J&J to not Enforce Patents on TB Drug Bedaquiline

J&J to not Enforce Patents on TB Drug Bedaquiline
Photo: freepik.com 03.10.2023 588

Healthcare major was under intense global pressure from public health advocacy groups.

Faced with global calls to not pursue secondary patents on its breakthrough tuberculosis (TB) drug, healthcare major Johnson & Johnson said it would not enforce patents that it owns and controls for Sirturo (bedaquiline), used in the treatment of multidrug-resistant tuberculosis (MDR-TB) in 134 low- and middle-income countries.

This move follows global pressure on the company to not pursue secondary patents on its breakthrough tuberculosis drug, including the Indian Patent Office’s rejection of J&J’s secondary patent application for the fumarate salt of bedaquiline.

Bedaquiline is the first drug for tuberculosis, or TB, to be globally approved in over 40 years, and is less toxic and more effective than traditional TB treatments. 

The Access Campaign, which is part of Médecins Sans Frontières (MSF), an international medical humanitarian organisation stated:

“This success is a testament to the persistent efforts of TB activists, civil society and also countries prioritising public health over corporations’ interests. The recent investigation by the South African Competition Commission undoubtedly added significant pressure on J&J, ahead of their announcement.”

The group’s statement notes that after J&J lost its attempt to extend its monopoly in India, national TB treatment programmes from Ukraine and Belarus also requested the company to drop its secondary patents in their countries.

The group added that they now want to see Japanese pharma major Otsuka follow suit and publicly announce that they will not enforce any secondary patents in low- and middle-income countries for the other critical new TB drug Delamanid, especially as the corporation’s primary patent is set to expire in 10 days in India and other countries.

Delamanid is another key drug resistant TB drug used in combination with bedaquiline, and is particularly important for the treatment of children.

Meanwhile, at least three Indian companies — Lupin, Natco, and Macleods — have reportedly said that they are preparing to bring out generic versions of bedaquiline.

Source:  The Hindu, The Hindu Business Line

pharmaceutical markets  India 

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