The Kerala High Court interpreted Section 100 of the Patents Act, 1970, permitting government use of a patented invention for public health, raising critical questions on access to medicine, patent rights, and pricing policy.
Kerala High Court Interprets Government Use Under Patents Act
In a significant development for public health and intellectual property law, the Kerala High Court delivered a ruling on government use of a patented pharmaceutical compound—ribociclib—under Section 100 of the Patents Act, 1970. The decision arises in the context of efforts to improve access to life-saving cancer medication amid ongoing patent enforcement and evolving drug pricing regulations.
The court examined whether the state could invoke compulsory licensing mechanisms or rely on government use provisions to allow local production or import of the drug. Section 100 permits the government or authorised entities to use any patented invention for governmental purposes without the patentee’s consent, subject to compensation. The ruling acknowledged the tension between patent rights and the right to health, particularly in cases involving high-cost oncology drugs.
“The balance between innovation incentives and access to medicine must tilt toward public welfare in matters of life and death,”
the court observed. The judgment also referenced parallel litigation involving ribociclib patents globally, underscoring the fragmented landscape of pharmaceutical IP enforcement. With the EU-India Free Trade Agreement negotiations ongoing, the decision may influence future positions on TRIPS flexibilities and data exclusivity.
For practitioners, this ruling reaffirms the applicability of Section 100 in public health emergencies and may prompt greater scrutiny of pricing and access commitments by patentees. It also invites legislative clarity on compensation mechanisms and procedural safeguards under government use provisions.
Citations
- Section 100, Patents Act, 1970
