Decision

Bayer Inc. Amgen Canada Inc., 2025 FC 107 (Aflibercept*)

Justice O'Reilly - 2025-01-20

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The decision addresses a judicial review regarding the listing date of a drug patent on the Minister of Health's register. The applicant claimed the Minister unreasonably delayed the listing, resulting in a loss of patent rights, and sought an earlier listing date. The court determined that the appropriate standard of review for the Minister's decision was unreasonableness, not correctness. The ruling concluded that the Minister's decision to list the patent on the date it was deemed eligible, rather than the submission date, was reasonable based on the Patented Medicines (Notice of Compliance) Regulations. The court affirmed the Minister's interpretation of the regulations, which necessitates that patents are added only when they meet eligibility criteria and supports the balance between patent enforcement and market entry for generics. Consequently, the court dismissed the application for judicial review, upholding the Minister's decision on the listing date.

Decision relates to:

 

Canadian Intellectual Property