Indian Patent Office rejects patent application for six-month TB treatment regimen

The Indian Patent Office on Tuesday rejected a patent application for a six-month treatment regimen for drug-resistant tuberculosis (TB). The application was filed for BPaL, which is a combination of the drugs bedaquiline, pretomanid, and linezolid. This combination can reduce the duration of TB treatment to six months. According to a joint statement by the opposing groups, this decision could open the doors for increased generic competition and lower drug prices in India and other countries.

The US-based non-profit organization 'Global Alliance for TB Drug Development' (TB Alliance), which developed pretomanid, had applied for this patent. BPaL has been recommended by the World Health Organization (WHO) as a complete oral treatment for eligible patients. This method replaces older treatments, which took over a year and required daily painful injections. Under India's National TB Program, more than 15,000 patients have started BPaLM treatment, in which a fourth drug, moxifloxacin, has been added.

This patent rejection follows two pre-grant oppositions filed in 2020. Under Indian patent law, any person can challenge a patent before it is granted. The first opposition was filed by Eldred Tellis of the Sankalp Rehabilitation Trust and Ganesh Acharya, a two-time TB survivor, supported by the Lawyers Collective and Médecins Sans Frontières' Access Campaign. The second opposition was filed by the Delhi Network of Positive People (DNP+) with the support of the Third World Network (TWN).

According to the opponents, the combination of bedaquiline, pretomanid, and linezolid, as well as its use in shorter treatment, had already been demonstrated in previous scientific research and clinical trials from 2015. They argued that combining known drugs does not prove any new innovation worthy of a new patent. Notably, in 2023, the Patent Office also rejected an application by Johnson & Johnson to extend its patent on bedaquiline.

Loon Gangte of DNP+ stated in a release that only those who have taken TB treatment know the experience of taking antibiotics for over a year with painful injections. Access to a shorter, oral, and effective treatment means returning to work, taking care of families, and rebuilding lives. According to the WHO, approximately 27.1 lakh new TB cases were reported in India in 2024, which is about a quarter of the global total cases.

The patent for the BPaL combination has been granted in 11 countries, including Armenia, Azerbaijan, Belarus, Bulgaria, Indonesia, Kazakhstan, Kyrgyzstan, Russia, South Africa, Tajikistan, and Turkmenistan, and is set to expire in 2036.