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Sarojam Radhakrishnan was 68 years old when she was diagnosed with breast cancer in 2021. Her diagnosis was not encouraging. A retired bank employee, Sarojam’s cancer – the Luminal A subtype (HR+/HER2-) – was in an advanced stage. The worst was yet to come, though. It was when she began her treatment that she realised the medicines she had been prescribed were so exorbitantly priced that they made it unaffordable.
She was prescribed three medicines – Ribociclib, Letrozole and Zoledronic Acid – which cost her a whopping Rs 63,480 per month. Though she and her husband had retired as bank employees and were not financially constrained, the expensive medical bills started taking a toll.
In February 2022, Sarojam approached the Kerala High Court with a plea. She wanted the court to order compulsory licensing or have a government use licence to make these medicines more affordable to people. A compulsory licence or government use licence is granted by the government to allow a third party to manufacture and sell the patented product without the patent owner's consent, provided a fee is paid to them.
Tragically, in September 2022, Sarojam passed away at the age of 69. Following her death, the Kerala High Court took suo motu action and continued the proceedings.
Over the past four years, her case has been heard by eight different judges in 58 sessions and has been adjourned 40 times.
In the second week of July this year, the Working Group on Access to Medicines and Treatments, a collaborative network of patient advocates, civil society organisations, legal experts, and healthcare professionals operating in India, wrote to the Chief Justice of the Kerala High Court, the Chief Justice of India and the President of India, urging their intervention to expedite the final hearing.
The matter was heard in the court on July 15, and Justice Harisankar V Menon of the Kerala High Court tasked three leading cancer institutions – the Chittaranjan National Cancer Institute (Kolkata), the National Cancer Institute, and the Regional Cancer Centre (RCC), Thiruvananthapuram – with examining and submitting a report in three weeks. The court wanted to know whether it was possible to substitute Ribociclib with another drug, Palbociclib, owned by Pfizer but no longer under patent and therefore cheaper.
There was a reason for this question. Palbociclib cost Rs 2,000 to Rs 4,000 per month, as per the Deputy Solicitor General of India’s report submitted to the Kerala High Court on December 18, 2023. Ribociclib cost Rs 58,140 per month in 2021.
On July 17, the Supreme Court intervened and took suo motu cognisance of the matter. The SC issued a notice on the broader public interest issue; allowed an intervenor to assist the Court; and directed the Kerala High Court to expeditiously decide the pending writ petition.
A note by the Working Group on Access to Medicines and Treatments said, “We hope that this timely action by the Supreme Court will serve justice to the lakhs of people facing premature death due to IP monopolies, especially patent monopolies. While a patent grants the patent owner a monopoly and prevents others from making affordable generic versions of medicines during the period of that monopoly, it creates no corresponding obligation on the patent holder to make the patented medicines available at an affordable price.”
Unaffordable essential medication
Sarojam and her husband, Radhakrishnan, had been living in Chennai since 1988; both worked as bank employees. When Sarojam was diagnosed with an advanced stage of cancer, her condition could only be managed, not cured. As a result, she would have been on cancer medication for the rest of her life.
Since the couple had good savings and received pensions, they thought they would be able to manage the expenses, according to Radhakrishnan. However, when they realised how much they had to spend each month, they were shocked.
The three medicines she used included Ribociclib, Letrozole and Zoledronic Acid, which cost Rs 58,140, Rs 1,027.75 and Rs 4,313, respectively, including tax, for a month in 2021. She needed to spend a total of Rs 63,480 in a month for the treatment. This made her realise this medication could not be afforded by many people in the country and prompted the petition in court. She particularly mentioned Ribociclib— the patent owned by Novartis, a Swiss-based pharmaceutical company and manufactured in India by Natco Pharma Ltd and MSN Laboratories Pvt. Ltd.
"We consider ourselves middle class or upper middle class, but we struggled to afford the tablet. So, just imagine the situation for ordinary people in the country," Radhakrishnan told TNM.
Seven months after filing the petition, Sarojam died. "Initially, she had hope, but since the petition was not considered, she lost that hope," Radhakrishnan added.
Radhakrishnan – who was impleaded in the petition after Sarojam’s death – mentioned that they had to use their pension and all their savings to purchase the medication. "I still feel regret and sadness because sometimes she would skip taking her medicine without our knowledge, as it is too expensive. Unfortunately, she cannot benefit from the writ petition. However, I hope that many others will receive help if we achieve a favourable judgement."
Why Ribociclib is important in breast cancer treatments
Treatment for breast cancer depends on the subtype of cancer and how much it has spread outside of the breast to lymph nodes or to other parts of the body and may be combined to minimise the chances of the cancer coming back. These include surgery to remove the breast tumour, radiation therapy to reduce recurrence risk in the breast and surrounding tissues and medications to kill cancer cells and prevent spread, including hormonal therapies, chemotherapy or targeted biological therapies.
