Agricultural Biotechnology and the "Early-Working" Exemptions Under the Patent Act

Authors

  • Martin Phillipson College of Law, University of Saskatchewan.

DOI:

https://doi.org/10.29173/alr369

Abstract

The author explores the availability to generic

manufacturers of two research exemptions under the Canadian <i>Patent Act</i>.  In order to expedite later market entry, processes of research and development and federal product approval are often initiated prior to patent expiry. The question arises of when these "early-working" endeavours will violate the protection offered hy a patent. The "research exemption " has been interpreted narrowly, and may only be of limited use to potential manufacturers engaging in early development of protected products. However, the "regulatory approval exemption" has been given a wider interpretation, both in Canada and the United States, and it is likely that processes related to regulatory approval will not as readily be considered as patent infringing. Finally, the author also briefly explores commercial and strategic considerations as they relate to these legal issues.

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Published

2015-12-30

Issue

Vol 44, No 4

Section

Articles

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