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

The Indian Patent Office on Tuesday rejected a patent application for BPaL, a combination of three medicines that has cut treatment for drug-resistant tuberculosis (TB) to six months, according to a joint statement by the groups that opposed it.India NewsThe application, for the combination of bedaquiline, pretomanid and linezolid, was filed by the Global Alliance for TB Drug Development (TB Alliance), a US-based non-profit that developed pretomanid.TB Alliance did not respond to HT’s requests for comment till the time of going to print.BPaL is an all-oral regimen recommended by the World Health Organization (WHO) for eligible patients with drug-resistant TB. It replaces older regimens that could run for more than a year and often involved painful daily injections. Under India’s national TB programme, more than 15,000 patients have started BPaLM, the same regimen with a fourth drug, moxifloxacin, added.The rejection followed two pre-grant oppositions filed in 2020. Indian patent law allows anyone to challenge a patent application before it is granted. One was filed by Eldred Tellis of the Sankalp Rehabilitation Trust and Ganesh Acharya, a two-time TB survivor, with support from the Lawyers Collective and Médecins Sans Frontières’ Access Campaign. The other was filed by the Delhi Network of Positive People (DNP+), with support from Third World Network (TWN).“The opponents challenged the patent application on the grounds that the combination of bedaquiline, pretomanid and linezolid, as well as its use in a shorter treatment regimen, had already been disclosed in earlier scientific research and clinical trials dating back to 2015,” the joint statement said. They argued that combining known medicines did not amount to an inventive step that justified a new patent.In 2023, the patent office had rejected an application by Johnson & Johnson to extend its patent on bedaquiline.The opponents said the decision could help open the door to generic competition and lower prices in India and elsewhere. Patents on the BPaL combination have been granted in 11 countries and are due to expire in 2036: Armenia, Azerbaijan, Belarus, Bulgaria, Indonesia, Kazakhstan, Kyrgyzstan, Russia, South Africa, Tajikistan and Turkmenistan.India had an estimated 2.71 million new TB cases in 2024, about a quarter of the global total, or 187 for every 100,000 people, according to WHO.“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,” said Loon Gangte of DNP+, one of the opponents, in the statement.