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44 Alta. L. Rev. 765 (2006-2007)
Agricultural Biotechnology and the Early-Working Exemptions under the Patent Act

handle is hein.journals/alblr44 and id is 773 raw text is: AGRICULTURAL BIOTECHNOLOGY AND EARLY-WORKING EXEMPTIONS AGRICULTURAL BIOTECHNOLOGY AND THE EARLY-WORKING EXEMPTIONS UNDER THE PA TENTA CT MARTIN PHILLIPSON* The author explores the availability to generic manufacturers of two research exemptions under the Canadian Patent Act. 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 by 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. L 'auteur explore la possibilit d'utiliser deux exemptions de recherche pour les fabricants g~ntiques en vertu de la Loi sur les brevets du Canada. Afin d'acc&lrer les entries tardives sur le marchi, lesproc~dures de recherche et ddveloppement et l'approbation du produit par le gouvernement ftdral sont souvent mises en marche avant I'expiration du brevet. Ilfaudrait se demander i quel moment ces dtmarches de q mise au pointi l'avance ) violent-elles la protection assure par le brevet. L' o exemption de recherche o a &ti interprte rigoureusement, et lesfabricants &ventuels intressds ct ddvelopper, de mani~re prcoce, les produits protg~s ne peuvent en faire qu 'un usage limitM. Cependant, 1'(' exemption d'approbation r~glementaire ) a td plus largement interprt6e, au Canada comme aux Etats-Unis, et il semble que les processus relatifs t I'approbation rdglementaire ne soient pas de sit6t considr~s comme tant une infraction au brevet. Enfin, I'auteur survole les implications commerciales et stratgiques relatives i ces questions juridiques. TABLE OF CONTENTS 1. INTRODUCTION .................................. II. THE UTILITY OF THE EARLY WORKING EXEMPTIONS ... 111. THE EXPERIMENTAL USE OR JUDICIAL RESEARCH EXEMPTION ........................... IV. THE REGULATORY APPROVAL EXEMPTION .......... V. THE SCOPE OF THE REGULATORY APPROVAL EXEM PTION .................................... VI. THE AMERICAN POSITION ......................... VII. LEGAL CONCLUSIONS ............................ VIII. EXTRA-LEGAL ISSUES: COMMERCIAL AND STRATEGIC CONSIDERATIONS ...................... IX . CONCLUSION ................................... ........... 765 ........... 766 ........... 767 ........... 770 ........... 773 ........... 774 ........... 777 ........... 777 ........... 778 I. INTRODUCTION The use ofbiotechnology in agricultural production is now widespread in Canada. Canola growers in particular have enthusiastically embraced herbicide tolerant (HT) varieties, most Associate Professor, College of Law, University of Saskatchewan. The author wishes to thank Stuart Smyth, Stephen J. Ferance, and Barbara Von Tigerstrom for their assistance in gathering materials and Lynda J. Lee for hereditorial assistance. The author would also like to thank the three anonymous expert reviewers for their insightful comments. All errors remain the fault of the author.

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