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Doctrine of Non-Obviousness, Supreme Court of Canada, Apotex Inc v Sanofi-Synthelabo Canada Inc, PHOSITA, Critique, Pharmaceutical Patents


The Supreme Court of Canada recently revised the doctrine of non-obviousness in a pharmaceutical “selection patent” case, Apotex Inc. v. Sanofi-Synthelabo Canada Inc. Although cognizant of changes to the same doctrine in the United States and the United Kingdom, a critical flaw in how the doctrine is being applied in Canada escaped the Court’s attention. Using content analysis methodology, this article shows that Canadian courts frequently fail to characterize the “person having ordinary skill in the art” (PHOSITA) for the purpose of the obviousness inquiry. The article argues that this surprisingly common analytical mistake betrays a deep misunderstanding of innovation, one which assumes that actors consult patents to learn about scientific developments, devalues the importance of the public domain, and ignores the industry-specific nature of innovation. The article also describes the historical evolution of the non-obviousness test, identifies factors that undermine PHOSITA’s characterization, and develops a multi-layered prescription to remedy the problem.