The High Court of Kerala at Ernakulam Bench has held that ‘purposes of Government’ under Section 100 read with Section 99 of the Patents Act, 1970, includes the State’s constitutional duty under Articles 21 and 47 to manufacture and vend patented medicines on a non-commercial basis, but leaves the actual invocation to the Central Government’s policy discretion.
The Court clarified that Section 100 of the Patents Act, 1970 empowers the Central Government to use a patented invention, including life-saving medicines, and authorise third parties to manufacture and sell the same on a non-commercial basis to needy patients, and this right is not restricted to mere departmental use.
While the Court expanded the legal scope of Section 100, it declined to issue a positive mandamus directing the Government to invoke the provision, holding that the actual decision to invoke Section 100 is a policy matter requiring the Central Government to first collate adequate data on affordability, patient numbers, and the impact of existing subsidy schemes.
A Single Judge Bench of Justice Harisankar V. Menon observed that Section 100 of the Patents Act, 1970, despite beginning with a non-obstante clause, must be read along with Section 99 (which defines ‘use of invention for purposes of Government’ as use by the Central Government, a State Government, or a Government undertaking). However, the Court rejected the narrow interpretation urged by the Government and the patent-holding companies (Eli Lilly and Novartis), holding that the term ‘purposes of Government’ is not restricted to mere departmental use.
Relying on sub-sections (4) and (6) of Section 100, which expressly include ‘medicine or drug’ and empower the Government to authorise any person to make, use, exercise, or vend the invention, including the right to sell on a non-commercial basis, the Court held that Section 100 contemplates the Government using the patent to manufacture the medicine and sell it on a non-commercial basis to needy patients. The Court further held that this interpretation is reinforced by Article 21 (right to life) and Article 47 (State’s primary duty to improve public health) of the Constitution, as well as by Section 83 of the Patents Act (which mandates that patents must not impede protection of public health and must be made available at reasonably affordable prices).
The Court also relied on the Lok Sabha debates on the Patent (Amendment) Bill, 2002, where it was clarified that under Section 100, the Government can use the patent ‘in the interest of the public health system’ and can ‘procure it and sell it to the hospitals or give it to third parties’. The Court ultimately held that whether Section 100 should actually be invoked in a given case is a policy decision for the Central Government, and the Court cannot issue a positive mandamus directing the Government to exercise this power without adequate data on affordability.
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Briefly, the petition was filed by a retired bank employee who was suffering from HR+/HER2- Metastatic Breast Cancer (Luminal A type) and was being treated with targeted therapy using CDK 4/6 inhibitors, specifically the medicine ‘Ribociclib’. The medicine cost approximately Rs. 58,140/- for a 21-day cycle (three tablets per day), which the petitioner found unaffordable. She sought directions to the Central Government to invoke either Section 92 or Section 100 of the Patents Act, 1970, to make the medicine available at an affordable price, and also to provide Ribociclib free of cost as part of the National Cancer Control Programme.
Unfortunately, the petitioner succumbed to her illness during the pendency of the petition. Taking suo motu cognizance of the larger issue of exorbitant pricing of life-saving patented medicines, the Court appointed Maitreya Sachidananda Hegde as Amicus Curiae and substituted the matter’s title. Subsequently, the husband of the deceased (R10), another breast cancer patient who is a lawyer (R15), the manufacturers of Ribociclib (Novartis AG, R9) and Abemaciclib (Eli Lilly, R8), the National Cancer Institute, Chittaranjan National Cancer Institute, Regional Cancer Centre (RCC), and the Drug Controller General of India were impleaded as parties.
