Mexico

Selection, clearance and registration

National and international regulatory bodies and requirements

Trademarks in Mexico are regulated under the Industrial Property Law and the IP Regulations. Mexico is a member of a number of international treaties relevant to the protection of trademarks, including:

• 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; and
• the Madrid Protocol for trademark registration

The exclusive right over a trademark for products or services 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 products or services to which they apply (or are intended to be applied) from other products or services in the same class (Article 89 of the IP Law).

Manufacturers must obtain a marketing authorisation to sell any medicine or certain medical devices. The authority in charge of granting marketing authorisations 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 for a pharmaceutical product, the distinctive name of this product must previously be approved by COFEPRIS and have trademark registration granted by IMPI (Article 2(iv) of the Health Regulations).

Rules

The Health Law and the Health Regulations lay down the specific requirements and rules for distinctive names. The principal rules for medicines’ names are as follows:

• The term ‘distinctive name’ refers to 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).
• Medicines, in their use and marketing, 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 medicinal product or its therapeutic action. No indications are permitted in relation to diseases, syndromes, symptoms, anatomical data or physiological phenomena, except for vaccines and biological products (Article 225 of the Health Law).
• A proposed distinctive name can be rejected when it is confusingly similar to a previous authorised medicine name, in which case the difference between the proposed name and the previous name should be at least three letters in each word (the ‘three-letter’ rule –Article 23 of the Health Regulations).
• A proposed distinctive name will also be rejected if it is identical to a 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

As yet, there is no clear link between the IP Law and the Health Law and their regulations regarding conflicts between registered trademarks and marketing authorisations or distinctive names.

On the one hand, IMPI examiners usually consider the three-letter rule when analysing the similarity of trademarks for pharmaceutical products, although this rule is not binding on them. On the other hand, 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 situation has had unfortunate consequences, such as contrary decisions issued by 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 such names are currently in use.

The COFEPRIS system gives pharmaceutical companies the possibility of obtaining pre-approval for distinctive names. This system results in a certificate of pre-approval, which is valid for 90 days and useful for any marketing authorisation.

However, the system allows only 10 certificates to be granted per company and such certificates do not bind COFEPRIS, as it may still reject a pre-approved distinctive name during the marketing authorisation procedure. Such rejection may be contested before the federal courts. Thus, a trademark linkage system between COFEPRIS and IMPI is required.

Confusion with international non-proprietary names

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 an INN, and Article 90(II) of the IP Law prohibits registration of generic names. Accordingly, IMPI has no legal basis on which to refuse a trademark that comprises both a stem or an INN and additional distinctive elements that make the trademark registrable as a whole.

On the other hand, 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 the challenge of following the World Health Organisation’s recommendations to safeguard the proper use of INNs and to avoid the registration of trademarks derived from them.

Non-traditional trademarks

Article 89 of the IP Law provides that only visible words, names and designs, including three-dimensional (3D) marks, can be registered as trademarks in Mexico.

Under the IP Law, colours alone are not registrable, “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 subject to trademark protection and registration, regardless of the form or surface on which they are applied.

Article 89 of the IP Law establishes that 3D signs have elements that can constitute a trademark and can thus be registered. However, the IP Law imposes the following limitations on 3D marks:

• They must not be in the public domain;
• They must not have fallen into common use;
• They must be sufficiently original to be easily distinguished; and
• The shape must not represent the product and not be required by the product’s function.

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

The IP Law does not recognise marks comprising sounds, smells, tastes and textures, since these are not visible and consequently cannot be registered as trademarks in Mexico.

Mexico is participating in the negotiations on the Trans-Pacific Partnership (TPP). The terms, conditions and wording of the TPP remain confidential; however, it has been made public that the main IP issues include non-traditional trademarks.

Parallel imports and repackaging

Any import of medicines, health or pharmaceutical products or raw material 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.

Regarding IP rights, parallel imports are allowed in Mexico in relation to trademarks as long as the product was legally introduced in the country of origin and the trademark is owned by the same company or a related company in Mexico.

