Federal Court Upholds Health Canada’s Interpretation of Patent Listing Deadline

In Merck Canada Inc. v. Canada (Health), 2021 FC 345, the Federal Court dismissed Merck Canada Inc.’s (“Merck”) application for judicial review of Health Canada’s decision refusing to add Canadian Letters Patent No. 2,830,806 (the “806 Patent”) to the Patent Register. The Court ruled that Health Canada’s decision was justified, intelligible and transparent, and therefore reasonable.

Background

The 806 Patent pertained to the formulation of Merck’s drug KEYTRUDA. KEYTRUDA is a biologic drug containing the medical ingredient pembrolizumab, which has been approved for treating certain cancers.

The 806 Patent was issued to Merck on May 12, 2020, and Merck submitted its patent list on June 12, 2020, but did so after the close of business. Under Health Canada’s electronic filing policies, the patent lists were considered to have been filed on the next business day, June 15, 2020. This date fell outside the thirty-day time limit as per subsection 4(6) of the Patented Medicines (Notice of Compliance) Regulations (“Patented Medicines Regulations”). As such, Health Canada viewed the patent lists as ineligible for listing on the Patent Register.

The Federal Court’s Decision

In its application to the Federal Court, Merck argued that Health Canada’s view that the Time Limits and Other Periods Act (COVID-19) (“Time Limits Act”) did not have the effect of suspending the thirty-day time limit was unreasonable. The Time Limits Act had suspended numerous federally-legislated deadlines, including time limits related to limitation periods for commencing a court proceeding. Merck argued that subsection 4(6) of the Patented Medicines Regulations functioned as a “gateway” to summary litigation provisions of the Patented Medicines Regulations, and therefore, the thirty-day limit was a “limitation period within a limitation period”.

The Federal Court did not accept Merck’s argument. It noted that the listing of a patent on the Patent Register performs a very different function than a limitation period. The Court stated that “the listing of a patent is not inextricably connected to a prospective civil action, and does not cause time to begin running. There is no precipitating event, and there is no defendant at the time of listing.” Given these factors, the Court concluded that a patent listing was too remote to the initiation of a court proceeding.

Merck alternatively argued that Health Canada had the discretion to extend the thirty-day time limit, which was grounded in jurisprudence and amendments to the Patented Medicines Regulations made in 2017. Given the circumstances brought about by the COVID-19 pandemic, Merck argued that Health Canada unreasonably refused to exercise its discretion. The Federal Court disagreed, and held that the case relied upon by Merck for the proposition that Health Canada has the discretion to accept a “late” patent to the Patent Register was decided on different grounds.

The Federal Court noted that the timelines established by the Patented Medicines Regulations were exact, and the amendments made to it in 2017 did not alter the criteria for eligibility or confer further discretion upon Health Canada. For these reasons, the Court dismissed the application.

Authors: Shannon Skillings and Mark Leonard