On 27 October 2026, the Indian Patent Office rejected a patent application by the U.S.-based Global Alliance for TB Drug Development (TB Alliance) for BPaL, a drug combination used to treat drug-resistant tuberculosis. BPaL combines bedaquiline, pretomanid and linezolid in a six-month, all-oral treatment regimen.
Patent application and opposition
Civil society organisations filed pre-grant oppositions against the application in July 2020. These included the Delhi Network of Positive People, Sankalp Rehabilitation Trust, Third World Network, Lawyers’ Collective and Médecins Sans Frontières Access Campaign. Pre-grant opposition under Section 25(1) of the Patents Act, 1970 allows any person to oppose a patent application after its publication and before the patent is granted. Opponents said scientific research and clinical trials dating from 2015 had already disclosed the medicines in combination and their use in a shorter treatment regimen.
Patentability provisions
The Patent Office cited lack of novelty, absence of an inventive step, non-patentability and insufficient disclosure. It invoked Sections 3(d), 3(e) and 3(i) of the Patents Act, 1970. Section 3(d) restricts patents on new forms of known substances unless they demonstrate enhanced efficacy. Section 3(e) excludes a mere admixture of known substances, while Section 3(i) excludes methods of treating human beings from patentability.
Tuberculosis treatment in India
India recorded an estimated 2.71 million people developing tuberculosis in 2024, equivalent to about one-quarter of global cases. More than 15,000 patients in India have received BPaLM under the National Tuberculosis Elimination Programme (NTEP). BPaLM combines bedaquiline, pretomanid and linezolid with moxifloxacin. The Patent Office’s decision rejects this particular application; it does not itself establish that all other patent rights or regulatory requirements relating to the medicines have ended.
Important Facts for Exams
:
- BPaL consists of bedaquiline, pretomanid and linezolid.
- BPaLM adds moxifloxacin to the BPaL combination.
- Section 25(1) of the Patents Act, 1970 provides for pre-grant opposition.
- TB Alliance holds 11 active patents related to BPaL in countries including Armenia, Azerbaijan and South Africa, with the patents set to expire in 2036.
Civil society groups have urged TB Alliance to withdraw related patent claims in other countries and surrender granted patents. The Indian rejection means that this application did not result in a patent grant in India.
