FOR IMMEDIATE RELEASE

Contact: Natalie Shure, Treatment Action Group (natalie.shure@treatmentactiongroup.org)

July 13, 2023 — After over a year of sustained advocacy from the TB community demanding that Johnson & Johnson publicly commit to non-enforcement or withdrawal of secondary patents on bedaquiline filed in 66 low- and middle-income countries (LMICs), Treatment Action Group (TAG) expresses qualified optimism at the news of a preliminary deal between J&J and the Stop TB Partnership’s Global Drug Facility (GDF). While the specifics of the deal are not yet fully disclosed, it appears to enable the GDF to tender, procure, and supply generic bedaquiline to LMICs, including those where secondary patents remain in effect.

We are heartened that this arrangement will likely reduce the cost of bedaquiline around the world. And we celebrate author John Green and his many followers for shining a light on this cause and campaigning with creativity and spirit to amplify the longstanding demands of TB survivors, communities, and civil society. Nonetheless, this deal falls short of the clearly articulated demands of communities affected by TB for patent non-enforcement or withdrawal. It is a creative procurement solution that will address the acute crisis in access to this lifesaving drug without solving the larger structural injustices that led to inequitable access to bedaquiline in the first place. Patent “evergreening” tactics like those deployed by J&J allow pharmaceutical companies to game an intellectual property regime in order to extend monopoly rights over publicly funded innovations. By refusing to publicly commit to withdrawal or non-enforcement of their indefensible secondary patents on bedaquiline, J&J is dodging accountability for how their patenting practices have harmed people with TB and taken advantage of the governments whose investments made this drug possible and those which have purchased bedaquiline at unjustifiably high prices.

While the deal between J&J and the STBP GDF will allow countries buying through GDF access to generics and lower prices, countries that don’t buy from the STBP GDF such South Africa and countries in the Commonwealth of Independent States (CIS), where J&J licensed bedaquiline to Pharmstandard, the unjustified secondary patents are still in play and blocking access to generics.  A competitive tender through GDF might also lower the price of bedaquiline available in these places, many of which have high TB burdens. But it raises the question of why this is only now suddenly possible.

As TAG TB Project Co-Directors Mike Frick and Lindsay McKenna demonstrated three years ago in PLOS ONE, public and philanthropic entities invested up to five times as much in bedaquiline R&D as J&J did. As this episode painfully illustrates, global health advocates must push for stringent access conditions placed upon private commodities developed with public funding. Governments and donors made those resources available because they understood the great need for safer, more effective treatments for TB. That foresight ought to benefit people living with TB disease, not J&J’s shareholders.

# # #