Legal Hurdles In Pharmaceutical Brand Naming

Posted August 21, 2017 by

Navigating the complicated field of trademarks when developing a Brand name can be a daunting task, which even more exemplified when it’s a pharmaceutical product and the regulatory authorities also have a say. A Company can create what they think is the perfect Brand name only to find itself staring trademark violations in the face. There are several legal hurdles that stand in the way of all pharmaceutical Brand names, but hurdles are not barricades, it is possible to overcome and successfully leap over them.

Trademark Screening

A trademark is defined as a word, phrase, symbol, and/or design that identifies and distinguishes the source of the goods or services of one party from another. With 8.5 million trademark applications submitted worldwide in 2015, an increase of 13.4% from 2014, the vein is becoming narrower and narrower in terms of what names can be owned, with the ever-growing trademark classes.

This makes it important now, more than ever, to combine the creative, name generation process with in-depth trademark screening. Before even looking at any possible Brand name candidates trademark screening should be performed. This ensures that the client won’t fall in love with names only to learn they have legal conflicts and can’t be considered. Without trademark screening names before presenting, around 50% of the name candidates on a list will be unusable due to trademark issues … which is the difference between a successful naming project and one that falls short.

Regulatory Testing

With the focus on consumer safety by the regulatory bodies when reviewing Brand names, this is a very necessary hurdle for companies to overcome. But with over 4.2 billion prescriptions written each year in the United States, this is not an easy hurdle to overcome. These regulatory bodies – Health Canada, Food and Drug Administration (FDA) in the United States, Name Review Group (NRG) in Europe, Ministry of Health Labour, and Welfare in Japan – exist to oversee the pharmaceutical naming evaluation processes and ensure that products are being named appropriately.

These bodies exist to ensure that drug names are not fanciful in their promotion, do not include any ingredient names that are not in the drug, and do not cause confusion with the name of an existing pharmaceutical product. An understanding of how to navigate through these regulatory bodies is crucial to any Company wishing to name one of their new products. This is where agencies and their expertise can be a great asset to any Company working on new pharmaceutical naming projects.

These legal hurdles should be thought about throughout the entirety of the naming project to ensure a smooth and successful process. Trademark prescreening should be done before the names are viewed to avoid looking at names with obvious legal issues, and regulatory testing should never be an afterthought, as it is necessary if a Company hopes to achieve a globally consistent name for its drug. It can be tempting to leave all this intense legal work for the end of a naming project when you have narrowed in on only a few top choices, but this strategy too often than not equates to an unsuccessful naming project, wasting valuable time and money.


Branding | Healthcare | Legal | Naming | Pharmaceutical | Trademark

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