Canada: CETA: Impact On Canada’s IP Regime

Last Updated: November 11 2013
Article by John Norman, Monique M. Couture and James Holtom

Most Read Contributor in Canada, October 2018


While the precise terms of the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) have not yet been published, on October 29, 2013, the Government of Canada tabled a technical summary of the agreement-in-principle. The summary included details of how CETA would impact Canada's intellectual property regime. Among other things, CETA stands to impact protections for pharmaceuticals with respect to patent term, appeal rights and data protection, as well as for trade-marks with respect to counterfeit goods and EU Geographical Indications. The technical summary assumes that CETA will be ratified in 2015.

Pharmaceutical Patents

Patent Term Restoration

Patent Term Restoration (PTR) is available in many industrialized nations, but not Canada. PTR will provide additional incentives to innovate for those innovative pharmaceutical companies whose drug approvals are "delayed" during the Health Canada regulatory marketing approval process. In those cases, patent protections may not be adequate. In particular, delayed drug approval means that the patent covering a drug may expire around the same time that approval is granted by Health Canada. CETA aims to lessen the impact of this problem by granting up to two additional years of Canadian market exclusivity beyond the expiry of any patents.

Application of PTR will not be retroactive; pharmaceuticals that are already approved for sale in Canada will not receive any additional protection as a result of PTR.

This change will require, minimally, either an amendment to the Patent Act or an amendment to the Food and Drugs Act. The enacting provisions may be embodied in an amendment to either act or, more likely, by Regulations made pursuant to the amendment. In the latter case, an amendment to either the Patent Act or the Food and Drugs Act will grant the regulation-making power necessary to create Patent Term Restoration Regulations.

Appeal Rights and Duplicative Litigation under the PM(NOC) Regulations

At present, within days of an innovator losing an Application under the Patented Medicines (Notice of Compliance) Regulations ("PM(NOC) Application") the generic is granted a Notice of Compliance, i.e., official approval to sell a drug in Canada. Canadian Courts have held that this renders any appeal by the innovative company moot. In short, the innovator may not appeal if it loses a PM(NOC) Application.

On the other hand, should the generic lose a PM(NOC) Application, the generic may appeal that decision to the Federal Court of Appeal and potentially even to the Supreme Court of Canada (for instance, Teva v. Pfizer (Viagra), 2012 SCC 60). CETA strives to introduce balance and fairness to the PM(NOC) Application process by granting the innovator a right of appeal, as similarly granted to the generic.

Currently, if the innovator loses a PM(NOC) Application, the usual course is to launch an action for patent infringement once the generic comes to market. Similarly, if the generic loses during the PM(NOC) Application process, it is open to the generic to initiate an action to impeach any pertinent patents. Both of these  actions proceed under the Patent Act.

The PM(NOC) Regulations currently prescribe a 24-month window during which the entire PM(NOC) Application must take place; after 24 months from the date the Application starts the generic will be issued a NOC. In the case of an appeal by the generic, the Federal Court will have decided that a NOC should not issue. Thus, the 24-month period is not implicated. However, any appeal by the innovator will almost certainly exceed the 24-month window. How CETA will address this issue is currently unknown.

For innovators appealing a PM(NOC) Application decision, the Federal Court will have decided that a NOC should issue to the generic. Another open question is whether the generic's NOC will be held in abeyance pursuant to a stay pending the outcome on appeal or, whether the generic's NOC will be revoked should the innovator succeed on appeal.

A stated goal of CETA is to prevent duplicative litigation, such as a PM(NOC) Application followed by a Patent Act action. While the final form of CETA is unknown, one possible way of preventing duplicative litigation is to require the loser at the PM(NOC) Application stage to elect either an appeal from the PM(NOC) Application or an action under the Patent Act for infringement (or impeachment). In that case, if the innovator loses the PM(NOC) Application, the innovator must elect between appealing that decision and the right to sue for infringement once the generic comes to market. It follows that if the generic loses the PM(NOC) Application, it too must elect between appealing that decision and bringing an action to impeach the relevant patents in rem.  Otherwise, the goal of preventing duplicative may not be achieved.

