Ribociclib case: Kerala HC says Centre can use patents power to ease cancer drug prices

The Kerala High Court has held that the Union government can use its powers under the Patents Act to manufacture and supply a patented medicine to needy patients on a non-commercial basis and said that Section 100 of the law can be invoked when a patented life-saving medicine is being sold at an exorbitant price.

The court, however, stopped short of directing the Centre to immediately invoke the provision for Ribociclib, the breast cancer medicine at the centre of a four-year-old legal battle. Instead, it has put the next step with the Union government, directing it to collect data on the number of patients affected, the number using the medicine, the number unable to use it because of its price, and the effectiveness of existing government schemes before deciding whether intervention under Section 100 is necessary.

Palbociclib not a substitute for Ribociclib

The judgment by Justice Harisankar V Menon has also rejected a key argument advanced by the Union government and the pharmaceutical companies during the proceedings. The court has found, on the basis of reports from the drug regulator and cancer institutions, that Palbociclib cannot be treated as a substitute for Ribociclib.

Also read: A Keralam patient dies, another joins legal battle as breast cancer drug case drags on

This distinction is important because the availability of cheaper Palbociclib had been one of the principal reasons cited by the government against invoking the special powers under the Patents Act.

The court found that the available expert material showed that Palbociclib was being used for advanced or metastatic breast cancer, while Ribociclib was also being administered for early breast cancer. The Regional Cancer Centre, Thiruvananthapuram, had specifically reported that Palbociclib was being administered for stage IV breast cancer. The court concluded that the two medicines were not interchangeable.

Case dates back to June 2022

The case was pursued with the support of the Third World Network’s International Working Group on Access to Medicines, which has been involved in the legal and public health aspects of the litigation. The court appointed Maitreyi Sachidananda Hegde as amicus curiae to assist it on the complex questions concerning patent law, access to medicines and the government’s powers under Section 100.

The ruling is the culmination of proceedings that began in June 2022 when a woman with HR-positive, HER2-negative metastatic breast cancer approached the High Court seeking government intervention to make Ribociclib available at an affordable price.

She died while the case was pending.

Also read: Cancer deaths to rise by 75 pc in 25 years, ageing among factors: Study

The court subsequently decided that her death should not bring the issue to an end. On September 16, 2022, it continued the proceedings on its own initiative and changed the title of the case to “In Re Exorbitant Pricing of Life Saving Patented Medicines”.

Rs 80,000 a month for treatment

The litigation continued for four years, with pharmaceutical companies, government authorities, and cancer institutions becoming parties to the proceedings. It was listed repeatedly and, despite the pleadings being completed, remained pending through several hearings.

Another cancer survivor, lawyer Majida AM, 49, later joined the proceedings. Majida was diagnosed with breast cancer in August 2025 and has been undergoing treatment with Ribociclib. Her family spends around Rs 80,000 a month on her treatment, including the medicine and other treatment.

The judgment records her impleadment as an additional respondent and notes that she is herself a breast cancer patient taking Ribociclib.

Cancer survivor to continue the fight

Speaking to The Federal after the judgment, Majida said she would continue the legal battle.

“I, along with the husband of the primary complainant, will approach the appellate bench, the Division Bench, invoking the constitutional question in the case. Article 21 and the right to life should be heard in the matter,” she said.

For Majida, the court’s finding on Section 100 does not by itself resolve the problem of affordability. The judgment has left it to the Union government to gather the necessary information and take a decision on whether the provision should be used.

Government asked to collect information

The court said the data currently before it was insufficient to determine whether the medicines in question were affordable. It said the government must collect information from hospitals across the country on the number of people suffering from the particular form of cancer, the number using the medicines and cases in which patients were unable to take them because of their price.

The government must also assess the number of patients benefiting from existing schemes that provide medicines at subsidised prices and examine whether those schemes are effective and need to be expanded.

Also read: 'India ranks 3rd in cancer cases, may see 2 million patients by 2040': Union minister

The court has also clarified the scope of the provision in a manner that could have implications beyond Ribociclib. It held that Section 100 includes the government’s power to use a patent for manufacturing the medicine covered by it and to sell the medicine to a person, including a needy patient, on a non-commercial basis. It further held that the provision is to be invoked in circumstances requiring government intervention, including when a patented medicine is being sold at an exorbitant price.

Wider affordability problem in cancer treatment

The issue assumes importance because Ribociclib remains an expensive patented medicine. When the original petition was filed in 2022, the monthly expenditure on the medicine was around Rs 58,000 or more. Figures placed before the court later put the monthly price at Rs 78,468.75. The case also involved Abemaciclib, another patented breast cancer medicine with a monthly price running into tens of thousands of rupees.

The court took note of the wider affordability problem in cancer treatment. It referred to the Parliamentary Standing Committee on Health and Family Welfare, which had recorded high out-of-pocket expenditure on cancer care and noted that a significant proportion of cancer hospitalisation cases were financed through borrowings, sale of assets, and contributions from friends and relatives.

The court also referred to the need to maintain a balance between access to affordable treatment and incentives for pharmaceutical innovation.

Court cites three-decade-old film

In an unusual epilogue to a judgment on patent law and cancer treatment, the court referred to the late MT Vasudevan Nair’s acclaimed Malayalam film Sukrutham, which dealt with the experience of a cancer patient and his family.

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Justice Menon referred to the film’s portrayal of patients and bystanders struggling to meet the cost of treatment and the protagonist’s account of families being driven into debt while trying to afford medical care. The judgment noted that more than three decades after the story was adapted into a film, and despite advances in technology, the plight of patients and their families in such cases remain largely unchanged.

The court has not ordered compulsory licensing or directly instructed the Centre to manufacture Ribociclib. It has held that Section 100 permits such government use and that the provision becomes relevant where intervention is required, including when a patented medicine is sold at an exorbitant price

The question now is whether the Union government will use that power after carrying out the assessment mandated by the court.