TB patients before patents: India rejects TB Alliance's BPaL patent application

For TB survivors, the decision removes one potential barrier to generic competition, but affordable treatment will depend on procurement and uninterrupted supplies

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

The regimen, known as BPal, combines bedaquiline, pretomanid and linezolid. The order, issued on October 27, 2026, under Section 15 of the Patents Act, 1970, 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, concluding that the application did not meet the requirements of Indian patent law.

For TB survivors and public-health advocates, the decision is an important milestone in efforts to protect access to affordable treatment. However, rejecting a patent application does not automatically lower medicine prices or guarantee the immediate availability of generic alternatives.

What is BPaL, and why does it matter?

BPaL comprises bedaquiline, pretomanid and linezolid. For eligible patients with drug-resistant TB, it offers a shorter, all-oral treatment option that can reduce the burden of prolonged therapy. India's National Tuberculosis Elimination Programme (NTEP) has also adopted the six-month BPaLM regimen, which adds moxifloxacin to the three BPaL medicines, for eligible patients with multidrug- or rifampicin-resistant TB.

Shorter treatment can ease the burden on patients, families and healthcare services. However, treatment eligibility, drug safety and monitoring must continue to follow clinical guidance and national protocols. Given India's substantial TB burden, access to effective and affordable treatment remains essential to improving patient outcomes and advancing the country's TB elimination goals.

What the decision means for patients

Ganesh Acharya, a two-time TB survivor and chair of TB People India Acharya, who had opposed the patent plea, described the refusal as a victory for people affected by drug-resistant TB, saying: "Medicines must serve people, not monopolies. Affordable access to life-saving TB treatment is a right, not a privilege."

He also cautioned that rejecting a patent is only the first step towards ensuring that everyone who needs BPaL can access quality-assured treatment without financial hardship or delays. The ruling removes this particular potential patent barrier to generic competition. But it does not set prices, automatically approve generic products or guarantee uninterrupted supplies.

The government, NTEP, procurement agencies and other stakeholders must ensure timely purchasing, reliable supply chains and affordable access across the country. Continued investment in TB services, safety monitoring and community participation will also be crucial.

Two pre-grant oppositions challenged the application

The application, numbered IN201817014361 and filed on April 16, 2018, faced two separate pre-grant oppositions. The first was filed jointly by Eldred Tellis and Acharya. The second was filed by the Delhi Network of Positive People (DNP+). Both challenges were brought under Section 25(1) of the Patents Act, 1970, which allows any person to oppose a patent application before a patent is granted.

The opponents argued that the claimed invention lacked novelty and an inventive step, involved subject matter excluded from patentability, and suffered from insufficient disclosure. They also questioned whether combining existing medicines justified fresh exclusive rights. Bedaquiline was already known, linezolid was off-patent, and pretomanid had benefited from public and philanthropic funding. The challengers argued that combining known medicines should not, by itself, provide grounds for an unjustified patent monopoly.

Decision based on technical merits

Controller General of Patents, Designs and Trademarks Dr Unnat Pandit told The Indian Express that the decision was based on the merits of the matter placed before the officer concerned.

"The role of the Patent Office is to pass a reasoned order on the technical merits, in accordance with the provisions of the Patents Act," Pandit said, emphasising that both applicants and opponents must receive a fair opportunity to present their cases.

On possible further remedies, Pandit said an aggrieved party could pursue options available under the applicable statutory framework, including an appeal before the High Court, where the question of maintainability would first be considered. He also noted that, where a patent is granted, an interested party may file a post-grant opposition within the applicable statutory period and subject to the conditions prescribed by law.

The next challenge: Turning a legal victory into access

More than eight years passed between the application's filing and the final refusal. The decision reinforces the importance of applying patentability standards rigorously, particularly for medicines used to treat life-threatening diseases.

For TB survivors and advocates, however, the ultimate test will be whether the ruling translates into tangible benefits: affordable medicines, timely treatment and uninterrupted access for patients who need them.