Contact: Natalie Shure, Treatment Action Group (natalie.shure@treatmentactiongroup.org)

MARCH 28, 2023 – The Indian Patent Office has taken a laudable step that will pave the way for generic manufacturing of a key tuberculosis (TB) drug. By rejecting Johnson & Johnson’s application for a secondary patent on the fumarate salt formulation of bedaquiline, India has taken a clear stand against the pharmaceutical tactic of “patent evergreening” and ensured that J&J’s legal monopoly on bedaquiline production in India will expire this year. As members of the 1/4/6×24 Campaign, a coalition of advocates representing communities affected by TB, we are hopeful this development will expand access to this life saving drug, and we reiterate our longstanding demands that J&J withdraw or not enforce its remaining secondary patents on bedaquiline worldwide.

India’s rejection of Johnson & Johnson’s secondary patent on bedaquiline thwarts the company’s attempt to extend market exclusivity beyond the expiry of its primary patent in July 2023 – a notorious pharmaceutical industry tactic called “evergreening,” which keeps prices high and curtails access to drugs in the process. This ruling leaves Indian generics manufacturers free to produce and sell the drug in India and other countries where the secondary patent has either not been filed or granted. Experts estimate generic production could reduce prices as much as 80%. The ruling in India is also likely to benefit people living with TB outside its own borders, since the country is such a large exporter of generics to low- and middle-income nations. However, the secondary patents have been granted in 15 other high TB burden countries, blocking their ability to import generics made in India or elsewhere until 2027.

Since entering the market in 2012, bedaquiline has become the cornerstone of treatment regimens for drug-resistant TB (DR-TB) – a difficult-to-treat form of TB that affects half a million people worldwide. In the successful lawsuit challenging J&J’s secondary patent application filed with the support of Medicins Sans Frontiers (MSF,) petitioner and DR-TB survivor Nandita Venkatesan emphasized the importance of universal access to bedaquiline given how vastly the drug improved upon the previously grueling standard of care for DR-TB: “I had to battle with this deadly disease for nearly eight years, enduring taking multiple medicines and painful injections with debilitating side effects. We filed this patent challenge to ensure access to the safer, more effective oral drug bedaquiline for all those who need it … by rejecting the patent, the Indian Patent Office will help save lives of people with DR-TB.”

This crucial step toward making generic bedaquiline a reality represents a victory for the TB-affected communities and allies behind the 1/4/6×24 Campaign, which demands universal implementation of the shortest available TB regimens – 1-month (or once weekly) for TB prevention, four months for drug-sensitive TB, and six months for drug-resistant TB – by the end of 2024. By driving down the price of the six-month regimen, generic bedaquiline could make resources available for other neglected aspects of TB care around the world, including diagnostics, patient support and more. For these reasons, the 1/4/6×24 Campaign Coalition has demanded that J&J commit to withdrawal or non-enforcement of its remaining patents on bedaquiline around the world .

We are hopeful that the Indian Patent Office’s rejection of Johnson & Johnson’s frivolous secondary patent on such a vital drug inspires other governments to side with patients over pharmaceutical profits. People affected by TB will benefit from the removal of this indefensible barrier to getting bedaquiline to everyone, everywhere who needs it.

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About the 1/4/6×24 Campaign: 

The 1/4/6×24 Campaign Coalition is an international network of TB survivors, researchers, clinicians, activists, and civil society professionals who advocate for communities affected by TB. Their institutional affiliations include:

Treatment Action Group (TAG)
Partners In Health (PIH)
Médecins Sans Frontières (MSF)
Global Coalition of TB Advocates (GCTA)
Treatment Action Campaign (TAC)
Global TB Community Advisory Board (TB CAB)
Stop TB Partnership
Survivors Against TB
Results Canada
The Sentinel Project Against Pediatric Drug-Resistant TB
We Are TB
TBPPM Learning Network
Asia Pacific Counsel of AIDS Service Organizations (APCASO)
African Coalition on TB (ACT)
TB Europe Coalition (TBEC)
Lean on Me Foundation
O’Neill Institute for National and Global Health Law at Georgetown University
TB Women Global
Wote Youth Development Projects
Zambia Association for Prevention of HIV and TB (ZAPHIT)