Explained | Will generic supply of bedaquiline be accessible? 

Is tuberculosis still a global health threat? How has Johnson & Johnson been trying to hold on to its patent of the TB drug after it expired last week? How was India able to reject J&J’s hold over the drug?

July 24, 2023 08:30 am | Updated 01:50 pm IST

The Johnson & Johnson company offices in Irvine, California, U.S.

The Johnson & Johnson company offices in Irvine, California, U.S. | Photo Credit: REUTERS

The story so far: Bedaquiline has now become the cornerstone to cure drug-resistant tuberculosis (DR-TB). Last week, a major barrier for drug resistant TB care ended, when Johnson & Johnson’s patent on bedaquiline expired on July 18. This long-awaited expiry will allow generic manufacturers to supply the drug, but J&J appears intent on maintaining its monopoly over the bedaquiline market.

What has J&J done?

J&J has filed secondary patents over bedaquiline till 2027, which were granted in 66 low-and middle-income countries. It includes 34 countries with a high burden of TB, multidrug-resistant TB (MDR-TB), and TB/HIV. Over the past week, J&J has faced public outrage for seeking to extend its patent on bedaquiline.

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A first of its kind deal between J&J and the Global Drug Facility (GDF), a non-profit distribution agency housed in the WHO, could expand access to the drug. Researchers estimate that, with the introduction of competition from India, the price of bedaquiline will reduce in the range of $48-$102 for a six-month treatment course — which is three to six times lower than the current globally negotiated price paid by countries ($272) when it is procured through the GDF.

What is the threat from tuberculosis?

Tuberculosis was the world’s deadliest infectious disease, as declared by the WHO, before COVID-19 swept the world. Each year, nearly half a million people develop drug-resistant TB and nearly 10.4 million people develop drug-sensitive TB. One-third of the world’s population has latent TB, a version of the disease that can turn active as immunity falls. Nearly 2.8 million patients, the most in the world, live in India making it a national public health emergency. Globally, DR-TB is a major contributor to antimicrobial resistance and continues to be a public health threat.

Who made bedaquiline?

Janssen Pharmaceutical (a subsidiary of J&J) made bedaquiline around 2002. Several of the phase I and II clinical trials — where the safety and efficacy of the drug is established before the drug’s registration —were sponsored by public and philanthropic organisations such as the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases, and the TB Alliance. Following the 2012 approval of bedaquiline based on phase II data, several research institutes, treatment providers, including national TB programmes and medical humanitarian organisations, have put in resources in additional trials, operational research, and pharmacovigilance to further document the safety, efficacy and optimal use of bedaquiline in DR-TB regimens. The recent WHO recommendation of bedaquiline being a core drug for the treatment of DR-TB is largely based on the evidence produced through these collective efforts. However, J&J has claimed sole ownership of it, protected by its aggressive patenting strategies.

Will the drug be available in India?

Other DR-TB drugs like linezolid have decreased in prices by over 90% with generic competition once Pfizer’s patent expired in 2015. Therefore, national TB programmes are waiting for the generic supply of bedaquiline from Indian manufacturers to reduce prices.

In India, a ‘pre-grant opposition’ was filed by a patient group and two TB survivors — Nandita Venkatesan from India, and Phumeza Tisile from South Africa — both of whom had to endure the more toxic DR-TB treatments that lasted up to two years and caused excruciating side effects: they both lost their hearing. As a result of their legal challenge, in a landmark decision before World TB Day, the Indian Patent Office rejected the U.S. corporation J&J’s secondary patent which would have extended its monopoly for four more years. Indian manufacturers will now be able to supply affordable, quality assured generic versions of bedaquiline in India as the primary patent expired on July 18. However, they will not be able to export the medicine to 34 of the 43 countries with a high burden of TB.

Will the J&J GDF deal solve the problem and make the generic of bedaquiline accessible?

Not just yet. The GDF deal claims to cover majority of low-and middle-income countries but some of the countries hardest hit by DR-TB will not benefit. Eastern European countries and China with high burden of TB are believed to be out of the agreement. Countries like South Africa are not purchasing from GDF and with the ever-greening patent inforce till 2027, it will not get access to generic Bedaquiline.

Excluded countries are raising concerns with J&J about patent barriers and their exclusion from benefiting from generic competition.

Vidya Krishnan is a health reporter and Leena Menghaney is Global IP Advisor to the MSF Access Campaign.

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