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Comprehensive Economic and Trade Agreement between Canada and Europe: a new age of IP reform?

Comprehensive Economic and Trade Agreement between Canada and Europe: a new age of IP reform?

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Published by: EU-Canada Partnership on Nov 08, 2013
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11/4/13Comprehensive Economic and Trade Agreement between Canada and Europe: a new age of IP reform? - Lexologywww.lexology.com/library/detail.aspx?g=887ff183-6489-44c8-8b8a-c474a8e277c11/4
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Comprehensive Economic and Trade Agreement between Canada andEurope: a new age of IP reform?
The Canadian government tabled a report yesterday with further details concerning theComprehensive Economic and Trade Agreement (CETA) between Canada and theEuropean Union (EU). 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 relating to intellectual property (IP). Although the final agreement has not yet been made public, the government is reporting the f ollowing outcomes with respect to IP protection:
CETA is expected to affect pharmaceutical IP protection in the following three areas:
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 
Smart & Biggar/FetherstonhaughJ. Sheldon Hamilton
Daphne C. Lainson
Nancy P. Pei
October 30 2013
11/4/13Comprehensive Economic and Trade Agreement between Canada and Europe: a new age of IP reform? - Lexologywww.lexology.com/library/detail.aspx?g=887ff183-6489-44c8-8b8a-c474a8e277c12/4
 Author page » Author page » Author page »
Compliance) Regulations
NOC Regulations
). The NOC Regulations linksubsequent entry drug regulatory approval to innovator patent status.There is also the possibility for “dual litigation” under the current system. The
NOC Regulations
provide a summary proceeding in which allegations of patent infringementand patent invalidity are found justified or unjustified. Irrespective of the final result insuch proceedings, the same patent can be asserted or challenged as between thesame parties and based upon 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: amendmentsto both the
Patent Act
and the
NOC Regulations
may be required.
Patent Term Restoration (PTR)
Canada has committed to provide additional protection to pharmaceutical productsprotected by eligible patents. A fixed cap of two years is being reported for this supplementary protection, with noretroactive effect for drugs previously approved. Reference points for the calculation aresaid to include the filing date of the patent application and the first marketingauthorization (NOC) for the drug. An export exception for Canadian-made generic medicines duringthis period of additional protection is expected.The
Patent Act
will likely need to be amended to include term extension.
Data Protection
Canada rejected the EU request to provide 10 years of data protection for pharmaceuticalinnovation. But, it has agreed to “lock in” the current term of eight years of market exclusivity.The
Food and Drug Regulations
presently provide a six-year “no file” period in which a subsequententry manufacturer cannot seek regulatory approval relying upon an innovator’s approval for aninnovative drug. There is a further two years of market exclusivity (2.5 years if the pediatric extensionapplies).The
Food and Drugs Act 
 will likely need amendment to “lock in” the term, entrenching this right.
Based on the information provided, it appears that CETA reflects Canada’s recently updatedcopyright regime (for more details see our November 20, 2012 article) such that Canada’s copyrightlegislation should not require revision. However, provisions dealing with Internet intermediary /service provider liability in the newly revised
 Copyright Act
still need to be proclaimed in force.
Trade-marks, Designs and Geographical Indications
11/4/13Comprehensive Economic and Trade Agreement between Canada and Europe: a new age of IP reform? - Lexologywww.lexology.com/library/detail.aspx?g=887ff183-6489-44c8-8b8a-c474a8e277c13/4
While Canada did not take on any specific commitments with respect to trade-marks and designs,there is a “best endeavours” commitment to make “all reasonable efforts” to comply with internationalagreements including the S
ingapore Treaty a
nd the
Madrid Protocol
relating to trade-marks and the
Hague Agreement
relating to Industrial Designs.Numerous provisions regarding geographical indications are included, designed to address EUconcerns relating to foods and beer. Many geographical indications will be protected, withexceptions including maintaining existing rights for Canadians to use common English and Frenchwords for food products, protecting existing Canadian trade-mark registrations, permitting thecontinued use of commonly used terms such as Black Forest ham and allowing for the continued useby users of certain geographical indications such as Asiago as well as components of certain termssuch as Gouda while protecting Gouda Holland.
Plants and Plant Protection Products
The report states that CETA “reflects the Canadian regime” and provides certainty for data protectionfor plant protection products. The
Pest Control Product Regulations
currently provide for, amongother things, the protection of certain data submitted for the registration of pesticides (includingherbicides, fungicides, and insecticides).The report indicates that both Canada and the EU are committed to co-operating to promote andreinforce the protection of plant varieties based on the International Union for the Protection of NewVarieties of Plants (UPOV). There is no indication whether Canada will become a party to the 1991 Act of the UPOV Convention. Canada is presently a party only to the 1978 Act.The report notes that CETA will not change the “farmers’ privilege” to save and replant seeds of aprotected variety under Canada’s P
lant Breeders’ Rights A
ct (PBRA). The PBRA does not presentlyexplicitly 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 UPOVConvention.
Based on the information provided, it appears that Canada will be CETA compliant in respect tocommitments regarding IP enforcement provisions, including civil and border remedies, if the regimepresented under Bill C-56 is enacted into law. Bill C-56 was re-introduced as Bill C-8 on October 28,2013 and has now been referred to committee for further consideration and possible amendment.(For more details on Bill C-8, see our  IP Update of October 29, 2013). However, there is a caveatthat commitments regarding “the handling of geographical indications at the border” are to beconfirmed.
Concluding Remarks
The CETA agreement has not yet been published nor finalized, leaving the possibility that thecommitments noted above may be subject to further comment and analysis.Once finalized, there will remain the requirement to ratify the agreement, which may not occur until2015. The long process of statutory reform (which will require Parliamentary approval for any

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