Kerala HC Opens New Route for Government to Tackle Costly Patented Drugs

The Kerala High Court has given the Union government a fresh legal avenue to step in when patented life-saving medicines are priced beyond the reach of patients, holding that Section 100 of the Patents Act, 1970 can be invoked for public health purposes.

The case began in June 2022, when a breast cancer patient petitioned the court seeking government intervention to make ribociclib, a patented drug from Novartis AG priced at roughly ₹75,000 a month, more affordable. The petitioner died in September 2022, but the court continued the matter on its own motion, treating it as a wider public health question. It later widened the scope to include Eli Lilly's abemaciclib, another breast cancer therapy.

The court did not direct the government to invoke the provision immediately, nor did it set a timeline. Instead, it asked the Centre to gather data on how many patients need the medicine, how many cannot afford it, and whether existing subsidies and price-control measures are working. It also made clear that a high price alone does not justify government intervention, and that each drug must be examined thoroughly.

On the question of alternatives, the court concluded that Pfizer's palbociclib, which lost exclusivity in 2023 and is cheaper, cannot be treated as interchangeable with ribociclib. The three drugs belong to the CDK4/6 inhibitor class of targeted therapies and are used for certain breast cancers, but are not substitutes for one another.

Section 100 permits the Centre to use a patented invention for the "purposes of government". The court examined whether this covered only medicines needed for direct government use or extended to supplies for individual patients. It held that the provision is broad enough to let the government, or someone authorised by it, use a patented medicine and supply it to needy patients on a non-commercial basis. The ruling linked this power to the state's obligation to protect public health under Article 47 of the Constitution and to the public health principles in Section 83 of the Patents Act.

Until now, the main route for third-party production or sale of a patented invention without the patent holder's consent has been compulsory licensing, which can be invoked in specified circumstances, including when a drug is not available at a reasonably affordable price. India has issued such a licence only once, in 2012, to Natco Pharma for Nexavar (sorafenib tosylate), a kidney and liver cancer drug patented by Bayer.

Legal experts said the judgment tries to balance patent protection with public health needs. Gitika Suri, director-patents at Cyril Amarchand Mangaldas, said the ruling is calibrated to preserve patent sanctity rather than erode it, noting that the court was explicit that recognising a government-use route does not compromise the patentee's underlying exclusivity. Sudarshan Singh Shekhawat, advocate, patent attorney and founder of Shekhawat Law, said the decision gives the government another legal option to make expensive life-saving drugs accessible.

Others flagged risks. Amit Panigrahi, a partner at Kochhar & Co. who handles the intellectual property practice, said the confirmation that the government can override a patent based solely on pricing data creates a regulatory risk that could make companies more cautious about investing in or launching expensive patented medicines in India. Tushar Gulati, associate partner at Dentons Link Legal, described a policy tension between innovators and access, noting that while companies invest heavily in research and development and rely on predictable patent protection, exclusivity can create an access problem when a life-saving medicine is priced beyond the reach of a substantial section of patients.

The implications for patients could be significant. India recorded over 237,000 new breast cancer cases in 2024, according to World Health Organization data. Access to specialised treatments remains a persistent challenge: a 2022 study by the Tata Memorial Centre found that fewer than 3% of patients in India had access to immunotherapies. Patient rights experts believe the judgment could extend to other life-saving drugs, though the absence of a direct order or deadline leaves the immediate impact uncertain.