Nandita Venkatesan and South African Phumeza Tisle, two TB survivors, filed an application challenging the patent application of Johnson and Johnson to extend their patent on bedaquiline, an important drug for drug-resistant TB in February 2019. With the drug becoming part of all recommended short-drug regimens for DR-TB, the Indian Patent Office’s rejection of the J&J application assumes considerable significance for making bedaquiline affordable, by allowing generic manufacture of the drug. Venkatesan talked to Rema Nagarajan about what drove her and Tisle to file their application and the implication of this decision on DR-TB treatment.What made you decide to file the application? Both Phumeza and I are TB survivors. I ended up losing my hearing, a known side effect of the kanamycin injection I took as part of the treatment for my second bout of TB. In Phumeza’s case, she had XDR-TB or extremely drug-resistant TB. As a result of the treatment, she too lost her hearing. People say at least you are done with TB, but the hearing loss has completely changed my life. People ought to have access to safer drugs and as both of us were already involved in advocacy for better access to TB drugs we decided to file the pre-grant opposition.How did you and Phumeza decide to team up? Many people suffer from varying degrees of hearing loss due to TB treatment but Phumeza is the only one I know who, like me, had suffered this extent of hearing loss and needed a cochlear implant. I had read about Phumeza as she was very active in South Africa’s access campaign. Then we met in person in the Hague during a TB conference and we realised that we were doing the same kind of work. Médecins Sans Frontières’ access campaign in India and Lawyers’ Collective had discussed with me about filing against J&J’s application to extend their patent. We thought it would be good to get Phumeza on board as she also had been vocal and both of us had similar journeys and South Africa had done very good work on TB and on improving access to bedaquiline. I did research on my own, talked to experts like Dr Zarir Udwadia and then asked my parents who asked me to go ahead. 98982904Why is bedaquiline so important? WHO has said that bedaquiline is the backbone of the multidrug-resistant TB treatment regimen. The current regimen is two years, but that can go up to three or even four years if the medicines do not work. It has now come down to one year, but the access problem remains. There was no option of bedaquiline when I was undergoing treatment. I had to take kanamycin, which is given as an injection for 100 days. TB patients have very little mass and injecting someone very thin in the butt can be very painful. Being made to swallow a pill is much better. You need someone to administer the injection rather than me being able to take it myself, like during the pandemic when you could not go to a healthcare facility.Most patients with multidrug-resistant TB are given bedaquiline right at the beginning so that the disease doesn’t progress much after that. The government itself is moving towards a shorter regimen. The shorter regimen is not possible without this medicine. Shorter and all-oral regimen. ShowBlurbsWhy was it important to oppose J&J’s application? Though the momentum for a shorter regimen has been gaining everywhere, the cost of bedaquiline was a barrier. Even the Indian government is procuring it at Rs 21,000 per patient for a six-month regimen. A person with a severe form of TB might need one more round of bedaquiline and so six months may not be enough. J&J has been supplying to India since 2015, which was the time when it started limited donation of the drug. But if more and more patients need to get it, the price has to come down. J&J’s patent expires in July this year. Their application was an attempt to extend the patent till 2027. A few generic companies in India have shown interest in producing it. Researchers say that from $45 per person per month, the cost can come down by 85% to $8-10 per person per month if generic production starts. Nothing changes for me if access improves. No part of my life is going to get reversed. It is just that when something better is available, why shouldn’t patients get it? It’s the best news for World TB day (on Friday) that the patent office has rejected J&J’s application and upheld our opposition.
