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India rejects application to extend patent on TB drug bedaquiline

BMJ 2023; 380 doi: (Published 28 March 2023) Cite this as: BMJ 2023;380:p724
  1. Kamala Thiagarajan
  1. Madurai, Tamil Nadu, India

The Indian patent office has rejected an application by the pharmaceutical company Johnson & Johnson to extend the patent on bedaquiline beyond July 2023, effectively ending its eight year monopoly on the tuberculosis (TB) drug.

The move opens the door for drug manufacturers to produce lower cost, generic versions of bedaquiline which should help India realise its goal of eliminating TB by 2025.

It’s a move in the right direction, says Sumanth Gandra, an expert in infectious diseases at Washington University School of Medicine and a member of the World Health Organization Essential Medicine List expert committee. “The company wanted to extend the patent by creating a new formulation with minor changes, without providing evidence on improved treatment efficacy,” he says. “This decision has huge implications. Bedaquiline is a vital drug for treating multidrug resistant TB (MDR-TB) and every year thousands of …

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