The Federal Court has quashed a notice of compliance (NOC) issued to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, over an issue concerning data protection for another amifampridine product.
The Minister provided no reasons for its issuance of the NOC, and the Court found that the Certified Tribunal Record (CTR) outlining the decision-making process did not allow the Court to determine how the Minister interpreted section C.08.004.1 of the Food and Drug Regulations (the Data Protection Provisions). The Court found that the decision was therefore unreasonable and remanded the matter back to the Minister of Health (Minister) for redetermination.
The dispute arose due to two concurrent New Drug Submissions (NDSs) filed by different drug manufacturers for products containing amifampridine. On November 16, 2019, Catalyst Pharmaceuticals, Inc. (Catalyst) filed an NDS for FIRDAPSE, which contains amifampridine. Less than a month later, Médunik filed an NDS for RUZURGI, which also contains amifampridine.
On July 31, 2020, the Minister issued Catalyst an NOC for FIRDAPSE. Ten days later, on August 10, 2020, the Minister issued Médunik an NOC for RUZURGI.
As FIRDAPSE was the first amifampridine product approved in Canada, FIRDAPSE was recognized as an “innovative drug” and was granted data protection under the Data Protection Provisions.
Catalyst applied for judicial review of the Minister’s decision to issue an NOC to Médunik, arguing in part that the Minister was prohibited from granting an NOC to Médunik on the basis of data protection for FIRDAPSE.
The Minister’s decision was unreasonable for lack of reasons
The Court found that the Minister’s decision was unreasonable.
The Minister did not provide written reasons and the CTR did not allow the Court to determine how the Minister interpreted the Data Protection Provisions, or whether the Minister even considered the relevant provisions. The Court held that affidavit evidence from a Patent Officer regarding the process when considering data protection was of no assistance, as the affiant lacked direct knowledge and could not satisfy that the process was in fact followed by the Minister in this case.
The Court concluded that since the CTR did not permit a review of the Minister’s decision, the Court could not assume that the Minister’s interpretation was reasonable or speculate as to what that interpretation may have been. Accordingly, the Court quashed the decision.
Remanded without further guidance on interpreting the Data Protection Provisions
The Court remanded the matter back to the Minister, but declined to give further guidance on interpreting the Data Protection Provisions or the underlying dispute as to whether data protection for FIRDAPSE should have prevented issuance of an NOC for RUZURGI.
Catalyst Pharmaceuticals, Inc. v Canada (Attorney General), 2021 FC 505