Canada’s Intellectual Property Firm

Federal Court upholds Health Canada’s strict interpretation of patent listing deadline for KEYTRUDA formulation patent

Authored byAndrea Berenbaum

Update: Merck’s appeal was dismissed.

The Federal Court recently dismissed Merck’s application for judicial review of Health Canada’s refusal to add Canadian Patent No. 2,830,806 (806 Patent) to the Patent Register, holding that Health Canada’s decision was justified, intelligible and transparent, and therefore reasonable: Merck Canada Inc v Canada (Health), 2021 FC 345. The 806 Patent issued on May 12, 2020, and contains claims directed to a formulation of Merck’s KEYTRUDA, a biologic drug containing pembrolizumab, approved for the treatment of certain cancers. Patent lists for the 806 Patent were submitted on June 12, 2020, but not until after the close of business. Pursuant to its electronic filing policies, Health Canada considered the patent lists filed on the next business day, June 15, 2020. This was outside the 30-day time period prescribed in subsection 4(6) of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) and Health Canada deemed the patent lists ineligible for inclusion on the Patent Register.

Merck argued Health Canada unreasonably held that the Time Limits and Other Periods Act (COVID-19) (Time Limits Act) did not have the effect of suspending this 30-day time period. The Time Limits Act suspended a number of federally-legislated deadlines, including time limits related to limitation periods for commencing a court proceeding. Merck argued that subsection 4(6) functions as a “gateway” to the summary litigation provisions of the PMNOC Regulations and therefore the 30-day time period is a “limitation period within a limitation period”. The Federal Court disagreed, holding that the listing of a patent on the Patent Register is too remote from the commencement of a court proceeding: it is not inextricably connected to a prospective civil action, it does not cause time to begin running, there is no precipitating event, there is no defendant at the time of the listing and it is not even the most proximate step to a possible court proceeding.

Merck alternatively argued that Health Canada had discretion to extend the 30-day time period, which it unreasonably refused to exercise given the extraordinary circumstances occasioned by the COVID-19 pandemic. According to Merck, this discretion has been recognized in jurisprudence, and enhanced by amendments to the PMNOC Regulations promulgated in 2017. The Federal Court disagreed, holding that the decision in Procter & Gamble Pharmaceuticals Canada, Inc v Canada (Minister of Health), 2003 FCT 583 – relied on by Merck in support of its proposition that Health Canada may add a “late” patent to the Patent Register – ultimately turned on other grounds. The Federal Court also held that it is well established that the timelines prescribed by the PMNOC Regulations are exact and that the 2017 amendments did not alter the eligibility criteria for listing nor confer upon Health Canada a new discretion to depart from those criteria. Merck may appeal as of right.

Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.

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