TB: 9 patent oppositions against J&Js overpriced drugs

  • 1.2 million lives were lost to TB last year. The reduction in TB deaths annually is slow, and even these modest gains are at risk of being ‘set back’ by COVID-19, with access to TB treatment reduced during the pandemic.
  • Bedaquiline (BDQ) is a core component of an ‘all-oral’ treatment regimens to multi-drug resistant TB (MDR-TB), recommended by the World Health Organization.
  • Treatment time is significantly less compared to older, injectable treatments for MDR-TB. This is around 9-12 months, compared to two years, and can be largely administered at home instead of hospital, with less side affects that were caused by injectable treatment, such as hearing loss.
  • Being forced to remain on outdated treatment reduces a patient’s chance of recovery from TB.
  • Monopolies, obtained at country-level, on BDQ are preventing access to improved TB treatment. The prices set by the patent holder, Johnson & Johnson, are not a fair price, especially considering the large public investment in the drug development.
  • Civil society is opposing J&Js unmerited patents on BDQ. Nine patent oppositions have been submitted so far, six of them by Make Medicines Affordable campaign partners.

For years, TB has been the world’s largest infectious killer, tragically only overtaken by COVID-19. The drive that currently surrounds COVID-19, to make sure treatment is affordable and accessible for all, died down along ago for TB, after it was mostly eradicated in western and high-income countries. Although it is on the rise in all areas of the world.

The desire to cure everyone from this life-threatening disease was no less potent at the start of the TB response than is the case with COVID-19 now, and for global treatment activists this drive has never gone away.

Monopolies allow pharmaceutical companies to dictate drug prices. When drugs are overpriced, as they typically are, this surmounts to denying the best chance of survival to millions of people. The prices dictated by J&J for this key TB drug are not fair. This is why there is a coordinated effort underway to prevent J&Js unmerited monopolies in countries around the world.

Nine oppositions have been filed against J&Js patent applications

Sending a message to J&J globally: Five more oppositions are expected before the end of the year.

A total of nine oppositions have been filed, so far, against Johnson & Johnson’s patent applications for the TB drug, bedaquiline, and oppositions from civil society organizations in five more countries are expected to be filed soon. The treatment has the potential to significantly shorten and improve TB treatment; massively increasing the odds of treatment adherence and saving lives.

Bedaquiline cannot save lives if it is out of reach because a country’s health budget cannot stretch to prices demanded, and despite the public deserving a return on its own, large investment into the development of the drug.

Six of the nine patent challenges were submitted by Make Medicines Affordable campaign partners, details below. See the complete, and hopefully growing, list of oppositions here.

  1. BRAZIL

    Opposition filed by: ABIA/GTPI
Drug registration: Bedaquiline fumarate salt (eq. to WO2008068231)
Decision: Under examination.

  2. THAILAND

    
Opposition filed by: AIDS Access Foundation & TNP+
Drug registration: Bedaquiline to treat MDR TB and/or combinations with other antimycobacterial agents (eq. to WO2005117875)
    
Decision: Under examination.

  3. THAILAND

    
Opposition filed by: AIDS Access Foundation & TNP+
Drug registration: Bedaquiline fumarate salt (eq. to WO2008068231)
    Decision: Under examination.

  4. THAILAND

    Opposition filed by: AIDS Access Foundation 
Drug registration: Bedaquiline to treat latent TB (eq. to WO2006067048)
    Decision: Under examination.

  5. INDIA

    
Opposition filed by: DNP+
Drug registration: BPaL – Bedaquiline/Pretomanid/linezolid (optionally pyrazinamide) compositions and their use in TB, (eq. WO2017066053)
    Decision: Under examination.

  6. UKRAINE

    Opposition filed by: 100% LIFE
Drug registration: Bedaquiline Pediatric Formulation (eq. to WO2016120258)
    Decision: Under examination.