Federal Court quashes RUZURGI NOC and returns matter to the Minister of Health for redetermination

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On May 31, 2021, the Federal Court quashed a decision of the Minister of Health (Minister) to issue Médunik Canada (Médunik) a Notice of Compliance (NOC) for its amifampridine product, RUZURGI, and sent the matter back to the Minister for redetermination: Catalyst and KYE v Canada (Attorney General), 2021 FC 505. Catalyst Pharmaceuticals Inc (Catalyst), who was granted an NOC for the first amifampridine product in Canada (FIRDAPSE), and KYE Pharmaceuticals Inc, a licensee of Catalyst, had sought judicial review of the Minister’s decision on the basis that the issuance of an NOC to RUZURGI was contrary to the data protection provisions of subsection C.08.004.1(3)(b) of the Food and Drug Regulations (Regulations). We earlier reported that the Court declined to grant an interlocutory injunction pending release of the decision on the merits.

Background

Catalyst filed its new drug submission (NDS) for FIRDAPSE on November 6, 2019, and Médunik filed its NDS for RUZURGI about one month later. Médunik’s product monograph submitted with its NDS contained references to FIRDAPSE’s data. Both NDSs were granted priority review status and were reviewed almost concurrently. On July 31, 2020, Catalyst was issued an NOC for FIRDAPSE. On August 10, 2020, Médunik was issued an NOC for RUZURGI, and on the same day FIRDAPSE was determined to be eligible for data protection. The Minister’s decision to issue the NOC to Médunik did not include any reasons.

The Federal Court’s Decision

Given the absence of reasons in the Minister’s decision, St-Louis J. followed the guidance in Canada (Minister of Citizenship and Immigration) v Vavilov, 2019 SCC 65 (Vavilov ) and Federal Court of Appeal jurisprudence by looking to the evidence in the record to determine whether the Minister’s interpretation and application of the law was reasonable. She found, however, that the record did not assist in such a determination, or in whether the Minister even considered the relevant provisions in the Regulations. Justice St-Louis concluded that without any indication of the Minister’s actual interpretation of the Regulations, she could not make the assumption that the interpretation was reasonable. Moreover, she was not persuaded that the intellectual property verification process described in the evidence accorded with the text and context of the data protection provision of the Regulations and, in any event, she would have concluded that there was no indication that this process was applied by the Minister.

Justice St-Louis therefore quashed the Minister’s Decision (the NOC) and returned the matter to the Minister for redetermination. In remanding the matter, Justice St-Louis declined to provide guidance to the Minister on interpretation of the Regulations as this would be inconsistent with the Supreme Court’s views on the reasonableness standard of review in Vavilov, and the record provided no insight on whether the Minister engaged in certain interpretations alleged by Catalyst to be improper. Médunik may appeal as of right.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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