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

PurposeAlthough 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).MethodsWe conducted in-depth semistructured interviews with 25 stakeholders across five Canadian provinces and supplemented this with a case analysis of the litigation.ResultsThe 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.ConclusionOur 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.

Fortune and hindsight: gene patents’ muted effect on medical practice

“…13 This link between patents and prices was similarly raised in a recent dispute in Canada concerning genetic testing for familial long QT syndrome. 14 This disconnect between gene patents' effects in the UK and elsewhere may have been partially tied to the patenting and licensing activities of a single company: Myriad Genetics and its patents covering BRCA1 and BRCA2, genes strongly implicated in early-onset breast and ovarian cancer. Unlike most other gene patent holders, Myriad Genetics both refused to outlicense its patents to other clinical laboratories and threatened to sue US clinicians who were performing BRCA1 and BRCA2 sequencing at their own laboratories.…”