Mexico: WTR Pharmaceutical Trademarks 2017-2018

Last Updated: 9 September 2016
Article by Víctor Ramírez and Erwin Cruz


Regulatory bodies and requirements

The Industrial Property Law and the Industrial Property Law Regulations regulate trademarks in Mexico. Mexico has acceded to the following international treaties relevant to trademark protection:

  • the Paris Convention for the Protection of Industrial Rights;
  • the North American Free Trade Agreement;
  • the Agreement on Trade-Related Aspects of Intellectual Property Rights;
  • the Madrid Protocol for trademark registration; and
  • the Trans-Pacific Partnership (TPP).

The exclusive right to a trademark is obtained through registration with the Mexican Institute of Industrial Property (IMPI).

All visible signs can be protected, provided that they are sufficiently distinctive and can distinguish the goods or services to which they apply from others in the same class (Article 89 of the Industrial Property Law). Once Parliament has enacted the amendments required by the TPP, non-traditional trademarks will be recognised.

New opposition system

The Industrial Property Law was recently amended to introduce an opposition system. As of the end of August 2016, the opposition system will work in parallel with the trademark prosecution system, as follows:

  • The trademark application will be published in the IP Gazette no later than 10 working days after its filing date.
  • Third parties can file observations against an application within one month (non-extendable) of publication. However, observations neither suspend prosecution of the application nor grant legal standing within this prosecution.
  • IMPI will publish a list of applications for which observations have been received.
  • Although IMPI is not obliged to assess observations, applicants can reply to these observations within one month of publication.

Regardless of observations, IMPI will decide on the grant or refusal of trademark applications.

Manufacturers must obtain marketing authorisation to sell any medicine or certain medical devices. The relevant authority is the Federal Commission for Protection against Sanitary Risk (COFEPRIS), which approves the names of medicines – referred to as 'distinctive names'. In order to apply for a marketing authorisation, the distinctive name of the product must be pre-approved by COFEPRIS (Article 2(iv) of the Health Regulations).


The Health Law and the Health Regulations specify the requirements for distinctive names. The principal rules for the names of medicines are as follows:

  • 'Distinctive name' means the name or trademark assigned to a pharmaceutical product in order to distinguish it from other similar products (Article 2(iv) of the Health Regulations).
  • In use and marketing, medicines must be identified by their distinctive and generic names (Article 225 of the Health Law).
  • The distinctive name must not refer to the composition of the product or its therapeutic action. Vaccines and biological products excepted, no indications may relate to diseases, syndromes, symptoms, anatomical data or physiological phenomena (Article 225 of the Health Law).
  • A proposed distinctive name can be rejected if it is confusingly similar to a previous authorised name. Under the 'three-letter rule', the difference between the proposed name and the previous name should be at least three letters in each word to prove dissimilarity (Article 23 of the Health Regulations).
  • A proposed distinctive name will be rejected if it is identical to the previous name of another approved medicine (Article 23 of the Health Regulations).
  • A distinctive name can be used for pharmaceutical products that have the same active ingredient and have been approved by the same laboratory, but have different pharmaceutical forms or doses (Article 23 of the Health Regulations).

Practical issues

There is no clear link between the Industrial Property Law and the Health Law and their regulations regarding conflicts between registered trademarks and marketing authorisations or distinctive names.

IMPI examiners usually consider the three-letter rule when analysing the similarity of pharmaceutical trademarks, although it is not binding on them. However, the Health Regulations do not require COFEPRIS to consider senior trademark registrations (for pharmaceutical products) when examining the similarity of distinctive names using its own software developed to apply the three-letter rule. This inconsistency has had unfortunate consequences, including contrary decisions of IMPI and COFEPRIS regarding the likelihood of confusion of trademarks and distinctive names.

Further, IMPI and COFEPRIS have different databases. The IMPI database comprises all trademark applications and registrations that have been filed with the agency or its predecessors, while the COFEPRIS database contains only the distinctive names allowed for medicinal products, regardless of whether they are in use.

The COFEPRIS system enables pharmaceutical companies to obtain a pre-approval certificate for distinctive names, valid for 90 days, which is useful for any marketing authorisation. However, the system allows only 10 certificates to be granted per company and such certificates do not bind COFEPRIS, which can still reject marketing authorisation for a pre-approved distinctive name. Such rejection may be contested before the federal courts.

The new opposition system might be useful for pharmaceutical trademark holders to detect and raise objections before IMPI based on the health law regulations.

