Introduction:

The Kerala High Court has reserved its verdict in a suo motu proceeding concerning the exorbitant pricing of patented life-saving medicines, particularly drugs used in the treatment of breast cancer. The proceedings raise important questions about the relationship between the right to health, access to essential medicines, patent protection and the powers of the Central Government under the Patents Act, 1970.

Justice Harisankar V. Menon heard detailed submissions from the amicus curiae, pharmaceutical companies, the Union Government, party respondents and an intervenor before reserving the matter on September 16, 2026. The case, titled In Re Exorbitant Pricing of Life Saving Patented Medicines, originated from a petition filed by a breast cancer patient seeking intervention by the Central Government to make a patented medicine more affordable.

The original petitioner was undergoing treatment with Ribociclib, a patented medicine used in the treatment of breast cancer. The drug was reportedly priced at approximately Rs. 75,000 per month, placing a substantial financial burden on the patient. She approached the Court seeking appropriate intervention by the Central Government under the Patents Act, particularly in view of the high cost of the medicine and the difficulties faced by patients in accessing treatment.

During the pendency of the proceedings, the original petitioner passed away. Recognising that the questions raised in the petition extended beyond her individual circumstances, the High Court decided to convert the matter into a suo motu proceeding.

The case thereafter developed into a broader examination of whether the existing statutory framework provides sufficient mechanisms to address the unaffordability of patented medicines and whether the Central Government should consider exercising its powers to facilitate access to such drugs.

The proceedings involve three medicines used in breast cancer treatment: Ribociclib, manufactured by Novartis; Abemaciclib, manufactured by Eli Lilly Pvt. Ltd.; and Palbociclib, a medicine whose patent protection has expired and which is also manufactured locally. The Court had earlier sought expert assistance to determine whether Palbociclib could serve as a substitute for the two patented medicines.

This question is particularly important because the availability of a less expensive medicine does not necessarily establish that it can be used interchangeably with another drug in every clinical situation. The medical suitability of an alternative depends upon factors such as the patient’s condition, the stage of the disease and the respective medicines’ therapeutic characteristics.

The proceedings also require the Court to consider the scope of Sections 84, 92 and 100 of the Patents Act, 1970. These provisions concern compulsory licensing and government use of patented inventions, mechanisms through which the statutory framework may permit the use or manufacture of patented medicines under specified circumstances.

The amicus curiae, Maitreyi Sachidananda Hegde, submitted that the unaffordability of patented medicines could prevent patients from accessing timely treatment and that the Central Government had a responsibility to examine the available statutory mechanisms.

The pharmaceutical companies, on the other hand, argued that patent protection serves a legitimate public interest by encouraging research and development, and that the Patents Act already contains a framework balancing the interests of patent holders with public health requirements.

The Union Government also opposed an approach that would result in intervention without a comprehensive assessment of the circumstances, including the availability of medicines, the costs of manufacturing, the financial implications and the interests of all affected stakeholders.

The Kerala High Court has now reserved its verdict after hearing the competing submissions. No final determination has been announced on whether the Central Government must invoke the relevant provisions of the Patents Act or whether any particular mechanism should be adopted to make the medicines more affordable.

The case is significant because it places the affordability of patented life-saving medicines within the broader legal discussion on public health, intellectual property rights and the statutory responsibilities of the government.

Arguments of the Parties:

Submissions of the Amicus Curiae

Amicus curiae Maitreyi Sachidananda Hegde placed before the Court the difficulties faced by cancer patients who require patented medicines but cannot afford their cost. Her submissions focused on the medical necessity of the drugs, the financial burden of treatment and the responsibility of the government to consider measures that could improve access to essential medicines.

A significant aspect of her argument concerned the differences between Palbociclib, Ribociclib and Abemaciclib. She submitted that Palbociclib could not simply be treated as a substitute for the two patented medicines because they have different toxicity profiles and may be prescribed in different clinical circumstances.

According to the amicus, Ribociclib is prescribed in certain early-stage breast cancer cases, whereas Palbociclib may be used in metastatic disease. She emphasised that early intervention is important in cancer treatment and argued that patients who cannot afford the prescribed patented medicine may be prevented from receiving timely treatment.

The submission was intended to demonstrate that the availability of a cheaper drug does not necessarily resolve the problem of affordability. If the less expensive medicine is not clinically appropriate for a particular patient, its availability cannot provide an effective alternative to the prescribed treatment.

The amicus also drew attention to the overall cost of cancer treatment. She submitted that the medicine accounted for approximately 36 per cent of the total treatment expenditure, which could include chemotherapy, surgery and other medical expenses.

She further stated that patients and their families frequently meet these expenses through borrowing money or pledging their assets. The financial burden, therefore, extends beyond the price of the medicine and may affect the ability of families to continue treatment.

