Ontario Court Of Appeal Allows Sanofi And Schering To Plead That Federal Court Ramipril Patent Invalidity Decision Was Flawed Due To 'Promise Doctrine'

In an action by Apotex for compensation from Sanofi and Schering under the Ontario Statute of Monopolies, U.K. Statute of Monopolies and the Trade-marks Act, the Ontario Court of Appeal has overturned a motion judge's decision denying Sanofi and Schering leave to amend their defences to plead the Supreme Court of Canada's decision in AstraZeneca Canada Inc. v Apotex Inc., 2017 SCC 36 [AstraZeneca]: Apotex Inc. v Schering Corporation, 2018 ONCA 890.

Background

The litigation relates to Canadian Patent No. 1,341,206 ("206 patent"), owned by Schering, and the drug ramipril (ALTACE), previously marketed by Sanofi.

In 2009, applying the "promise doctrine" of patent utility, the Federal Court held that certain claims of the 206 patent were invalid (Sanofi-Aventis Canada v Apotex Inc., 2009 FC 676 ("invalidity decision") aff'd 2011 FCA 300). Relying on that invalidity decision, Apotex brought the present action in 2011 seeking damages beyond those available under section 8 of the PMNOC Regulations. The Federal Court has already awarded damages under section 8 (Apotex Inc. v Sanofi-Aventis, 2012 FC 553, var'd 2014 FCA 68, aff'd 2015 SCC 20).

The Supreme Court of Canada subsequently rejected the promise doctrine, finding in AstraZeneca that it was "unsound" law and not the correct approach for assessing patent...