Canada has added the UK to the list of countries that must be considered for the “timely submission requirement” in an application for a Certificate of Supplementary Protection (CSP). The change was implemented by an amendment to the CSP Regulations that came into force on January 6, 2021.
Impact on “timely submission requirement”
CSP eligibility is tied to both a patent and a medicinal ingredient contained in an approved drug. There are also certain timing requirements.
The “timely submission requirement” in paragraph 106(1)(f) of the Patent Act stipulates that the Canadian application for market authorization for the approved drug in question must have been filed within 12 months of the earliest market authorization application in certain prescribed countries.
The prescribed countries relevant to the “timely submission requirement” are set out in paragraph 6(1)(a) of the CSP Regulations. Prior to the January 6, 2021 amendment, the list of jurisdictions included the European Union and its member countries, along with the United States, Australia, Switzerland, and Japan. The list has now been amended to include the United Kingdom.
This amendment comes in response to the fact that the United Kingdom is no longer a member country of the European Union following Brexit.
Patentees are required to include an attestation that they have complied with the “timely submission requirement” as part of their CSP applications (see s. 8). The CSP application form and Guidance Document have now been amended to reflect this change.
CSP applicants should consult the applicable legislation and guidance documents for detailed information on CSP eligibility requirements, including details on complying with the “timely submission requirement”.
Links to Health Canada Notice, Guidance Document, and updated CSP application form: