Indian Patent Office rejects patent application for drug-resistant TB regimen

BPaL offers a shorter course of treatment than older, longer regimens, reducing the burden of treatment on patients and their families. Representative image | Photo Credit: AP The Indian Patent Office has rejected a patent application filed by the U.S.-based Global Alliance for TB Drug Development (TB Alliance) for the combination of bedaquiline, pretomanid, and linezolid (BPaL), a six-month, all-oral treatment regimen for drug-resistant tuberculosis. The Delhi Network of Positive People (DNP+), Sankalp Rehabilitation Trust and Third World Network (TWN) welcomed the development.Recommended by the WHO for eligible people, BPaL offers a shorter course of treatment than older, longer regimens, reducing the burden of treatment on patients and their families. “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. Access to a shorter, oral and effective treatment can mean returning to work, caring for their families and rebuilding their lives”, explained Loon Gangte of DNP+. The decision follows two pre-grant oppositions filed in 2020—one by Eldred Tellis (Sankalp Rehabilitation Trust) and Ganesh Acharya, with support from the Lawyers’ Collective and Médécins Sans Frontières Access Campaign, and the other by the Delhi Network of Positive People (DNP+), with support from TWN.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 scientific research and clinical trials dating back to 2015. They argued that combining these known medicines did not constitute an inventive step warranting a new patent monopoly. The Opposition invoked key safeguards under India’s Patents Act, including Section 3(d), which restricts patents on new uses of known substances, Section 3(e), which excludes mere admixtures, and Section 3(i), which excludes methods of medical treatment. The opponents further argued that the application failed to sufficiently disclose the claimed invention. All four grounds were upheld by the Indian Patent Office. India has the world’s largest tuberculosis burden. According to WHO estimates, approximately 2.71 million people developed TB in the country in 2024, accounting for a quarter of global cases, with an incidence rate of 187 per 1,00,000 people. Civil society groups are also demanding that the TB Alliance stop the pursuit of proprietary rights over BPaL in other countries.“Having received public and philanthropic support to develop pretomanid, one of BPaL’s components, they should not be applying for a patent, let alone over frivolous secondary patents on its combination with the other two known medicines,” said Mr. Tellis.In light of the weak claims by the TB Alliance, Prathibha Sivasubramanian, senior researcher at TWN, endorsed the call for the waiving of patents. “The Indian Patent Office’s decision should serve as a clear signal to the TB Alliance to voluntarily surrender granted patents and to withdraw all corresponding pending applications in other jurisdictions. TB Alliance should also publish its pretomanid licence agreements,” she said.Patents on the BPaL combination have been granted in 11 countries and are set to expire in 2036: Armenia, Azerbaijan, Belarus, Bulgaria, Indonesia, Kazakhstan, Kyrgyzstan, Russia, South Africa, Tajikistan and Turkmenistan. Published - October 28, 2026 06:43 pm IST