Why India's rejection of a TB drug patent matters for patients

The decision could open the door to greater competition and lower costs for BPaL, a shorter treatment regime of drug-resistant tuberculosis.

The Indian Patent Office's rejection of a patent application for a combination of three tuberculosis (TB) medicines -- bedaquiline, pretomanid and linezolid, collectively known as BPaL -- has been welcomed by experts as a major step towards making treatment for drug-resistant TB more affordable and accessible.

The application was filed by the US-based Global Alliance for TB Drug Development (TB Alliance). Its rejection means that the company cannot use this particular patent application to claim exclusive rights over the combination in India. This could allow more manufacturers to produce the medicines, encouraging competition and potentially bringing down prices.

The decision follows two formal objections, known as pre-grant oppositions, filed in 2020. Such oppositions allow individuals or organisations to challenge a patent application before it is granted. The first was filed by Eldred Tellis of Sankalp Rehabilitation Trust and Ganesh Acharya, with support from the Lawyers' Collective and Médécins Sans Frontières Access Campaign. The second was filed by the Delhi Network of Positive People (DNP+), with support from Third World Network.

Experts, however, say that rejecting the patent application is only one part of the larger effort. The more important task is to ensure that every patient who is medically eligible can access the shorter treatment regimen through the national TB programme. India has the world's largest TB burden, accounting for nearly a quarter of all cases globally. The country's TB incidence rate was 187 cases per 100,000 people in 2024.

What is BPaL?

It is a six-month, all-oral treatment regimen recommended by the World Health Organization (WHO) for eligible patients with drug-resistant TB. It combines three medicines: bedaquiline (B), pretomanid (Pa) and linezolid (L). A related regimen, BPaLM, adds a fourth medicine, moxifloxacin (M). The BPaLM regimen recorded a treatment success rate of 89 per cent, compared with 52-75 per cent for standard regimens. More than 15,000 patients have already started BPaLM treatment under India's national TB programme.

Unlike older treatment regimens, which could involve taking antibiotics for many months and sometimes receiving painful injections, BPaL-based treatment offers a shorter course using oral medicines. This can reduce the physical, financial and emotional burden on patients.

What does the patent ruling mean for patients?

It removes one potential legal barrier to competition among manufacturers of the BPaL combination. However, the ruling does not automatically make treatment cheaper or guarantee that medicines will become available everywhere. That will depend on the number of quality-assured suppliers, government procurement arrangements and uninterrupted supplies.

"The ruling is an opportunity to improve access to affordable treatment for drug-resistant TB. It does not approve a new medicine or change treatment guidelines," says Dr Vikas Oswal, pulmonologist and former National Technical expert member of the National Tuberculosis Elimination Programme.

"With this rejection, every bedaquiline-related patent application that was challenged in India has been refused. These include the bedaquiline salt form (2023), the paediatric formulation (2024), the long-acting injectable and now the BPaL combination. No single company can claim exclusive rights over this regimen in India and any TB drug manufacturer can produce it for the Indian programme and export," said Leena Menghaney, lawyer/consultant, public health, pharmaceuticals and access.

Pratibha Sivasubramanian, senior researcher with Third World Network, feels the ruling acknowledges patients' fight against frivolous and secondary patents on known medicines. "In short, the evergreening of patents on important TB medicines." she said. Evergreening refers to attempts to extend a company's period of patent protection by seeking additional patents for minor changes or new formulations of an existing medicine. Patient groups and access campaigners have argued that such practices can delay competition from generic manufacturers.

Will TB treatment become cheaper?

For patients, the importance of shorter treatment goes beyond the number of medicines they take. "Only those who have been treated for TB know what it feels like to go through more than a year of antibiotics with painful injections. Access to a shorter, oral and effective treatment can mean returning to work, caring for their families and rebuilding their lives," Loon Gangte from the Delhi Network of Positive People (DNP+) said.

The potential savings, however, need to be understood in context. Patients receiving drug-resistant TB treatment through the public health system already get their medicines free of cost. Therefore, the main financial benefit of lower drug prices would initially accrue to the government, which purchases medicines for the national programme. Menghaney said generic competition had already helped reduce the cost of treatment following the rejection of the patent on bedaquiline fumarate salt in India. "A six -month BPalM course now costs $284 down from $588 in 2022," Menghaney said.

In simple terms, if the government can purchase each treatment course at a lower price, the same budget could potentially cover treatment for more patients. Greater competition could also make supplies more dependable by reducing reliance on a limited number of manufacturers.

"Patients can still face substantial expenses for travel, investigations outside the programme, nutrition and lost income. Lower medicine prices alone will not remove these burdens. Any additional savings attributable specifically to this ruling must be assessed once actual prices and supply arrangements are known," Dr Oswal said.

Will cheaper generic medicines become available soon? What steps remain?

The Central Drugs Standard Control Organisation (CDSCO), India's national drug regulator, has approved bedaquiline and pretomanid for use under the National TB Elimination Programme (NTEP). Linezolid and moxifloxacin are older antibiotics that are now being used as part of treatment for drug-resistant TB. The most important step, according to Menghaney, is for the government to scale up BPaL/BPaLM to every eligible patient diagnosed with rifampicin-resistant TB.

However, the rejection of the patent application should not be mistaken for automatic permission to sell the combination without restrictions. Patent approval and drug regulatory approval are two different processes. A patent determines whether a company can claim exclusive rights over an invention, while drug regulators assess whether a medicine can be marketed and used under specified conditions. In India, access to these regimens is linked to the national TB programme and its treatment standards.

Similarly, WHO prequalification -- an assessment of whether a medicine meets international standards of quality, safety and efficacy -- does not replace the marketing permissions required from Indian regulators.

Who stands to benefit most?

The biggest potential beneficiaries are patients with multidrug-resistant or rifampicin-resistant TB (MDR/RR-TB), particularly those who face financial difficulties, delays in starting treatment or problems reaching treatment centres.

Could cheaper generic medicines compromise quality or safety?

Generic medicines contain the same active pharmaceutical ingredients as the corresponding reference medicines and are expected to meet the applicable regulatory standards. As Dr Oswal said, quality checks should continue even as more manufacturers enter the market.