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International Divergence in Gene Patenting.

Accepted version
Peer-reviewed

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Type

Article

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Authors

Nicol, Dianne 
Dreyfuss, Rochelle C 
Gold, E Richard 
Li, Wei 

Abstract

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.

Description

Keywords

Myriad, diagnostics, genetics, international divergence, patentable subject matter, patents, Genes, Genetics, Genomics, History, 20th Century, History, 21st Century, Humans, Patents as Topic

Journal Title

Annu Rev Genomics Hum Genet

Conference Name

Journal ISSN

1527-8204
1545-293X

Volume Title

20

Publisher

Annual Reviews

Rights

All rights reserved