The continuing saga of patents and non-invasive prenatal testing

Abstract

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