Johnson & Johnson has agreed not to enforce secondary patents on the multi-drug-resistant tuberculosis drug bedaquiline less than 24 hours after issuing a controversial statement on Twitter claiming that its patents do not prevent access to the drug.
The drugmaker’s original patent on the medication is set to expire on 18 July, but the company had been granted secondary patents that would block the sale of generics in several countries by at least four years.
Its last secondary patent was for a new formulation of the drug using fumarate salt.
This practice is called “evergreening”, and Johnson & Johnson came under heavy criticism after best-selling author and elder statesman of the modern web John Green (pictured, left) catalysed an awareness campaign about the issue.
It trended on Twitter on Tuesday under the slogan #PatientsNotPatents, a reference to Johnson & Johnson’s corporate credo, which begins, “We believe our first responsibility is to the patients, doctors and nurses, to mothers and fathers and all others who use our products and services.”
The hashtag has been trending again since Wednesday evening following a now infamous statement by Johnson & Johnson on which they disabled comments.
Green had vowed to escalate the campaign to a full protest outside Johnson & Johnson’s offices in New Jersey in the US if needed.
The brothers Green are pioneers in Internet video and online community building. They’ve been operating their YouTube channel since before creators could earn an income and make a living off their share of the platform’s advertising revenue.
Both brothers are also New York Times-bestselling authors of young adult fiction.
In addition to their YouTube channel, they launched various other projects, including Crash Course, SciShow, PBS Eons, the Awesome Socks Club, and the Awesome Coffee Club.
Green’s brother Hank (pictured, right) is the CEO of their production company Complexly and creator merchandise marketplace DFTBA.com.
John published his call to action on their popular YouTube channel, in addition to posts on social media.
In the video, Green blind quotes an expert who likened the situation to Johnson & Johnson obtaining a patent on a pen cap after inventing and patenting the pen (subsidised with a chunk of public money).
Although the cap is an important and useful addition to the product, it is not the pen itself. Furthermore, Johnson & Johnson knew full well that it would need to add the pen cap (i.e. fumarate salt) in future.
Green argued that the current disregard from affluent countries for TB is not only a humanitarian issue, but also a huge risk to global public health.
“If we continue this strategy of global health — caring about infectious disease only when it affects rich countries — we will continue to see more and more drug resistance until a strain of disease emerges that we can’t cure,” he said.
This ultra-drug-resistant disease will then spread globally and cause a pandemic that will impact people in wealthy nations.
“That’s one reason to end TB now,” said Green. “Another reason is that all human lives are equally valuable, and it’s completely unacceptable that this year 1.6 million people will die of a curable disease.”
Green also argued that Johnson & Johnson should consider that enforcing its secondary patents, obtained with US taxpayers’ help, is actually a bad business move.
“A company’s reputation is extremely valuable, and denying bedaquiline to 6 million people over the next four years will be very bad for your reputation.”
Green’s full-throated advocacy for ending tuberculosis dates back several years.
It stepped up a gear in 2023 and became a running joke in the videos and podcasts he creates with his brother that he can and will make any topic about TB.
However, this week Green did away with his usual humorous tone when tackling serious subject matter, as he added fuel to a campaign launched by Doctors Without Borders years ago.
Nearly 200 tuberculosis researchers and civil society organisations also signed an open letter to Johnson & Johnson on 11 July 2023, demanding that it publicly announce its commitment not to enforce its secondary patent.
MyBroadband contacted Johnson & Johnson for comment on Tuesday about Green’s video and the specifics around the patents it holds in South Africa.
However, it declined to answer our questions and instead pointed us to a now infamous generic statement the company issued on Wednesday evening.
Johnson & Johnson’s response
In the statement, which trended on Twitter for all the wrong reasons, Johnson & Johnson said: “It is false to suggest—as some recently have—that our patents are being used to prevent access to Sirturo (bedaquiline), our medicine for [multi-drug-resistant] TB.”
Green immediately took issue with this, stating that Johnson & Johnson’s response was saying the people who signed the open letter were lying.
The company said it entered into a collaboration with the Stop TB Partnership’s Global Drug Facility (GDF) — the largest procurer of TB medicines — enabling them to invite generic suppliers and purchase generic versions.
This claim would be clarified a day later when the Stop TB Partnership announced that it had reached a landmark agreement with the drugmaker.
Johnson & Johnson also intimated that it was fighting against opening the floodgates for generic manufacturers to prevent TB from developing resistance to bedaquiline.
“Our patents… [enable] us to assist countries to scale-up their use of our medicine responsibly and sustainably and invest in multiple, critical, anti-TB efforts,” it stated.
“For instance, in the face of rising drug resistance, we support stewardship efforts that ensure MDR-TB patients can benefit from our medicine today and in the future.”
TB patients halting their treatment courses partway through is a major problem, as it creates a risk that the bacteria will develop resistance to the drugs used to treat it — as has already happened.
Specialist South African public health publication SpotlightNSP reports that some patients find it difficult to complete their treatment for various reasons — including side effects or because they feel well long before completing the gruelling months-long course.
Johnson & Johnson also said the most significant barrier to treatment access for patients is that millions go undiagnosed every year.
“This is a challenge that we have invested significant resources to overcome and must all get behind if we are to achieve the global goal of ending TB,” Johnson & Johnson said.
With this, Green agreed. However, he added that access to treatment is essential to increasing diagnosis campaigns.
“Absolutely agree that diagnosis is key to ending TB. One of the reasons we struggle with diagnosis, though, is because [Johnson & Johnson] makes lifesaving treatment harder to access. Why work hard to diagnose a disease you can’t treat?” he said.
