Published Jul 18, 2026 | 5:32 PM ⚊ Updated Jul 18, 2026 | 5:32 PM
Patent monopoly puts many life-saving drugs beyond the reach of the common man. (iStock)
Synopsis: A breast cancer patient’s fight—continuing even years after her death—for access to an unaffordable patented drug has evolved into a landmark legal battle over whether patent rights can outweigh the constitutional promise of affordable healthcare. With the Supreme Court pressing the Kerala High Court for an early decision, the case now carries far-reaching implications for the pricing of life-saving medicines, patients’ right to treatment, and the government’s use of patent law to improve access to essential drugs.
The woman knew she was running out of time when she approached the Kerala High Court in June 2022.
Diagnosed with HER2-negative metastatic breast cancer a year earlier, the retired bank employee from Ernakulam was not asking the court to cure her disease.
She wanted access to the one medicine her doctors had prescribed—Ribociclib—too expensive and beyond her means.
The woman argued that the drug’s patent monopoly had placed it beyond the reach of ordinary patients, turning the right to health guaranteed under Article 21 of the Constitution into an empty promise.
Two months later, she died.
More than four years on, her plea remains undecided.
On Friday, 17 July, the case reached the Supreme Court, where the legal battle over access to the life-saving breast cancer drug continues long after the woman had gone.
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A writ petition filed in the Kerala High Court by a retired bank employee seeking access to an unaffordable cancer drug has outlived the woman who had filed it, evolving into a larger legal battle over the pricing of life-saving patented medicines in India.
The petition, moved on 2 June, 2022, was filed by a couple who had retired from the banking sector and were living on a combined monthly pension of ₹2.74 lakh.
Almost their entire income was being drained by the cost of cancer treatment and medicines, the petition said.
In July 2021, the woman had been diagnosed with HER2-negative metastatic breast cancer, an advanced stage of the disease that could only be managed, not cured.
Doctors prescribed targeted therapy using Ribociclib, a CDK4/6 inhibitor marketed under the brand name Kisqali, along with Letrozole tablets and Zolendronic injections.
The petition said Ribociclib alone cost ₹58,140 a month in 2022, while Letrozole and Zolendronic added another ₹5,340. The monthly bill for cancer medicines came to about ₹63,480. She was also spending around ₹25,000 every month on medicines for cardiac hypertension and other health conditions.
The petition argued that Ribociclib had to be taken for life because metastatic breast cancer has a high risk of recurrence. However, the drug remained beyond the reach of many patients because it was protected by a patent, preventing other manufacturers from producing cheaper generic versions.
Describing the patent monopoly as the reason for the drug’s unaffordable price, the petitioner contended that the lack of competition had made a life-saving medicine inaccessible. She argued that it violated the right to health guaranteed under Article 21 of the Constitution and sought judicial intervention to make Ribociclib available at an affordable price.
On 9 June 2022, the High Court permitted the petitioner to remain anonymous. Before the case could be decided, she died on 16 September 2022.
Her death, however, did not bring the proceedings to an end.
Taking note of the larger public importance of the issues raised, the High Court decided to continue hearing the matter on the question of exorbitant pricing of patented life-saving medicines. The Registry was directed to substitute the case title with “In Re Exorbitant Pricing of Life Saving Patented Medicines.”
The directive transformed an individual’s struggle into a public interest case that continues to examine the balance between patent protection and the right to affordable healthcare.
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The case seeking access to a life-saving breast cancer drug has once again been deferred by the Kerala High Court, prolonging a legal battle that has stretched over several years despite dozens of court listings.
The petition, which was heard on 15 July, has now been postponed to 21 August after the court sought additional reports.
The latest adjournment comes even as a collective of patient advocates, doctors, legal experts and civil society organisations, under the banner Working Group on Access to Medicines and Treatment, has urged the Chief Justice of the Kerala High Court to ensure an early conclusion of the proceedings.
Data compiled by them shows that since the petition was filed, the case has been listed 58 times.
On 40 of those occasions, it was adjourned without a final hearing.
During its pendency, the matter came up before eight different judges of the High Court.
Days before the 15 July hearing, the Working Group submitted a representation to Chief Justice Soumen Sen, pointing to the prolonged delay and stressing that patients in urgent need of the medicine could not afford to wait any longer.
The representation noted that the writ petition had been listed for final hearing 57 times since 21 January 2023, but was never conclusively heard. It also recalled that the original petitioner had died during the early stages of the litigation. Recognising the larger public interest involved, the High Court continued the proceedings on its own.
According to the representation, all stakeholders have already been heard, every report sought by the court has been placed on record, scientific developments have been brought before the Bench, and the pleadings stand completed.
Yet, it said, the constitutional questions relating to the state’s obligations under Article 21 to ensure access to essential medicines remain undecided.
