Friday, December 29 2023   \  Published by BLG.

Patent term restoration in Canada

Patent term restoration in Canada

The Certificate of Supplementary Protection (CSP) regime aims to restore some of the time lost to regulatory approval of patented medicines in Canada. Up to two years of patent term can be restored by way of CSP.

Three main requirements

1. Eligible regulatory approval:

- NOC pursuant to Canada’s Food and Drug Regulations;

- It must be the first NOC for that medicinal ingredient;

- It must have issued after September 21, 2017; and

- If Canada is not the first country for which an application for marketing approval for that medicinal ingredient or combination has been submitted, the application in Canada must have been filed within 12 months of the earliest foreign application for marketing approval in: The European Union and any country that is a member of the EU; The United States of America; Australia; Switzerland; United Kingdom; and Japan. Read more

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