April 27, 2021
In Catalyst Pharmaceuticals Inc. v. Canada (Attorney General), 2020 FC 938, the Federal Court denied Catalyst Pharmaceuticals Inc. (“Catalyst”) and KYE Pharmaceuticals Inc.’s (“KYE” and together with Catalyst, the “Applicants”) request for an interlocutory injunction to stay the decision of the Minister of Health’s decision to grant Médunik Canada (“Médunik”) a Notice of Compliance (“NOC”) for its amifampridine product, Ruzurgi.
The motion follows the Applicants’ application for judicial review of the Minister’s decision regarding Medunik’s product. The Applicants seek to challenge the decision as contrary to Section 3(b) of Section C.08.004.1 of the Food and Drug Regulations, CRC, c 870 (the “Regulations”).
Catalyst, a Florida-based biopharmaceutical company, and KYE, a Canadian company focused on bringing medicines that fulfill clinically significant unmet needs to Canada, entered into an agreement to launch KYE's amifampridine product, Firdapse. The drug treats an ultra-rare and debilitating autoimmune disorder called Lambert-Eaton myasthenic syndrome.
Until the approval of Firdapse, amifampridine was not commercially available in Canada. As the first approved amifampridine product in Canada, Firdapse was recognized as an "innovative drug" and was thus entitled to data protection under the Regulations. On July 31, 2020, the Minister granted Catalyst a NOC for Firdapse. On August 10, 2020, the Minister issued a NOC to Médunik for Ruzurgi. The Applicants commenced a motion to prevent Médunik’s drug from being approved.
The Federal Court’s Decision
In the Court’s analysis, Justice St-Louis relied on the test for an interlocutory injunction established by the Supreme Court of Canada in RJR-Macdonald Inc. v. Canada (Attorney General),  1 SCR 311(“RJR”): (i) is there a serious issue to be tried, (ii) will the party seeking the injunction suffer irreparable harm if it is not granted, and (iii) does the balance of convenience favour the party seeking the injunction.
The Court did not need to address the first part of the RJR test, as the injunction failed on the second and third parts of the test. On the second part of the RJR test, the Applicants failed to adduce clear and convincing evidence that they would suffer irreparable harm.
The Applicants argued that the loss of exclusivity, even in the short term, would cause unrecoverable loss of profits and an irreversible price erosion, relying heavily on the testimony of the President of KYE and the Chief Medical Officer of Catalyst. The Court classified the Chief Medical Officer’s testimony as a very general assertion, which failed to meet the test. The Court noted that the evidence must be “more than a series of possibilities, speculations, or hypothetical or general assertions”, citing Gateway City Church v Canada (National Revenue), 2013 FCA 126.
The Court agreed with Médunik that the affidavit was replete with suggestions of "possible" or "likely" harm rather than actual harm that will be suffered if a stay is not granted. The Court held that the Applicants did not meet the burden at the second part of the test. By relying on their own experience, rather than providing documentary evidence to support these allegations, the Applicants failed to adduce clear and non-speculative evidence of irreparable harm.
Under the third component of the RJR test, the balance of convenience assessment, the Court determined which of the parties would suffer the greatest harm from the granting or denial of the injunction pending the judicial review application. The Court emphasized that “the Supreme Court of Canada's recognition of the role of public authorities in protecting the public interest was an important factor in assessing the balance of convenience.”
The Court noted that the “Minister is charged with the promotion of the public interest, and the Minister's Decision was made pursuant to that responsibility.” The Court was “also mindful of the fact that KYE entered into the License Agreement with Catalyst knowing that a NOC had been issued to Médunik, which further tilts the balance of convenience towards the respondents.”
The Applicants did not convince the Court that the harm they expected to suffer in the absence of a stay outweighed the harm that would be caused to the public interest by a suspension of the Minister's Decision and the NOC issued to Médunik. The balance of convenience did not favour granting the stay requested by the applicants.
In conclusion, as the Applicants failed to meet the three parts of the test set forth in RJR, the Court dismissed the motion.
Author: Shannon Skillings