Introduction
The distinctive name or pharmaceutical trademark plays a fundamental role in the regulation of pharmaceutical products. This name, which commercially identifies a medicine, not only has legal and commercial implications, but also a direct impact on public health and patient safety. Pharmaceutical trademarks help differentiate products, encourage consumer confidence, and avoid confusion in the prescription and dispensing of medications.
Therefore, their creation, use, and protection are carefully regulated by health and intellectual property agencies around the world. Hence, this article explores the nature, function, regulation, and importance of distinctive names in medicines, with an emphasis on Mexican legislation.
We must take into consideration that the development of a trademark for a new pharmaceutical product is a complex process for companies, that most of the time involves several aspects such as legal, regulatory, linguistic, and marketing, in fact, many pharmaceutical companies follow a lengthy process for the selection of a trademark.
The process of selecting the correct name of a pharmaceutical product begins frequently with the development by the company of several name candidates checked against databases of pending or registered trademarks for related products, some of them make a more detailed trademark search to eliminate names that might be confusingly similar to existing trademarks, and also to reject name candidates that can have unintended meanings or connotations in any of the languages of the territories where the product would be sold.
Currently, in Mexico, pharmaceutical trademarks are regulated by a combination of standards that address both industrial property, managed by the Mexican Institute of Industrial Property, and health aspects, overseen by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS).
For the purpose of this analysis it is important to differentiate between the three main types of names used in connection with medicines:
- Generic name (INN): This is the International Common Name of the active ingredient, recommended by the WHO, such as “paracetamol” or “amoxicillin”.
- Chemical name: Name based on the chemical structure of the compound, for example, “N-acetyl-p-aminophenol.”
- Distinctive name or trademark: means the name or trademark assigned to a pharmaceutical product in order to distinguish it from other similar products, and it must not refer to the composition of the product or its therapeutic action. It may be registered as a trademark with the Mexican Institute of Industrial Property (IMPI), such as ” Tylenol ” or ” Augmentin.”
The World Health Organization (WHO) meets with national nomenclature committees to determine a single, globally accepted nonproprietary name based on the active ingredient in each pharmaceutical preparation. These names are declared “nonproprietary” by the WHO and therefore enter the public domain.
Each INN must be unique and distinct, both phonetically and orthographically. Generally, an INN contains a common syllable (root) that refers to the pharmacological or chemical family to which the substance belongs. For example, the ending “-mycin ” refers to a class of antibiotics. Separate syllables, letters, or words are then added to differentiate between substances in the same family, such as kanamycin and erythromycin.
The INN must remain in place as long as the substance exists. Substances such as aspirin and morphine do not have INNs because those names were already widely used when the system was introduced, and were well-established.
WHO also requests that these names be recognized as non-proprietary names for the substance and that Member States take the necessary measures to prevent the acquisition of proprietary rights to the name, including prohibiting the use of the name as a trademark or commercial name.
Importance of the pharmaceutical trademark in Mexico
Although trademark registration is not a prerequisite to the launch of a pharmaceutical product, the involvement of two administrative authorities (COFEPRIS and IMPI), in the clearance of trademarks and commercial names for drugs has become crucial for the pharmaceutical companies.
In fact, in what respects to pharmaceutical trademark registration, the Mexican Trademarks Office follows the same guideline to study other trademarks, i.e. it refrains from granting registrations to marks which are confusingly similar to registered or applied for trademarks covering the same or similar products, and in some cases, it might cancel trademark registrations that have been granted in error or that prove to be confusingly similar to senior marks used on the same type of goods.
Since there are few legal precedents establishing particular rules for the assessment of the likelihood of confusion between pharmaceutical trademarks, some of them have indicated that in these cases, likelihood of confusion should be minimal as it could jeopardize the health of consumers.
In light of the above, the Health Supplies Regulation, establishes that when similarity is found between a commercial name and an earlier drug name, at least three letters should differ. This provision is known as the ‘three-letter rule’. Its rationale is to avoid granting marketing authorization to a commercial name which is similar to that of a prior marketing authorization.
Furthermore, the General Health Law establishes that the distinctive name may not clearly or obscurely include the composition of the medicine or its therapeutic action. It may also not include indications related to diseases, syndromes, symptoms, or those that recall anatomical data or physiological phenomena, except in the case of vaccines and biological products.
To market a medicine in Mexico, the owner must obtain a health registration issued by COFEPRIS. During this process, the proposed distinctive name is evaluated.
A term may be accepted as a trademark by IMPI, but rejected as a drug name if it does not meet health requirements.
Additionally, when part of the international non- proprietary name of the drug is included in conflicting pharmaceutical trademarks, the analysis should focus on the distinctive elements of the marks, taking into consideration the trademarks as a whole.
