After pushback, J&J authorizes generics of its tuberculosis drug

Following a campaign of public pressure, Johnson & Johnson (J&J) will allow a Swiss non-profit organization to supply generic bedaquiline (Sirturo) to low- and middle-income countries for the treatment of multidrug-resistant tuberculosis (TB).

The campaign accused the global pharmaceutical maker of playing patent games to prevent wider distribution of the drug in low-income countries.

The movement gained traction earlier this week when John Green, a popular vlogger and author, posted a YouTube video titled “Barely Contained Rage: An Open Letter to Johnson & Johnson” that garnered attention on social media. along with the hashtag #PatientsNotPatents.

Other global health groups, including Doctors Without Borders/Médecins Sans Frontières (MSF) and Partners in Health (PIH), have also spoken out, urging the company not to extend its patent on the drug.

ON Thursday morningSwiss nonprofit Stop TB Partnership, which is hosted by the United Nations Office for Project Services, said J&J has granted its Global Drug Facility division licenses to “offer, procure and supply generic versions” of the drug for “the majority of low- and middle-income countries, including countries where patents remain in force.”

Bedaquiline was approved by the FDA in 2012 and its primary patent, which covers its composition, was reported to have expired on July 18, according to S. Sean Tu, PhD, JD, a law professor at West Virginia University in Morgantown. But the company also has a secondary patent covering its formulation — a strategy described as “patent evergreening” — that could extend its monopoly even longer.

Tu said the patent expiration is closer to December 2026, which is the date listed in the FDA’s “Orange Book,” also known as “Approved Pharmaceuticals with Therapeutic Equivalence Ratings.” But critics said J&J may choose not to enforce this patent.

J&J he tweeted a statement in response to allegations of evergreening. In a separate statement sent by email to MedPage Todaya J&J spokesperson said the company had “extensive discussions with the Global Drug Facility regarding access to bedaquiline. We had our first meeting with them earlier this year and reached an agreement on June 13.” “.

The spokesperson also stressed that J&J believes proprietary drugs and their generics are “part of the normal, balanced and healthy life cycle of a product” and that the current intellectual property framework stimulates innovation.

“[Intellectual property] The caps enable companies to make sustained financial commitments to discover and develop new and improved medicines needed to end diseases such as tuberculosis that primarily affect people in low- and middle-income countries and protect the efficacy of existing ones,” he added the spokesperson “Generic manufacturers, which typically do not reinvest in the development of new drugs, will be able to start supplying bedaquiline once the patents expire.”

Tu said Green and others “publicly shamed J&J, and I think he actually moved the ball.”

“What should really infuriate people is that this is all publicly sponsored research, right? So we pay for it twice as taxpayers — once when we invest in research, because NIH grants are all funded by taxpayer dollars, and then we pay for it again when we buy it off the shelf,” Tu added.

Green credited organizations such as PIH, MSF and the Stop TB Partnership, which have long been raising awareness of TB, as well as Tuberculosis survivors and activists such as Phumeza Tisile and Nandita Venkatesan who successfully challenged J&J’s 2019 attempt to extend their bedaquiline patent in India.

Jennifer Karnakis, JD, director of intellectual property programs at Suffolk Law School in Boston, noted that there is “a louder voice these days for the public interest, where in the past it may have just been the prevailing interest were the exclusive rights in corporate welfare as opposed to social welfare”.

“You can win a lawsuit and lose in a court of public opinion,” Karnakis said.

As of press time, neither Green nor the Stop TB Partnership have responded MedPage Today’s requests for comment.