Cheaper cancer medication: Kerala HC ruling is an opportunity for Centre to take the lead

The Kerala High Court clarified that Section 100 of the Patents Act reaches beyond government use inside its own institutions. It can support manufacturing and supplying a patented medicine for a public purpose, including providing it to a needy patient on a non-commercial basis. The ruling matters because price itself may become a reason for intervention when a life-saving medicine is unaffordable.

The case involved ribociclib and abemaciclib, patented breast cancer medicines. A retired bank employee with metastatic breast cancer sought affordable ribociclib in 2022. She died while the case continued, but the court kept examining the issue on its own motion. It held that Section 100 could potentially provide a legal route to wider access.

The court did not order the Centre to use that power. Instead, it asked the government to assess affordability and access before deciding. The power therefore exists, but the ruling does not automatically reduce prices or guarantee medicines to patients.

Section 100 of India’s Patents Act gives the government a route to use a patented invention for public purposes. The Kerala High Court said this power is not limited to using the invention within government departments or institutions. It may also cover manufacturing and supplying the patented medicine, including to a patient, on a non-commercial basis.

This differs from compulsory licensing under Sections 84 and 92. In the breast cancer case, the provision was considered for ribociclib and abemaciclib. The court also held that an exorbitant price could be a circumstance supporting government intervention. That makes affordability part of the public-purpose discussion, rather than treating patent ownership as the only concern.

Section 100 creates a possible legal avenue, not an automatic price cut. The Centre must decide whether to use it after examining affordability and access. The court left that decision with the government and set no deadline for completing the assessment.

If the Centre uses Section 100, it could potentially arrange manufacture or supply of ribociclib and abemaciclib on a non-commercial basis. That could reduce the financial barrier for patients who currently cannot afford these medicines. It could also offer a public-health response when a patented treatment’s price prevents access.

The case shows why this possibility matters. Ribociclib was reported to cost Rs 78,400 per month, before other treatment expenses. A retired bank employee with metastatic breast cancer had sought affordable ribociclib. Although she died during the proceedings, the court continued the case and clarified that government-use powers could reach patient supply.

The court did not itself make either medicine cheaper. It left the Centre to collect information and decide whether intervention is appropriate. No timeline was set. The ruling therefore opens a route to affordability, but patients must still await a policy decision and its implementation.

Ribociclib’s reported price was Rs 78,400 per month. That amount excludes other treatment costs, so the medicine is only one part of the financial pressure facing patients and families. The figure helps explain why the Kerala High Court considered whether an exorbitant price could justify government action under Section 100.

The article also refers to a study of 12,148 cancer patients estimating mean annual direct out-of-pocket expenditure. However, the supplied text ends midway through that sentence, at “expendi,” and does not provide the study’s actual rupee figure. The number of patients studied is therefore clear, but the wider average financial burden cannot be quantified from the provided text.

The broader point remains that affordability cannot be judged by medicine price alone. Cancer care can continue for months and includes other expenses. The Centre’s requested assessment should examine affordability and access, including research-cost claims and the wider cost of treatment.

A lower-priced or off-patent medicine is not automatically a suitable replacement for every patient. Treatment decisions depend on clinical evidence, disease stage, treatment goals, and individual needs. The Kerala High Court relied on expert evidence and declined to treat palbociclib as interchangeable with ribociclib or abemaciclib.

The article gives a clear example from early-stage, high-risk breast cancer. Ribociclib and abemaciclib showed benefit after surgery, but palbociclib did not show benefit in a major trial of adjuvant treatment. That difference means their broad therapeutic category does not make them equivalent options in every situation.

Evidence is also mixed in advanced disease. A German real-world study found comparable survival outcomes for patients treated with palbociclib and ribociclib. Even so, affordability cannot be reduced to choosing the cheapest medicine. Clinicians must weigh the available evidence and the patient’s specific circumstances before changing treatment.

India’s 2012 compulsory licence for Nexavar showed how patent law can address unaffordable cancer medicines. The Indian Patent Office allowed Natco Pharma, an Indian manufacturer, to produce and sell sorafenib tosylate. The medicine was patented by Bayer Corporation and marketed under the name Nexavar.

The licence changed who could make and sell the patented drug. Natco was authorised to enter the market and offer the medicine at a substantially lower price than Bayer’s. This mechanism uses compulsory licensing to respond to concerns about a patented medicine’s availability and affordability, rather than leaving supply entirely with the patent holder.

The example is separate from Section 100. Compulsory licensing operates under Sections 84 and 92, while Section 100 provides another government-use route. Together, these provisions show that India’s patent framework includes public-health safeguards alongside patent protection. The Kerala case considered whether that balance could help patients facing high prices for newer medicines.

Patent systems grant exclusive rights so companies can develop and market inventions while seeking to recover the costs of research and development. In this case, Novartis and Eli Lilly said their breast cancer medicines were costly to develop, although they reportedly gave the court no figures. Exclusivity is therefore linked to encouraging and financing new medicines.

Those rights are not absolute under India’s framework. Section 83 says patents should not impede public-health protection and should make patented inventions available at reasonably affordable prices. The 2012 compulsory licence for Bayer’s Nexavar illustrates this balance: Natco Pharma was allowed to produce and sell the cancer medicine at a substantially lower price.

Section 100 provides another possible safeguard. The Kerala High Court said it can cover non-commercial manufacture and supply, including to a needy patient, when prices are exorbitant. Yet the Centre must still assess affordability and access. The ruling protects room for public action without automatically removing patent rights.