Certificate of Supplementary Protection (CSP) Regime in Canada: Amendments and Analysis of Granted, Pending, and Refused CSP Applications

According to the Comprehensive Economic and Trade Agreement (CETA), Canada introduced Certificate of Supplementary Protection (CSP) regime on 21 September 2017. Before CETA was executed, Canada was the only country of G7 (Group of 7) countries not to legislate Patent Term Extension (PTE). On 21 September 2020, CSP regime completed three years of existence. During these three years, few changes took effect in CSP regime. This article provides in-depth evaluation of CSP regime and such relevant changes. It also covers comparative analysis of number of CSP applications granted, pending, refused, and withdrawn. During these three years, about 95% CSP applications were filed for medicinal ingredient for human use and about 5% CSP applications were filed for medicinal ingredient for veterinary use. This article also provides analysis of type of patents referred in CSP applications, CSP applicant-wise analysis, and terms of granted CSPs. Comprehensive summary of Federal Court of Canada cases which involved challenges filed by CSP applicants over refusal of their CSP applications by the Minister of Health Canada is also provided. For example, decisions released by Federal Courts are providing directions to the Minister of Health Canada and has potential to act as guidance for future decisions regarding CSP applications. Basis analysis of three years CSP data, this article also provides some suggestions to the CSP applicants