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Johnson & Johnson not to enforce patents on TB drug

October 01, 2023 08:03 pm | Updated October 02, 2023 01:25 pm IST - NEW DELHI

The move follows global pressure on the company, with India’s Patent Office rejecting J&J’s attempt to extend its monopoly on the drug, which is critical for the treatment of drug resistant TB

Bedaquiline is the first drug for tuberculosis, or TB, to be globally approved in over 40 years. File | Photo Credit: AP

U.S.-based drug maker Johnson & Johnson has announced that it will not enforce patents for Sirturo — its brand name for bedaquiline, which is used in the treatment of multidrug-resistant tuberculosis — in 134 low- and middle-income countries.

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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.

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Also read: Is there a TB drugs shortage in India? | Explained

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. 

‘Prioritising public health’

“The announcement will finally pave the way for unfettered access to affordable generic versions of bedaquiline for all people living with drug-resistant tuberculosis who need the drug in low- and middle-income countries. This success is a testament to the persistent efforts of TB activists, civil society and also countries prioritising public health over corporations’ interests,” said the Access Campaign, which is part of Médecins Sans Frontières (MSF), an international medical humanitarian organisation.

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 recent investigation by the South African Competition Commission undoubtedly added significant pressure on J&J, ahead of their announcement,“ the Access Campaign said.

Japanese drug is next target

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.

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