The Indian Patent Office rejected the application for the BPaL combination therapy after determining it lacked novelty and inventive step, while also citing statutory prohibitions on patenting mere admixtures and treatment methods. Civil society organizations and patient advocates challenged the filing, pointing to existing scientific literature published as early as 2015. Although the Indian government currently provides the expanded BPaLM therapy for free to thousands of patients, generic competition will likely reduce global procurement costs. This shift effectively bypasses previous licensing agreements that activists had criticized as overly restrictive.
Key points
Domestic drug manufacturers are now cleared to develop cheaper generic alternatives of th…: Domestic drug manufacturers are now cleared to develop cheaper generic alternatives of the all-oral tuberculosis regimen.
Pre-grant oppositions by civil society groups effectively curbed restrictive licensing pr…: Pre-grant oppositions by civil society groups effectively curbed restrictive licensing practices previously maintained by the TB Alliance.
Legal provisions barring patents on known substances and medical treatment methods succes…: Legal provisions barring patents on known substances and medical treatment methods successfully safeguarded affordable therapy access.
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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.
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…
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