Decision

Serono v. Canada (Health), 2024 FC 1848 (Cladribine*)

Justice O'Reilly - 2024-11-20

Read full decision. Automatically generated summary:

A company that holds a drug patent can protect the patent from infringement by other companies under rules set out in patented medicine regulations. That protection begins when the Minister of Health lists the patent on the patent register. The listing date is critical. ... The applicants [collectively, Serono] are drug companies who argue that the Minister unreasonably delayed listing their patent on the register, resulting in a loss of their patent rights. ... I find that the Minister’s decision on the listing date for Serono’s patent was not unreasonable in light of the governing Regulations and case law. The Minister adds patents to the register when they are eligible for listing – not sooner, not later. Accordingly, I must dismiss Serono’s application for judicial review. ... 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)).

Decision relates to:

  • T-1369-23 - EMD SERONO ET AL v. THE MINISTER OF HEALTH

 

Canadian Intellectual Property