The text of CETA (the Comprehensive Economic and Trade Agreement between Canada and Europe) was released on September 26, 2014. The release follows the conclusion of an agreement in principle on October 18, 2013 (see report) and an announcement on August 5, 2014 that the text had been finalized. See our earlier IP Updates of October 30, 2013, November 14, 2013, December 16, 2013, and August 6, 2014.
Chapter 22 addresses Intellectual Property and provides that the objectives of the chapter are to:
- facilitate the production and commercialization of innovative and creative products, and the provision of services, between the Parties; and
- achieve an adequate and effective level of protection and enforcement of intellectual property rights.
The following areas are addressed:
Trademarks and Geographical Indications
As provided in the previously released summary, the final text indicates that the parties will make all reasonable efforts to comply with the Singapore Treaty on the Law of Trademarks and to accede to the Madrid Protocol. Canada has already taken steps to comply with this provision through the passage of Bill C-31, which includes the necessary amendments to the Trademarks Act in order to move forward with these agreements.
The additional provisions relating to trademarks are straightforward and already within the scope of Canadian law. Each party is to provide a system for registering trademarks, with a system to appeal refusals to register and to oppose applications and registrations. In addition, the parties are to provide an electronic database of pending and registered marks. Provision must be made for the fair use of descriptive terms, including terms descriptive of geographical origin, as a limited exception to the rights conferred by a registration.
A “geographic indication” identifies an agricultural product or foodstuff as originating in the territory, region or locality of one of the parties to the agreement, in circumstances where the quality, reputation or other characteristic of the product is essentially attributable to its geographical origin. Examples of geographic indications that are protected by the agreement include ROQUEFORT for cheese and RICCLARELLI DI SIENA for confectionery and baked products. The provisions of the agreement relating to geographic indications are extensive and will be the subject of a more detailed upcoming IP Update.
Contact: Keltie Sim Luft
CETA will affect pharmaceutical/biologic protection in the following three areas:
Patent Term Restoration (PTR)
Patent term restoration (PTR) is termed Sui Generis [Latin for “unique”] protection in the text. Broadly, PTR effectively extends patent term to account for marketing delays resulting from the time required to obtain regulatory approval. While the EU has had patent term restoration — granted by way of supplementary protection certificates (“SPCs”) — for a number of years, the protection will be entirely new to Canada.
Details regarding the proposed PTR are provided in the Rx IP Update article CETA text released: Patent Term Restoration for pharmaceutical/biologic patents coming to Canada.
Contact: Daphne C. Lainson
Innovator Right of Appeal in Patented Medicines (Notice of Compliance) Regulations
The text provides for an “equivalent and effective right of appeal” for all litigants in jurisdictions that provide "patent linkage" mechanisms linking the granting of marketing authorisations (such as notices of compliance) for generic pharmaceutical products and patent protection.
Currently, an innovative pharmaceutical company may be unable to pursue an appeal of a negative decision in a proceeding under the Patented Medicines (Notice of Compliance) Regulations (the NOC Regulations).
The government indicated in its October 2013 release that it will also “end the practice of dual litigation”. Under the present system, the NOC Regulations provide a summary proceeding in which allegations of patent infringement and invalidity are decided. Parties however remain free to challenge or assert the same patent as between the same parties and for the same drug in a separate (“dual”) proceeding under the Patent Act. The Government may address the issue of dual litigation during treaty implementation.
Contact: J. Sheldon Hamilton
The text requires that Canada’s current data protection term (6/8 years) at minimum be maintained.
Canada’s Food and Drug Regulations presently provide a six-year “no file” period in which a subsequent entry manufacturer cannot submit an application for marketing approval relying upon an innovator’s approval for an innovative drug. The Regulations also provide an eight-year period during which the subsequent entry manufacturer cannot receive marketing approval. The eight years can be extended to 8.5 years if the pediatric extension applies.
As reported previously, Canada rejected the EU request to provide 10 years of data protection for pharmaceutical innovation.
Contact: Nancy P. Pei
Data Protection on Plant Protection Products
The text requires a period of data protection of at least ten years starting at the date of the first authorisation with respect to data supporting the authorisation of a new active ingredient and data supporting the concurrent registration of the end-use product containing the active ingredient. A period of exclusive use consistent with this requirement is specified under section 17.5 of Canada’s Pest Control Products Regulations.
The Parties shall co-operate to promote and reinforce the protection of plant varieties based on the International Convention for the Protection of New Varieties of Plants (UPOV). Canada is a party to the 1978 Act but not the 1991 Act of the UPOV Convention. Bill C-18, currently before Parliament, brings Canada’sPlant Breeders’ Rights Act into conformance with the 1991 Act of the UPOV Convention, which is a precondition to ratification of, or accession to, the 1991 Act. See our IP Update of May 26, 2014 for further details.
Contact: David E. Schwartz
It appears that CETA reflects Canada’s recently updated copyright regime (for more detail see our IP Updatesfrom November 20, 2012 and June 24, 2014) such that Canada’s copyright legislation should not require revision in order to be compliant with CETA.
Enforcement and Border Measures
It appears that Canada will be CETA compliant in respect of commitments regarding IP enforcement without any legislative changes. However, with respect to border measures, Canada’s laws must be updated in order to be CETA compliant. That said, pending Bill C-8 (the Combatting Counterfeit Products Act) will amend Canada’s laws such that they should be compliant, except with respect to requirements for border measures in respect of geographical indications. Additional legislative changes may be required in order to deal with that aspect of border measure obligations under CETA. For more details on Bill C-8 and its predecessor Bill C-56, see our IP Updates dated March 4, 2013 and October 29, 2013. Bill C-8 is currently awaiting third reading in Canada’s parliament and it is expected to be passed into law during this session of parliament.
Contact: Brian P. Isaac
As indicated in the disclaimer that accompanies the text, it is presented for information purposes and will be subject to legal review. Following legal review and formatting, the complete text will become binding upon the completion of the ratification process by both Canada and the EU. The parties have committed to full support of its early ratification (See: Declaration by the Prime Minister of Canada and the Presidents of the European Council and the European Commission).
The long process of statutory reform and regulatory reform will likely not begin until the agreement is ratified. It may therefore be a number of years before specific changes to Canadian law are implemented.