The Indian Patent Office on Tuesday rejected a patent application for BPaL, a combination of three medicines that has cut treatment for drug-resistant tuberculosis (TB) to six months, according to a joint statement by the groups that opposed it.
The application, for the combination of bedaquiline, pretomanid and linezolid, was filed by the Global Alliance for TB Drug Development (TB Alliance), a US-based non-profit that developed pretomanid. BPaL is an all-oral regimen recommended by the World Health Organization (WHO) for eligible patients with drug-resistant TB. It replaces older regimens that could run for more than a year and often involved painful daily injections. They argued that combining known medicines did not amount to an inventive step that justified a new patent. “Only those who have been treated for TB know what it feels like to go through more than a year of antibiotics with painful injections.
Under India’s national TB programme, more than 15,000 patients have started BPaLM, the same regimen with a fourth drug, moxifloxacin, added. India had an estimated 2.71 million new TB cases in 2024, about a quarter of the global total, or 187 for every 100,000 people, according to WHO.
“The opponents challenged the patent application on the grounds that the combination of bedaquiline, pretomanid and linezolid, as well as its use in a shorter treatment regimen, had already been disclosed in earlier scientific research and clinical trials dating back to 2015,” the joint statement said. Access to a shorter, oral and effective treatment can mean returning to work, caring for their families and rebuilding their lives,” said Loon Gangte of DNP+, one of the opponents, in the statement.
