- Kerala High Court ruled Centre can use patents to supply costly medicines to needy patients
- Section 100 of Patents Act allows government to make patented drugs available non-commercially
- Court asked Centre to assess affordability and patient need before deciding on drug manufacturing
She went to court because the cancer medicine that could help her stay alive was too costly. She died before the case ended.
More than four years later, the Kerala High Court has ruled that the central government has the legal power to manufacture patented life-saving medicines, or authorise another company to make them, and supply them to patients who cannot afford market prices.
Justice Harisankar V Menon ruling stated that Section 100 of the Patents Act, 1970, allows the government to use a patented invention for government purposes. The court said this power can include making a patented medicine available to "the needy patient" on a non-commercial basis when the medicine is sold at an exorbitant price.
But the court did not direct the Centre to immediately start manufacturing the drug. It said the final decision must be taken by the government after collecting data on affordability, the number of patients who need such medicines, and the impact of existing subsidy schemes.
Case That Continued After Death
The case began on June 2, 2022, when a retired bank employee approached the High Court. She was living on a monthly pension of Rs 28,400. Her husband, also a retired bank employee, received Rs 46,000 a month as pension.
She was suffering from breast cancer and was being treated with Ribociclib, a targeted therapy made by Swiss drug major Novartis. A 21-day course, involving three tablets a day, would cost around Rs 58,140.
She asked the court to direct the Centre to use its powers under the Patents Act so that the medicine could be made affordable for ordinary patients.
She died while the case was still pending. On September 16, 2022, the Kerala High Court converted the petition into a case titled "In Re Exorbitant Pricing of Life Saving Patented Medicines" and appointed advocate Maitreyi Sachidananda Hegde as amicus curiae.
Speaking to NDTV, Adv Maitreyi stated "This is a milestone judgment on access to life-saving medicines, though it falls short on implementation," the amicus curiae explained, " there is no timeline given to the Centre to implement it."
What The Centre And Drug Companies Said
The Centre argued that Section 100 is meant only for the government's own use and cannot be used as a price-control tool for the public. It said the price of Ribociclib was already being monitored and capped.
The government also told the court that a customs duty cut from February 1, 2026, had brought down the price of 21 tablets from Rs 24,355 to Rs 22,217.85 in April, though it rose again to Rs 22,335 in July.
Novartis said India already gets the drug at its lowest global price. It also pointed to the 30 per cent cap on trade margins imposed by the National Pharmaceutical Pricing Authority.
The companies argued that patents must be protected because research and innovation involve huge costs. They also said a cheaper, off-patent medicine, Palbociclib, was available as an alternative.
The high court rejected the argument that Palbociclib could be treated as a simple substitute for Ribociclib, saying the two medicines were not interchangeable.
It said the duty to improve public health under Article 47 of the Constitution and the right to life under Article 21 are also part of "purposes of Government."
The court also noted that the Patents Act itself says patents should not block public health and that inventions should reach people at reasonably affordable prices.
Justice Menon said patent holders are entitled to strong protection and that courts must be careful before interfering with that system. Weakening patents without enough data, the court said, could discourage inventors.
At the same time, the court said the government cannot ignore the suffering of patients who are priced out of life-saving treatment.
The Human Cost Of Cancer Treatment
During the hearing, the amicus curiae told the court that one woman is diagnosed with breast cancer in India every three minutes and one dies every six minutes. Nearly 80,000 breast cancer deaths were recorded in 2024.
The court was also told that medicines account for nearly 36 per cent of cancer treatment costs. A parliamentary committee report cited in the verdict said about 40 per cent of cancer hospitalisations are funded through loans, sale of assets or help from relatives.
A lawyer from Ponnani, who is undergoing breast cancer treatment and later joined the case, told the court that she spends around Rs 7.90 lakh a year on Ribociclib alone.
The Centre has now been asked to collect details from hospitals across the country, including how many patients need these drugs, how many are unable to buy them, and whether existing financial support schemes are enough.
