Minister of Health’s Decision Regarding the Interpretation of “Medicinal Ingredient" Reinstated

In the decision below, 2020 FC 397, the Federal Court set aside the Minister’s refusal to issue a Certificate of Supplementary Protection (“CSP”) to GlaxoSmithKline (“GSK”) for its drug SHINGRIX, which is a vaccine against shingles. The Minister appealed, and the FCA overturned the lower Court’s decision, finding that the Minister’s decision to refuse the CSP was reasonable.

The goal of the CSP regime is to extend the rights under an eligible patent but only with respect to the making, using and selling of the actual drug or pharmaceutical product containing the medicinal ingredient or combination of medicinal ingredients set out in the CSP, for a maximum of two years.

The Minister’s Decision

GSK sought a CSP for its Patent No. 2,600,905 (the “905 Patent”), which claimed both the antigen and adjuvant in its SHINGRIX drug. The Minister denied the CSP on the basis that the claims in the 905 Patent were directed to a formulation (a composition containing medicinal ingredients and non-medicinal ingredients), and not “the medicinal ingredient or combination of all the medicinal ingredients” as contemplated by subsection 3(2) of the CSP Regulations.

GSK submitted that the claims at issue were not formulation claims, and that the adjuvant was itself an active ingredient, in that it had biological activity, but the Minister interpreted the adjuvant as a non-medicinal ingredient, which made the 905 Patent ineligible for a CSP.

The Federal Court’s Decision

GSK applied for judicial review, and the Federal Court found the Minister’s decision to be unreasonable.

The Federal Court found the Minister’s requirement that a medicinal ingredient have an independent therapeutic effect on the body (which would only include the antigen, and not the adjuvant) was “administrative tunnel vision”. It further held that the Minister failed to take appropriate account of Canada’s obligations under the Canada-European Union Comprehensive Economic and Trade Agreement (“CETA”). Specifically, “active ingredient” under CETA would include an ingredient such as the adjuvant where its biological activity was necessary for the efficacy of the vaccine.

The Federal Court sent the matter back to the Minister for redetermination.

The FCA’s Decision

On appeal, the FCA noted that the standard of review applicable to the Minister’s decision was reasonableness. The FCA proceeded to assess whether: (a) the Minister’s interpretation of “medicinal ingredient” was reasonable; and (b) the Minister’s interpretation and application of subsection 3(2) of the CSP Regulations to exclude patent claims directed to a formulation, particularly those at issue in the 905 Patent, was reasonable.

The FCA confirmed the Minister’s interpretation of “medicinal ingredient” as one that provides an independent therapeutic effect on the body, which can exclude accessory molecules such as a vaccine adjuvant. The FCA determined that the Minister’s interpretation of medicinal ingredient under the CSP Regulations was consistent with CETA and with the interpretation of medicinal ingredient applied under Canada’s domestic legislation pertaining to pharmaceutical products. Finally, the FCA noted that the only “medicinal ingredient” listed in GSK’s Notice of Compliance and CSP application was the antigen.

The FCA also confirmed that a “formulation”, which includes a medicinal ingredient and other active or inactive ingredients, is not eligible for a CSP, and found that it was reasonable for the Minister to conclude that subsection 3(2) of the CSP Regulations did not include claims for formulations. The FCA noted this view was supported by the Regulatory Impact Analysis Statement of the CSP Regulations, and rejected GSK’s argument that this view was inconsistent with Canada’s obligations under CETA. The FCA noted that, although CETA’s objective was “to grant some patent-like rights to compensate for the time lost in obtaining approval of innovative drugs and vaccines, Canada only understood and agreed to a very specific and limited way of doing so".

The FCA was prepared to accept that there could be more than one reasonable interpretation of the expression “medicinal ingredient”, but emphasized that “it is not for reviewing courts to choose the one they find the most logical from their point of view”. The FCA noted that, while the vaccine was an important development, “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”.

The FCA’s decision emphasizes the importance of deference when reviewing a decision for reasonableness. Decision makers with specialized knowledge are in the best position to understand the purpose and practical realities of the administrative regime, and their decisions may be difficult to challenge under judicial review.

Authors: Shannon Skillings