FCA upholds OSIP decision on timing of patent listing and retroactive eligibility
Bayer submitted a patent list in relation to its 315 Patent and drug submissions for its aflibercept product, EYLEA, on August 22, 2023. Health Canada’s Office of Submissions and Intellectual Property (OSIP) reviewed Bayer’s submission and found the 315 Patent eligible for inclusion on the Patent Register on August 30, 2023.
In the intervening period, Amgen filed a NDS for its own aflibercept product. OSIP determined that Amgen’s NDS was administratively complete on August 31, 2023, but treated its submission date, August 24, 2023, as its filing date. OSIP decided that Amgen was not required to address the 315 Patent because the 315 Patent had not been added to the register on August 24, 2023.
Bayer’s application for judicial review of OSIP’s decision was dismissed by the Federal Court (2025 FC 107).
Bayer appealed the Federal Court’s decision, arguing that the only plausible interpretation of the PM(NOC) Regulations is that a patent is added to the register on the date of submission of the corresponding patent list and not the date that the Minister deems the patent eligible for inclusion on the register.
Justice Locke, writing for the Federal Court of Appeal, held that OSIP’s decision met the requirements of reasonableness. OSIP engaged directly with the text, context, and purpose of sections 3, 4, and 5 of the Regulations and found that a patent list, if determined to be eligible, is added to the register as of the date of the eligibility decision and not before. Contrary to Bayer’s argument that the Regulations do not contemplate any passage of time between filing a patent list and adding a patent to the register, OSIP reasonably concluded that the Regulations do not direct OSIP to add a patent to the register on the date the patent list is submitted, or require it to assess eligibility immediately upon submission. OSIP reviews eligibility before adding a patent to the Register and that review cannot be instantaneous. Further, the Regulations do not contemplate any retroactive effect of a patent eligibility decision.
Justice Locke held that OSIP’s textual analysis of section 5 of the Regulations was also reasonable. Subsection 5(1) requires that a second person who compares its drug with another drug marketed by a first person in Canada under a NOC and “in respect of which a patent list has been submitted” include in its submission statements or allegations set out in subsection 5(2.1). Though subsection 5(1) refers to a patent list that has been submitted, the requirements for the second person set out in subsection 5(2.1) are limited to patents that are “included on the register”. Moreover, subsection 5(4) explicitly exempts the second person from addressing any patents added to the register on or after the filing date of its NDS (the “frozen register”). A patent is included on the register only after its eligibility has been confirmed. A second person’s NDS need not address any patents included on the register after the NDS has been filed.
OSIP also explained that if a second person were required to address a patent added to the register prior to determining patent eligibility, or retroactively after determining patent eligibility, the purposive balance between innovators and generics underlying the Regulations would be skewed. A second person only knows that a patent has been submitted by a first person for inclusion on the register once the patent is added to the register. The register, which serves a notice function for the second person at the time of filing its NDS, does not include unvetted patent lists submitted by first persons. Since a second person cannot be sure what steps the first person and OSIP will take regarding a patent on a patent list, the regulatory scheme contemplates the possibility of a subsequent entry drug submission being filed while the eligibility of a patent is still under consideration. Further, the subsection 5(4) “frozen register” contemplates that there may be a patent on a patent list that is later added to the register and potentially infringed by a second person who receives a NOC. The Governor in Council determined that such a patent should not preclude the issuance of a NOC to the second person because the first person has recourse under the Patent Act.
Justice Locke dismissed Bayer’s appeal. A copy of the decision is available here.
