With the Indian Patent Office (IPO) rejecting Johnson & Johnson’s (J&J) patent application on the paediatric formulation of its breakthrough tuberculosis drug bedaquiline, public health voices are calling on Indian drugmakers to develop and supply these drugs for children.
The IPO’s rejection earlier this month followed a pre-grant opposition by The Delhi Network of Positive People (DNP+) and a Mumbai-based tuberculosis (TB) survivor Ganesh Acharya, supported by Médecins Sans Frontières/Doctors Without Borders (MSF). The application was rejected for lacking an inventive step. J&J had not replied to the pre-grant opposition.
MSF urged generic manufacturers “to take the opportunity to develop and supply the paediatric formulation to TB programmes.” The organisation 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.
An email query was sent to the US healthcare company by businessline, on the development and a response is awaited.
Regulatory barrier
Public health lawyer working on access to medicines, Leena, Menghaney said: “While we’ve removed the IP barriers, there are significant regulatory barriers for the youngest of children – to be provided the new drug. And the alternative is to put them on injection-based regimens which we know have significant side effects such as hearing loss. So we appeal to the Indian drug regulator to look into the matter, particularly in the light of the WHO’s recommendation to provide the drug to children of all ages and support the TB programme.“
About a year ago, the primary patent on the adult version had lapsed and Indian drugmakers including Lupin, Natco and Macleods had confirmed to businessline, they were making versions of the product.
In March 2023, a patent challenge in India by two TB survivors, Nandita Venkatesan and Phumeza Tisile (a South African TB advocate), had resulted in the IPO rejecting J&J’s attempt to patent the salt form of bedaquiline. This would have extended their market control over the drug for an additional four years (beyond the primary patent’s expiry of July 2023, MSF pointed out.