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Federal Court rules on patent listing again, confirms generic not required to address patent submitted before ANDS filing but listed after

Authored byChristian Bekking

On January 20, 2025, Justice O’Reilly of the Federal Court dismissed Bayer’s judicial review of the Minister of Health’s decision to list Canadian Patent No. 2,970,315 (315 Patent) on the Patent Register eight days after it was submitted to Health Canada: Bayer Inc v Amgen Canada Inc, 2025 FC 107. This decision followed EMD Serono v Canada (Health), 2024 FC 1848 (EMD Serono) in which the Court (also Justice O’Reilly) held that the Minister’s decision was not unreasonable to list a patent on the Register when it is determined to be eligible, not when it is submitted.

The relevant dates were:

  • August 22, 2024 – 315 Patent was granted; Bayer submitted patent lists against EYLEA (aflibercept); Health Canada screened the patent lists
  • Date not provided – preliminary analysis of eligibility by staff (Eligibility Analysis Date)
  • August 24, 2024 – Amgen filed a new drug submission for its aflibercept biosimilar; because the 315 Patent was not added to the Register, it appeared Amgen did not have to address the 315 Patent
  • August 30, 2024 – 315 Patent added to the Register

Bayer brought an application for judicial review of the Minister’s decision. The Court held that the standard of review was reasonableness. Bayer argued that the Minister’s decision was unreasonable because the Patented Medicines (Notice of Compliance) Regulations (Regulations) do not allow for discretion to delay listing. Further, Bayer argued, similar to EMD Serono, that Amgen should have to address the 315 Patent on the date it was submitted, not the date it was actually added to the Register.

The Court’s interpretation of the Regulations followed EMD Serono. The Court concluded that:

  1. a patent must await eligibility determination before being listed on the Register and
  2. the second person is not obligated to address patents submitted to the Register, but not yet listed.

Bayer may appeal as of right.

Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group or the Pharmaceutical Litigation Group. 

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