The Kerala High Court on Monday, 28 September 2026, asked the Centre to examine whether its powers under Section 100 of the Patents Act could be invoked to improve patient access to costly patented life-saving medicines, particularly those priced beyond the reach of ordinary patients. The directive came from Justice Harisankar V. Menon, who observed that government intervention could be considered where medicines were being sold at exorbitant prices.

What Section 100 of the Patents Act Allows

Section 100 of the Patents Act empowers the Central government to authorise the use of a patented invention for government purposes without requiring the consent of the patent holder. Justice Menon acknowledged that invoking this provision is ultimately a policy matter, but noted it remains a legitimate tool where affordability is demonstrably absent.

The court stopped short of directing the Centre to invoke the provision in the immediate case. Instead, it asked the government to collect relevant data on drug affordability and consider intervention wherever necessary — both in the present matter and in future cases involving life-saving medicines.

The Drugs at the Centre of the Case

The proceedings centred on two breast cancer treatments: Ribociclib, a patented drug manufactured by Novartis, and Palbociclib, another breast cancer drug whose patent has expired and is available at a significantly lower price. Expert opinions from cancer treatment institutions and the Drugs Controller General of India (DCGI) confirmed that the two medicines cannot be treated as interchangeable, limiting patients' ability to simply switch to the cheaper option.

Origins of the Case and the Petitioner's Death

The case originated from a petition filed in 2022 by a cancer patient seeking affordable access to Ribociclib, which was then priced at approximately ₹78,468.75 per month. The petitioner passed away in September 2022, but the High Court chose to continue examining the broader legal and policy questions raised, recognising their significance for cancer patients across the country.

Broader Implications for Drug Access in India

The court's observations carry significant weight beyond this single case. India has a long-standing legal framework — including Section 3(d) of the Patents Act and compulsory licensing provisions — aimed at balancing intellectual property rights with public health imperatives. This comes amid ongoing debates about the affordability of patented oncology drugs, where monthly treatment costs frequently run into tens of thousands of rupees, placing them out of reach for most patients. Notably, Section 100, a government-use provision, has rarely been invoked in India, making the court's suggestion particularly pointed. The Centre's response to the court's direction is now awaited.