The Federal Court has once again quashed the Minister of Health’s decision to issue Médunik a NOC for RUZURGI (amifampridine), for treatment of the rare condition of Lambert-Eaton myasthenic syndrome and has once again remitted the issue to the Minister for redetermination. The prior decision is here.
Justice St-Louis found the Minster’s interpretation of the timing requirement in ss. C.08.004.1(3) of the Food and Drug Regulations was unreasonable. The Court held that if a manufacturer’s drug is placed on the Register of Innovative Drugs after another manufacturer’s NDS is filed, but before its NOC is issued, and if the other manufacturer seeks its NOC on the basis of a direct or indirect comparison with the innovative drug, the data protection provisions prohibit the Minister from issuing an NOC.
Justice St-Louis held that the Minister’s decision that there was no “direct or indirect comparison” because the data was not relied upon to approve the NOC, was unreasonable. The Court noted:
- Médunik communicated with BCANS, CNSD, and the OSIP about the carcinogenicity and reproductive toxicity FIRDAPSE studies prior to the RUZURGI NOC approval;
- Médunik relied on FIRDAPSE’s non-clinical data in seeking its NOC as it referred to the “available nonclinical data” in its response to the CNSD who required studies to evaluate RUZURGI’s safety; and
- emails showed that the TPD required the FIRDAPSE data for market authorization, and that it was known data protection was in play, but its application was discarded based on the timing.
Justice St-Louis refused Catalyst’s request to direct the Minister not to issue an NOC for RUZURGI before the end of the 8-year data protection period, apparently because a particular outcome was not inevitable.
The full decision can be found here.