Public Interest Challenges to Gene Patents

: An Analysis of the Obstacles Faced

Abstract

Legal challenges are an important element of the regulation of gene patents (e.g. Consumer Watchdog v Wisconsin Animal Research Fund), yet successful challenges are rare. The difficulties faced by the public, notably procedural and substantive legal barriers, when seeking to invalidate patents are understudied from a doctrinal and socio-legal perspective. The contribution of this thesis is to address this gap in knowledge by investigating those barriers through a theoretically informed doctrinal and empirical perspective. The doctrinal case study of the legal challenges to BRCA patents held by Myriad in the United States, Australia, and at the European Patent Organisation identifies initial procedural barriers to gene patent challenges, and substantive barriers resulting from judicial interpretations of patent eligibility criteria. The consequent empirical study, informed by 12 interviews with key actors involved in challenging the BRCA patents, identifies further substantive institutional, and cultural hurdles which limit the public’s ability to identify, understand, and successfully challenge such patents. This raises questions about the effectiveness of previously identified mechanisms to increase public engagement with the patent system, including improving access to patent information and relaxing procedural rules; and identifies the difficulties in creating cohesive, consistent coalitions to represent the public interest in the patent system.

Date of Award	2 Dec 2021
Original language	English
Awarding Institution	University of Bristol
Sponsors	Economic and Social Research Council
Supervisor	Aurora Plomer (Supervisor) & Andrew J Charlesworth (Supervisor)