Bayer Inc. v. Amgen Canada Inc., 2025 FCA 142 (Aflibercept*)
Justice Locke; Justice LeBlanc; Justice Goyette - 2025-08-08
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This appeal addresses the interpretation of the Patented Medicines (Notice of Compliance) Regulations and the timing of adding patents to the Patent Register, which impacts market access for generic or biosimilar drugs. The challenge arose when an appellant submitted a patent related to its drug, which was later deemed eligible for the register after a competing respondent filed a New Drug Submission (NDS) prior to this eligibility determination. The Office of Submissions and Intellectual Property concluded that the respondent was not required to address the appellant's patent due to the timing of its submissions, applying a standard of reasonableness for its decision. The appeal court affirmed that the Federal Court had correctly identified and applied this standard of review, concluding that the OSIP's decision was reasonable and dismissing the appeal.
Decision relates to:
- A-64-25 - BAYER INC. v. AMGEN CANADA INC. et al. which is an appeal from 2025 FC 107 in T-2728-23