New Delhi: In a move that will benefit tuberculosis patients, Indian Patent Office (IPO) has denied the US giant Johnson & Johnson’s request to extend its patent on the life-saving TB drug Bedaquiline. This ruling potentially facilitates the entry of affordable versions of the long-acting injectable Bedaquiline over the next few years, improving access for millions of patients in India, and globally, patent experts told TOI.
The cost of therapy for the injectable long-acting bedaquiline runs into hundreds of dollars, making it unaffordable for millions of patients in developing countries, including India, which are also tuberculosis hotspots. While tuberculosis drugs are supplied free of charge under the govt-run programme in India, the steep cost of treatment remains a significant challenge.
With this decision, all three patent applications by Johnson & Johnson’s pharma arm – Janssen – for Bedaquiline stand rejected by Indian Patent Office. Earlier in July, the company was denied a patent for a paediatric version of bedaquiline, a key treatment for drug-resistant tuberculosis recommended by WHO. Last year, the company lost protection on the drug’s primary patent.
The present 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.
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