Canada: Procedures And Strategies For Pharmaceutical Brands

Last Updated: March 27 2018
Article by Susan Keri, Meghan Dillon and Ainslie Parsons

Sweeping amendments to the Trademarks Act are expected to be implemented in 2019 which will bring Canada into line with international practices, allowing it to accede to the Madrid Protocol, the Nice Agreement and the Singapore Treaty. Canadian businesses will be better positioned to compete globally and it should also be easier for foreign companies to expand their operations into Canada. The legislative amendments will fundamentally affect the way in which all trademark owners will need to approach their selection, clearance and registration strategies, and the pharmaceutical industry is no exception.

Selection, clearance and registration

Drug name approval by Health Canada is distinct from the trademark registration process handled by the Canadian Intellectual Property Office (CIPO) and approval by one branch of government will not necessarily lead to approval by the other. Therefore, drug names must be selected and cleared having regard to both regulatory and trademark registration issues. While both processes deal with the potential for confusion between proposed brand names, the confusion analysis associated with each system differs. Health Canada assesses drug name confusion based on health and safety concerns, while CIPO examiners focus on the likelihood of confusion as to the source of origin of the trademarked products.

Drug names, confusion and regulatory approval

Under the Food and Drug Regulations, a drug's proposed brand name must be submitted to Health Canada for approval. Health Canada can refuse to issue a notice of compliance for new drugs or a drug identification number for new and existing drugs if confusion between a proposed drug name and an existing drug name is considered likely to result in health and safety issues.

Health Canada is not bound by drug name approvals in other jurisdictions and accordingly, a brand name approved and used internationally is not guaranteed to be allowed in the Canadian market.

The current Health Canada guidance document dealing with the drug name review process for lookalike, soundalike (LASA) drug names came into effect on June 13 2015. The guidance provides that a sponsor must first carry out an initial brand name review to determine whether the name is misleading with respect to the composition, effectiveness or safety, and then provide a LASA brand name assessment to determine the likelihood of confusion between the proposed name and authorised product names. The testing of LASA attributes involves a multi-step approach, including:

  • searching relevant drug name and medication error databases and identifying drug names with a combined orthographic and phonetic similarity score of 50% or more;
  • assessing the confusability of a proposed name using simulations; and
  • synthesising the evidence obtained from the database search results and the simulations.

Non-prescription products and natural health products are excluded from the scope of the guidance.

Raw data to be submitted is limited to database search results (although Health Canada reserves the right to request additional material where necessary). Psycholinguistic tests are not required.

Drug names, confusion and trademark registration

Clearance searches for prior confusing marks will be fundamentally different once the new Canadian trademark legislation is implemented, although the analysis for assessing confusion will remain the same.

For a trademark to be registrable in Canada, it cannot cause a likelihood of confusion with a trademark previously used, applied for, registered or made known in Canada as to the origin of the goods or services with which the mark is associated. When assessing likelihood of confusion, several factors are examined, including the nature of the goods and services associated with the marks and the degree of resemblance between them.

When evaluating risk based on prior trademark rights, the Canadian Trademarks Register is of significant importance, since it reflects marks that have been commercially used. This is due to the fact that under the current trademark system in Canada, trademarks cannot issue to registration without use somewhere. An application filed on the basis of intent to use will issue to registration only on filing a declaration attesting to commercial use of the mark in Canada for those goods or services contained in the application. The declaration of use requirement is particularly onerous for pharmaceutical companies, since pharmaceutical products cannot be sold commercially in Canada until the drug is approved for sale by Health Canada. As such, applicants often need to file multiple extension requests for submitting the declaration of use and, in many cases, new filings are necessary once the maximum allowable extension period has expired.

Under the new regime, applications will issue to registration on expiry of the opposition period, regardless of whether use has commenced anywhere. In the pharmaceutical field, this will mean that trademarks covering pharmaceutical products can issue to registration in Canada before the products are even approved for domestic sale. Moreover, the elimination of use as a prerequisite to registration will allow pharmaceutical companies to secure trademark registrations covering virtually all pharmaceutical products and services. The prospect of trademarks issuing to registration covering lengthy lists of goods and services, without use anywhere, is likely to result in a cluttered Trademarks Register. In addition, the Trademarks Register will no longer contain information on use. As such, the evaluation of risk through register searching will be rendered practically impossible under the new trademark regime and marketplace investigations will likely be necessary for clearance purposes.

