On November 10, 2021, the Minister of Health refused to reassess its decision that Janssen’s esketamine hydrochloride product (SPRAVATO) was not an “innovative drug” and therefore not entitled to data protection. As previously reported, the Federal Court dismissed Janssen’s application for judicial review. On April 10, 2024, the Federal Court of Appeal dismissed Janssen’s appeal for substantially the same reasons given by the Federal Court: Janssen Inc v Canada (Attorney General), 2024 FCA 66.
The Federal Court of Appeal expressly agreed with the Federal Court that the Canada-United States-Mexico Agreement (CUSMA) did not change subsection C.08.004.1(1) of the Food and Drug Regulations (Regulations), including the definition of “innovative drug”. The Minister’s interpretation remains reasonable. Other legal and political recourses are available if subsection C.08.004.1(1) does not conform with CUSMA including, as explained by the Federal Court, amendments to the Regulations by the Governor-in-Council.
Any further appeal would require leave to appeal from the Supreme Court of Canada.
Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.