The Top Line
The Federal Court held that standing for judicial review requires a party to be directly affected by an administrative decision. Neither commercial/economic impact nor indirect impact on legal rights are sufficient to ground standing.
Context
In Boehringer Ingelheim v Canada (Health), 2024 FC 1766, Case Management Judge Cotter struck out Boehringer’s application for judicial review for a lack of standing. Boehringer had brought its application to quash a Notice of Compliance (NOC) issued by Health Canada to Jamp Pharma for a generic version of 150 mg nintedanib (a drug used to treat idiopathic pulmonary fibrosis).
Boehringer previously sued Jamp under s. 6(1) of the PMNOC Regulations for Jamp’s generic nintedanib, but waived its right to a 24-month regulatory stay. In the absence of a stay, Health Canada issued an NOC to Jamp (which was the decision at issue in this judicial review) while the PMNOC case was still underway.
Inadmissible evidence on motions to strike
In reaching its conclusion here, the court held that factual and expert affidavit evidence submitted by both Jamp and Boehringer was inadmissible. The Court relied on JP Morgan, 2013 FCA 250 and held that for a motion to strike an application for judicial review based on standing, like in any other motion to strike, affidavit evidence will only be admissible under exceptional circumstances.
The only affidavit evidence permitted was the attachment of documents referenced in the notice of application for judicial review. This holding demonstrates the importance of drafting a comprehensive notice of application when pursuing judicial review, which should include the grounds for a party’s standing.
Standing not established
Despite Boehringer’s attempts to make creative arguments to establish standing, the Court held that they were not directly affected by the issuance of the NOC to Jamp. Boehringer argued that it was directly affected by the issuance of the NOC for two reasons:
- The issuance would impact its patient assistance program related to nintedanib; and
- The issuance had affected its legal rights in the related PMNOC proceedings.
On the first ground, the Court held that Boehringer had failed to plead what impact the notice of compliance had on its patient assistance program. Further, the court held that, that even if Boehringer had sufficiently particularized, any impact would only be commercial or economic and thus insufficient to ground standing for judicial review.
The fact that Jamp’s proposed product monograph referred to a 100mg product, even though Jamp did not have approval to sell a 100mg product, was found to be irrelevant. The Court held that the Notice of Application did not sufficiently link the product monograph to Health Canada’s decision at issue.
On the second ground the court held that any impact of the issuance of an NOC on Boehringer’s legal rights in the PMNOC cases was indirect. The court found that effects on the PMNOC proceedings following the issuance of the notice of compliance were caused by choices made by Jamp and Boehringer related to the NOC and not directly caused by Health Canada’s issuance of the NOC.
After receiving the NOC for the 150mg strength, Jamp filed a supplemental new drug submission for a 100mg version of its product, and served a new notice of allegation which in turn led Boehringer to bring a new claim against Jamp. The court held that these decisions made by the parties were a product of their free choice rather than direct consequences of the issuance of the NOC. This causal separation led the court to hold that the impacts on Boehringer’s legal rights were not direct and thus insufficient to ground standing.
Despite the overall favourable finding for Jamp, the decision is unlikely to be a cause for celebration in the Jamp camp as the related 6(1) PMNOC decision was decided two months earlier in favour of Boehringer, where it was held that one of Boehringer’s patents (CA 2,591,083) was valid and infringed. Even with an issued NOC, Jamp is enjoined from the market until Boehringer’s patent expires, or unless they succeed on appeal (an appeal of the PMNOC decision was filed on September 27, 2024).
This article is intended as a timely legal update and does not constitute legal advice. For more information, contact a member of our Life Sciences team.