Canada (Health) v. Glaxosmithkline Biologicals S.A., 2021 FCA 71

Justice Gauthier; Justice Locke; Justice Rivoalen - 2021-04-14

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This is an appeal from the Federal Court decision (2020 FC 397) setting aside the Minister of Health’s decision refusing to issue a Certificate of Supplementary Protection to GSK in respect of the 905 Patent and the drug SHINGRIX, a vaccine against shingles. ... This is the first time that the Minister’s interpretation of the expressions “medicinal ingredient” and “a claim for the medicinal ingredient or combination of all the medicinal ingredients” under subsection 3(2) of the CSP Regulations are challenged before this Court. ... This indicates to me that “active ingredient” and “medicinal ingredient” referred to the same thing in these regulations. I simply cannot discern any other intention of Parliament in respect of CETA or the CSP Regulations in that respect. ... As mentioned earlier, the NOC for SHINGRIX listed only one medicinal ingredient, the antigen. This is the sole medicinal ingredient for which GSK had applied for a CSP. I therefore see no reviewable error in the Minister’s perceived desire for consistency between the two regimes. ... Thus, given that I have already determined that it was reasonable for the Minister to conclude that the only medicinal ingredient here is the antigen, it also appears reasonable at this stage of the analysis (words read in context) to conclude that a claim for the medicinal ingredient refers only to a claim for the antigen and not a mixture of ingredients in an approved drug. ... Considering the submissions before her, and her reasoning, I conclude that the Minister’s decision was reasonable. Therefore, the Federal Court did not apply the applicable standard of review correctly, and I propose that the appeal be allowed.

Decision relates to:


Canadian Intellectual Property