People with drug-resistant tuberculosis in India could soon have access to critical medication at a far lower cost after the authorities rejected US pharmaceutical giant Johnson & Johnson’s application to extend a patent.
The firm wanted to extend its patent on bedaquiline, which expires in July, until 2027, which would have prevented cheaper generic versions reaching the market.
It was seen as a victory for two women who have been fighting to make a drug for the disease affordable to all. Nandita Venkatesan from India and Phumeza Tisle from South Africa filed a petition in 2019 with the Indian Patent Office to stop Johnson & Johnson’s application, a petition supported by the medical NGO Médecins Sans Frontières (MSF).
The decision by the patent office opens the door for other companies to produce accessible versions, with some health experts estimating that the costs of treatment could be cut by 80%, from $46 (£37) a month per patient to $8 (£6.50).
Given that India sends generic drugs to many low-income countries, this breakthrough will help patients in states that obtain their TB drugs through the World Health Organization.
Bedaquiline is considered the last resort for those with advanced TB. Like most treatments for drug-resistant TB, it has unpleasant side-effects, but when the FDA approved it in 2012 it was the first new drug for the disease in 40 years.
Pharmaceutical companies in India have started work on generic versions of the drug. Some have submitted data to the WHO and have pre-qualified to become suppliers. A version is expected to be available as soon as August.
Venkatesan, who lost her hearing in 2013 as a result of treatment for intestinal TB and has had to endure years of painful operations and injections, said she could not hold back tears when the patent office announced its decision on Friday.
“The verdict is too late for me, my hearing has gone for good. But the fight had to be fought because if something better and easier is available, then why shouldn’t patients have access to it?” said the 33-year-old journalist from Mumbai.
Leena Menghaney, a global intellectual property adviser at MSF in New Delhi, said: “Bedaquiline was a breakthrough drug for TB and now it’s going to be more easily available.” Johnson & Johnson’s “evergreening” – continuously extending patent rights – was “unacceptable”, she said. “All the company did was change the compound into a salt to justify an extension.”
India has the highest burden of TB and drug-resistant TB in the world. More than 1,000 Indians a day die of the disease.
Covid made the situation worse. A WHO global report last year found that India had 18% more cases in 2021 than in 2020 – a consequence largely of the pandemic and lockdowns as patients were unable to visit clinics to get tested or collect medicines. The number of TB cases detected in April 2020 fell by 80% from the previous April as Indians missed test appointments and some labs closed.
India’s target is to end TB by 2025, five years earlier than the global deadline of 2030.
Bedaquiline is procured by the Indian government for its TB programme and is available in most TB clinics in large cities, but not in smaller towns and in rural areas. “Now, when the price of the generic version comes down, it will be much cheaper for the government to buy, and this will make it more accessible,” said Venkatesan.
She understood the argument made by Johnson & Johnson that the massive cost of developing a new drug has to be recouped through patents. “But their patent lasted 20 years. That’s a good chunk. Why try to extend it? Why not be cognisant of the fact that lives are at stake?”