The new trademark legislation will also affect the assessment of confusion during examination for trademark registration. Examination for confusion with previously filed applications and prior registrations considers, among other things, the degree of resemblance between the marks and the similarities between the goods or services with which they are associated. With the elimination of use as a prerequisite to registration, applicants are likely to overclaim, resulting in applications and registrations covering multiple – and often entirely unrelated – classes of goods and services. The corollary to this will likely be an increase in Trademarks Office citations based on confusion.

Moreover, while public health concerns, such as drug name mistakes, are not strictly relevant to the assessment of confusion between marks for trademark registration purposes (which deals essentially with the issue of confusion as to the source of origin), recent Canadian jurisprudence suggests that such mistakes may nevertheless be considered by Trademarks Office examiners as a surrounding circumstance. In Sanofi-Aventis v GlaxoSmithKline Biologicals SA ((2010) 89 CPR (4th) 378 (TMOB)) the Trademarks Opposition Board (TMOB) considered the issue of medication errors as a surrounding circumstance contributing to the likelihood of confusion between the trademarks PACIRIX and PLAVIX, finding the marks to be confusing even though they were associated with different pharmaceutical preparations. However, if a trademark contains a formative common to the industry, the likelihood of confusion will likely be deemed quite low. In Ferring, Inc v Apotex Technologies, Inc (2013 TMOB 225) the trademark FERRIPROX was held not to be confusing with the trademark FERRING, although both marks covered related preparations. The TMOB held that since the first portion of the marks consisted of 'fer' – which was highly suggestive of iron – consumers would focus on the suffix components of the marks 'prox' and 'ing', and these differences were considered sufficient to prevent a likelihood of confusion.

Cancellation for non-use

Under both the current trademark regime and the new legislation, trademark registrations are vulnerable to cancellation for non-use from three years after the registration date. Under the current system, trademarks can issue to registration only with use somewhere. Once the new legislation is implemented, situations may arise in the pharmaceutical field where a trademark registration (issued without use) could be challenged for non-use before the drug with which the mark is associated has been approved for sale in Canada. The inability to market a product due to a pending regulatory approval process may be considered a special circumstance permitting the registration to be maintained. However, even if the registration is cancelled for non-use, a fresh application can be filed and, under the new legislation, can issue to registration without use (subject to any intervening right). The new registration will therefore be immune from a non-use cancellation attack for a further three years following the new registration date.

Non-traditional marks

At present, registration of certain non-traditional marks (eg, colours, shapes and sounds) is permitted in Canada. The new trademark legislation will permit registration of various other non-traditional marks, including scents, tastes and textures; however, applications to register such marks will be subject to examination for distinctiveness, which is not presently the case. If the registrar of trademarks holds that a mark is not inherently distinctive, the applicant will have to file evidence attesting to acquired distinctiveness across Canada as of the application filing date, failing which, the registration will be territorially restricted to the area in Canada where the mark is proven distinctive, or refused outright for lack of distinctiveness.

Examination for distinctiveness will be particularly relevant in the pharmaceutical field, where trademark protection is often sought for non-traditional marks such as colour and shape. Under the new regime, evidence of distinctiveness will be required to support these applications and the Trademarks Office will likely apply the high threshold currently required in opposition and litigation proceedings for establishing distinctiveness of such marks. Examination for distinctiveness will therefore add a further hurdle to securing registration of non-traditional marks in the pharmaceutical field.

The recent decision in Pfizer Products Inc v Canadian Generic Pharmaceutical Assoc (2015 FC 493) highlights the high evidential burden on an applicant in establishing that a colour applied to a pharmaceutical tablet or capsule serves to distinguish the goods of the trademark owner from those of others. The case dealt with an application by Pfizer to register a trademark consisting of the colour blue applied to the visible surface of a diamond-shaped tablet (the Viagra tablet design). The Federal Court upheld the decision of the TMOB that the tablet design was not distinctive of Pfizer or any single source. The court agreed with Pfizer that distinctiveness need not be established in each consumer subgroup (ie, physicians, pharmacists and patients), but rather that a significant degree of recognition among the whole constituency of ordinary consumers was required. However, it nevertheless found that the limited use which physicians, pharmacists and patients made of the colour tablet design for identification purposes was not sufficient to establish the distinctiveness required for trademark registration.

Parallel imports and repackaging

Pharmaceutical preparations cannot be sold in Canada without prior Health Canada approval. Further, such preparations must comply with the labelling requirements set out in the Food and Drug Regulations – including Section C.01.005, which requires the inner and outer label of a drug to display the drug identification number assigned to that product. Accordingly, the parallel import of pharmaceutical preparations that do not have Health Canada approval or the requisite drug identification number is illegal, even if the drug has been approved for sale in another country.

Bilingual language requirements further reduce the likelihood of a parallel import being legally sold in Canada.

