Kerala HC Upholds Govt Use of Ribociclib Patent for Public Health

Kerala High Court Rules on Government Use of Ribociclib Patent

In a significant ruling, the Kerala High Court upheld the Central Government’s use of Novartis’s patented drug Ribociclib—used in breast cancer treatment—under Section 100 of the Patents Act, 1970. Invoking government or 'Crown use' provisions, the court validated the use of the patented invention for public health purposes during a health emergency, rejecting claims of patent infringement.

The court reasoned that Section 100 permits the government to authorise use of a patented invention without the patentee’s consent, provided compensation is paid. Citing Bayer Corporation v. Union of India, the court reaffirmed that public health imperatives can justify such use under TRIPS Article 31. The court emphasized equitable access, noting that high drug prices and limited availability warranted state intervention. It also referenced the Everest Industries v. Ozone Properties principle that public interest outweighs private profit in exceptional circumstances.

This decision reinforces the state’s authority to invoke compulsory licensing and government use mechanisms during public health crises. For practitioners, it signals stronger judicial support for balancing IP rights with access to medicines—especially in non-communicable diseases. The judgment may influence ongoing debates over the WHO’s Pandemic Agreement and domestic pricing policy under the Drug Price Control Order.