Patented medicines can be made and sold non-commercially to needy patients under government-use powers, Kerala High Court says

The petition was initially brought by a breast-cancer patient seeking affordable access to Ribociclib, a patented medicine, and directions to the Union Government to act under Sections 92 or 100 of the Patents Act, 1970.

The petitioner died while the case was pending; the Court continued the matter in its own name and appointed an amicus curiae.

The Court later impleaded, among others, the relevant patent holders and cancer-treatment institutions.

The Union relied on Palbociclib as an alternative, while the amicus and expert material maintained that it was not interchangeable with Ribociclib for early breast cancer.

1. Whether “use of an invention for the purposes of Government” under Sections 99 and 100 of the Patents Act includes government-authorised manufacture of a patented medicine and its non-commercial sale to needy patients.

2. Whether the Court should direct the Central Government to invoke Section 100 where a patented life-saving medicine is alleged to be unaffordable.

3. Whether Palbociclib could be treated as an interchangeable substitute for Ribociclib in the circumstances considered.

Section 99 of the Patents Act defines use for government purposes to include an invention made, used, exercised or vended for the purposes of the Central Government, a State Government or a government undertaking; Section 100 authorises government use and permits an authorised person to make, use, exercise or vend a patented medicine, including its non-commercial sale.

Section 83 requires the patent system to promote public health and public interest, avoid impeding public-health measures, and make patented inventions available at reasonably affordable prices.

Article 21 imposes a State obligation to protect life, while Article 47 makes improvement of public health a primary duty of the State.

The Supreme Court’s decision in In Re: Distribution of Essential Supplies and Services During Pandemic recognised government-use powers under Section 100 as a public-health flexibility, but treated whether and to what extent to exercise those powers as a policy decision for the Central Government.

Paschim Banga Khet Mazdoor Samity v. State of W.B. and Pt. Parmanand Katara v. Union of India affirm the State’s duty to preserve life and provide medical assistance.

Government policy is generally for the executive, subject to constitutional and statutory limits; the Court also relied on State of Punjab v. Ram Lubhaya Bagga and Siddharth Dalmia v. Union of India concerning judicial restraint in policy matters.

The Court read Sections 99 and 100 together and held that the authority to “vend” under Section 100, read with the express references to medicines and non-commercial sale, permits the Government to authorise manufacture of a patented drug and sell it to needy patients.

It considered this construction consistent with the State’s public-health duties under Articles 21 and 47 and the principles in Section 83.

The Court rejected the contention that Palbociclib was an adequate substitute for Ribociclib, relying on the Drug Controller General’s affidavit and the Regional Cancer Centre’s report distinguishing their stated uses.

However, the Court declined to order the Government to invoke Section 100: affordability and the appropriate response required countrywide data on patients, medicine use, unmet need and the effectiveness of existing schemes.

The decision whether to exercise Section 100 remained a matter for the Central Government, informed by that data and subject to judicially stated legal principles.

It did not issue a mandamus requiring the Government to invoke Section 100.

Instead, it disposed of the petition, holding that the Government should collect the necessary data, determine affordability and proceed under Section 100 if warranted.