The Effects of Myriad and Mayo on Molecular Test Development in the US and Europe: Interviews from the Frontline
35 Pages Posted: 29 May 2019 Last revised: 31 Oct 2019
Date Written: April 2, 2019
The US Supreme Court decisions in Mayo Collaborative Services v. Prometheus Laboratories and Association for Molecular Pathology v. Myriad Genetic Inc. introduced significant divergences between US and European patentable subject matter law. Both cases related to molecular test technology and changed decades of patent practice. Whether the decisions adversely affect the development of molecular tests has been a matter of much speculation but limited empirical investigation. This interview-based study has three main findings. First, it provides evidence that Myriad and Mayo have negatively affected the development of some molecular tests. Notably, several organizations decided not to develop tests, and many have found the legal uncertainty following the cases problematic. Second, the results show that small, “patent precarious” organizations that rely heavily on patents for competitive advantage have been most affected. Third, the study indicates that US headquartered organizations have been more affected by 35 USC § 101 case law developments than European organizations, even though both types of organizations file for US patents.
Keywords: patent, patentable subject matter, patent eligibility, 35 USC 101, US, Europe, interviews, empirical, comparative
JEL Classification: D23, L24, K1, O3, O30, O31, O32, O33, O34, O38, O57, K4, K40, K49
Suggested Citation: Suggested Citation