The final regulations for implementing CETA in Canada were published today in a special edition of the Canada Gazette. As compared to the proposed regulations published earlier this summer, the final versions the IP related regulations are very similar, with no changes to the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, 2017, two changes to the Certificate of Supplementary Protection Regulations and no changes to Rules Amending the Patent Rules. As reported yesterday, the changes come into force September 21, 2017. Continue reading CETA
A series of Orders in Council dated last week but published today confirm that most of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act will come into force September 21, 2017. This includes expanded geographic indicators, certificates of supplementary protection and changes to the PM(NOC) 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.
According to an article about the timing of CETA implementation by the CBC, “the European pharmaceutical industry doesn’t want the EU to set a date to start implementing the deal until Canada publishes and consults on some regulatory changes promised to generic drug manufacturers, and some member states are expressing these concerns to the European Commission.” Implementation of CETA requires among other things, amendments to the patent linkage system and patent term adjustment (see earlier post).
Bill C-30 has been introduced to implement the Comprehensive Economic and Trade Agreement (CETA) with Europe. The Bill includes amendments to the Patent Act, regarding supplementary protection for pharmaceutical products and altering the PM(NOC) procedure, and to the Trade-mark Act regarding geographic indicators with grounds of opposition and certain exceptions for prior use, acquired rights and generic terms. Amendments are also proposed to a number of other acts. Continue reading CETA Implementation