Why did India reject J&J’s patent on TB drug?

Last Updated28/03/2023

Recently, the Indian Patent Office rejected an application by Johnson & Johnson (J&J) to extend its patent on the drug bedaquiline (a drug in tablet form used to treat drug-resistant TB beyond July 2023.
This opens the door for drug manufacturers to produce generic versions of bedaquiline.

As of 2017, India accounted for around one-fourth of the world’s burden of multi-drug-resistant (MDR) TB and of extensively-drug-resistant (XDR) TB.
MDR TB: It resists treatment by at least two frontline drugs in TB treatment, isoniazid and rifampicin.
XDR TB: It resists these two drugs as well as fluoroquinolones and any second-line injectable drug.
XDR TB is rarer than MDR TB .
TB incidence in India has been on the decline, but MDR TB and XDR TB endanger initiatives to locally eradicate the disease.

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TB is an infection of the bacterium Mycobacterium tuberculosis in the lungs.
However, it is often in other organs as well.
Treatment: By strictly adhering to the doses and frequencies of drugs prescribed by a physician.

Unlike second-line treatment options that are injected and can have severe side effects, like hearing loss, bedaquiline is available as tablets and is less harmful.
Potential side effects: can be toxic to the heart and the liver.

India has the largest population of people living with drug-resistant TB.
J&J’s patent on bedaquiline meant the drug cost $400 (revised to $340 in 2020) per person, plus the cost of other drugs.
The rejection is expected to lower the cost of bedaquiline by up to 80%.
So far, the Indian government has directly procured the drug and distributed it through State-level TB programmes.
After July 2023, manufacturers of generic drugs such as Lupin will be able to produce generic versions of bedaquiline.