India rejects TB Alliance’s BPaL patent application

Why in News?

The Indian Patent Office rejected a patent application filed by the Global Alliance for TB Drug Development (TB Alliance) for a combination antibacterial composition and short-course treatment regimen for drug-resistant tuberculosis (DR-TB).

• Date of order: 27 October 2026.
• Legal provision: Section 15 of the Patents Act, 1970.
• The decision followed two pre-grant oppositions filed in July 2020.
• The Controller upheld objections relating to lack of novelty, lack of inventive step, non-patentability and insufficient disclosure.

What is the BPaL Regimen?

BPaL is a combination of three medicines used to treat eligible patients with drug-resistant tuberculosis.

Medicine	Role
Bedaquiline	Anti-TB medicine
Pretomanid	Anti-TB medicine
Linezolid	Antibiotic used as part of the combination

Key features:

• Provides a shorter, all-oral treatment option for eligible patients with drug-resistant TB.
• Can reduce the burden associated with prolonged treatment.
• Treatment eligibility, safety and monitoring must follow clinical guidelines and national protocols.

BPaL and BPaLM: Difference

• BPaL: Bedaquiline + Pretomanid + Linezolid.
• BPaLM: Bedaquiline + Pretomanid + Linezolid + Moxifloxacin.

India’s National Tuberculosis Elimination Programme (NTEP) has adopted the six-month BPaLM regimen for eligible patients with multidrug-resistant or rifampicin-resistant TB.

Significance of the Patent Office Decision

• Affordable treatment access:
• Supports efforts to improve access to effective and affordable TB medicines.
• Shorter treatment regimens can reduce the financial, social and medical burden on patients and their families.
• Access to affordable treatment is important for improving patient outcomes and strengthening national TB-control efforts.

Relevant Provisions of the Patents Act, 1970

• Section 15: Empowers the Controller to refuse a patent application or require amendments if the application does not comply with the requirements of the Act.
• Section 3: Lists inventions that are not patentable, including certain exclusions relating to discoveries and pharmaceutical substances.
• Section 25(1): Provides for pre-grant opposition to a patent application by any person on specified grounds.

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