The Effects of Myriad and Mayo on Molecular-Test Development in the United States and Europe: Interviews from the Frontline

Johnathon Liddicoat, Kathleen Liddell & Mateo Aboy · 22 Vand. J. Ent. & Tech. 785

Abstract

US Supreme Court decisions in Mayo Collaborative Services v. Prometheus Laboratories and Association for Molecular Pathology v. Myriad Genetics Inc. caused US and European law on what is patentable subject matter to diverge significantly. Both cases related to molecular tests and changed decades of patent practice. Whether the decisions adversely affect the development of molecular tests in the United States and Europe has been a matter of much speculation but limited empirical investigation. This interview-based study has three main findings. First, Myriad and Mayo have negatively affected the development of some molecular tests. Notably, half of the US university technology-transfer offices interviewed decided not to develop tests, and many other organizations have found the legal uncertainty following the cases problematic. Second, small “patent-precarious” organizations—those that rely heavily on patents for competitive advantages, such as technology-transfer offices—have been the most affected because patent protection is now often weaker and more difficult to obtain. Third, US-headquartered organizations have been more affected by 35 U.S.C. § 101 case law developments than European organizations, even though both types of organizations file for US patents. This Article refrains from advising law reform, however, because this study only focused on the adverse effects of the decisions and the positive effects remain unexamined.