Johnson & Johnson Loses Key Tuberculosis Drug Patent In India, Makes Way For Domestic Generic Players

The Indian Patent Office rejected Johnson and Johnson's JNJ application to extend its patent on tuberculosis treatment, bedaquiline, beyond July 2023.
The decision paves the way for the entry of cheaper generics by domestic players.
Many such manufacturers have already expressed an interest in supplying the drug at more affordable prices under the WHO's pre-qualification program.
Janssen, a subsidiary of J&J, filed for multiple patents on bedaquiline in India, not limiting itself to the basic compound patent but also filing secondary patents to stake claims on routine improvements, a patent expert said in a TOI report.
Developed by Janssen, FDA conditionally approved bedaquiline for multidrug-resistant (MDR) TB in 2012.
A 2018 WHO rapid communication on MDR-TB treatment guidelines prioritized bedaquiline among drugs for treatment, and in 2019, it was launched in India.
Indian Prime Minister Narendra Modi has committed to eradicating tuberculosis from India by 2025, as the country accounted for nearly 29% of 10.6 million tuberculosis cases worldwide, according to the WHO's 2022 Global TB report.
Johnson and Johnson had applied to extend its patent on the drug bedaquiline until 2027 after it was challenged by two tuberculosis survivors in Mumbai in 2019 as part of a campaign to make the drug more affordable, noted an NDTV report.
In response, Johnson and Johnson applied to extend its patent beyond 2023.
In 2020, Johnson and Johnson announced it was cutting the price of bedaquiline tablets, made available to the Stop TB Partnership in around 135 low- and middle-income countries, to $340 from $400 for a six-month treatment course.
The medical charity Doctors Without Borders (MSF) welcomed that decision at the time but said the price should come down further and be extended to more countries.
Price Action: JNJ shares are down 0.25% at $150.75 during the premarket session on the last check Friday.

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