The US giant Johnson & Johnson’s attempt to prolong its patent on the life-saving TB drug Bedaquiline was rejected by the Indian Patent Office (IPO), a decision that will help tuberculosis patients. This decision may make it easier for millions of patients in India and throughout the world to obtain more affordable versions of the long-acting injectable Bedaquiline in the coming years, patent experts said to TOI.
The high cost of therapy for injectable Bedaquiline, running into hundreds of dollars, has rendered it inaccessible to patients in many developing countries, including India—one of the world’s tuberculosis hotspots. Although TB drugs are provided free of cost under India’s government-run programs, the steep price remains a significant barrier to treatment.
The rejection marks the denial of all three patent applications filed by J&J’s pharmaceutical arm, Janssen, for Bedaquiline. Earlier in July, the IPO had rejected a patent for the pediatric version of the drug, a critical treatment for drug-resistant tuberculosis endorsed by the World Health Organization (WHO). This follows the expiry of the drug’s primary patent last year.
The current application filed by Johnson & Johnson’s in 2020 seeking a patent for the long-acting injectable bedaquiline, primarily developed for tuberculosis preventive therapy, was opposed by patient groups Delhi Network of Positive People, Ganesh Acharya and Sankalp Rehabilitation Trust. The patent was rejected on the grounds of lack of inventive step and novelty.
Bedaquiline, the first drug approved to treat tuberculosis in 40 years, is hailed as a “wonder drug” due to its lower toxicity and greater effectiveness compared to traditional treatments that have been the standard for TB over the past five decades.
