Naomi Hawkins is a Senior Lecturer in Law at the University of Exeter, as well as a Research Fellow of the Oxford Intellectual Property Research Centre and a Research Associate at the Centre for Health Law and Emerging Technologies at Oxford. Her research focuses on the interaction of law and biomedical science, particularly around IPR. She uses traditional legal research and empirical methods to investigate the impact of patents on the development of translational outcomes of genetics and genomics research.
Non-invasive prenatal testing (NIPT) is an exciting new technology enabling safe and accurate testing of the fetus from maternal blood samples, without risk of harm to the fetus. NIPT is one of the first applications of genomic medicine to reach widespread clinical application, and its development and widespread adoption in the clinic around the world has been very rapid. Alongside enthusiasm about the potential of this technology to improve prenatal care, there is also considerable concern about the legal and ethical implications. This paper will report the results of empirical work considering the role of patents in the development and delivery of NIPT. It will examine the results of a qualitative interview study of stakeholders in the translational research process for NIPT in Europe and the USA, exploring their approach to patents. It will then consider the differences in the role of patents between the fields of single gene testing as opposed to NIPT, and analyse the reasons for those differences. The research explores the behaviour of individuals and motivations for compliance with law, in cultural and institutional context. Single gene testing and NIPT are two of the earliest innovations in genomic medicine to be implemented into clinical practice, and are the precursors of many new technologies which are predicted to transform medical practice in the near future. The role that patents play in these two fields therefore constitutes an excellent case study to predict the impact of patents in practice in the burgeoning field of genomic medicine.