Patent Rejection Opens Possibilities for Generic Competition

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 the BPaL regimen — has been welcomed by health experts as an important development in improving access to affordable treatment for drug-resistant tuberculosis.

The application was filed by the US-based Global Alliance for TB Drug Development (TB Alliance). Its rejection means the applicant cannot claim exclusive rights over this particular combination through the rejected patent application in India. This could allow more pharmaceutical manufacturers to produce the medicines, encourage generic competition and potentially reduce treatment costs.

The decision followed two pre-grant patent oppositions filed in 2020. These objections were raised by organisations and individuals seeking to prevent the grant of the patent.

Shorter Oral Treatment Offers Relief to Drug-Resistant TB Patients

The BPaL regimen is a six-month, all-oral treatment recommended by the World Health Organization (WHO) for eligible patients with drug-resistant TB. A related treatment, BPaLM, includes an additional medicine, moxifloxacin.

The BPaLM regimen has recorded a treatment success rate of 89 per cent, compared with 52–75 per cent for standard treatment regimens. More than 15,000 patients have already started BPaLM treatment under India's national TB programme.

India accounts for nearly one-fourth of the global TB burden, with an incidence rate of 187 cases per 100,000 people in 2024.

However, experts caution that patent rejection alone cannot guarantee affordable medicines or their widespread availability. Effective government procurement, adequate supplies and the presence of quality-assured manufacturers will remain essential.

The development could strengthen India's efforts towards TB elimination by improving access to shorter, more effective and affordable treatment options.