JAMP and the Minister of Health Strike Boehringer's Application for Judicial Review

In Boehringer Ingelheim (Canada) Ltd. v. Canada (Health), 2024 FC 1766, the Federal Court reinforced the longstanding legal principle concerning the inability of "brand" drug manufacturers to challenge a decision by the Minister of Health (the “Minister”) to grant a Notice of Compliance (“NOC”) to a "generic" competitor.

Boehringer Ingelheim (Canada) Ltd. (“BI”) brought a judicial review application regarding the Minister’s decision to issue an NOC to JAMP Pharma Corporation (“JAMP”) for its 150 mg nintedanib esilate capsules. 

BI, which markets the same drug in 100 mg and 150 mg strengths under the brand name OFEV®, asserted that it had standing to bring the application for judicial review as it was “directly affected” by the Minister's decision for two primary reasons:

The Federal Court, however, found that the essence of BI's claim primarily revolved around concerns of patient safety or competitive consequences rather than direct legal rights or interests. Citing Novo Nordisk Canada Inc v. Canada (Health), 2019 FC 822, the Court reaffirmed that "brand" manufacturers do not have standing to challenge decisions of the Minister regarding "generic" regulatory submissions based solely on matters of safety and efficacy or competitive consequences. 

As set out in Novo Nordisk, the rationale for the consistent (and longstanding) rejection of such applications is the fact that the Minister alone is charged with the protection of the public’s health and safety, that issues regarding the safety and efficacy of drugs are of no concern to third-party manufacturers, and that the economic and competitive impact on "brand" companies is not sufficient for a holding that they are “directly affected” by the issuance of a NOC to a "generic" competitor.

The Court went on to find that, in any event, BI was not directly affected by the Minister’s decision, as any alleged impact on BI’s patient assistance program was still a competitive interest and that any alleged impact on BI’s rights under the PM(NOC) Regulations was not a direct result of the Minister’s decision and thereby too remote to meet the test for standing.

In essence, the Federal Court once again shut the door on "brand" drug companies attempting to use the judicial review process to protect their commercial (and competitive) interests. 

The Federal Court also provided helpful commentary regarding procedural matters on judicial review applications (and motions to strike such applications), including regarding the appropriate contents of a notice of application and the appropriate (and inappropriate) use of evidence on such motions.

 

Author: Arash Rouhi