Compulsory Licensing – The Effect on Generics, Patents and Drug-Development in Indian Pharma

Abstract

The objective of the present study was to analyse the effect of compulsory licensing (CL) on Generics, Patents and Drug-Development in India. This analytical study was
carried out by collection of the data with respect to research questions. The data were collected from WTO, research articles, journals, ICMR and DCGI guidelines, Drugs and Cosmetics Act, WHO guidelines, TRIPS agreement, Indian Patents Act. The results revealed that expiry of three years from the date of grant of patent still remains a dilemma of whether it is best suited for pharmaceutical industry per se or not. Expiry of three years from the date of marketing approval also seems to be a good option but a bit troublesome considering the public health orientation of India. CL `s do not hamper or regress the new drug development. CL is powerful tool when utilized correctly can make sure that the innovations are utilized in a useful way and not wasted. CL is a way to protect public health. From the present study it can be concluded that the compulsory licenses are not an imminent threat to the patented drug companies. If pharmaceutical companies adopt suitable modifications to their marketing strategies, especially in developing countries keeping the economy of the state in consideration, can lead to good industrial relationships. Once the application for the grant of CL is made the outcome of the judgement need not be either granting or rejection, it can also result in ordering the patentees to cut down their prices. Price Control is also an equally powerful tool when compared with CL.

Keywords: Licence, drug and cosmetics, patents