The Federal Court (O’Reilly J.) dismissed an application for judicial review brought by Bayer Inc. (“Bayer”). The Court found that the Minister of Health (the “Minister”) was not unreasonable in not determining the Bayer patent’s eligibility for listing on the patent register the same day it was received for consideration.
Bayer Inc. v. Amgen Canada Inc., 2025 FC 107
Background
This decision follows Serono v Canada (Health), 2024 FC 1848 (“Serono”), also by O’Reilly J., released in November 2024, which raised substantively similar issues.
The Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the “PMNOC Regulations”) impose on the Minister an obligation to maintain a register of patents for approved drugs. Once a patent has been added to the register, another drug company (the “second person”) is prohibited from entering the market for the same medicine, except in accordance with strict conditions. The second person can address listed patents in one of three ways, by: 1) accepting that it will not enter the market until the listed patents expire; 2) obtaining the first person’s consent; or 3) alleging that the patent is invalid or would not be infringed by the second person’s product. The register is often referred to as a “frozen register” because a second person is not required to address any patents listed after the filing date of its drug submission.
Amgen Canada Inc. (“Amgen”) filed its regulatory submission for a generic version of EYLEA on August 24, 2023, before Bayer’s patent (the “315 Patent”) was listed on the patent register against the drug product, EYLEA, but after the patent was submitted for listing on August 22, 2023.
Bayer asked the Office of Submissions and Intellectual Property (“OSIP) to reconsider the listing date but the Minister maintained its decision. Bayer then applied to the Federal Court for judicial review of the Minister’s decision.
Standard of Review
Bayer filed its patent application in December 2015, and the Canadian Intellectual Property Office granted the 315 Patent on August 22, 2023. Bayer submitted the 315 Patent to the Minister that day, and eight days later, it was added to the patent register on August 30, 2023. Records showed that the patent lists for the 315 Patent were screened on the day they were submitted. Bayer argued that it was possible that the Minister had completed the screening before August 24, 2023, since the “Eligibility Analysis Date” was missing from the Patent List Screening and Eligibility sheet, although Amgen pointed out metadata showing comments from screening staff as late as August 28, 2023.
On August 24, 2023, Amgen had made its own regulatory submission to the Minister for a generic version of the same drug contemplated in the 315 Patent, only 2 days after Bayer’s submission. Because the 315 Patent was not yet added to the register, Amgen did not need to address it in its submission.
On September 7, 2023, Bayer asked that OSIP reconsider the August 30, 2023 listing date as being the date on which Bayer had submitted its patent lists, i.e., August 22, 2023, which would have required Amgen to address the 315 Patent in its submission. In response, the Minister maintained the listing date of August 30, 2023. The Minister observed that the PMNOC Regulations distinguished between “submitting” a patent list and “adding” a patent to the register. The Minister highlighted that section 5(1) of the PMNOC Regulations imposed a requirement on second persons to address “submitted” patent lists, but the contents of second persons’ NOAs must only address patents “included” on the register.
The Minister rejected Bayer’s argument that second persons should have to address patents as of the date of their submission, and that the date of submission should be the same date as its registration. Citing the Regulatory Impact Assessment Statement, SOR/2006-242, October 5, 2006, PC 2006-1077 (“2006 RIAS”) and the Health Canada’s Guidance Document for the PMNOC Regulations (“Guidance Document”), the Minister concluded that a patent is only added to the register the day that it is found to be eligible, not the date it is submitted. The Minister found that the purpose of the PMNOC Regulations is to “balance effective patent enforcement over new and innovative drugs with the timely entry of their lower priced generic competitors”. In the Minister’s view, it would be unfair to require second persons to address patents added to the register after having already filed their drug submission.
While Bayer argued that the appropriate standard of review of the Minister’s interpretation of the PMNOC Regulations was correctness, the Court disagreed and held that the proper standard of review to be applied was unreasonableness.
Listing Date
Bayer argued that the delay between submitting and registering the patent risked depriving first persons of their patent rights. Bayer offered an alternative interpretation of section 5(1) of the PMNOC Regulations, and argued that s 3(2) of the PMNOC Regulations required the Minister to maintain a register of “patents that have been submitted for addition to the register.” Bayer argued that section 5(1) of the PMNOC Regulations was consistent with section 3(2), which both use the word “submitted”, and not the word “added”, in the context of a patent being added to the register. Bayer therefore argued that the appropriate date is the date that a person submits a patent for addition to the register, and not the date that the patent is actually listed.
Bayer further argued that earlier versions of the RIAS (1993 and 1996) support the position that sections 3 and 5 of the PMNOC Regulations impose a duty on Minister to maintain a register of submitted patent lists, and that these regulations do not differentiate “submitted” and “added.” Bayer also argued that the Minister’s reliance on the 2006 RIAS was misplaced, as the amendments within it were not intended to apply to the issue at hand and instead were meant to address the issue of “ever-greening”.
Bayer argued that in the case where a second person addresses a patent found to be ineligible, they can rely on section 7(3) of the PMNOC Regulations which provides that deleted patents no longer block a second person’s notice of compliance. Bayer argued that the Minister’s interpretation gives a first person no recourse in this situation except to bring an infringement action, and in such a scenario the harm to the first person would be catastrophic, far exceeding the potential harm for second person who might have to address patents later found to be ineligible.
Bayer’s arguments were not accepted by the Court, which ultimately found the Minister’s decision to be not unreasonable in the context of the PMNOC Regulations, the case law and the facts.
While the Court agreed with Bayer’s description of the PMNOC Regulations’ purpose, it disagreed that these factors led to an interpretation of the PMNOC Regulations that would require the Minister add patents to the register immediately, or that would require second persons to address patents that had not yet been added to the register. The Court held that the Minister does not have discretion to delay adding eligible patents but does have discretion in determining whether patents are eligible for listing.
The Court found that Bayer’s interpretation of the PMNOC Regulations required that some of the provisions be read in isolation. The Court held that it would be unreasonable to read the PMNOC Regulations in this way as the remaining provisions provide additional information and context.
The Court also found that the Minister reasonably relied on the 2006 RIAS and the Guidance Document for the PMNOC Regulations in support of his conclusions.
Conclusion
Ultimately, the Court found that the Minister’s decision was not unreasonable, as Bayer’s patent was properly added to the register on the date it was found eligible. Bayer’s application for judicial review was therefore dismissed.
Bayer has thirty days from the date of the decision to file an appeal in the Federal Court of Appeal.