Johnson & Johnson offers a deal
In a statement issued on Thursday afternoon, the Stop TB Partnership said it had concluded “lengthy negotiations” with Johnson & Johnson.
It said the company granted Stop TB Partnership’s Global Drug Facility (GDF) licenses that allow it to tender, procure, and supply generic versions of Sirturo (bedaquiline) for most low-and middle-income countries, including countries where patents remain in effect.
“GDF has shared with the TB community important updates on plans to launch a global, competitive tender for bedaquiline by end July 2023,” it said.
“All bedaquiline suppliers that meet GDF’s quality criteria are eligible to participate in the GDF bedaquiline tender and have been briefed on the tender goals, processes, and timelines.”
Green celebrated the breakthrough on Twitter, but pointed to comment from one of the world’s leading TB researchers and Harvard professor Carole Mitnick indicating that it wasn’t a total capitulation from Johnson & Johnson.
“Very encouraging development… [Johnson & Johnson] still needs to publicly: commit to patent non-enforcement and withdrawal, commit to the deal with GDF in perpetuity, and provide the list of countries that can access generic bedaquiline through this deal,” she said.
“I want to be clear that while I think our pressure may have affected the timing, this must have been in the works for a while,” Green stated.
“The real heroes here aren’t us but the Stop TB Partnership and other activists who’ve been working for YEARS to get to this moment. You rule. THANK YOU.”
South Africa’s biggest killer
Although there is some discrepancy between different data sets about whether TB is South Africa’s biggest killer, you will usually find it in the top six causes of death in various mortality reports.
Depending on the methodology, some reports will attribute more TB deaths to HIV, significantly skewing results.
Most recently, World Health Organization (WHO) figures showed that in 2021 an estimated 304,000 people in South Africa fell ill, and 56,000 died from tuberculosis.
SpotlightNSP reports that although Covid–19 was the biggest infectious diseases killer in South Africa by some margin, it seems plausible that TB will overtake it in the 2022 statistics.
StatsSA’s latest mortality and causes of death report stated that TB was the biggest killer in the country in 2018, followed by diabetes, then heart attacks and cerebrovascular diseases like strokes.
There is concern among some healthcare professionals that diabetes could overtake TB as South Africa’s biggest killer this year.
Big questions for South Africa
Despite being a world leader in TB research and treatment, South Africa is struggling to reduce the number of deaths due to the disease.
In 2018, before the WHO updated its guidelines, South Africa took the bold decision to adopt bedaquiline for treating MDR-TB.
Before treatments like bedaquiline, patients had no option but to take a toxic cocktail of drugs that offered no better than a 50% recovery rate and an almost-guaranteed chance of going deaf.
One of South Africa’s foremost TB activists, Phumeza Tisile, survived this treatment in 2013 after being diagnosed with extensively drug-resistant TB.
She was given a 20% chance to live and a 100% chance of going deaf. In 2015, she got surgery for Cochlear implants, allowing her to hear again and complete her studies at the University of Cape Town.
Together with journalist and fellow TB survivor Nandita Venkatesan and Doctors Without Borders, Tisile challenged Johnson & Johnson’s attempt to get a secondary patent on bedaquiline in India and won.
They filed the patent challenge in 2019, and the ruling was handed down in March this year.
Spotlight reports that In South Africa, Johnson & Johnson has five patents on bedaquiline, with the base patent granted in 2005 and only expiring in 2025 — two years after many other countries.
According to the report, its new formulation patent was granted in 2009 and is set to expire in 2029.
When South Africa first adopted bedaquiline for treating MDR-TB in 2018, a six-month course cost the Department of Health R9,950. By 2019, this price had almost halved to R5,400.
Between then and now, the price has stagnated, even increasing slightly to R5,744 by 2022.
Spotlight also reported that University of Liverpool researchers calculated the price could reduce to $100 (currently around R1,800) with adequate volume and generic competition.
While South Africa appears to be in the privileged position where funding and access to treatment are less of a concern than detection, University of Cape Town associate professor Helen Cox tells MyBroadband that it’s not quite so simple.
Cox is an epidemiologist with drug-resistant-TB experience at the Institute of Infectious Diseases and Molecular Medicine, a Division of Medical Microbiology at UCT.
“South Africa is very constrained in our TB response by available budgets,” Cox explained.
“Cost savings in one area, such as the price of bedaquiline, could easily be repurposed into funding activities to diagnose more individuals with TB and drug-resistant TB, treat them more rapidly, and treat them with a more person-centred approach.”
Regarding improving diagnosis, Cox said South African guidance now endorses more comprehensive management and follow-up for individuals most at risk for TB.
This includes people living with HIV and people who were in close contact with an individual already diagnosed with TB.
“These individuals should be managed with a ‘test and treat’ approach, where they are all offered testing for active TB,” explained Cox.
Those who are positive are provided TB treatment. At the same time, those who are negative are offered preventive therapy, which will substantially reduce their risk of getting active TB in the succeeding 6–12 months.
“This is an ambitious proposal that will likely require additional funding to effectively roll out,” said Cox.
“As I understand the current funding situation in the TB programme, there have been no additional funds allocated to this new strategy.”
Cox said that reducing the cost of bedaquiline for the estimated 22,000 individuals who develop drug-resistant TB in South Africa each year would be a big win for the TB programme.
South Africa procures TB medicines via direct tender and not the GDF.
Johnson & Johnson has not answered MyBroadband’s questions about its patents in South Africa and has yet to confirm whether it will continue enforcing them here.