Uhthoff, Gómez Vega & Uhthoff
Similarity among prescription drug names should be avoided, as the potential confusion carries a risk to consumer health. Bringing the best pharmaceutical trademark to market can be arduous, but it will assist in the safe prescription of medication.
Trademark lawyers deal with trademarks such as TAMIDIN and TAMICIN-G on a daily basis – peculiar terms that share a similar sound and appearance. TAMIDIN and TAMICIN-G are registered by different trademark owners in Mexico, but both cover pharmaceutical products in International Class 5.
As with any trademark, using these pharmaceutical marks in a manner that is likely to confuse consumers jeopardises goodwill, threatens fair competition and could result in serious health problems for users.
There should be no risk of confusion among prescription drug names since, according to the Food and Drug Administration, mistaking one drugs for another with a similar name accounts for approximately 10% of all reported medication errors and injures approximately 1.3 million people every year. One example involved an eight-year-old boy who was to be treated for attention deficit disorder with the drug methylphenidate; the boy died after being prescribed and ingesting methadone, an opiate-based drug used to treat heroin withdrawal. In light of such cases, it is vital that each pharmaceutical trademark is different from others to assist health professionals reduce medication errors. This also helps consumers to choose and identify the drugs that are right for them and provides manufacturers with an incentive to develop new pharmaceuticals and monitor the safety of existing ones.
The development of a trademark for a new pharmaceutical product is complex and often involves legal, regulatory, linguistic and marketing aspects. As a result, many pharmaceutical companies follow a lengthy process for trademark selection. Because the timeline from the development of a name to a marketing launch is so long, it is advisable to commence the naming selection one to two years in advance, to ensure that all necessary factors are considered.
The process of selecting the correct name for a pharmaceutical product often begins with the company taking several names and checking them against the databases of pending or registered trademarks for related products. Some companies will make a more detailed search to eliminate names that might be confusingly similar to existing trademarks, and also to reject names that may have unintended meanings or connotations in the languages of any of the territories where the product is to be sold.
Chemical and generic names
A pharmaceutical has both a chemical name and a generic name adopted by national and international nomenclature agencies.
Non-propriety generic names are used to assist healthcare professionals to identify the pharmacological properties of drugs. They are granted by the World Health Organisation under the International Non-propriety Names (INN) system. Since names of pharmacologically related substances demonstrate their relationship by using a common stem, additional letters are added to this stem (usually as a prefix) to create the generic name.
There will always be a degree of built-in similarity for INNs for pharmaceuticals that are in the same class, since it is helpful for doctors when identifying the properties of a pharmaceutical product – a fact that runs the risk of creating problems for companies.
In Mexico, after the selection of a pharmaceutical product name, the company will need to acquire a trademark registration for long-term protection and enforcement. In addition, manufacturers must also obtain a marketing authorisation to sell any medicine. The Mexican authority in charge is the Federal Commission for Protection Against Sanitary Risk (COFEPRIS), which approves the names of medicines, which it refers to as ‘distinctive names’.
Distinctive names before COFEPRIS
COFEPRIS must follow Mexico’s Health Law, which sets out specific requirements and rules for distinctive names:
- The distinctive name refers to the name or trademark assigned to a pharmaceutical product to distinguish it from others.
- In both their use and marketing, medicines must be identified by their distinctive and generic names.
- The distinctive name must not refer to the composition of the medicinal product or its therapeutic action, including the diseases, syndromes and symptoms.
- A proposed distinctive name can be rejected when it is confusingly similar or identical to a previously authorised pharmaceutical name, in which case the difference between the proposed name and the previous name should be at least three letters in each word.
Nevertheless, there is as yet no clear link between the Mexican Industrial Property Law and the Health Law regarding conflicts between registered trademarks and marketing authorisations or distinctive names. However, pharmaceutical companies must consider the criteria of both administrative authorities if they want to have a title of registration for a trademark and commercialise it in the market.
Likelihood of confusion
The IMPI follows the same guidelines for pharmaceutical trademark registration as it does for other trademarks – meaning that it refrains from granting registrations to marks that are confusingly similar to registrations or applications covering the same or similar products. In some cases, it might cancel trademark registrations that have been granted in error or that have proved to be confusingly similar to senior marks used for the same type of goods.
Some courts have established certain guidelines to analyse the likelihood of confusion between conflicting marks, as follows:
- When comparing trademarks, the examiner in charge must consider the graphic, sound and meaning aspects of the marks.
- The examiner must study conflicting trademarks as a whole, refraining from dividing or disregarding elements of the marks.
- Distinctive signs have more weight than descriptive or generic terms, which lack relevance in the analysis, even if they are part of the trademark.
- In the case of composed trademarks, the courts have established that the word element has more weight than the design, and that distinctive signs have more weight than descriptive generic terms.
- When any part of the INN of the drug is included in conflicting pharmaceutical trademarks, analysis should focus on the distinctive elements of the mark.
There are a number of Mexican legal precedents that establish particular rules for the assessment of the likelihood of confusion between pharmaceutical trademarks, since such confusion could jeopardise consumer health.
The double requirement for authorisation and registration of pharmaceutical trademarks by two different administrative authorities means that IMPI examiners must typically consider the ‘three-letter rule’ when analysing the similarity of trademarks for pharmaceutical products. It is not, however, mandatory and the Health Regulations do not require COFEPRIS to consider senior trademark registrations for pharmaceutical products when examining the similarity of distinctive names. Pharmaceutical companies must consider the involvement of the two administrative authorities in the clearance of trademarks and commercial names for pharmaceutical products and develop a wise and cost-effective registration strategy based on previous trademark searches.
Registering a trademark has several benefits to pharmaceutical companies, since it will ensure that they can enforce their IP rights through customs authorities and the courts in the event of trademark infringement. Being able to identify a pharmaceutical product by its trademark is helpful to consumers in the rare event of an adverse reaction and will assist them in recognising the source of any problems which may result.
Pharmaceutical trademarks will facilitate legal action against counterfeits, since if they were marketed by their generic name only, it would be difficult to know whether a particular formulation was being counterfeited.
Bringing a pharmaceutical trademark from its initial phase to market is often arduous, time consuming and expensive for pharmaceutical companies; nevertheless, since trademarks provide the best method by which pharmaceuticals can be safely prescribed and prescriptions filled, the use of pharmaceutical trademarks together with efforts to encourage healthcare providers to prevent lookalike and soundalike pharmaceutical names, is far more likely to minimise medication errors than any alternative.