Minister of health
Previous CSP decisions
On 9 August 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 29 September 2021, the Federal Court set aside the minister's decision and remitted Merck's CSP application for redetermination.(1)
The dispute related to the interpretation of certain CSP eligibility requirements.
The first requirement is that an authorisation for sale – that is, a notice of compliance (NOC) – be issued for the drug. Section 106(1)(c) of the Patent Act states as follows:
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;
The second requirement is 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. Section 106(1)(f) of the Patent Act states as follows:
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.
Section 6(1) of the CSP Regulations states as follows:
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 30 August 2012, a Merck affiliate filed an application for approval of Belsomra with the United States Food and Drug Administration.
On 15 November 2012, Merck filed a new drug submission (NDS) 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 the 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 had been submitted within 12 months of the first foreign application seeking authorisation for sale (the US application).
On 13 May 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 section 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 9 August 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 section 106(1)(f).
Justice McHaffie of the Federal Court held that the minister's decision was unreasonable.
Relying on Canada (Minister of Citizenship and Immigration) v Vavilov,(2) 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 the 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 may appeal as of right.
This decision adds to the Federal Court's growing CSP jurisprudence, summarised below.
The 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.(3)(4)
The minister's refusal to issue a CSP for a patent claiming dolutegravir for Juluca, as it contains a combination of dolutegravir and rilpivirine, was remitted for redetermination.(5)(6) The minister of health again refused the application for reconsideration. Viiv commenced but discontinued its second judicial review application.(7)
For further information on this topic please contact Brandon Heard at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.
(1) Merck Canada Inc v Canada (Health), 2021 FC 1015.
(3) Canada (Health) v Glaxosmithkline Biologicals SA, 2021 FCA 71, rev'g 2020 FC 397.
(4) For further information, please see "Federal Court of Appeal finds Minister of Health's refusal to grant a CSP for SHINGRIX is reasonable" and "First decision on CSPs: SHINGRIX refusal remanded to Health Canada".
(5) ViiV Healthcare ULC v The Minister of Health, 2020 FC 756.
(6) For further information, please see "JULUCA CSP application remitted to Minister of Health for reconsideration".