A powerful online protest succeeded in stopping pharmaceutical corporation Johnson & Johnson (J&J) from enforcing secondary patents on a critical drug used to treat multidrug-resistant tuberculosis (MDR-TB).
Bedaquiline is on the World Health Organisation’s list of essential medicines. J&J wanted to extend its secondary patent on bedaquiline (marketed as SIRTURO). This would have prevented generic manufacturers from developing more affordable versions of the treatment until 2027.
The practice known as “evergreening” allows corporations to make minor modifications to drugs to extend the period of patent protection.
If J&J had not been pressured to withdraw, people would have had to pay about 70% more for their life-saving drug.
J&J has secondary patents — on modifications that improve the drug's absorption — in 25 of the 43 countries with the highest number of people suffering MDR-TB — mostly in the impoverished Global South.
Vlogger, author and tuberculosis activist John Green added his voice to the pressure on J&J, releasing the video Barely Contained Rage – An Open Letter to Johnson & Johnson, on July 12. He made an impassioned plea for J&J to abide by its credo, “We believe our first responsibility is to the patients,” and allow around 6 million people to access an affordable version of bedaquiline.
Green encouraged his 1.3 million viewers to voice their opposition to J&J’s actions on social media and the company’s complaints page. Thousands answered the call, including non-profit health organisations Partners in Health and Médecins Sans Frontières (Doctors Without Borders), which put the case out on April 26, ahead of J&J’s annual general meeting.
“Back when HIV treatment was first rolled out, competition among generic producers helped lower drug prices and accelerated treatment rollout in many countries,” said Christophe Perrin, TB pharmacist with MSF’s Access Campaign.
“We are deeply concerned that the persistently high price of bedaquiline will continue to block countries from rolling out the newer, shorter, game-changing, all-oral regimens for treating deadly, drug-resistant forms of TB.
“It is high time that J&J act responsibly by pledging not to enforce secondary patents for bedaquiline, withdrawing all related patent applications, and not pursuing any action against generic manufacturers who could export affordable versions of the drug to high-TB-burden countries where secondary patents remain.”
J&J announced an about-face on July 13. It said it would grant licences to Swiss non-profit Stop TB Partnership, to allow it to “tender, procure, and supply generic versions” of bedaquiline for “the majority of low-and middle-income countries, including countries where patents remain in effect”.
A J&J spokesperson tried to justify its patenting, telling MedPage Today that the intellectual property rights framework for patented drugs is “part of the normal, balanced and healthy lifecycle for a product” and stimulates innovation.
The idea that this drug is the intellectual property of a private company is true only in a legal sense. The drug was developed with publicly-funded research, via grants from the United States government’s National Institutes of Health.
So committed is J&J to “its” intellectual property that it attempted to evergreen the same patent on bedaquiline in 2019 in India, which experiences a third of the 11 million worldwide cases of TB. Activists and MDR-TB survivors Nandita Venkatsen and Phumeza Tisile went into action, and their petition to end J&J’s patent extension was accepted by Indian authorities on March 23.
The campaign against corporations’ profit-gouging has helped bring a decisive win for people living with TB, although more needs to be done.
Lindsay McKenna, co-director of the TB project at Treatment Action Group, said the new licensing agreement “hasn’t done anything to dismantle or even acknowledge how insidious the practice of patent evergreening is. These secondary patents are an issue across the board for lots of drugs that should be considered public goods.”