Merck Canada Inc. v. Minister of Health

(Federal) (Civil) (By Leave)


Intellectual property — Patents – Medicines — Legislation — Interpretation — Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 — Applicant failing to file patent lists for 806 Patent within 30 day time limit specified in Regulations — How should decision-makers determine the consequences of non compliance with statutory requirements where those consequences are not spelled out in the legislation? — Does the Minister of Health have discretion to waive non compliance with the 30 day time requirement in s. 4(6) of the Regulations in exceptional circumstances?


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The applicant, Merck Canada Inc. (“Merck”), markets Keytruda, an innovative biologic drug that was approved for use in Canada for the treatment of certain advanced stage cancers. The 806 Patent for Keytruda was issued on May 12, 2020. In order to obtain certain advantages in the Regulations, Merck was required to submit its patent lists for inclusion on the patent register within 30 days of patent issuance. The Minister refused to accept the Merck’s patent lists for filing because they were submitted after the expiry of the 30 day deadline set out in s. 4(6) of the Patented Medicines (Notice of Compliance) Regulations. Merck applied for judicial review of that decision.

Lower Court Rulings

April 20, 2021
Federal Court

2021 FC 345, T-1476-20
Applicant’s application for judicial review of Minister’s decision not to waive non compliance with statutory time limit dismissed
November 22, 2021
Federal Court of Appeal

2021 FCA 224, A-143-21
Applicant’s appeal dismissed.