TB survivors file challenge to prevent J&J from extending patent life on Bedaquiline

PT Jyothi Datta Mumbai | Updated on February 08, 2019 Published on February 08, 2019

Security guards stand outside the office of Johnson & Johnson in Mumbai.   -  REUTERS

Two tuberculosis survivors have filed a patent challenge on Johnson and Johnson’s TB drug Bedaquiline.

Nandita Venkatesan from Mumbai and Phumeza Tisile from South Africa have filed a challenge at the Mumbai Patent Office to prevent the company from extending its monopoly on the patented drug, a note from humanitarian organisation Médecins Sans Frontières (MSF – Doctors without Borders) said, adding that they were supporting the challenge.

Both individuals had survived drug-resistant TB (DR-TB), but lost their hearing because of the toxicity of the treatment. “They are now fighting to ensure that newer drugs like Bedaquiline – which are safer and more effective – are made affordable and accessible to everybody with DR-TB, to replace painful and toxic drugs that need to be injected,” the note said.

The J&J patent application being challenged is for the salt form of Bedaquiline, which does not merit patenting under India’s patent law, the MSF note said. If granted, J&J’s monopoly on Bedaquiline would be extended from 2023 to 2027, delaying entry of generics by four additional years. This strategy of ‘patent ever-greening’ by filing additional, often unmerited patents, is commonly used by corporations to extend monopolies on their drugs beyond the standard 20 years.

“Preventing this patent barrier is expected to encourage TB drug manufacturers from India to enter the market with generics and supply Bedaquiline at lower prices to national TB programmes and TB care providers globally,” it added.

About 558,000 people developed DR-TB in 2017, but only 25 per cent of them were treated. The standard DR-TB treatment in most countries has included drugs that need to be injected daily and are associated with several serious side-effects. The cure rate is only 55 per cent, the note explained.

“I lost my hearing when I was 24 because of the brutal side-effect of an injected DR-TB drug,” said Nandita Venkatesan, who completed her treatment in 2015. “I was devastated by this loss, which took a heavy financial, emotional and mental toll on me. How many more people will have to die or go deaf, waiting to access safer and more effective drugs that can save their lives, without such devastating side-effects? With this patent challenge, we want to prevent an extension of the patent monopoly that will continue to block people from accessing more affordable generic versions of Bedaquiline.”

As seen with cancer drugs, here, too, high prices remain a significant barrier, despite the benefits of the drug. J&J recently announced a reduced price of $400 for six months of Bedaquiline treatment for South Africa and countries procuring the drug through the Global Drug Facility, but this falls short of making the drug affordable in all countries affected by the DR-TB epidemic, the note said.

WHO recommended

The World Health Organization (WHO) recently recommended Bedaquiline as a core part of an all-oral treatment regimen for DR-TB, and relegated drugs that must be injected and cause serious side-effects to last-resort options. A scale-up of WHO’s recommendations will dramatically increase the number of people who should receive this drug. Up to November 2018, only 28,700 people had received Bedaquiline worldwide – nearly 70 per cent of whom have been treated in South Africa, the note said.

“I know what it means to be faced with the choice of being deaf or dead, because the only drugs that can save your life will also rob you of your hearing,” the note says, quoting Phumeza Tisile, who completed her treatment for extensively drug-resistant TB (XDR-TB) in 2013, which included toxic injected drugs. “I wouldn't wish anyone to go through what I did with DR-TB. Pharmaceutical corporations like J&J should stop controlling the price of the drug that will restrict people’s access to safer and more effective tuberculosis treatment.”

The development of Bedaquiline benefitted from considerable public investment, and the evidence for its potential to improve cure rates with fewer side-effects was the result of a collective effort of the global TB community, MSF said, urging J&J to refrain from attempts to extend its monopoly, that will further delay the availability of quality-assured generic versions of Bedaquiline in India, South Africa and other countries.

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Published on February 08, 2019
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