GURGAON: The Indian Patent Office has rejected a patent application by US-based Global Alliance for TB Drug Development for BPaL, a life-saving tuberculosis therapy, citing lack of novelty and inventive step. The decision could allow domestic drugmakers to launch cheaper generic versions in India and other high-burden countries, health experts said.Govt provides BPaL, a combination of bedaquiline, pretomanid and linezolid, free under National TB Elimination Programme. However, treatment costs remain a challenge. The six-month all-oral regimen is shorter than older treatments and reduces patients’ compliance burden. More than 15,000 patients have begun BPaLM, which adds moxifloxacin, under the programme.Pre-grant oppositions were filed separately by Sankalp Rehabilitation Trust’s Eldred Tellis and TB survivor Ganesh Acharya, supported by Lawyers’ Collective and Médécins Sans Frontières Access Campaign; and Delhi Network of Positive People, supported by Third World Network.
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Patent Controller upheld grounds of lack of novelty, lack of inventive step, non-patentability and insufficient disclosure, refusing application under Sec 15 of Patents Act. Opponents argued the combination and its use in a shorter regimen had been disclosed in scientific research dating to 2015.The opposition invoked Sections 3(d), 3(e) and 3(i), which restrict patents on new uses of known substances, exclude mere admixtures and methods of medical treatment. All four grounds were upheld.TB Alliance had earlier licensed generic firms, including Macleods Pharma and Lupin, to manufacture pretomanid for BPaL in India, though health activists called the agreements restrictive. This could widen the supplier pool.
