Two tuberculosis survivors from India and South Africa have challenged a patent to prevent pharmaceutical giant Johnson & Johnson (J&J) from extending its monopoly on bedaquiline, one of the two newest anti-TB drugs in 50 years.
Mumbai’s Nandita Venkatesan and Cape Town’s Phumeza Tisile are both survivors of drug resistant TB, who lost their hearing because of the toxicity of anti-TB treatment. They are now advocating for a wider rollout of newer drugs like bedaquiline over other painful injections and drugs with severe side effects.
“With this patent challenge, we want to stop an extension of the patent monopoly that will continue to block people from accessing more affordable generic versions of bedaquiline,” Ms. Venkatesan said in a statement.
The patent challenge has been filed with support from Médecins Sans Frontières (MSF). “Despite the benefits of the drug, high prices remain a barrier. J&J recently announced a reduced price of $400 for six months of bedaquiline treatment for South Africa and countries procuring the drug through the Global Drug Facility, but this falls short of making the drug affordable in all countries affected by the DR-TB epidemic,” a statement from the MSF said.
The statement also said the J&J patent application being challenged is for the salt form of bedaquiline, which does not merit patenting under India’s patent law. If granted, J&J’s monopoly on bedaquiline would be extended from 2023 to 2027, delaying entry of generics by four additional years.
A J&J spokesperson said the company is committed to ensuring that bedaquiline reaches as many patients as possible, and it is a committed partner in India’s efforts to combat TB. “The patent application in question – for the formulation of bedaquiline – was filed in 2007, and became publicly available in 2008, as part of standard procedures when developing new medicines. The application was first considered by the Indian Patent Office in 2012 and remains under review. A formulation patent would not prevent generic manufacturers from developing the active pharmaceutical ingredient in their own formulations after July 2023,” the spokesperson said.
The spokesperson also said since the introduction of bedaquiline in India, J&J has donated more than 10,000 courses to support the government’s efforts to scale up access. “Beyond providing access to bedaquiline, we have also supported efforts to improve diagnostic capacity, train health workers on the clinical management of TB, and raise awareness of TB at the community level.”
