What’s in a claim? The FCA weighs in on CSP eligibility

In Canada v. Glaxosmithkline Biologicals S.A.¹, the Federal Court of Appeal (FCA) upheld the Minister of Health’s refusal to issue a Certificate of Supplementary Protection (CSP) to GSK for its SHINGRIX vaccine. Overturning the application judge, the FCA concluded that the Minister’s determination that the relevant patent did not contain “a claim for the medicinal ingredient” in SHINGRIX, as required by the CSP Regulations, was reasonable.

The decision marks the first opportunity that the FCA has had to consider the patent eligibility criteria under Canada’s CSP Regulations, and in particular, the interpretation of the phrase “a claim for the medicinal ingredient”.

What you need to know

• The FCA affirmed the Minister’s interpretation of “medicinal ingredient” as one that provides an independent therapeutic effect. This may exclude accessory molecules (such as, in this case, vaccine adjuvants).
• “Formulation claims” (i.e., those reciting the “medicinal ingredient” along with other active or inactive ingredients) cannot support eligibility for a CSP.
• This case confirms that CSP applicants need to be mindful of “matching” between the medicinal ingredient(s) listed in the approved products and the subject matter of patent claims when considering eligibility.

Canada’s CSP legislation

The CSP regime was introduced in Canada in 2017 through legislation implementing the Canadian-European Union Comprehensive Economic and Trade Agreement (CETA), which among things, required the parties to the agreement to provide a period of additional patent protection for new patented pharmaceutical products².

The eligibility requirements are set out in section 106(1) of the Patent Act and section 3(2) of the CSP Regulations. Together, they provide the circumstances in which a patent will be considered to “pertain to the medicinal ingredient, or combination of medicinal ingredients” and therefore be eligible for CSP protection. The patent must contain:

• a claim for the medicinal ingredient or a combination of all the medicinal ingredients contained in the approved drug;
• a claim for the medicinal ingredient or a combination of all the medicinal ingredients contained in the approved drug when made by a specified process; or
• a claim for the use of the medicinal ingredient or combination of all the medicinal ingredients contained in the approved drug.

A key issue in this case was the meaning of “medicinal ingredient”.

The CSP application for SHINGRIX

GSK’s 905 patent claimed immunogenic compositions comprising a certain antigen in combination with an adjuvant and other non-active ingredients. The 905 patent was not the first patent covering the antigen. Therefore, the antigen was not “new”, but in order for it to have the desired clinical effect and be useful as a vaccine against shingles, the adjuvant was required.

On October 13, 2017, Health Canada issued a notice of compliance for SHINGRIX—a vaccine containing the antigen and adjuvant. On January 25, 2018, GSK filed an application for a CSP in respect of the 905 patent and SHINGRIX. The Minister denied the CSP application on the basis that the patent did not contain a claim for the “medicinal ingredient or combination of all the medicinal ingredients” as required by the CSP legislation. In her view, the 905 Patent was directed to a formulation since it claimed a composition containing a combination of a medicinal ingredient (the antigen) and a non-medicinal ingredient (the adjuvant). Although the Minister accepted that the adjuvant was required for the antigen to have the desired clinical activity, she held that it was not a “medicinal ingredient” in SHINGRIX. GSK brought an application for judicial review of the Minister’s decision.

The Federal Court allowed GSK’s application and ordered that the matter be returned to the Minster for re-determination in light of the requirements of CETA, which used the term “active ingredient” in describing the types of claims that would be eligible for supplemental protection. In the Federal Court’s view, the CETA definition of “active ingredient” could include a “biologically active” ingredient such as the adjuvant. The Federal Court further noted that nothing in the legislation supported the exclusion of formulation claims nor justified excluding a novel and useful vaccine such as SHINGRIX³. The Minister appealed.

The FCA’s analysis

On appeal, applying Vavilov, the FCA held that the standard of review applicable to the Minister’s decision was reasonableness⁴. It explained that the FCA’s role was to ensure that the Federal Court had applied that standard correctly, essentially “stepping into the shoes” of the Federal Court to assess the reasonableness of the Minister’s conclusion.

