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ARTICLE · 08 MAY 2025

Listing Date Is Confirmed As Key Date For Addressing Patents Under PMNOC Regulations

In two recent decisions, the Federal Court ruled that the critical date for determining which patents must be addressed under the PMNOC Regulations is the date a patent is actually listed by the Minister on the Patent Register—not the date it was submitted for inclusion. A second person need not address patents that were submitted but not yet listed as of the date of their ANDS.

CanadaIntellectual Property

The Top Line

In two recent decisions, the Federal Court ruled that the critical date for determining which patents must be addressed under the PMNOC Regulations is the date a patent is actually listed by the Minister on the Patent Register—not the date it was submitted for inclusion. A second person need not address patents that were submitted but not yet listed as of the date of their ANDS.

In two recent judgments authored by Justice O'Reilly of the Federal Court, Bayer Inc v Amgen Canada Inc, 2025 FC 107(EYLEA/aflibercept), and Serono v Canada (Health), 2024 FC 1848(MAVENCLAD/cladribine), the Court held that the Minister was reasonable in listing a patent on the Patent Register on thedate they were determined to be eligiblefor listing, and refusing to retroactively set the listing date as the date on which the patent was submitted.

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