The continuing saga of patents and non-invasive prenatal testing.
The continuing saga of patents and non-invasive prenatal testing.
复制标题
专利和无创产前检测的持续传奇。
DOI：
10.1002/pd.5450
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发表时间：
2019
影响因子：
3
通讯作者：
Hawkins N
中科院分区：
文献类型：
--
作者：
Hawkins N
本文研究了三个关键地区的无创产前检测（NIPT）知识产权（IP）格局：美国;欧洲，特别关注英国; and Australia.MethodWe explore the patent law issues against the commercial and healthcare environment in these regions and consider the implications for development and implementation of NIPT.ResultsThere are many patents held by many parties international，在许多国家，对这些专利的诉讼仍在进行。重要的是，专利法在国际上有很大的差异，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，有多个供应商的测试国际，专利似乎并没有阻止患者获得测试那些谁可以支付pocket.ConclusionThe专利的情况下，NIPT仍然处于不断变化的状态，不确定性如何专利权将被赋予不同的司法管辖区，以及如何专利可能会影响临床访问。然而，专利不太可能导致单一供应商的垄断，几个供应商和测试技术，包括公共和私营部门实体，可能会继续参与NIPT的交付。然而，对获得公共保健系统的影响更为复杂，需要加以监测。
ObjectiveThis 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.MethodWe explore the patent law issues against the commercial and healthcare environment in these regions and consider the implications for development and implementation of NIPT.ResultsThere 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.ConclusionThe 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.