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Kerala High Court Clarifies Government Powers Over Patented Medicines

The Court held Section 100 may authorize non-commercial government use of a patented medicine for needy patients and left any invocation to the Union after affordability data is collected.

The Kerala High Court has held that Section 100 of the Patents Act permits the Union government to use a patented invention to make a medicine and sell it on a non-commercial basis, including to a needy patient.

In a 28 September judgment in a suo motu case on pricing of life-saving medicines, Justice Harisankar V. Menon said the power may be relevant when a patented drug is sold at an exorbitant price. The court linked that reading to the Act’s public-health principles and the State’s duties to protect life and health.

The court did not order immediate government intervention. It said the Union must gather data on affordability and access, then decide whether to invoke Section 100. The ruling recognises a statutory route to broaden access while leaving the policy decision with the executive and accounting for the patent-holder’s protections.

Explore topicsAccess to MedicinesPatents ActPublic HealthRibociclib
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