The Kerala High Court addressed the scope of Section 100 of the Patents Act, 1970, in the context of access to the cancer drug ribociclib. The ruling balances public health interests against patent rights, emphasizing lawful government use for public welfare.
Kerala High Court Interprets Section 100 on Government Use of Patented Medicine
In a significant development for public health and intellectual property law, the Kerala High Court recently examined the application of Section 100 of the Patents Act, 1970, concerning government use of a patented invention — ribociclib, a drug used in breast cancer treatment. The judgment emerged in the context of ongoing litigation surrounding access, pricing, and overlapping patent protections, highlighting the tension between equitable access to life-saving medicines and patent enforcement.
The court reaffirmed that Section 100 permits the government to use a patented invention for its own purposes, including public health programs, without the patent holder’s consent, provided compensation is paid. This power, the court noted, must be exercised in a manner consistent with public interest and due process. While the judgment did not invalidate the patent, it underscored the state’s authority to invoke such provisions during health emergencies or to ensure affordability.
"The right to health cannot be held to ransom by monopolistic pricing,"
The ruling has broad implications for future negotiations around drug pricing and compulsory licensing, particularly amid evolving regulatory frameworks under India’s national health policies and international trade agreements like the EU-India FTA. Practitioners should anticipate increased scrutiny of pricing practices and a potential uptick in government-led use of patented pharmaceuticals, especially in critical care domains. The decision may also influence pending litigations involving similar oncology drugs with overlapping patent claims.
Citations
- Section 100, Patents Act, 1970
