The world has the science, targets and a plan to eliminate tuberculosis (TB). However, Johnson & Johnson, the patent holder of an essential TB drug, is blocking progress – and civil society is taking a stand.
World TB Day – 24 March 2021.
TB is preventable and curable, yet in 2019, 10 million people fell ill with tuberculosis (TB) globally, and 1.4 million people died. TB remains the number one cause of death among people living with HIV.
Multidrug-resistant TB (MDR-TB) is challenging to treat, not least for the patient. Many older treatment courses are less effective and difficult to endure. Prior to the COVID-19 pandemic which began in 2020, TB was the world’s largest infectious killer, year after year. Overall rates of TB are reducing, but too slowly to have a chance of meeting global targets any time soon, and MDR-TB is on the rise.
Bedaquiline (BDQ) is a core component of an ‘all-oral’ treatment regimen, recommended by the World Health Organization (WHO), which can treat all forms of TB, including MDR-TB.
Treatment time for these newer regimens is significantly less compared to older, injectable treatments for TB; it can largely be administered at home instead of hospital; and with less side-effects, such as hearing loss, which can be caused by injectable treatment.
However, Johnson & Johnson (J&J) and their commercial partners have chosen to overprice BDQ.
Monopolies, obtained at country-level, enable the companies to push the prices up, due to a lack of competition. “The prices are based on what J&J and their partners can get away with charging. These prices are spurious, it is not related to research and development, nor do prices reflect the large public investment into the development of the drug,” says Sergey Golovin, Make Medicines Affordable coordinator for Eastern Europe and Central Asia (EECA) at ITPCru.
“That’s why three patent oppositions have been filed against J&J’s applications in Kazakstan, Kyrgyzstan and Belarus, in 2020/21, adding to the backlash around the world, which is being led by civil society. Our partners are also exploring opportunities for issuing compulsory licenses for bedaquiline. The region continues to be heavily affected by TB and yet we know the drug can be produced affordably, and we also have capacity to produce BDQ within the region – but the intellectual property owners’ actions prevent us. We will use all the TRIPS flexibilities, which are available to all countries, to ensure people can access the best treatment.”
A growing opposition
“Johnson & Johnson needs to stop this tactic and withdraw all its patent applications around the world,” says Sergey Kondratyuk from ITPC Global.
“The company has even submitted applications for pediatric version of BDQ. This is simply a soluble version of the adult version. It lacks ‘inventive step’ and is ‘obvious to any expert in that sphere’, which means it fails to achieve any grounds for patenting,” says Kondratyuk.
“1.2 million children who fall ill with TB annually around the world rely on this drug, so I hope many more countries follow this action. The patent applications are not justified, but if J&J succeed in obtaining a monopoly on this drug, they will inevitably overprice it due to lack of competition. Bedaquiline has the ability to make TB treatment less lengthy and traumatic for millions of people,” says Chalermsak Kittitrakul, Project Manager of AIDS Access Foundation, in Thailand, where the patent application on the paediatric version is being challenged, along with a number of other applications submitted for the same drug.
Of the growing number oppositions, 10 have been submitted by Make Medicines Affordable partners. The MMA-related oppositions are listed below, and you can find more information on the global picture here.
Thailand
Opposition filed by: AIDS Access Foundation & TNP+
Patent application scope: Bedaquiline to treat MDR TB and/or combinations with other antimycobacterial agents (eq. to WO2005117875)
Thailand
Opposition filed by: AIDS Access Foundation & TNP+
Patent application scope: Bedaquiline fumarate salt (eq. to WO2008068231)
Thailand
Opposition filed by: AIDS Access Foundation
Patent application scope: Bedaquiline to treat latent TB (eq. to WO2006067048)
Thailand
Third party observation filed by: AIDS Access Foundation
Patent application scope: Bedaquiline Pediatric Formulation (1701004168)
Brazil
Opposition filed by: ABIA/GTPI
Patent application scope: Bedaquiline fumarate salt (eq. to WO2008068231)
Ukraine
Opposition filed by: 100% LIFE
Patent application scope: Bedaquiline Pediatric Formulation (eq. to WO2016120258)
India
Opposition filed by: DNP+
Patent application scope: BPaL – Bedaquiline/Pretomanid/linezolid (optionally pyrazinamide) compositions and their use in TB, (eq. WO2017066053)
Kyrgyzstan
Opposition filed by: Partnership Network Association
Eurasian patent scope: 017091, bedaquiline fumarate salt (eq. to WO2008068231)
Kazakhstan
Opposition filed by: Answer Public Foundation
Eurasian patent scope: 017091, bedaquiline fumarate salt (eq. to WO2008068231)
Belarus
Opposition filed by: People Plus Public Organization
Eurasian patent scope: 017091, bedaquiline fumarate salt (eq. to WO2008068231)
Related content
- Photo gallery: World TB Day 2021
- ITPCru’s World TB Day press release (Russian)
- Additionally, press releases from Belarus; Kazakhstan; and Kyrgyzstan on the countries’ patent oppositions.
All have versions in English after the original articles. - Thailand submits patent opposition on TB drug for children
- COVID-19 & TB: Why whether you live or die is a matter of justice, not science
- Brazil and Thailand: Activists oppose more TB patents during COVID-19 pandemic
