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:	Refereed Article
Keywords:	patents, genetics, Myriad, diagnostics, patentable subject matter, BRCA, international divergence
Research Division:	Law and Legal Studies
Research Group:	Law
Research Field:	Intellectual Property Law
Objective Division:	Law, Politics and Community Services
Objective Group:	Justice and the Law
Objective Field:	Law Reform
UTAS Author:	Nicol, D (Professor Dianne Nicol)
UTAS Author:	Liddicoat, J (Mr John Liddicoat)
ID Code:	137424
Year Published:	2019
Funding Support:	Australian Research Council (DP180101262)
Deposited By:	Law
Deposited On:	2020-02-12
Last Modified:	2020-03-11
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