Kerala High Court tests limits of patent protection for cancer drugs
15 October 2026
The Kerala High Court has given India’s central government a much broader reading of its power to use patented medicines. However, it stopped short of ordering the government to use that power. On 28 September 2026, Justice Harisankar V. Menon held that Section 100 of the Patents Act, 1970 allows the government to make a patented medicine and sell it to needy patients on a non-commercial basis. He also held that the provision is required to be invoked where government intervention is necessary, such as when a medicine is unaffordable because of its exorbitant price.
The case, In Re Exorbitant Pricing of Life Saving Patented Medicines (WP(C) No. 18999 of 2022; 2026:KER:74251), began in June 2022. The petitioner was a retired bank employee with HR+/HER2- metastatic breast cancer, and she asked the court to make the Novartis drug ribociclib affordable. Her monthly pension was Rs28,400 (US$360 at 2022 rates). A 21-day course of ribociclib cost about Rs58,140 (US$740). She died while the case was pending, but the court continued the matter on its own motion to prevent the issue from becoming “infructuous”.
The court added Novartis AG (patentee of ribociclib) and Eli Lilly (patentee of abemaciclib) as respondents, along with cancer institutes and the Drugs Controller General of India. Senior advocate Joseph Kodianthara and Hemant Singh from Inttl Advocare represented Novartis, while senior advocate G. Shrikumar and Praveen Anand from Anand & Anand represented Eli Lilly.
Novartis, through Kodianthara, argued that Section 100 applies only when the government needs a patent “for the purposes of government”, not when it is informed that a price reduction is required. He told the court that Novartis charges its lowest price in India and that a 30 percent trade-margin cap already applies. Novartis also said its Kryxana brand sells for Rs23,625 (US$250) for 21 tablets, which it claimed was 57 percent to 96 percent below prices in other key markets. It further argued that Section 100 could not be used before compulsory licensing under Sections 84 and 92 had been considered. Eli Lilly argued that there was no national emergency and that the decision rested with the government.
The court rejected the narrow reading. “The provisions of Section 100 impose no restriction on who the purchaser could be,” Justice Menon wrote. The government could therefore manufacture the medicine and “sell the same on a non-commercial basis to a person who can be none other than the needy patient”. The court tied “purposes of government” to the state’s public-health duty under Article 47 of the Constitution. Based on expert material, it also found that the cheaper off-patent drug palbociclib is not interchangeable with ribociclib.
The ruling also acknowledged the importance of patent protection. “If such sanctity is not being extended to a patentee… no one will come forward to register their patent under the statute,” the court said. “It is for the central government to consider whether Section 100 of the Act requires to be invoked since ultimately the same is a policy decision.” Before deciding, the government must first collect data on how many patients are affected, how many take the drug and how many go without it because of price.
Advocate Maitreyi Sachidananda Hegde, the amicus curiae, called it “the first judgment that actually discusses Section 100 of the Patents Act in the context of the exorbitant pricing of patented medicines.” She added: “This judgment in itself is not remedial.”
Access campaigners were critical. K.M. Gopakumar of the Working Group on Access to Medicines and Treatments said leaving the decision to government policy discretion “is a denial of justice to breast cancer patients.” He warned that because there is no deadline, “the government can simply sit on this.”
Chetali Rao of Third World Network noted that, unlike compulsory licensing – which has been granted only once in India, to Natco for Bayer’s sorafenib – Section 100 does not require a generic company to apply.
For originator pharmaceutical companies, the ruling changes the risk landscape for their Indian patents. It recognizes exorbitant pricing as a circumstance in which government use under Section 100 may be warranted, although the court did not compel the central government to invoke the provision. Patentees should expect affordability data collection and possible appeals, and should review their Indian pricing, patient-access programmes and Form 27 disclosures.
- Asia IP
