India Rejects Johnson & Johnson’s Attempt To Extend Monopoly On Lifesaving TB Drug

According to the Hindu, the Indian Patent Office has rejected Johnson & Johnson’s attempt to extend a monopoly on a lifesaving TB drug.

In a victory for patients fighting for wider access to crucial anti-tuberculosis drug Bedaquiline, the Indian Patent Office on Thursday rejected U.S. pharmaceutical giant Johnson & Johnson’s (J&J) attempt to extend its monopoly on manufacturing the drug in India beyond July 2023.

J&J’s primary patents on Bedaquiline expire in July, paving the way for generic drug manufacturers such as Lupin and Macleods, among others, to produce Bedaquiline, thus ensuring cheaper and wider access to the drug. Currently, Bedaquiline tablets are priced at $400 per six-month treatment course.

Bedaquiline is a crucial drug in the treatment of multi-drug resistant TB patients for whom the first-line drug treatment — using Isoniazid, Rifampicin, Pyrazinamide and Ethambutol — has stopped working.

Evergreening attempts

Since 2007, J&J had indulged in ‘evergreening’ — a strategy to extend the life of patents about to expire in order to retain revenues from them — by making multiple claims in its applications for patent extensions.

When the company filed for evergreening of its patent on fumarate salt (a formulation salt of Bedaquiline), the practice was challenged by two TB survivors, Nandita Venkatesan and Phumeza Tisile. “We filed a patent challenge in 2019, because we wanted to ensure that safer, oral and efficacious drug Bedaquiline was available to all people who need it. Our attempt to break the monopoly of a pharma company over this life saving drug has been successful,” Ms. Venkatesan told The Hindu.

Tranq dope, the street drug linked to severe skin wounds and amputations, has spread to at least 48 states, the Drug Enforcement Administration said in a public safety alert issued Monday.

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