Author: Bhavesh Patel, C. Chem. Natco Pharma (Canada) Inc.

Health Canada has released the Guidance Document - Certificate of Supplementary Protection Regulations which provides information for industry regarding the recently implemented Certificates of Supplementary for medicinal ingredients.

As part of its obligations under the Comprehensive Economic and Trade Agreement with the European Union, Canada agreed to provide innovators with a period of extended market exclusivity to compensate for the time lost due to regulatory obligations in obtaining market approval. This protection, termed a Certificate of Supplementary Protection, is a form of sui generis exclusivity for up to two years and applies to patents claiming the medicinal ingredient contained in pharmaceuticals, biologics, and veterinary drugs.

An applicant for a CSP must file an application within 120 days from the date of issuance of the Notice of Compliance. At the time of filing, an applicant is required to submit the CSP application form along with advance payment details form and the required fee. The fee for filing a CSP application is  $9,011 which is set to increase by 2% per year. The required forms are available on Health Canada’s website.

To be eligible for a CSP, the patent claims must pertain, in the case of a drug containing one medicinal ingredient, to the one medicinal ingredient, or, in the case of a drug containing two or more medicinal ingredients, to the combination of all medicinal ingredients. Please note only one CSP will be granted for a given medicinal ingredient or combination. 

Reference: 

Canada Gazette, Part Ⅱ, Ottawa, Registration SOR/2017-165 September 1, 2017 Patent Act, Certificate of Supplementary Protection Regulations

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