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

The Indian Patent Office has rejected a patent application by the US-based Global Alliance for TB Drug Development for BPaL, a treatment for drug-resistant tuberculosis. The decision follows objections from patient groups citing a lack of inventive steps and prior research, paving the way for potential generic competition.

NEW DELHI — The Indian Patent Office has officially rejected a patent application filed by the US-based Global Alliance for TB Drug Development, commonly known as the TB Alliance, for BPaL. The treatment is an all-oral regimen used for drug-resistant tuberculosis.

According to the official order dated October 27, the patent application did not meet the necessary requirements under the Patents Act, 1970, and was rejected under Section 15. The ruling followed two pre-grant objections initially filed in July 2020 by patient groups and public health advocates, including representatives from the Sankalp Rehabilitation Trust, the Delhi Network of Positive People, with support from organizations such as the Lawyers’ Collective, Médecins Sans Frontières’ Access Campaign, and the Third World Network. TB Alliance did not attend the final hearings.

The opposing groups argued that the drug combination was already known, lacked an inventive step, and failed to meet standard patent requirements, citing prior research and clinical trials dating back to 2015.

BPaL is a regimen that combines three medicines: bedaquiline, pretomanid, and linezolid. The World Health Organization recommends this six-month, all-oral treatment for eligible patients suffering from drug-resistant TB, noting that it is significantly shorter than many older treatments and reduces the overall medical burden on patients.

India carries the world’s largest tuberculosis burden. According to World Health Organization estimates, approximately 2.71 million people developed TB in India in 2024, accounting for roughly a quarter of all cases globally. Data shows that more than 15,000 patients have already started BPaLM treatment under the national TB programme, which combines the three BPaL medicines with a fourth drug, moxifloxacin.

Following the decision, patient groups welcomed the ruling, stating that it could encourage generic competition and help drive down treatment costs both in India and internationally. Representatives from the advocacy groups pointed out that since pretomanid—one of the core components of BPaL—received public and philanthropic support during its development, seeking commercial patents is unwarranted. Patient advocates also emphasized that shorter, effective oral treatments are vital in helping patients return to work, care for their families, and recover from the exhaustive physical toll of older treatments that often involve over a year of antibiotics and painful injections.

"This decision by the Indian Patent Office highlights the critical intersection between public health priorities and intellectual property rights, particularly in healthcare markets with high disease burdens like India. For the pharmaceutical and healthcare sectors, regulatory outcomes regarding drug patents directly influence market dynamics, generic competition, and pricing accessibility. Companies operating in this space must carefully navigate patent compliance, prior art, and public health advocacy when introducing complex therapeutic regimens into emerging markets." — Dr. Shishir Gupta, Founder & CEO, StartupLanes