BEDAQUILINE

Why in the news

• Last week, a major barrier for drug resistant TB care ended, when Johnson & Johnson’s (J&J) patent on bedaquiline expired on July 18. This long-awaited expiry will allow generic manufacturers to supply the drug.

J&J move post patent expiration

• Johnson and Johnson have filed secondary patents over bed aquiline till 2027, which were granted in 66 low-and middle-income countries. It includes 34 countries with high burden of TB, multidrug-resistant TB (MDR-TB), and TB/HIV. This has resulted in public outrage.
• Introducing competition from India and breaking the monopoly of Johnson and Johnson will make the treatment three to six times lower in comparison to current price offered by Global Drug Facility (GDF).

Tuberculosis and related threats

• Tuberculosis is a deadly infectious disease, with a third of world population having latent TB which activates with compromised immunity.
• Tuberculosis in India is a national public health emergency, as India has the most number of TB patients in the world.
• Globally, DR-TB is a major contributor to antimicrobial resistance and continues to be a public health threat.

Bedaquiline

• The drug was made by Janssen Pharmaceutical (a subsidiary of J&J) in 2002. The clinical trials were sponsored by public and philanthropic organisations like the TB Alliance.
• Research Institutes have now put in resources for additional trials to further document the safety, efficacy and optimal use of bedaquiline in DR-TB regimens.
• Based on these collective efforts WHO recommended Bedaquiline to be a core drug for the treatment of Drug resistance Tuberculosis.

Indian supply of generic drugs

• The national TB programmes are waiting for the generic supply of bedaquiline from Indian manufacturers to reduce prices. As was seen in the case of linezolid, where priced reduced by over 90%.
• 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.

Conclusion

With these developments the Indian manufactures will now be able to supply affordable, quality assured generic versions of bedaquiline in India as the primary patent expired on July 18. This way profit maximisation of the drug manufactures and the health of patients suffering from TB can be balanced effectively.