Dr Aisling M. McMahon, Lecturer Newcastle Law School, and our Caroline Miles visiting Scholar in March this year
Recent international developments in gene patenting raise questions again about how bioethical concerns surrounding the grant of patents on health-related technologies are addressed or engaged with by patent law. In 2013 and 2015, the Supreme Court of the United States and the Australian High Court, respectively, delivered judgments rejecting the patentability of isolated genes. Both disputes involved Myriad’s patents on BRCA1 and BRCA2 genes. Subsequently, in March 2016 a Canadian case involving the Children’s Hospital of Eastern Ontario’s (CHEO) challenge to patents on genes related to Long QT Syndrome (LQTS) (a condition that can potentially cause irregular and chaotic heartbeats) was settled. The settlement provided a licence to CHEO to test for the syndrome and this has appeared to quell public concerns.
Despite differences in the legal frameworks for gene patentability in these jurisdictions, a common thread is that the primary impetus for the above legal challenges were concerns relating to the alleged implications such gene patents had for individuals’ health, however, there was limited engagement with such concerns in the resulting judgments. Instead, the legal cases focused on whether isolated genes met: (1) patent eligibility standards i.e. are isolated genes suitable patent subject matter – are they akin to an invention which is patentable, or a discovery/natural substance which is not patentable; (2) patentability criteria i.e. are they novel, do they demonstrate inventive step and industrial application. In contrast, objections relating to access to health derive from the fact that the grant of a patent gives the patent holder a right to exclude others from using that invention. Accordingly, patents on isolated genes result in a right to exclude others from isolating a gene under patent. This has implications for genetic testing as patent holders can limit/prohibit others offering genetic tests to isolate such genes. For example, prior to the US decision in 2013, Myriad held a patent over the BRCA1/2 genes which they used to stop other companies providing genetic test for mutations on the BRCA1/2 genes. Such mutations give rise to an increased risk of developing breast and ovarian cancers and individuals sought to test for these as if positive, among other options, they could decide whether to undergo preventive surgical measures. If there is only one genetic test provider this can result in high costs for tests which can mean some patients may be unable to afford testing. Moreover, if only one provider exists there is no way to obtain a second opinion from a different provider. The quality/standard of testing can also be an issue if no alternative provider is in operation. Furthermore, at a general level, gene patents can potentially hinder downstream biomedical research if researchers cannot get access to such genes under patent.
The public debate and legal challenges to gene patentability highlighted above in the US, Australia and Canada, were driven primarily by access to health objections, including difficulties for patients to access genetic testing under patent e.g. due to high costs. However, in the US/Australian decisions, which ultimately rejected patentability of isolated genes, the focus of the reasoning of the Supreme and High Courts, respectively, was on objections surrounding patent eligibility of isolated genes, with limited direct engagement or discussion of the access to health issues involved. Accordingly, although the outcome of the decisions has the effect of rejecting patents on the isolated genes in question, the reasoning is based on a narrower application of technical patent eligibility criteria. The Canadian challenge involving CHEO’s dispute over genes related to LQTS is different in the sense that it was settled by providing a public health licensing agreement between CHEO and Transgenomic (who hold the patents). This settlement provides a tailored solution in the case of these particular patents which could potentially be used in other cases provided other patent holders wished to do so. However, the settlement also means that the Canadian courts have not had the opportunity to decide on the validity of isolated gene patents in Canada – or engage with the health implications of patents on genes – and thus for the time being at least, such patents still appear available.
In short, a disconnect is evident between how concerns surrounding gene patents are framed in public debate and policy circles – which focus on the health implications – and how these concerns are engaged with in the patent law context – where broader public health issues tend to be marginalised and instead the focus is on how isolated genes meet traditional patentability standards. Dialogue across health and legal disciplines is needed in order to bridge this disconnect as at the moment intellectual property frameworks and public health discussions around gene patentability appear to be speaking at but not to each other.
The author would like to acknowledge the support of a Caroline Miles Scholarship which funded a visit to the Ethox Centre, University of Oxford in March 2017. Later in 2017, the author will also conduct empirical work on gene patentability in the US, Canada and Europe with the support of a British Academy/Leverhulme Small Grant.
 Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S., 133 S. Ct. 2107 (2013).
 D’Arcy v. Myriad Genetics Inc.,  HCA 35.
 See generally, CHEO reaches ‘historic’ settlement with gene patent owner’ CBC News Ottawa, 9th March 2016 available at http://www.cbc.ca/news/canada/ottawa/cheo-gene-patent-lawsuit-settlement-1.3483433 .
 This is the European terminology, but similarly in the US, patentability criteria focus on if an invention is new, non-obvious and useful.
 For a general overview of arguments on gene patentability, see: Naomi Hawkins, ‘Human Gene Patents and Genetic Testing in Europe: A Reappraisal’ (2010) 7(3) SCRIPTed 453-473 available at https://script-ed.org/wp-content/uploads/2016/07/7-3-Hawkins.pdf .