According to the Working Group on Access to Medicines and Treatments, 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 costs Rs 78,469 per month, and Abemaciclib (Eli Lilly) costs Rs 47,752 to 95,504 per month,” they said.
Ribociclib is a crucial and commonly prescribed medication for specific types of breast cancer. According to Cancer Research UK, Ribociclib targets specific proteins on breast cancer cells and works by blocking these proteins to slow down or halt the growth of the cancer. It is taken as an oral tablet once daily on a strict cyclical schedule. The typical regimen involves taking the medication for 21 consecutive days, followed by a 7-day break, completing a 28-day cycle. This means every month the patient needs to buy 21 tablets.
According to the petition, the patent monopoly on Ribociclib created a lack of competition and unaffordable prices. This high cost directly impacted the right to health, a fundamental right under Article 21 of the Constitution.
“This writ petition is filed to seek directions and intervention to ensure that Ribociclib, a lifesaving medicine, is available at an affordable price, allowing for the enjoyment of the right to health,” the petition reads.
Sarojam's treatment included Abemaciclib and Palbociclib. Abemaciclib is an oral kinase inhibitor considered a breakthrough therapy for advanced cancer, used as an initial endocrine treatment or after prior endocrine therapy. Palbociclib, a CDK4/6 inhibitor like Ribociclib, is effective and safe for managing HR-positive, HER2-negative metastatic breast cancer.
Four years in court
One of the most significant challenges in this case has been the extreme delays in the judicial process. Throughout the pendency of the case, it was listed 58 times, suffered 40 adjournments, and was heard by 8 different judges. These delays occurred for various reasons, including cancelled sittings due to jurisdictional changes, missing instructions from counsel, and the court not convening on certain dates.
In response to the request for a compulsory licence or authorising use of the patent to lower costs, the Union government filed a counter-affidavit arguing that the legal requirements for such intervention, specifically a national emergency or extreme urgency, had not been met.
Government agencies noted that although the drug is expensive, a private patient support programme provides the medicine for free after an initial nine-month period. Ultimately, the Department for Promotion of Industry and Internal Trade (DPIIT) rejected the request for a compulsory licence, maintaining that the current circumstances did not warrant overriding existing patent protections.
Based on the statement filed by the Deputy Solicitor General of India, the National Cancer Institute AIIMS and Jhajjar and the Chittaranjan National Cancer Institute, Kolkata, recommended the drug Palbociclib as the best alternative to Ribociclib for the management of metastatic hormone-positive breast cancer.
“The cheaper version of this drug is available through local manufacturers like Sun Pharma, Intas Pharmaceuticals and Zydus. The cost of treatment is around Rs 2,000 to Rs 4,000 per month if the patient is put on the generic version of the drug Palbociclib,” the DSP response said.
However, on January 3, 2024, amicus curiae Maithreyi Hegde submitted a report to the Kerala High Court that cheaper generic versions of certain drugs are not necessarily suitable substitutes for all patients. She said that while several treatments existed, they possessed unique chemical structures and toxicity profiles that made them non-interchangeable.
“The generic versions of Palbociclib do not have an effective impact on the health of HR+/ HER-2 Negative Breast Cancer patients who are prescribed Ribociclib and Abemaciclib because every patient is different and all three drugs respond differently in patients,” the amicus curiae report read.
The report highlighted that medical choices depended on individual patient conditions, such as heart health or cancer stage, and that switching drugs solely based on cost could lead to treatment failure. She argued that the government’s refusal to include high-cost, patented medicines in welfare schemes violated the fundamental right to health.
Breast cancer and growing threats
According to the American Institute for Cancer Research, breast cancer is the most commonly diagnosed cancer in women and the second most common cancer overall. The World Health Organisation (WHO) reported that in 2020, there were 2.3 million new cases of breast cancer diagnosed worldwide, and 6,85,000 people died from the disease. Additionally, by the end of 2020, there were 7.8 million women who had been diagnosed with breast cancer within the past five years, making it the most prevalent cancer globally.
WHO also reports that breast cancer is the most common cancer among women in 158 countries. In 2024, it resulted in approximately 6,94,000 deaths globally.
Figures from the National Cancer Registry Programme (NCRP) showed that breast cancer cases rose from approximately 2.13 lakh to almost 2.4 lakh cases. NCRP also mentioned that breast cancer deaths increased from about 91,700 in 2021 to over 1.03 lakh in 2025.
Official data tabled in Parliament by the Ministry of Health and Family Welfare in early February 2026 made an estimated projection of 2.4 lakh new breast cancer cases annually.