The Top Line
In two recent decisions, the Federal Court ruled that the critical date for determining which patents must be addressed under the PMNOC Regulations is the date a patent is actually listed by the Minister on the Patent Register—not the date it was submitted for inclusion. A second person need not address patents that were submitted but not yet listed as of the date of their ANDS.
In two recent judgments authored by Justice O’Reilly of the Federal Court, Bayer Inc v Amgen Canada Inc, 2025 FC 107 (EYLEA/aflibercept), and Serono v Canada (Health), 2024 FC 1848 (MAVENCLAD/cladribine), the Court held that the Minister was reasonable in listing a patent on the Patent Register on the date they were determined to be eligible for listing, and refusing to retroactively set the listing date as the date on which the patent was submitted.
These rulings confirm that a “second person” does not need to address patents submitted for listing before the filing date of their (A)NDS, but which had not yet been added to the Patent Register. This approach reinforces the role of the Patent Register as a definitive, public notice mechanism for identifying patents that second persons must address upon filing their regulatory submissions.
Context
Under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations), s. 5, a second person (usually a generic or biosimilar manufacturer) must address “each patent included on the register” in respect of a drug to which their submission makes any comparison or reference.
This provision is important as it determines whether a second person must serve notices of allegation or notify the Minister that they will await expiry of the listed patent(s) upon the filing of their submission. It has also been described as a “freezing” of the Register. Under pre-existing case law, patents have been held to be listed on the date on which they are determined to be eligible for listing by the Minister.
As the Court succinctly noted in the two recent cases:
“The Minister adds patents to the register when they are eligible for listing – not sooner, not later.”
The Cases: Bayer v Amgen and Serono v Canada
In Bayer and Serono, the Federal Court was seized of essentially the same issue: was the Minister of Health acting reasonably by setting the “listing date” as the date on which the Minister determined that the patent was eligible for listing, or should the patents have been deemed to be listed on the date of their submission?
These cases arose out of a relatively rare circumstance in which the dates became of utmost importance. While previous case law had already held the date of listing is the same as the date that the Minister deemed a patent eligible, the issue had not previously come down to a matter of a few days.
On the facts of each case, the first person submitted a patent for inclusion on the Patent Register, and the Minister took about one week to review the submission and list the patent (7 days in Serono and 8 days in Bayer). During the period between submission and listing, a second person filed an ANDS/NDS referencing the first person’s drug product. Because the Minister considered that the patent(s) were not listed as of the date of the second person’s filing, the second person did not have to address that patent under the PMNOC Regulations.
In both cases, the first person (Serono and Bayer respectively) argued that the Minister ought to have retroactively declared that their respective patents were listed on the date on which it was “submitted” for inclusion on the Patent Register. They further argued that these decisions were of paramount importance since they were deprived of their rights under the PMNOC Regulations (including an automatic 24-month stay against the issuance of the second person’s Notice of Compliance). However, the first person/patentee remained entitled to commence standard patent infringement actions under the Patent Act.
The Federal Court ruled that the Minister’s decision was reasonable in both instances. The key points were:
- Regulatory Context Distinguishes Submission and Listing:
The PMNOC Regulations distinguish between the submission of a patent and its listing. A patent is not automatically added upon submission; the Minister must determine its eligibility based on regulatory criteria. - Listing Requires Ministerial Review:
The Court emphasized that the listing process involves reviewing the patent to ensure it claims an approved medicinal ingredient, formulation, dosage form, or use. Until this review is complete, the patent cannot be considered listed. - Second Persons Address Listed Patents Only:
Under the Regulations, a second person must address patents that were submitted, reviewed, and listed before their (A)NDS filing date. They are not required to address patents listed after their filing.
The Court set out the appropriate procedure under its interpretation of the Regulations as follows:
The Regulations permit a first person to submit a patent for addition to the register. The Minister must add to the register those patents that meet the regulatory requirements, and must refuse to add patents that do not meet those requirements (ss 3(2)(a),(b)). Accordingly, once a patent has been submitted for addition to the register, the Minister must determine whether the regulatory requirements have been met (s 4(2)). The addition of a patent to the register is not automatic; it must await a determination of whether the patent is eligible. Determining eligibility requires a review of the patent to see whether it claims an approved medicinal ingredient, formulation, dosage form, or use.
A second person must address those patents that have been submitted by a first person, reviewed by the Minister and added to the register (ss 5(1),(2.1)). A second person does not have to address a patent that was submitted by a first person for addition to the register but not yet added to the register. Nor does a second person need to address a patent added to the register on or after the date of the second person’s drug submission (s 5(4)(a)).
Notably, the Court rejected the first persons’ arguments on several grounds, including:
- The reasonableness of the Minister’s eligibility review timeline.
- Alleged inconsistencies in the Regulations regarding filing versus deemed acceptance dates.
- Statutory interpretation arguments relating to the term “submitted” in relation to the Minister’s obligation to maintain the Patent Register.
Practical Implications
While these decisions do not materially alter existing law, they provide additional clarity and certainty for generic and biosimilar manufacturers. Second persons can rely on the freezing of the Patent Register as of their filing date, with no retroactive listing dates allowed.
Conversely, first persons / patentees must act swiftly. First persons should submit patents for listing immediately or as soon as possible upon issuance (in Serono, a 9-day delay in submission may have been critical). It may also be useful to engage with Health Canada to prevent unnecessary delays in the eligibility review process and to build any record of undue delays.
The decision in Serono has been appealed to the Federal Court of Appeal, while Bayer remains appealable within 30 days.
For further information and assistance, please contact a member of our Life Sciences team.