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.
- Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, 2017 – implementing substantive changes to the patent linkage system.
- Certificate of Supplementary Protection Regulations – new regulations allowing up to two years of supplementary patent term relating to regulatory approval delays for pharmaceutical products.
- Rules Amending the Patent Rules – minor amendments arising from the removal of section 29 from the Patent Act.
For the Certificate of Supplementary Protection Regulations, the final regulations have some changes to section 6:
- 24 months in section 6(1)(b)(i) for the period of time for which applications for authorization may be filed from a foreign marketing authorization if the application for the CSP was filed by September 21, 2018, extended from 18 months proposed earlier.
- The 2 year exclusion period prior to the expiry of a patent for filing for a CSP application was removed – former section 6(3).
Changes to the Patent Act relating to the Patented Medicines Prices Review Board are not coming into force at this time. The explanatory note states:
The amendments extend PMPRB price-review powers to include medicines protected by the new Certificate of Supplementary Protection (CSP) regime that is required by CETA. It is the government’s intention to bring these provisions into force together with corresponding amendments to the PMPRB-related regulations.
Changes to the Trade-marks Act will also come into force on September 21, 2017. The changes, among other things,