Author: Daphne Lainson
The first decision considering the scope and meaning of the provisions in the Patent Act relating to Certificates of Supplementary Protection (CSPs) has now been released. Justice Barnes of the Federal Court in GlaxoSmithKline Biologicals SA v The Minister of Health, 2020 FC 397 found the decision of the Minister of Health (the Minister) refusing to issue a CSP in respect of Canadian Patent No. 2,600,905 (905 patent) and SHINGRIX unreasonable.
The decision is important insofar as it considers:
i) the meaning of “medicinal ingredient” for the purposes of the CSP provisions in the Patent Act and related Certificate of Supplementary Protection Regulations (CSP Regulations), and
ii) whether a claim to a formulation—and specifically a vaccine—may be eligible for a CSP.
The interpretation of “medicinal ingredient” may have broader implications, as the term is also found in the Patented Medicines (Notice of Compliance) Regulations and the data protection provisions of the Food and Drug Regulations.
The Court ultimately did not decide these issues, returning the matter to the Minister to redetermine the CSP application on the merits and in accordance with the Court’s reasons. The Minister has advised it intends to appeal the decision to the Federal Court of Appeal.
The attached article will expand on the following:
- CSPs in context
- The refusal
- The reasonableness of a decision
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