aLawyers have been battling Johnson & Johnson for years over a patent on a life-saving tuberculosis pill. On Thursday, they won a partial victory as United Nations-affiliated group STOP TB announced an agreement to make cheaper generic drugs available in dozens of low- and middle-income countries with high disease rates.
The deal had been in the works for months and was signed in June, according to Brenda Waning, head of STOP TB’s global drug facility. But the announcement appeared to be precipitated this week by a press campaign from an unusual source: novelist and YouTube star John Green, who, in consultation with activists, video On Tuesday, J&J charged with 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 more than 40 years and revolutionized the treatment of drug-resistant infections. But the relatively high cost restricts access in many low- and middle-income countries hardest hit by an epidemic that continues to kill about 1.5 million people each year, most of them among the world’s poorest. According to a 2016 report, the company initially charged $900 per course in low-income countries, but gradually reduced it, most recently to $340.
“It cost a damn fortune when they first released it,” said Carole Mitnick, a professor at Harvard Medical School. And still ‘often stays out of reach’.
With bedaquiline’s original patent expiring this month, activists hoped that low-cost generics would increase the drug’s availability. But they feared that J&J would use a practice sometimes called “evergreening” to limit competition.
Essentially, proponents say, drug companies are selectively imposing additional patents on their drugs that don’t show significant improvements but may extend their monopoly. In the US and Europe, activists have accused companies of using the approach to make billions from complex autoimmune drugs like Enbrel and Humira. In the Global South, it has been at the center of battles over HIV and Hepatitis C drugs and a Novartis cancer pill.
In this case, J&J has an important secondary patent, expiring in 2027, on a way to optimize the original molecule for use as a medicine. If J&J were to enforce the patent, it could delay the arrival of generics in countries where more than three-quarters of people with drug-resistant TB live, according to Treatment Action Group, an advocacy group. TAG and dozens of other interest groups insisted J&J to relinquish the patents in an open letter this week.
According to a 2020 analysis, the secondary patent particularly irked some proponents because the drug’s development was largely funded by public funds. That study found that public sector funds contributed $455 million to $747 million to bring bedaquiline to market, compared to J&J’s $90 million to $240 million. J&J has disputed the study’s interpretations.
And proponents 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 increased from activists and the community of devoted, sometimes ardent fans of Green and his brother Hank – nerdfighters, they call themselves. The video was viewed more than 500,000 times and followers lobbied the company on Facebook, Twitter and Instagram and through a hotline J&J set up where people could report ethical violations. Green mused on Twitter about organizing a protest outside J&J’s New Jersey headquarters.
In response, J&J released a withing tweet arguing that it did not prevent the arrival of cheap generics. “It is false to suggest – as some have recently done – that our patents are being used to prevent access to SIRTURO® (bedaquiline), our MDR-TB drug,” the company tweeted. And J&J added that it had begun a partnership with STOP TB’s global drug facility, a mechanism for buying and distributing drugs.
What J&J didn’t say was that a new deal had been reached that will basically expand access to generic versions.
The new deal with STOP TB expands access to a spinal treatment to fight TB. Three years ago, J&J and STOP TB signed a distribution agreement to supply Sirturo to 113 low- and middle-income countries. But there were obstacles to getting cheaper generics to many of these countries because J&J had formally applied for or obtained patents in many of those countries.
In recent years, J&J and STOP TB discussed ways to broaden access, but the company got more serious earlier this year under 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 start selling cheaper versions of Sirturo, Waning explains.
In June, J&J and STOP TB reached an agreement that will allow the UN-backed organization to solicit bids from generic drug manufacturers 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 had no patents on its drug. But the license makes it possible to expand distribution to another 44 countries.
“Thanks to the license agreement, J&J allows us to provide generic versions in those 44 countries where the secondary patent extended its ownership rights. Before we had the agreement, we couldn’t have done this,” explains Waning. She added that a Russian company, Pharmstandard, divides the J&J branded drug to 17 countries in Eastern Europe and Central Asia.
J&J has yet to issue a press release regarding the STOP TB deal. Via email, a company spokesperson declined to make executives available and deferred questions to Waning.
Nevertheless, some advocates argued that J&J can do even more to broaden access.
“It is a start because it will enable countries to buy TB through the STOP facility [to] gain access to generics and lower prices, but it doesn’t remove the larger structural barrier that the secondary patents represent,” said Lindsay McKenna, co-director of the TB project at Treatment Action Group. “Countries that are not bought from [STOP TB]will, like South Africa, not have access to generic medicines.”
She argued that J&J should have made a commitment not to enforce its patents, which would have been “a simpler and preferred solution, or not evergreen in the first place.”
McKenna further claimed that “J&J says it is false to suggest that its patents are used to prevent access. But on the other hand, why do they defend them so fiercely in places like Brazil? If they succeed in court, it would result in access being blocked,” she told us. “The company will still have a monopoly as long as they have a second patent.”
In addition, according to Doctors Without Borders, nine countries in Eastern Europe and Central Asia, which have some of the world’s largest cases of drug-resistant tuberculosis, are excluded from the deal.
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 has a secondary patent in each of those countries, said Christophe Perrin, a TB advocate. patient. pharmacist’s advocate with the access campaign of Doctors Without Borders.
Nevertheless, 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’, although he later reiterated MSF’s call for further action.
“This isn’t a perfect solution, but it’s a better solution,” he told STAT, adding “it marks progress, it doesn’t mark destination.”
He suggested that in the future he might try to garner public outcry for tuberculosis efforts. He pointed to the high cost of TB diagnostics, one of the main barriers to curbing the epidemic and a focus of efforts by Doctors Without Borders and other interest 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 [public outcry] can happen,” he said.