Mexico: WTR Pharmaceutical Trademarks 2017-2018

Last Updated: 9 September 2016
Article by Víctor Ramírez and Erwin Cruz
Most Popular Article in Mexico, September 2016

SELECTION, CLEARANCE AND REGISTRATION

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).

Rules

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.

PARALLEL IMPORTS AND REPACKAGING

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).

ANTI-COUNTERFEITING AND ENFORCEMENT

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.

ADVERTISING

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.

Surveillance

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).

GENERIC SUBSTITUTION

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.

ONLINE ISSUES

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 Mondaq.com.

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

Authors
 
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 Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.