Novartis AG v Union of India (2013)

Intellectual Property Rights II · WTO, the Doha Round and Dispute Settlement

Facts.

Novartis sought an Indian patent for a beta-crystalline salt form (Glivec/imatinib mesylate) of a known anti-cancer molecule. The patent office refused it under s.3(d) of the Patents Act, which bars patents on new forms of known substances that show no enhanced therapeutic efficacy.

Issue.

Is s.3(d) — and India’s refusal of the patent — consistent with the TRIPS Agreement?

Held.

The Supreme Court upheld the refusal. TRIPS sets a minimum standard and leaves members free to fix genuine patentability criteria and protect public health; s.3(d) is a valid anti-“evergreening” measure and does not violate TRIPS.

Why it matters.

The leading authority that India can be fully TRIPS-compliant while using flexibilities to keep medicines affordable — the practical meeting-point of TRIPS, the Doha Declaration and Indian patent law.

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