A recent decision by the United States Supreme Court places the patenting of diagnostic tests to the forefront of medical policy, bringing into sharp focus the potential conflict between access to the latest diagnostic techniques and encouraging invention and commercialisation.
Against this backdrop, the Centre for Law, Medicine and Life Sciences, together with the Centre for Science and Policy, hosted an Expert Workshop on genomic medicine and intellectual property, bringing together academics, law professionals, medical practitioners and policy makers.
The Supreme Court decision in question relates to the case of Ariosa Diagnostics v Sequenom in which the US Federal Circuit Court deemed that Sequenom’s method of detecting paternally-inherited DNA using a non-invasive prenatal diagnostic technique was, as written in the patent application, not eligible for a patent. In effect this meant that Sequenom was not allowed a patent for its innovation, and could not prevent other companies from copying or developing an equivalent method. This has, of course, affected the price at which it can sell or licence its innovation. The Supreme Court’s decision (not to allow Sequenom to appeal the Federal Circuit’s decision) compounds an earlier similar decision in the case of Mayo Collaborative Services v Prometheus Laboratories in 2012. The combined effect of these cases, and the now-diminishing likelihood of the Supreme Court revisiting and overturning recent case law, threatens to invalidate a number of similar patents in the US, and may influence legal developments in Europe.
The purpose of this workshop was to discuss the likely ripples these recent decisions will have in the near future for similar patents, with considerations divided broadly between the effects on innovation and the effects on access to treatment, and what research was needed to inform future policy.
Discussion at the workshop revealed that the Supreme Court’s justifications in Ariosa and Prometheus were controversial and not clear-cut. One perspective was that the rulings would be highly problematic for further advances in US genomic medicine, particularly when viewed in the light of other rulings preventing the patenting of stretches of isolated genomic DNA. Relatedly, unpublished research shown during the workshop demonstrates that the Prometheus ruling has lengthened processing time for US patent applications and resulted in more patent applications being abandoned. However, some viewed these data as representing a period of adjustment and adaptation in patent practice. Therefore diagnostic innovations, if carefully described in patent applications, could still receive patent protection. Another view was that the rulings were a welcome development, ensuring competitive pricing for innovative diagnostics and thus making them affordable for a greater number of patients.
Notwithstanding these divergent perspectives, there was general agreement that there is inadequate understanding of measures to promote innovation of new diagnostics, and that further research into the effectiveness of incentives would benefit innovators and patients alike.
What will be the impacts of these decisions?
Although US Supreme Court decisions and US patent legislation is binding only in the US, the US position on the patentability of genomic tests has the potential to impact on patients in the UK and Europe. Legal arguments and opinions are ‘transferable’, even if decisions are not enforceable. Already the NHS is reassessing the financial viability of some non-invasive prenatal diagnostic tests due to royalty claims from Illumina who control the patents in the UK.
Some business-minded participants at the workshop saw an economic opportunity for the UK to consolidate its position as a fertile location for innovation in genomic and precision medicine – since Europe is offering patent protection where the US is not. Other participants saw an opportunity to persuade national patent judges to follow the general direction of US judges. With the European Patent Office still approving patents of a similar nature to those which are now invalid in the US, the jury is out on which approach to patenting genomic tests will benefit patients and genomic science in the long term.
The organisers are immensely grateful to everyone who participated on the day, and to the Philomathia Foundation and the Cambridge-Wellcome Trust Institutional Strategic Support Programme for funding the event.
6 September 2016
This workshop will bring together academic and industry experts with relevant policy makers to discuss and analyse recent legal decisions in the US and Europe, and their implications for the future of precision medicine.