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在迈利亚德公司案之后的专利组合,如何纳入那些新基因?

Patent portfolios after myriad, how to fit in those new genes?

作者信息

Aceto Joseph F

机构信息

Joseph F. Aceto, Ph.D., Esq., Attorney at Law , 1617 Newark Road, Kennett Square, Pennsylvania 19348, United States.

出版信息

ACS Med Chem Lett. 2013 Jul 12;4(8):681-3. doi: 10.1021/ml400254f. eCollection 2013 Aug 8.

Abstract

The recent US Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. clarified what is considered patentable subject matter. Patent claims limited to the composition of isolated nucleic acid sequences are now considered a product of nature and not patent eligible, while man-made variants of nucleic acid sequences may still be patentable. The decision is consistent with an earlier ruling in Mayo Collaborative Services v. Prometheus Laboratories., Inc. related to diagnostic methods. In Prometheus, the Court held that a method simply reciting known steps used to observe a natural event is not patentable subject matter. Taken together, the Court's decisions provide guidance as to what constitutes a natural phenomenon outside patent protection and what is considered a man-made creation worthy of protection. Despite misgivings, both decisions will provide impetus for increased genetic research and development of new therapeutics and diagnostics, especially in genomic and personalized medicine.

摘要

美国最高法院最近在“分子病理学协会诉麦利亚德基因公司案”中的裁决澄清了可授予专利的主题。限于分离核酸序列组成的专利主张现在被视为自然产物,不符合专利资格,而核酸序列的人工变体仍可能获得专利。该裁决与早些时候“梅奥协作服务公司诉普罗米修斯实验室公司案”中关于诊断方法的裁决一致。在普罗米修斯案中,法院认为,一种仅仅叙述用于观察自然事件的已知步骤的方法不属于可授予专利的主题。综合来看,法院的这些裁决为哪些构成不受专利保护的自然现象以及哪些被视为值得保护的人工创造物提供了指导。尽管存在疑虑,但这两项裁决都将推动基因研究以及新疗法和诊断方法的开发,尤其是在基因组学和个性化医疗领域。

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