The case raised two questions regarding the interpretation of the CSP provisions. First, whether the Minister’s interpretation of “medicinal ingredient” was reasonable, and second, whether it was reasonable for the Minister to exclude claims like the ones in the 905 Patent from CSP eligibility.

Turning first to the meaning of “medicinal ingredient” and whether it could include the adjuvant, the Court noted that there may be more than one reasonable interpretation of the term “medicinal ingredient”. However, consistent with Vavilov, it explained that it was not the role of the appellate court to choose the definition it preferred. Ultimately, the FCA concluded that the Minister’s interpretation that the adjuvant was not a medicinal ingredient was reasonable. The FCA found that this interpretation was based on the Minister’s scientific and legal judgment and was consistent with CETA and how the term had been used under related Canadian legislation. The FCA also noted that, while not binding, the European Court of Justice had reached a similar conclusion in respect of a vaccine adjuvant⁵. Finally, the FCA noted that the only “medicinal ingredient” listed in both the NOC for SHINGRIX and the CSP application was the antigen. The FCA held that the Minister’s focus on consistency across these different regulatory regimes was not unreasonable.

Having concluded that the adjuvant was reasonably excluded from the definition of a “medicinal ingredient”, the FCA then considered the second question: did the 905 Patent contain a claim for the “medicinal ingredient or combination of all medicinal ingredients” in SHINGRIX? The FCA held again that it was reasonable for the Minister to conclude that it did not and that section 3(2) of the CSP Regulations did not include formulation claims. The FCA noted that this view was supported by the words of the CSP Regulations as informed by the accompanying Regulatory Impact Analysis Statement (RIAS), which expressly stated an intention to exclude formulation claims from eligibility as they “do not protect the medicinal ingredient or combination of medicinal ingredients per se”. Although the CSP Regulations do not use the per se language, the FCA held that this meaning could be implied. In their view, a “claim for the medicinal ingredient” is one which defines the subject matter of the invention as the medicinal ingredient or the combination of medicinal ingredients. In argument, GSK submitted that this approach was inconsistent with the European approach where formulation-type claims that clearly identified the active ingredient had been found to be eligible. The Court rejected this, noting that it was conceivable that each party to CETA would have to find a way to implement its requirements under their own domestic laws and jurisprudence. Given the differences between the European and Canadian patent systems and the clear wording of the Canadian legislation, the European approach was not determinative, and the Minister’s approach was not clearly inconsistent with CETA.

The FCA concluded by noting that there was no doubt that the SHINGRIX vaccine was a valuable development but that “it is not for judges to rewrite government policies when they are of the view that such policies are not fair or broad enough to cover, as in this case, a vaccine that they believe to be a welcome improvement”⁶. The FCA held that the Federal Court failed to apply the applicable standard of review correctly; the Minister’s decision was in fact reasonable.

The decision demonstrates an application of a deferential approach to reasonableness as set out by the Supreme Court of Canada in Vavilov. Where a decision maker has specialized knowledge and “an understanding of the purposes and practical realities of the relevant administrative regime” including an understanding of the “operational impact of the decision” under the Vavilov reasonableness standard, these decisions may be difficult to challenge on judicial review⁷. Moreover, given the Minister’s interpretation of the CSP Regulations and the Vavilov requirement for consistency of administrative decisions, going forward, CSP applicants will need to be mindful of “matching” between the medicinal ingredient(s) listed in the approved products and the subject matter of patent claims when considering eligibility.

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¹ 2021 FCA 71 rev’g 2020 FC 397 [GSK]

² Read more about CSPs in our article.

³ Read more in our bulletin.

⁴ Canada (Minister of Citizenship and Immigration) v. Vavilov, 2019 SCC 65 at para. 17 [Vavilov]

⁵ Glaxosmithkline Biological S.A. v. Controller General of Patents, Design and Trademarks, case C-210/13, November 14, 2013

⁶ GSK at para. 125

⁷ Vavilov, para. 93; GSK at para. 73