On August 8, 2025, the Federal Court of Appeal (FCA) determined that the Minister of Health’s decision to list Canadian Patent No. 2,970,315 on the Patent Register eight days after it was submitted to Health Canada was reasonable, upholding the Federal Court’s decision: Bayer Inc v Amgen Canada Inc, 2025 FCA 142.
In the first instance, the Federal Court found the Minister’s decision reasonable. The Minister had decided that (i) a patent must await an eligibility determination before being listed on the Register and (ii) a second person is not obligated to address patents that have been submitted to the Register but not yet listed (see our previous article).
On appeal to the FCA, Bayer argued, inter alia, the Minister’s interpretation was unreasonable, incorrect, and created an unfair “race” between the first and second person. It noted that Amgen’s submission filing date was the day its NDS was submitted, while Bayer’s patent listing date was the day it was found eligible, not when it was submitted. Bayer asked the Court to treat both parties consistently.
The FCA rejected Bayer’s arguments, finding the Minister was reasonable in holding that patents are only effective on the Register once Health Canada confirms eligibility, not on the date of submission. The FCA highlighted that section 5(4) of the Patented Medicines (Notice of Compliance) Regulations “freezes” the Register as of the generic or biosimilar submission filing date, shielding submission applicants from later additions—a principle reflected in the Regulatory Impact Analysis Statement. Acknowledging that this outcome disadvantaged Bayer, the FCA nevertheless found the Minister’s decision reasonable.
Bayer would require leave from the Supreme Court of Canada should it wish to appeal.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.