Kerala High Court seeks reports on whether cheaper alternative can substitute patented cancer drug

The Kerala High Court has directed the National Cancer Institute, Jhajjar; Chittaranjan National Cancer Institute, Kolkata; the Regional Cancer Centre (RCC), Thiruvananthapuram; and the Drug Controller General of India (DCGI) to file reports on whether Ribociclib and Palbociclib, medicines used in breast cancer treatment, can be substituted for each other.

Justice Harishankar V. Menon issued the directive while considering a suo motu petition questioning the exorbitant prices of life-saving drugs. The petition arose from a writ petition filed by a breast cancer patient who succumbed to the illness while her plea challenging the inaccessibility of the expensive medicine prescribed to her was pending before the court.

The amicus curiae informed the court that Ribociclib, used in the treatment of breast cancer and manufactured by Novartis AG, cost around ₹58,000 a month when the petition was first filed in 2022. The amicus curiae submitted that the government should either take over the patent for the medicine for the “purposes of the government”, as provided under the Patents Act, 1970, or declare the medicine an essential product and prevent a monopoly over it.

Pharmaceutical companies Eli Lilly and Company and Novartis AG submitted that there was no need to invoke the provisions of the Patents Act, as the Central government had earlier found no necessity to declare Ribociclib an essential product. They also contended that the alternative medicine, Palbociclib, was being manufactured by various companies in India and was available at a more affordable price.

In response, the amicus curiae contended that the two medicines had different clinical and toxicological profiles and were not interchangeable. Novartis AG, however, submitted that they were merely two different molecules used to treat the same type of breast cancer.

The court said the views of the two cancer institutes, the RCC, and the DCGI were required. Their reports will be considered on August 21, when the matter will be taken up again.