CETA agreement and the Canadian patent landscape
By Randy Marusyk and Hyun Woo Choi, October 16th, 2017
On September 21, 2017, The Canada-European Union (EU) Comprehensive Economic and Trade Agreement (CETA) came into force.
Three areas part of the CETA agreement relating to a range of issues in Canadian patent protection are worth noting:
1. Certificate of Supplementary Protection Regulations
2. Regulations Amending the Patented Medicines (Notice of Compliance)
3. Amendments to the Patent Rules
1. Certificate of Supplementary Protection Regulations: the Certificate of Supplementary Protection Regulations (CSP Regulations) were created to provide additional protection for patent-protected pharmaceutical products. The new Certificate of Supplementary Protection (CSP) regime will provide additional period of patent-like protection for drugs containing a new medicinal ingredient or a new combination of medicinal ingredient. The CSP Regulations provide various timelines, requirements and procedures needed to carry out the regime and are defined in sections 104-134 of the Patent Act. The additional protection term under CSP can be calculated as the difference between the patent filing date and the Notice of Compliance date, reduced by 5 years, up to a maximum of 2 years (i.e. CSP term = [Notice of Compliance date – Patent filing date] – 5 years, with a cap of 2 years). The additional protection period under this regulation will take effect from the patent expiry date.
2. Regulations Amending the Patented Medicines (Notice of Compliance): These amendments were made to address a number of issues described below and to meet Canada’s obligations under CETA:
- to resolve a number of problems by replacing summary prohibition proceedings with full actions to determine patent validity and infringement;
- to expand the scope of the PMNOC Regulations to cover relevant Certificate of Supplementary Protections by providing an additional period of protection for new patented pharmaceutical products;
- to help expedite proceedings by introducing a limited number of procedural rules, while still leaving the Court broad discretion to manage proceedings;
- to address concerns about how damages arising from delayed generic drugs market entry are currently addressed; and
- to remove barriers that may prevent innovators and generics from litigating certain patents outside the PMNOC Regulations prior to generics entering the market.
3.Amendments to the Patent Rules: Based on the recent amendments, section 29 of the Patent Act is being repealed and those provisions under the Patent Rules that refer to appointment of the representative under this section of the act are also being removed. The repealed provisions under the Patent Rules are section 78, clause 94(2)(b)(ii)(I), subparagraph 94(3)(b)(vi) and paragraph 148(1)(d). As a result, information regarding appointment of a representative is no longer required for completion of a patent application or the national phase of a patent application. To reflect the change, Form 1 (Application for Reissue) and Form 3 (Petition for a Grant of Patent) are also replaced to delete references to representative appointment required under section 29 of the Patent Act.
For more information please contact:
T: 613.801.1088
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Hyun Woo Choi, Articling Student
T: 604.239.0274
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DR. CLAIRE PALMER
