KOCHI: The Kerala High Court on Monday directed the Union government to collate data on the affordability of patented life-saving medicines and assess whether existing price control and subsidy measures were benefiting cancer patients, while also observing that the Centre had the right to use a patented invention for government purposes without its holders’ permission.
Hearing petitions filed by two breast cancer patients, one of whom died while the case was pending, Justice Harisankar V Menon observed that the government had not placed on record data required to determine whether patented cancer medicines were affordable. He said data on the number of persons affected by this type of cancer, those consuming patented medicines and those not consuming it citing high prices should be collected from hospitals.
Saying there could be no doubt that the government was required to provide all necessary facilities to citizens to ensure access to healthcare, including life-saving treatment, the HC observed that the Centre can invoke Section 100 of the Patents Act, which allows it, or a person it authorises, to use a patented invention for government purposes without the permission of the patent holder. “The government, people and stakeholders...should ensure no man is refused or refuses treatment exclusively due to financial constraints,” the court said.
In her petition filed in 2022, one of the patients, a retired bank employee getting monthly pension of `28,400 then, had submitted that she was undergoing targeted therapy and Ribociclib was one of the medicines used. It cost about `58,140 for 21 days, with three tablets required per day. She had contended that steps were needed to reduce the cost of such medicines.
‘Ribociclib unaffordable for majority of population’
Although she died while the case was pending, the court decided to proceed with the matter considering the larger public interest. Her husband, also a retired bank employee with a monthly pension of `46,000 then, had submitted that its high price had made Ribociclib unaffordable for his spouse.
Another patient submitted that she had to spend around `7.90 lakh annually on Ribociclib. The petitioners argued that India’s per capita income was `2.19 lakh and that this indicated that Ribociclib was unaffordable for a majority of the population.
The manufacturers of Ribociclib argued that Section 100 of the Patents Act could be invoked only when the patented invention is required to be used exclusively “for the purposes of government”. They contended that pricing could not be a criterion for denying or restricting a patent.
The Union government counsel submitted that it had reduced basic customs duty on Ribociclib with effect from February 1. As a result, the price of 21 tablets, which was `24,355 during January and March, came down to `22,217.85 in April, before rising again to `22,335 in July. The HC ruled that the Centre was required to intervene in instances where a medicine manufactured on the basis of a patent was being sold at an exorbitant price.
