Companion Diagnostics – A Strategic Review from an IP Perspective (TechVision)

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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.

Table of Contents

1.0 Executive Summary1.0 Executive Summary2.0 Research Objectives and Background2.1 Research Objectives2.2 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 Sector3.0 Key IP Issues for CDx3.1 Key IP Issues Relevant to CDx3.2 TRIPS Agreement Provides Member States Flexibility to Notify Various Categories That Are Excluded from Patenting3.3 Patentability Criteria for Diagnostics in Major Markets3.4 Patenting Opportunities for Diagnostics3.5 Recent Cases Involving Diagnostics/Gene Patenting4.0 Case Study: Understanding Association of Molecular Pathology (AMP) vs. Myriad Genetics4.1 Myriad Genetics – Company and Product Overview4.2 AMP vs. Myriad Case – Facts of the Case and Timeline4.3 AMP vs. Myriad Case – Key Issues and Arguments of Litigants4.4 AMP vs. Myriad Case – Decision of the District Court4.5 Decision of the Court of Appeals for the Federal Circuit4.6 First appeal to the US Supreme Court4.7 AMP vs. Myriad Case – Decision of the US Supreme Court4.8 Business Impact of AMP vs. Myriad Case in Diagnostics Sector4.9 Business Impact of AMP vs. Myriad Case in Therapeutics Sector5.0 History of Gene Patenting5.1 History of Genes and Gene Patenting5.1 History of Genes and Gene Patenting (continued)5.1 History of Genes and Gene Patenting (continued)6.0 Standards of Patentability for Diagnostics Involving Genes6.1 Standards of Gene Patentability6.2 Standards of Gene Patentability: Schematic of Guidelines6.3 Standards of Gene Patentability: Schematics Explained6.4 Factors for “significantly different”: Weighing towards Patent Eligibility 6.5 Factors for “significantly different”: Weighing against Patent Eligibility7.0 Companion Diagnostics – Patent Landscape Analysis7.1 Patent Research Scope and Concepts7.2 Top 20 Patent Holders in the Area of Companion Diagnostics 7.3 Patent Office-wise Distribution of Companion Diagnostics Patent Portfolios, 1996–20167.4 Publication Year-wise Distribution of Companion Diagnostics Patent Portfolio, 2008–20168.0 Profiling of Top 10 Patent Holders in the Area of Companion Diagnostics8.1 Abbott – CDx Patents8.1 Abbott – CDx Patents (continued)8.2 Denovo Biomarkers Inc.8.3 Expression Pathology Inc.8.3 Expression Pathology Inc. (continued)8.4 Immune Therapy Holdings AB8.4 Immune Therapy Holdings AB (continued)8.5 The University of California8.6 Sanofi8.7 Roche (Genentech)8.8 Boston University8.9 Genomic Vision8.10 Zensun Shanghai Science & Technology Ltd.9.0 Key Findings and Strategic Recommendations9.1 Key Findings9.2 Strategic RecommendationsLegal Disclaimer10.0 The Frost & Sullivan Story10.1 The Frost & Sullivan Story10.2 Value Proposition: Future of Your Company & Career10.3 Global Perspective10.4 Industry Convergence10.5 360º Research Perspective10.6 Implementation Excellence10.7 Our Blue Ocean Strategy




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