However, there is no clear link between the Intellectual Property Law and the Health Law and their regulations regarding conflicts between registered trademarks and marketing authorizations or distinctive names.
It is important to notice that The General Health Law (LGS) and the Health Supplies Regulation (RIS) contain specific provisions on the distinctive name of medicines authorized by COFEPRIS, and a brand name may be accepted as a trademark, but rejected as a drug name if it does not meet health requirements.
Tips for choosing a pharmaceutical name:
- Avoid names that contain elements of the active ingredient.
- Do not use common prefixes or suffixes in other medications.
- Verify that the name is not registered or authorized by IMPI and COFEPRIS.
- Conduct phonetic and graphic tests to reduce the risk of confusion.
Similar names and health risk
One of the biggest challenges in approving pharmaceutical brands is avoiding confusion between drugs with similar names, which can lead to medication errors. These errors include:
- Administration of the wrong medication.
- Duplication of treatment.
- Adverse reactions due to unexpected interaction.
The history of the pharmaceutical industry offers numerous examples where similar names led to medication errors with serious consequences. For example:
- “Celebrex” (anti-inflammatory) was confused with “Celexa” (antidepressant), and also with “Cerebyx” (antiepileptic).
- In some countries, medications with almost identical names but different active ingredients have led to prescription errors and serious adverse effects.
These cases have led regulatory agencies to strengthen their review processes for proposed names and to use phonetic and visual analysis tools to prevent dangerous similarities.
In this regard, COFEPRIS and the WHO and PAHO (Panamerican Health Organization) have issued recommendations for health authorities to carefully review proposed names. Mexico has adopted preventive measures, including the possibility of rejecting a trademark already registered with the Mexican Institute of Industrial Property (IMPI) if it poses a health risk, thus reinforcing the priority of public health over commercial rights.
Impact of trademarks on generic drugs
The situation is different with generic drugs. Although they must use the generic name, many pharmaceutical companies also assign their own tradename, which can raise concerns among patients about whether the drug is truly a generic or a new product.
This has been the subject of debate in multiple countries, as it can lead to a misperception of superiority between equivalent products. To counteract this, many authorities require the generic name to appear clearly on the packaging, even if there is an additional brand name.
Some examples of non-traditional trademarks
In Mexico, a company can register a package or a bottle of a medicine as a trade dress, and some examples of this are the following:
Registration No. 1446902
Registration No. 2113622
Registration No. 2113623
Conclusion
A distinctive name or pharmaceutical brand is much more than a commercial label. It is an essential component of a medicine that influences its identification, market positioning, and, most critically, patient safety. For this reason, the process of creating, evaluating, and registering brand names must be rigorous, ethical, and oriented towards the public good. While brands are a key asset for pharmaceutical companies, they must also meet standards that ensure clarity, precision, and distinction from other products. In a sector where errors can have fatal consequences, the importance of a well-designed and regulated distinctive name cannot be underestimated. In this regard, technological tools are beginning to be implemented to analyze proposed names and avoid phonetic or graphic errors.
Although there is no clear link between the IP Law and the Health Law and their regulations regarding conflicts between registered trademarks and marketing authorizations or distinctive names, examiners of the Mexican Trademarks Office must study trademarks as a whole when analyzing the similarity of pharmaceutical marks, and usually consider the three-letter rule when analyzing the similarity of pharmaceutical trademarks.
As a manner of recommendation, a shared database between Mexican Trademarks Office and COFEPRIS should be implemented, given that the MTO 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, in order to avoid unfortunate consequences, including contradictory decisions by MTO and COFEPRIS regarding the likelihood of confusion of trademarks and distinctive names.
The Mexican legal framework, comprised primarily of the LFPPI (Mexican Federal Law for the Protection of Industrial Property), the General Health Law, and its Regulations, provides the foundation for a robust protection and oversight system that seeks to ensure both the rights of drug owners and the safety of patients. In this sense, the proper management of distinctive names is a key link in the life cycle of medicines, with implications that go far beyond the name printed on the box.
REFERENCES
- Federal Law for the Protection of Industrial Property. 2020
- General Health Law. 2024
- Health Supplies Regulations. 2021
- MSD Manuals. (2025, July 14 ). The Trusted Provider of Medical Information since 1899. https://www.msdmanuals.com/
- World Health Organization: WHO. (2018, February 6 ). The Importance of a Name. https://www.who.int/news-room/feature-stories/detail/what-s-in-a-name-
- Impulso. (2023, November 23). Pharmaceutical nomenclature. How are medicines named? Impulso06. https://impulso06.com/nomenclatura-farmaceutica-como-se-pone-nombre-a-los-medicamentos/
By: Janett Lumbreras and Marisol Balandra
