The Federal Court of Appeal (FCA) has overturned a decision of the Federal Court (FC) that found the Minister of Health’s (Minister) analysis of the data protection provisions of the Food and Drug Regulations unreasonable. The FCA restored the Minister’s decision granting an NOC to Médunik Canada (Médunik) for its amifampridine product, RUZURGI.
Catalyst Pharmaceuticals Inc. and KYE Pharmaceuticals Inc. (together, Catalyst) and Médunik filed NDSs for drugs containing amifampridine. Catalyst’s submission was filed first and led to an NOC for its product, FIRDAPSE. When the NOC issued, FIRDAPSE was recognized as an innovative drug and granted data protection. Ten days later, the Minister issued an NOC for Médunik’s product, RUZURGI.
Catalyst brought a judicial review application seeking to set aside the Minister’s decision to issue the RUZURGI NOC on the basis of FIRDAPSE’s data protection. As we reported, the FC granted Catalyst’s judicial review and instructed the Minister to redetermine the matter.
In the redetermination, the Minister again concluded that the data protection regime did not apply to RUZURGI. The Minister gave two reasons. First, the Minister concluded that because FIRDAPSE was not yet an “innovative drug” when Médunik submitted its NDS for RUZURGI, the data protection provisions did not apply (the Timing Issue). Second, while the product monograph for RUZURGI referred to some FIRDAPSE carcinogenicity and toxicity studies, those studies were not relied upon by the TPD to establish the safety and efficacy of RUZURGI (the Reliance Issue).
Catalyst brought a second judicial review application to challenge the redetermination. As we reported, the FC found that the Minister’s decision was unreasonable and remitted the issue back to the Minister a second time. The Attorney General of Canada appealed.
The FCA concluded that the FC erred with respect to the Reliance Issue and data protection did not apply in this case. This was sufficient basis to overturn the FC’s decision and restore the Minister’s decision. As a result, the FCA did not comment on the Timing Issue.
With respect to the Reliance Issue, the FCA disagreed with the FC on two main points.
1. Reasonable to look to TPD’s analysis of safety and efficacy to establish Medunik’s reliance
In the redetermination, the Minister found that the data protection regime only applies where the manufacturer seeking an NOC relies on the data in question. The Minister concluded that Médunik did not rely on the FIRDAPSE data because the TPD did not rely on the FIRDAPSE data. The FC found that the Minister erred by conflating reliance by an NDS applicant with reliance by the TPD.
The FCA disagreed, finding that there was nothing unreasonable about the Minister using the TPD’s analysis to determine whether Médunik relied on the FIRDAPSE data. The FCA reasoned that since the TPD did not find the FIRDAPSE studies necessary to assess the safety and efficacy of RUZURGI, it was reasonable to conclude that Médunik was not relying on them to obtain its NOC.
2. Reasonable for the Minister to not consider certain evidence
In the redetermination, the Minister did not review certain correspondence between the Office of Submissions and Intellectual Property (OSIP), Médunik, and the TPD from April to July 2020 (the Additional Documents). The FC found that the Additional Documents showed that Médunik did in fact rely on the FIRDAPSE data; the Minister’s decision was unreasonable because it ignored these documents.
The FCA disagreed, finding that there was nothing in the Additional Documents that undermined the Minister’s conclusion that Médunik did not rely on the FIRDAPSE data.
In particular, the FCA pointed to the Minister’s reliance on its executive summary dated July 31, 2020 (Executive Summary), which set out the basis for the Minister’s decision to approve RUZURGI. In the Executive Summary, the Minister noted that while studies regarding the carcinogenicity and toxicity were not included in the RUZURGI NDS, these studies were not critical. The FCA found that the mention of these nonclinical studies in the RUZURGI product monograph was likely for the purpose of providing publicly available safety information on a similar drug to RUZURGI, rather than for the purpose of relying on the data.
Canada (Attorney General) v. Catalyst Pharmaceuticals, Inc., 2022 FCA 3