The Federal Court has released the first Judicial Review decision addressing the Certificate of Supplementary Protection Regulations (CSP Regulations), in a case pertaining to a refusal by the Minister of Health to award a CSP to Glaxosmithkline Biologicals for a patent covering its SHINGRIX® product. The decision raises a number of interesting points with respect to interpretation of the CSP Regulations, as well as the administrative processes of Health Canada.

Background of the decision

The patent at issue was Canadian Patent No. 2,600,905 (the 905 Patent), which claimed both the antigen and adjuvant in SHINGRIX®. The Minister had refused GSK's application for a CSP in respect of the 905 Patent on the basis that the claims at issue were not eligible for a CSP, with the Minister taking the position that the claims were not to the medicinal ingredient or use of the approved medicinal ingredient, as required per subsection 3(2) of the CSP Regulations. In refusing to issue the CSP, the Minister took the position that the adjuvant was a non-medicinal ingredient, and the 905 Patent therefore claimed a formulation.

The Minister justified its refusal by relying upon Health Canada's internal Guidance Document classifying adjuvants as excipients, i.e. non-medicinal ingredients. The Minister's refusal relied upon a desired "linguistic consistency" in terms of the treatment of adjuvants within Health Canada.

The Court's analysis

The Court's analysis focussed primarily on a purposive interpretation of the CSP Regulations, with significant focus on the purpose of the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) as the impetus for the CSP Regulations. In doing so, the Court drew principles from the SCC's recent analysis of standard of review for regulatory decisions discussed in Canada (Minister of Citizenship and Immigration) v Vavilov.

While recognizing that this was an issue of interpretation of a home statute, and therefore subject to the reasonableness standard, the Court provided helpful context on what "reasonableness" means post-Vavilov. As put forward by the SCC in Vavilov, the Court began with a review of the Minister's reasons and examined them for justification, intelligibility and transparency, "but with sensitivity to context". In this case, the relevant "context" was not only the Canadian CSP Regulations, but as the CSP Regulations were implemented to meet Canada's commitment under CETA the Court further sought to find harmonization with the desired intent as set out in CETA's IP provisions.

The Court's decision hinges on the interplay between the term "medicinal ingredient" as used in the CSP Regulations, and the term "active ingredient" as used in CETA. The CSP Regulations do not define "medicinal ingredient", and therefore the Court determined the purposive construction required the definition to be harmonious with CETA's broader use of the term "active ingredient".

Having concluded that "medicinal ingredient" should not be construed too narrowly, the Court turned to the claims directed to the antigen and an adjuvant. The evidence supported that both the antigen and the adjuvant were required for the vaccine to have biological efficacy. In other words, both the antigen and the adjuvant appeared to be "active" ingredients in the pharmaceutical product.

Notably, the Court rejected any suggestion that Health Canada's internal categorization or administrative pathway was determinative of CSP eligibility, referring to this as "administrative tunnel vision". While Health Canada is free to streamline its internal process, the Court noted that the CSP Regulations serve a very different purpose than the requirements for pharmaceutical licensing, and the two should not constrain one another.

In the result, the Court declined to direct the Minister to issue the CSP, instead setting aside the decision and ordering the Minister to redetermine the matter in accordance with the Court's reasons.

Application to formulation claims

In an interesting statement at paragraph 44 of the decision, the Court concluded that there is nothing within the CSP Regulations or relevant Patent Act sections that expressly excluded claims directed to formulations to be eligible for a CSP. While the Court did not go so far as to say claims to formulations were eligible for a CSP, it did stress that the focus is to be on the purpose of the statute, and not simply the classification of the patent claim.

Specifically, the Court noted that the only basis for Health Canada to exclude claims to formulations was the RIAS, and that such a strict exclusion was not found within the CSP Regulations or CETA. The Court suggested that a balance should be struck between claimed improvements consisting of minor variations that do not affect the performance of the active ingredient, with those that impact the biological activity.

This statement will likely be of greater focus both in CSP filings and future Judicial Reviews. For now, patentees should consider if elements within a claim contribute to the medicine's overall biological effect, and if so, whether these elements can be distinguished from other "inactive" substances such as fillers, stabilizers, or preservatives.