On April 7, 2020, the Federal Court issued a decision in Canada’s first judicial review under the Patent Act and new Certificate of Supplementary Protection Regulations (CSP Regulations). It is the first decision issued under this regime, and also one of the first decisions to apply the Supreme Court of Canada’s new standard of review framework set out in Canada (Minister of Citizenship and Immigration) v Vavilov, 2019 SCC 65 (Vavilov).

The judicial review application was brought by GlaxoSmithKline Biologicals S.A. (GSK) in respect of an August 3, 2018 decision (Decision) by the Minister of Health (Minister) refusing to issue a CSP in respect of its Canadian Patent No. 2,600,905 (905 Patent) and the drug SHINGRIX®.  SHINGRIX® is a vaccine indicated for the prevention of herpes zoster (HZ or shingles) in adults 50 years of age or older (SHINGRIX).

SHINGRIX and the 905 Patent: an immunogenic composition

SHINGRIX contains two active components: (i) an antigen derived from glycoprotein E (gE antigen) from varicella zoster virus (VZV), the virus that causes shingles, and (ii) a biologically active adjuvant (the AS01B Adjuvant). Together, these components make a clinically effective shingles vaccine.

The 905 Patent pertains to a novel and improved vaccine useful in the prevention or amelioration of shingles in adults older than 50, or in immunocompromised persons. It contains claims to an immunogenic composition comprising the combination of the antigen and adjuvant contained in SHINGRIX.

Decision under review – is the AS01B Adjuvant a medicinal ingredient?

The Minister refused to grant a CSP to GSK in respect of the 905 Patent including for the following reasons:

  • To be eligible for a CSP, a patent must include at least one claim limited to one or more medicinal ingredients, or to their use;
  • the sole medicinal ingredient approved in SHINGRIX is the gE antigen as set out in the notice of compliance (NOC);
  • the AS01B Adjuvant is not a “medicinal ingredient” for the purposes of the CSP Regulations due to Health Canada’s decision to regulate all adjuvants as inactive excipients; and
  • the CSP amendments to the Patent Act and the CSP Regulations (the CSP Regime), in particular subsection 3(2) of the CSP Regulations, do not permit an eligible patent to pertain to or claim a formulation of medicinal ingredients (e.g., gE antigen) and non-medicinal ingredients (e.g., AS01B Adjuvant) or uses of same.

Reasonableness standard of review

In Vavilov, the Supreme Court of Canada “set a new course forward for determining the standard of review” and provided more guidance on the “reasonableness” analysis.  Under the Vavilov framework, there is now a presumption that judicial review of administrative decisions will apply a reasonableness standard, subject only to limited exceptions which include (1) express legislative intent; or (2) as required by the rule of law.

Further to Vavilov, the parties agreed that the reasonableness standard applied to the issues of statutory interpretation before the Minister.  GSK maintained that a correctness standard should apply to the Minister’s claims construction.  The Court held that claims construction is not addressed in Vavilov and remains open for debate, but rejected any application to the decision at hand, which did not turn on a disagreement about the 905 Patent claims.  The applicable standard of reasonableness was applied throughout.

In respect of the reasonableness analysis, the court noted that the focus of the judicial review must be the reasons supplied by the decision-maker. A decision should only be set aside based on serious shortcomings that are sufficiently central or significant that the decision cannot stand.

Purposive statutory interpretation

Canada enacted the CSP Regime further to implementing the Comprehensive Economic and Trade Agreement (CETA) in September of 2017. CETA provides for “Sui generis protection for pharmaceuticals” protected by a basic patent in force provided that the product has not already been the subject of a period of protection and the marketing authorization for that product is the first authorisation to put that product on the market. This has been described as a form of patent term restoration intended to provide eligible pharmaceutical patentees with up to two-years of additional “patent-like” rights to partly compensate for time that new patented drugs spend in research and obtaining marketing authorization.

Invoking Vavilov, the Court held that as a matter of purposive statutory interpretation, the Decision must comply with the rationale, purview, and specific constraints of the statutory scheme, including any relevant international law. This must be done in a manner consistent with the modern principles of statutory interpretation. To the extent that the CSP Regime is open to interpretation, it must therefore be interpreted in a manner consistent with CETA.  Section 3 of the CETA Implementation Act provides for consistent interpretation between CETA and any federal law that implements its provisions.

The Court noted that CETA defines an eligible patent as one that protects a “product as such”, and the protected product as “the active ingredient or combination of active ingredients”.

Minister’s decision unreasonable

The Minister agreed that a “medicinal ingredient” is the substance in the formulation, which once administered, is responsible for the drug’s desired effect in the body (see Bayer Inc v Canada, 2009 FC 1171). Despite undisputed scientific evidence that the AS01B Adjuvant is biologically active and essential to SHINGRIX’s clinical efficacy, the Minister maintained a position that the AS01B Adjuvant was not a “medicinal ingredient” based on Health Canada’s general regulatory classification of all vaccine adjuvants as non-medicinal excipients.  As a result, the Minister held that the 905 Patent was ineligible for a CSP because it contains claims directed to a mixture of medicinal and non-medicinal ingredients.

In the Court’s view, the key question the Minister needed to consider was whether its perceived need for administrative consistency in the regulation of adjuvants was a reasonable basis to deny a CSP to GSK for its 905 Patent. The Court held that it was not. Rather, the Minister’s reasoning failed to address “highly relevant considerations”, including the requirement to interpret the CSP Regime in a manner consistent with CETA and the uncontested evidence that the gE antigen alone is not effective as a vaccine in the absence of the adjuvant. The Court further noted that despite Health Canada’s position on adjuvant regulation in the judicial review, it did not consistently treat vaccine adjuvants as non-medicinal excipients for all purposes (e.g., SHINGRIX product monograph).

The Decision was set aside as unreasonable. It was remitted back to the Minister for redetermination in light of the Court’s reasons.

Norton Rose Fulbright Canada LLP represented GSK before the Minister and in this application, which commenced in 2018.

Link to decision:

Glaxosmithkline Biologicals S.A. v. Canada (Health), 2020 FC 397