Kochi, September 30 (APAC Media): The Kerala High Court has opened a significant legal route for government intervention when patented life-saving medicines become prohibitively expensive. The order came in a case involving ribociclib, a patented breast cancer medicine manufactured by Novartis that was cited as costing around Rs 75,000 a month.
Kerala High Court has directed the Union Government to collect data on their affordability before deciding whether to exercise its powers under the Patents Act.
Justice Harisankar V. Menon, while hearing a case concerning the high cost of patented breast cancer medicines, said the Centre can invoke Section 100 of the Patents Act, 1970 to use a patented invention for government purposes without the permission of the patent holder. The court also said this power can extend to manufacturing a patented medicine and supplying it to needy patients on a non-commercial basis.
However, the court did not direct the Centre to immediately invoke Section 100 for ribociclib. Instead, it directed the government to collate relevant data and determine whether a particular life-saving medicine is affordable and whether government intervention is necessary.
What the Kerala HC Said About Expensive Cancer Drugs?
The proceedings originated from a 2022 petition filed by a breast cancer patient who sought affordable access to ribociclib, a patented medicine used in breast cancer treatment.
The patient, a retired bank employee, had stated that the medicine cost around Rs 58,140 for a 21-day course, with three tablets required per day. She died while the case was pending, but the High Court decided to continue examining the issue in the larger public interest. Another patient told the court that she was spending around Rs 7.90 lakh annually on ribociclib.
The court observed that sufficient data had not been placed before it to determine whether patented cancer medicines were genuinely affordable for patients.
It directed that information be collected on the number of people affected by the relevant cancer, those using patented medicines and those who are unable to use them because of high prices.
What Is Section 100 of the Patents Act?
Section 100 allows the Central Government, or a person authorised by it, to use a patented invention for government purposes without requiring the patent holder’s permission.
The Kerala High Court’s interpretation is significant because it said government use can include manufacturing a patented medicine and selling or supplying it to a person, including a needy patient, on a non-commercial basis. The court also identified exorbitant pricing as a circumstance in which government intervention may be required.
This does not mean that every expensive patented medicine will automatically be brought under government use. The court specifically left the decision to the Centre after the necessary affordability data is collected.
Why Ribociclib Became the Centre of the Case
The case also examined whether palbociclib, another breast cancer medicine whose patent has expired and which is available at a lower price, could be treated as an alternative to ribociclib.
The High Court considered material from cancer treatment institutions and the Drugs Controller General of India. Based on the evidence placed before it, the court did not accept the argument that the two medicines could simply be treated as interchangeable.
The manufacturers, meanwhile, opposed government intervention, arguing that Section 100 could not be invoked merely to reduce the price of a patented medicine and stressing the importance of patent protection. The Centre also pointed to existing price-control measures and a reduction in basic customs duty affecting ribociclib prices.
What the Verdict Could Mean for Patients
The immediate outcome is not a reduction in the price of ribociclib. Instead, the judgement places affordability data at the centre of any future decision on government intervention.
The ruling could provide a legal reference for examining access to other patented life-saving medicines where high prices are shown to prevent patients from accessing treatment. Any such action, however, would still depend on the Central Government’s assessment, the applicable provisions of the Patents Act and the specific circumstances of each medicine.
Could Other States Follow This Approach?
The judgement concerns the Central Government’s powers under the Patents Act, rather than creating an automatic mechanism for state governments to override patents.
However, the approach could become a reference point for states seeking stronger evidence on the affordability and accessibility of high-cost medicines. States could potentially use the broader policy discussion around price monitoring, subsidies, procurement and patient access to identify medicines where financial barriers are preventing treatment.
The Kerala High Court’s emphasis on collecting actual data from hospitals also points towards an evidence-based approach to assessing affordability rather than relying only on the listed price of a medicine.
The larger question now moves to the executive: whether the Centre, after collecting and analysing the required data, decides to use the powers available under Section 100 for medicines found to be unaffordable.
