Blog written by: Dhrithi Bhat
According to the World Health Organization's Global Tuberculosis Report 2022, India accounts for around 29% of the world's 10.6 million TB cases, a major public health concern in the fight against resistant strains to medications.
Bedaquiline is an important drug in the treatment of multidrug-resistant tuberculosis, which is a growing problem in many parts of the world, especially in low- and middle-income countries. The drug has been approved in the United States. The drug was used by the Food and Drug Administration in India and other countries in 2012 as part of the treatment regimen for multidrug-resistant tuberculosis recommended by the World Health Organization.
Two tuberculosis survivors in Mumbai, India, challenged the copyright of the drug bedaquiline in 2019 when Johnson & Johnson sought to extend its patent. The company applied for a patent extension until 2027.
On March 2021, Johnson & Johnson (J&J) lost the patent battle in India. The decision was made by the Intellectual Property Appeals Board (IPAB), an independent government body that hears patent appeals. The board revoked the bedaquiline patent granted by J&J in 2007 due to a lack of innovation.
When Johnson & Johnson applied for a patent extension to 2023, Latika Dawara, Deputy Director of the Patent and Design Office, said the claimed invention was obvious and not based on an inventive step and, therefore, not patentable. The team provided evidence that the method of producing a water-soluble compound by salt formation for the manufacture of the drug bedaquiline has long been known to drug manufacturers. Many widely used textbooks on the subject even mention this approach.
According to Leena Menghaney, Global Intellectual Property Advisor for the Access Campaign of Médecins Sans Frontières, it is time for alternative manufacturers to start offering bedaquiline at a lower price. The good news, for now, only applies to India, she added, as J&J still holds patents on bedaquiline in other major markets, such as South Africa, preventing Indian generic drug manufacturers from exporting the drug to the country.
- India Patent Office. Intellectual Property Appellate Board. (2021). Order in revocation petition no. 222/2015/PT/DEL dated 18th March, 2021. Retrieved from https://ipab.gov.in/wp-content/uploads/2021/03/222-2015-PT-DEL.pdf
- Johnson & Johnson. (2021). Johnson & Johnson comments on intellectual property appellate board decision in India. Retrieved from https://www.jnj.com/johnson-johnson-comments-on-intellectual-property-appellate-board-decision-in-india