Vol. 3 (2007)

Data Exclusivity With Regard To Clinical Data

Animesh Sharma

Intellectual property rights have evolved over the years with the intention of protecting novelty and innovation of ideas while creating a competitive market, at both a local and global level. The strongest tools to achieve this end have arguably been patents – protecting inventions that are novel, non-obvious and demonstrate utility. Most countries give a protection term of twenty years from the date of filing a valid submission. In the field of pharmaceuticals, foods and agrochemicals, marketing of products requires statutory clearances from the appropriate national regulatory bodies, in order to ensure that the products satisfy certain minimum criteria of quality and safety. Generating such data generally involves elaborate experimentation, trials in various phases, chemical analysis, and an estimation of the impact on the environment, all of which are time-consuming and expensive processes. Thus the intellectual property right of data exclusivity becomes important, as it involves the question of whether these processes, once completed, can be taken advantage of by other applicants. This paper analyses the concept of data exclusivity, studying article 39 of TRIPS, and addresses the question of whether data exclusivity laws should be introduced in India.


5 th Year Student, National Law School of India University.