TB Alliance fails to get patent for six-month treatment regimen

BPaL is a combination treatment for eligible people with drug-resistant tuberculosis. Its name comes from bedaquiline, pretomanid and linezolid. The World Health Organization recommends it as an all-oral regimen. That matters because drug-resistant TB can require long, difficult treatment, and shorter care may help patients resume work and family responsibilities sooner.

The regimen uses three medicines together rather than relying on older treatment plans. Pretomanid was developed by the Global Alliance for TB Drug Development, also called TB Alliance. In India’s national TB programme, more than 15,000 patients have started BPaLM, which adds moxifloxacin as a fourth drug.

BPaL has reduced treatment for drug-resistant TB to six months, according to the article. Older regimens could last more than a year and often included painful daily injections. The Indian patent decision could help generic competition develop, potentially improving access and lowering prices in India and elsewhere.

The Indian Patent Office rejected TB Alliance’s application for a patent covering BPaL. The application concerned the combination of bedaquiline, pretomanid and linezolid, including its use in a shorter treatment regimen. TB Alliance is a US-based nonprofit that developed pretomanid. The decision followed challenges filed before the application could be granted.

Two pre-grant oppositions were filed in 2020. One came from Eldred Tellis and TB survivor Ganesh Acharya, supported by the Lawyers Collective and Médecins Sans Frontières’ Access Campaign. The Delhi Network of Positive People filed the other, with support from Third World Network. They argued that earlier research and trials had already disclosed the combination and shorter regimen.

The opponents said the ruling could help generic manufacturers compete in India and elsewhere. Patents on the BPaL combination remain active in 11 countries and are due to expire in 2036. TB Alliance had not responded to requests for comment when the article went to print.

The opponents argued that BPaL was not a genuinely new invention because its key elements had already been disclosed. They pointed to earlier scientific research and clinical trials dating back to 2015. Their position was that the combination of bedaquiline, pretomanid and linezolid, along with its shorter treatment use, was already known before the patent application.

Their argument focused on the requirement for an inventive step. A patent is not normally justified merely because existing medicines are placed together if that combination was already revealed publicly. Here, the opponents said the evidence showed both the medicines used and the shorter regimen had appeared in earlier work.

This reasoning helped form the basis of the pre-grant challenges filed in India in 2020. The Indian Patent Office ultimately rejected the application. The ruling may allow generic competition for BPaL in India, although the article notes that combination patents have been granted in 11 other countries.

BPaL cuts drug-resistant TB treatment to six months. Older regimens could continue for more than a year. Because the older treatments sometimes included painful daily injections, the change is not only about time. It also changes how treatment is delivered, making the regimen all-oral for eligible patients.

The article gives a clear contrast. BPaL combines bedaquiline, pretomanid and linezolid in an oral regimen recommended by WHO. Under India’s national TB programme, BPaLM adds moxifloxacin as a fourth drug, and more than 15,000 patients have started it. The article does not provide an exact duration for every older regimen, only that some lasted more than a year.

The shorter course may reduce the burden of treatment for patients and families. Loon Gangte of DNP+ said access to shorter, effective oral treatment can help people return to work, care for families and rebuild their lives. The practical benefit depends on eligible patients receiving access.

If generic manufacturers can produce BPaL in India, competition could increase. The opponents said this could lower prices and improve availability in India and elsewhere. That matters because India carries a large TB burden, with an estimated 2.71 million new TB cases in 2024, about a quarter of the global total.

The key mechanism is the patent decision. Rejecting TB Alliance’s application means that particular application does not create the claimed barrier to competition in India. Manufacturers may then have more room to seek production and sale of the combination, subject to other legal and regulatory requirements. The article specifically describes this as opening the door to generic competition.

The future effect is not guaranteed or quantified in the article. It does not give a new price or say how many manufacturers will enter. It does show why access matters: BPaL is a six-month oral option, while older treatments could last more than a year and involve painful injections.

Indian patent law allows anyone to challenge a patent application before the patent is granted. These challenges are called pre-grant oppositions. In this case, two were filed in 2020. One came from Eldred Tellis and two-time TB survivor Ganesh Acharya, supported by the Lawyers Collective and Médecins Sans Frontières’ Access Campaign.

The Delhi Network of Positive People filed the second opposition, with support from Third World Network. The challengers argued that research and clinical trials dating to 2015 had already disclosed the BPaL combination and its shorter treatment regimen. They said combining known medicines did not qualify as a new inventive step.

Their action also reflected treatment access concerns. Loon Gangte of DNP+ described the hardship of more than a year of antibiotics and painful injections. The opponents said rejecting the application could help generic competition and lower prices, potentially making a shorter, oral treatment more reachable for people with drug-resistant TB.

A patent is a legal right that can give its holder exclusive control over making, using or selling a claimed invention for a limited period. For medicines, that control can reduce direct competition while the patent remains valid. In return, patent systems require applicants to disclose the invention. The Indian case concerned whether BPaL deserved that protection.

If a patent is granted, other manufacturers may be blocked from producing the patented combination without permission, which can limit competition and affect prices. If it is rejected, the rejected application does not provide that particular patent barrier. Other patents or legal requirements can still matter, so rejection does not automatically guarantee cheap supply.

Here, opponents said BPaL had already been disclosed in research and trials dating to 2015. The Indian Patent Office rejected TB Alliance’s application. The opponents said this could open the door to generic competition and lower prices in India and elsewhere, potentially improving access to the six-month oral regimen.