By Lucy Rana
Introduction
For a woman battling metastatic breast cancer on a retired bank employee’s pension, the cost of a single 21-day course of targeted therapy, more than Rs. 58,000, was not merely a medical burden. It raised a larger legal question: can the Government use the statutory power available to it under the Patents Act to make a patented, life-saving medicine available to patients who cannot afford its market price? The Kerala High Court addressed that question in In Re Exorbitant Pricing of Life Saving Patented Medicines, decided at Ernakulam on 28 September 2026.[1]
The Court examined the scope of Section 100 of the Patents Act, 1970, which empowers the Central Government to use patented inventions for the purposes of Government, in the context of Ribociclib, a CDK4/6 inhibitor used to treat HR positive, HER2 negative breast cancer. The judgment is significant for two related reasons. First, the Court read the phrase “purposes of Government” broadly, holding that Section 100 can extend to the Government manufacturing a patented medicine and selling it, on a non-commercial basis, to needy patients. Second, it declined to direct the Central Government to exercise that power here, treating that as a matter of executive policy, to be considered only after the Government gathers data on affordability and access. The judgment therefore separates the legal availability of the government-use power from the executive decision to exercise it.
Background
The writ petition was filed in June 2022 by a retired bank employee receiving a modest monthly pension. She had been diagnosed with HR positive, HER2 negative metastatic breast cancer and was undergoing targeted therapy with CDK4/6 inhibitors, including Ribociclib, at a cost of approximately Rs. 58,140 for a 21-day course. She contended that government assistance for breast cancer treatment was inadequate, and sought directions to invoke Sections 92 and 100 of the Patents Act to make Ribociclib affordable, including a scheme to supply it free of cost under the National Cancer Control Programme.
The petitioner passed away while the petition was pending. Rather than let her death render the proceedings infructuous, the Court continued the matter suo motu as In Re Exorbitant Pricing of Life Saving Patented Medicines and appointed an Amicus Curiae. The array of parties then grew: the manufacturers of Ribociclib and of a related CDK4/6 inhibitor, Abemaciclib, were impleaded, as were the principal national cancer institutes and the Drug Controller General of India. The Government relied on Palbociclib, a lower-priced alternative, as an interchangeable substitute, and argued that intervention on Ribociclib was unnecessary. That contention became the first issue the Court had to resolve.
The legal questions
The proceedings raised three interconnected questions. Whether Palbociclib could be treated as a substitute for Ribociclib, rendering the grievance academic. Whether Section 100 permits the Government to manufacture a patented medicine and supply it to patients non-commercially, or is confined to strictly departmental use. And whether the Court could direct the Government to invoke Section 100 where a patented life-saving medicine is priced exorbitantly. The Court’s answers were nuanced: the two drugs were not interchangeable; Section 100 was read broadly enough to cover non-commercial supply to needy patients; but the actual exercise of that power was left to the Central Government as a matter of policy.
The statutory and constitutional framework
Section 100 empowers the Central Government, or a person it authorises, to use a patented invention for the purposes of Government. Section 100(4) permits the Government to authorise a person to make, use, exercise or vend the invention, or import the medicine or drug it covers, and Section 100(6) permits goods so made to be sold on a non-commercial basis. Section 99 defines use for the purposes of Government, which the respondents read as confining Section 100 to departmental use. Section 83 requires that patents not impede the protection of public health, that they not prohibit Government measures to protect it, and that they be worked so that their benefits reach the public at reasonably affordable prices. Section 156 provides that a patent has effect against the Government as it does against any person. Section 92, the compulsory-licensing route, was also pleaded, although the Amicus relied chiefly on Section 100. This scheme was read against Article 21, the right to life, understood to include access to medical treatment, and Article 47, the State’s directive obligation to improve public health.
The parties’ submissions
The Amicus Curiae placed before the Court data on the burden of breast cancer in India and the cost of treatment, relying on the 139th Parliamentary Standing Committee Report on Cancer Care Plan and Management, argued that Ribociclib and Palbociclib are not interchangeable, and submitted that the word “may” in Section 100 should, on the facts, be read as “shall”. An intervenor relied on authority holding that access to life-saving medicines implicates Article 21. The deceased petitioner’s husband and another patient submitted that Ribociclib was unaffordable, a similarly placed patient facing an annual cost far above the per capita income, and that the manufacturers had not substantiated their research costs.
The Union Government and the regulatory respondents maintained that the Central Government had already considered and rejected the request to invoke Sections 92 and 100, by a reasoned order that stood unchallenged, that Section 100 applies only to use for the purposes of Government, and that Ribociclib, although non-scheduled, was already price-monitored and margin-capped under the Drugs (Price Control) Order, 2013, with customs duty reduced from early 2026. Novartis, the manufacturer of Ribociclib, argued for a narrow reading of “purposes of Government”, pointed to its already lowest global price and the trade-margin cap, contended that Section 100 could not be invoked without first adverting to compulsory licensing under Sections 84 and 92, and argued that a patent is the quid pro quo for costly research and disclosure. Eli Lilly, the manufacturer of Abemaciclib, similarly stressed patent protection and pointed to its patient-assistance schemes.
