Canada’s Intellectual Property Firm

Federal Court denies stay of decision issuing NOC for RUZURGI

On September 30, 2020, the Federal Court dismissed an application by Catalyst Pharmaceuticals Inc (Catalyst) and KYE Pharmaceuticals Inc (KYE) (collectively, the applicants) for an interlocutory injunction to stay the decision of the Minister of Health granting Médunik Canada (Médunik) a notice of compliance (NOC) for its amifampridine product, RUZURGI: Catalyst and KYE v Canada (Attorney General), 2020 FC 938. Catalyst, who was granted an NOC for the first amifampridine product in Canada (FIRDAPSE), and KYE, a licensee of FIRDAPSE, sought the stay pending disposition of their underlying application for judicial review of the Minister’s decision.  In the judicial review application, which was heard on December 7, 2020, the applicants argued that the Minister should not have issued the NOC as FIRDAPSE is subject to data protection.

The Court concluded that the applicants had not satisfied components (2) or (3) of the test for interlocutory injunctive relief, which required the applicants to establish that: (1) a serious issue has been raised in the underlying application; (2) they will suffer irreparable harm if the stay is not granted; and (3) the balance of convenience favours them. The Court found that the applicants had not met their burden with respect to irreparable harm as the evidence showed that such harm was merely “possible” or “likely” if a stay is not granted. On the balance of convenience, the applicants did not satisfy the Court that the harm they expected to suffer in the absence of a stay outweighs the harm to the public interest that would be caused by a stay of the Minister’s decision and Médunik’s NOC. The Court did not arrive at a decision on component (1) of the test, given the conclusion on the other two components.

The applicants did not appeal the decision.

Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.

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