Law School, University of Exeter, Exeter, UK.
Law School, University of Tasmania, Hobart, Australia.
Prenat Diagn. 2019 May;39(6):441-447. doi: 10.1002/pd.5450. Epub 2019 Apr 26.
This paper examines the Intellectual Property (IP) landscape for non-invasive prenatal testing (NIPT) in three key regions: the United States; Europe, with particular focus on the United Kingdom; and Australia.
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.
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.
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.
本文考察了非侵入性产前检测（NIPT）在三个关键地区的知识产权（IP）格局：美国、欧洲，特别关注英国；以及澳大利亚。
我们探讨了这些地区的专利法问题对商业和医疗环境的影响，并考虑了这些问题对 NIPT 的开发和实施的影响。
国际上有许多各方持有的专利，许多国家正在对这些专利进行诉讼。重要的是，专利法存在很大的国际差异，在美国无效的专利在欧洲仍然有效。尽管有许多专利和正在进行的诉讼，但国际上有多个检测提供商，而且专利似乎并没有阻止那些能够自费接受检测的患者获得检测。
NIPT 的专利状况仍处于不断变化的状态，对于不同司法管辖区将如何授予专利权利以及专利可能如何影响临床准入存在不确定性。然而，专利不太可能导致单一提供商的垄断，因为多个提供商和检测技术，包括公共和私营部门实体，可能会继续参与 NIPT 的提供。然而，对公共医疗体系中准入的影响更加复杂，需要进行监测。