The packaging and labelling of pharmaceutical products are governed by the Health Law and its regulations. These activities must be approved 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 is using a confusingly similar or identical trademark for goods or services that are identical or similar to those covered by the trademark registration, an infringement action can be brought before IMPI.
• If the infringer is using an identical trademark for goods or services that are identical to those covered by the registration, 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 at any time 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, after which the case is ready to be decided. 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 is entitled to submit any type of evidence available, except confessional and testimonial evidence. The most common evidence used to prove an 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 the corresponding establishment (Article 214 of the IP Law). Repeated infringement is also considered a criminal offence (Article 223 of the IP 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 IP 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 retail price to consumers.

Attorney General’s Office

In addition to the infringement action explained above, the federal prosecutor at the Attorney General’s Office investigates alleged IP crimes. The federal prosecutor has the authority to 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. While the federal prosecutor carries out an investigation, if they are available in public places the goods in question can be seized without the need for a search or warrant order. However, if the goods are stored on private property, a search or warrant order must be obtained in advance.

Once an investigation has been completed, the federal prosecutor should bring the case before a federal court.

A raid instigated by the federal prosecutor may take between 15 and 45 days, depending on the type of premises to be searched and their distance from Mexico City.

Indictments may be issued within 48 hours of execution of a search or warrant order if any suspect is arrested; this term may be increased if the request relates to the investigation of 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 while further research is ongoing.

Trademark database at Customs

Recent efforts at the border have culminated in the creation of a database 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.

With regard to medicines, pharmaceutical substances, chemicals and active pharmaceutical ingredients (APIs), Customs’ efforts are limited to detecting prohibited drugs and narcotics. The next step will be 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 border measures ordered by IMPI. As a result of cooperation between Customs and IMPI, there have been bulk border seizures of patented APIs which unauthorised companies had attempted to import.

Advertising

Regulatory framework

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

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 versions of these codes came into force on April 1 2013. Affiliate members of the National Chamber of the Pharmaceutical Industry (CANIFARMA) are required to adhere to the codes, and CETIFARMA supervises members’ and adherents’ compliance.

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

In addition, other general legislation may be relevant to the advertising of medicinal products, in particular the IP 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 to enable them to form their own opinion of the therapeutic value of the corresponding medicine.

Surveillance

COFEPRIS has specific authority to order the suspension of an advertising activity in breach of the legal framework. The responsible party and the media channel must comply with the order within 24 hours.

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

Generic and biosimilar substitution

Pursuant to 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

Pursuant to the Health Regulations, medicines must be made available in authorised drug stores and can be sold to patients only with a physician’s prescription, especially antibiotics (with the exception of 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 to date have been less stringently monitored than television or radio ads.

All pharmacies must obtain permission to operate on health grounds and the marketing of prescription medicines in other stores is forbidden.

The Code of Good Promotion Practices requires the adoption of proper measures to ensure that the promotion of prescription medicines on websites will be 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.

OLIVARES

Pedro Luis Ogazon 17

Col San Angel

01000 Mexico DF

Mexico

Tel +52 55 5322 3000

Fax +52 55 5322 3001

Web www.olivares.com.mx

Erwin Cruz

Associate

[email protected]

 

Erwin Cruz is a member of the life sciences law group of Olivares and holds an LLM (first) from the University of Sheffield (2014), a postgraduate IP specialisation (first) from the National Autonomous University of Mexico (UNAM) (2009) and an LLB (first) from UNAM (2006).

He has extensive expertise in pharmaceutical law, patent law, IP rights litigation and enforcement and regulatory compliance. He has worked closely with the Federal Commission for the Protection against Health Risk, the Mexican Patent and Trademark Office and the federal courts.

Mr Cruz is the author of several articles on patents, marketing authorisations and pharmaceutical regulatory compliance, including the Mexico chapter of Practical Law, Pharmaceutical IP and Competition Law in Mexico 2014.

Victor Ramirez

Associate

[email protected]

 

Victor Ramirez obtained his law degree from the Pan-American University in Mexico City in 2000. He completed a postgraduate major in IP law at the same university in 2005 and attended the IP Summer Institute at the Franklin Pierce Law Centre in 2007.

As an associate at Olivares & Cia, Mr Ramirez has extensive experience litigating industrial property matters, at first instance as well as at appellate level before the Federal Court of Tax of Administrative Affairs. He also regularly provides legal opinions on negotiations relating to IP matters and handles licence, assignment, franchise and technology transfer agreements. In addition, Mr Ramirez analyses and reports on the availability of trademarks, slogans and commercial names, as well as filing trademark applications.