The Kerala High Court’s decision in In Re: Exorbitant Pricing of Lifesaving Patented Medicines sympathises with the plight of cancer patients and their families who cannot afford lifesaving care but fails to take meaningful action to deliver justice.
A retired bank employee with invasive breast cancer filed a petition in 2022 to ask the government to invoke its powers under Section 100 of the Patents Act, and permit a local manufacturer to produce Ribociclib, a patented cancer drug costing anywhere between ₹66,000-78000/- monthly. The woman died that same year, and the court took up her case suo motu in the larger public interest. When the case was listed for its final hearing, the roster abruptly changed, and it languished for years before the Supreme Court ordered the hearing be expedited.
On September 28, 2026, the High Court delivered its verdict. It upheld patients’ constitutional right to access lifesaving medicines and rightly confirmed the Government’s obligation under the Patents Act to intervene where exorbitant prices render medicines unaffordable. The judgment goes on to note that the government should collect the data required to make an assessment but fails to issue any direction to that effect, ultimately passing the buck and providing no accountability to the lakhs of women in India currently suffering from HR+HER2-negative breast cancer.
Breast cancer is ubiquitous; you would be hard-pressed to find someone who has not been touched by it, directly or as a relative or loved one. In fact, it is the most common cancer in India. In 2025, it accounted for 2.4 lakhs or 15.3 per cent of all new cancer diagnoses, according to data from the National Cancer Registry Programme. It is also one of the deadliest, with the International Agency for Research on Cancer’s GLOBOCAN attributing over one lakh women’s deaths to it in 2024 alone.
Treatment for breast cancer has transformed in the last decade with the introduction of CDK 4/6 inhibitor therapies, which target specific proteins that slow cancer growth. Ribociclib, patented by Novartis, is one such treatment that can be used to treat early-stage HR+ HER2-negative breast cancer.
Patented CDK 4/6 therapies are so unaffordable that government doctors rarely prescribe them, shutting the door on lifesaving medicines for poor patients entirely. For comparison, a generic version of another CDK 4/6 medication, Palbociclib, used for treating advanced-stage cancer, is available for ₹2,000-4,000/- per month. The difference is stark, and there is no ignoring the evidence. The introduction of generic antiretrovirals in 2001 brought down drug prices by over 99 per cent and saved millions of lives in the HIV/AIDs epidemic; it continues to do so today.
Our lawmakers foresaw the challenges brought about by patented medicines and integrated several public health safeguards in the Patents Act, 1970. One of them is Section 100, where the Central government can issue a compulsory license to an Indian manufacturer to produce and sell a patented drug for 'Government Use'. The Kerala High Court affirms that “use” includes making it available to a needy patient on a non-commercial basis, i.e., through a government scheme. The Act further recognises that granted patents should not impede the protection of public health. However, the centre has refused to issue compulsory licenses, even at the height of the covid pandemic when affordable vaccines and medical equipment were not available.
Pharmaceutical companies have strongly opposed the Section 100 license, stating that public interest will only be served by enforcing the patent to promote innovation. Both the Patent Act and the WTO Doha Declaration on TRIPS and Public Health 2001 in fact affirm the rights of the government to issue compulsory licenses to protect public health.
Pharmaceuticals also justify their pricing as fair recompense for their R&D costs. This theory has been debunked; a 2022 report in the Journal of the American Medical Association found that pharmaceuticals’ pricing strategy is not linked to R&D costs, but to what consumers are willing to pay. This strategy nets exponential or supernormal profits, which are unnecessary to sustaining business. It’s also significant to point out that companies will receive royalties for the sale of the licensed medicines, while also being allowed to sell their own stocks.
The centre dismissed the petition’s plea for a Section 100 order as “non-est”, without providing any reasons. The shallow defence illustrates how the government has ceded its responsibility to protect its citizens to the whims of predatory drug pricing.
Importantly, the High Court notes that the prohibitive cost of Ribociclib “virtually defeats” the fundamental right to health. It goes on to affirm that when medicines become unaffordable, Section 100 has to be invoked. However, it then backtracks and declares that no data on whether the medicines are affordable was brought before it.
The data exists; the National Cancer Registry Programme has been systematically collecting data on clinical management and outcomes for various cancers, including breast cancer, from hospitals around the country. The government possesses data on drug pricing and stocking at all government hospitals. All they need to do is look at it.
The High Court concludes that a Section 100 license is a policy decision only the government can take after considering the data. Policy decisions are under the remit of the government, but it is well within this court’s power to direct them to, at the very least, fix a timeline for carrying out the exercise and report to the court.
The Supreme Court in Navtej Singh Johar recognised the court’s power to direct the State to take positive steps to provide treatment to secure the right to health. Judges have routinely employed this power, whether to ensure the right to food in PUCL or access to COVID treatment in In Re: Distribution of Essential Supplies and Services during the Pandemic. The failure of this court to issue any mandatory directions to consider the plea only upholds the status quo.
Governmental inaction is inequality in practice. A 2022 study in the World Journal of Clinical Oncology reveals that India boasts a lower breast cancer survival rate as compared to the West because of glaring socio-geographical inequalities, system inefficiencies, and cost, which result in later diagnoses and delayed or incomplete treatment. Access to life-saving medicines is critical for women with breast cancer, and as long as the government ignores the issue, swathes of women will continue to be left facing either poverty or death.
The High Court’s decision needs to be appealed, and what’s needed now is for a judgment to issue specific, time-bound directions to the government to carry out a price assessment, establish clear criteria for drugs eligible for a Section 100 license and provide a reasoned justification for whether or not Ribociclib qualifies.
The woman at the centre of this case never saw justice. For the women continuing in her stead, their rights cannot be allowed to remain only on paper.
(The author is a law and policy professional)
The opinions expressed in this article are those of the author and do not purport to reflect the opinions or views of THE WEEK.
