Kerala HC on Govt Use of Patented Medicine in Ribociclib Case

Kerala High Court Rules on Government Use of Patented Drug Ribociclib

In a significant ruling, the Kerala High Court examined the scope of government use of patented inventions under Section 100 of the Patents Act, 1970, in the context of Ribociclib — a cancer medication. The court’s decision arises from proceedings where the state sought to procure or authorise the use of the drug for public health programmes, despite existing patents held by pharmaceutical companies.

The judgment evaluates whether such government action constitutes lawful use under Section 100, which permits central or state governments to use inventions for purposes of government or public health without prior consent of the patent holder, provided compensation is determined. The court referenced Section 100(2), which mandates reasonable remuneration to the patentee, and stressed that such use must not unreasonably prejudice the patentee’s commercial interests.

"Access to life-saving medicines cannot be held hostage to monopolies, but neither can innovators be deprived of just returns,"

observed the court, aligning with India’s obligations under the TRIPS Agreement while affirming its commitment to public health. The order also notes ongoing litigation involving parallel patents on formulation and process, which could affect generic availability.

For practitioners, this reinforces the need to assess both validity and enforceability of pharmaceutical patents in public procurement cases. Legal challenges under Section 100 are likely to increase as health authorities expand access initiatives, especially in oncology and rare diseases. Counsel should closely monitor compensation mechanisms and procedural safeguards in such government uses.