MSF welcomes Indian Patent Office’s rejection of J&J’s application for paediatric formulation of lifesaving TB drug 

Mumbai, 17 July 2024 – On Friday 5 July 2024, the “pre-grant opposition” filed in December 2020 by The Delhi Network of Positive People (DNP+) and a Mumbai-based tuberculosis (TB) survivor Ganesh Acharya, and supported by Médecins Sans Frontières/Doctors Without Borders (MSF) was successful: the Indian Patent Office 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. 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 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. 

Ganesh Acharya, TB survivor/TB-HIV activist, India: 

“We welcome the news that the Indian Patent Office rejected J&J’s patent application on the paediatric formulation of bedaquiline. As TB activists and survivors, we are now hoping that the Indian TB programme will up its game following the removal of patent barriers. The WHO has recommended the new TB drugs bedaquiline and delamanid for all ages to ensure access to injection-free short oral regimens for children. However, there are regulatory barriers to providing regimens containing bedaquiline and delamanid due to the lack of approval in India for children below 10 kgs for delamanid and children below 5 years for bedaquiline. It’s unconscionable that this breakthrough medical innovation like a short oral regimen exists, is recommended by the WHO, and yet we are denying it to the youngest children with rifampicin-resistant TB who can benefit from it.” ​ 

Dr Aparna Iyer, Project Medical Referent, MSF Mumbai drug-resistant TB (DR-TB) project: ​ 

“With still 1.3 million children and young adolescents developing TB globally in 2022 according to the WHO, of whom 135,000 children between birth and 14 years were in India, governments need to do more to ensure effective TB and DR-TB treatment reaches all children, in line with the WHO’s treatment recommendations. WHO recommends bedaquiline and delamanid for children of all ages affected by DR-TB, so governments need to make sure that child-friendly formulations of these new medicines are available in India and everywhere else in the world. It’s high time to ensure every child, everywhere, has access to life-saving early TB diagnosis and treatment.” 

Background:

Concerns over evergreening—a practice that extends patent monopolies through patenting of obvious forms, improvements and modifications of life saving medicines have led to several such pre-grant oppositions in the past. ​ 

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 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. 

For interviews, please contact Morag McKenzie, Morag.McKENZIE@berlin.msf.org