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. In fact, for every 100 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 legal screening will conduct a robust trademark and common law screening on all name candidates presented to clients. An all-embracing branding partner will not only look at ownability for all candidates but also conduct brief regulatory prescreen prior to selecting the final names to take into safety research … saving the client 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 screening provides project teams with name candidates that they can feel confident in sharing with your Intellectual Property (IP) group, without fear that they will knockout a majority of the names. and taking into name safety testing, allowing you to grow attached to a name candidate you love and increasing the likelihood that these name candidates will not be eliminated later down the line.
After name creation and screening, presentation, and client selection, a prioritized list of name candidates should undergo robust name safety testing. The more names, and obviously stronger name candidates you can take into name safety testing, the more options you will have at the close of the project 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: 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).
Prior to final name selection a risk assessment should be conducted by experienced regulatory professionals that incorporates the output of all the research conducted. This should include name candidate review on FDA’s POCA 4.0, a name pair analysis where name candidates are compared to potential conflicts using multiple international databases, and a Failure Modes & Effects Analysis (FMEA) to evaluate medium and high-risk names for likelihood of occurrence, severity of patient harm, and detectability. The findings of the risk assessment should be presented to your team with the perceived risk level (low, moderate, high) for all the name candidates tested to aid in final name selection for submission. Upon selection, submission reports are created summarizing the findings for both your primary and alternate name candidates and 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.