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

1.0 Executive Summary

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

3.1 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

4.1 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

5.1 History of Genes and Gene Patenting

5.1 History of Genes and Gene Patenting (continued)

5.1 History of Genes and Gene Patenting (continued)

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

7.1 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

8.1 Abbott – CDx Patents

8.1 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 AB

8.4 Immune Therapy Holdings AB (continued)

8.5 The University of California

8.6 Sanofi

8.7 Roche (Genentech)

8.8 Boston University

8.9 Genomic Vision

8.10 Zensun Shanghai Science & Technology Ltd.

9.1 Key Findings

9.2 Strategic Recommendations

Legal Disclaimer

10.1 The Frost & Sullivan Story

10.2 Value Proposition: Future of Your Company & Career

10.3 Global Perspective

10.4 Industry Convergence

10.5 360º Research Perspective

10.6 Implementation Excellence

10.7 Our Blue Ocean Strategy