The group argued that the case extends far beyond the plight of a single patient and concerns the health, dignity and survival of countless women battling breast cancer across the country. An early verdict, it said, would honour the memory of the deceased petitioner while offering hope to patients who lack the financial means to pursue lengthy litigation.
Copies of the representation were also sent to the President of India and the Chief Justice of India.
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Hearing the matter on 15 July, Justice Harisankar V Menon decided to seek the views of the National Cancer Institute, Jhajjar, the Chittaranjan National Cancer Institute, Kolkata, the Regional Cancer Centre, Thiruvananthapuram, and the Drug Controller General of India (DCGI).
The court is examining the contention that Palbociclib, which is no longer under patent and is manufactured by several Indian companies at a much lower price, could be used instead of Ribociclib.
The expert opinions are expected by 21 August.
Reacting to the development, Jyotsna Singh, co-convener of the Working Group, said the commencement of detailed hearings was a positive step but urged the court to avoid further delays.
“The hearing finally started. That’s a good thing. But we hope that the court will now continue to hear and won’t take too long to pass a judgment,” she told South First.
At the same time, Singh alleged that the government was presenting a misleading picture before the court.
She said regulatory authorities across the world, including the US Food and Drug Administration (USFDA) and the European Medicines Agency (EMA), have approved Ribociclib and Abemaciclib for the treatment of early-stage HR-positive, HER2-negative breast cancer, while Palbociclib has been approved only for metastatic disease.
“This makes clear that the three drugs are not interchangeable. Every day this judgment is delayed costs lives,” she said.
She added that the court’s directive to three leading cancer institutions to examine the scientific and clinical issues alongside impleading the DCGI as a party to the proceedings was an important step forward in the case.
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Kerala High Court’s consideration of the plea received a significant push after the Supreme Court stepped in on 17 July. The apex court directed the High Court to dispose of the pending writ petition without delay.
The Supreme Court had taken suo motu cognisance of the issue on 16 July.
While issuing notice on the larger public interest questions involved, the court also permitted an intervenor to assist in the proceedings and asked the Kerala High Court to expeditiously decide the writ petition pending before it.
Welcoming the development, KM Gopakumar, another co-convenor of the Working Group, said the Supreme Court’s intervention offered hope to lakhs of patients whose access to life-saving medicines continues to be affected by intellectual property monopolies, particularly patent monopolies.
He, however, criticised the Union Government’s repeated contention that Ribociclib could simply be replaced with other medicines that have recently gone off patent. Such an argument shifts the focus away from the central legal and public health issues before the court, he argued.
Instead of debating substitute medicines, Gopakumar said the government should address the larger question of how the public health safeguards and TRIPS flexibilities available under the Indian Patents Act can be effectively used to ensure affordable treatment for patients.
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As the case progresses, the court will examine a crucial question that could have a bearing on the affordability of breast cancer treatment: Can the cheaper generic drug, Palbociclib, be used instead of the patented and far more expensive Ribociclib?
The drug Ribociclib, manufactured by Novartis AG, costs around ₹58,000 a month, prompting High Court-appointed Amicus Curiae Maitreyi Sachidananda Hegde to argue that the Centre should invoke provisions of the Patents Act to make the drug affordable.
Hegde submitted that the government could exercise its powers under Section 100 of the Patents Act to use the patented invention for government purposes or issue a notification under Section 92 to facilitate wider access in the public interest.
The pharmaceutical company’s representatives, however, contended that an affordable alternative is already available.
They told the court that Palbociclib, originally patented by Pfizer Products India Pvt. Ltd., is now off-patent and is being manufactured by several Indian companies at a fraction of the cost.
The submission has narrowed the dispute before the High Court to a single question: Is Palbociclib a clinically acceptable substitute for Ribociclib in the treatment of breast cancer?
Hegde disputed the claim by relying on a government report, which states that the two medicines contain different molecules and have distinct clinical and toxicological profiles. According to the report, they are not interchangeable despite belonging to the same therapeutic class.
The company maintained that while Ribociclib and Palbociclib are different molecules, both are CDK4/6 inhibitors used to treat the same category of hormone receptor-positive breast cancer.
The debate also brought back into focus the Centre’s 2023 in the High Court.
The Deputy Solicitor General of India had then informed the court that premier cancer institutions — the National Cancer Institute, AIIMS Jhajjar, and the Chittaranjan National Cancer Institute, Kolkata — had opined that Palbociclib could be used as an alternative to Ribociclib with similar efficacy.
According to that submission, Palbociclib is available in India through more than 20 manufacturers, including Sun Pharma, Intas Pharmaceuticals and Zydus, with generic versions reducing the monthly treatment cost to around ₹2,000-₹4,000.
The High Court will now examine these conflicting opinions before deciding, a finding that could shape the course of the larger case on access to affordable cancer treatment.
(Edited by Majnu Babu).
