ENANTIOMERS NOVELTY PROTECTION AND ITS INFLUENCE ON GENERIC MARKET: AN EXAMPLE WITH ESCITALOPRAM PATENT PROTECTION

The aim of this study was to analyze the patent policy for protection of escitalopram as an enantiomer of citalopram and its effect on the penetration of the generic molecules on the market. The analysis was done by exploring the pharmaceutical manufacturers' protection policy for enantiomers, the differences among the patent protection policy of racemic and enantiomer molecules, and their influence on the date of entrance of generics on the market. The patent protection policy for the racemic mixtures and the enantiomers did not differ significantly. We found seven juridical cases claiming against the novelty of some of the methods for purification and against the supplementary protection certificate but most of them were solved in the interest of the originator. However, this led to a delay in the entrance of the generic products on the market.