Kerala High Court Holds Section 100 of the Patents Act Lets the Centre Make and Sell a Patented Medicine Non-Commercially

Kaustav Chowdhury

5 hours ago

6 min read

Background and Facts

Government use of a patent is usually discussed as though it meant use inside a government department. The Kerala High Court has read it wider. In a judgment reported on September 28, 2026, the Court held that Section 100 of the Patents Act, 1970 allows the Central Government to authorise the manufacture of a patented medicine and its sale to a patient who needs it, provided the sale is on a non-commercial basis. The judgment was delivered by Justice Harisankar V. Menon.

The proceedings began in 2022 as a writ petition by a woman suffering from metastatic breast cancer who could not afford the patented drug ribociclib. She died while the petition was pending. Rather than close the file, the Court continued the matter of its own motion, treating the pricing of patented life-saving medicines as a question that outlived the petitioner.

The familiar answer to an unaffordable patented medicine is a compulsory licence, machinery that lies with the Controller. The Court took the compulsory licence provisions as they are, and then asked a different question: what else does the Act already permit the Government itself to do.

Key Legal Issue

Whether the power conferred on the Central Government by Section 100 of the Patents Act, 1970 to use a patented invention for the purposes of Government is confined to the Government's own internal use, or extends to manufacturing a patented medicine and supplying it to individual patients on a non-commercial basis.

The High Court's Ruling

The Court held that the power is not so confined. The proposition was put shortly:

"the scope of Section 100 is not confined merely to governmental use of a patented invention".

On that reading, the Central Government, or a person it authorises in writing, may use a patent to manufacture the medicine it covers and sell that medicine to a person who needs it, including an individual patient, so long as the sale carries no commercial object. The Court went on to say that the Government should gather the material needed to judge whether a patented medicine is affordable, and should invoke the section where intervention is called for. It issued no mandatory direction to do so in any particular case, leaving the decision where the statute leaves it.

What Section 100 Actually Says

The section rewards reading, because its width is on its face. Sub-section (1) permits the Central Government, and any person authorised in writing by it, to use an invention for the purposes of Government. Sub-section (2) deals with an invention already recorded or tried by Government before the priority date, which may be used free of any royalty or other remuneration to the patentee. Sub-section (3) governs the ordinary case, where use is on terms agreed before or after the use, and where in default of agreement the patentee is entitled to no more than adequate remuneration in the circumstances of the case.

Two further sub-sections carry the judgment. Sub-section (5) obliges the Government to notify the patentee of the use as soon as practicable and to furnish information as to its extent. And sub-section (6) expressly confers the right to sell, on a non-commercial basis, goods made in exercise of the right conferred by the section. A power to make coupled with an express power to sell non-commercially is not a power limited to internal consumption.

Why This Is Not a Compulsory Licence

The distinction matters in practice because the two routes run through different hands. A compulsory licence under Section 84 is granted by the Controller, on the application of any person interested, at any time after three years from the grant of the patent, on one or more of three grounds: that the reasonable requirements of the public with respect to the patented invention have not been satisfied, that the patented invention is not available to the public at a reasonably affordable price, or that the patented invention is not worked in the territory of India. It is adversarial, it is published, and the patentee is heard.

Section 92 sits between the two. It allows the Central Government, in circumstances of national emergency or extreme urgency or in a case of public non-commercial use, to make a declaration by notification in the Official Gazette, after which the Controller grants licences to applicants on terms he thinks fit, endeavouring to secure that articles made under the patent are available at the lowest prices consistent with the patentees deriving a reasonable advantage from their patent rights. Section 100 requires no notification and no application to the Controller at all. It is an executive power, exercised on terms and against remuneration, and the patentee's protection lies in notice and in the adequacy of what is paid rather than in a hearing before a grant.

The Limits of the Judgment

It is worth being precise about what the Court did not do. It did not order the Government to invoke Section 100 in respect of ribociclib or any other drug. It did not fix a price, direct a manufacturer, or hold any patent to have been abused. What it decided is a question of construction, and what it added was that the Government should equip itself with data on affordability so that the discretion can be exercised on a footing other than impression.

For a patentee, therefore, the judgment does not create an immediate exposure. It does change what a petitioner can put to the Union, because the answer that the only available mechanism is a compulsory licence before the Controller is no longer complete. Section 83 already states, among the general considerations governing the working of patented inventions, that patents granted do not in any way prohibit the Central Government from taking measures to protect public health.

Practice Notes

In practice, the judgment changes how an affordability argument should be framed and how a patentee should prepare for one:

Plead Section 100 alongside, not instead of, Section 84: The two are cumulative and run through different decision makers. A petition that asks only for a compulsory licence leaves the executive power untouched, and a petition that asks only for government use gives up the Controller's jurisdiction.
Address the non-commercial condition directly: The permission in sub-section (6) is to sell on a non-commercial basis. Any scheme proposed to the Government has to be built so that the sale carries no commercial object, and the pricing has to be capable of being explained on that footing.
For a patentee, prepare the remuneration case now: Absent agreement, remuneration is capped at what is adequate in the circumstances. The evidence that fixes adequacy is commercial and should be assembled before it is needed.
Do not expect notice before the decision: Sub-section (5) requires notice as soon as practicable after the fact. A patentee planning on a pre-decision hearing is planning on the wrong provision.
Build the affordability record around data, not adjectives: The Court asked for material on whether a medicine is affordable. Submissions on patient numbers, supply and comparative pricing are more useful than a price characterised as exorbitant.

Key Provisions Discussed

Section 100 of the Patents Act, 1970: Use of inventions for the purposes of Government. The Central Government, and any person it authorises in writing, may use the invention; use is free of remuneration where the invention was recorded or tried by Government before the priority date and otherwise is on agreed terms or, in default, on not more than adequate remuneration; the patentee must be notified as soon as practicable; and goods so made may be sold on a non-commercial basis.
Section 84 of the Patents Act, 1970: Compulsory licences. After three years from grant, any person interested may apply to the Controller on the ground that the reasonable requirements of the public have not been satisfied, that the invention is not available at a reasonably affordable price, or that it is not worked in the territory of India.
Section 92 of the Patents Act, 1970: Compulsory licences following a notification by the Central Government in circumstances of national emergency or extreme urgency, or in a case of public non-commercial use, with the Controller directed to secure the lowest prices consistent with the patentees deriving a reasonable advantage from their patent rights.
Section 83 of the Patents Act, 1970: General principles governing the working of patented inventions, including that patents do not impede the protection of public health and do not in any way prohibit the Central Government from taking measures to protect public health.

Case Details

Court: High Court of Kerala
Bench: Justice Harisankar V. Menon
Reported: September 28, 2026
Proceedings: Continued by the Court of its own motion after the death of the petitioner in a writ petition of 2022 concerning access to a patented breast cancer drug
Drug in Issue: Ribociclib
Outcome: Section 100 of the Patents Act, 1970 held not to be confined to the Government's own use. The Central Government may authorise manufacture of a patented medicine and its sale to a needy patient on a non-commercial basis, and should collect data on affordability and decide whether to invoke the section. No mandatory direction issued.

Sources and References

Disclaimer: This article is for informational purposes only and does not constitute legal advice. Readers should consult a qualified legal professional for advice specific to their circumstances.