Confusion with INNs

Including international non-proprietary names (INNs) or their stems as part of pharmaceutical product trademarks creates conflicting situations.

On the one hand, Article 225 of the Health Law expressly forbids the use of pharmaceutical trademarks that clearly resemble INNs and Article 90(II) of the Industrial Property Law prohibits registration of generic names. Accordingly, IMPI has no legal basis for refusal of a trademark that comprises a stem or an INN and additional distinctive elements that make the trademark registrable as a whole.

However, INNs are generic and cannot be treated otherwise, which makes it impossible for IMPI to assess the likelihood of confusion between pharmaceutical trademarks and INNs.

Hence, IMPI faces a challenge in following the World Health Organisation's recommendations to safeguard the proper use of INNs and to avoid the registration of trademarks derived therefrom.

Non-traditional trademarks

Article 89 of the Industrial Property Law provides that only visible words, names and designs, including three-dimensional (3D) marks, are registrable as trademarks.

Under the Industrial Property Law, colours alone are unregistrable, "unless they are combined or accompanied by elements such as symbols, designs or denominations that give them a distinctive character". Thus, combinations of two or more colours can be registered as trademarks, regardless of the form or surface on which they are applied.

Article 89 of the Industrial Property Law establishes that 3D signs have elements that can constitute a trademark and are thus registrable. However, a 3D mark must:

  • not be in the public domain;
  • not have fallen into common use;
  • be sufficiently original to be easily distinguished; and
  • not have a shape that represents the product or is required by its function.

Motion marks cannot be protected. Article 90(1) of the Industrial Property Law establishes that names, figures or forms expressed in a dynamic way cannot be registered as trademarks, regardless of whether they are visible.

The Industrial Property Law does not recognise marks comprising sounds, smells, tastes or textures, since they are not visible. However, Mexico has signed the TPP, whose provisions on non-traditional trademarks will require amendments to the legal framework once it enters into force.


Any import of medicines, health or pharmaceutical products – or raw materials for such products – must be approved by COFEPRIS. Medicines must have marketing authorisation. Under certain circumstances (eg, clinical trials and orphan drugs), the import of a minimal quantity of products without marketing authorisation can be approved.

In relation to trademarks, parallel imports are allowed, provided that the product was legally introduced in the country of origin and the trademark is owned by the same company or group of companies in Mexico.

The packaging and labelling of pharmaceutical products are governed by the Health Law and its regulations and require approval by COFEPRIS. Altering or modifying the authorised packaging or labelling of approved pharmaceutical products can be considered a criminal offence (Article 464ter of the Health Law).


Trademark infringement action

A trademark registration can be enforced against alleged infringers in two ways:

  • If the infringer uses a confusingly similar or identical trademark for identical or similar goods or services, an infringement action can be brought before IMPI.
  • If the infringer uses an identical trademark for identical goods or services, a criminal action can be brought before the Attorney General's Office.

Infringement actions are filed before IMPI, which is an administrative authority rather than a court. Once admitted, IMPI serves notice of the infringement action on the alleged infringer, granting it 10 working days to reply.

On request, IMPI may impose provisional injunctions before the filing of an infringement claim or during the case.

Both the claimant and the alleged infringer must submit evidence at the time of filing or answering the claim. Subsequently, IMPI grants the parties a common term to file closing arguments. IMPI's decision is subject to appeal before the Federal Court of Tax and Administrative Affairs, whose decision can be further appealed before the circuit courts.

In order to prove infringement, the plaintiff may submit any type of evidence except confessional or testimonial evidence. The most common evidence used to prove infringement is an inspection of the alleged infringer's premises.

Infringers can incur penalties ranging from a fine of up to 20,000 times the minimum wage (around $100,000) to closure of their businesses (Article 214 of the Industrial Property Law). Repeated infringement is a criminal offence (Article 223 of the Industrial Property Law).

IMPI can impose a penalty and order the immediate cessation of the infringing activities. A civil action to claim damages in a civil court is possible once an IMPI decision of infringement is final and binding.

The Industrial Property Law establishes that the damages awarded to the owner of an infringed IP right should not be less than 40% of the sales of the infringing product at the consumer retail price.

Attorney General's Office

The federal prosecutor at the Attorney General's Office also investigates IP crimes and can use force during raids related to IP rights. However, it must obtain a search warrant from a federal court and can intervene only in cases involving the falsification of goods for which IP rights are held.

