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

Accepted version
Peer-reviewed

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Type

Article

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Authors

Liddicoat, Johnathon 
Liddell, Kathleen 
Aboy, Mateo 

Abstract

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.

Description

Keywords

48 Law and Legal Studies, 4806 Private Law and Civil Obligations

Journal Title

Vanderbilt Journal of Entertainment and Technology Law

Conference Name

Journal ISSN

1942-678X

Volume Title

22

Publisher

Elsevier

Rights

All rights reserved
Sponsorship
Novo Nordisk Foundation (via University of Copenhagen) (NNF17SA0027784)