Among the other 44 civil society organizations, TBEC signed an open letter to Johnson & Johnson company requesting urgent action to improve equitable access to bedaquiline based regimens and so to achieve the 1/4/6×24 Campaign targets.
“We urge Johnson & Johnson to commit that the company will not enforce the patent on the fumarate salt or any other patents beyond the primary patent’s expiration in July 2023. Widespread access to bedaquiline is indispensable in order to scale up treatment for drug-resistant TB, in particular through the 1/4/6/x24 campaign.”- commented the document Jonathan Stillo, Co-Chair of the TBEC Board.
Recall that the goal of the 1/4/6×24 campaign is to take action and introduce into state TB treatment programs short, effective and affordable anti-TB regiments – one month or once-weekly for TB prevention, four months for drug-sensitive TB, and six months for drug-resistant TB (DR-TB) — by the end of 2024. The newer regimens, particularly those containing bedaquiline lead to faster cure and better treatment outcomes with fewer adverse effects.
Janssen, Johnson & Johnson’s subsidiary, has enjoyed a monopoly over bedaquiline for over a decade. The patent for the main base compound expires in July 2023, but the owner company decided to resort to the so-called “evergreen patent” — permanently renewable patent mechanism by filing a patent application for the fumarate salt. Thus, where granted, this patent will extend Johnson & Johnson’s monopoly until 2027, hampering entry of alternative suppliers, diminishing affordability and accessibility of bedaquiline.
The signatory organizations call on Johnson & Johnson to publicly announce before World TB Day, 24 March 2023, its commitment to withdraw and not enforce the fumarate salt patent claims and other secondary patents on bedaquiline, as part of its commitment to the goals of the 1/4/6×24 Campaign to ensure everyone with TB can benefit from access to the shortest, safest possible TB treatment regimens recommended by the WHO.