Federal Court Finds Minister Of Health's Refusal Of BELSOMRA CSP Unreasonable, Remits For Redetermination

• Published date: 24 November 2021
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Law Firm: Bereskin & Parr LLP
• Author: Ms Melanie Szweras and Nyrie Israelian

For the third time since the Canadian Certificate of Supplementary Protection (CSP) regime came into force, the Federal Court has reviewed the decision to refuse a CSP application. In Merck Canada Inc v Minister of Health (2021 FC 1015), Merck sought judicial review of the Minister of Health's refusal to issue a CSP for suvorexant, the medicinal ingredient in Merck's drug product BELSOMRA. In this case, the Minister's failure to consider the context and purpose of the CSP regime in the interpretation of CSP eligibility requirements was fatal, resulting in Merck's CSP application being remitted for redetermination. The Federal Court's decision highlights the critical importance of considering the objectives underlying the CSP Regime during the application process.

Two CSP eligibility requirements as set out in s 106(1) of the Patent Act were at issue in this decision. The first is the "authorization for sale requirement" (s 106(1)(c)), which requires an authorization for sale to have been issued for the medicinal ingredient, or combination of medicinal ingredients, after the CSP provisions came into force in September 2017. The definition of "authorization for sale" includes a Notice of Compliance (NOC), but also covers any authorizations under the Food and Drugs Act, save for certain exclusions.

The second eligibility requirement at issue is the "timely submission requirement" (s 106(1)(f)), which requires a Canadian New Drug Submission (NDS) to be filed within 12 months after authorization is first sought in a prescribed country (the US, UK, the EU or any member country, Japan, Switzerland, and Australia). The goal of the timely submission requirement is to incentivize the early introduction of innovative drugs into the Canadian market (CSP Regulations Regulatory Impact Statement).

Merck first filed an NDS for Canadian approval of BELSOMRA on November 15, 2012, which was within 12 months after authorization was first sought in the US. Health Canada issued a Notice of Deficiency, citing concerns that the NDS contained insufficient information about the benefit/risk profile of suvorexant, and that additional clinical trial data were required to satisfy these concerns. Merck withdrew this NDS in February 2014. After Health Canada indicated that other post-market data could satisfy the need for additional safety evidence, Merck filed a second NDS in 2016. It was as a result of this second NDS that the NOC for BELSOMRA was issued in November 2018. In 2019...