On August 8, 2025, the Federal Court of Appeal (“FCA”) held that Amgen Inc. (“Amgen”), a biosimilar manufacturer, was not required to address Bayer Inc.’s (“Bayer”) newly issued patent (the “315 Patent”) for EYLEA (aflibercept) under the PM(NOC) Regulations because it had not been added to the Patent Register when Amgen’s New Drug Submission ( “NDS”) was filed. This decision highlights the nuanced distinction under the PM(NOC) Regulations between “submitting” a patent list (s. 4(7)) and “adding” a patent to the Patent Register (s. 3(2)), the application of the “frozen register” provisions (s. 5(4)), and the deference afforded to administrative decision makers under the reasonableness standard.
Bayer Inc. v. Amgen Canada Inc. – Federal Court of Appeal
Background
Bayer sells EYLEA (aflibercept) in Canada. On August 22, 2023, Bayer submitted the 315 Patent for listing on the Patent Register within thirty days of its issuance, thereby satisfying the timing requirements under s. 4(7) of the PM(NOC) Regulations. The Office of Submissions and Intellectual Property (“OSIP”) found the 315 Patent eligible for inclusion and added it to the Patent Register on August 30, 2023, pursuant to s. 3(2) of the PM(NOC) Regulations.
On August 24, 2023, after the 315 Patent list had been submitted but before it was added to the Patent Register, Amgen filed an NDS for a subsequent-entry version of EYLEA. OSIP concluded that Amgen was not required to serve a Notice of Allegation in respect of the 315 Patent because it had not been added to the Patent Register when Amgen filed its NDS. This is due to the “frozen register” rule under s. 5(4) of the PMNOC Regulations, whereby patents added to the Patent Register on or after the NDS filing date do not need to be addressed for that NDS.
Bayer’s application for reconsideration was rejected. As such, Bayer applied to the Federal Court for judicial review of OSIP’s decision. The Court held that OSIP’s decision was reasonable and dismissed the application (see our blog post). Bayer appealed to the FCA.
The Federal Court of Appeal’s Decision
Bayer argued that the PM(NOC) Regulations do not contemplate any passage of time between “submitting” a patent list (s. 4(7)) and “adding” a patent to the Patent Register (s. 3(2)). Rather, OSIP must receive the patent list, assess its eligibility, and add the patent to the Register without delay. Bayer argued that OSIP’s eight-day delay in adding the 315 Patent to the Patent Register in this case took away Bayer’s opportunity to assert its patent rights against Amgen prior to market entry, and upset the balance that exists between innovators and biosimilars under the PM(NOC) Regulations. As such, Bayer argued that the 315 Patent should be deemed to have been added to the Patent Register on the date the patent list was submitted (August 22) and not on the date it was actually added (August 30). This would ensure that Amgen must address the 315 Patent under the PM(NOC) Regulations prior to obtaining a notice of compliance.
The FCA rejected Bayer’s arguments. The FCA held that OSIP acted “eminently reasonabl[y]” by analysing the text, context and purpose of ss. 3, 4 and 5 of the PM(NOC) Regulations and by providing lengthy reasons outlining its analysis. There was no basis on the facts to conduct a de novo “correctness” review. The FCA held that the PM(NOC) Regulations must allow for some period of delay between submitting a patent list and adding a patent to the Patent Register to ensure that ineligible patents are screened out.
The FCA dismissed Bayer’s appeal with costs payable to Amgen in an agreed amount. Bayer does not have an automatic right of appeal but can seek leave to appeal to the Supreme Court of Canada within 60 days of the FCA judgment.