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International divergence in gene patenting

Nicol, D ORCID: 0000-0002-6553-2839, Dreyfuss, RC, Gold, ER, Li, W, Liddicoat, J ORCID: 0000-0001-7370-3936 and Van Overwalle, G 2019 , 'International divergence in gene patenting' , Annual Review of Genomics and Human Genetics, vol. 20, no. 1 , pp. 519-541 , doi: 10.1146/annurev-genom-083118-015112.

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This review explores the recent divergence in international patent law relating to genes and associated subject matter. This divergence stems primarily from decisions of the highest courts in the United States and Australia on the eligibility of patent claims relating to the BRCA gene sequences. Patent offices, courts, and policy makers have struggled for many years to clearly articulate the bounds of patent claims on isolated and synthetic DNA and related products and processes, including methods for their use in genetic diagnostics. This review provides context to the current divergence by mapping key events in the gene patent journey from the early 1980s onward in five key jurisdictions: the United States, the member states of the European Patent Convention, Australia, Canada, and China. Early approaches to gene patenting had some commonalities across jurisdictions, which makes exploration of the recent divergence all the more interesting.There is insufficient empirical evidence to date to confidently predict the consequences of this recent divergence. However, it could potentially have a significant effect on local industry and on consumer access.

Item Type: Article
Authors/Creators:Nicol, D and Dreyfuss, RC and Gold, ER and Li, W and Liddicoat, J and Van Overwalle, G
Keywords: patents, genetics, Myriad, diagnostics, patentable subject matter, BRCA, international divergence
Journal or Publication Title: Annual Review of Genomics and Human Genetics
Publisher: Annual Reviews
ISSN: 1545-293X
DOI / ID Number: 10.1146/annurev-genom-083118-015112
Copyright Information:

Copyright 2019 Annual Reviews

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