The Indian Patent Office has turned down a patent application filed by the Global Alliance for TB Drug Development (TB Alliance) for BPaL, the three-drug combination of bedaquiline, pretomanid and linezolid that has brought treatment for drug-resistant tuberculosis (TB) down to six months. The order, dated 27 October 2026, rejected the application under Section 15 of the Patents Act, 1970, after finding that it did not meet the requirements of the law.

The decision is being read across the generics and public-health ecosystem as a significant development for access to one of the most important TB regimens of the past decade, in the country that carries the world’s largest TB burden.

What the Patent Office Decided

TB Alliance, a US-based non-profit that developed pretomanid, filed the application on 16 April 2018. It sought protection for the BPaL combination and its use in a shorter treatment regimen. TB Alliance did not attend the final hearings, according to reports, and had not responded to requests for comment at the time of reporting.

The rejection follows two pre-grant oppositions filed in July 2020. Indian patent law allows any person to challenge an application before a patent is granted, a provision that has repeatedly shaped access to medicines in the country.

• The first opposition was filed by Eldred Tellis of the Sankalp Rehabilitation Trust and Ganesh Acharya, a two-time TB survivor, with support from the Lawyers Collective and Médecins Sans Frontières’ (MSF) Access Campaign.
• The second was filed by the Delhi Network of Positive People (DNP+), with support from the Third World Network (TWN).

The opponents argued that the combination of the three medicines, and its use in a shorter regimen, had already been disclosed in scientific research and clinical trials dating back to 2015, and that combining known drugs did not amount to an inventive step deserving a fresh patent.

Why BPaL Matters

BPaL is an all-oral regimen recommended by the World Health Organization (WHO) for eligible patients with drug-resistant TB. It replaces older treatments that could stretch beyond a year and often involved painful daily injections. Under India’s national TB programme, more than 15,000 patients have started BPaLM, which adds a fourth drug, moxifloxacin, to the three BPaL medicines.

According to WHO estimates, India recorded about 2.71 million new TB cases in 2024, roughly a quarter of the global total, or 187 cases for every 100,000 people.

A Signal for Generic Manufacturing

The opponents said the decision could open the door to wider generic competition and lower prices in India and other markets. Patents on the BPaL combination have been granted in 11 countries, including Russia, South Africa, Indonesia and Kazakhstan, and are due to expire in 2036.

For Indian drugmakers, which supply a large share of the world’s TB medicines, the order removes one potential barrier around the combination in the domestic market. It also follows an earlier move in 2023, when the Patent Office rejected Johnson & Johnson’s attempt to extend its patent on bedaquiline, one of the regimen’s three components.

Patient groups have also urged TB Alliance to stop pursuing BPaL patents 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,” said Eldred Tellis of Sankalp Rehabilitation Trust.

Loon Gangte of DNP+ said patients who have been through more than a year of antibiotics with painful injections know what a shorter, oral and effective treatment can mean, from returning to work to caring for their families and rebuilding their lives.

What Comes Next

The order is expected to add weight to calls for affordable access to shorter regimens for drug-resistant TB. For the pharmaceutical industry, it is another reminder that India’s patent framework, particularly its pre-grant opposition route and its strict tests for inventive step, remains a decisive factor in how quickly generic versions of new treatment combinations can reach patients.

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