Patentability of Pharmaceutical Dosage Regimens in Europe

Akin to other inventions, new methods need to be devised allowing for registration of pharmaceutical dosage regimens in much the same way as other patents. In doing so, there are two main challenges ahead. First, whether these dosage regimens, excluded expressly from the list of patentable products in Europe, may in fact be considered as a novel therapy method? And second, given that ingredients and composition of such patents are no longer an innovative secret, whether sole variation in their usage dosage may possibly fall within the scope of novel inventions? The answer to the above controversial questions have been the notion of challenge addressed by several European patent forums. This article will review the approaches adopted by European Patent Administration in dealing with recent trends introduced on the topic of new customized dosage regimens.