Kerala HC widens patent ‘government-use’ power for cheap life-saving drugs, but leaves the trigger to the Center

Context: In June 2022, a retired bank employee surviving on a monthly pension of 28,400 Indian rupees (INR: $299) and her husband, also a retired banker, drawing INR 46,000 ($484), went to the Kerala High Court (HC) over the price of a cancer drug. She was diagnosed with metastatic breast cancer, for which the targeted therapy of choice is a class of drugs called CDK 4/6 inhibitors, which block the cyclin-dependent kinases 4 and 6 that drive tumour growth. One of them, Ribociclib, was costing her roughly INR 58,140 for a 21-day cycle. Her petition asked the court to order the Union to invoke either Section 92 (compulsory licensing on a third party’s application) or Section 100 (the Central Government’s own power to use a patented invention) of the Patents Act, 1970, so that Ribociclib would be available at an affordable price. While the case was pending, she died. On September 16, 2022, the Court converted the matter into a suo motu proceeding on the “exorbitant pricing of life-saving patented medicines”, renaming the petition after that issue.

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Court and counsel

High Court of Kerala: Mr. Justice Harisankar V. Menon

Amicus Curiae: Smt. Maitreyi Sachidananda Hegde

Counsel for the Union/Central Government side: Additional Solicitor General of India P. Sreekumar, Deputy Solicitor General of India O.M. Shalina, Senior Panel Counsel T.C. Krishna.

Counsel for the manufacturer of Abemaciclib: Senior Counsel G. Shrikumar, P. Arun Kumar, Praveen Anand.

Counsel for the Regional Cancer Center: Senior Counsel T.A. Shaji

Counsel for the deceased petitioner’s husband, and a breast-cancer patient and lawyer who told the court she spends around Rs 7.90 lakhs a year on Ribociclib: K.M. Gopakumar.

Counsel for the Intervenor: Rahul Bajaj.