Anti-counterfeiting and enforcement

The sale of counterfeit health products in Canada is governed primarily by the Customs Act, the Trademarks Act, the Copyright Act and the Criminal Code. However, rights holders have traditionally found it difficult to use the relevant legislation to effectively address counterfeiting in Canada. Over the past several years, the Canadian government has attempted to improve border protection measures to combat the import of counterfeit goods and on December 9 2014 Bill C-8, the Combating Counterfeit Products Act, received royal assent.

Key to the act is a request for assistance (RFA) procedure, which provides the Canada Border Services Agency (CBSA) with the power to detain alleged counterfeit products. The RFA process permits the owner of a registered trademark or copyright to record its rights, enabling customs personnel to then seize and detain suspected counterfeit goods and provide information about the detained goods to the registered trademark or copyright owner.

The RFA procedure is available only for owners of copyright and registered trademarks; accordingly, trademark owners would be well advised to register all marks that are potential counterfeiting targets in Canada and record their rights under the RFA process.

The provisions relating to the RFA procedure – including the required form for recording IP rights – came into force on January 1 2015, along with expanded definitions of 'infringement' and new criminal penalties.

In addition, on September 13 2017 the CBSA announced that it will accept information from rights holders regarding imminent shipments of dangerous counterfeit or pirated goods destined for Canada. This will be particularly useful to the pharmaceutical industry and supplements the RFA programme.


Section C.01.044 of the Food and Drug Regulations restricts consumer-related advertising for prescription drugs to the mention of the name, price or quantity. Under this regulatory framework, Health Canada permits two types of prescription drug message directed to consumers: reminder ads and help-seeking messages.

Reminder ads, where only the name of a prescription drug is mentioned (not the disease), are interpreted as staying within the restrictions. However, depictions of easily recognisable product packages (eg, blister packs or inhalers) in reminder ads that lead to the identification of the therapeutic indication of a prescription drug are not permitted.

Help-seeking messages, where a disease is discussed without reference to a specific prescription drug product, are considered to be information and not advertising, provided that the criteria outlined in Health Canada's Distinction Between Advertising and Other Activities Policy are met.

Generic substitution

Both the federal and provincial governments regulate the pharmaceutical industry in Canada. The federal government has jurisdiction over IP rights, the approval of prescription drugs and labelling. The provincial governments oversee healthcare services funding. Each provincial drug plan sets specific price and other cost-containment guidelines (eg, drug product substitution laws and interchangeability designations) with respect to the pharmaceutical coverage provided.

Drug substitution regulations have been in place in most provinces for many years. These regulations typically focus on promoting the substitution of lower-priced generic drugs for brand-name drugs through implementation of product and price selection rules. Product selection involves switching from a branded to a generic drug, whereas price selection involves choosing the least costly generic available.

In Katz Group Canada Inc v Ontario (Health and Long-Term Care) (2013 SCC 64), the Supreme Court upheld the validity of Ontario regulations prohibiting 'private label products' (ie, generic drugs sold under the brand name of a pharmacy, but manufactured by a third party) from obtaining an interchangeability designation in Ontario, which would have entitled the dispensing pharmacy to reimbursement from the government under the various provincial health plans.

Online issues

Online pharmacies

Canada does not prohibit the online sale of prescription drugs and, given the comparatively low cost of pharmaceuticals in Canada, there is a market for pharmaceuticals sold through Canadian online pharmacies. However, online consumers should be aware that the absence of personal contact between consumer and pharmacist may increase the risk of health and safety issues with such products.

Domain names

The Canadian Internet Registration Authority (CIRA) administrates '.ca' domain name registrations and restricts registrant eligibility through its Canadian Presence Requirements (CPRs) to certain qualifying parties, including those holding a Canadian trademark registration that corresponds to the domain name to be registered.

CPR-eligible parties, including trademark owners, may lodge complaints seeking the transfer of domain names registered in bad faith through the CIRA Domain Name Dispute Resolution Policy. Before it will order a domain name transfer, CIRA requires the complainant to demonstrate prior rights to the trademark, as well as the registrant's bad faith and lack of legitimate interest in the domain name.

This article first appeared in Pharmaceutical Trademarks: A Global Guide 2018/2019, a supplement to WTR, published by Globe Business Media Group - IP Division.

To view the guide in full, please go to

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.

Susan Keri
Meghan Dillon
Similar Articles
Relevancy Powered by MondaqAI
Smart & Biggar/Fetherstonhaugh
Bereskin & Parr LLP
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Smart & Biggar/Fetherstonhaugh
Bereskin & Parr LLP
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