Co-authored by Sue Fei
Update On The Finalized Certificate Of Supplementary Protection Regulations
The finalized Certificate of Supplementary Protection Regulations (CSP Regulations) were published in Canada Gazette, Part II on September 7 and will come into force on September 21.1 The CSP Regulations are part of the Government of Canada's effort to implement the Comprehensive Economic and Trade Agreement (CETA).
What You Need To Know
- The finalized CSP Regulations remain largely similar to the proposed regulations, of which we provide full analysis here. Two changes that were made to the final version of the regulations are outlined below.
- The transitional period for timely filing of a Canadian new drug submission has been extended: for CSP applications filed by September 21, 2018, where an application for foreign marketing approval was submitted in prescribed countries, the Canadian new drug submission must be filed 24 months from the first such foreign application submission date in order to obtain a patent term extension. This is a 6-month increase from the previously proposed 18-month period.
- Timing of application: the proposed regulations required an application for a CSP to be filed more than two years before the expiry of the patent term. This requirement has been removed from the regulations.
Footnote
1. See: http://www.gazette.gc.ca/rp-pr/p2/2017/2017-09-07-x1/html/sor-dors165-eng.php
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.