Indian Patent Office Refuses TB Alliance Patent Application for BPaL Tuberculosis Regimen
The Indian Patent Office has declined a patent claim submitted by the non-profit Global Alliance for TB Drug Development seeking exclusive rights over an antibacterial formulation for drug-resistant tuberculosis, according to reporting by The Indian Express and The Hindu on Thursday, October 29, 2026. The quasi-judicial order, issued on October 27 under Section 15 of the Patents Act, 1970, concluded an eight-year examination of application IN201817014361, which sought proprietary protection over the three-drug BPaL regimen combining bedaquiline, pretomanid, and linezolid. The Patent Office upheld statutory objections citing a lack of novelty, absence of an inventive step, non-patentability under Section 3, and insufficient disclosure.
Patent Controller Ruling and Statutory Grounds
The rejection followed pre-grant opposition petitions lodged in July 2020 under Section 25(1) of the Patents Act by health advocacy coalitions. One challenge was filed jointly by Eldred Tellis of the Sankalp Rehabilitation Trust and tuberculosis survivor Ganesh Acharya of TB People India, supported by the Lawyers Collective and the Médecins Sans Frontières Access Campaign. A parallel petition was submitted by the Delhi Network of Positive People alongside the Third World Network. Opponents argued that combining previously existing pharmaceutical compounds did not satisfy inventive step criteria, noting that scientific research and clinical evaluations dating to 2015 had already published the combination's therapeutic utility.
Civil Society Pre-Grant Opposition Filings
The opposition cited Sections 3(d), 3(e), and 3(i) on known substances, mixtures and treatment methods. The Controller rejected the application under Section 15 after considering novelty, inventive step, patentability and disclosure. The BPaL therapy provides an all-oral, six-month treatment protocol for highly drug-resistant tuberculosis, replacing older conventional regimens that spanned 18 to 24 months and required painful daily injections. Under the National Tuberculosis Elimination Programme, India has already initiated more than 15,000 patients on the related BPaLM regimen, which incorporates moxifloxacin alongside the core three-drug combination.
Statutory Exclusions and Regimen Shortening Benefits
Public health advocates welcomed the ruling as an important development to foster affordable generic competition across high-burden countries. India bears a substantial epidemiological burden, recording an estimated 2.71 million new tuberculosis cases in 2024, representing approximately one-quarter of global incidence, or 187 infections per 100,000 individuals. While combination patents covering BPaL have been granted in 11 countries with exclusivity extending until 2036, the refusal removes this particular application as a potential barrier, but does not itself guarantee generic availability or remove every other patent and licensing constraint.
Civil society groups subsequently called on the developer to voluntarily surrender granted patents and publish its licence agreements, according to Pharmabiz.
In March 2023, the Indian Patent Office in Mumbai declined a separate application to prolong exclusivity on bedaquiline, according to PubMed Central.
Those approved jurisdictions include South Africa, Indonesia, and the Russian Federation, according to Pharmabiz.