As previously reported, the Ontario Court of Appeal (ONCA) granted 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”). In the underlying action, Apotex relies on Sanofi-Aventis Canada v Apotex Inc., 2009 FC 676 (“invalidity decision”) as a central element of its novel claims under the Ontario Statute of Monopolies, U.K. Statute of Monopolies and Trade-Marks Act. The invalidity decision found certain claims of Canadian Patent No. 1,341,206 invalid on the basis of the “promise doctrine”, which was subsequently rejected as “unsound” in AstraZeneca. The ONCA concluded that depriving Sanofi and Schering of the opportunity to argue that the invalidity decision is suspect would be “fundamentally unfair”. On January 7, 2019, Apotex applied for leave to appeal to the Supreme Court of Canada (docket No. 38471).
Related Publications & Articles
-
Alexion awarded injunction against Amgen in SOLIRIS patent action; Court considers anticipation by incorporation by reference
The Federal Court has granted Alexion a declaration of infringement and an injunction preventing Amgen from manufacturing, using, and selling its proposed biosimilar eculizumab product, BEKEMV, in Can...Read More -
Update on biosimilars in Canada – June 2025
This article provides an update on developments in the biosimilar space in Canada—regulatory, approvals, pending submissions, litigation, and market access.Read More -
Health Canada must redetermine exemption requests for psilocybin (magic mushroom)-assisted psychotherapy training
TheraPsil, a patient advocacy organization, and 73 healthcare practitioners (HCPs) have succeeded in the Federal Court of Appeal to overturn the refusal of the Minister of Mental Health and Addictions...Read More