PMNOC regulations amendments

CSP regulations


On September 7 2017 the Canadian government published the final pharmaceutical regulations resulting from the Comprehensive Economic and Trade Agreement (CETA). According to an order in council, the new regulations will come into force on September 21 2017.

The amended regulations mark a significant change to the environment for pharmaceutical companies in Canada, with long-lasting consequences for innovators in terms of exclusivity and drug product lifecycle management.

This update reviews the drafts(1) of:

  • the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, 2017 (PMNOC regulations amendments); and
  • the Certificate of Supplementary Protection Regulations (CSP regulations) which, together with the amendments to the Patent Act in the Canada-European Union Comprehensive Economic and Trade Agreement Implementation Act (for further details please see "Bill C-30 ushers in changes to Canadian pharma patent regulations") will compensate innovators for lost patent terms due to regulatory delays.

PMNOC regulations amendments

There are no differences between the draft and the final regulations.

When in force, the amended regulations will immediately apply to all submissions for which a notice of allegation is served on or after the effective date of the regulations (September 21 2017). Any notice of allegation served before that date will be governed by the existing regulations.

The amendments to the regulations are accompanied by a regulatory impact analysis statement outlining the background and objectives and describing the changes. The objectives are stated to include:

  • replacing summary proceedings with a full right of action;
  • providing equivalent and effective rights of appeal to all litigants; and
  • ending dual litigation.

According to the précis published with the order in council announcing the amended regulations, the regulations were amended in order to:

  • resolve a number of problems by replacing summary prohibition proceedings with full actions to determine patent validity and infringement;
  • 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;
  • expedite proceedings by introducing a limited number of procedural rules, while still leaving the court broad discretion to manage proceedings;
  • address concerns about the assessment of damages arising from delayed generic market entry; and
  • remove barriers that may prevent innovators and generics from litigating certain patents outside the regulations before generic market entry.

The new scheme includes the following key specific amendments:

  • new right of action for a declaration of infringement after the receipt of notice of allegation extending to all claims of listed patents;
  • sole opportunity to litigate listed patents – a first person cannot bring an action outside the regulations unless it did not have a reasonable basis for bringing the action within the 45-day deadline;
  • no end date for Section 8 damages period – however, a first person can renounce application of the 24-month stay, precluding any Section 8 liability; and
  • certificates of supplementary protection (CSPs) can be listed on the Patent Register (see below).

CSP regulations

The regulations will allow for protection to take effect at the end of the relevant patent's term, which 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 authorisation for sale is issued, for a maximum of two years.

The final regulations have two amendments, discussed below, over the draft regulations (for further details please see "CETA draft regulations on patent linkage and term restoration published for public comment").

The CSP regulations include the following key provisions:

  • Prior approvals and excluded variations – a CSP is available only where no other CSP has been issued with respect to the medicinal ingredient or the combination of medicinal ingredients, which is defined to exclude prescribed variations (eg, esters, non-covalent derivatives, enantiomers, solvates, polymorphs and post-translational modifications). The list of variations has not changed from the draft regulations.
  • Eligible patents – the patent must be in force and must include:
    • at least one claim directed at the same medicinal ingredient or combination;
    • use of the same medicinal ingredient or combination; or
    • the same medicinal ingredient, or combination, as produced by a defined process (product-by-process).
  • Pure process patents and patents claiming formulations are therefore excluded. The list of eligible patents has not changed from the draft regulations.
  • CSP applications must be filed in a timely manner – the 120-day deadline for applying for a CSP has not changed from the draft regulations. However, the final regulations eliminate the proposed requirement that applications can be filed only if there are more than two years remaining in the patent term.
  • The application for marketing authorisation must be filed in a timely manner relative to foreign applications – the final regulations extend the deadline to 24 months, rather than the previously proposed 18 months (if the CSP application is filed no later than September 21 2018, the first anniversary of the day on which the CSP provisions come into force) and 12 months in any other case.


Health Canada is expected to update its guidance documents in light of the amendments to the PMNOC regulations and release new guidance documents relating to the CSP regulations. The Federal Court is also working to settle guidelines that will apply to actions covered by the amendments to the PMNOC regulations.

For further information on this topic please contact Urszula Wojtyra or Nancy Pei at Smart & Biggar/Fetherstonhaugh's Toronto office by telephone (+1 416 593 5514) or email ([email protected] or [email protected]). Alternatively, please contact Daphne Lainson at Smart & Biggar/Fetherstonhaugh's Ottawa office by telephone (+1 613 232 2486) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at


(1) For further details please see "CETA draft regulations on patent linkage and term restoration published for public comment".