India Rejects Patent Application for the BPaL Drug-Resistant TB Regimen
The Indian Patent Office rejected a patent application for the BPaL treatment for drug-resistant tuberculosis (TB), in an order dated 27 October 2026.
BPaL is a combination of three medicines: bedaquiline, pretomanid and linezolid. It is an all-oral, six-month treatment. The application had been filed in April 2018 by the TB Alliance (Global Alliance for TB Drug Development), a US-based non-profit that developed pretomanid.
In July 2020, two pre-grant oppositions (objections filed before a patent is granted) were filed: one by TB survivor groups and a rehabilitation trust supported by legal and medical charities, and one by the Delhi Network of Positive People.
The opponents argued that the combination and its use in a shorter treatment were already described in research and trials from 2015. The Patent Office accepted objections on lack of novelty, lack of inventive step, non-patentability and insufficient disclosure.
The decision applies only in India. BPaL-related patents granted in 11 other countries are due to expire in 2036.
The ruling could make it easier for Indian generic (low-cost copy) makers to produce the combination. More than 15,000 patients have already started the related BPaLM regimen (BPaL plus moxifloxacin) under India's National TB Elimination Programme.
Patents Act, 1970: How India Decides What Can Be Patented
The Patents Act, 1970 is India's law on patents. A patent is a right given by the government to an inventor: for 20 years, nobody else can make, use, sell or import the invention in India without the inventor's permission. In return, the inventor must publish full details of how the invention works, so that everyone can use it once the patent ends. The Act also decides what cannot be patented, and lets the public object to a patent before or after it is granted.
The BPaL application failed at the pre-grant opposition stage under Section 25(1). Opponents showed that the three-drug combination and its shorter use were already in the prior art from 2015, and the Controller refused the application under Section 15 for lack of novelty, lack of inventive step, non-patentability and insufficient disclosure. Sections 3(e) (mere admixture) and 3(i) (methods of treatment) explain why combinations of known drugs and treatment schedules are hard to patent in India.
Drug-Resistant Tuberculosis (DR-TB): MDR, XDR and the Shorter BPaLM Treatment
Drug-resistant tuberculosis (DR-TB) is TB caused by bacteria that are no longer killed by one or more of the main TB medicines. Normal TB can be cured in six months with cheap, common drugs. When the bacteria resist the two most powerful of these drugs, the disease becomes much harder, longer and costlier to treat. India has the largest number of TB patients in the world, and also a large share of the world's drug-resistant TB cases.
BPaL is one of the shortest and easiest treatments for drug-resistant TB, replacing older courses of up to two years with daily injections. By refusing the patent, India has made it easier for Indian generic companies to make the combination for the more than 15,000 patients already on BPaLM in India and for patients abroad.
- Rejection order date: 27 October 2026; application filed 16 April 2018 by the TB Alliance
- Pre-grant oppositions filed in July 2020 under Section 25(1) of the Patents Act, 1970
- Grounds accepted: lack of novelty, lack of inventive step, non-patentability, insufficient disclosure
- BPaL = bedaquiline + pretomanid + linezolid; six-month, all-oral regimen
- BPaL patents granted in 11 countries, due to expire in 2036
- More than 15,000 patients in India have started BPaLM under the National TB Elimination Programme
- Earlier precedent: bedaquiline patent extension rejected in March 2023
- India: about 2.71 million TB cases in 2024, about a quarter of the global total