In Serono v. Canada (Health), 2024 FC 1848, issued on Nov. 20, 2024 and published online on Jan. 15, 2025, Justice James O'Reilly rejected arguments that the health minster was required to add patents to the register immediately upon submission or after a preliminary review by staff.
“The addition of a patent to the register is not automatic; it must await a determination of whether the patent is eligible,” the judge wrote.
The applicants, EMD Serono, a division of EMD Inc. Canada and Merck Serono SA, had filed an application for Canadian Patent No 3,087,419 (‘419 patent) entitled “Cladribine Regimen for Treating Multiple Sclerosis” in December 2005.
The patent was granted on March 7, 2023. Nine days after the patent was granted, Serono submitted patent lists for the ‘419 patent against MAVENCLAD, a drug used in the treatment of adult patients with relapsing-remitting multiple sclerosis.
Health Canada screened the patent the next day and carried out a preliminary analysis of the patent’s eligibility for listing on March 21, 2023, and Serono was informed that its patent lists had been added to the register as of March 23, 2023.
However, the respondent, Apotex Inc., had already filed a regulatory submission on March 22, 2023, for a generic version of MAVENCLAD and did not have to address the ‘419 patent since Serono’s patent lists had not been added to the register at the time.
On April 20, 2023, Serono asked the Office of Submissions and Intellectual Property (OSIP) to reconsider the listing date, arguing that the proper date should have been March 16, 2023, the date on which it had submitted its patent lists.
The Minister of Health decided to maintain March 23, 2023, as the listing date, noting that the Patented Medicines (Notice of Compliance) Regulations distinguish between submitting a patent list and adding a patent to the register.
The minister rejected Serono’s argument that eligible patent lists should be added to the register on the date they are submitted and that second persons should have to address those patents as of the date of submission.
Serono sought judicial review of the decision, arguing that the minister’s decision to add the patent to the register a week after it was submitted was unreasonable.
The applicant submitted that the regulations do not allow any discretion to delay and that the minister was required by the regulations to simply add eligible patents to the register when submitted.
They argued that any delay between submission of an eligible patent and its listing on the register risks depriving first persons of their patent rights, contrary to the intent of the regulations.
Serono cited Abbott Laboratories Limited v Canada (Attorney General), 2007 FC 797, which concerned a patent that was delisted on the grounds that it was no longer eligible after an amendment to the regulations.
In Abbott, the Federal Court found that the patent should not have been delisted and ordered that it be relisted retroactively to the date on which the minister had delisted it.
In the alternative, Serono submitted that its patent should have been added to the register on March 21, 2023, the date on which staff completed the screening and eligibility review form, arguing that there was no justification for the two-day delay between that review and the eligibility decision.
It also submitted that under the regulations, a second person or company seeking to market a generic version of a patented drug must address patent lists that have been “submitted” by a first person or drug patent holders.
Justice O’Reilly noted that interpreting the regulations in the manner urged by Serono would require reading certain provisions, such as s. 5(1), in isolation.
The judge observed that while s. 5(1) of the Regulations states that a second person must address patents that have been submitted by a first person, the regulations also require that second persons must address submitted patents by setting out statements and allegations in a notice of allegation with respect to each relevant patent “included” on the register.
The court further observed that according to a 2016 regulatory impact analysis statement, the intention of the regulations is to require second persons to address patents that have been found to be eligible and added to the register, not those that have merely been submitted.
The judge also observed that the guidance document for the regulations “makes clear that patents are added to the register only after they have been reviewed and found to be eligible, and that second persons need only address patents that have actually been added.”
Justice O’Reilly also found that the case at bar was distinguishable from Abbott, noting that in that case, the court had not ordered that the patent be added to the register as of the date it was originally submitted.
The court held that the minister’s interpretation of the regulations was not unreasonable, noting that the addition of a patent to the register is not automatic and must await a determination of whether the patent is eligible.
Justice O’Reilly also concluded that a second person does not have to address a patent that was submitted by a first person but has not yet been added to the register.
The court dismissed the application for judicial review.
Counsel for the parties were not immediately available for comment.
Counsel for the applicants were Fiona Legere of Blake, Cassels & Graydon LLP, James Holtom and Bohdana Tkashuk of McCarthy Tétrault LLP, and Veronica Van Dalen of Gowling WLG.
Counsel for Canada were J. Sanderson Graham, James Schneider, Leah Bowes and Sahara Douglas of the Department of Justice Canada.
Counsel for Apotex were Ben Hackett, Harry Radomski and Caitlin Woodford of Goodmans LLP.
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