From trademark registration to regulatory submission, the ultimate goal of any pharmaceutical naming project is name approval. An experienced branding partner will always create names with this goal in mind, incorporating legal and regulatory efforts from project kickoff to completion.
With millions of registered trademarks around the world, finding a name that is registerable and protectable is one of the biggest hurdles in naming a new product. Of all the names created, only 20% will make it through a strenuous trademark search, and from there, additional names will be eliminated due to linguistic conflicts, regulatory concerns, or team disapproval. This turns the creative process into a numbers game, meaning the more names created the greater the probability you will have more names at the end to select from.
A branding partner with extensive experience in trademark and regulatory will conduct upfront vetting on you names via the following steps to ensure overall success of name creations that are viable from a legal and regulatory perspective. These steps should include:
1) A robust trademark, POCA, and common law search on all name candidates presented;
2) A regulatory prescreen prior to selecting the final names to take into safety research … saving you valuable time and money by eliminating high-risk name candidates with obvious conflicts (i.e., promotional concerns, sound-alike/look-alike conflicts, USAN/INN stem conflicts, problematic medical terminology).
Detailed name prescreening provides project teams with name candidates that they can feel confident in sharing with the company’s legal counsel and regulatory panel. This prevents your team from falling in love with a name option they have no chance of owning and, ultimately, increases the likelihood that the preferred name candidates will not be eliminated or rejected later down the line.
After name creation, screening, and client review and selection, a prioritized list of name candidates should undergo additional robust name safety testing. We suggest a minimum of 20 names taken into the final vetting stages. Think about it this way, the more shots on goal you enter name safety testing with, the more name options you will have at the close of the project in order to select the most strategically aligned and creatively appealing name to submit to regulatory. This will also provide you with strong back-up name options, should your name get rejected.
Detailed name safety testing will have several different aspects which may change depending upon which regions/regulatory bodies you’re ultimately going to file the name with:
1) A survey administered to healthcare professionals that includes questions regarding name similarity, word construction, and distinctiveness;
2) A prescription simulation study where medical professionals are asked to interpret medication orders based on the product’s particular prescribing environment;
3) A promotional review; and
4) Commercial metrics (i.e., fit to concept, pronunciation, images & associations).
5) A proactive risk assessment on the final top name candidates by experienced regulatory professionals to prioritize them for regulatory submission utilizing name safety testing tools such as the FDA POCA, name pair analysis, word construction analysis, and the failure modes and effect analysis.
Ultimately, the findings of the risk assessment should be presented to your team with the perceived risk level (low, moderate, high) as well as a final score-based recommendation based upon not only the safety and commercial results but also the internal ranking and any linguistic challenges in identified target regions. Upon selection, submission reports should be created summarizing the findings for both your primary and alternate name candidates to be included in your regulatory submission application. Partnering with experienced branding professionals that work towards name approval from project start to finish is crucial to achieving ultimate name approval.