Kerala HC Examines Generic Alternative to Costly Breast Cancer Drug
Kerala: The Kerala High Court has sought expert opinions from leading cancer institutes and the Drug Controller General of India (DCGI) to determine whether the generic drug Palbociclib, which is no longer protected by patent, can serve as a clinically appropriate and affordable alternative to the costly patented breast cancer medicines Ribociclib and Abemaciclib.
The move comes as part of the court's ongoing examination of the high cost of patented cancer therapies and their impact on patient access.
According to news reported by the Economic Times, Justice Harisankar V. Menon directed the National Cancer Institute, Jhajjar, Chittaranjan National Cancer Institute, Kolkata, Regional Cancer Centre, Thiruvananthapuram, and the Drug Controller General of India (DCGI) to submit expert opinions on the issue. The court has listed the matter for further hearing on August 21.
The proceedings stem from a writ petition filed in 2022 by a breast cancer patient from Ernakulam, who had challenged the prohibitively high prices of patented medicines used in her treatment. Although the petitioner passed away while the case was pending, the High Court decided to continue the matter on its own motion, considering its wider implications for public health. The case has since been retitled 'In Re Exorbitant Pricing of Life Saving Patented Medicines'.
During the latest hearing, amicus curiae Maitreyi Sacchidananda Hegde argued that the patented medicines remain beyond the reach of a large section of Indian patients due to their high prices and lack of domestic manufacturing. She contended that the Central Government has legal provisions under the Patents Act, 1970, to improve access to such medicines. Referring to Sections 83 and 92, she submitted that patent rights should not stand in the way of protecting public health and that compulsory licences can be issued in situations involving public health needs. She also pointed to Section 100, which empowers the government to authorise the use, manufacture or sale of patented inventions for government purposes.
The pharmaceutical companies holding patents for the drugs opposed these arguments. They relied on a 2022 statement issued by the Central Government, which recognised Palbociclib as a lower-cost, domestically manufactured treatment option and suggested that it could serve as an alternative medicine.
To resolve the dispute, the High Court has asked leading cancer institutions and the national drug regulator to provide scientific and clinical opinions on whether Palbociclib can effectively replace Ribociclib and Abemaciclib in the treatment of breast cancer. Although the court initially considered referring the matter to a Division Bench because of its significant public interest, it ultimately chose to continue hearing the case itself.
ET reports that the petition has been listed for final hearing 57 times since January 21, 2023, without reaching final arguments. ET also reported that a working group on access to medicines recently urged the Chief Justice of India to facilitate an early hearing, stressing that delays in adjudication could adversely affect patients who urgently depend on these life-saving therapies.
