Gene Patents and the Marginalisation of Ethical Issues.
European Intellectual Property Review (Forthcoming)
23 Pages Posted: 28 May 2019
Date Written: April 30, 2019
In 2013 and 2015, the Supreme Court of the United States (US) and Australian High Court, respectively, rejected the patentability of isolated genes. Subsequently, in March 2016 a case in the Federal Court of Canada involving the Children’s Hospital of Eastern Ontario’s (CHEO) challenge to patents on genes related to Long QT syndrome was settled. The settlement provided a licence to CHEO to test for the syndrome. A primary driver of the litigation in all three jurisdictions, was the broader ethical issues posed by such patents, including, the potential healthcare implications of such patents. The European Union adopted tailored legislation to deal with biotechnology patents in 1998, including gene patents. Again, in Europe, a primary concern underlying the drafting of the Directive was the ethical issues posed by biotechnological patents.
Nonetheless, despite ethical issues driving challenges to, and debates on changes of patent law in such contexts, in practice ethical issues are given limited consideration within patent law cases in each of these jurisdictions. Using gene patents as a case study, this article argues patent law in these jurisdictions, has failed to engage with the broader ethical issues (including potential healthcare implications) of biotechnological patents in any meaningful way. In effect, a marginalisation of ethical issues is evident within patent law. The only exception to this is Canada, where solutions outside patent law, via licensing, have been devised to deliver access to technologies under patent, focusing on the public health issues at stake.
The article argues that unless and until we adopt fundamental institutional change within patent law to address broader ethical issues inherent in the grant of patents, it behoves us to take seriously and devise appropriately, solutions outside patent law to address such ethical issues including potential healthcare implications posed by patent use. For such reasons, at a practical level, the solution offered by tailored licensing approaches in the Canadian context, although not without some potential shortcomings, is arguably a preferable solution in the short term. Such licensing approaches should be taken seriously in other jurisdictions.
Keywords: Gene Patents, Ethical Issues, Biotechnology, Health
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