Apotex Inc. v. Pfizer Canada Inc., 2019 FCA 16 (Desvenlafaxine*)

Justice Webb; Justice Boivin; Justice de Montigny - 2019-01-25

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On August 22, 2017, following proceedings under the Patented Medicines (Notice of Compliance) Regulations, Brown J. of the Federal Court issued an order as part of his judgment (2017 FC 774) prohibiting the Minister of Health from issuing a (NOC to Apotex in respect of a NOA sent by Apotex to Pfizer until the expiry of Canadian Patent No. 2,436,668. The ‘668 Patent concerns a drug called O-desmethyl-venlafaxine (ODV). It is used for the treatment of depression. This appeal relates to Form I ODV succinate which is a particular crystal form of a particular salt of ODV, namely ODV succinate. Apotex appeals the Federal Court Judge’s decision. This appeal, along with the companion appeal in Teva Canada Ltd. v. Pfizer Canada Inc. et al. (2019 FCA 15), concern issues related to the Federal Court Judge’s obviousness analysis in respect of the ‘668 Patent. ... In essence, Apotex argues that the Federal Court Judge misconstrued and misapplied the test for obviousness as set out in Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61 and that his obviousness analysis is directly contrary to two judgments rendered by our Court: Bristol-Myers Squibb Canada Co. v. Teva Canada Limited, 2017 FCA 76 [Atazanavir]; and Pfizer Limited v. Ratiopharm Inc., 2010 FCA 204 [Amlodipine]. Apotex also argues that the Federal Court Judge made palpable and overriding errors in considering the properties in his reasons because they are not part of the inventive concept and further erred in including certain elements of the invention story such as the work that occurred prior to the salt screen and after Wyeth first discovered Form I ODV succinate. Apotex also contends that the Federal Court Judge erred in law by rejecting its evidence on anticipation and concluding that its allegations of anticipation were not justified. For the reasons below, I would dismiss the appeal with costs.

Decision relates to:


Canadian Intellectual Property