Canadian Court Interprets CETA Drug Patent Extensions More Broadly Than EU Equivalent

It is a delicate balance between promoting pharmaceutical innovation and ensuring affordable access to pharmaceuticals. Every decade or so, the Canadian government seeks to recalibrate the balance, most recently with entry into the Canada-EU Comprehensive Economic and Trade Agreement (CETA) in 2014. One of Canada's CETA obligations, ratified in September 2017, was to provide at least an additional two years of supplementary protection beyond the term of the "basic patent" protecting a drug product.

Prior to CETA, Canada had never recognized any form of patent term extension. The best blueprint available to show how supplementary protection would work was the EU's supplementary protection certificate (SPC) regime, which has been in place for several decades. EU courts have grappled with many challenging questions regarding how and when a party should be entitled to an SPC.

Canada's Federal Court just ruled in its first case that considers the Canadian supplementary protection scheme. The case addressed whether a certificate of supplementary protection (CSP) could be granted for a patent covering the combination of an antigen and an adjuvant. The Court of Justice of the European Union had previously dealt with the same question in respect of a different product and found that no supplementary protection was permitted. The Federal Court came to the opposite conclusion, finding Health Canada to be unreasonable in concluding that no protection was available for the adjuvant.

Federal Court finds denial of CSP for adjuvant patent to be unreasonable

Justice Barnes of Canada's Federal Court found for GlaxoSmithKline (GSK) in Glaxosmithkline Biologicals SA v Canada (Health), 2020 FC 397, a decision issued on April 7, 2020. GSK had applied to the Court to challenge an August 2018 decision of Health Canada, which had refused to issue a CSP respecting Canadian Patent No. 2,600,905 (905 Patent) and the shingles vaccine, SHINGRIX®. The Court found that Health Canada had unreasonably restricted the definition of a medicinal ingredient in refusing GSK's application for a CSP and directed that the matter be redetermined.

Health Canada deemed the 905 Patent ineligible for a CSP because the 905 Patent claims a formulation consisting of an antigen and an adjuvant. The Regulatory Impact Analysis Statement (RIAS) introducing CSPs expressly excluded CSP protection for patents directed to formulations. In evaluating the argument that the claims were directed to a...