A petition before the Kerala High Court has brought an old but consequential urban public-health question into sharp focus: how can patients access patented cancer medicines when the price charged in India is many times higher than estimates of their manufacturing cost? The case concerns ribociclib, sold by Novartis, and abemaciclib, sold by Eli Lilly, two breast cancer drugs whose prices and sales have become central to arguments over affordability, innovation and government intervention.
Novartis and Eli Lilly have opposed the petition seeking government action to make the medicines cheaper. Their counter-affidavits argue that the companies incurred substantial costs in developing the drugs, although the submissions did not provide specific figures for those expenses, according to the report on which this account is based. The court is considering the petition against evidence placed before it about global revenues, India sales, clinical-trial expenditure and manufacturing costs.
The dispute is not only about two medicines or one court proceeding. It shows how access to advanced treatment is shaped by the interaction between patent rights, pricing, clinical research, manufacturing, public regulation and household finances. For patients, the policy debate becomes a monthly cost of treatment. For the state, it raises the question of how far government intervention can go when private companies hold patents over medicines used in serious illnesses.
What the India sales figures show
Data placed before the court indicates a significant difference between the drugs’ global revenues and their sales in India. Novartis generated about $12.7 billion from ribociclib sales worldwide between 2020 and 2025, while sales of the drug in India during the same period were reported at $55.7 million. That represented about 0.4% of its global revenue from the medicine.
Eli Lilly’s abemaciclib generated $19.6 billion globally during the period, compared with $31.5 million in India, or about 0.16% of worldwide sales. The India figures were sourced from market research firm IPSOS, while global revenue figures were based on disclosures by the drugmakers.
These figures do not by themselves establish what either company should charge in India. They do, however, provide the court with a basis to examine the relationship between the Indian market, global returns and the affordability of treatment. A small share of global revenue can still represent a substantial burden for patients if treatment costs are high relative to household incomes and insurance coverage.
The report does not provide information on the number of Indian patients using either medicine, the proportion of treatment financed out of pocket, or the extent of insurance coverage. Those missing details matter because total India sales cannot, on their own, show how the cost is distributed across patients or how many people may be unable to begin or continue treatment.
The manufacturing-cost argument
The petition has also placed estimates of manufacturing costs before the court. Yale University drug-costing expert Melissa Barber estimated that producing a 200 mg ribociclib tablet would cost about $0.85, or approximately Rs 81, when the active pharmaceutical ingredient is manufactured in-house. The estimate rises to about $1.29, or roughly Rs 123, when the active ingredient is imported.
The prescribed regimen cited in the case involves three tablets a day for 21 days. On the basis of those estimates, the monthly manufacturing cost would be about Rs 5,100 to Rs 7,750. The price charged by Novartis in India was cited as Rs 78,400 a month. The comparison therefore places the retail price at a substantially higher level than the production estimates submitted to the court.
Manufacturing cost is not the same as the final price of a medicine. A final price can also reflect research and development, clinical trials, regulatory compliance, distribution, marketing, taxes, financing, failed candidates and the recovery of investment across markets. The court submissions have consequently focused not only on production but also on the cost of developing the medicines.
The companies have argued that they incurred substantial development costs. At the same time, the supplied report says they did not provide the court with specific figures for those expenses in their counter-affidavits. That leaves the court to assess competing estimates rather than a single agreed accounting of what the drugs cost to bring to market.
Why drug-development estimates are contested
An affidavit filed by Jamie Love, executive director of the US-based Knowledge Ecology International, estimated that Novartis spent $494.5 million on clinical trials for ribociclib. The same affidavit estimated that Lilly spent more than $469 million on clinical trials for abemaciclib.
A separate calculation submitted by two respondents, including advocate Majida MA, who is undergoing treatment for breast cancer, placed the estimated clinical-trial costs higher. It calculated about $667.5 million for ribociclib and more than $633 million for abemaciclib. The calculation used a more recent estimate of the cost per clinical-trial participant from a 2024 paper published in JAMA Network Open.
The difference between these estimates illustrates why the cost of pharmaceutical innovation is difficult to settle through a single headline figure. The court has also been presented with a Tufts Center for the Study of Drug Development estimate that bringing a prescription drug to market costs about $2.6 billion. The centre receives substantial funding from the pharmaceutical industry and bases its estimates on data supplied by drug companies.
That $2.6 billion estimate has faced criticism over claims that it may overstate development costs and support pharmaceutical companies’ justification for high prices. Even using it as a broad benchmark, the sales figures cited in the case indicate that the combined global revenues from the two drugs have exceeded that amount by several multiples. The comparison does not resolve how revenues should be allocated between products, markets and development programmes, but it is central to the affordability argument presented before the court.
The generic competition question
India’s generic-drug industry provides the petition with examples of how prices can change when patent-protected medicines face generic competition. The case cites Bayer’s patented kidney and liver cancer drug Nexavar, which was priced at about $5,500 a month, while Natco’s generic version cost around $175.
It also refers to the hepatitis C treatment combination of sofosbuvir and daclatasvir. The medicines reportedly cost almost $150,000 in the United States before generic production brought the price in India to about $200-$350. These examples are being used to demonstrate the potential scale of price reduction after generic production begins.
They do not establish that the same price movement would occur immediately for ribociclib or abemaciclib. The drugs in the present case remain linked to patent rights held by Novartis and Eli Lilly, and the petition is seeking government intervention in that context. The examples instead place the current dispute within a broader question about what happens to access when competition is legally or commercially restricted.
What the court is being asked to examine
The Kerala High Court is considering the petition against a conflict between two public objectives. One is the protection of intellectual property and the recovery of investment in research and clinical development. The other is the need to make life-extending treatment available at prices that patients can afford.
The supplied material does not indicate that the court has reached a final decision or ordered a price reduction. It shows that the court has received competing submissions on sales, clinical-trial costs and manufacturing estimates, while the drugmakers have opposed the request for intervention. The eventual legal assessment will have to distinguish between estimates, company assertions and established financial or regulatory records.
The case also shows the limits of looking at medicine affordability only through the lens of the retail price. The final cost to a patient depends on the prescribed dosage, duration of treatment, availability of insurance or public support, distribution arrangements and whether lower-priced alternatives are legally and medically available. The supplied report does not provide those patient-level details, but their absence is itself significant for any wider assessment of access.
For Indian cities, the issue is tied to the functioning of public-health systems and household finances. Specialist cancer care is concentrated in urban hospitals, while the cost of medicines can determine whether treatment is continued after diagnosis. A court dispute over two drugs therefore reaches beyond pharmaceutical balance sheets: it concerns the capacity of urban health services to connect patients with treatment that exists medically but may remain financially out of reach.
The Kerala case confirms the scale of the disagreement but not its final resolution. The evidence before the court points to a wide gap between the Indian price of ribociclib and submitted manufacturing-cost estimates, while the companies maintain that development expenditure must be considered. The next significant development will be the court’s consideration of these competing claims and the petition’s request for government intervention to improve access to the two breast cancer treatments.
