On August 9, 2019, the Minister of Health denied Merck’s application for a Certificate of Supplementary Protection (CSP) for Canadian Patent No 2,670,892 relating to the drug suvorexant (Merck’s BELSOMRA). On September 29, 2021, the Federal Court set aside the Minister’s decision and remitted Merck’s CSP application for redetermination: Merck Canada Inc v Canada (Health), 2021 FC 1015.
The dispute related to interpretation of certain CSP eligibility requirements.
- that an authorization for sale – i.e., a notice of compliance (NOC) – be issued for the drug:
Patent Act, s. 106(1)(c):
the patent pertains in the prescribed manner to a medicinal ingredient, or combination of medicinal ingredients, contained in a drug for which an authorization for sale of the prescribed kind was issued on or after the day on which this section comes into force;
- that the Canadian regulatory submission be filed within a prescribed period (12 months) after the first regulatory submission was filed in a prescribed foreign country:
Patent Act, s. 106(1)(f):
if an application for a marketing approval, equivalent to an authorization for sale, was submitted in a prescribed country with respect to the medicinal ingredient or combination of medicinal ingredients, as the case may be, before the application for the authorization for sale was filed with the Minister, the application for the authorization for sale was filed before the end of the prescribed period that begins on the day on which the first such application for a marketing approval was submitted.
CSP Regulations, s. 6(1):
For the purpose of paragraph 106(1)(f) of the Act,
(a) the prescribed countries are
…(ii) the United States of America…
(b) the prescribed period for filing the application for the authorization for sale is
…(ii) 12 months, in any other case.
On August 30, 2012, a Merck affiliate filed an application for approval of BELSOMRA with the United States FDA.
On November 15, 2012, Merck filed a New Drug Submission in Canada (the “first NDS”). Merck withdrew the first NDS in 2014 as it could not provide further data required by Health Canada.
After Health Canada indicated that post-marketing data could be sufficient to address remaining safety concerns, Merck filed a second NDS in 2016 with further safety data. In 2018, the Minister issued an NOC for BELSOMRA corresponding to the second NDS.
Merck applied for a CSP in 2019, attesting that the first NDS was submitted within 12 months of the first foreign application seeking authorization for sale (the US application).
The Minister’s Decision
On May 13, 2019, Health Canada preliminarily rejected Merck’s CSP application on the basis that it referred to the first NDS, which did not result in an NOC as required by s. 106(1)(c). In response, Merck made submissions addressing, among other arguments, the “object and purpose” of the CSP provisions and Canada’s obligations arising from the Canada-European Union Comprehensive Economic and Trade Agreement (CETA). Merck submitted, in part:
Furthermore, the [Minister]’s preliminary decision is contrary to the object and purpose of the Patent Act and CSP Regulations to promote innovation and investment in new drugs in Canada by compensating innovators for patent term lost during research and while obtaining marketing authorization. Merck Canada’s application for an authorization for sale for suvorexant necessitated an extended time obtaining marketing authorization in Canada by reason of Health Canada requirements. The [Minister]’s interpretation of the CSP regime results in a denial of CSP rights on the basis of the exact harm a CSP is intended to address.
On August 9, 2021, the Minister issued a final decision, affirming that the first NDS “did not support the grant of a CSP” as it did not result in an NOC. Though the second NDS resulted in an NOC, it was not filed within 12 months of the US regulatory submission, as required by s. 106(1)(f).
The Minister’s Decision was Unreasonable
Justice McHaffie of the Federal Court held that the Minister’s decision was unreasonable.
Relying on Canada (Minister of Citizenship and Immigration) v Vavilov, 2019 SCC 65, the Court concluded that statutory interpretation by an administrative decision maker requires “consideration of the ‘text, context and purpose’ of the legislation”; the “purpose of a legislative provision is thus a relevant aspect of its interpretation”. An international treaty provides relevant context where the legislation seeks to implement treaty obligations.
The Minister failed to address Merck’s key argument relating to the purpose of the CSP provisions in implementing CETA. Merck’s arguments regarding CETA were “sufficiently material” that “a reasonable interpretation of subsection 106(1) of the Patent Act had to take them into account”. Failure to do so caused the Court to “lose confidence in the Minister’s decision” in view of “the central role of CETA” in enactment of the CSP provisions.
The Court remitted the decision to the Minister for redetermination. Justice McHaffie did not find that there was room for only one reasonable interpretation of the statutory provisions at issue, and therefore declined to substitute his own opinion for that of the Minister.
The Minister of Health may appeal as of right.
Previous CSP Decisions
This decision adds to the Federal Court’s growing CSP jurisprudence, summarized below.
Drug Product: SHINGRIX
Decision: Canada (Health) v Glaxosmithkline Biologicals S.A., 2021 FCA 71, rev’g 2020 FC 397
Result: Minister’s refusal to issue a CSP, including the Minister’s interpretation and application of the CSP provisions to exclude patent claims directed to a formulation, was reasonable.
Detailed in our previous articles:
Drug Product: JULUCA
Decision: ViiV Healthcare ULC v The Minister of Health, 2020 FC 756
Result: Minister’s refusal to issue a CSP for a patent claiming dolutegravir for JULUCA, as it contains a combination of dolutegravir and rilpivirine, remitted for redetermination.
Read our previous article: JULUCA CSP application remitted to Minister of Health for reconsideration.
The Minister of Health again refused the application for reconsideration. Viiv commenced but discontinued its second judicial review application (T-258-21).