Kerala High Court Orders Expert Reports on Whether Cheaper Palbociclib Can Replace Patented Breast‑cancer Drugs

Overview

• The High Court sought written reports on July 15 from the National Cancer Institute (Jhajjar), Chittaranjan National Cancer Institute (Kolkata), the Regional Cancer Centre (Thiruvananthapuram) and the Drugs Controller General of India on whether Palbociclib can be used in place of Ribociclib and Abemaciclib.
• Parties told the court that Palbociclib is off patent and is made in India at lower cost while the amicus curiae argued the drugs have different clinical and toxicological profiles and are not interchangeable.
• The amicus highlighted rising prices for Ribociclib, saying it cost about ₹58,000 per month in 2022 and roughly ₹75,000 now, and urged the Centre to consider compulsory licensing under Section 92 or requisition under Section 100 of the Patents Act.
• Drug companies responded that a 2022 government order had already declined patent remedies and recognised Palbociclib as an alternative, prompting the court to seek independent expert views instead of making a prima facie move on patent powers.
• The court will review the expert reports on August 21 and has signalled that the matter may be treated as a broader public‑interest case heard by a Division Bench, a step that could shape future access‑to‑medicines rulings.