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.

An earlier post (link) had identified September 21, 2017 as the likely provisional implementation date for CETA in Canada.

The lead Order in Council (link) states:

His Excellency the Governor General in Council, on the recommendation of the Minister for International Trade, pursuant to subsections 138(1), (3) and (4) of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act [link], chapter 6 of the Statutes of Canada, 2017, fixes September 21, 2017 as the day on which that Act comes into force, other than subsection 8(3), paragraph 11(1)(a), subsection 11(2), paragraph 13(a) and sections 45 to 58, 90 and 133 to 137. (emphasis and link added)

Sections 45 to 58 of the CETA implementation act relate to amendments in the Patent Act to sections 79 through 103 pertaining to the Patented Medicines Prices Review Board.

Orders in Council also address the coming into force of the following regulations/rules as summarized in the orders:

  • Rules Amending the Patent Rules – remove the references to representatives appointed under section 29 of the Patent Act, as that section is repealed with the coming into force of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act.
  • Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, 2017 – (1) resolve a number of problems by replacing summary prohibition proceedings with full actions to determine patent validity and infringement; (2) expand the scope of the Regulations to cover relevant certificates of supplementary protection, by providing an additional period of protection for new patented pharmaceutical products; (3) expedite proceedings by introducing a limited number of procedural rules, while still leaving the Court broad discretion to manage proceedings; 4) address concerns about how damages arising from delayed generic market entry are currently assessed; and 5) remove barriers that may prevent innovators and generics from litigating certain patents outside the Regulations prior to generic market entry.
  • Certificate of Supplementary Protection Regulations – establish the Certificates of Supplementary Protection regime which implements Canada’s commitment in the Canada-European Union Comprehensive Economic and Trade Agreement by providing for an additional period of patent-like protection for drugs containing a new medicinal ingredient, or a new combination of medicinal ingredients.

Fifteen other Orders in Council implement other aspects of the CETA implementation act.