As previously reported, the Federal Court quashed a second decision by the Minister of Health (Minister) to issue a Notice of Compliance (NOC) to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, following the Minister’s redetermination. The Federal Court found that subsection C.08.004.1(3) of the Food and Drug Regulations applied to prevent the Minister from issuing an NOC in view of the data protection granted to FIRDAPSE, a drug containing amifampridine phosphate.

Catalyst Pharmaceuticals, Inc (Catalyst) filed a new drug submission (NDS) for FIRDAPSE one month before Médunik filed its NDS for RUZURGI. The two NDSs were co-pending until July 31, 2020, when an NOC was issued for FIRDAPSE. An NOC issued for RUZURGI shortly thereafter on August 10, 2020 and was quashed by the Federal Court for lack of reasons in the Minister’s decision. A second NOC, following the Minister’s redetermination, was issued on June 24, 2021.

In a decision released on January 9, 2023, the Federal Court of Appeal (FCA) allowed the Minister’s appeal of the second judicial review decision and restored the Minister’s decision to grant an NOC to Médunik: Canada (Attorney General) v Catalyst Pharmaceuticals, Inc, 2023 FCA 3.

In the redetermination, the Minister provided two grounds for concluding that the data protection regime did not apply to RUZURGI. First, FIRDAPSE had not yet been designated an innovative drug at the time the NDS for RUZURGI was filed (the timing issue). Second, while the product monograph for RUZURGI referred to the FIRDAPSE studies (carcinogenicity and reproductive and development toxicity studies), those studies were not relied upon by the Therapeutic Products Directorate (TPD) to establish the safety and efficacy of RUZURGI. Médunik therefore did not seek an NOC “on the basis of a direct or indirect comparison” with FIRDAPSE, and subsection C.08.004.1(3) was not engaged (the reliance issue). 

The FCA found it unnecessary to consider the timing issue, as a finding in Médunik’s favor on either ground was sufficient for the Minister to conclude that the data protection regime did not apply. For the following reasons, the FCA concluded that the Federal Court erred with respect to the reliance issue:

• The Federal Court erred in finding that the Minister conflated reliance on information by an NDS applicant, on the one hand, and by the Minister, on the other. It is reasonable to look into the TPD’s analysis of safety and efficacy to conclude that Médunik did not rely on the FIRDAPSE studies.
• The additional documents not considered by the Minister in the redetermination, even if relevant, do not support the Federal Court’s conclusion that Médunik in fact relied on the FIRDAPSE studies to support its NDS. It is likely that the FIRDAPSE studies were mentioned in the RUZURGI product monograph to provide publicly available safety information concerning a similar drug.

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