The Kerala High Court ruled on government use of a patented cancer drug Ribociclib under Section 100 of the Patents Act, balancing access to medicine against patent rights amid evolving drug pricing and enforcement policies.
Kerala HC Permits Government Use of Ribociclib Patent
In a significant ruling, the Kerala High Court upheld the government’s use of a patented cancer drug, Ribociclib, under Section 100 of the Patents Act, 1970, which allows government or government-authorized use without the patentee’s consent under certain conditions. The judgment comes amid growing tension between intellectual property protection and access to essential medicines, particularly for high-cost oncology drugs.
The Court emphasized the state’s obligation to ensure public health access under Article 21 of the Constitution, particularly where life-saving drugs are concerned. It examined whether the government’s procurement and distribution of generic versions of Ribociclib qualified as 'public non-commercial use' or fell under 'emergency public non-commercial use' as permitted under the statutory exception. The ruling referenced international obligations under TRIPS and India’s flexibility in implementing compulsory licensing and government use provisions.
Notably, the judgment situates the decision within a broader policy context, including ongoing debates on drug pricing regulation and proposed amendments to patent enforcement norms. This decision may influence future government interventions in public health emergencies and set a precedent for invoking Section 100 in cases involving high-cost therapeutics.
Citations
- [Case name not provided] (2026)
