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

This is the author accepted manuscript. The final version is available from Oxford University Press via the DOI in this record.Data Access Statement: Anonymised interview transcripts from participants who consented to data sharing, plus additional supporting information, are available from the UK Data Service ReSHARE archive, subject to registration, at: 10.5255/UKDA-SN-854190Intellectual 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.Economic and Social Research Council (ESRC

The continuing saga of patents and non-invasive prenatal testing

This is the final version. Available on open access from Wiley via the DOI in this recordObjective: This paper examines the IP landscape for NIPT in three key regions: USA; Europe, with particular focus on the UK, and Australia. Method: We explore the patent law issues against the commercial and healthcare environment in these regions, and consider the implications for development and implementation of NIPT. Results: There are many patents held by many parties internationally, with litigation over these patents ongoing in many countries. Importantly, there are significant international differences in patent law, with patents invalidated in the USA that remain valid in Europe. Despite the many patents and ongoing litigation, there are multiple providers of testing internationally, and patents do not appear to be preventing patient access to testing for those who can pay out of pocket. Conclusion: The patent situation in NIPT remains in a state of flux, with uncertainty about how patent rights will be conferred in different jurisdictions, and how patents might affect clinical access. However, patents are unlikely to result in a monopoly for a single provider, with several providers and testing technologies, including both public and private sector entities, likely to remain engaged in delivery of NIPT. However, the effects on access in public healthcare systems are more complex and need to be monitored.Economic and Social Research Council (ESRC)Australian Research CouncilNational Institute for Health Research (NIHR