Earlier today, the Supreme Court of Canada allowed AstraZeneca’s application for leave to appeal from the Federal Court of Appeal decision in AstraZeneca Canada Inc. v Apotex Inc., 2015 FCA 158, with costs in the cause (see SCC file no. 36654). The leave application was decided by a panel of Chief Justice McLachlin, and Justices Moldaver and Gascon.
At issue is the controversial “promise of the patent” aspect of the law of utility—a topic that has dominated discussion in Canadian patent law for the past several years. With leave from the SCC, this decision gives new hope to many in the intellectual property community in Canada and abroad following the collective disappointment with last minute discontinuance of the Plavix® appeal in 2014 (Apotex Inc., et al. v. Sanofi-Aventis, et al. (SCC file no. 35562)).
In the decision under appeal, the Federal Court of Appeal upheld the Federal Court decision (2014 FC 638) holding AstraZeneca’s patent for Nexium® (esomeprazole) invalid. In dismissing AstraZeneca’s appeal, the Federal Court of Appeal confirmed that promised utility may be construed against some or all of the claims, the level of promised utility need not be coterminous with the inventive concept, and the construction of the promised utility is based on a purposive construction of the patent which may, where necessary, have regard to the disclosure.
At the Federal Court, Rennie J (as he then was), held the patent invalid for inutility, noting that “it promised more than it could provide”. The Court construed the promised utility of the claims in suit as comprising three elements, including “improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile”. This element was not demonstrated by the Canadian filing date for the patent, and the Court held it was also not soundly predictable as of that date. Although in obiter, Rennie J included a thorough analysis of the “unsettled” law regarding the level of disclosure required in cases of sound prediction. After considering the Supreme Court of Canada decisions in AZT and Viagra, Rennie J ultimately held that there is no heightened disclosure in sound prediction cases, except in the context of “new use” patents.
The decision to grant leave in this case promises to generate much discussion and speculation in the coming months. A clear statement of the law on this issue is welcome, and many will eagerly await the Court’s reasons.