Patents and non-invasive prenatal testing: Is there cause for concern?

Abstract

Abstract Intellectual property rights are key to the translation of discoveries into clinical use in personalised medicine. This article explores the interaction of intellectual property rights, specifically patents, with the field of genomic personalised medicine, through empirical work investigating the role that patents play in the development and delivery of non-invasive prenatal testing (NIPT). Single gene testing (SGT) and NIPT represent examples of two different types of innovation likely to be important in personalised medicine, and which operate differently in terms of how the law is applied in practice. In SGT, on the one hand, previous studies demonstrate that patents have little impact on practice for those developing genetic tests in the public sector in the UK because they are largely ignored. In contrast, however, this qualitative interview study finds that law and law-in-practice in NIPT are much more convergent than found in SGT. Those involved in the development and delivery of NIPT are more aware of patents, and balance the costs and benefits of greater engagement or compliance with patent law, in relation to factors such as freedom to operate, litigation, and licensing, in favour of compliance. Compliance can take different forms; licensing is compliance, as is forbearance from using a patented invention in the absence of a patent licence. This article explores the factors relevant to patent law compliance in NIPT, and further considers the implications for the field of personalised medicine. It argues that, as the prevalent means to promote openness, access, and affordability in biomedicine are founded on the existing legal structures of intellectual property rights, such solutions will only be effective and adopted when these existing legal structures of intellectual property law are recognised and respected in the relevant field. It is therefore essential that such solutions only be deployed with a nuanced understanding of the operation of the law-in-practice.