India Pharma Outlook Team | Thursday, 29 October 2026
India rejected the TB Alliance’s application for a patent on the BPaL fixed-dose combination, the six-month all-oral regimen for drug-resistant tuberculosis.
This patent fight keeps a WHO-recommended shorter cure free from monopoly restrictions in the country that carries the world’s highest TB burden.
Around 2.71 million people in India developed TB in 2024, accounting for a quarter of global cases.
The decision marks a clear win for access over secondary patent claims on known medicines and reinforces public health priorities in the ongoing patent fight.
BPaL combines bedaquiline, pretomanid, and linezolid, with the option of adding pyrazinamide. It delivers a six-month all-oral treatment that patients can complete far more easily than older regimens lasting 18 to 24 months that often required painful injections.
The World Health Organization already recommends BPaL for eligible patients with multi-drug-resistant TB. India’s National TB Elimination Program provides the regimen free of cost, and health facilities have already started more than 15,000 MDR/RR-TB patients on it.
An ICMR study earlier this year found the six-month course more effective and cost-saving than standard treatment, with the health system spending only Rs 37 for each additional quality-adjusted life year gained compared with Rs 406 under the longer regimens.
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The TB Alliance sought a patent on the “unitary dosage form” or fixed-dose combination of three known drugs. Patient groups and civil society filed pre-grant opposition. Sankalp Rehabilitation Trust, the Delhi Network of Positive People, and supporters including the MSF Access Campaign, Lawyers’ Collective and Third World Network challenged the claim.
They argued that prior research and clinical trials had already disclosed the combination since 2015, that the application lacked inventive step, and that it failed to prove additional clinical benefit or product stability in humans.
And locking all three drugs in one pill would make it harder for doctors to manage side effects by temporarily stopping linezolid. The applicant did not even appear for the hearing. The Patent Office found the application failed to satisfy the requirements of the Patents Act, 1970.
This patent fight outcome shows once again that India’s Patents Act, especially Sections 3(d), 3(e) and 3(i), prioritises public health over secondary claims. The rejection removes a potential barrier to affordable generic production and wider access in the country that needs the regimen most.
Civil society groups now urge the TB Alliance to withdraw similar patents already granted in 11 other countries and to publish its pretomanid license agreements. The organization received public and philanthropic support to develop pretomanid, one of the three components.
A non-profit that helped bring one of the drugs to patients has lost its patent fight to claim a monopoly on combining known medicines. For people facing drug-resistant TB, the rejection keeps the shorter, all-oral cure more firmly in the public domain at least in India.
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