A petition before the Kerala HC praying for compulsory licensing of breast cancer drug, Ribociclib

Recently, the Kerala High Court directed the Department for Promotion of Industry and Internal Trade (DPIIT) under the Union Ministry of Commerce and Industry to consider mandatory licensing of the breast cancer drug, Ribociclib. Justice VG Arun called for immediate action, noting that at present, an alarming number of breast cancer patients are dying due to the inability to afford the prohibitively priced drug.

The HC was hearing a petition filed by a person diagnosed with HER2- Negative Metastatic Breast Cancer and undergoing targeted therapy.

The petitioner claimed to receive a monthly pension of only ₹28,000 for being an ex-bank employee.

The petitioner claimed that despite such a low pension, he paid Rs 63,000 per month for three cancer drugs, of which one life-saving drug, Ribocicilib, cost Rs 58,140. 

The Petitioner submitted that Ribocicilib is not being manufactured in India and if the drug is manufactured in India, the cost will come down. It will be affordable for her and other breast cancer patients to get treatment.

At present, Ribociclib enjoys a patent monopoly, and its manufacturers are prohibited from producing the medicine without the consent of the patent holder, Novartis.

Advocate Maitreyi Sachidananda Hegde, appearing for the petitioner, informed that the government could invoke Section 92 of the Patents Act, 1970 (provides for mandatory license) and Section 100 (empowers the government to requisition life-saving medicines in extreme cases.)

It was also contended that the inaction by the government in providing access to medication infringes Article 21 of the Constitution and the directive principles of state policy which impose an obligation on the government to provide public health.

The matter will be taken up next on July 18.