Tag Archives: PM(NOC)

CETA

Changes to the Patent Act, Patent Rules, Patented Medicines (Notice of Compliance) Regulations and the Trade-marks Act, and new Certificate of Supplemental Protection Regulations come into force on September 21, 2017 as part of Canada’s implementation of CETA. Today, Health Canada released guidance documents on applying for Certificates of Supplementary Protection and on Health Canada’s administration of the PM(NOC) Regulations.

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CETA Proposed Regulations

Proposed amendments to overhaul the patent linkage regime and add certificates of supplementary protection were published today in the Canada Gazette, Part 1. Amendments to the Patented Medicines (Notice of Compliance) Regulations will replace the current summary procedures with full actions including rights of appeal. New Certificate of Supplementary Regulations are proposed to provide for up to two years of additional exclusivity based on the time to obtain a notice of compliance for a drug containing a new medicinal ingredient or combination of medicinal ingredients.  A number of other proposed regulatory amendments relating to CETA were also published. There is a 15-day consultation period.

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Patent Amendments

Two IP related amendments are included in the July 1st Canada Gazette: