Why India Rejected a Patent Application for Shorter Drug-Resistant TB Treatment

The Indian Patent Office has rejected a patent application filed by the U.S.-based Global Alliance for TB Drug Development (TB Alliance) for BPaL, a combination of bedaquiline, pretomanid, and linezolid. This reported decision follows pre-grant oppositions filed in 2020 by civil society groups and health advocates. While reported claims suggest the decision could facilitate generic competition, actual outcomes will depend on market dynamics, regulatory approvals, and public health procurement strategies.

Background of the Patent Rejection

• The Applicant: U.S.-based TB Alliance sought patent protection for the BPaL combination.
• The Opponents: Groups including Eldred Tellis, Ganesh Acharya, the Delhi Network of Positive People (DNP+), supported by organizations like Lawyers’ Collective, Médecins Sans Frontières Access Campaign, and Third World Network (TWN).
• Grounds for Rejection: The Indian Patent Office upheld arguments that the combination lacked an inventive step under sections 3(d), 3(e), and 3(i) of India's Patents Act, noting that earlier clinical research had already disclosed the regimen.

Medical Context and Public Health Impact

• Shorter Regimen: BPaL offers a six-month, all-oral treatment recommended by the WHO for eligible patients with certain drug-resistant forms of tuberculosis, compared to older regimens lasting 18–24 months.
• India's TB Burden: According to WHO's Global Tuberculosis Report 2025, India recorded an estimated 2.71 million TB cases in 2024, representing about 25% of the global total.
• National Programme: India's National TB Elimination Programme (NTEP) provides free diagnosis and treatment through public health services and approved the BPaLM regimen (adding moxifloxacin) in 2024.

Practical Implications and Verification

• Generic Competition: Civil society groups argue that removing patent barriers can encourage generic manufacturers to supply the combination, potentially influencing pricing.
• Verification: Interested parties can review official filings through the Indian Patent Office portal and consult WHO guidelines regarding multidrug-resistant tuberculosis treatment protocols.