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The Working Group on Access to Medicines and Treatments, a network of patient advocates and civil society organisations, has submitted a representation to the Chief Justice of the Kerala High Court requesting an expedited and uninterrupted final hearing in a public interest matter related to access to the breast cancer medicine Ribociclib.
The case has been pending since June 2022 and has been listed 57 times for final hearing without the matter being finally heard. Ribociclib is a selective cyclin-dependent kinase inhibitor to treat certain kinds of breast cancer, and the drug has been developed by Novartis and Astex Pharma, which is currently part of Otsuka Group.
The case raises important questions concerning the affordability of patented cancer medicines, the use of public health safeguards under the Patents Act, and the government’s obligations regarding access to life-saving medicines and the right to health, said the Working Group.
The original petitioner passed away during the early stages of the litigation, following which the Kerala High Court continued the matter suo motu in recognition of its wider public importance.
The Group elaborated that breast cancer is the most common cancer among women and the leading cause of cancer-related deaths.
As per the GLOBOCAN report, in 2022, India reported over 1.9 lakh new cases and nearly 98,337 deaths from breast cancer. Official data tabled in Parliament by the ministry of health and family welfare in early February 2026 made an estimated projection of 2.4 lakhs.
Among these, patients with Luminal A (HR+/HER2-) breast cancer, an invasive subtype that can spread to other parts of the body, require targeted medicines, such as Ribociclib and Abemaciclib to save their lives. These medicines are critical for HR+HER2- patients because these medicines can be used to treat patients at an early stage.
"However, these medicines are prohibitively expensive as they are under patent protection (Ribociclib Rs.78,468.75 per month and Abemaciclib Rs. 47,752 to Rs. 95,504 per month)," said the Group in its representation to the High Court.
In June 2022, the original petitioner filed a petition seeking government use license under Section 100 of the Patents Act, which facilitates production of the generic version of the drug locally, and at an affordable price, since the price of the generic versions are 90-95% cheaper than that of the originator.
While the government acknowledged the medicine’s effectiveness, it refused to issue a government use license, stating that breast cancer did not constitute a matter of national urgency. Besides, the government has not yet provided a reasoned response regarding access to life-saving medicines and the enjoyment of right to health, it alleged.
The Court took suo moto cognisance of the exorbitant pricing of life-saving patented medicines and appointed an Amicus Curiae directing that the proceedings to continue, through an order on September 16, 2022. The Court called for a preliminary report, and the Central government submitted the final report to the Court.
While the matter was posted for final hearing on January 21, 2023, owing to change in roster and jurisdiction, the hearing did not take place. The Court later directed the manufacturers of the patented medicines to implead in the matter and the Central government had to examine the availability of alternative therapies such as Palbociclib, and patient assistance mechanisms. The Court also directed that the scientific issues should be examined by expert bodies.
"As of now every stakeholder was heard. Every report sought by the Court was placed on record. Every scientific development was brought before the Hon’ble Court. The pleadings stand completed. Yet the constitutional questions on the obligations of the government under Article 21 with regard to access to medicines remain unaddressed," points out the Group.
It added that the untimely demise of the petitioner in this matter highlights the devastating human cost of judicial delays in cases involving access to lifesaving drugs.
"Delays in adjudicating cases involving access to essential medicines deprive patients of their fundamental right to health and life under Article 21 of the Constitution of India, which has repeatedly been underlined by the Hon’ble Supreme Court of India. Moreover, such delays undermine India’s public health obligations under international agreements, including the Doha Declaration on the TRIPS Agreement and Public Health, which emphasizes the importance of ensuring access to affordable medicines," it submitted in the representation submitted with copies to the President of India, Droupadi Murmu and Chief Justice of India, Justice Surya Kant.
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