The patent on the tuberculosis drug bedaquiline expires today (July 18). But while its manufacturer, Johnson & Johnson, intends to use secondary patents to extend its exclusive right to sell the drug, an innovative deal will lower its price and expand access to millions around the globe.
The drug improves the outcomes for patients with multidrug-resistant tuberculosis, reducing the risk of death by approximately 10%, according to a study in BMC Infectious Diseases, a U.K. medical journal. Tuberculosis is the world’s deadliest infectious disease, infecting approximately 10 million people per year and killing 1.5 million people globally. Over the decades, strains of the bacteria that cause TB can no longer be treated with the most common TB medicines and approximately half a million people become infected with multidrug-resistant TB each year, requiring the treatment of bedaquiline.
Johnson & Johnson initially planned to enforce a secondary patent on a slightly altered version of the drug in more than 30 lower and middle income countries including South Africa, Pakistan, and Indonesia. Secondary patents are awarded to pharmaceutical companies for drugs that are similar to ones it has already patented. By carefully timing the second patent, a pharmaceutical company can effectively maintain its exclusive right to manufacture a drug for years after the expiration of its original patent.
The high cost of a life-saving TB drug
Most patients who need bedaquiline receive it for free through their respective governments. However, because bedaquiline prices are so expensive, many low- and middle-income governments buy fewer courses of bedaquiline and use older, more toxic and less effective drugs to treat tuberculosis because they are cheaper. According to a study by Medicines Sans Frontiers (MSF) and Stop TB Partnership, at least 11 countries—including Vietnam, Sierra Leone, and Brazil—are not routinely using sufficient bedaquiline to treat children with uncomplicated drug-resistant TB. At least 24 countries place limitations on the routine use of bedaquiline beyond six months.
However, a never-before-seen deal between Johnson & Johnson and Global Drug Facility, a non-profit organization, could dramatically expand access to bedaquiline. The agreement, which was finalized in June but announced July 13 after a social media campaign spearheaded by author John Green, will allow for the sale and manufacture of generic bedaquiline in most lower and middle income countries, says Brenda Waning, chief of Global Drug Facility.
“The license J&J gave us covers all low- and middle-income countries, with the exception of countries where they had a pre-existing agreement with a different generic supplier,” she tells TIME. “J&J has said despite those countries having a patent that remains in effect, we’re giving you permission to supply generics to those countries.”
Founded in 2001, Global Drug Facility is funded primarily by the U.S. Agency for International Development (USAID) to promote access to tuberculosis treatments and diagnosis around the world. It negotiates with drug companies to buy tuberculosis drugs at a single, lower price for all lower and middle income countries. As of July, GDF pays $272 for a six month period of treatment of bedaquiline. Other countries are free to negotiate prices with Johnson & Johnson independently, but they are less likely to get a price that low.
A unique collaboration between a pharma company and a nonprofit
“This is the first I’m aware of an innovative company like J&J giving a license to a unique entity like GDF,” says Waning. She says that while deals between pharmaceutical companies and generic suppliers are common, the collaboration with a large negotiating block like GDF is unprecedented.
Johnson & Johnson says its patents are essential so it can continue to develop TB drugs.
“When we introduced bedaquiline in 2012, it was the first TB drug with a novel mechanism of action in more than 40 years,” a Johnson & Johnson spokesperson told TIME. “More and faster innovation is needed, and intellectual property protections make it possible for companies to make the sustained financial commitments to discover and develop new and improved medicines needed to end diseases like TB that primarily affect people in low- and middle-income countries.”
When GDF became aware of the patent expiring and the company’s plans to enforce its secondary patent, the organization began negotiating with Johnson & Johnson to allow for a generic version of bedaquiline.
At the end of the month, GDF will put out a call for bids for companies that wish to supply it with bedaquiline. Johnson & Johnson and two manufacturers of generics are expected to place bids. GDF will then sell the drug to lower and middle income countries at what is expected to be a lower price.
At the same time that GDF was negotiating privately with Johnson & Johnson, activists, doctors, and public health experts were becoming increasingly infuriated by the lack of access to generic bedaquiline in lower and middle income countries.
An appeal from author John Green
“There are lots of small, deeply impoverished countries like Guinea, Malawi, and Zambia where it’s just unconscionable. Johnson & Johnson must know that filing a secondary patent like this in Malawi is going to cost a lot of lives,” Green, the author of The Fault in Our Stars, said in an interview before the deal was announced.
Green pleaded with his millions of followers to put pressure on the company, calling for action in his Twitter bio, making a Youtube video about the subject, and writing an op-ed in the Washington Post. At the time of his campaign, the deal had already been made, but was not yet announced to the public. The social media push led to the deal being announced early, says Waning.
Other organizations also made significant efforts. MSF Access Campaign published an open letter calling on the company to give up its secondary patents. Activists in India successfully campaigned to get the secondary patent overturned in the country in March.
Tuberculosis is most deadly in lower and middle income countries, but if not controlled properly, it has the potential to become a pandemic threat that could impact the entire globe, according to David Bishai, clinical professor and director of the school of public health at the University of Hong Kong.
So long as tuberculosis goes untreated, the disease can spread from person to person, increasing the chance that it eventually mutates to become an even greater threat to humanity. Thus, making sure bedaquiline and TB diagnosis tools are easily accessible to those in low and middle income countries could benefit rich countries too in the long run, says Bishai.
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