Most industry professionals will agree that the dual challenges of regulatory approval and trademark registration in the pharma space plays a preeminent role in every aspect of the process. Because of these challenges in the context of the global marketplace, many pharmaceutical companies are compelled to file a greater number of trademark applications to address the risk of not having an approvable trademark by the intended launch date in critical markets.

According to Thomson CompuMark, “Between 1980 and 2010, the number of pharmaceutical trademarks filed increased over 300%.” Although a total of 238,010 pharmaceutical trademarks were filed globally in 2010, there were only a total of 21 new drugs approved by the FDA and 14 new molecular entities for the EMA. For the 2011 calendar year, Bloomberg recently announced and PhRMA confirmed that U.S. approval of new drugs hit a seven-year high with 30.

In combination with the filing of a greater number of trademark applications, certain companies have instituted standard commercialization guidelines and procedures to trigger trademark development as early as the end of Phase I. Others have instituted an annual budget for the creation and maintenance of a ‘name bank’ to prepare for a potential candidate shortfall or regulatory rejection. One benefit is the ability to match fast-moving licensing opportunities with a set of names that have cleared the preliminary screening process.

Although these steps can be effective techniques to manage the high degree of unpredictability associated with pharmaceutical trademark development, the increasing percentages of FDA and EMA regulatory rejection can negate the launch strategy for even the most prepared companies. According to industry experts, the FDA rate of rejection has increased to a high of 36% above the historical norm of 30%. For Europe, the EMA reported that of the 455 names reviewed in 2008, 43% were rejected.

Although a small circle of specialized companies, including Brandpersand, provide naming services and offer ‘best practices’ for successful pharmaceutical trademarking and related engagements, there are number of key takeaways from these trends that can be applied by any company seeking to create a name for a new molecular entity: Empower a team of internal professionals to develop a formalized process, begin early and always remember that it is the ability to identify the proper balance of creativity and clearance that often determines a successful outcome.