Patentability of Pharmaceutical Dosage Regimens in Europe

Abstract

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

Keywords

• european patent convention
• dosage regimens
• methods for treatment by therapy
• novelty
• patentability
• pharmaceutical products