What the Court held
Palbociclib is not a substitute for Ribociclib
The Court first asked whether the availability of Palbociclib made the Ribociclib dispute academic. Examining the regulator’s affidavit and the cancer centre’s report, it found Palbociclib used for advanced or metastatic disease, while Ribociclib was also used for early-stage disease, and the two drugs carried differing toxicity profiles. On that material they could not be treated as interchangeable, and the Court proceeded to Section 100 on its merits.
Section 100 extends beyond departmental use
The core of the judgment concerns the phrase “purposes of Government”. Read with Section 99 alone, it might seem confined to use by Government departments or undertakings. But the Court held that Section 100(4) and (6) change the picture: they allow the Government to authorise the manufacture of a medicine or drug and its sale, on a non-commercial basis, without restricting who may buy it. These provisions, the Court reasoned, would have little meaning for medicines if the buyer could only be another Government department. It accordingly held that Section 100 includes the Government’s entitlement to manufacture a patented medicine and sell it non-commercially to a needy patient, and that the section imposes no restriction on who the purchaser may be.
The public-health reading, and the limits of Article 21
The Court’s reading was reinforced by Article 47 and by Section 83’s requirement that patents be worked at reasonably affordable prices and not impede public-health measures, and it noted Parliamentary material indicating that Section 100 could be used in the interest of the public health system. It drew on established authority that the preservation of life is paramount and that the State’s obligation under Article 21 to provide medical services cannot be avoided on purely financial grounds. Those authorities informed the interpretation of the statute, but they did not convert every healthcare-pricing grievance into a judicially enforceable command.
The power exists; its exercise is executive policy
Having found the power available, the Court declined to direct its use. Patents protect an incentive structure for disclosure and innovation, even the Government is bound by a granted patent under Section 156, and indiscriminate interference could deter future filings. Relying on the Supreme Court’s ruling on the distribution of essential supplies during the pandemic, which held that the extent to which such statutory mechanisms are used is a policy decision for the Central Government, the Court held that whether Section 100 is actually invoked for Ribociclib is for the Executive to decide, and that courts do not ordinarily weigh government policy save where it is arbitrary or unconstitutional.
Evidence, not assumption, must ground intervention
The Court found that neither side had placed on record the data needed to determine whether Ribociclib is genuinely unaffordable, such as the number of patients with the relevant cancer, how many use the drug, how many are priced out of it, and how effective existing subsidy schemes are. It directed the Government to collect this data from hospitals nationwide before deciding whether to invoke Section 100, and noted that its interpretation would apply equally to other patented life-saving drugs, even though only two manufacturers were before it.
What this means for business and policy
The decision reshapes the access-and-pricing conversation without dismantling the patent bargain. The practical implications differ by audience.
- For patentees and pharmaceutical companies: the government-use lever is now clearly available for public-health supply, not only departmental consumption. Robust affordability, pricing justification and patient-assistance evidence, and engagement on the regulatory record, will matter if a specific drug becomes the focus of intervention.
- For generic and domestic manufacturers: Section 100(4) and (6) contemplate an authorised person manufacturing and supplying a patented medicine on a non-commercial basis, which is a mechanism worth understanding for any manufacturer that might be authorised.
- For government and policymakers: the judgment supplies a broad legal foundation, but couples it with a duty to gather data and a discretion to act. The direction to collect nationwide data is the immediate operative step.
- For patient groups and access advocates: the ruling clarifies that the law reaches beyond the Government’s own consumption to public-health supply, while leaving the timing and choice of intervention with the Executive. It is a foundation, not an automatic trigger.
Conclusion
The Kerala High Court’s decision is significant chiefly for the distinction it draws between what Section 100 permits and when the Government should exercise it. On the first question, it read Sections 99 and 100 broadly: the phrase “purposes of Government” extends to the Government manufacturing a patented medicine and selling it non-commercially to needy patients, a reading anchored in the statutory references to medicines and non-commercial sale and reinforced by Section 83 and Articles 21 and 47. On the second, it stopped short of a mandatory direction, leaving the decision to invoke the power with the Central Government, to be taken only after it gathers reliable data on affordability, patient access and the effectiveness of existing schemes. The judgment does not create an automatic trigger for government use whenever a patented medicine is expensive. It supplies a broader legal foundation for intervention in appropriate cases, while leaving the decision to invoke it with the Executive. In an epilogue that lends the judgment its human register, the Court reflected on the cost of illness borne by ordinary families, a reminder that behind the statutory language lies a question of access to life itself.
In Re Exorbitant Pricing of Life Saving Patented Medicines v. Union of India & Ors. (Neutral Citation: 2026:KER:74251)