For years, advocates have been battling Johnson & Johnson over a patent on a medicine that can treat tuberculosis and save lives. They gained some ground on Thursday when the UN-affiliated organization STOP TB announced a deal to make less expensive generic medications available in a number of developing nations with high incidence of the disease.
Brenda Waning, director of the STOP TB global drug facility, stated that the agreement had been in the works for several months and was inked in June. A pressure campaign this week from an unexpected source, novelist and YouTube celebrity John Green, who in consultation with campaigners uploaded a video on Tuesday accusing J&J of keeping the drug out of the hands of millions of people, however, seemed to hasten the news.
The bedaquiline pill, the first novel TB medication in more than 40 years, transformed the way infections that are drug-resistant were treated when it was initially licensed in 2012. However, its relatively high price prevented many low- and middle-income nations, the majority of whom are among the world’s poorest, from accessing it. Every year, the disease still claims the lives of some 1.5 million people. According to a 2016 study, the corporation started out charging $900 for each course in low-income nations but then reduced it, most recently to $340.
According to Carole Mitnick, a professor at the Harvard Medical School, “It cost a bloody fortune when they first released it.” Nevertheless, “often remains out of reach.”
Bedaquiline’s initial patent is set to expire this month, and activists thought that low-cost generic versions would increase the drug’s accessibility. However, they were concerned that J&J would employ a tactic known as “evergreening” to stifle competition.
In essence, according to supporters, pharmaceutical companies selectively tack on extra patents to their products in order to prolong their monopoly even while the improvements made to the treatments are negligible.
Activists in the U.S. and Europe have charged businesses with utilizing the strategy to profit enormously from expensive autoimmune medications like Enbrel and Humira.
It has been at the center of disputes over HIV and hepatitis C medications as well as a Novartis cancer medicine in the Global South.
J&J now holds a significant secondary patent that will expire in 2027 on a method of enhancing the original chemical for use as a medication.
According to the advocacy group Treatment Action Group, if J&J upheld the patent, it may postpone the delivery of generic drugs in nations where more than 75 percent of persons with drug-resistant TB reside.
In an open letter this week, TAG and numerous other advocacy organizations requested J&J to renounce the patents.
A 2020 review revealed that the drug’s research was substantially supported by public monies, which infuriated certain proponents more than others over the secondary patent.
According to that analysis, public monies helped get bedaquiline to market to the tune of $455 to $747 million as opposed to J&J’s $90 to $240 million. J&J has contested the study’s conclusions.
The medicine could be sold by generic manufacturers for between $47 and $103 for a six-month course and still turn a profit, according to a 2017 estimate cited by supporters.
Nerdfighters, as Green and his brother Hank’s group of ardent, occasionally fervent admirers are known, and activists increased the pressure online during this week.
Over 500,000 people watched the film, and viewers petitioned J&J on social media sites like Facebook, Twitter, and Instagram as well as through a hotline the business put up for individuals to report ethical transgressions. Green discussed organizing a protest outside of J&J’s corporate offices in New Jersey on Twitter.
John Green, a novelist and popular YouTuber, last week joined a cause to increase access to a TB medication worldwide. AFP/Justin Talis via Getty Pictures
J&J responded with a scathing tweet, claiming that it was not preventing the introduction of affordable generics. It is untrue—as some have lately claimed—that our patents are being utilized to restrict access to SIRTURO® (bedaquiline), our treatment for MDR-TB, according to a tweet from the business.
Additionally, J&J stated that it had started working with STOP TB’s global drug facility, a system for acquiring and distributing medications.
J&J omitted to mention that a new agreement had been made, which will actually increase access to generic versions.
The new agreement with STOP TB broadens access to a crucial treatment for TB. Sirturo is now available in 113 low- and middle-income nations thanks to a distribution deal that J&J and STOP TB struck three years ago. But because J&J had formally requested or acquired patents in many of these countries, it was difficult to import less expensive generic medications.
J&J and STOP TB had been talking about methods to increase access for a few years, but last year, under pressure from advocacy organizations, the corporation became more serious. The Indian Patent Office invalidated the secondary patent in March, causing a setback for J&J and allowing Indian generic producers to start offering cheaper versions of Sirturo, according to Waning.
By June, J&J and STOP TB had achieved a deal that would let the U.N.-backed group seek generic Sirturo bids and market those products in low- and middle-income nations.
In 52 nations where J&J did not hold medication patents, STOP TB might have initiated this action without a license. However, the license enables the expansion of distribution to an additional 44 nations.
“J&J is allowing us to supply generic versions in the 44 nations where the secondary patent expanded its property rights thanks to the license agreement. We would not have been able to do this prior to the agreement, according to Waning.
She also mentioned that 17 nations in Eastern Europe and Central Asia receive the J&J brand-name medication via a Russian company called Pharmstandard.
Regarding the STOP TB agreement, J&J has not yet released a press release. A firm representative declined to make executives available for inquiries through email and referred them to Waning.
However, some supporters claimed J&J can still broaden access more.
According to Lindsay McKenna, co-director of the TB Project at Treatment Action Group, “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.” ”
Countries that don’t purchase from [STOP TB] won’t have access to generics, like South Africa.”
She asserted that J&J ought to promise not to pursue its patents in court, calling that “a simpler and preferred solution, or not evergreening in the first place.”
McKenna continued, “J&J claims that it is untrue to suggest that their patents are being exploited to restrict access. However, why do people in countries like Brazil support them so vehemently? She explained to us that if they win in court, access will be blocked.
“As long as they still have a second patent in force, the company will continue to have a monopoly.”
According to Doctors Without Borders, nine Eastern European and Central Asian nations with some of the highest rates of drug-resistant tuberculosis are also left out of the agreement.
Why? According to Christophe Perrin, a TB advocacy pharmacist with the Doctors Without Borders access campaign, these nine countries won’t be able to use the STOP TB global drug facility or buy directly from generic manufacturers because J&J holds a secondary patent in each of those nations.
Green nevertheless hailed the agreement between J&J and STOP TB as a success. He shared a meme on Thursday morning praising “Friendship with J&J,” but subsequently reiterated Doctors Without Borders’ demands for more action.
According to him, “this is not a perfect solution, but it’s a better solution,” adding that “it marks progress, it doesn’t mark the destination.”
He stated that in the future he would try to stir up public outcry for tuberculosis initiatives. He emphasized that one of the main obstacles to containing the pandemic is the high cost of TB diagnostics, which is the focus of efforts from Doctors Without Borders and other advocacy organizations.
