Canada: Federal Court Finds Minister Of Health's Refusal To Grant CSP Based On The "Timely Submission Requirement" Unreasonable

SUMMARY

The Federal Court has granted Merck Canada Inc.'s (Merck) application for judicial review of a decision of the Minister of Health (Minister) denying a Certificate of Supplementary Protection (CSP) for Canadian Patent No. 2,670,892 (892 Patent) and the drug BELSOMRA (suvorexant).

BACKGROUND

A CSP provides patent-like rights and is intended to compensate patentees for a period of patent term lost while innovative pharmaceutical products undergo research and regulatory approval.¹

As a condition of CSP eligibility, CSP legislation provides that a Canadian drug submission should be filed within 12-months of any first drug submission filed for the same product in Australia, Japan, EU, UK, US or Switzerland. The Regulatory Impact Analysis Statement (RIAS) calls this the "Timely Submission Requirement".²

Merck filed a Canadian New Drug Submission (NDS) for suvorexant within 12 months of filing its US submission. In the context of addressing Health Canada's requirements for approvability, the submission was withdrawn, refiled and a market authorization was issued. The refiled submission contained the same pivotal clinical trial data as the original submission together with post-marketing data obtained from the United States and Japan - both of which are prescribed benchmark jurisdictions under the Timely Submission Requirement - that had already approved suvorexant based on lesser data requirements than Health Canada.

In denying Merck's application for a CSP, the Minister "concluded the first NDS could not satisfy the timely submission requirement since it did not result in the NOC for BELSOMRA, while the second NDS was not filed within the prescribed time."³

FEDERAL COURT

The Court concluded that 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: "in particular, Merck's arguments regarding the object and purpose of the legislation being to promote innovation and investment of drug products in Canada and to partly compensate for the time spent in research and obtaining marketing authorization were sufficiently material.that a reasonable interpretation of subsection 106(1) of the Patent Act had to take them into account."⁴

Merck's application for judicial review was granted, the Minister's decision was set aside and the application remitted to the Minister for redetermination.

Footnotes

1. RIAS, p. 7.

2. RIAS, p. 11.

3. 2021 FC 1015 at para 3.

4. 2021 FC 1015 at para 45.

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