Kerala HC Asks Centre to Assess Cancer Drug Ribociclib's Affordability Before Patent Use Decision

New Delhi: In a case arising from the cost of the breast cancer drug ribociclib, the court clarified that the provision permits the government to use a patented invention to manufacture medicine and sell it to needy patients on a non-commercial basis.

The Kerala High Court has asked the Centre to gather data and assess whether patented cancer medicines are affordable before deciding if it should use its powers under Section 100 of the Patents Act, 1970.

Justice Harisankar V. Menon delivered the final judgment on September 28, 2026, in In Re Exorbitant Pricing of Life Saving Patented Medicines, W.P.(C) No. 18999 of 2022.

The petition had originally been filed by a retired bank employee receiving a monthly pension of ₹28,400. She said she had been diagnosed with HR-positive, HER2-negative metastatic breast cancer and required treatment that included ribociclib, a CDK 4/6 inhibitor. According to her petition, the medicine cost about ₹58,140 for a 21-day course of three tablets a day. She argued that government assistance was inadequate and that the price put the treatment beyond patients’ reach.

Filed on June 2, 2022, the petition sought directions to the Centre to act under Section 92 or Section 100 of the Patents Act to make ribociclib available at a reasonably affordable price. It also sought a scheme to provide the drug free of cost to patients with HER2-negative metastatic breast cancer and the publication of data on categories of breast cancer cases. The petitioner died while the case was pending. By an order dated September 16, 2022, the High Court decided that the issue should remain before it, continued the proceedings as a matter taken up on its own motion, and appointed advocate Maitreyi Sachidananda Hegde as amicus curiae to assist the court.

As the case progressed, the court brought the manufacturers of relevant medicines and additional public bodies into the proceedings. Eli Lilly Company (India) Pvt. Ltd., which addressed the court on abemaciclib, and Novartis AG, which addressed it on ribociclib, were among the respondents. The National Cancer Institute, Chittaranjan National Cancer Institute, Regional Cancer Centre (RCC), Thiruvananthapuram, and the Drug Controller General of India were also added. The husband of the original petitioner and another breast cancer patient joined the proceedings in support of the petition’s concerns.

The amicus curiae argued that the cost of cancer treatment, particularly medicines, warranted government intervention. Referring to a parliamentary committee report on cancer care, she pointed to the financial burden on families who fund treatment through borrowing or the sale of assets. She submitted that patents are subject to the principles in Section 83 of the Patents Act, including making their benefits available to the public at reasonably affordable prices. In her view, the government should use its power under Section 100 when a patented medicine is inaccessible because of its price. Although the original petition invoked both Sections 92 and 100, she ultimately pressed the case under Section 100, explaining that the procedure under Section 92 made it a less viable route for the relief sought.

The amicus curiae also disputed the suggestion that lower-priced palbociclib could simply replace ribociclib for every patient. She relied on the material placed before the court concerning their use at different stages of breast cancer. Counsel for the deceased petitioner’s husband said she had been unable to afford ribociclib. Counsel for another patient submitted that she spent approximately ₹7.90 lakh a year on the medicine. They argued that the State’s public-health duties and the conditions attached to patent rights required a meaningful examination of affordability.

The Union government argued that it had already considered whether to invoke Sections 92 and 100 in an order dated October 7, 2022, and that the evidence necessary to establish unaffordability had not been provided. Its counsel submitted that Section 92 applies only in the circumstances specified in that provision, while Section 100 concerns the use of an invention “for the purposes of Government.” Counsel appearing for the government also contended that ribociclib was a non-scheduled drug whose price was being monitored under the Drugs (Prices Control) Order, 2013. The court was told that a reduction in basic customs duty had affected the price and that existing price-control measures had already been taken.

Novartis argued that Section 100 could not be used merely because a reduction in a medicine’s price was sought. It submitted that government use must be understood in light of Section 99 of the Act and pointed to a 30% cap on ribociclib’s trade margin as evidence of regulatory intervention. Its counsel also stressed the investment and research involved in developing the medicine and the protection afforded by a patent. Eli Lilly, whose medicine abemaciclib was discussed in material before the court, submitted that its patent should not be disturbed when the original petition had not sought relief concerning that medicine. It also referred to patient-access arrangements described in its affidavit.

The High Court first addressed the claim that palbociclib and ribociclib were interchangeable. Referring to the Drug Controller General of India’s affidavit and the RCC’s report, it noted the material distinguishing the medicines’ reported uses at different stages of breast cancer. On that record, the court did not accept interchangeability as an answer to the concerns raised in the case.

Turning to the Patents Act, the court read Sections 99 and 100 together. It noted that Section 100(4) permits government authorisation relating to a patented medicine or drug, while Section 100(6) includes a right to sell goods made under that authority on a non-commercial basis. In the court’s view, the phrase “for the purposes of Government” does not exclude supply to a needy patient. The judgment linked that interpretation to the State’s public-health duty under Article 47 of the Constitution and its obligation to protect life under Article 21.

The court nevertheless drew a distinction between the government’s legal power and an order requiring its use for these medicines now. It recognised the protection owed to patent holders and said the decision to invoke Section 100 ultimately involves government policy. It found that the record lacked the data needed to determine whether the medicines in question were affordable: how many patients had the relevant cancer, how many used the medicines, how many could not obtain them because of price, and how effective existing assistance and price-control measures had been. The government would need to collect and assess that information before deciding what action was warranted.

The court disposed of the writ petition with three findings:

“i. Provisions under Section 100 of the Act would also include the entitlement of the Government to use the patent or invention for manufacturing the medicine covered by the patent and sell the same to a person, including a needy patient, on a non-commercial basis.
ii. Section 100 of the Act is required to be invoked in circumstances where the Government is required to intervene, such as an instance where a medicine manufactured on the basis of a patent is being sold at an exorbitant price.
iii. The Government requires to collate the required data and arrive at a decision as to whether a particular medicine is affordable or not and, on that basis, proceed in accordance with Section 100 of the Act, if found necessary.”

To view the official order, click the link below: