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Federal Court of Appeal finds Minister of Health’s refusal to grant a CSP for SHINGRIX is reasonable

In the first appellate decision relating to Certificates of Supplementary Protection (CSPs), the Federal Court of Appeal has allowed the appeal of the Minister of Health (the Minister), setting aside the lower court judgment.

In a unanimous decision released on April 14, 2021, the Federal Court of Appeal in Canada (Health) v Glaxosmithkline Biologicals S.A., 2021 FCA 71 found that the Federal Court (see article here) did not correctly apply the applicable standard of review.

The Decision Under Review

The Minister had found that SHINGRIX contained only one medicinal ingredient—a Varicella Zoster Virus (VZV) gE antigen, and that the adjuvant in SHINGRIX was not a medicinal ingredient. 

The Minister also found that Canadian Patent No. 2,600,905 (905 patent) did not claim the medicinal ingredient or combination of all the medicinal ingredients in the drug, per se or in product by process form, or use thereof, as required by the CSP provisions in the Patent Act and section 3(2) of the CSP Regulations.  Rather, the 905 patent was characterized as claiming a formulation of the antigen and the adjuvant. 

The Federal Court found that the Minister’s decision was unreasonable as it “failed to take appropriate account of Canada’s [Canada-European Union Comprehensive Economic and Trade Agreement (CETA)] commitments and the full scope and purposes of the applicable statutory provisions, most notably Article 20.27 of CETA and s 3 of the CETA Act” and sent the matter back to the Minister for redetermination.

The “Medicinal Ingredient”

While the Federal Court of Appeal was “prepared to accept that there is not only one possible reasonable interpretation of the expression ‘medicinal ingredient’…it is not for reviewing courts to choose the one they prefer or that they find the most logical from their point of view” (see para 64). 

In the instant case, the Notice of Compliance (NOC) (i.e., marketing authorization) had only identified the “medicinal ingredient” as the antigen, and the CSP application itself only referred to the “medicinal ingredient” as the antigen.  The Federal Court of Appeal noted that:

[67] […] there is a definite link in the CSP Regulations between the medicinal ingredient listed in the NOC issued by Health Canada for SHINGRIX and the medicinal ingredient referred to at paragraph 106(1)(c) of the Patent Act (see subsection 106(4)). The medicinal ingredient referred to in the Patent Act and CSP Regulations is the medicinal ingredient listed in the authorization for sale, i.e. the NOC issued under the Food and Drug Regulations, C.08.004 or C.08.004.01.

[70] […] The Minister adopted a reasonable interpretation of the words “medicinal ingredient” and made a scientific determination that in this case, the adjuvant was not in fact a medicinal ingredient because it had no independent therapeutic effect on the body; thus the Minister’s decision was based on a legal and scientific position backed up by the consistency between the medicinal ingredient listed in the NOC issued under the Food and Drug Regulations, the medicinal ingredient referred to in the application for a CSP and the Patent Act.

Formulation Claims

The Federal Court of Appeal also found that the Minister’s interpretation and application of the CSP provisions to exclude patent claims directed to a formulation, “particularly the one at issue”, reasonable. 

Madame Justice Gauthier, writing for the Court, observed that “I do not believe that it was incumbent on the legislator to exclude expressly from eligibility patent claims directed to a formulation” (see para 95). 

Considering the Regulatory Impact Analysis Statement that accompanied the CSP Regulations, the Court found “no reason to conclude that subsection 3(2) as it was intended to be read and applied by the legislator is inconsistent with Canada’s obligation under Article 20.27 [of CETA]” (see para 115).

The Federal Court of Appeal concluded that the Minister’s decision refusing to issue a CSP was reasonable.

GlaxoSmithKline Biologicals SA may seek leave to appeal to the Supreme Court of Canada.

Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.

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