The Kerala High Court is presently hearing a suo motu petition that was initiated after the demise of a breast‑cancer patient whose original plea remained pending. The Court has taken up the matter under the title “In Re Exorbitant Pricing of Life Saving Patented Medicines”. Justice Harisankar V. Menon, who is presiding over the bench, has impleaded several institutions as respondents, namely the National Cancer Institute (Jhajjar), the Chittaranjan National Cancer Institute (Kolkata), the Regional Cancer Centre (Thiruvananthapuram) and the Drugs Controller General of India. Notices have been issued to these entities calling upon them to furnish detailed reports on the substitutability of Ribociclib with Palbociclib.
The direction to obtain expert opinion arises from the Court’s concern over the high cost of patented breast‑cancer drugs. The amicus curiae, Advocate Maitreyi Sachidananda Hegde, who was appointed to represent the interests of the deceased petitioner, submitted that Ribociclib, marketed by Novartis, was priced at approximately Rs 58,000 in 2022 and has since risen to about Rs 75,000. She contended that the medicine is not manufactured within India and therefore remains beyond the financial reach of a large segment of patients. In her view, the Central Government could intervene by invoking provisions of the Patent Act, specifically Sections 83 and 92, which relate to the working of patented inventions and the grant of compulsory licences. She further suggested that Section 100, which permits the requisition of life‑saving medicines in circumstances of extreme necessity, could be activated, noting that this provision has never been used by the government.
Opposing these submissions, counsel for the patent‑holding drug manufacturers, including Senior Advocate Hemant Singh, argued that the Government had already examined the applicability of the aforementioned statutory provisions in an order dated October 2022 and found no basis to invoke them. They pointed out that the same order recognised Palbociclib, a molecule originally developed by Pfizer whose patent has expired, as a viable substitute. According to the manufacturers, Palbociclib is produced domestically and is available at a substantially lower price, thereby addressing the affordability concern without recourse to compulsory licensing or requisition.
During the hearing, the Court observed that the central question before it is whether Palbociclib can be employed to treat the condition highlighted in the petition. The Bench remarked that, if Palbociclib proves to be a suitable alternative, there would be no prima facie need to refer to Sections 92 or 100 of the Patent Act. The amicus curiae, however, countered that the Government’s recognition of Palbociclib as a substitute was made without undertaking a comprehensive study of the drugs’ clinical and toxicological profiles. She submitted that Ribociclib and Palbociclib, although both used for the same type of breast cancer, possess differing efficacy and safety characteristics, and therefore are not interchangeable. She also noted that, contrary to the typical market behaviour where the entry of generic versions reduces the price of the originator drug, the cost of Ribociclib has continued to increase even after the expiry of the patent covering Palbociclib.
In response, Senior Advocate Hemant Singh maintained that Ribociclib and Palbociclib are distinct molecules that target the same pathological pathway in breast‑cancer treatment and, consequently, can be used interchangeably. He stressed that the therapeutic equivalence of the two compounds justifies considering Palbociclib as a cheaper alternative.
Having heard the arguments, the Court concluded that expert insight is indispensable to resolve the dispute over substitutability. Accordingly, it has directed the National Cancer Institute (Jhajjar), the Chittaranjan National Cancer Institute (Kolkata), the Regional Cancer Centre (Thiruvananthapuram) and the Drugs Controller General of India to submit their respective reports on whether Palbociclib can replace Ribociclib in clinical practice. The matter has been adjourned for further consideration on 21 August 2026, with the impleaded parties required to file their reports before that date.
The suo motu proceeding originated from a petition filed in 2022 by a breast‑cancer patient who passed away while the case was still pending. After the patient’s death, the Court decided to proceed on its own motion to examine the broader issue of excessive pricing of patented life‑saving medicines. The appointment of Advocate Maitreyi Sachidananda Hegde as amicus curiae was made to ensure that the interests of the patient community are represented in the proceedings.