No Patent for an Old Idea: India’s TB Ruling Could Make a Six-Month Cure Cheaper
India’s patent office has turned down an application that could have shaped the price of tuberculosis treatment for years. The decision concerns BPaL, the six-month, all-oral regimen that combines bedaquiline, pretomanid and linezolid. The applicant was the US-based TB Alliance, a non-profit drug developer. The examiners concluded that the claimed invention lacked novelty and an inventive step.
What the objectors argued
Two sets of pre-grant oppositions were filed. One came from a Mumbai rehabilitation trust together with a TB survivor, backed by a lawyers’ group and the access campaign of Médecins Sans Frontières. Another came from a Delhi network of people living with HIV. Their core point was simple: the combination and its use in a shorter course had already been described in scientific literature as early as 2015. Something already public cannot be patented again as new.
They also relied on India’s well-known safeguards in patent law. These limit protection for new uses of known substances, for simple mixtures that do not create something more than the sum of their parts, and for methods of medical treatment. All four grounds were accepted.
Why it matters beyond India
India carries the world’s largest TB burden, and its programme already provides BPaL free of charge. More than 15,000 patients have started the related BPaLM regimen, which adds moxifloxacin. But free for the patient does not mean cheap for the state. Every rupee saved on drugs can pay for screening, nutrition support and follow-up, the weak links that let patients slip out of care.
The ruling also matters for other high-burden countries that buy Indian generics. TB Alliance had licensed firms such as Macleods and Lupin to make pretomanid, but activists considered those deals restrictive. Without a combination patent, more manufacturers may enter, and competition usually pushes prices down faster than licences do.
There is a balance to keep. Non-profit developers need some way to recover costs and fund the next drug. Yet the ruling sends a clear message: in India, patents are for real inventions, not for packaging known medicines in a new order. For patients facing a disease that still kills more than a million people a year worldwide, that distinction could be measured in lives.