J&J loses attempt to extend patent in India for tuberculosis drug

23 Mar 2023
endpts.com
Drug Approval
India’s patent office denied Johnson & Johnson’s attempt to extend the company’s patent on a formulation of bedaquiline, which is used to treat drug-resistant tuberculosis, until 2027. Critics of the company’s move to file a secondary patent say the office’s decision means a monopoly on the drug is over, at least in India, in part thanks to a 2019 challenge filed by two TB survivors, Nandita Venkatesan and Phumeza Tisile. They argued that approving the patent would block manufacturers’ ability to make generics. The office decided this week that the patent could not go past July of this year after J&J tried to extend it with bedaquiline fumarate salt, “which is a tiny variation of the initial compound bedaquiline which was (rightly) not considered as a valid innovation by the Indian Patent Office to justify a patent extension,” said Christophe Perrin, a tuberculosis advocacy pharmacist at Médecins Sans Frontières (MSF) Access Campaign. The MFS Access Campaign described what J&J was trying to do as “evergreening,” a practice used by pharmas to delay the entry of affordable generics into the marketplace. The drug is approved by the FDA in the US as part of a combination therapy in adults with pulmonary multidrug-resistant TB. A spokesperson for J&J told Endpoints News that “whether this patent was granted or not, a formulation patent would not have prevented generic manufacturers from developing the active pharmaceutical ingredient (API) in their own formulations after July 2023.” A 6-month course of bedaquiline costs $272, while quality-assured versions of its generic could cost $48 to $100, according to research from MSF. Perrin told Endpoints to bear in mind that bedaquiline’s cost must be combined with other drugs to build a drug-resistant TB treatment regimen “as per the recommendations of WHO in terms of short all-oral treatments.” The cost of bedaquiline accounts for 35% to 70% of the overall cost of most drug-resistant tuberculosis treatment regimens. Venkatesan, one of the opposition petitioners, said in a statement that she wanted to make sure the “safer, oral and more efficacious drug” was accessible, so others didn’t suffer some of the side effects she has from using other treatments, like permanent hearing loss. “This win needs to be followed by the scale-up of shorter oral TB treatment regimens by TB programmes globally to really reduce unnecessary suffering caused by older toxic drugs and treatment regimens,” Venkatesan added.
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