In a significant development, the Indian Patents Office on Thursday rejected an application of global pharma major Johnson and Johnson seeking extension of its patent on anti-Tuberculosis (TB) drug Bedaquiline beyond July 2023, when it is set to expire.
The judgment was given in a plea filed by two TB survivors — Nandita Venkatesan and Ilaria Motta, a medical advisor for Médecins Sans Frontières/Doctors Without Borders (MSF), in 2019.
The patents office invoked Section 3 (d) in its judgment as the Indian patent law does not allow evergreening of patents and prevents pharma majors from extending the patent beyond the stipulated monopoly on the drug.
Bedaquiline is essentially used in the treatment of drug-resistant TB patients and rejection of the patent extension would open the doors for drugmakers to produce generics at a cheaper price.
“There are half a dozen Indian drugmakers who have the capability to produce Bedaquiline generic as soon as possible,” the director of a major Hyderabad-based pharma told businessline.
There has been no official response from J&J on the development till the time of going to press.
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Nandita Venkatesan said the price of J&J drug has been a barrier for many in India. “It costs about ₹21,000 for a six-month course for drug-resistant TB patients. The judgment leads to much cheaper availability of this drug,” she said.
As of now, Bedaquiline is supplied only through government procurement. A reduction in price would apparently expand the reach of the drug to the poor TB patients. “The development needs to be welcomed as lots of TB patients who can’t afford these drugs can access them and get relief,” K Hari Prasad, President, Apollo Group of Hospitals, said.
According to WHO’s Global TB report 2022, 1.4 lakh TB cases were notified in India in 2021, a growth of 18 per cent from 2020 levels. As per the Government of India data, over 22 crore people screened for TB in 2021 across the country for early detection and treatment of TB.