Indian Patent Office rejects J&J’s application for paediatric formulation of lifesaving TB drug

The Indian Patent Office has rejected the US pharmaceutical corporation Johnson & Johnson’s (J&J) application for a patent on the paediatric formulation of World Health Organization (WHO)-recommended TB drug bedaquiline.

The MSF welcomed this as a significant step toward increasing affordable access to the lifesaving TB drug for children and urged generic manufacturers to take the opportunity to develop and supply the paediatric formulation to TB programmes. MSF has also called on the Indian government to implement the WHO’s 2022 treatment recommendations, and make paediatric bedaquiline available to children with TB of all ages.

Last year, on 23 March 2023,  a patent challenge initiated in 2019 in India by two TB survivors, Nandita Venkatesan and Phumeza Tisile (a South African TB advocate), was successful and resulted in the Indian Patent Office rejecting the US pharmaceutical corporation Johnson & Johnson’s (J&J) attempt to patent the salt form of bedaquiline, which would have extended their market control over the drug for an additional four years (beyond the primary patent’s expiry of July 2023).

Following this rejection, national TB treatment programmes from Ukraine and Belarus also requested J&J to drop its secondary patents in their countries and others heavily affected by TB, and the South African Competition Commission launched an investigation into J&J’s evergreening patenting practices and anti-competitive pricing conduct. The pressure – a testament to the effort of TB activists, civil society, and countries prioritising public health over corporations’ interests – worked and J&J announced they would not enforce patents on the drug in 134 low- and middle-income countries, and prices dropped by over 50% with generic companies competing with J&J in bids to supply the drug to the Global Drug Facility.