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FCA finds that data protection does not prevent a competing amifampridine product

The Federal Court Appeal has reversed the decision of Justice St-Louis (2022 FC 292) quashing the Minister of Health’s decision to issue Médunik Canada an NOC for RUZURGI (amifampridine), for treatment of the rare condition of Lambert-Eaton myasthenic syndrome. This means that RUZURGI will compete with FIRDAPSE, the earlier filed and approved amifampridine product sold by Catalyst Pharmaceuticals, Inc.

Catalyst and Médunik filed separate new drug submissions on November 6, 2019 and December 20, 2019, respectively. Catalyst received its NOC on July 31, 2020, and FIRDAPSE was designated an “innovative drug” under section C.08.004.1 of the Food and Drug Regulations. An NOC issued to Médunik for RUZURGI ten days later.

Catalyst sought judicial review on the basis that Médunik compared RUZURGI to FIRDAPSE by including FIRDAPSE studies in the RUZURGI product monograph, and thus the data protection regime should have prevented the Minister from issuing an NOC for RUZURGI. Justice St-Louis granted Catalyst’s application (2021 FC 505) and remitted the matter for redetermination by the Minister.  The Minister determined that data protection did not prevent the issuance of an NOC for Rizurgi because:

  1. FIRDAPSE was not designated an innovative drug at the time the NDS for RUZURGI was filed;
  2. paragraph C.08.004.1(3)(b) of the Food and Drug Regulations does not prevent the Minister from approving a drug when paragraph C.08.004.1(3)(a) did not prevent the manufacturer from filing an NDS; and
  3. the Therapeutics Products Directorate did not rely on the FIRDAPSE studies to determine the safety and efficacy of RUZURGI, and therefore Médunik did not seek an NOC for RUZURGI “on the basis of a direct or indirect comparison” with FIRDAPSE.

This decision was then judicially reviewed, and once again the decision of the Minister was quashed and remitted for determination (2022 FC 292). The Minister appealed this decision. For a description of the first and second decisions, see our previous post here.     

Justice Locke, for the Court of Appeal only found it necessary to address the third basis for granting the NOC for Ruzurgi  (the reliance issue). The Court of Appeal concluded that “[s]ince the TPD did not find the FIRDAPSE studies necessary to assess the safety and efficacy of RUZURGI, then it is reasonable to conclude that Médunik was not relying on them to obtain its NOC.” The Court of Appeal granted the appeal.

A copy of the decision can be found here.