The Federal Court (FC) has granted an application for judicial review involving the data protection provisions in section C.08.004.1 of the Food and Drug Regulations in a case involving new drug submissions (NDSs) for two different amifampridine products.
This is the second time that the FC has set aside a decision to issue a notice of compliance (NOC) for the product in question on data protection grounds. The FC again remitted the decision to issue the NOC for redetermination by the Minister of Health (Minister).
The Applicants are Catalyst Pharmaceuticals Inc. (Catalyst) and KYE Pharmaceuticals Inc. (KYE); the Respondents are the Attorney General of Canada and Médunik Canada (Médunik).
The Applicants and Médunik filed NDSs for drugs containing amifampridine. The Applicants’ submission was filed first and led to an NOC for its product, FIRDAPSE. When the NOC issued, FIRDAPSE was recognised as an innovative drug and granted data protection. Ten days later, the Minister issued an NOC for Médunik’s product, RUZURGI.
The Applicants sought judicial review of the decision to issue the RUZURGI NOC and took the position that FIRDAPSE’s data protection should have blocked this NOC from issuing. As we reported, the FC granted the Applicants’ judicial review because the Minister failed to provide sufficient reasons for her decision to issue the RUZURGI NOC. The FC instructed the Minister to redetermine the matter.
On redetermination, the Minister held that paragraph C.08.004.1(3) does not prohibit an NOC for RUZURGI because Médunik did not seek on NOC for RUZURGI on the basis of a “direct or indirect comparison” to FIRDAPSE.
The Minister’s decision was based on two points of interpretation concerning (1) the timing of the NDS filings and (2) the extent of reliance on nonclinical studies for FIRDAPSE (the Impugned Information) in the approval of Médunik’s RUZURGI product.
The NDS timing issue turned on the Minister’s position that information relating to data protection is assessed at the time that it is provided to Health Canada. In short: since FIRDAPSE was not yet an “innovative drug” when Médunik submitted its NDS for RUZURGI, the data protection provisions did not apply and the Minister could issue the RUZURGI NOC.
The Minister also reasoned that she could issue the RUZURGI NOC because the Impugned Information was not essential for market authorization
The Applicants sought judicial review of this second decision to issue the RUZURGI NOC despite data protection for FIRDAPSE.
The Minister’s interpretation of the NDS timing issue was unreasonable
The Minister reasoned that the data protection prohibition on approving a drug and issuing an NOC in paragraph C.08.004.1(3)(b) is only engaged if the underlying submission was originally blocked by the six-year no-file rule in paragraph C.08.004.1(3)(a). By this reasoning, the RUZURGI NDS was not blocked because it was filed before the six-year no-file period for FIRDAPSE started to run on the date it was approved.
The FC found that this interpretation was unreasonable, as the Minister did not attempt to reconcile it with the actual text of subsection C.08.004.1(3). The text suggests a continuous verification process and prohibits issuing an NOC based on a comparison to an innovative drug. This prohibition applies even if the underlying submission was initially allowed to be filed because the no-file rule did not yet apply. The FC also found that the decision ignored the purpose of the data protection provisions and was unreasonable on this basis as well.
The Minister’s application of the data reliance requirement was unreasonable
The Minister interpreted subsection C.08.004.1(3) as requiring the manufacturer—as opposed to the Minister—to rely on a comparison to the innovative drug in order to trigger data protection. The FC found that this interpretation was reasonable, but that the Minister failed to apply this interpretation in practice. For example, the Minister disregarded certain evidence that Médunik had in fact relied on the Impugned Information in the RUZURGI NDS. The failure to account for the evidence before the decision-maker rendered the decision to issue the NOC unreasonable.
The FC remitted the matter to the Minister for redetermination, rejecting an argument that it ought to (1) quash the RUZURGI NOC and (2) order the Minister not to issue an NOC for RUZURGI until the earlier of (i) the expiry of data protection or (ii) Médunik filing its own version of the FIRDAPSE data. The Court held that the remedy sought by the Applicants was exceptional, and found that there was no basis to substitute its views for those of the Minister.
Link to decision: Catalyst Pharmaceuticals, Inc. v Canada (Attorney General), 2022 FC 292