In Re Exorbitant Pricing of Life Saving Patented Medicines

What happened

The petition was filed on 2 June 2022 by a retired bank employee with hormone-receptor-positive, HER2-negative metastatic breast cancer who was treated with the targeted therapy Ribociclib, a CDK 4/6 inhibitor that she said cost about ₹58,140 for 21 days at three tablets a day. She sought a declaration and a writ of mandamus that the Union respondents must take steps under section 92 or section 100 of the Patents Act, 1970 to make Ribociclib available at a reasonably affordable price, a scheme to provide it free as part of the National Cancer Control Programme, and publication by the Indian Council of Medical Research of data on each category of breast cancer. She died while the petition was pending, and by an order of 16 September 2022 the Court continued it on its own motion as a matter concerning the exorbitant pricing of life-saving patented medicines, appointed an Amicus Curiae and renamed the petition accordingly. An intervenor, the deceased petitioner's husband and a breast cancer patient who is a lawyer were later impleaded in support of the prayers; the Court impleaded the patent holder for Ribociclib, Novartis AG, and Eli Lilly (India), whose medicine Abemaciclib is also a CDK 4/6 inhibitor, in 2023, and on 15 July 2026 the National Cancer Institute at AIIMS Jhajjar, the Chittaranjan National Cancer Institute, the Regional Cancer Centre at Thiruvananthapuram and the Drugs Controller General of India.

The Union said that another CDK 4/6 inhibitor, Palbociclib, whose patent has expired, is available at a lower price and can be used instead, and that the Central Government had considered sections 92 and 100 and rejected the deceased petitioner's representation by an order of 7 October 2022 (Ext. R1(b)), which was not challenged. It said that Ribociclib is a non-scheduled drug whose price is monitored and capped under the Drugs (Prices Control) Order, 2013, that the basic customs duty on it was reduced from 1 February 2026, that no data on affordability had been produced, that section 92 applies only in the circumstances it states, and that section 100 applies only where the invention is to be used for the purposes of Government. The patent holder relied on section 99, on the decision of the Nagpur Bench of the Bombay High Court in Garware Wall Ropes v. A.I. Chopra, Engineers and Contractors, on section 156, under which a patent binds the Government, on a notified 30% cap on the trade margin, on the lowest price charged in India and on the fact that CDK 4/6 inhibitors are used by about 13% of breast cancer patients. The Amicus Curiae pressed only section 100, saying that may should be read as shall, that the patent holders' rights are subject to the general principles of section 83, and that Palbociclib is not a substitute at the early stage of the disease.

Questions before the court

• Does section 100 of the Patents Act, 1970 allow the Central Government to use a patent to manufacture a life-saving medicine and sell it to needy patients on a non-commercial basis, and can the High Court direct the Government to invoke it for a patented cancer medicine said to be unaffordable?

Why the court ruled this way

The Court first found, on the Drugs Controller General's affidavit of 14 August 2026 and the Regional Cancer Centre's report of 20 August 2026, that Palbociclib is used for advanced or stage IV breast cancer and Ribociclib for early breast cancer, so that the two are not interchangeable (paragraphs 21-22). The argument that purposes of Government in section 100, read with section 99, confines use to the Government's own use appeared attractive at first, but sub-section (4) lets the Government authorise any person to make, use, exercise or vend the invention or to import a medicine or drug covered by the patent, and sub-section (6) includes the right to sell the goods on a non-commercial basis, with no restriction on who the purchaser may be, so that section 100 includes using the patent to manufacture the medicine and sell it on a non-commercial basis to a needy patient (paragraphs 24-27). Garware Wall Ropes, which contrasted the words merely of its own use in section 47 with purposes of Government in sections 99 and 100, does not narrow this, because purposes of Government include the vending provided for in sub-sections (4) and (6) (paragraph 28). Article 47 makes the improvement of public health a primary duty of the State, and with article 21, as the Supreme Court said in Parmanand Katara, Paschim Banga Khet Mazdoor Samity and Vincent Panikurlangara, it requires the Government to give access to life-saving treatment, so that purposes of Government include that duty, and the high cost of the drug virtually defeats articles 21 and 47 (paragraphs 29-34). In Distribution of Essential Supplies and Services During Pandemic, In Re, the Supreme Court had also referred to section 100 and the public health flexibilities of the TRIPS agreement, section 83 requires that patents do not impede the protection of public health and that their benefit be available at reasonably affordable prices, and the Lok Sabha debates on the 2002 amendment show that the Government can use a patent in the interest of public health, procure the product and sell it to hospitals or give it to third parties, so that section 100 is to be invoked where the Government must intervene, as when a medicine is unaffordable because of its exorbitant price (paragraphs 31 and 35-37).

The Court nevertheless declined to direct the Government to invoke the section. The patent recognises a new invention and protects the patentee, the Government is itself bound by the patent under section 156, and if that sanctity were not respected no one would patent inventions, so that, as the Supreme Court said in Distribution of Essential Supplies and in State of Punjab v. Ram Lubhaya Bagga, whether and to what extent the powers should be used is a policy decision for the Central Government, which a court does not weigh (paragraphs 38-41). The data needed to decide whether the medicines are affordable had not been placed on record, namely the number of persons with the particular cancer, the number taking the medicines, the cases in which they are not taken because of price, and the reach and effectiveness of the existing subsidy and price-control schemes, and since the findings on section 100 would apply to other life-saving drugs while the manufacturers of only two medicines were before the Court, it is for the Government to consider invoking section 100 in appropriate cases after collecting the data (paragraphs 42-43). The Court noted the 139th report of the Parliamentary Standing Committee on Health and Family Welfare, which found a glaring gap in the affordability of cancer care and a strong need for interventions by the Government and the private sector, and left it to the Government to move forward (paragraph 44).

Controlling point

Section 100 of the Patents Act, 1970 includes the Government's entitlement to use a patent to manufacture the medicine it covers and sell it, including to a needy patient, on a non-commercial basis. It is to be invoked in circumstances where the Government is required to intervene, such as the sale of a medicine made on a patent at an exorbitant price, and the Government is to collate the data needed to decide whether a particular medicine is affordable and, on that basis, proceed under section 100 if found necessary.

Order and next steps

The Court disposed of the writ petition with three findings: that section 100 includes the Government's entitlement to use the patent to manufacture the medicine and sell it to a person, including a needy patient, on a non-commercial basis; that section 100 is required to be invoked in circumstances where the Government is required to intervene, such as where a medicine manufactured on the basis of a patent is sold at an exorbitant price; and that the Government is to collate the required data, arrive at a decision whether a particular medicine is affordable and, on that basis, proceed in accordance with section 100 if found necessary. It recorded its appreciation of the Amicus Curiae's assistance.

Practical implications

Those seeking relief against the price of a patented medicine should put before the Central Government, and the court, data on how many patients need the medicine, how many go without it because of its price and what existing price controls and subsidy schemes achieve, since the Court said that the decision under section 100 turns on such data. Patent holders should note that a patent does not place a medicine sold at an exorbitant price beyond government use under section 100, and the Government is expected to examine the affordability of life-saving patented medicines on data.

Limits of this ruling

• The Court issued no direction to invoke section 100 for Ribociclib or any other medicine and treated the choice as a matter of policy for the Central Government. It found that the data needed to decide affordability was not on record, did not decide the validity of any patent or the reasonableness of any price, and did not consider section 92, which the Amicus Curiae did not press. The petition's prayers for a free-treatment scheme and for the publication of breast cancer data are not separately addressed in the judgment.