Author: Karen Zhou

Health Canada recently announced an update to Guidance Document: Certificate of Supplementary Protection Regulations. The purpose of the guidance is to outline the Certificate of Supplementary Protection (CSP) application process, the service standards, and roles and responsibilities of both applicants and the Therapeutic Products Directorate (TPD).

On September 21, 2017, the Certificate of Supplementary Protection Regulations (“CSP Regulations”) came into force to permit patent owners to obtain an extended period of patent protection for human and veterinary drugs in Canada. The CSP framework is set out in an amendment to the Patent Act in 2017 pursuant to Canada’s obligations under the Comprehensive Economic and Trade Agreement with the European Union (CETA). As part of this agreement, Canada has committed to provide up to two years of sui generis protection for new patented pharmaceutical products following the expiry of the patent. To implement this commitment, Canada has introduced the CSPs for medicinal ingredients, applicable for pharmaceuticals, biologics and veterinary drugs.

The updates to the guidance include:

·         Clarification of the roles and responsibilities of applicants and TPD;

·         New e-mail contact for corresponding with TPD;

·         Clarification of how TPD calculates the CSP term to reflect the maximum two-year term prescribed by the Patent Act.

The original CSP application form is being phased out, and a new CSP application form is intended for use on or after September 22, 2018, which provides a 12-month timely submission attestation. The new form also has new fields for the agent name, the notice of compliance (NOC) date, and the product (brand) name.

Questions related to the guidance should be directed to the Office of Patented Medicines and Liaison by e-mail at:  hc.opml-bmbl.sc@canada.ca

Reference

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/publication-guidance-certificate-supplementary-protection-notice.html