In the United States like in Europe, the approval of a drug brand name faces many obstacles. Beyond the classical requirements for any trademark filing, the registration of a trademark for a drug largely depends on the approval of the Food and Drug Administration (FDA).
The FDA examines several criteria. First and foremost, the deceptiveness of the sign and the likelihood of confusion (mainly with another drug on the market), are analyzed to ensure safety and to prevent medication errors. Other tests are conducted on packaging, patient populations, generic names, dosage strength or even handwriting. It is indeed essential that the prescription be fully understood by doctors and by the chemist delivering the drug to the patient.
This procedure is fully funded by the PDUFA (Prescription Drug User Free Act), which also obligates the FDA to reach performance goals. Since 1992, this process halved the time it takes for a drug to be approved in the United States. However, a drug trademark will be registered only when the component will be authorized by its agent.
An emergency procedure also exists as regard to treatment of life-threatening diseases which shows a unique potential clinical success. The outcome of this procedure might be disadvantageous for candidates following the ordinary process. A trademark filed with the emergency procedure has priority, even if the application is subsequent.
Due to these monitoring, only 40% of applied drugs names are registered as trademarks – safety of patients being a priority.