Kerala High Court directs DPIIT to contemplate compulsory licensing of breast cancer-saving drug Ribociclib

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Justice VG Arun of the Kerala High Court has directed the Department for Promotion of Industry and Internal Trade (DPIIT) to contemplate compulsory licensing of Ribociclib, a breast cancer-saving drug. The judge said,

“I find that the issue projected through the writ petition requires serious consideration at the hands of the authorities available. As per the available statistics, an alarming number of women succumb to Breast cancer because of their inability to afford expensive treatment and medication. The right to life guaranteed under the Constitution, coupled with the State’s duty to improve public health, call for emergent and effective action in the matter.”

Court was hearing a petition of a retired Bank employee who receives a monthly pension of Rs. 28000, and got diagnosed with HER2- Negative Metastatic Breast Cancer. The employee is undergoing 'targeted therapy’ treatment. The monthly cost of the medicines for treatment works out to Rs. 63,480. The split-up details of which are as under:

  1. Ribociclib – Rs. 58,140 (including tax)
  2. Latrazole – Rs. 1,027.75 (including tax)
  3. Zolendronic – Rs. 4,313 (including tax)

Case of the petitioner was that as Ribociclib is not manufactured in India being the costliest medicine costs Rs.58, 140 per month alone. According to the petitioner, if the medicine is manufactured in India, the cost will come down substantially and will become affordable for her and other patients suffering from breast cancer.

“Ribociclib presently enjoys a patent monopoly and their manufacturers are hence prevented from producing the medicine without the consent of the patent holder,” stated the petitioner.

Counsel for the petitioner referred to Section 92 of the Patents Act, 1970 which provides for a compulsory license, and Section 100 which empowers the Government to requisition life-saving medicines in cases of extreme necessity.

It was further pointed out that these aspects require immediate action, and the petitioner had already submitted her representation before various authorities and had received an acknowledgment from the Ministry of Child and Development informing her that the representation is pending before the DPIIT.

In view of these submissions, Court directed “the DPIIT to take up the pending representation and pass a reasoned order thereon after consultation with the other authorities within four weeks.

The matter has been listed for July 18. 

Case Title: XXX v. Union of India and Ors.