Subscribe
Follow TNM's WhatsApp channel for news updates and story links.
In a ruling on Monday, September 28, the Kerala High Court held that the Union government can invoke Section 100 of the Patents Act to override pharmaceutical patents to enable the government to manufacture and supply life-saving drugs to underprivileged patients on a non-commercial basis.
The order was issued while considering a petition filed in 2022 by a woman seeking to reduce the cost of life-saving breast cancer drugs.
The woman, identified as Sarojam Radhakrishan, who was diagnosed with advanced-stage breast cancer in 2021, approached the High Court in 2022 to make it affordable. She died while the case was pending, but her petition continues to be heard after the court took it up suo motu.
Justice Harisankar V Menon delivered the order, clarifying that the government can invoke Section 100 of the Patents Act, 1970, if a patented life-saving medicine is being sold at an exorbitant price.
Section 100 allows the Union government and those authorised by them to use any patented invention for government purposes at any time after a patent application has been filed or granted.
“Section 100 of the Act is required to be invoked in circumstances where the government is required to intervene, such as an instance where a medicine manufactured on the basis of a patent is being sold at an exorbitant price. The government is required to collate the required data and arrive at a decision as to whether a particular medicine is affordable or not and, on that basis, proceed in accordance with Section 100 of the Act, if found necessary,” the order said.
Following the diagnosis, Sarojam was prescribed three medicines – Ribociclib, Letrozole and Zoledronic Acid – which cost her Rs 63,480 per month. Though she and her husband had retired as bank employees and were not financially constrained, the expensive medical bills started taking a toll.
In February 2022, Sarojam approached the Kerala High Court with a plea. She wanted the court to order compulsory licensing or have a government use licence to make these medicines affordable to people.
Over the past four years, her case has been heard by eight different judges in 58 sessions and has been adjourned 40 times.
