A suite of amendments to the Patent Act and the Patented Medicines Regulations (the Regulations) will soon require holders of Certificates of Supplementary Protection (CSPs) to report information to the Patented Medicine Prices Review Board (PMPRB) on substantially the same terms and conditions as would be reported by patentees.
Regulations amending the Regulations, which will come into force on June 30, 2021, were recently published in the Canada Gazette, Part II. The corresponding amendments to the Patent Act are also set to come into force on this date.
Certificates of Supplementary Protection and CETA
A CSP can provide up to two years of “patent-like” rights beyond patent expiry for eligible medicinal ingredients protected by an eligible patent. Canada introduced CSPs in order to implement obligations under the Canada-European Union Comprehensive Economic and Trade Agreement (CETA). As we reported, the CSP regime was introduced through amendments to the Patent Act and the introduction of the Certificate of Supplementary Protection Regulations, which came into force on September 21, 2017.
As part of Canada’s domestic implementation of CETA, the Patent Act was also amended to bring medicines that are protected by a CSP within the PMPRB’s jurisdiction. However, these amendments were not brought into force in 2017 and have remained pending since that time.
On June 9, 2021, the government published notice that the PMPRB-related CSP amendments to the Patent Act would come into force on June 30, 2021. At the same time, the government also introduced the amendments to the Regulations. These include amendments to the version of the Regulations currently in force, as well as the pending Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements).
Together, these amendments serve to require holders of CSPs to report information to the PMPRB on substantially the same terms and conditions as would be reported by patentees. This objective is achieved primarily by:
- replacing the term “patentee” in the Regulations with “rights holder”, where “rights holder” includes both patentees and holders of CSPs; and
- requiring rights holders to report identity information regarding any CSPs pertaining to a medicine (e.g., CSP number, the date on which the CSP term begins, the date on which the CSP term ends and the number of the patent set out in the application for the CSP).
The government indicated that the coming-into-force date of these amendments was chosen to ensure they were in place before any CSP had taken effect. According to the Regulatory Impact Analysis Statement, the earliest possible date for a CSP to take effect is June 2022.