FC strikes notice of application for lack of standing
Background
Boehringer Ingelheim markets and sells nintedanib esilate capsules in strengths of 100 mg and 150 mg under the brand name OFEV. JAMP was granted an NOC for its generic nintedanib capsules in the 150 mg strength.
Boehringer filed a Notice of Application, which was issued in October 2023, for a judicial review of the Minister of Health’s decision to grant JAMP its NOC. The Decision quashed the NOC on the basis that the NOC did not include both strengths of the generic JAMP product, despite the 100 mg strength being required for dose reduction purposes as referenced in JAMP’s product monograph.
The issue before the Federal Court on this motion was whether the Decision and the Notice of Application should be struck for lack of standing.
Motion to Strike Notice of Application
Section 18.1(1) of the Federal Courts Act provides that “an application for judicial review may be made by the Attorney General of Canada or by anyone directly affected by the matter in respect of which relief is sought [emphasis added].”
The meaning of “directly affected” had been considered by the FCA in Forest Ethics Advocacy Association v Canada (National Energy Board), where Justice Stratas stated:
[20] A party has a “direct interest” under subsection 18.1(1) of the Federal Courts Act when its legal rights are affected, legal obligations are imposed upon it, or it is prejudicially affected in some direct way…
Boehringer asserted two bases for standing:
- The “impact of the Decision on the operation of BI Canada’s HeadStart patient assistance program”; and
- “the effect of the Decision on BI’s rights under the PMNOC Regulations […] In particular, the Decision has effectively bifurcated a single ANDS into two submissions, one for each strength.”
On the first ground, Boehringer argued that its patient assistance program was directly affected by the Decision and issuance of the NOC because the JAMP Product Monograph referred to a 100 mg strength product, which JAMP did not offer. As a result, the reader was effectively referred to Boehringer’s nintedanib, which was the only 100 mg nintedanib product on the market.
The Court rejected this argument, finding that the Notice of Application did not allege any specific link between the Decision and JAMP’s Product Monograph. Further, any impact on Boehringer’s patient assistance program was a commercial or economic impact, which was insufficient for Boehringer to be “directly affected”.
On the second ground, Boehringer argued that it had been required to bring a second action in relation to JAMP’s supplemental ANDS filed for approval of its 100 mg product, instead of the one action it initiated in relation to both strengths.
The Court also rejected this argument because JAMP’s actions to seek regulatory approval or to serve an NOA relating to its 100 mg product were the result of decisions that JAMP made and were not required by the Decision. Similarly, the second action brought by Boehringer was not something that was required by the Decision. Any impact on Boehringer under the PMNOC Regulations was not found to be a direct result of the Decision, but many steps removed.
Despite rejecting Boehringer’s bases for standing, the Court found that the “real essence” of Boehringer’s challenge to the NOC was the basis of patient safety, and the commercial consequences to Boehringer. These bases were sufficient to strike the Notice of Application, and the proceeding was dismissed.
A copy of the Federal Court decision can be found here.
