Apotex filed an application for leave to appeal the decision allowing its claim for damages for misfeasance of public office, negligence and breach of contract against Health Canada based on its review of Apotex’s drug submission for Apo-Trazodone. Apotex has appealed the finding that Health Canada does not owe a duty of care to drug manufacturers in reviewing drug submissions.

Case: Apotex Inc v Canada (Minister of Health) (SCC Docket 37593)

Drug: Apo-Trazodone

Nature of case: Application for leave to appeal related to action for damages in tort and breach of contract

Appellant: Apotex Inc. (Apotex)

Respondent: Her Majesty the Queen

Date: June 5, 2017

Federal Court of Appeal decision

As we reported, the Federal Court of Appeal (FCA) allowed Apotex’s appeal, in part, from the Federal Court decision that found Apotex was entitled to damages for misfeasance of public office. The FCA found that Apotex was not required to mitigate its damages by providing Health Canada with evidence of bioavailability of Apo-Trazodone based on a comparison to a Canadian reference product. Apotex was entitled to specific performance to receive a Notice of Compliance based on a foreign reference product, and had a legitimate business interest in doing so.

The FCA dismissed Apotex’s claim that the Federal Court erred in failing to conduct an analysis of negligence outside of Health Canada’s liability arising from the settlement agreement between the parties, finding that Health Canada does not owe a prima facie duty of care to Apotex, or any other drug manufacturer, because this duty would conflict with the intent of the Food and Drugs Act and Regulations, which is directed to public health and safety through regulation of drug manufacturers. Apotex has filed leave to appeal to the Supreme Court of Canada on this question.


SCC Docket: 37593

FCA Decision: Apotex Inc v Her Majesty the Queen, 2017 FCA 73

Trial Decision: Apotex Inc v Canada (Minister of Health), 2014 FC 1087