Kerala High Court expands Union government’s power to intervene in pricing of patented drugs

Kochi: Kerala High Court, in a landmark judgment with far-reaching implications on accessing life-saving medicines, has significantly expanded the scope of the Union govt’s power to intervene in the pricing of patented drugs.A bench of Justice Harisankar V Menon ruled that Section 100 of the Patents Act, 1970, empowers govt to use a patented invention for the “purposes of govt”, including manufacturing and selling essential medicines on a non-commercial basis to needy patients. The judgment was delivered ona petition originally filed by a breast cancer patient who succumbed to her illness while the plea was pending. The court continued the case suo motu in public interest, focusing on the exorbitant prices of patented cancer drugs such as Ribociclib, which costs more than Rs 58,000 for a 21-day course. Another breast cancer patient who was impleaded in the petition also claimed that she had to spend around Rs 7.90 lakh a year on Ribociclib.The court rejected the narrow interpretation of Section 100 advanced by the Union govt and pharmaceutical companies, which argued that it applied only to direct govt use. The bench further held that the provision’s clear language, particularly sub-sections (4) and (6), allows the govt to authorise any person to manufacture and sell patented medicines on a non-commercial basis. The court linked this power directly to the State’s constitutional duty to improve public health under Article 47 and protect the right to life under Article 21 of the Constitution.While refraining from issuing a direct mandamus, the court declared that Section 100 must be invoked when a patented medicine is sold at an exorbitant price. It directed the Union govt to collect comprehensive data on the affordability of such drugs and the number of patients affected to determine whether intervention is necessary.The judgment also settled a key factual dispute, noting that Ribociclib and Palbociclib are not interchangeable, as they are used for different stages of cancer. The decision followed consideration of expert opinions from the Drug Controller General of India and various national research institutions. The ruling marks a significant judicial push to make essential medicines more accessible, balancing patentees’ rights with the State’s obligation to protect public health.The petition filed in 2022 was listed for final hearing 57 times since Jan 21, 2023, without being heard. Recently, TOI reported that a working group on access to medicines wrote to the Chief Justice of India, requesting administrative steps to expedite the final hearing and stating that timely adjudication was essential for patients who urgently require these medicines.A cinematic reminder of the cost of cancer careThe court concluded the judgment with a moving epilogue invoking M T Vasudevan Nair’s acclaimed film Sukrutham, which depicts the plight of cancer patients and their caregivers. In the film, the protagonist tells his doctor that he will not opt for further treatment, delivering a heartbreaking monologue on how families pledge their entire lives to afford medical care, only to be buried in debt.The court observed that despite more than three decades having passed since Sukrutham won national and state accolades, the situation remains unchanged. Urging a joint effort by govt, people and stakeholders, the court called for ensuring that no one is denied treatment solely because of financial constraints, while maintaining a balance between affordable access and adequate incentives for innovation.You Can Also Check: Gold Rate in Kochi | Silver Rate in Kochi | Bank Holidays in Kochi | Public Holidays in KochiStay updated with the latest Kochi news. Download the TOI App.