Federal Court instructs Health Canada to reconsider “medicinal ingredient” in the context of CSP

On April 7, the Federal Court of Canada issued its decision on the judicial review of a denial of the Minister of Health to issue a Certificate of Supplementary Protection (CSP) in respect of the drug Shingrix^® and Canadian Patent No. 2,600,905 to GlaxoSmithKline Biologicals S.A. (GSK). The Court found the denial of the CSP to be unreasonable because the Minister did not give due regard to CETA in determining whether something is a “medicinal ingredient” for the purpose of the grant of a CSP.

What you need to know

• This is the first judicial review of a refusal of a CSP in Canada.
• The Court affirmed the appropriate standard of review is reasonableness for the questions of statutory interpretation under the Patent Act and in the Certificate of Supplementary Protection Regulations (CSP Regulations).
• The Court remarked that if the Minister’s position were to be applied uniformly, any new and useful vaccine requiring an adjuvant to be effective would be denied a CSP, eliminating CSPs for many novel vaccines.
• The matter is not yet concluded and has been returned to the Minister for redetermination. If the Minister were to appeal the Court’s decision, the deadline to file the appeal is May 7, 2020 subject to COVID-19 extensions and delays. 

Background

A CSP provides up to two years of sui generis protection for new drug products protected by an eligible patent, from the expiry of the patent. GSK applied for a CSP in respect of the drug Shingrix^® and Canadian Patent No. 2,600,905 (905 Patent). The 905 Patent has claims directed to the combination of an antigen and an adjuvant. The Minister refused to issue the CSP on the basis that the 905 Patent claims are directed to a formulation, rather than to one or more “medicinal ingredients”, as required by Canadian CSP legislation¹. The Minister’s view was that the “medicinal ingredient” was the antigen. Further, the Minister argued that the claims of the 905 Patent are not directed to the “medicinal ingredient” alone, and instead are directed to both a medicinal ingredient (i.e., an antigen) and a non-medicinal ingredient (i.e., an adjuvant)—tantamount, in its view, to a formulation claim—rendering the patent ineligible for a CSP.

Analysis

On judicial review, Justice Barnes set aside the Minister’s decision as unreasonable on the basis that it failed to consider Canada’s commitments under the Canada-European Union Comprehensive Economic Trade Agreement (CETA), as well as the statutory purpose and language of Canada’s CSP regime and the Minister’s decision was deficient in adopting “administrative tunnel vision to the exclusion of several highly relevant considerations”.

First, the Court noted that the Minister failed to have due regard to the statutory requirement that the interpretation of Canadian CSP legislation was to be done “in a manner consistent with the CETA Agreement”². Failing to note and abide by this statutory mandate, the Minister failed to consider and apply the language of CETA when it interpreted the statutory term “medicinal ingredient”. Further, the Court noted that article 20.6 of CETA makes it clear that CSPs were intended to be available for eligible pharmaceutical patents covering a “vaccine”.

The Court stated that the use of the term “active ingredient” in CETA indicates that biological activity is the measure by which CSP relief is to be made available in Canada³. Since adjuvants have biological activity, it was unreasonable for the Minister to assert that an adjuvant can never be a medicinal ingredient, simply because it does not independently trigger an immune response. If the Minister’s position were to be applied uniformly, any new and useful vaccine requiring an adjuvant to be effective would be excluded from protection, eliminating CSPs for many novel vaccines. The Court doubted that such a result was intended by CETA. The Court also noted that there is nothing in the relevant provisions of the Patent Act or in the CSP Regulations that require an eligible claim to be one directed to the medicinal ingredient per se.

Justice Barnes also remarked that, even though the adjuvant was not identified as a medicinal ingredient in the regulatory filing for Shingrix^®, neither the antigen nor adjuvant on their own would produce a clinically useful response. Here, Justice Barnes commented, the adjuvant is an “active and necessary ingredient of the medicine”. Furthermore, Health Canada does not treat vaccine adjuvants as excipients for all purposes in certain Health Canada guidance. As a result, even though Health Canada classifies adjuvants as excipients for the purpose of regulatory filings, Health Canada’s regulatory approach should not dictate whether a CSP should be available.

Justice Barnes also remarked that there is nothing in the CSP provisions of the Patent Act or the CSP Regulations that expressly excludes a formulation claim from being CSP eligible (despite the fact that the Regulatory Impact Analysis Statement for the CSP Regulations states that formulation claims are not CSP eligible). Justice Barnes commented that the eligibility limitation that Health Canada was reading into the CSP Regulations made some sense to the extent that it is employed to prevent forms of evergreening. While minor variations that do not affect the performance of an active ingredient would presumably be ineligible, said Justice Barnes, a novel and useful vaccine made up of two biologically active components should be CSP eligible.  

The Court concluded that these points should have been addressed by the Minister in the decision-making process. Rather than directing the Minister to issue the CSP to GSK, the case was sent back to the Minister for redetermination (a relatively standard form of relief in judicial review applications). It will be interesting to see whether the Minister appeals the decision (which must be filed by May 7, subject to further extension as a result of COVID-19, to do so) and how the Minister decides the matter on reconsideration in light of Justice Barnes strong decision that would support the grant of a CSP in this circumstance.

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¹ See section 106 of the Patent Act, R.S.C., 1985, c. P-4 and section 3 of the CSP Regulations, SOR/2017-165.

² Canada-European Union Comprehensive Economic and Trade Agreement Implementation Act, S.C. 2017, c. 6, s. 3.

³ Canada-European Union Comprehensive Economic and Trade Agreement, Article 20.27.

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