Twenty years have passed since India implemented product patent protection for pharmaceutical inventions, in compliance with its obligations under the TRIPS Agreement as a member of the World Trade Organization (WTO). While this move brought India in line with global patent norms, it also raised concerns about the impact on access to essential medicines and the pharmaceutical industry as a whole.
Product patents often lead to monopolies on new medicines, making them unaffordable for many patients. They also allow for practices like ‘evergreening’, where companies obtain multiple patents on the same molecule to delay the entry of generic alternatives. In response to these challenges, India amended its Patents Act in 1970 to include public interest safeguards.
Key provisions such as Section 3(d) aim to limit evergreening by requiring evidence of enhanced therapeutic efficacy for patents on known molecules. Sections 84 and 100 allow for compulsory licensing (CL) and government-use licenses, enabling the production of patented medicines at reasonable prices to address public health needs.
However, the enforcement of these provisions has been inconsistent, with patents still being granted on known molecules. Only one compulsory license has been issued in the past 20 years, and even during the Covid-19 pandemic, the government hesitated to invoke government-use licenses, possibly due to political considerations and international commitments.
To ensure affordable healthcare for all, a multi-faceted approach is needed. Comprehensive data on patented medicines in India, including prices and market accessibility, should be compiled to guide targeted interventions. An inter-ministerial mechanism should address public health challenges posed by product patents and recommend actions to balance innovation with public health priorities.
Strict application of Section 3(d) is crucial to ensure that patents are granted only for genuine innovations. Utilizing Section 100 for local manufacturing of patented drugs can provide low-cost alternatives, especially for economically vulnerable populations. Access to healthcare is a constitutional right, and the government must uphold it.
As India commemorates 20 years of product patent protection, the government should prioritize public health over patent monopolies. By taking action to ensure that pharmaceutical innovation serves the goal of accessible healthcare, India can make significant progress in this direction. The time for action is now.
(The writer, a Member of Parliament from Patiala Lok Sabha constituency, Punjab, expressed personal views in this article)
