People with drug resistant tuberculosis in India could have access to critical medication at a much lower cost after the authorities rejected Johnson Johnson's application to extend a patent.
The patent on bedaquiline was due to expire in July, but it wanted to extend it 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 affordable to all. 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 are working on generic versions of the drug. Some of the data has been submitted to the WHO and have been 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.
My hearing went for good, and the verdict is too late for me. The fight had to be fought because if something better and easier was available, then why shouldn't patients have access to it? A 33-year-old journalist from Mumbai said so.
Leena Menghaney, a global intellectual property adviser at MSF in New Delhi, said: Bedaquiline is a breakthrough drug for TB and now it's going to be more easily available. She said Johnson Johnson's constant extending patent rights was unacceptable. The compound was changed into salt to justify an extension. India has the highest burden of TB and drug-resistant TB in the world. More than 1,000 Indians die every day of the disease.
Covid made the situation worse. In the last year, a WHO global report found that India had 18% more cases in 2021 than in 2020, a result of the pandemic and lock-ins, because 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 has a target of ending 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 small towns and rural areas. When the price of the generic version comes down, it will be cheaper for the government to buy, and this will make it more accessible, said Venkatesan.
She understood Johnson's argument that the huge cost of developing a new drug has to be recouped through patents. Their patent lasted for 20 years. That is a good chunk.