Hyderabad, March 24 Johnson and Johnshon, the maker of anti-TB drug  Bedaquiline, on Friday said a formulation patent would not have prevented generics manufacturers from developing the active pharmaceutical ingredient (API) in their own formulations after July 2023, when its patent expires in India.

The Indian Patents Office on Thursday rejected an application from Johnson and Johnson seeking extension of its patent on its anti-Tuberculosis (TB) drug bedaquiline beyond July 2023. 

Reacting to the judgement, J&J said the patent application in question – for a formulation of bedaquiline – was filed in India over a decade ago, as part of standard procedures when developing new medicines, it said.”

“Whether this patent was granted or not, a formulation patent would not have prevented generics manufacturers from developing the active pharmaceutical ingredient (API) in their own formulations after July 2023, when our API patent expires in India,’‘ it added. 

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J&J’s application for patent extension on TB drug rejected

“Johnson & Johnson is a long-standing partner in India’s efforts to combat TB, providing access to Sirturo (bedaquiline), improving diagnostic capacity, training health workers on the clinical management of TB and DR-TB, and raising awareness about TB at the community level,’‘ the company said in a statement. 

“We remain committed to supporting India’s efforts to end TB and look forward to participating in the TB high-level summit hosted by Prime Minister Modi later this week.’‘ it said. 

The company refused to divulge further information when asked on the future course of action.

Also read: Hetero buys Johnson & Johnson’s plant in Telangana for ₹130 crore

Indian patent law

The judgement was given in a plea filed by two TB survivors, Nandita Venkatesan, and Dr Ilaria Motta, a medical advisor for Médecins Sans Frontières/ Doctors Without Borders (MSF) in 2019.

The patents office invoked Section 3 (d) in its judgement as the Indian patent law does not allow “evergreening of patents and prevents pharma majors from extending the patent beyond the stipulated monopoly on the drug”.

Also read: Two new shortened treatments found to be effective in treating multi-drug resistant TB: Study

Bedaquiline is essentially used in the treatment of drug-resistant TB patients and rejection of the patent extension would open the doors for the drug-makers to produce generics. 

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