Merck Canada Inc. v. Canada (Health), 2021 FC 1015 (Suvorexant*)
Justice McHaffie - 2021-09-29
Read full decision. Automatically generated summary:
Merck Canada Inc seeks judicial review of the Minister of Health’s refusal to grant it a Certificate of Supplementary Protection (CSP) for the ’892 Patent. The claims of the ’892 Patent cover suvorexant, the medicinal ingredient in Merck’s drug product BELSOMRA. Merck argues it satisfies the requirements for a CSP, since it first filed a New Drug Submission (NDS) for BELSOMRA in Canada within the prescribed period after approval was sought in the United States, even though that first NDS was not approved. Rather, a second NDS filed about three and a half years later was ultimately approved and resulted in a Notice of Compliance (NOC) being issued for BELSOMRA. ... I conclude the Minister’s decision was unreasonable because it failed to meaningfully account for a key argument raised by Merck pertaining to a relevant issue of statutory interpretation. ... The Minister’s decision is therefore set aside and Merck’s application for a CSP for BELSOMRA is remitted for redetermination.
Decision relates to:
- T-1471-19 - MERCK CANADA INC. v. The Minister of Health