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Introduction
In In Re Exorbitant Pricing of Life Saving Patented Medicines, W.P.(C) No. 18999 of 2022 (2026:KER:74251), the Kerala High Court (Harisankar V. Menon, J.) held on 28 September 2026 that Section 100 of the Patents Act, 1970 allows the Government to use a patented invention to manufacture the medicine it covers and sell it on a non-commercial basis, including to needy patients. The Court held that the Section is required to be invoked where the Government is required to intervene, such as where a patented medicine is sold at an exorbitant price. It did not itself direct the Government to do so. It held that the Government must first collect the data needed to decide whether a particular medicine is affordable, and then proceed under Section 100 if found necessary.
Facts of the Case
A retired bank employee, who stated that she received a monthly pension of Rs. 28,400, filed the writ petition on 2 June 2022. Diagnosed with HR+/HER2- metastatic breast cancer, she was treated with CDK 4/6 inhibitors, of which Ribociclib is stated to be one, at about Rs. 58,140 for 21 days. She sought a declaration and a mandamus that the concerned among Respondents 1 to 3 (the Union Ministry of Health and Family Welfare, the Department of Pharmaceuticals and the Department for Promotion of Industry and Internal Trade ( “DPIIT”)) take steps under Section 92 or Section 100 of the Patents Act to make Ribociclib available at a reasonably affordable price, and a scheme providing it free of cost.
She died while the petition was pending. By order dated 16 September 2022, the Court held that her death did not render the cause infructuous, continued the petition as a suo motu matter on the exorbitant pricing of life saving patented medicines, appointed Adv. Maitreyi Sachidananda Hegde as Amicus Curiae, and retitled it accordingly.
Mr. Rahul Bajaj and, later, the husband of the deceased petitioner and another breast cancer patient (Respondents 10 and 15) were impleaded in support of the prayers. On 7 February 2023 the Court held the manufacturers proper and necessary parties, and Eli Lilly Company (India) Pvt. Ltd. (Respondent 8) and Novartis AG (Respondent 9), which manufactures Ribociclib on the basis of the patent, were impleaded.
Argument in Favour
The Amicus Curiae argued that almost 80,000 patients diagnosed with breast cancer died in 2024, that medicines account for around 36% of cancer treatment expenses and, citing the 139th report of the Parliamentary Standing Committee on Health and Family Welfare, that almost 40% of cancer hospitalisations are financed through borrowings and sale of assets. Ribociclib and Palbociclib, she said, are not interchangeable, since Palbociclib can only be used in advanced stages whereas Ribociclib is administered at the early stage.
She pressed only Section 100 of the Patents Act, since Section 92 requires a company to come forward for a licence and involves an adjudicating process. Patents, she argued, are subject to the general principles in Section 83, so Section 100 is attracted when patented medicines are not available at affordable prices. The word “may” in Section 100 should be read as “shall”, and the Government, as custodian of patients’ interests, must intervene. She called the rejection of the deceased petitioner’s representation (Ext.R1(b), 7 October 2022) flawed.
Mr. Rahul Bajaj adopted these submissions and relied on Devika Biswas v. Union of India ((2016) 10 SCC 726) and Mohd. Ahmed (Minor) v. Union of India ((2014) SCC OnLine Del 1508) for the right to health under Article 21. Counsel for Respondents 10 and 15 added that one of them spends about Rs. 7.90 lakhs a year on Ribociclib against a per capita income of Rs. 2.19 lakhs, and that Article 47 casts on the State a duty to improve public health.
Argument Against
The Union of India said that Palbociclib, now off patent, is available at a lower price and can treat the same type of cancer, so the two medicines are interchangeable. It said the Central Government had considered Sections 92 and 100 in rejecting the deceased petitioner’s representation (Ext.R1(b)); that no data showing unaffordability had been provided; that Section 100 applies only where an invention is used for the “purposes of Government”, read with Section 99; and that no request to invoke Section 100 had been made, so no mandamus could issue. It added that a writ court should not interfere with policy decisions.
Novartis argued that Section 100 can be invoked only where the patent is used for the purposes of Government as defined in Section 99, and not to reduce prices, relying on Garware Wall Ropes Ltd. v. A.I. Chopra, Engineers and Contractors ((2008) SCC OnLine BOM 1225). It said that its price in India is the lowest among various countries and, without prejudice, that Palbociclib is a substitute. It added that Section 100 must be read with Section 156, under which the patent binds the Government.
Eli Lilly argued that Indian patents were once process patents and are now product patents, and must be protected. It said that it manufactures Abemaciclib, another CDK 4/6 inhibitor, in respect of which no relief was sought. It relied on Aravindan K.P. (Dr.) v. Union of India (2022 KHC Online 7761), a Kerala High Court Division Bench judgment, and Distribution of Essential Supplies and Services During Pandemic, In Re ((2021) 18 SCC 201).
Court’s Decision
The Court first held, on the Drug Controller General of India’s affidavit of 14 August 2026 and the Regional Cancer Centre’s report of 20 August 2026, that Palbociclib (used for “advanced or Metastatic Breast Cancer”) and Ribociclib (used for “early Breast Cancer”) are not interchangeable. On Section 100, it accepted that the Government’s argument “appears attractive” at first reading in light of Section 99. However, sub-section (4) lets the Government authorise any person to make, use, exercise or vend the invention or import the “medicine or drug” covered by the patent, and sub-section (6) includes the right to sell the goods on a non-commercial basis. Since Section 100 places no restriction on who the purchaser may be, it held that the Section entitles the Government to use the patent to manufacture the medicine and sell it non-commercially to a person who “can be none other than the needy patient”.
The Court noted that Garware Wall Ropes itself distinguishes Section 100 from Section 47, which uses the words “merely of its own use”. Since Article 47 makes improvement of public health a primary duty of the State, it held that “purposes of Government” also includes that duty, including supplying the medicine to needy patients on a non-commercial basis under Section 100(6). It held that reliance on Distribution of Essential Supplies and Services During Pandemic, In Re “may also not be apposite”, since the Supreme Court there had held that Section 100 is required to be enforced in the interest of the public at large, particularly to protect patients.
On Article 21, the Court cited Supreme Court decisions on the State’s duty to preserve life, including Pt. Parmanand Katara v. Union of India ((1989) 4 SCC 286). It held that the Government must provide access to healthcare, including life-saving treatment, and that the high cost of the drug “virtually defeats” Articles 21 and 47. Drawing also on Section 83(d) and (g) and the Lok Sabha debates on the Patent (Amendment) Bill, 2002, it concluded that Section 100 is required to be invoked where the Government is required to intervene, such as when a medicine is unaffordable on account of its exorbitant price.
The Court then asked whether to direct the Government to invoke Section 100, and declined to issue a direction. A patent binds even the Government under Section 156, and without that sanctity no one would register patents. Whether to invoke Section 100 is, ultimately, a policy decision for the Central Government, as the Supreme Court said in Distribution of Essential Supplies. The data on whether the medicines are affordable had not been brought on record, and the Government must collect it, including the number of patients affected, those consuming the medicines and those who do not because of price. The Court noted that its findings would apply to other life saving drugs, though only two manufacturers were before it.
Conclusion
The judgment reads Section 100 of the Patents Act, 1970 as covering the Government’s use of a patent to manufacture a medicine and sell it on a non-commercial basis, and identifies an exorbitant price as an instance where the Section is required to be invoked. The Court stopped short of directing the Government to act; that decision rests with the Central Government, after it collates the data needed to judge whether a particular medicine is affordable.