Another concern raised by the amicus was the absence of a comprehensive scientific assessment of cancer diagnoses and deaths across different categories of cancer. She pointed out that there was no systematic or scientific study establishing the number of diagnoses and deaths reported for each type of cancer.

This submission highlighted the importance of reliable data in understanding the scale of the problem and determining whether existing public health measures adequately address the needs of patients requiring expensive medicines.

The amicus also raised the issue of gender inequality in access to healthcare. She submitted that women’s health frequently receives inadequate attention and that women may be expected to make sacrifices when family resources are limited.

In the context of breast cancer treatment, she argued that financial barriers could therefore have consequences beyond the immediate medical condition of the patient. The inability to afford prescribed medicines may place women in a particularly difficult position when treatment expenses compete with other household needs.

Referring to the circumstances of a newly impleaded cancer patient, the amicus submitted that the patient was able to afford the medicine because of insurance coverage. However, the insurance claim had reportedly been rejected on three occasions before being accepted.

She also expressed uncertainty about whether the insurance coverage would be renewed. According to the submission, dependence upon insurance does not necessarily provide a permanent solution when access to life-saving medicines is concerned.

The amicus accordingly argued that the affordability of patented medicines should not be considered solely in terms of whether some patients are presently able to obtain them. The broader question, according to her, was whether patients who require these medicines can access them without being exposed to severe financial hardship.

Reliance on Section 100 of the Patents Act

The amicus placed particular emphasis on Section 100 of the Patents Act, 1970, which concerns the use of patented inventions for government purposes.

She submitted that the provision permits government use for public purposes and that such use should be understood as including non-commercial use. According to her, the provision could provide a statutory basis for government intervention where patented medicines are required to meet public health needs.

The argument was that the government should examine the available powers under the Patents Act instead of allowing the high price of a patented medicine to remain an obstacle to treatment.

The amicus contended that the public health objective of the legislation required the Central Government to consider whether Section 100 could be invoked in the circumstances.

She also pointed out that two domestic companies had obtained approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture the medicines in question, although they had not applied for compulsory licences under the Patents Act.

This submission brought another dimension to the proceedings: whether the existence of domestic manufacturing capacity and regulatory approval could be relevant to a government decision concerning access to patented medicines.

The amicus maintained that the availability of statutory mechanisms should be examined in light of the public interest involved, particularly where the medicines are used in the treatment of a life-threatening disease.

Arguments advanced by Novartis

Senior Advocates Joseph Kodianthra and Hemant Singh appeared for Novartis, the company manufacturing patented Ribociclib.

Novartis opposed the proposed invocation of Section 100 and submitted that the statutory framework governing compulsory licensing had to be considered before government use could be authorised.

According to the company, Sections 84 and 92 of the Patents Act provide the relevant mechanisms for compulsory licensing, and Section 100 could not be invoked without first addressing the applicability of those provisions.

The company argued that the availability of a statutory mechanism for compulsory licensing could not be disregarded while considering a request for government intervention.

Novartis also informed the Court that Ribociclib was already being made available under a price arrangement involving a cap on trade margins. It submitted that the trade margin had been capped at 30 per cent.

The company relied upon this arrangement to contend that measures had already been taken concerning the pricing of the medicine.

Another central submission concerned the investment required to develop patented medicines. Novartis argued that pharmaceutical research and development involves substantial financial resources and that patent protection provides an incentive for companies to undertake such investment.

The company submitted that invoking Section 100 without adequately considering the interests of the patent holder could undermine the commercial basis upon which pharmaceutical research is conducted.

It argued that the development of a life-saving medicine requires substantial investment and that the patent system is intended to provide a period of protection during which the innovator can recover its investment and obtain a return.

Novartis further contended that the existence of complaints from a limited number of patients regarding affordability was not, by itself, sufficient to justify government intervention under the provision.

The company maintained that a decision affecting patent rights required consideration of the statutory requirements and the broader consequences for pharmaceutical innovation.

It also relied upon the public interest underlying the patent system. According to Novartis, the grant of a patent encourages companies to disclose their inventions rather than retain them as trade secrets.

The company submitted that patent protection ultimately benefits the public because the invention and its associated knowledge become available for public use after the patent protection period expires.

On this basis, Novartis argued that any intervention concerning the patented medicine had to account for both the immediate public health concerns and the longer-term objectives of the patent system.

Arguments advanced by Eli Lilly Pvt. Ltd.

Senior Advocate G. Shrikumar and Advocate Praveen Anand appeared for Eli Lilly Pvt. Ltd., the manufacturer of patented Abemaciclib.

Eli Lilly opposed the proposed intervention and submitted that the circumstances did not establish a national emergency warranting the exercise of the government’s powers under the Patents Act.

The company argued that the three medicines under consideration were substitutable and that there was no situation in which the medicines were unavailable.

