Advocates have been fighting Johnson & Johnson for years over a patent on a lifesaving tuberculosis pill. On Thursday, they won a partial victory as the United Nations-affiliated group STOP TB announced an agreement to make cheaper generics available across dozens of low- and middle-income countries with high rates of disease.
The deal had been in the works for months and was signed in June, according to STOP TB global drug facility chief Brenda Waning. But its announcement appeared to be sped up by a pressure campaign this week from an unusual source: novelist and YouTube star John Green, who, in consultation with activists, posted a video Tuesday accusing J&J of keeping the drug out of the hands of millions of people.
The pill, called bedaquiline, was first approved in 2012 as the first new TB drug in over 40 years and revolutionized treatment for drug-resistant infections. But its relatively high cost limited access in many low- and middle-income countries hit hardest by an epidemic that still kills around 1.5 million people every year, most of them among the world’s poorest. The company initially charged $900 per course in low-income countries, according to a 2016 report, but gradually lowered it, most recently to $340.
“It cost a bloody fortune when they first released it,” said Carole Mitnick, a professor at the Harvard Medical School. And still “often remains out of reach.”
With the initial patent on bedaquiline expiring this month, activists hoped cheap generics would widen the drug’s availability. But they feared that J&J would use a practice sometimes called “evergreening” to limit competition.
Essentially, advocates say, pharmaceutical companies selectively layer on additional patents for their drugs that don’t show significant improvements but can extend their monopoly. In the U.S. and Europe, activists have accused companies of using the approach to make billions off of complex autoimmune drugs like Enbrel and Humira. In the Global South, it’s been at the center of fights over HIV and hepatitis C drugs and a Novartis cancer pill.
In this instance, J&J has a key secondary patent, expiring in 2027, on a way of optimizing the original molecule for use as a drug. If J&J enforced the patent, it could delay the arrival of generics in countries where over three-quarters of people with drug-resistant TB live, according to Treatment Action Group, an advocacy organization. TAG and dozens of other other advocacy groups urged J&J to abandon the patents in an open letter this week.
The secondary patent particularly irked some advocates because the drug’s development was largely underwritten by public funds, according to a 2020 analysis. That study found public sector funds contributed $455 million to $747 million to getting bedaquiline to market, compared to $90 million to $240 million from J&J. J&J has disputed the study’s interpretations.
And advocates pointed to a 2017 analysis that suggested generic manufacturers could sell the drug for between $47 and $103 for the six-month course and still make a profit.
During this week, online pressure mounted from activists and Green and his brother Hank’s community of devoted, occasionally fervent fans — nerdfighters, they call themselves. The video was viewed over 500,000 times and followers lobbied the company on Facebook, Twitter, and Instagram and through a hotline J&J set up for people to report ethical violations. Green mused on Twitter about gathering a protest outside J&J’s corporate headquarters in New Jersey.
In response, J&J released a withering tweet arguing it was not forestalling the advent of low-cost generics. “It is false to suggest—as some recently have—that our patents are being used to prevent access to SIRTURO® (bedaquiline), our medicine for MDR-TB,” the company tweeted. And J&J added it had begun a collaboration with STOP TB’s global drug facility, a mechanism for purchasing and distributing medicines.
What J&J didn’t say was that a new deal had been reached that, in fact, will expand access to generic versions.
The new deal with STOP TB expands access to a backbone treatment for combating TB. Three years ago, J&J and STOP TB signed a distribution agreement to provide Sirturo to 113 low- and middle-income countries. But there were obstacles to getting lower-cost generics to many of these countries, because J&J had formally sought or obtained patents in many of those nations.
For the past few years, J&J and STOP TB discussed ways to widen access, but the company grew more serious earlier this year amid pressure from advocacy groups. But in March, J&J suffered a setback when the Indian Patent Office invalidated that secondary patent, allowing Indian generic manufacturers to begin selling lower-cost versions of Sirturo, Waning explained.
By June, J&J and STOP TB reached an agreement that allows the U.N.-backed organization to solicit bids from generic makers and distribute those versions of Sirturo in low- and middle-income countries. Without a license, STOP TB could have taken this step for 52 countries where J&J did not have patents on its drug. But the license makes it possible to expand distribution to another 44 countries.
“Thanks to the licensing deal, J&J is allowing us to supply generic versions in those 44 countries where the secondary patent extended its property rights. Before we had the agreement, we would not have been able to do so,” explained Waning. She added that a Russian company, Pharmstandard, distributes the J&J brand-name drug to 17 countries in Eastern Europe and Central Asia.
J&J has yet to issue a press release about the STOP TB deal. Via email, a company spokesperson declined to make executives available and deferred questions to Waning.
Nonetheless, some advocates argued J&J can still do more to widen access.
“It’s a start in that it will allow countries buying through the STOP TB facility [to] gain access to generics and lower prices, but it doesn’t remove the larger structural barrier the secondary patents present,” said Lindsay McKenna, the co-director of the TB Project at Treatment Action Group. “Countries that don’t buy from [STOP TB], like South Africa, won’t be able to access generics.”
She argued that J&J should make a commitment not to enforce its patents, which would have been “a simpler and preferred solution, or not evergreening in the first place.”
McKenna further maintained that “J&J says that it’s false to suggest its patents are being used to prevent access. But on the other hand, why are they so fiercely defending them in places like Brazil? If they succeed in court, it would have the effect of blocking access,” she told us. “The company will still have a monopoly so long as they still have a second patent in place.”
In addition, nine countries in Eastern Europe and Central Asia, which have some of the world’s highest burden of drug-resistant TB, are excluded from the deal, according to Doctors Without Borders.
Why? These nine countries will not be able to access a potentially lower price for a generic through the STOP TB global drug facility, or purchase directly from generic manufacturers, because J&J holds a secondary patent in each of those countries, according to Christophe Perrin, a TB advocacy pharmacist with the Doctors Without Borders access campaign.
Nonetheless, Green called the deal between J&J and STOP TB a positive step. On Thursday morning, he retweeted a meme about “Friendship with J&J,” though he followed up later reiterating Doctors Without Borders’ calls for further action.
“This is not a perfect solution but it’s a better solution,” he told STAT, adding “it marks progress, it doesn’t mark the destination.”
He suggested that he could try to summon public outcry for tuberculosis efforts in the future. He noted the high cost of TB diagnostics, one of the major barriers to curbing the epidemic and a focus of efforts from Doctors Without Borders and other advocacy groups.
“I think it’s really important for other companies, especially companies that work in diagnostics, to pay attention to what happened in the last 72 hours, and be reminded that that [public outcry] could happen,” he said.