Another option would be for Canada to follow the U.S.'s lead and require a full action on the merits in lieu of a PM(NOC) Application as a condition for generic market approval. This would require the generic to commence an action to impeach the relevant patents in advance of being issued a NOC. This may require longer than the currently-prescribed 24-months.

These changes will require an amendment to the Patented Medicines (Notice of Compliance) Regulations. Since these regulations were enacted pursuant to a regulation-making power set out in s 55.2 of the Patent Act, no amendment to the Patent Act will likely be required.

Data Protection

CETA will enshrine Canada's current term of data protection (i.e., 6 years before a generic can file an Abbreviated New Drug Submission if it relies on the innovator's data, and 8/8.5 years before issuance of a Notice of Compliance to the generic).

The commitment to providing 8 years of data protection does not differ from current Canadian law. Thus, no changes are required to the Data Protection Regulations (DPR). However, CETA will prevent any amendments to the DPR that would decrease the term of protection to less than 8 years.


Treaty Compliance

The trade-mark profession had speculated that CETA might require Canada to accede to the Madrid Protocol. However, in light of the technical summary released by the Government of Canada, this requirement does not appear to be part of CETA. In fact, Canada will not be required under CETA to take on any specific trade-mark treaty commitments. Rather, Canada has instead agreed to make "best endeavours" and "all reasonable efforts" to ensure compliance with international trade-mark agreements and standards (including the Singapore Treaty on the Law of Trademarks, and the Madrid Protocol). These "endeavours" have the goal of "encourag[ing] more effective trade-mark procedures".  

Counterfeit Goods

CETA will also include several commitments aimed at curtailing trade in counterfeit goods. Civil remedies and border enforcement rights will likely form much of Canada's obligations. These are already in line with Canada's anti-counterfeiting regime, and are in keeping with the proposals found in pending Bill C-8, the Combating Counterfeit Products Act, introduced to Canadian Parliament on October 28, 2013.

Bill C-8 has passed second reading, and is now before a Committee for review.  While this is an encouraging development in the fight against the counterfeit trade, concerns exist that further amendments to Bill C-8 may be required to enhance the effectiveness of Canada's anti-counterfeiting and anti-piracy regime as it relates to border enforcement, resource allocation, and the bearing of costs related to storage, handling and destruction of counterfeit goods.   Additionally, the offences, punishment and remedy provisions may need further revisions if brand owners are to rely on these provisions to enforce their rights in a pragmatic and meaningful manner.

Geographical Indications (GIs)

Under CETA, Canada will provide protection for 179 terms covering various foods and beer, in addition to those EU wines and spirits GIs currently recognized by Canada. The nature and scope of protection will vary depending upon the specific GI in question. Protection will not prejudice any existing Canadian trade-mark holders and will not impact customary names for plant and animal breeds.

CETA preserves the right to use common English and French names for food products.  For example, Canadian producers would be able to use English and French but not the German language for Black Forest ham. Terms that continue to be free for use in Canada include Valencia orange, Black Forest ham, Tiroler bacon, Parmesan, Bavarian beer, and Munich beer.

CETA also limits the GI rights provided to EU with respect to Asiago, feta, fontina, Gorgonzola and Munster. While current users are unaffected, future users will be able to use the names only when accompanied by expressions such as "kind," "type," style," "imitation" or the like.

CETA also allows Canada to maintain the ability to use components of multi-part terms. For example: "Brie de Meaux" will be protected, but the term "brie" can be used on its own;         "Edam Holland" will be protected, but the term "Edam" can be used on its own.

Ultimately, according to the technical summary of CETA, enforcement of GIs in Canada is expected to remain a private matter to be determined by the Courts. Commitments as to border enforcement of GIs are to be confirmed at a later date.


It appears that Canada's copyright regime is compliant with CETA. The Recent Copyright Modernization Act effected significant amendments to the prior version of the Copyright Act and brought Canada into compliance with the 1996 World Intellectual Property Organization treaties: Copyright, and Performances and Phonograms.

Additionally, certain provisions regarding the term of protection, broadcasting, and others have been enshrined in CETA. As a result, no amendments to the Copyright Act are anticipated.


According to the technical summary of CETA, Canada's existing legal regime is compliant with CETA.  For example, CETA will not change the "farmers' privilege" to save and replant seeds of a protected variety on their own land under the federal Plant Breeders' Rights' Act.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions