According to experts, between 1980 and 2010 the number of pharmaceutical trademarks filed increased over 300%. Although 238,010 pharmaceutical trademarks were filed globally in 2010, there were only 21 new drugs approved by the US Food and Drug Administration (FDA) and 14 new molecular entities approved by the European Medicines Agency (EMA). In 2011, the US FDA’s approval of new drugs was the highest it had been in seven years, with a total of 30 new drugs. The trend is consistent in subsequent years, with an average of 30 new drugs approved a year. The number of approvals reached its peak in 2015, when the US FDA approved 45 new drugs.
Pharmaceutical companies can face some problems when filing a new trademark or commercial name for their drugs. In order to avoid expanding the already lengthy process of getting your drug approved, the FDA gives companies the following tips:
- Avoid obvious similarities in both sound or spelling with other drugs already registered
- Do not use medical abbreviations or the name of inactive ingredients that are present in the drug
- Either use all of the names of the active ingredients for the trademark, or don’t use any at all; it could lead the patient to think that only some of them are actually present on the drug
- Don’t reuse the proprietary name of a drug that contains different active ingredients
In order to avoid these problems and seeking to be prepared in the event that the first name they had in mind doesn’t fulfill the FDA’s requirements, pharmaceutical companies have come up with various systems. In combination with the filing of a greater number of trademark applications, some companies have instituted standard commercialization guidelines and procedures to initiate trademark development as early as the end of Phase I. Others have earmarked an annual budget for the creation and maintenance of a ‘name bank’ to prepare for a potential candidate shortfall or regulatory rejection. One benefit that has resulted from this is the ability to match fast-moving licensing opportunities with a set of names that have cleared the preliminary screening process.
A number of key lessons can be learned from this that can be applied by all companies interested in naming a new molecular entity. These are some recommended best practices for drug trademark:
- Employ a team of professionals to develop a formalized process
- Employ experts who have experience with FDA and EMA trademark requirements
- Begin the process early so that this does not become the limiting factor
- Identify the proper balance of creativity and clearance to help ensure a successful outcome
Are trademarks names suitable for international markets?
Pharmaceutical companies sell worldwide, not just locally. However, when the time comes to enter the international market, many of them may face the fact that some trademarks don’t work as good out of the country they were created in. In these cases, the need for partnering with a professional language service provider (LSP) seems obvious.
Some international markets are specially hard to penetrate, as they have hard, specific regulations regarding languages. One good example for this would be the European Union (EU), with 28 member states, most of them requiring the documents that accompany the drug to be translated to their official language(s).
Even though using machine translation or a bilingual internal staff member could look like a fast, money saving solution when getting into the translation phase, it would be a smart move to search for professional localization and translation services. A professional LSP will grant you not only proficiency in the source and target languages, but also expertise in the two different cultures and the pharmaceutical industry. Moreover, it will ensure that the whole translation process undergoes a thorough quality assurance procedure, so that it meets the highest quality standards.
If done wrong, life sciences translation can cost more than money, and the producer will always be liable for any problems that may arise. Trusting your trademark and accompanying documents translation to a LSP will save you the trouble.
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