Do recent US Supreme Court rulings on patenting of genes and genetic diagnostics affect the practice of genetic screening and diagnosis in prenatal and reproductive care?
Do recent US Supreme Court rulings on patenting of genes and genetic diagnostics affect the practice of genetic screening and diagnosis in prenatal and reproductive care?
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美国最高法院最近关于基因和基因诊断专利的裁决是否会影响产前和生殖保健中基因筛查和诊断的实践？
DOI：
10.1002/pd.4445
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发表时间：
2014
影响因子：
3
通讯作者：
VandenVeyver,IgnatiaB
中科院分区：
文献类型：
--
作者：
Chandrasekharan,Subhashini;McGuire,AmyL;VandenVeyver,IgnatiaB
数以千计的专利已经被授予，声称人类基因序列及其用途，有些已经在法庭上受到质疑。在最近一个备受瞩目的案件中，分子病理学协会等诉Myriad遗传学公司，例如，美国最高法院裁定，基因是自然产生的物质，因此不能通过“物质组成”申请专利。这一裁决的后果将远远超出结束Myriad对BRCA测试的垄断，并可能影响其他商业实验室对其他基因测试的类似垄断。它还可以简化围绕全基因组临床测序的知识产权问题，这可以为知识产权所涵盖的基因产生结果。使用母体血液中的无细胞胎儿（cff）DNA进行常见非整倍体的无创产前检测（NIPT）目前通过商业实验室提供，也是正在进行的专利诉讼的主题。最近最高法院在Myriad案中的裁决已经被下级地区法院在NIPT诉讼中援引，并导致目前市场上基于cffDNA的染色体非整倍性检测专利的主要权利要求无效。© 2014约翰威利父子有限公司.
Thousands of patents have been awarded that claim human gene sequences and their uses, and some have been challenged in court. In a recent high‐profile case,Association for Molecular Pathology, et al.v.Myriad Genetics, Inc.,et al., the US Supreme Court ruled that genes are natural occurring substances and therefore not patentable through ‘composition of matter’ claims. The consequences of this ruling will extend well beyond ending Myriad's monopoly overBRCAtesting and may affect similar monopolies of other commercial laboratories for tests involving other genes. It could also simplify intellectual property issues surrounding genome‐wide clinical sequencing, which can generate results for genes covered by intellectual property. Non‐invasive prenatal testing (NIPT) for common aneuploidies using cell‐free fetal (cff) DNA in maternal blood is currently offered through commercial laboratories and is also the subject of ongoing patent litigation. The recent Supreme Court decision in theMyriadcase has already been invoked by a lower district court in NIPT litigation and resulted in invalidation of primary claims in a patent on currently marketed cffDNA‐based testing for chromosomal aneuploidies. © 2014 John Wiley & Sons, Ltd.