Cancer, Costs and Compulsion: Kerala High Court Opens the Section 100 Patents Act Door

Summary

A retired bank employee with metastatic breast cancer sought government action to make Novartis's Ribociclib affordable, and the Kerala High Court converted her petition into a suo motu proceeding after her death. Novartis, Eli Lilly and the Union of India argued that government use covers only departmental use and that price controls already apply. The court held that Section 100 of the Patents Act allows the Government to make a patented medicine and sell it on a non-commercial basis to needy patients where the price is exorbitant. It left the decision to invoke the provision to the Centre, after it collects affordability data. The ruling matters because it gives public health a clear statutory route that does not depend on a compulsory licence.

Background

A year of the breast cancer drug Ribociclib costs about Rs. 7.90 lakhs in India, against a per capita income of Rs. 2.19 lakhs. That gap put the Section 100 Patents Act government-use power before the Kerala High Court.

In 2022, a retired bank employee with HR+/HER2- metastatic breast cancer filed WP(C) No. 18999 of 2022, asking the Union of India (“Union”) to invoke Section 92 or Section 100 of the Patents Act, 1970 (“Patents Act”) for Ribociclib, covered by Patent No. 283133 held by Novartis A.G. (“Novartis”). After she died, the court converted the petition on 16.09.2022 into a suo motu proceeding titled In Re Exorbitant Pricing of Life Saving Patented Medicines and appointed an amicus curiae. The Central Government rejected her representation on 07.10.2022.

The court later impleaded Eli Lilly Company (India) Pvt. Ltd. (“Eli Lilly”), which holds the patent for Abemaciclib, along with cancer institutes and the Drug Controller General of India (“DCGI”). The Union pointed to the Drugs (Price Control) Order, 2013, a 30 percent trade margin cap, and a customs duty cut effective 01.02.2026. The court heard the matter finally on 16.09.2026 and delivered judgment on 28.09.2026.

Issues

1. 1. Whether “purposes of Government” in Section 100, read with Section 99, covers the Government manufacturing a patented medicine and selling it on a non-commercial basis to needy patients, given Garware Wall Ropes.
   2. Whether off-patent Palbociclib could substitute Ribociclib and make the petition academic.
   3. Whether the court could direct the Centre to invoke Section 100, or whether that is a policy decision needing affordability data.

Amicus Curiae and Patient Respondents’ Arguments

• • Ribociclib and Palbociclib are not interchangeable: a DCGI affidavit dated 14.08.2026 and a Regional Cancer Centre report dated 20.08.2026 place Palbociclib in advanced disease and Ribociclib in early breast cancer.
  • Section 100 should be read as mandatory, with the Government as custodian of patient interests under Article 21 and Article 47. Section 92 is unsuitable because it requires adjudication.
  • The 2002 Lok Sabha debates on the Patents (Amendment) Bill show that the Government can procure patented goods and sell them to hospitals or third parties.

Union and Controller’s Arguments

• • Section 100 applies only when an invention is used “for purposes of Government” as Section 99 defines it, which means departmental use, not a response to an affordability complaint.
  • Price controls already operate, the 07.10.2022 rejection was never challenged, and no prior request to invoke Section 100 was shown.

Novartis and Eli Lilly’s Arguments

• • Garware Wall Ropes Ltd. v. A.I. Chopra confines the phrase to departmental use, and Section 156 binds the Government to the patent like any person.
  • Research costs justify patent protection, Palbociclib is a substitute, and only 13 percent of breast cancer patients use CDK 4/6 inhibitors.
  • Eli Lilly added that its patent was applied for in 2008 and granted in 2018, which halved effective protection, and that no prayer concerns Abemaciclib.

Court’s Analysis

Government Use Is Wider Than Departmental Use

The court noted that Section 99 initially suggests a narrow reading, because an invention is used for the purposes of Government when made or vended for the Central Government, a State Government or a Government undertaking. The court reasoned, however, that sub-sections (4) and (6) of Section 100 settle the question. Sub-section (4) allows authorisation of any person to make or vend a “medicine or drug” covered by a patent, and sub-section (6) includes the right to sell the goods on a non-commercial basis without restricting the purchaser. The court held that the Section 100 Patents Act power therefore includes manufacture and non-commercial sale to a needy patient.

The court observed that Garware Wall Ropes Ltd. v. A.I. Chopra (2008 SCC OnLine Bom 1225) itself contrasted Section 47, which speaks of “merely of its own use”, with Section 100, and recognised use beyond purely departmental functions. The court found that the decision did not stand in the way.

Public Health Is a Purpose of Government

The court stated that Article 47 makes improving public health a primary duty of the State, so the purposes of Government include using a patent, manufacturing the medicine and supplying it on a non-commercial basis to needy patients. The court further observed that Article 21 gives paramount weight to preserving life. The court relied on the Supreme Court’s pandemic-era ruling in Distribution of Essential Supplies and Services During Pandemic, In Re ((2021) 18 SCC 201), which noted that Section 100 lets the Centre authorise companies to use patents.

The court noted that Section 83(d), (e) and (g) confirm that patents must not impede public health and should be available at reasonably affordable prices. The court also found support in the 2002 parliamentary debates. It concluded that Section 100 must be invoked where the Government has to intervene, such as when a medicine is unaffordable because of an exorbitant price.

Patent Sanctity and the Limits of Judicial Direction

The court opined that Section 156 binds the Government to the patent, and that denying patentees this sanctity would discourage patent filing. The court held that whether to invoke Section 100 is a policy decision for the Central Government. It found that the record lacked data on the number of affected patients, the number of patients who forgo the drug because of its price, and the reach of existing subsidy schemes. The court observed that its findings apply to other life-saving drugs too, and that the Government should decide after collecting that data.

The court accepted the expert material that Palbociclib and Ribociclib are not interchangeable, which removed the substitution defence.

Findings

In view of the observations and the arguments presented by both the parties, the Kerala High Court held that:

• • Section 100 includes the Government’s entitlement to use a patented invention to manufacture the medicine and sell it on a non-commercial basis to a person, including a needy patient.
  • “Purposes of Government” includes the State’s duty to improve public health under Article 47.
  • Section 100 is to be invoked where intervention is needed, such as when a patented medicine is sold at an exorbitant price.
  • Ribociclib and Palbociclib are not interchangeable.
  • The Government must collate the required data, decide whether a medicine is affordable, and proceed under Section 100 if found necessary. The court issued no direction to invoke the provision for Ribociclib, and disposed of the writ petition.

Case Citation: In Re Exorbitant Pricing of Life Saving Patented Medicines, WP(C) No. 18999 of 2022 (2026:KER:74251), High Court of Kerala, decided on 28 September 2026.

Authored by Gaurav Mishra, Patent Attorney, BananaIP Counsels