KERALA HIGH COURT SAYS CENTRE CAN USE PATENT LAW TO ADDRESS EXORBITANT MEDICINE PRICES

September 29, 2026

The Kerala High Court has held that the Central Government can invoke Section 100 of the Patents Act, 1970, to use a patented invention for manufacturing medicines and make them available to needy patients on a non-commercial basis when government intervention is warranted.

The ruling came in proceedings concerning the high cost of the patented breast-cancer drug Ribociclib. The case originated with a patient who had sought government intervention over the medicine’s price and was subsequently continued by the Court as a suo motu matter after her death.

Justice Harisankar V. Menon held that the expression “purposes of Government” under Section 100 can encompass the State’s public-health responsibilities. The Court said the provision could be considered where a patented medicine is being sold at an exorbitant price, including circumstances in which the government may manufacture or authorise the manufacture of the medicine and supply it to patients on a non-commercial basis.

The Court, however, did not order the Centre to immediately invoke the provision for Ribociclib. Instead, it directed the government to collect relevant nationwide data to determine whether particular life-saving medicines are affordable and whether existing measures provide adequate access before deciding on intervention.

The proceedings also examined Ribociclib and Palbociclib, another breast-cancer medicine whose patent protection has expired. Based on expert material before it, the Court found that the two medicines could not simply be treated as interchangeable for all indications.

The judgment therefore clarifies the potential scope of Section 100 while leaving the ultimate decision on whether and when to exercise that power with the Central Government. The case also highlights the continuing policy challenge of balancing patent protection and pharmaceutical innovation with access to costly life-saving treatment.