Patents over genes and related diagnostic tests are highly controversial as they can increase costs of diagnostic tests, thereby reducing patients’ access to genetic testing and access for researchers. There is little clarity on the merits of different legal approaches to this issue. However, recent developments internationally raise questions on why divergent legal approaches arise and attract different levels of support across jurisdictions. For instance, in 2013 and 2015, the US Supreme Court and Australian High Court, respectively, rejected the patentability of genes. In both jurisdictions licensing failed to quell public concerns around gene patents. Whilst, in March 2016 a Canadian case involving the Children’s Hospital of Eastern Ontario (CHEO) disputing patents on genes related to Long QT syndrome (a condition involving irregular heart rhythms) was settled by providing a licence to CHEO to test for the syndrome and has quelled public concerns. Conversely, European law expressly allows for genes patent but does not currently give rise to similar levels of controversy. 

This paper examines these divergent legal approaches to gene patentability, using a comparative institutional approach to investigate why these approaches emerged. Drawing on interviews with key actors as well as a close analysis of the legal regimes and the public controversies about those regimes, the paper explores how each jurisdiction’s institutional context – the patent and healthcare systems, and other applicable formal and informal institutions – affected the evolution and success of that jurisdiction’s approach to resolving issues of access, and its social reception and consequences. In doing so, the paper seeks to fill a significant gap highlighting the significance of institutional frameworks applicable within the gene patenting frameworks studied.


Each year the OIPRC hosts a number of leading academics from around the world as part of its Invited Speaker Series. These events typically run from 5:15-6:45pm on Thursday evenings at St. Peter’s College; if the venue or time is different, it will be noted on the Events calendar.  The Speaker Series consists of a presentation of about 45 minutes, followed by a Q&A session with the assembled group of academic staff, students (both undergraduate and graduate), researchers, and interested members of the public.  Discussion is informal and includes participants from several disciplines, with a wide range of prior knowledge.

Convenors: Dev Gangjee and Robert Pitkethly

Refreshments and snacks are served at the conclusion of the discussion.  All are welcome.