Changes to the Patent Act, Patent Rules, Patented Medicines (Notice of Compliance) Regulations and the Trade-marks Act, and new Certificate of Supplemental Protection Regulations come into force on September 21, 2017 as part of Canada’s implementation of CETA. Today, Health Canada released guidance documents on applying for Certificates of Supplementary Protection and on Health Canada’s administration of the PM(NOC) Regulations.
Earlier this week, Canada published its Statement on Implementation (link), including on intellectual property:
This Statement provides the Government’s understanding of the rights and obligations set out in the CETA. For each chapter, the Statement sets out what the Agreement says and how Canada has implemented the Agreement in domestic law and other actions the Government will undertake to ensure that Canadians will benefit from the Agreement.
Links to the changes:
- Patent Act – adds certificates of supplementary protection for pharmaceutical products and supports altering of the patent linkage system
- Trade-marks Act – amendments to address expansion of geographic indicators, with grounds of opposition and certain exceptions for prior use, acquired rights and generic terms
- 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.
Health Canada’s guidance relate to the application process for obtaining certificates of supplementary protection (link). For the PM(NOC) Regulations, the guidance (link) addresses
- how to notify Health Canada of proceedings (since Health Canada will no longer be a party),
- how to provide other information to Health Canada under the regulations,
- provides an updated Form V;
- verification under section 6.05 of the Regulations; and
- the addition of CSPs to the Patent Register
[Update – fixed link to Health Canada’s PM(NOC) guidance]