Indian Patent Office Rejects Patent Application for BPaL Drug-Resistant TB Treatment Regimen

The Indian Patent Office has rejected a patent application filed by the U.S.-based Global Alliance for TB Drug Development (TB Alliance) for the BPaL combination regimen—bedaquiline, pretomanid, and linezolid—used for treating drug-resistant tuberculosis.

According to reported details, the decision follows pre-grant oppositions filed in 2020 by civil society representatives and health advocates. The opponents argued that the combination and its use in a shorter regimen lacked an inventive step, citing prior disclosures in scientific research and clinical trials dating back to 2015. They invoked provisions under India’s Patents Act, including Section 3(d), Section 3(e), and Section 3(i). The patent office reportedly upheld all four grounds raised by the opponents.

Background on the BPaL Regimen

• Composition: Combines bedaquiline, pretomanid, and linezolid.
• Duration: Designed as a six-month, all-oral treatment regimen recommended by the World Health Organization (WHO) for eligible individuals.
• Significance: Offers a shorter alternative to older, longer regimens that often involved painful injections.

Civil Society and Advocacy Responses

Groups such as the Delhi Network of Positive People (DNP+), Sankalp Rehabilitation Trust, and Third World Network (TWN) welcomed the patent office's decision. Advocates highlighted that shorter, oral treatments reduce the physical and emotional burden on patients, helping them return to work and care for their families.

Civil society representatives have also called on the TB Alliance to withdraw pending applications and surrender granted patents in other jurisdictions, noting that public and philanthropic support contributed to the development of pretomanid.

Practical Implications and Verification

• Global Context: Reports indicate that BPaL patents have been granted in 11 other countries, with expiration dates projected for 2036.
• Verification: Interested parties can review official decisions and patent status updates directly through the portal of the Controller General of Patents, Designs and Trade Marks (India) or consult WHO guidelines regarding drug-resistant tuberculosis management.