Gene Patents Still Alive and Kicking: Their Impact on Provision of Genetic Testing for Long QT Syndrome in the Canadian Public Health-Care System

Abstract

Purpose: Although the Supreme Court of the United States limited their availability in Association for Molecular Pathology v. Myriad Genetics, gene patents remain important around the world. We examine the situation in Canada, where gene patents continue to exist, in light of recent litigation relating to familial long QT syndrome (LQTS).

Methods: We conducted in-depth semistructured interviews with 25 stakeholders across five Canadian provinces and supplemented this with a case analysis of the litigation.

Results: The majority of LQTS testing was carried out outside Canada. Rising costs prompted several provinces to attempt to repatriate testing. However, LQTS gene patents stymied efforts, particularly in provinces where testing was more centralized, increasing costs and lowering innovation. It was in this context that a hospital launched a test case against the LQTS patents, resulting in a novel agreement to free Canadian hospitals from the effects of patents.

Conclusion: Our analysis reveals a rapidly evolving genetic test provision landscape under pressure from gene patents, strained budgets and poor collaboration. The litigation resulted in a blueprint for free public use of gene patents throughout Canada's health-care system, but it will only have value if governments are proactive in its use.

Keywords: Access, Equity, Gene Patents, Intellectual Property, Long QT Syndrome