EMD Serono v. Canada (Health), 2024 FC 562 (Cladribine*)

Associate Justice Crinson - 2024-04-09

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The application for judicial review which provides the context for this motion brought by the Applicants, EMD Serono, is in respect of a decision of the Minister, issued through the Office of Submissions and Intellectual Property wherein the Minister determined: (1) that the “419 Patent”, was found eligible for listing on the Patent Register for MAVENCLADTM as of the date of the Minister’s eligibility decision ... The amendments to the original application proposed on this motion can be broadly described as changing the description of the communicated decision of June 15, 2023 to define it as the “Final Decision”, and add in particulars of an alleged determination by the Minister on March 21, 2023 that the patent lists for the 419 Patent were eligible for listing such that a such that a second person who filed its drug submission after that date would be required to address the ‘419 Patent pursuant to the PM(NOC) Regulations. ... The Court is satisfied, taking a realistic view based on the records before it, that the proposed amended notice of application when examined in the context of the law and the litigation process meets the threshold of having a reasonable prospect of success. ... I am satisfied in light of the general scheme of the Federal Court Rules that there is no purported “gap” and what the Applicants are seeking by way of production of a witness from the Minister is in effect an amendment to those Rules. The Applicants’ motion for production of a witness, who has not sworn an affidavit in this proceeding is denied.

Decision relates to:



Canadian Intellectual Property