In the challenging and complex world of life sciences product development, choosing a brand that survives the US Patent and Trademark Office and US Food and Drug Administration clearance processes is critical. Brand names in this industry are subject to heightened scrutiny because confusingly similar names may lead to medication error and patient harm. The proliferation of brands in this field, combined with financial and public relations consequences of a potential rebrand in the event of infringement, has made selecting a brand riskier than ever.

There is no magic formula for creating a successful life sciences brand. Given the high stakes, pharmaceutical companies often retain specialists to help compile lists of names for legal consideration and brand clearance, a process that usually entails a few rounds of searching and often includes both preliminary and full searches. Preliminary trademark searches typically provide a review of nearly identical federal applications and registrations. Full trademark search reports are generated by experienced search vendors and generally include state registrations, common law references, Orange Book references, United States Adopted Names (USAN) and FDA Phonetic Orthographic Computer Analysis (POCA) scores. Reviewing these sources is crucial when analyzing whether a potential name is likely to survive both FDA and USPTO scrutiny.

Experienced trademark counsel can help anticipate potential issues associated with these clearance processes. FDA clearance includes promotional and safety reviews, taking into account various ways in which a name may trigger a medication error including, but not limited to, POCA scores, existing medication error data and name simulation studies/assessments. USPTO clearance primarily consists of distinctiveness and likelihood of confusion considerations by the Examining Attorney.

START THE CLEARANCE PROCESS EARLY

It often takes several rounds of searches to identify viable names. The FDA and USPTO clearance processes usually take at least a few months. Thus, names should be generated and vetted at least two to three years before a scheduled product launch.

TRY UNIQUE LETTER COMBINATIONS AND MULTIPLE SYLLABLES

Viable names often share certain characteristics. For example, they may incorporate three or more syllables and/or include unusual letter combinations. Viable names generally steer away from incorporating terms which may be deemed to constitute an expressed or implied product claim.

AVOID USAN STEMS AND OTHER POTENTIAL SOURCES OF MEDICATION ERROR

A USAN is a nonproprietary, generic name assigned to a new pharmaceutical product. Given that pharmaceutical manufacturers are required to use certain stems in connection with their products, it is important that brands do not incorporate such elements because such use generally violates naming convention requirements issued by the USAN Council and World Health Organization.

PHONETIC SEARCHING IS IMPORTANT

Slight spelling modifications can sometimes make a meaningful difference in the availability of a name (e.g., substituting the letter “I” for “Y”). We recommend conducting phonetic searches from the outset to capture these types of substitutions.

DEVELOP DISTINGUISHABLE BACKUPS

Companies should submit at least several names which are meaningfully different from one another in appearance, sound and commercial impression. For example, name candidates featuring the same letter strings or phonetics may all suffer the same fate if one is rejected.

Through a sound investment in strategic name generation and thorough legal analysis from the outset, life sciences companies can make the most of their branding efforts in the long run.