番茄社区

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

The campaign accused the global drugmaker of playing patent games to prevent the drug's wider distribution in lower income countries.

The movement gained steam earlier this week when John Green, a popular vlogger and author, to YouTube 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 Médecins Sans Frontières/Doctors Without Borders (MSF) and Partners in Health (PIH) urging the company .

On , the Swiss non-profit Stop TB Partnership -- which is hosted by the United Nations Office for Project Services -- said J&J granted its Global Drug Facility division licenses to "tender, procure, and supply generic versions" of the drug for "the majority of low-and middle-income countries, including countries where patents remain in effect."

Bedaquiline was approved by the FDA in 2012, and its primary patent -- which covers its composition -- was set to expire on July 18, according to S. Sean Tu, PhD, JD, professor of law at West Virginia University in Morgantown. But the company also has a secondary patent that covers 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 the "Approved Drug Products with Therapeutic Equivalence Evaluations." But critics said J&J could choose not to enforce this patent.

J&J in response to the allegations of evergreening. In a separate statement emailed to 番茄社区, a J&J spokesperson said the company had "been in lengthy discussions with the Global Drug Facility regarding access to bedaquiline. We had our first meeting with them at the beginning of this year and reached an agreement on June 13."

The spokesperson also emphasized that J&J believes patented drugs and their generics are "part of the normal, balanced and healthy lifecycle for a product," and that the current intellectual property framework stimulates innovation.

"[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 and protect the effectiveness of existing ones," the spokesperson added. "Generic manufacturers, which do not typically reinvest in the development of new medicines, will be able to begin supplying bedaquiline once patents expire."

Tu said Green and others "publicly shamed J&J, and I think it actually moved the ball."

"What really should infuriate people is that this is all public-sponsored research, right? So we're paying twice for it as taxpayers -- once when we invest in the 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 gave credit to organizations like PIH, MSF, and Stop TB Partnership, who have long been raising awareness of TB, as well as like Phumeza Tisile and Nandita Venkatesan who 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's a "louder voice these days for the public interest, whereas in the past it might have just been the most prevailing interest was the exclusive rights in the corporate welfare as opposed to the social welfare."

"You can win a legal case and lose in the court of public opinion," Karnakis said.

As of press time, neither Green nor Stop TB Partnership responded to 番茄社区's requests for comment.

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