Published Sep 28, 2026 | 11:58 AM ⚊ Updated Sep 28, 2026 | 12:03 PM
Kerala High Court. (iStock)
In a ruling that could make prohibitively expensive life-saving medicines more accessible, the Kerala High Court held that the government can invoke Section 100 of the Patents Act to manufacture and supply a patented invention as a medicine, including directly to a needy patient, on a non-commercial basis.
Justice Harisankar V Menon made the observation while disposing of a suo motu petition initiated over the steep prices of patented life-saving drugs, bringing to a close a legal battle that began more than four years ago.
The case, as South First earlier reported, had its roots in the plight of an Ernakulam woman, a retired bank employee diagnosed with HER2-negative metastatic breast cancer. She approached the High Court in June 2022 seeking access to Ribociclib, a drug prescribed by her doctors but priced beyond her financial means.
She and her husband had retired from the banking sector and were living on a combined monthly pension of ₹2.74 lakh.
Almost their entire income was being drained by the cost of cancer treatment and medicines, the petition said.
She died two months later, on September 16, 2022.
The proceedings, however, continued, with questions raised about the government’s power to intervene when patented medicines become unaffordable for patients who need them.
The court held that the scope of Section 100 is not confined merely to governmental use of a patented invention. The provision can also enable the government to manufacture a patented medicine and make it available to an individual, including a needy patient, without a commercial objective.
The government, the court said, must collect the necessary data and determine whether the price of a particular medicine is affordable. If it finds that intervention is warranted, it can proceed under Section 100. The court specifically noted that such intervention may become necessary where a patented medicine is being sold at an exorbitant price.
The proceedings had also brought scrutiny on the regulatory position surrounding Ribociclib and its cheaper alternative, Palbociclib.
An affidavit filed by the Central Drugs Standard Control Organisation (CDSCO) had claimed that both medicines were approved for the same indications.
However, records before the court indicated that Ribociclib had an additional approval for certain high-risk early-stage breast cancer patients, an indication not reflected for Palbociclib.
During the proceedings, the court-appointed amicus curiae, Maitreyi Sachidananda Hegde, had argued for government intervention to make the patented medicine more accessible. She submitted that the Centre could invoke Section 100 to use the patented invention for government purposes, or resort to Section 92 to facilitate wider availability in the public interest.
The matter had also attracted the attention of the Supreme Court, which took suo motu cognisance of the delay on July 16, 2026 and directed the High Court to conclude the proceedings expeditiously.
With the High Court’s ruling, the long-running litigation has now ended with a clear finding that the statutory powers available to the government can extend to making patented medicines available to patients on a non-commercial basis when circumstances warrant such intervention.
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₹2.5 lakh to ₹8,800: The Kurien order that made patent history
(Edited by R Rajesh Kumar.)
