Notice: Publication of update to the Guidance Document: Certificate of Supplementary Protection Regulations

September 4, 2018

Our reference number: 18-108554-113

Health Canada is pleased to announce the second publication of the Guidance Document: Certificate of Supplementary Protection Regulations.

Since September 21, 2017, the Office of Patented Medicines and Liaison, within the Office of Submissions and Intellectual Property, Therapeutic Products Directorate (TPD), has administered sections 104 to 134 of the Patent Act and the Certificate of Supplementary Protection Regulations.

As some experience has been gained since the first publication, the Guidance Document has been updated to provide additional guidance regarding the roles and responsibilities of applicants and the TPD with respect to CSPs and applications.

As certificate of supplementary protection (CSP) applications are filed with the TPD by email, it is important to note the new email address for corresponding with the TPD effective immediately. The new email address is also provided below. 

The Guidance Document has also been updated to explain how the TPD calculates the CSP term. This aligns with an update to the Register of Certificates of Supplementary Protection and Applications to correct the “CSP Term Ends” field for the CSPs issued between March 15, 2018 and June 25, 2018, wherein it was identified that these CSPs were granted a term of 2 years plus 1 day. The CSPs have been amended to reflect the maximum 2 year term prescribed by the Patent Act.

The Certificate of Supplementary Protection Regulations contain a requirement with a transitional provision; therefore, the original CSP application form is being phased out and a new CSP application form is being introduced. The new CSP application form is intended for use on or after September 22, 2018, and it provides a 12 month timely submission attestation. The new form also has new fields for the agent name, the notice of compliance date and the product (brand) name. The original CSP application form providing a 24 month timely submission attestation will continue to be available on Health Canada’s website at least until September 21, 2018, after which time it should no longer be used.

Questions or concerns related to this Guidance Document should be directed to the Office of Patented Medicines and Liaison at:

E-mail: hc.opml-bmbl.sc@canada.ca

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