Centre can invoke Patents Act to make costly patented cancer drugs affordable: Kerala High Court

The court stopped short of ordering the government to act, treating the matter as a policy call and asking the Centre to first gather nationwide data on how affordable such medicines are.

Kochi: The Kerala High Court has held that the Centre can use its powers under Section 100 of the Patents Act, 1970, to make patented life-saving medicines affordable when they are priced beyond the reach of patients, according to a report on the judgment delivered by Justice Harisankar V. Menon on 28 September.

The case began with a petition from a retired bank employee with HR-positive, HER2-negative metastatic breast cancer who could not pay for ribociclib, which cost about Rs 58,140 for each 21-day course. She died while the matter was still being heard. The court then turned the petition into a public-interest proceeding and named advocate Maitreyi Sachidananda Hegde as amicus curiae, The Week reported.

The proceedings examined ribociclib, marketed by Novartis AG, and abemaciclib from Eli Lilly, while palbociclib, also discussed, is already off patent. Drawing on Sections 99 and 100 and Section 83 of the Patents Act, along with Articles 21 and 47 of the Constitution, the court read government use as reaching beyond departmental needs to cover public health. On that reading, the Centre could authorise manufacture of a patented medicine and its non-commercial sale to patients.

The judgment also treated patent rights as conditional, holding that they cannot stand in the way of public health and that medicines have to stay reasonably affordable. Where prices of patented drugs are exorbitant, the government is required to use Section 100, the court said, according to the report.

Even so, the bench declined to issue a mandamus directing the Centre to invoke the provision, describing the choice as an executive policy decision. Noting that the record lacked sufficient affordability data, it asked the government to collect such information across the country but did not fix a deadline.

The open-ended nature of the direction drew criticism. K.M. Gopakumar, co-convenor of the Working Group on Access to Medicines and Treatments, warned: “The government can simply sit on this and keep saying, ‘We are assessing it.'” He also pointed to a tension in a ruling that links high drug prices to the right to health yet leaves enforcement to the government’s discretion.

Source: The Week, 29 September 2026

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