Johnson & Johnson, amid a public firestorm, has allowed a Swiss non-profit to manufacture a generic version of the corporation’s tuberculosis drug, Sirturo (bedaquiline). This license will allow non-wealthy nations to treat cases of multidrug-resistant tuberculosis among their populations.
Bedaquiline was approved by the FDA in 2012 to treat multidrug-resistant TB. The primary patent held by J&J covers its composition and was set to expire on July 18, S. Sean Tu, Ph.D., JD, professor of law at West Virginia University in Morgantown told MedPage Today. The controversy surrounding J&J came from a secondary patent that controls bedaquiline’s formulation, which could have extended the corporation’s monopoly to as late as December 2026. This practice is known as “patent evergreening,” and while J&J could have chosen not to enforce the patent, the existence of the second patent still jeopardized generic manufacturers’ ability to create more affordable bedaquiline medications.
A campaign began that accused the multinational corporation of playing “patent games” in order to prevent the drug from receiving wider distributions to less prosperous nations. The campaign was significantly boosted when on July 11, popular influencer, vlogger, and author, John Green posted a video to YouTube titled "Barely Contained Rage: An Open Letter to Johnson & Johnson." In his video, Green, who has nearly 4 million subscribers on YouTube alone, called the decision to evergreen the patent “reprehensible and completely out of line with their credo.” Additional support for the campaign was rallied around the hashtag #PatientsNotPatents.
In addition to social media personalities and the public, J&J felt pushback from global health groups such as Doctors Without Borders and Partners in Health who have urged the company not to extend their patent on a drug that could save 6 million people if generic, more affordable versions were approved.
Now, after “lengthy negotiations,” according to the Stop TB Partnership, the nonprofit’s Global Drug Facility license has been granted to “tender, procure, and supply generic versions of SIRTURO® (bedaquiline) for the majority of low-and middle-income countries, including countries where patents remain in effect.”
This decision will allow millions of patients living with multidrug-resistant TB to receive treatment by slashing the cost of bedaquiline from $1.50/pill to $0.50/pill. According to Stop TB, this action is an important step supporting the common goal of ending tuberculosis as a disease.