The Indian Patent Office rejected an application from Johnson & Johnson to patent a WHO-recommended TB drug. File | Photo credit: Reuters
The Indian Patent Office has rejected an application by American pharmaceutical company Johnson & Johnson (J&J) for a patent on a pediatric formulation of the World Health Organization (WHO)-recommended TB drug bedaquiline.
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The decision follows a “pre-grant opposition” filed in December 2020 by the Delhi Network of Positive People (DNP+) and Mumbai-based tuberculosis (TB) survivor Ganesh Acharya, supported by MĂ©decins Sans Frontières/Doctors Without Borders (MSF ). ).
Welcoming the decision, MSF in a statement released on Wednesday said that this is an important step to increase affordable access to life-saving TB drugs for children, and called on public manufacturers to take the opportunity to develop and provide pediatric formulations for TB programs. .
The group also called on the Indian government to implement WHO’s 2022 treatment recommendations and provide pediatric bedaquiline to children with TB of all ages.
Speaking about the development, Aparna Iyer, project medical reference, MSF Mumbai’s drug-resistant TB project (DR-TB), noted that around 1.3 million children and adolescents will still suffer from TB globally in 2022 according to the WHO, of which 135,000 are children. between birth and 14 years in India, the government needs to do more to ensure effective TB and DR-TB treatment reaches all children, in line with WHO treatment recommendations.
“WHO recommends bedaquiline and delamanid for children of all ages affected by DR-TB, so the government must ensure that these new child-friendly drug formulations are available in India and everywhere in the world. It is time to ensure that every child , everywhere, have access to life-saving early TB diagnosis and treatment,” he said.
Concerns about evergreening — the practice of extending a patent monopoly through patenting clear forms, improvements and modifications of life-saving drugs — have fueled some of these pre-grant oppositions in the past.
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On March 23, 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 J&J’s attempt to patent the salt form of bedaquiline. , which will increase market control of the drug for an additional four years (beyond the July 2023 main patent expiration). Following this rejection, national TB treatment programs from Ukraine and Belarus asked J&J to release secondary patents in their countries and others affected by TB, and the South African Competition Commission launched an investigation into J&J’s continued patent practices and anti-competitive pricing practices.
“The efforts of TB activists, civil society, and countries that prioritize public health over corporate interests, and J&J announced that it will not enforce the drug’s patent in 134 low- and middle-income countries, and prices have fallen by more than 50% in general. competing with J&J in the bid to supply the drug to the Global Drug Facility,” MSF said in a statement.
Responding to the move, TB survivor/TB-HIV activist Mr. Acharya, said rejecting J&J’s patent application on pediatric bedaquiline formulation would be a game changer. “WHO has recommended the new TB drugs bedaquiline and delamanid for all ages to ensure access to a short oral regimen without injections for children. However, there are regulatory barriers to providing regimens containing bedaquiline and delamanid as there is no approval in India for children under 10 kg for delamanid, and children under five years for bedaquiline. It is not known whether the breakthrough medical innovation of this short oral regimen exists, but we reject it for the youngest children with rifampicin-resistant TB who can benefit from it,” he said.
