Regulatory Exclusivity in the United States and European Union and its Impact on Generic Entry

Author : Sanjaykumar Patel

Page Nos : 03 - 10

Abstract :

Regulatory exclusivity is one of strategy apart from an intellectual property rights to get profit and return on investment done by the pharmaceutical industry on development of drugs. The reason of introducing regulatory exclusivity for drug products was that a lot of time would lost during approval of drug product and because of that at the time of approval of drug very little patent protection available to that drug. Pharmaceutical companies usually file patent application at respective countries at the time of an invention related to drug and it will take time more than 10 years to get approval from the authorities (FDA- Food and Drug Authority or EMEA-European Medicines Agency) and that leaves the patent holder with a much lesser duration, and sometimes none, to actually avail a return on the huge investment in R&D.