Health · Pharma & Biotech · 2 hrs ago
India rejects patent application for BPaL tuberculosis treatment
India’s Patent Office rejected a patent application for BPaL, a treatment for drug-resistant tuberculosis.
BPaL combines bedaquiline, pretomanid and linezolid in a six-month course taken by mouth.
The application came from the US-based TB Alliance, and two groups of opponents argued that research had already disclosed the drug combination and its use in a shorter treatment course.
The Patent Office upheld objections including lack of novelty, lack of inventive step and insufficient disclosure.
The decision could widen access to cheaper generic versions in India and other countries with high TB burdens, though it does not guarantee that new suppliers will enter the market.
India has the world’s largest TB burden, and the shorter course can reduce the treatment burden compared with older, longer regimens.
Patents on the combination remain in 11 other countries, while civil society groups are urging TB Alliance to withdraw pending applications and give up granted patents.
The Indian Patent Office rejected a U.S.-based company’s application to patent the BPaL treatment for drug-resistant tuberculosis.
BPaL combines bedaquiline, pretomanid and linezolid in a six-month, all-oral regimen.
The office upheld objections that the application lacked novelty and an inventive step and failed other patentability requirements.
Two pre-grant oppositions argued that the combination and its use in a shorter regimen had been disclosed in research and clinical trials dating to 2015.
The decision could enable more Indian drugmakers to produce generic versions, while civil society groups are urging the company to relinquish patent claims elsewhere.
- Who
- The Indian Patent Office rejected an application by the U.S.-based Global Alliance for TB Drug Development, also known as TB Alliance.
- What
- It rejected a patent application for BPaL, a six-month, all-oral treatment for drug-resistant tuberculosis.
- When
- The decision was reported on October 28, 2026.
- Where
- India.
- Why
- The office upheld objections including lack of novelty and inventive step, and insufficient disclosure. Opponents said the treatment combination and its use had already been disclosed in research and clinical trials.
TB Alliance
Patent opponents
Patent application
TB Alliance
TB Alliance filed an application to patent the BPaL combination.
Patent opponents
Opponents argued the combination and its use in a shorter regimen had already been disclosed in research and clinical trials dating to 2015.
Patentability
TB Alliance
TB Alliance sought a patent for BPaL.
Patent opponents
Opponents argued the combination did not merit a new patent and cited safeguards concerning new uses, admixtures and methods of medical treatment.
Scientific research and clinical trials had disclosed the BPaL combination and its use in a shorter regimen, according to the opponents.
Two pre-grant oppositions against the patent application were filed.
The Indian Patent Office’s rejection of the application was reported.
- Treatment
- BPaL: bedaquiline, pretomanid and linezolid
- Regimen
- Six months; all oral
- Patent applicant
- Global Alliance for TB Drug Development (TB Alliance)
- Oppositions
- Two pre-grant oppositions filed in 2020
- Patent decision
- Application rejected by the Indian Patent Office
2 sources
What people are saying
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
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
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