Proceedings begin with the mandatory filing of a special type of criminal complaint. In the context of an investigation, infringing goods can be seized without a search or warrant order if they are publicly available. However, if they are stored on private property, a search or warrant order must be obtained.

A raid may take place within 15 to 45 days, depending on the type of premises to be searched and its distance from Mexico City.

Indictments may be issued within 48 hours of execution of a search or warrant order if a suspect is arrested; it may take longer if the request relates to organised crime. If no suspect is arrested, an indictment may be issued within approximately two months. During that time, the seized goods are stored in government warehouses.

On completing the investigation, the federal prosecutor will bring the case before a federal court.

Trademark database at Customs

A database has been created, managed by Customs in coordination with IMPI, which contains the registered trademarks of owners interested in monitoring their rights at the 49 customs checkpoints at the country's borders, ports, bus and train stations and airports.

Regarding medicines, pharmaceutical substances, chemicals and active pharmaceutical ingredients (APIs), Customs' efforts are limited to detecting prohibited drugs and narcotics. The next step is to strengthen IP protection for patents within Mexico, particularly for those that protect pharmaceutical products.

Recently, Customs has collaborated with rights holders to detect and seize APIs based on IMPI-ordered border measures. Thanks to cooperation between Customs and IMPI, bulk border seizures of patented APIs have taken place.


Regulatory framework

The primary legislation for the advertising of medicinal products is the Health Law and the Health Law Advertising Regulations, supplemented by COFEPRIS guidelines.

Industry codes of practices complement these regulations. The Council of Ethics and Transparency of the Pharmaceutical Industry (CETIFARMA) has issued various self-regulatory codes, the latest of which came into force on April 1 2013. Affiliate members of the National Chamber of the Pharmaceutical Industry must adhere to the codes and CETIFARMA supervises compliance.

Further, the Advertising Council – comprising representatives from the Ministry of Health, the academic and scientific communities, the business sector, the media and consumer groups – also issues opinions.

Other general legislation may be relevant to the advertising of medicinal products – in particular, the Industrial Property Law and the Federal Law for the Protection of Consumers.

Further considerations

The Code of Ethics and Transparency of the Pharmaceutical Industry requires the provision of accurate and objective explanations of the characteristics, functions, advantages or disadvantages of pharmaceutical products or services.

Non-prescription medicines

According to the Health Law Advertising Regulations, only non-prescription medicines can be advertised to the general public, subject to approval by COFEPRIS. The media must require certified copies of the relevant marketing authorisations for the corresponding medicines before publishing or broadcasting related ads.

In February 2014 COFEPRIS issued detailed guidelines regarding the approval of ads for non-prescription medicinal products. According to these guidelines, COFEPRIS will not approve ads comparing products with the same therapeutic indication or questioning the quality of products with marketing authorisation.

Prescription medicines

Prescription medicines can be advertised to health professionals. However, this advertising can be done only through specialised media and must be based on medical prescription information.

The Code of Good Promotion Practices requires that the information provided to healthcare professionals be accurate, balanced, fair and objective, and sufficiently complete for them to form their own opinion of the therapeutic value of the corresponding medicine.


COFEPRIS can order the suspension of advertising activity in breach of the legal framework. The responsible party and the media channel must comply within 24 hours.

The penalties for failure to comply with the advertising rules are suspension of advertising activities by the responsible party or the media and a fine of between 2,000 and 16,000 times the minimum wage (around $10,000 to $80,000).


Under the Health Regulations, a physician must prescribe medicines and biologics using the INNs and may choose to indicate the preferred distinctive name. Thus, patients may receive from the pharmacist any product with the same active ingredient. At present, a proposal to amend the Health Law to prevent automatic switching from biologic innovators to biosimilars as a result of potential health issues is pending.


Under the Health Regulations, medicines must be made available in authorised pharmacies and can be sold only to patients with a physician's prescription, especially antibiotics (except over-the-counter products).

Electronic advertising falls under the general advertising rules in Article 2 of the Health Regulations. At present, COFEPRIS is increasing its monitoring of online ads for medicinal products, which have been less stringently monitored than television or radio ads.

Pharmacies must obtain permission to operate on health grounds and other stores are forbidden from marketing prescription medicines.

The Code of Good Promotion Practices requires the adoption of measures to ensure that the promotion of prescription medicines on websites is accessible only to healthcare professionals. Such websites must have a warning stating that they may be used only by healthcare professionals allowed to prescribe drugs.

Originally published by World Trademark Review.

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
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

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