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PATENTS - Licences - Compulsory - Food or medicine

Wednesday, June 09, 2021 @ 5:39 AM  


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Appeal by the Minister of Health from a Federal Court decision setting aside the Minister’s decision refusing to issue a Certificate of Supplementary Protection (CSP) to the respondent GSK in respect of its 905 Patent and the drug SHINGRIX shingles vaccine. The goal of the CSP regime was 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. A Notice of Compliance for SHINGRIX identified the antigen as the only medicinal ingredient. SHINGRIX was listed in the register of innovative drugs where the antigen was the only medicinal ingredient identified. GSK filed its CSP application for the 905 Patent in relation to SHINGRIX and identified the antigen as the single medicinal ingredient. The Minister determined that the 905 Patent did not meet the requirements of s. 3(2) of the CSP Regulations since its claims were directed to a formulation and not to the medicinal ingredient or combination of all the medicinal ingredients contained in the SHINGRIX vaccine. The Minister also noted that the antigen itself was not novel, having been the subject of two prior patents. Health Canada’s position was that adjuvants, even those with biological activity, were not medicinal ingredients. The Federal Court held that “active ingredient”, the term used in Canada–European Union Comprehensive Economic and Trade Agreement (CETA) would include an ingredient such as the adjuvant whose biological activity was necessary for the clinical efficacy of the vaccine.

HELD: Appeal allowed. The Federal Court erred in concluding that the Minister’s interpretation of medicinal ingredient under the CSP Regulations was unreasonable. There was a definite link in the CSP Regulations between the medicinal ingredient listed in the Notice of Compliance issued by Health Canada for SHINGRIX and the medicinal ingredient referred to in s. 106(1)(c) of the Patent Act. The medicinal ingredient referred to in the Patent Act and CSP Regulations was the medicinal ingredient listed in the authorization for sale. The Notice of Compliance for SHINGRIX listed only one medicinal ingredient, the antigen. This was the sole medicinal ingredient for which GSK had applied for a CSP. There was no reviewable error in the Minister’s perceived desire for consistency between the two regimes. 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. The Minister’s decision was based on a legal and scientific position backed up by the consistency between the medicinal ingredient listed in the Notice of Compliance issued under the Food and Drug Regulations, the medicinal ingredient referred to in the application for a CSP and the Patent Act.

Canada (Minister of Health) v. Glaxosmithkline Biologicals S.A., [2021] F.C.J. No. 316, Federal Court of Appeal, J. Gauthier, M. Rivoalen and G.R. Locke JJ.A., April 14, 2021. Digest No. TLD-June72021007