Canadian patents claiming a formulation for a medicinal ingredient may be eligible for patent term extension

In an April 7th ruling, Canada’s Federal Court required the Minister to re-determine its conclusion that a patent, which claims an antigen in combination with an adjuvant and protects the vaccine SHINGRIX®, was ineligible for a Certificate of Supplementary Protection (“CSP”) – Canada’s version of patent term extension – because there is nothing in Canada’s Patent Act or CSP Regulations that expressly excludes formulation patents from eligibility: GlaxoSmithKline Biologicals S.A. v. The Minister of Health 2020 FC 397.

At the core of the Minister’s refusal was the position that a patent must include at least one claim that covers only the medicinal ingredient. All of the claims of the patent at issue here required a combination of the medicinal ingredient (the antigen) with an adjuvant. The Minister decided the patent was not eligible for a CSP. The necessary adjuvant could not be considered a medical ingredient, despite undisputed evidence that an adjuvant was essential to the vaccine’s clinical efficacy, since it did not independently initiate an immunological reaction.

The Court agreed that the “presumptive standard of reasonableness applies to the issues of statutory interpretation that were before the Minister”.[1] The Court noted however that, in light of the principles set out in the Supreme Court’s decision in Vavilov[2], a court on judicial review had to be cognizant of whether the Minister applied the purpose of the entire statutory scheme when making its decision.

On review, the Court held that a reasonable decision must include a purposive interpretation of the legislative scheme. In this context, the Court held that the origins of Canada’s CSP legislative regime lie in the Canada-European Union Comprehensive Economic Trade Agreement (“CETA”) which “makes it clear that supplementary protection was intended to be available for eligible pharmaceutical patents covering a “vaccine” useful for “preventing disease.”[3] That is what this patent does.

The Court acknowledged that although the Regulatory Impact Analysis Statement relating to the CSP Regulations purports to exclude formulation patents from eligibility, it was “noteworthy that there is nothing relevant in the CSP provisions of Canada’s Patent Act or the CSP Regulations themselves that expressly supports a requirement that an eligible claim is one that only protects a medical ingredient.”[4] The Court also noted that there is nothing in the “Patent Act or in the CSP Regulations that expressly excludes from eligibility patent claims directed to a formulation.”[5]

In light of these determinations the Court found that the Minister failed to adopt a purposive approach when interpreting the Patent Act  and the CSP Regulations. Accordingly, the decision was not reasonable. In light of the Minister’s failure to properly consider CETA, the Court sent the issue back to the Minister for redetermination.

For more information, please contact the McCarthy Tétrault Intellectual Property Litigation group in Toronto.

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[1] At para 11.

[2] Canada (Minister of Citizenship and Immigration) v Vavilov, 2019 SCC 65

[3] At para 20.

[4] At para 26.

[5] At para 44.

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