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03 November 2014
Trademarks and geographical indications
Pharmaceuticals and biologics
Data protection on plant protection products
Enforcement and border measures
The text of the Comprehensive Economic and Trade Agreement (CETA) between Canada and Europe was released on September 26 2014. The release follows the conclusion of an agreement in principle on October 18 2013 and an announcement on August 5 2014 that the text had been finalised (for further details please see "CETA between Canada and Europe: a new age of IP reform?", "Expanded protection for geographical indications introduced" and "Text of CETA finalised – finally!").
Chapter 22 addresses intellectual property and provides that its objectives are to:
The final text indicates that the parties will make all reasonable efforts to comply with the Singapore Treaty on the Law of Trademarks and 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 must provide a system for registering trademarks, with a system to appeal refusals to register and to oppose applications and registrations. In addition, each party must 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 geographical 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 geographical 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 geographical indications are extensive.
CETA will affect pharmaceutical and biologic protection in three areas:
Patent term restoration
Patent term restoration is termed sui generis protection in the text. It effectively extends the patent term to account for marketing delays resulting from the time required to obtain regulatory approval. While the European Union 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.
Innovator right of appeal under 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 (eg, notices of compliance) for generic pharmaceutical products and patent protection. Currently, an innovative pharmaceutical company may be unable to appeal a negative decision in a proceeding under the Patented Medicines (Notice of Compliance) Regulations.
The government indicated in October 2013 that it will also "end the practice of dual litigation". Under the present system, the regulations provide a summary proceeding in which allegations of patent infringement and invalidity are decided. However, parties 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.
The text requires that Canada's current data protection term (six to eight years) at minimum be maintained.
Canada's Food and Drug Regulations currently 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. This period can be extended to 8.5 years if the paediatric extension applies.
The text requires a period of data protection of at least 10 years from 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 the Pest Control Products Regulations.
The parties shall cooperate to promote and reinforce the protection of plant varieties based on the International Convention for the Protection of New Varieties of Plants (UPOV Convention). 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's Plant 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 (for further details please see "Bill C-18 modernises the Plant Breeders' Rights Act").
CETA appears to reflect Canada's recently updated copyright regime (for further details please see "'Made in Canada' online copyright infringement regime to come into force"), such that Canada's copyright legislation should not require revision in order to comply with CETA.
Canada is likely to 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, the pending 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 further details see "Analysis of proposed Combating Counterfeit Products Act" and "Combating Counterfeit Products Act reintroduced"). The Combating Counterfeit Products Act is currently awaiting third reading in Parliament and is expected to be passed during this parliamentary session.
As indicated in the disclaimer that accompanies the text, CETA is presented for information purposes and is subject to legal review. Following legal review and formatting, the complete text will become binding upon completion of the ratification process by both Canada and the European Union. The parties have committed to full support of its early ratification.
The long process of statutory and regulatory reform is unlikely to begin until the agreement is ratified. It may therefore be a number of years before specific changes to Canadian law are implemented.
For further information please contact Keltie Sim Luft or Brian P Isaac at Smart & Biggar/Fetherstonhaugh's Toronto office by telephone (+1 416 593 5514), fax (+1 416 591 1690) or email (email@example.com or firstname.lastname@example.org). Alternatively, contact Daphne C Lainson or David E Schwartz at Smart & Biggar/Fetherstonhaugh's Ottawa office by telephone (+1 613 232 2486), fax (+1 613 232 8440) or email (email@example.com or firstname.lastname@example.org). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
The materials contained on this website are for general information purposes only and are subject to the disclaimer.
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