NEW DELHI: In a major development, the Indian Patents Office on Thursday rejected global pharma major Johnson & Johnson (J&J) application seeking an extension of its patent on anti-Tuberculosis (TB) drug Bedaquiline beyond July 2023, when it is set to expire.
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 as it will break the monopoly of the pharma major on a key anti-Tuberculosis drug.
This will also 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 patients 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 TB survivors -- had filed pre-grant opposition against the application.”
“Bedaquiline is a key anti-TB drug for people with severe forms of TB that has been shown to improve cure rates and have lesser side effects. I can't think of better news ahead of #WorldTBDay2023!,” 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 due to toxic injected drugs.”
“We are thrilled to see that our attempt to break the monopoly of a pharmaceutical corporation over this lifesaving drug has been successful. This win needs to be followed by the scale-up of shorter oral TB treatment regimens by TB programmes globally to reduce unnecessary suffering caused by older toxic drugs and treatment regimens,” she added.
Dr Ilaria Motta, TB Medical Advisor for MSF’s Access Campaign, urged generic manufacturers to use this opportunity to enter the market and produce and supply quality-assured generic versions of the lifesaving TB drug bedaquiline without the fear of litigation hanging over their heads.
“With more affordable generic versions of bedaquiline likely to become available soon, governments worldwide must act now to roll out the shorter oral regimen for patients with drug-resistant TB, as recommended by the WHO, into their national guidelines so that everyone who needs it has access.”
“In addition, to ensure that more people affected by drug-resistant TB are swiftly and adequately treated, governments should ensure access to early and adequate diagnosis for all people suspected of having TB and drug-resistant TB.”
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 percent 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, the WHO said.
