India Refuses TB Alliance's Patent Bid for BPaL Drug-Resistant TB Treatment

Key facts

• The Indian Patent Office refused a patent application by the Global Alliance for TB Drug Development (TB Alliance) for a combination antibacterial composition and short-course treatment regimen for drug-resistant tuberculosis, via an order issued on October 27, 2026 under Section 15 of the Patents Act, 1970.
• The BPaL regimen combines bedaquiline, pretomanid and linezolid, offering eligible drug-resistant TB patients a shorter, all-oral treatment; India's National Tuberculosis Elimination Programme (NTEP) has adopted the six-month BPaLM regimen, which adds moxifloxacin, for multidrug- or rifampicin-resistant TB patients.
• The application, numbered IN201817014361 and filed on April 16, 2018, faced two pre-grant oppositions under Section 25(1) of the Patents Act, 1970 — one jointly by Eldred Tellis and Ganesh Acharya, and another by the Delhi Network of Positive People (DNP+).
• The Controller upheld objections on lack of novelty, lack of inventive step, non-patentability and insufficient disclosure, noting bedaquiline was already known, linezolid was off-patent, and pretomanid had benefited from public and philanthropic funding.
• Controller General of Patents, Designs and Trademarks Dr Unnat Pandit said the decision was based on technical merits, and an aggrieved party may appeal before the High Court.