Association for Molecular Pathology v. Myriad Genetics: A Critical Reassessment

Abstract

The Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is part of the Court’s recent quartet of patent eligibility decisions, which also includes Bilski v. Kappos, Mayo v. Prometheus and Alice v. CLS Bank. Each of these decisions has significantly shaped the contours of patent eligibility under Section 101 of the Patent Act in ways that have been both applauded and criticized. The Myriad case, however, was significant beyond its impact on Sec-tion 101 jurisprudence. Perhaps one of the most remarkable things about Myriad is that it meant so many different things to so many different people. It was seen, and tried, as a case impacting patient rights, access to healthcare, scientific freedom, and human dignity. In this article, portions of which will appear in a forthcoming book, I offer a close textual analysis of the Myriad decision, responding to both its critics and supporters. I then situate Myriad within the larger context of biotechnology patenting, the commercialization of publicly funded university research and the U.S. healthcare system. I conclude with observations about the ways that cases like Myriad exemplify the manner in which the common law evolves, particularly in areas of rapid technological change.

Keywords: Myriad, BRCA, Diagnostics, Patent, Gene, ACLU, Patentability