Canada has amended its Certificate of Supplementary Protection Regulations (the ‘Regulations’). The amendments were required to address the fact that the UK ceased to be a Member State of the EU from 1st January 2021. Following the amendments, qualifying supplementary patent protection in Canada is still available to applicants of UK marketing authorisations.

Background

In Canada, a Certificate of Supplementary Protection (or ‘CSP’ as supplementary protection certificates are known there), provides an additional period of patent protection of up to two years, for pharmaceutical products containing a new medicinal product, or a new combination of medicinal ingredients protected by an eligible patent.

In order to qualify for a CSP, applicants must file their regulatory submission to Health Canada for marketing approval no later than one year after they file an equivalent submission in a country designated in section 6(1)(a) of the Regulations.

Although the Regulations were originally drafted with the EU-Canada Comprehensive Economic and Trade Agreement (CETA) in mind, the scope of the CSP regime was never intended to cover only the Member States of the EU. However, prior to the amendment the only countries outside the EU designated as qualifying jurisdictions were the United States, Australia, Switzerland and Japan.

As the UK no longer qualified for preferential treatment under CETA following Brexit, the UK was not covered by the Regulations. Following the amendment taking effect, Section 6(1)(a) of the Regulations now includes the UK as an independent designated qualifying jurisdiction. Therefore, applicants who have applied for marketing authorisations for medicinal products in the UK are not precluded from applying for a CSP in Canada as a result of Brexit.

The amendments took effect on December 21st, 2020 and so are already in force. The changes to the Regulations bring them into conformity with Canadian international trade obligations, and ensure that the Regulations as originally drafted continue to operate consistently with their policy intent.

Comment

The pragmatic amendment by the Canadian legislature and guidance by the Canadian health authority will provide reassurance to pharmaceutical companies looking to market medicinal products containing novel active ingredients in Canada.

It is important to note that although SPCs are provided for by EU legislation (Regulation (EC) No 469/2009), SPCs operate as national rights that flow from national patents. The Patents (Amendment) (EU Exit) Regulations 2019 have already incorporated the provisions of the SPC Regulation into UK national law and so the UK’s SPC regime will remain largely unchanged in the short term.

We will continue to monitor and report on whether any other countries amend their domestic SPC legislation to take account of the UK being a third country following Brexit. We also look forward to updating on the wider post-Brexit landscape for SPCs in the UK, as the EU and UK undoubtedly diverge further in this important area.

The Regulations Amending the Certificate of Supplementary Protection Regulations can be found here.

Health Canada has also updated its guidance in relation to CSPs, whih can be read here.