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02 December 2013
The Canadian government recently tabled a report with further details concerning the Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union. An agreement in principle was reached on October 18 2013, concluding more than four years of negotiation.
CETA is being touted as Canada's most ambitious trade agreement to date, with far-reaching provisions, including those relating to intellectual property. Although the final agreement has not yet been made public, the government is reporting the following outcomes with respect to IP protection.
Innovator right of appeal
Canada has committed to providing an effective right of appeal to all litigants. Further, the government has indicated that it will "end the practice of dual litigation".
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 regulations link subsequent entry drug regulatory approval to innovator patent status.
There is also the possibility for 'dual' litigation under the existing system. The regulations provide for a summary proceeding in which allegations of patent infringement and patent invalidity are found justified or unjustified. Irrespective of the final result in such proceedings, the same patent can be asserted or challenged as between the same parties and based on the same drug in a separate ('dual') proceeding under the Patent Act.
There are no details on how these changes in the law will be implemented; amendments to both the Patent Act and the regulations may be required.
Patent term restoration
Canada has committed to providing additional protection to pharmaceutical products protected by eligible patents.
A fixed cap of two years is being reported for this supplementary protection, with no retroactive effect for drugs previously approved. Reference points for the calculation are said to include the filing date of the patent application and the first marketing authorisation (notice of compliance) for the drug. An export exception for Canadian-made generic medicines during this period of additional protection is expected.
The Patent Act will likely need to be amended to include term extension.
Canada rejected the EU request to provide 10 years of data protection for pharmaceutical innovation. However, it has agreed to lock in the current term of eight years of market exclusivity.
The Food and Drug Regulations provide a six-year 'no file' period in which a subsequent entry manufacturer cannot seek regulatory approval relying on an innovator's approval for an innovative drug. There is a further two years of market exclusivity (two-and-a-half years if the paediatric extension applies).
The Food and Drugs Act will likely need to be amended in order to lock in the term, entrenching this right.
Based on the information provided, CETA appears to reflect Canada's recently updated copyright regime, such that Canada's copyright legislation should not require revision. However, provisions dealing with internet intermediary/service provider liability in the newly revised Copyright Act must still be proclaimed in force.
While Canada took on no specific commitments with respect to trademarks and designs, there is a 'best endeavours' commitment to make "all reasonable efforts" to comply with international agreements, including the Singapore Treaty and the Madrid Protocol relating to trademarks and the Hague Agreement relating to industrial designs.
Numerous provisions regarding geographical indications are included, designed to address EU concerns relating to foodstuffs and beer. Many geographical indications will be protected, with exceptions including:
The report states that CETA "reflects the Canadian regime" and provides certainty for data protection for plant protection products. The Pest Control Product Regulations provide for, among other things, the protection of certain data submitted for the registration of pesticides (including herbicides, fungicides and insecticides).
The report indicates that both Canada and the European Union are committed to cooperating to promote and reinforce the protection of plant varieties based on the International Union for the Protection of New Varieties of Plants (UPOV). There is no indication as to whether Canada will become a party to the 1991 act of the UPOV Convention – at present, it is party only to the 1978 act.
The report notes that CETA will not change the farmers' privilege to save and replant seeds of a protected variety under the Plant Breeders' Rights Act. The act does not explicitly provide for a farmers' privilege, although one is implied by the limited rights of the breeder specified in the legislation. A farmers' privilege is explicitly defined in the 1991 act of the UPOV Convention.
Based on the information provided, it appears that Canada will be CETA-compliant with respect to commitments regarding IP enforcement provisions, including civil and border remedies, if the regime presented under Bill C-56 is enacted into law. Bill C-56 was reintroduced as Bill C-8 on October 28 2013 and has now been referred to committee for further consideration and possible amendment (for further details please see "Combating Counterfeit Products Act reintroduced"). However, there is a caveat that commitments regarding "the handling of geographical indications at the border" are to be confirmed.
The CETA agreement has not yet been published or finalised, leaving the possibility that the commitments noted above may be subject to further comment and analysis.
Once finalised, the agreement must be ratified, which may not occur until 2015. The long process of statutory reform (which will require parliamentary approval for any changes to the various acts noted above) and regulatory reform (which will require only approval through designated agencies) 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.
For further information please contact Brian P Isaac or Keltie Sim Luft 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.
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