May 8, 2020
In Glaxosmithkline Biologicals S.A v. The Minister of Health, 2020 FC 397, which is the Federal Court’s first judicial review of a decision made under the Patent Act and Certificate of Supplementary Protection Regulations (the “Regulations”), the Minister of Health’s (the “Minister”) decision was found to be unreasonable and was ordered to be redetermined on the merits.
Glaxosmithkline Biologicals S.A. (“GSK”) applied to the Minister for a Certificate of Supplementary Protection (“CSP”) for its patent on the vaccine SHINGRIX® (the “Patent”). The Minister found the Patent ineligible for a CSP (the “Decision”). A CSP would have effectively provided an additional patent-like protection term for the Patent.
The Court reviewed the Decision in light of the Supreme Court of Canada’s recent decision in Vavilov. After finding that the appropriate standard of review was reasonableness, the Court held that the Decision was unreasonable for failing to apply a purposive interpretation of the entire statutory framework.
The Minister’s Decision Regarding CSP Eligibility
The Minister interpreted the relevant statutory framework as requiring a patent to include a claim covering only medicinal ingredients to be eligible for a CSP. The Patent claimed combinations of an antigen and an adjuvant. The Minister acknowledged that the adjuvant was biologically active and necessary for SHINGRIX®’s clinical efficacy. Despite that, the Minister found the Patent ineligible for a CSP, as the Minister recognized only the antigen as a medicinal ingredient.
The Judicial Review Decision
On review, the Court determined that the applicable standard of review was reasonableness. Relying on Vavilov, the Court held that, in order for the Decision to be found reasonable, the Minister must have read the statutory language under consideration in its entire context and in its grammatical and ordinary sense harmoniously with the legislative scheme.
Under the Patent Act and Regulations, a CSP eligible patent is one that contains a claim for a “medicinal ingredient” or a combination of medicinal ingredients. However, “medicinal ingredient” is not defined. In the absence of a definition for “medicinal ingredient”, the Minister was required to look to Canada’s CSP statutory regime and resolve any interpretive ambiguities in a manner consonant with the broad purpose of the legislation.
The Court found that the relevant statutory framework includes the Canada-European Union Comprehensive Economic Trade Agreement (“CETA”), and that CETA “clearly” contemplates the grant of supplemental protection to inventive vaccines, which “often require both an antigen and an adjuvant to be effective”. CETA defines the protected product as “the active ingredient or combination of active ingredients” in the approved drug or vaccine [emphasis added].
Nothing in the Patent Act or Regulations expressly supported the Minister’s position that an eligible claim is only one that protects a “medicinal ingredient” per se. Furthermore, the Minister’s treatment of adjuvants as non-medicinal ingredients for purposes of granting a CSP was inconsistent with the Minister’s treatment of adjuvants in other contexts.
Authors: Larissa Fulop and Jon Wall