TB treatment cost likely to come down as patent for key drug by Johnson and Johnson rejected

NEW DELHI:  In a major development, the Indian Patents Office on Thursday rejected global pharma major Johnson and Johnson’s (J&J) application seeking an extension to its patent on anti-Tuberculosis (TB) drug Bedaquiline beyond July 2023.

The news, which came on the eve of World TB Day, will help bring down the treatment cost for the disease that affects the lungs. The development will break the monopoly of the pharma major on the key anti-Tuberculosis drug.

This will open doors for Indian manufacturers to manufacture generic medicines at an affordable cost. The life-saving drug is combined with other medicines to treat tuberculosis when the first line of treatment fails. The judgment was given in a plea filed by two TB survivors, Nandita Venkatesan, a two-time TB survivor, and Phumeza Tisile, another TB survivor from South Africa.

The patent office invoked Section 3 (d) in its judgment as the Indian patent law does not allow the evergreening of patents and prevents pharma majors from extending the patent beyond the stipulated monopoly on the drug. Tweeting the announcement, Venkatesan said, “We did it! In a landmark verdict, the Indian Patent Office rejected Johnson and Johnson’s patent application to extend the monopoly on key anti-TB drug #Bedaquiline! @ptisile and I – both of us TBsurvivors — had filed pre-grant opposition against the application.”

“Bedaquiline is a key anti-TB drug for people with severe TB that has been shown to improve cure rates and have lesser side effects,” she tweeted. Venkatesan, in a statement by Médecins Sans Frontières/Doctors Without Borders (MSF), said, “My fellow TB survivor Phumeza Tisile from South Africa and I filed a patent challenge against J&J in 2019, because we wanted to ensure that the safer, oral and more efficacious drug Bedaquiline was available to all people who need it and to make sure that no one ever has to endure side effects like we did, such as permanent hearing loss.”

A total of 21.4 lakh tuberculosis (TB) cases were notified in India in 2021 — 18 per cent higher than in 2020 — with over 22 crore people screened nationwide for early detection and treatment, according to the WHO’S Global TB report. With 28 per cent of cases, India was among the eight countries accounting for more than two-thirds (or 68.3 per cent) of the total TB patients’ count.

No ever-greening, drug prices set to fall

Indian Patents Office rejects J&J request for for an extension of its patent on anti-TB drug beyond July 2023

The decision will lower the cost as it will break the monopoly of the pharma major

The patent office in its judgment says the Indian law doesn’t allow the evergreening of patents