The Federal Court previously found certain claims of Canadian Patent No. 1,341,206 (“206 patent”), relating to ramipril (ALTACE) invalid. In the present action, Apotex seeks relief in the Ontario Superior Court of Justice pursuant to the Ontario Statute of Monopolies, U.K. Statute of Monopolies and the Trade-Marks Act. On February 6, 2018, Dunphy J. dismissed motions by the Defendants Sanofi and Schering for leave to amend their statements of defence following the recent decision by the Supreme Court of Canada in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 (AstraZeneca): Apotex v Schering Corporation, 2018 ONSC 903.
The Defendants sought to plead that they should not be estopped or otherwise precluded from taking the position that Apotex cannot rely on the earlier Federal Court decision invalidating the patent at issue, which was arguably wrong in view of AstraZeneca. In AstraZeneca, as previously reported, the Supreme Court of Canada struck down the promise doctrine as “incongruent with both the words and the scheme of the Patent Act”.
Dunphy J. relied on the doctrines of issue estoppel and collateral attack in denying Sanofi and Schering leave to amend. He distinguished jurisprudence indicating that an exception to these doctrines is available in special circumstances; i.e. in the event of a change in the law. In his view, AstraZeneca did not result in a change in the law, but merely a change in an “aspect of the interpretation of a statutory provision that was not amended.” In view of AstraZeneca, it was arguable, but not certain, that the Federal Court’s earlier decision was in error. Moreover, allowing the proposed amendments would effectively require re-litigation of the entire issue previously decided at trial (i.e. the validity of the 206 patent). Dunphy J. also dismissed the motions on the alternative basis of sections 62 and 63 of the Patent Act. In his view, the appeal available under section 63 is the only avenue “by which a patent that has been declared to be void can be treated otherwise”.