It is two decades since India introduced product patent protection for pharmaceutical inventions, a move compelled by its obligations under the TRIPS Agreement as a World Trade Organization (WTO) member. This change aligned India with global patent norms, but also ignited concerns about its adverse effects on access to essential medicines and the broader pharmaceutical industry.

Product patents create monopolies on new medicines, often pricing them beyond the reach of ordinary patients. They also enable practices like ‘evergreening’, where companies secure multiple patents on the same molecule to delay affordable generics. Recognising these challenges, India amended its Patents Act in 1970 to incorporate public interest safeguards.

Key provisions include Section 3(d), which limits 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 licences, enabling the production of patented medicines at reasonable prices to address public health needs.

Inconsistent enforcement

Section 3(d) has been inconsistently applied, with patents granted on known molecules. In 20 years, India has issued only one compulsory licence — for the kidney cancer drug Nexavar. Even during the Covid-19 pandemic, when urgent access to critical drugs was paramount, the government refrained from invoking government-use licences.

Political considerations appear to have influenced this reluctance. Reports suggest India’s commitment to international stakeholders had deterred action on CLs. Patients, meanwhile, remain unable to invoke these safeguards directly, leaving a critical gap in access to life-saving medicines.

The barriers created by patent monopolies call for an immediate and multi-faceted approach to ensure affordable healthcare for all.

The first step involves compiling comprehensive data on patented medicines in India, including their prices and market accessibility. This would act as a foundational tool for policymakers, highlighting critical gaps in access and guiding targeted interventions.

Parallelly, an inter-ministerial mechanism should address the public health challenges posed by product patents, assessing the need for invoking safeguards, and making informed recommendations to balance innovation with public health priorities.

Affordable generics

Section 3(d) must be rigorously applied to ensure that patents are granted only for genuine innovations. Similarly, the active use of Section 100 — authorising local manufacturing of patented drugs — can be a game-changer in ensuring availability of low-cost alternatives, especially for economically vulnerable populations.

Access to healthcare is a constitutional right, and the government is responsible for upholding it.

As India marks 20 years of product patent protection, the milestone offers an opportunity to realign its policies. By prioritising public health over patent monopolies, the government can ensure that pharmaceutical innovation serves the broader goal of accessible healthcare. The time for action is now.

(The writer is a Member of Parliament from Patiala Lok Sabha constituency, Punjab. Views are personal)