Johnson & Johnson’s utility for patent extension on key TB drug rejected  

Express News Service

NEW DELHI: In a significant growth, the Indian Patents Office on Thursday rejected international pharma main Johnson & Johnson (J&J) utility searching for an extension of its patent on anti-Tuberculosis (TB) drug Bedaquiline past July 2023, when it’s set to run out.

The information, which got here on the eve of World TB Day, will assist carry down the remedy value for the illness that impacts the lungs as it’ll break the monopoly of the pharma main on a key anti-Tuberculosis drug.

This can even open doorways for Indian producers to fabricate generic medicines at an inexpensive value.

The life-saving drug is mixed with different medicines to deal with tuberculosis sufferers when the primary line of remedy fails.

The judgment was given in a plea filed by two TB survivors, Nandita Venkatesan, a two-time TB survivor, and Phumeza Tisile, one other TB survivor from South Africa.

The patent workplace invoked Section 3 (d) in its judgment because the Indian patent regulation doesn’t permit the evergreening of patents and prevents pharma majors from extending the patent past the stipulated monopoly on the drug.

Tweeting the announcement, Venkatesan stated, “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 press release by Médecins Sans Frontières/Doctors Without Borders (MSF) stated, “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 producers to make use of this chance to enter the market and produce and provide quality-assured generic variations of the lifesaving TB drug bedaquiline with out the concern 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 complete of 21.4 lakh tuberculosis (TB) instances have been notified in India in 2021 – 18 per cent increased than in 2020 – with over 22 crore individuals screened nationwide for early detection and remedy, in accordance with the WHO’S Global TB report.

With 28 p.c of instances, India was among the many eight international locations accounting for greater than two-thirds (or 68.3 per cent) of the overall TB sufferers’ depend, the WHO stated.

NEW DELHI: In a significant growth, the Indian Patents Office on Thursday rejected international pharma main Johnson & Johnson (J&J) utility searching for an extension of its patent on anti-Tuberculosis (TB) drug Bedaquiline past July 2023, when it’s set to run out.

The information, which got here on the eve of World TB Day, will assist carry down the remedy value for the illness that impacts the lungs as it’ll break the monopoly of the pharma main on a key anti-Tuberculosis drug.

This can even open doorways for Indian producers to fabricate generic medicines at an inexpensive value.googletag.cmd.push(perform() googletag.show(‘div-gpt-ad-8052921-2’); );

The life-saving drug is mixed with different medicines to deal with tuberculosis sufferers when the primary line of remedy fails.

The judgment was given in a plea filed by two TB survivors, Nandita Venkatesan, a two-time TB survivor, and Phumeza Tisile, one other TB survivor from South Africa.

The patent workplace invoked Section 3 (d) in its judgment because the Indian patent regulation doesn’t permit the evergreening of patents and prevents pharma majors from extending the patent past the stipulated monopoly on the drug.

Tweeting the announcement, Venkatesan stated, “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 press release by Médecins Sans Frontières/Doctors Without Borders (MSF) stated, “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 producers to make use of this chance to enter the market and produce and provide quality-assured generic variations of the lifesaving TB drug bedaquiline with out the concern 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 complete of 21.4 lakh tuberculosis (TB) instances have been notified in India in 2021 – 18 per cent increased than in 2020 – with over 22 crore individuals screened nationwide for early detection and remedy, in accordance with the WHO’S Global TB report.

With 28 p.c of instances, India was among the many eight international locations accounting for greater than two-thirds (or 68.3 per cent) of the overall TB sufferers’ depend, the WHO stated.