- Parties: The appellant was Janssen Inc. The respondents were the Attorney General of Canada and Minister of Health.

- Subject Matter: The Minister of Health issued a decision determining that the appellant’s nasal spray, SPRAVATO, was not entitled to data protection since it was not an “innovative drug” under s. C.08.004.1(1) of the Food and Drug Regulations. The appellant filed a judicial review application challenging the Minister’s decision. The Federal Court dismissed the application. The appellant challenged the Federal Court’s decision.

- Ruling: The appeal court ruled in the respondents’ favour and dismissed the appeal. The appeal court agreed with the Federal Court’s dismissal of the application, substantially for the reasons that it gave on the reasonableness of the Minister’s interpretation and application of s. C.08.004.1(1). The appeal court also agreed with the Federal Court’s conclusion that the Canada-United States-Mexico Agreement, effective July 2020, did not displace the court’s previous interpretation of s. C.08.004.1(1). The wording of the definition of “innovative drug” in s. C.08.004.1(1) has not changed since this agreement, the appeal court noted.

- Date: The hearing was set on Apr. 10, 2024. The court released its decision on Apr. 10, 2024.

- Venue: This was a federal case before the Federal Court of Appeal.

- Amount: The court fixed costs at the agreed-upon amount of $4,000.