It further informed the Court that it operated patient assistance schemes under which eligible patients could receive medicines free of cost in certain circumstances.

The company also submitted that cancer centres provided medicines at affordable prices, and that the Court should consider these existing arrangements before directing any further intervention.

A substantial part of Eli Lilly’s argument concerned the respective roles of the judiciary and the government. It submitted that decisions concerning the invocation of statutory powers under the Patents Act were matters for the government to determine in accordance with the legislation.

The company also highlighted the research and development process involved in discovering pharmaceutical medicines. It argued that developing a drug may take more than ten years and require investment running into billions of dollars.

Referring to the patent for the medicine in question, Eli Lilly submitted that although the patent application had been filed in 2008, the patent was granted only in 2018. It contended that the delay had reduced the period of effective patent protection available to the company.

The company maintained that the statutory patent framework must be respected because it seeks to balance the interests of innovators with the public interest.

According to Eli Lilly, the Patents Act is a self-contained legislation that already provides mechanisms for addressing public health concerns while protecting the legitimate rights of patent holders.

It argued that the Court should not direct intervention without considering the consequences for the patent system and the pharmaceutical industry.

The company accordingly submitted that the existing statutory arrangements, including patient assistance programmes and the possibility of obtaining medicines through cancer centres, had to be considered before any further action was contemplated.

Submissions of the Union Government

The Union Government opposed the proposition that the Central Government should be directed to invoke the relevant provisions of the Patents Act without a comprehensive examination of the circumstances.

Additional Solicitor General P. Sreekumar and Deputy Solicitor General O.M. Shalina appeared for the Union. Their submissions focused on the statutory framework governing patented medicines, the interests of patent holders and the practical implications of government intervention.

The Union submitted that the existing system governing the manufacture of patented medicines was intended to ensure that patent holders received the benefits and profits associated with their inventions. It argued that even where compulsory licensing is considered, the statutory framework recognises the need to protect the interests of the patent holder.

The government also pointed out that the suo motu proceedings had a wide scope, extending beyond the circumstances of the original petitioner to the broader question of exorbitant pricing of life-saving patented medicines.

It contended that if the Court were to consider directions affecting the manufacture or pricing of such medicines generally, all companies manufacturing the medicines concerned would have to be heard.

The Union further submitted that affordability had to be considered from the perspectives of both patients and manufacturers. According to the government, the question was not merely whether a medicine could be made available at a lower price, but whether the proposed mechanism was financially and practically sustainable.

The government argued that there was no single scientific study or reliable dataset establishing what price would necessarily make a particular patented medicine affordable to patients.

It also submitted that compulsory licensing or government use would not automatically establish that the medicine could be manufactured or supplied at an affordable price.

The Union maintained that competition in manufacturing could help bring down prices, but that any such approach would require the invocation of the relevant statutory provisions and an assessment of whether the circumstances justified their use.

It therefore argued that the Court should not presume that compulsory licensing or government use was warranted merely because the medicines were expensive.

The government also referred to the financial implications of establishing domestic manufacturing facilities. It submitted that the manufacture of such medicines would require investment in factories, machinery, raw materials and technical expertise.

According to the Union, these practical requirements had to be considered before assuming that local manufacturing would immediately resolve the affordability problem.

The Department of Pharmaceuticals also referred to existing government assistance measures. It submitted that central government schemes provided financial assistance of approximately Rs. 15 lakh or enabled eligible persons to obtain medicines free of cost, subject to the applicable conditions.

The Union accordingly urged the Court to consider the existing assistance mechanisms, the requirements of pharmaceutical manufacturing and the statutory interests of patent holders before directing any intervention.

Contentions of the party respondents

The counsel appearing for the husband of the original petitioner and the newly impleaded cancer patient placed before the Court the actual expenditure involved in obtaining the medicines.

According to their submissions, the annual cost of the medicines ranged from approximately Rs. 7 lakh to Rs. 10.8 lakh.

They argued that these expenses created a substantial financial burden for patients who required the medicines as part of their cancer treatment.

The party respondents submitted that where no affordable alternative is available for the prescribed treatment, the government has a responsibility to consider invoking the relevant provisions of the Patents Act.

Their submissions reinforced the central concern underlying the proceedings: whether the existing legal and administrative arrangements adequately enable patients to obtain medicines that may be necessary for their treatment.

They contended that the financial burden could not be assessed solely by examining the price of a medicine in isolation, particularly when patients also incur expenses for surgery, chemotherapy and other treatment-related services.

The party respondents therefore supported the need for government intervention, arguing that the statutory powers under the Patents Act should be examined in the context of the public health concerns raised before the Court.

Suggestions made by the intervnor

Advocate Rahul Bajaj, appearing in person as an intervenor, made several suggestions