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Proposed Amendments to Patented Medicines (Notice of Compliance) Regulations

The Patented Medicines (Notice of Compliance) Regulations (“PM(NOC)”) provides a link between Canada’s patent and drug approval systems. The Canada-EU Comprehensive Economic and Trade Agreement (“CETA”) calls for significant overhauls to the Canadian patent system. The Canada Gazette recently published proposed amendments to the PM(NOC), as well as proposed Certificate of Supplementary Protection Regulations. Highlights include: early and mandatory case management in PM(NOC) proceedings, a new appeal framework for PM(NOC) decisions, and supplementary protection for patents relating to human drugs. Comments on the proposed regulations must be submitted before 31 July 2017. Read more here and here.

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