As Precision Medicine becomes a reality, molecular tests are an increasingly critical part of patient care. While patients and their physicians would like to maximize access, they have confronted a roadblock in the form of patents covering genes and methods of diagnosis. Many hoped that the landmark 2013 Supreme Court of the United States decision in Myriad v AMP spelled the end of these patents, but the number of gene patents has actually increased since that decision. This is because, while limiting the availability of patents over genomic DNA, the court decision was narrow, leaving substantial grey zones such as over cDNA or where the patent covers a sequence of DNA used in a particular way. Patent agents have been assiduous in exploiting these grey zones to file for and obtain patents over molecular tests. This development points to continued adverse consequences of gene patents not only in the US, but around the world. Our recently published GIM article ‘Gene patents still alive and kicking: their impact on provision of genetic testing for Long QT syndrome in the Canadian public health-care system’, not only examines the impact of gene patents in one country, Canada, but shows how 21st Century contracting can provide a nuanced and pragmatic means to enabling both access and innovation around patented genetic tests.
In Nov 2014, in the first Canadian instance of a public interest ‘test case’ in intellectual property and public health, The Children’s Hospital of Eastern Ontario (CHEO) challenged five patents held by Transgenomic Inc. over a genetic test for Long QT Syndrome (LQTS), a potentially fatal cardiac disorder most commonly striking in children and youth. Widely reported, settled in March 2016, and named as one of the year’s cases having the most impact on intellectual property, the case produced the CHEO Public Health Access Agreement. The Agreement does not itself alter law– gene patents remain valid in Canada. Rather, it constitutes a contractual agreement between parties to the litigation, allowing for efficient, no-cost test implementation. The Agreement explicitly states that Transgenomic will freely grant a license to test the LQTS-associated genes to any entity providing services within Canada’s public healthcare system. That is, except for a marginal private market, all LQTS in Canada can now be provided free.
While the CHEO Agreement is specific to LQTS testing, it threshes a path to achieve similar access to any patented DNA sequence or method. Importantly, this path applies no matter how creative patent agents become in securing patents over molecular tests. To take advantage of this path, hospitals and laboratories wishing to offer a molecular test would simply do so. If a patent holder should come forward and threaten litigation, the hospital or laboratory would simply ask them to sign an analogous agreement to provide a free license concerning those patents. If the patent-holder declines, the hospital or institution has grounds to request the Canadian Commissioner of Patents, under Section 19 of the Patent Act – legislation which is similar in many countries – to compel the patent-holder to issue the license.
We recognize that individual healthcare providers are unlikely to undertake this process alone, given the resources and legal expertise required. Thus, to maximize the efficiency and efficacy of the CHEO Agreement, provincial governments, which fund the healthcare system, will need to take the lead in making these requests. To do so, they need to adopt appropriate procedures and policies.
In summary, the 21st century contracting precedent established by the CHEO Agreement, if properly implemented, has the potential to redress current imbalances between patients and patents, in Canada and beyond. Contracting can achieve rapid public access to much-needed technologies, while sidestepping the need for time-consuming legislative changes, the uncertainties of often piecemeal judicial decisions, and changing patent agent behavior. Finally, by leaving intellectual property law unchanged, biotechnology patents retain their potential to satisfy a key policy goal – providing incentives for the next generation of valuable biotechnology innovation.