Bolar Exemption Law in India: An Analysis in Light of Current Trends in Pharmaceutical Market

Abstract

This paper deals with the Bolar exemption, a significant balancing provision under the Ind Patents Act, 1970, that protects public interest without unfairly encroaching upon patenti rights. The Bolar exemption allows the use of patented invention for carrying out research c taking regulatory approval without a license from the patentee, thereby contributing to public interest by early introduction of generics. The article aims to understand and anal the Indian law providing for Bolar exemption and its implication on the pharmaceutical mar while also covering origin of Bolar Exemption in international patent regime. The paper touches upon highly volatile questions like extent of commercial use and data exclusivity pei In light of the current state of affairs the paper strongly recommends an amendment in patent law allowing for the Bolar exception.