Clinical trials in the pharmaceutical industry: The scope of the research exemption under French patent law – clarification is still awaited

Marina Cousté
François Jonquères

DOI:https://doi.org/10.5912/jcb9

Abstract:

This paper discusses a recent French Court decision and its impact on the judicial interpretation of the extent to which pharmaceutical clinical trials may or may not fall within the scope of the exemption provided under French law for infringement of patent rights when conducting unauthorised clinical trials aimed at securing marketing authorisation of a patented drug substance.

Keywords:plea of research ,marketing authorisation ,clinical trials ,generic ,infringement ,experimental acts ,en ,