Update: On December 4, 2024, Serono filed a notice of appeal (A-398-24).
On November 20, 2024, the Federal Court dismissed EMD Serono (Serono)’s judicial review of the Minister of Health’s decision to list Canadian Patent No. 3,087,419 (419 Patent) on the Patent Register one week after it was submitted to Health Canada: EMD Serono v The Minister of Health and Apotex, 2024 FC 1848. The 419 Patent was submitted for listing against regulatory submissions for MAVENCLAD (cladribine), a treatment for patients with relapsing-remitting multiple sclerosis.
At issue was the timing of listing: one day before the 419 Patent was added to the Register, Apotex filed a regulatory submission for a generic version of MAVENCLAD.
- March 7, 2023 – 419 Patent granted
- March 16, 2023 – Serono submitted patent lists for the 419 Patent against MAVENCLAD
- March 21, 2023 – Health Canada carried out a preliminary analysis of patent eligibility
- March 22, 2023 – Apotex filed an abbreviated new drug submission (ANDS) for generic cladribine
- March 23, 2023 – 419 Patent added to the Register
Serono asked the Minister to reconsider the listing date, arguing the proper date for listing should have been the date on which Serono submitted its patent lists to Health Canada, such that Apotex was required to address the 419 Patent.
The Minister maintained the listing date, concluding that a patent is to be added to the Register once it is found eligible to be listed, not on the date it is submitted.
The Court dismissed Serono’s application for judicial review, finding that the Minister’s interpretation of the Patented Medicines (Notice of Compliance) Regulations was not unreasonable. Serono argued the Minister unreasonably delayed listing the 419 Patent. The Court ruled the Minister does not have discretion to delay listings but can exercise discretion to determine whether the patent should be listed. The Court held that “[t]he addition of a patent to the register is not automatic; it must await a determination of whether the patent is eligible”. Further, the Court held that a second person need only address patents listed on the Register; patents that have been submitted but not yet added need not be addressed.
Serono may appeal as of right.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group or the Pharmaceutical Litigation Group.
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