Vacillating Vaccination Post-Vavilov

Published on
April 23, 2020

On April 7th, the Federal Court released its first ruling on the interpretation of the Certificate of Supplementary Protection (CSP) regime, in GlaxoSmithKline Biologicals SA v Canada (Health), 2020 FC 397. This case came in the wake of a recent Supreme Court of Canada decision, Canada (Minister of Citizenship and Immigration) v Vavilov, 2019 SCC 65, which rewrote standards of review in the judicial review context barely a decade after the Supreme Court last overhauled the issue in Dunsmuir.

CSPs provide patent-like protection after the expiry of eligible pharmaceutical patents. The rationale behind them is to compensate patentees for the parts of the patent lifespan lost to regulatory testing and approval before sales (and profits) are possible. This case is valuable for its concise, informative overview of the CSP legislative regime, which was implemented in 2017 to comply with the Canada-European Union Comprehensive Economic Trade Agreement (CETA) and is administered by the Minister of Health.

The first salient point of the GlaxoSmithKline decision is the example it sets in determining and applying the standard of review of Ministerial decision-making post-Vavilov. Presuming and ultimately settling on reasonableness as the proper standard, Justice Barnes set out the usual hallmarks of that standard (“justification, intelligibility, and transparency but with sensitivity to context”) and recited relevant constraints in the statutory interpretation context ­— the rationale, purview, and specific constraints of the statutory scheme on the one hand, and even international law (with or without domestic implementation) on the other — all in accordance with the Vavilov decision.

In this case, the Court’s decision turned on whether the Minister demonstrated the aforementioned reasonableness in deciding that a particular patent for a shingles vaccine (trade name SHINGRIX) would not be eligible for a CSP. The Minister determined that, to be CSP-eligible, a patent had to have a claim that narrowly matched the medicinal ingredient(s) present in the corresponding drug product. Deciding that an adjuvant (a common ingredient in vaccines to make the antigen more efficacious) was non-medicinal, the Minister determined that none of the claims of the patent in suit rendered it eligible for CSP protection in relation to SHINGRIX because the claims covered the combination of an antigen and an adjuvant. The Minister’s determination of non-medicinal status rested principally on the fact that the adjuvant would do nothing on its own: it could only enhance the effect of the antigen, which by itself would indeed have an effect, but one below the standards of clinical significance.

A key distinction in this case was the difference between medicinal and active ingredients. The former term is defined nowhere in Canadian legislation! According to the Court, instead of focusing on a particular passage of the Regulatory Impact Analysis Statement for the CSP Regulations that supported the Minister’s interpretation, the Minister should have looked to the language and intent of CETA (the purposive wellspring for the entire CSP regime) and determined that the adjuvant in question does count as a medicinal ingredient because it is biologically active. Under CETA, that is the yardstick to determine medicinal status. (In fact, if the requirement of an adjuvant alongside an antigen rendered these patent claims ineligible for a CSP, then many patents directed to vaccines would fall short, a consequence that likely is not the intention of CETA or the domestic legislation implementing that agreement.)

Health Canada sometimes chooses to define adjuvants as non-medicinal ingredients for its own scientific and regulatory purposes, but according to the Court, this can have no bearing on the interpretation of legislation passed to implement CETA. An estoppel argument that the patentee had listed the adjuvant as non-medicinal for certain regulatory purposes was quickly dispensed with by the Court: the Minister’s administrative quirks are not legally binding.

Rather than direct the Minister to issue a CSP, Justice Barnes hewed to the Supreme Court’s guidance in Vavilov that “it will most often be appropriate to remit the matter to the decision maker to have it reconsider the decision, this time with the benefit of the court’s reasons.” To date, the CSP for SHINGRIX is still publicly listed as “Refused”.

Should you have any questions about the impact of this case on judicial review in the intellectual property sphere, or about CSPs more generally, please contact a member of our Regulatory or Patents teams.