets
3.4 Patenting Opportunities for Diagnostics
3.5 Recent Cases Involving Diagnostics/Gene Patenting
4. Case Study: Understanding Association of Molecular Pathology (AMP) vs. Myriad Genetics
4.1 Myriad Genetics – Company and Product Overview
4.2 AMP vs. Myriad Case – Facts of the Case and Timeline
4.3 AMP vs. Myriad Case – Key Issues and Arguments of Litigants
4.4 AMP vs. Myriad Case – Decision of the District Court
4.5 Decision of the Court of Appeals for the Federal Circuit
4.6 First appeal to the US Supreme Court
4.7 AMP vs. Myriad Case – Decision of the US Supreme Court
4.8 Business Impact of AMP vs. Myriad Case in Diagnostics Sector
4.9 Business Impact of AMP vs. Myriad Case in Therapeutics Sector
5. History of Gene Patenting
5.1 History of Genes and Gene Patenting
6. Standards of Patentability for Diagnostics Involving Genes
6.1 Standards of Gene Patentability
6.2 Standards of Gene Patentability: Schematic of Guidelines
6.3 Standards of Gene Patentability: Schematics Explained
6.4 Factors for “significantly different”: Weighing towards Patent Eligibility
6.5 Factors for “significantly different”: Weighing against Patent Eligibility
7. Companion Diagnostics – Patent Landscape Analysis
7.1 Patent Research Scope and Concepts
7.2 Top 20 Patent Holders in the Area of Companion Diagnostics
7.3 Patent Office-wise Distribution of Companion Diagnostics Patent Portfolios, 1996–2016
7.4 Publication Year-wise Distribution of Companion Diagnostics Patent Portfolio, 2008–2016
8. Profiling of Top 10 Patent Holders in the Area of Companion Diagnostics
8.1 Abbott – CDx Patents
8.2 Denovo Biomarkers Inc.
8.3 Expression Pathology Inc.
8.4 Immune Therapy Holdings AB
8.5 The University of California
8.7 Roche (Genentech)
8.8 Boston University
8.9 Genomic Vision
8.10 Zensun Shanghai Science & Technology Ltd.
9. Key Findings and Strategic Recommendations
9.1 Key Findings
9.2 Strategic Recommendations
10. The Publisher's Story
10.1 Value Proposition: Future of Your Company & Career
10.2 Global Perspective
10.3 Industry Convergence
10.4 360º Research Perspective
10.5 Implementation Excellence
10.6 Our Blue Ocean Strategy
- Abbott – CDx Patents
- Boston University
- Denovo Biomarkers Inc.
- Expression Pathology Inc.
- Genomic Vision
- Immune Therapy Holdings AB
- Roche (Genentech)
- The University of California
- Zensun Shanghai Science & Technology Ltd