Centre for Intellectual Property Policy, Faculty of Law, McGill University, Montreal, Canada.
Department of Human Genetics, McGill University, Montreal, Canada.
Genet Med. 2017 Nov;19(11):1253-1259. doi: 10.1038/gim.2017.43. Epub 2017 May 11.
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.
目的
尽管美国最高法院在 Association for Molecular Pathology v. Myriad Genetics 一案中限制了它们的可用性,但基因专利在全球仍然很重要。我们根据与家族性长 QT 综合征(LQTS)相关的最新诉讼,考察了加拿大的情况,该国的基因专利仍然存在。
方法
我们在加拿大五个省与 25 名利益相关者进行了深入的半结构化访谈,并对诉讼进行了案例分析。
结果
大多数 LQTS 检测是在加拿大境外进行的。成本上升促使几个省份试图将检测收回。然而,LQTS 基因专利阻碍了这一努力,尤其是在检测更加集中的省份,增加了成本并降低了创新性。正是在这种情况下,一家医院对 LQTS 专利提起了诉讼,导致达成了一项新的协议,使加拿大的医院免受专利的影响。
结论
我们的分析揭示了在基因专利、紧张的预算和不佳的合作的压力下,遗传检测服务不断变化的格局。这场诉讼为加拿大医疗保健系统内免费使用基因专利提供了一个蓝图,但只有在政府积极利用这一蓝图的情况下,它才具有价值。