Critical Appraisal of Bolar Exemption with Respect to Indian Patent Act 1970

Abstract

With the reform of intellectual property provisions including the Patent Act, 1970, it reveals the dynamic behavior of India's policy to make it at par with the TRIPS provisions. Patents protect industrial innovations and grant the inventor a limited monopoly over his invention. India established a patent system that sought to balance the need for public interest along with encouraging innovation. This was in tune with the mission for development of indigenous science and technology. India's patent policy was largely supported by domestic industry and pharmaceutical development on account of its support of only process patents instead of product patents. But, for falling in line of TRIPS compliance, product patent was also recognized in India following an amendment. Thus, with the introduction of product patent regime in India, it created a wide avenue of reformations and its scope. Its importance can be judged upon the fact that the rapid progress of Indian generic pharmaceutical companies have made in the last decade. However, with the present Act, it involves a clause that the use of a patent related to the development and submission of information for the purpose of getting regulatory approval before the expiry of the patent is not an act of infringement. This provision is also termed as Provision. However, there is another side of the Bolar provision which was left out in the Act with respect to data exclusivity.