The Federal Court recently issued two decisions relating to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133: Bayer Inc. v. Amgen Canada Inc., 2025 FC 107 [Bayer] and Serono v. Canada (Health), 2024 FC 1848 [Serono].
Both decisions related to delays by the Minister of Health in listing drug patents on the Patent Register. Registration on the Patent Register grants broad rights to drug patentees to prevent competitors from entering the market, and those rights may be significantly broader than standard patent rights.
In both Bayer and Serono, the patentees submitted patent lists to the Minister of Health, who then reviewed the submitted lists for approximately a week before adding the drug patents to the Patent Register. During this brief delay, competitors had filed regulatory submissions for generic versions of the patented drugs.
Under the Patented Medicines (Notice of Compliance) Regulations, submissions for generic drugs are required to address drug patents that are listed on the Patent Register. Consequently, the submitted patents, which had not yet been added to the Patent Register at the time, did not affect the regulatory submissions for the generic drugs, as would have been the case if the submitted patents had been on the Patent Register.
In both Bayer and Serono, the Minister of Health decided that the relevant listing date for the patents was the date that the patents were added to the Patent Register (and not the date the patent lists were submitted). The Federal Court held that the Minister's decisions were reasonable.
Drug patentees should be aware of the delay between submitting patent lists and having their patents listed on the Patent Register, and how this delay may affect their patent rights.
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