On January 6, Regulations Amending the Certificate of Supplementary Protection Regulations were published in the Canada Gazette, Part II1. These amendments to the Certificate of Supplementary Protection Regulations (Regulations)2 were specifically required to address the fact that following Brexit, the United Kingdom ceased to be a Member State of the European Union and, but for the amendment, would no longer be a qualifying jurisdiction for the purposes of assessing Certificate of Supplementary Protection (CSP) eligibility in Canada.
What you need to know
- A CSP provides for an additional period of patent protection, of up to two years, for drugs containing a new medicinal ingredient or a new combination of medicinal ingredients protected by an eligible patent. This additional period of patent protection is intended to partly compensate patentees for time spent on R&D and obtaining regulatory approval of drugs containing new medicinal ingredients or new combinations of medicinal ingredients.
- In order to qualify for a CSP under section 106 of the Patent Act, applicants must file their Health Canada regulatory submission 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.
- Section 6(1)(a) of the Regulations has been amended to specifically include the United Kingdom as a designated qualifying jurisdiction, so that that Brexit does not change CSP eligibility requirements where an application for marketing approval for a drug is filed in the United Kingdom prior to a marketing approval application being submitted to Health Canada.
- Prior to these amendments, the Regulations included as designated qualifying jurisdictions the European Union and any country that is a member of the European Union, the United States of America, Australia, Switzerland and Japan. Until Brexit, the United Kingdom had been captured under the Regulations as a country that is a member of the European Union.
- Applicants wishing to obtain a CSP should consider whether they have submitted an application for marketing approval in the EU or in the UK (as well as the additional countries mentioned above) not more than 12 months before filing their regulatory submission for marketing approval in Canada.
- Health Canada’s Guidance Document - Certificates of Supplementary Protection has also been updated to reflect the addition of the United Kingdom as a qualifying jurisdiction.
- Timing: These amendments took effect on December 21, 2020.
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