Canada’s Intellectual Property Firm

Bill C-30 passes Senate today to usher in changes to Canadian pharma patent regulations

Authored byNancy Pei and Daphne Lainson

Bill C-30 was passed by the Senate today, May 11, 2017 without amendment.  Bill C-30 is the bill that will implement the Canada-European Union Comprehensive Economic and Trade Agreement (CETA).  As reported here, this Bill was first tabled in the House of Commons on October 31, 2016.  Before becoming law, however, the Bill will need to be given Royal Assent by the Governor General or one of his deputies—a formality.  Before many of the provisions come into force, however, regulations will need to be registered.

Bill C-30 includes a number of intellectual property law provisions, with the most notable relating to the protection of pharmaceuticals.  As we previously reported, CETA requires Canada to provide all parties to linkage litigation an effective right of appeal and also restoration of patent term to account for marketing delays resulting from the time required to obtain regulatory approval.  Bill C-30 addresses each of these issues: 

  • The regulation making authority in the Patent Act under which the current linkage regulations, the Patented Medicines (Notice of Compliance) Regulations [PMNOC Regulations], were made is being revised; and
  • The Patent Act will include Certificates of Supplementary Protection (CSPs) that will allow up to a 2-year restoration of patent term for regulatory delays. 

The new linkage regime will be governed by regulations, which we expect will be pre-published or published shortly.  The CSP framework will be governed by the Patent Act, and by regulations to be pre-published/published. 

In our earlier report, we highlighted key features of CSPs under Bill C-30.  These include: 

Term:  the term of the CSP will be calculated by subtracting five years from the period beginning on the filing date of the patent application and ending on the day on which the authorization for sale is issued, for a maximum of two years. The CSP will take effect at the end of the patent term, and the term may be reduced if the holder of the actions of the CSP result in a period of unjustified delay in obtaining the authorization for sale.  

Relevant patents:

  • The patent meets “any prescribed requirements”;
  • The patent pertains “in the prescribed manner” to a medicinal ingredient, or combination of medicinal ingredients, contained in a drug for which an authorization for sale was issued”;
  • The application relates to the first authorization (an NOC) for sale for the medicinal ingredient/combination;
  • No other CSP has been issued with respect to the medicinal ingredient/combination; and
  • The application for authorization for sale is filed within a deadline to be prescribed relative to the first corresponding foreign application for marketing approval. 

Application for a CSP:  There will be a prescribed deadline for filing the application.  Only one patent can be named in each application.

We will report further once further details of the application process are made clear.  For any questions, please contact a member of our firm’s Pharmaceutical or Life Sciences — Regulatory & Compliance groups.

The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.