International Divergence in Gene Patenting

Annual Review of Genomics and Human Genetics

Posted: 27 Jun 2019

See all articles by Dianne Nicol

Dianne Nicol

University of Tasmania

Rochelle Cooper Dreyfuss

New York University - School of Law

E. Richard Gold

McGill University - Faculty of Law

Wei Li

Zhejiang University - Ningbo Institute of Technology

Johnathon Liddicoat

University of Cambridge - Faculty of Law; University of Tasmania

Geertrui Van Overwalle

KU Leuven - Centre for IT & IP Law (CiTiP)

Date Written: August 1, 2019

Abstract

This review explores the recent divergence in international patent law relating to the patenting of genes and related 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.

Keywords: divergence, patent law, gene patents, DNA, diagnostics, methods, US, Australia, China, Canada, Europe, comparative

Suggested Citation

Nicol, Dianne and Dreyfuss, Rochelle Cooper and Gold, E. Richard and Li, Wei and Liddicoat, Johnathon and Van Overwalle, Geertrui, International Divergence in Gene Patenting (August 1, 2019). Annual Review of Genomics and Human Genetics. Available at SSRN: https://ssrn.com/abstract=3409055

Dianne Nicol

University of Tasmania ( email )

French Street
Sandy Bay
Tasmania, 7250
Australia

Rochelle Cooper Dreyfuss

New York University - School of Law ( email )

40 Washington Square South
New York, NY 10012-1099
United States
212-998-6258 (Phone)
212-995-4760 (Fax)

E. Richard Gold

McGill University - Faculty of Law ( email )

3644 Peel Street
Montreal H3A 1W9, Quebec
Canada

Wei Li

Zhejiang University - Ningbo Institute of Technology ( email )

1 Xuefu Rd
Yinzhou,
Ningbo, Zhejiang 315100
China

Johnathon Liddicoat (Contact Author)

University of Cambridge - Faculty of Law ( email )

10 West Road
Cambridge, CB3 9DZ
United Kingdom

University of Tasmania ( email )

French Street
Sandy Bay
Hobart, Tasmania 7001
Australia

Geertrui Van Overwalle

KU Leuven - Centre for IT & IP Law (CiTiP) ( email )

Sint-Michielsstraat 6 box 3443
Leuven, 3000
Belgium

HOME PAGE: https://www.law.kuleuven.be/citip/en/staff/00015469

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