Hearing in TB drug patent case ends, verdict likely in a month
The Indian Patent Office had held its final hearing on a challenge filed by two tuberculosis survivors to prevent the Indian arm of drugmaker Johnson & Johnson from extending its patent on bedaquiline, used against drugresistant TB, beyond the primary patent’s expiry in July.
If the patents regulator decides in the favour of the challengers, it will pave the way for generic versions of the drug in the local market that will likely be 80% cheaper for a six-month course. The hearing took place on January 17.
“The arguments have been concluded, pronouncing objections
against the patent. This was the 4th hearing in the matter and the verdict is expected in about four weeks,” a person familiar with the matter said, seeking anonymity.
The TB survivors—nandita Venkatesan from Mumbai and Phumeza Tisile from Khayelitsha in South Africa—who filed the challenge at the Mumbai Patent Office in 2019, along with Médecins
Sans Frontières (or MSF), has been urging the rejection of the secondary patent application filed by Johnson. In 2019, the managing director of Janssen in India, the local arm of Johnson, stated that in July 2023, generic manufacturers will be able to make their own versions of bedaquiline, and yet, the corporation reportedly began pushing for another patent for the drug in India.
Both the challengers survived severe forms of TB, but lost their hearing because of the toxicity of older treatments before there was access to the improved and bettertolerated drugs like bedaquiline and delamanid. Johnson has primary patent on the bedaquiline compound that will expire in July.