The International Tinnitus Journal

Harmonizing Access to Medicine: Exploring India's Process Patent in Intellectual Property Rights Amid Global Pressures

This paper examines the impact of the pharmaceutical patent system, particularly under the TRIPS Agreement and the Indian Patent Act of 1970, on access to medicines. The TRIPS Agreement aims to balance private and public interests by protecting patent holders while allowing countries to safeguard public health. However, this balance has been contentious, especially in developing countries where patent protections can lead to high drug prices and restricted access to life-saving medications. India’s approach has been pivotal, initially excluding medicine patents under its 1970 Patent Act, which fostered a robust generic drug industry and kept drug prices affordable. With the TRIPS compliance amendments in 2005, India shifted to recognizing product patents, significantly impacting the generic drug market and accessibility of affordable medicines. The amendments, however, incorporated mechanisms such as compulsory licensing and safeguards against patent abuse, reflecting attempts to maintain access to essential drugs. This study highlights the tension between global intellectual property laws and national public health objectives. It discusses India’s strategic use of TRIPS flexibilities and the ongoing challenges posed by stringent global patent policies. The paper argues for the necessity of maintaining a balance that does not compromise public health for intellectual property rights, with a focus on India’s role in the global pharmaceutical landscape and its efforts to navigate these competing demands.