Remarkably, the European Medicines Agency (EMA) does not speak about “Trademarks” but calls it “Invented Names”. It is a requirement of EMA that there is only a single Invented Name for a drug and this name should be used in all 27 Member States of the European Community.
A different brand name in Spain, for example is not allowed. In the mutual recognition procedure more than one name is allowed. However, pharmaceutical companies often opt for the central procedure through the EMA because it is a faster procedure. It also appears that on average, EMA rejects 50% of the submitted names based on possible health risk of confusion with other approved names for medicines in the European Community.
If EMA provisionally approves three of the four submitted names, the proprietor can choose which name it shall be of the three names. It is also possible to lodge an appeal against a rejection or to offer a new name instead. After preliminary approval of the brand the process of health approval can continue to run. It happens that when the health dossier is approved there is still a rejection of the brand possible because another drug came on the market in the meantime with a name too similar to the brand name. In that case it is possible to quickly select an already provisionally approved backup name for the drug to not lose too much time. A rejection of a brand name at the last moment gives extra logistical problems and extra costs because the packages are usually already made ??and ??new custom packages should be made again.
With he Food and Drug Administration (FDA) in America is adopting brand names of drugs slightly more difficult than with EMA and the percentage of rejections of brand names is also about 50%. Usually, only one brand at a time is submitted with the FDA for approval. If the mark is rejected one may appeal, but the chances are slim that the brand is approved yet and the appeals process can be a considerable delay of the planned introduction of the drug. Usually, after rejection ??a new name is submitted for approval. In dire need, after several rejections what is no exception, a company may decide to submit two names. The advantage is that the FDA looks at two names together and there is a higher chance that one is approved. The disadvantage is that the company is unable to express a preference for one of the two names.
