The Federal Court of Appeal (“FCA”) confirmed that in assessing the availability of a non-infringing alternative (“NIA”) defence, the NIA must be legal and cannot infringe any patent, and its economic viability must be considered objectively.

David Yi
ONCA Permits Pleading Amendments Asserting Validity of Previously Invalidated Patent following Nexium Decision
This decision of the Ontario Court of Appeal (ONCA) arises in the context of a novel action brought by Apotex seeking damages for the delayed market entry of its generic version of Sanofi’s blockbuster ramipril drug.
Apotex’s claims…
Ontario Superior Court rejects Apotex attempts to revive the Promise Doctrine by dismissing motion for leave to amend, awards substantial indemnity costs
The Ontario Superior Court of Justice (ONSC) recently denied Apotex’s attempt to repackage the now defunct “promise of the patent” doctrine (the Promise Doctrine). Apotex sought to amend its pleadings to reintroduce the Promise Doctrine under the…
Pharma in Brief – Federal Court dismisses application for a prohibition order regarding prasugrel hydrochloride under the old PM(NOC) Regulations
The Federal Court dismissed an application by Eli Lilly Canada Inc., Ube Industries, Ltd., and Daiichi Sankyo Company, Limited (the Applicants) seeking a prohibition order regarding Apotex’s generic version of Lilly’s EFFIENT® (prasugrel hydrochloride). While the Court rejected…
ONCA upholds dismissal of summary judgment in lansoprazole s. 8 case
As we reported, Abbott Laboratories Limited, Takeda Pharmaceuticals Company Limited and Takeda Pharmaceuticals America Inc. sought dismissal of Apotex’s action for s. 8 damages in the Ontario Superior Court by summary judgment. The Ontario Court of Appeal (ONCA…
Change in utility law not a factor in s. 8 damages
The Federal Court of Appeal (FCA) has refused to apply the “special circumstances” exception to issue estoppel in view of a change in law arising from the rejection of the “promise doctrine” in AstraZeneca Canada Inc v Apotex…
Section 8 liability offset by patent infringement in esomeprazole case
The Federal Court denied Apotex’s section 8 claim relating to esomeprazole on the basis that its product would have infringed a valid AstraZeneca patent. This aligns with a previous decision of the court that placed significant weight on patent infringement…
Ontario Superior Court denies pleading amendments based on Supreme Court of Canada’s rejection of promise doctrine in ramipril damages action
As we reported, Federal Court jurisprudence is being continually reshaped by the Supreme Court’s decision in AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36 (NEXIUM Decision). In Apotex v. Schering Corporation, 2018 ONSC 903,…
FCA Limits Scope of Dutch Industries and Declines to Invalidate Patent on the Basis of Administrative Non-Compliance with Patent Act in latanoprost s. 8 case
Pfizer Canada Inc. successfully resisted Apotex’s appeal of the Federal Court’s dismissal of Apotex’s motion for summary judgment for invalidity based on a failure to pay the correct “final fee” owing prior to patent grant. The Federal Court of Appeal…
Apotex disentitled to section 8 recovery on the basis of patent infringement in omeprazole case
For the first time, the Federal Court has disentitled compensation pursuant to section 8 of the Regulations on the basis of infringement of a patent. This holding was also based on the court’s finding that Apotex would not have had…