The IPO has to take a decision on granting the secondary patent to bedaquiline in a month’s time from the hearing, said a person who is aware of the matter.
The latest secondary patent application, if granted, allows J&J to extend the monopoly on the drug used for treatment of drug resistant (DR-TB) till December 2027.
Several Indian manufacturers are ready to supply the generic version of the drug upon the expiry of the primary patent in July 2023. Generic manufacturers have already applied to the WHO’s ‘pre-qualification’ programme, to supply the drug to low- and middle-income countries.
Paris-based Medecins Sans Frontieres/Doctors Without Borders (MSF) is also party to the challenge against the patent application of J&J along with petitioners.
J&J has also filed for multiple secondary patents not just in India, but many other countries for the bedaquiline compound.
“..the secondary patent application on the fumarate salt of bedaquiline filed in India, which if granted, would potentially extend J&J’s monopoly until December 2027, thereby blocking Indian generic manufacturers from entering the supply chain with more affordable generic versions for four more years,” MSF said in a statement.