J&J must stop blocking generic versions of lifesaving TB drug

NEW YORK/GENEVA, APRIL 26, 2023—Johnson & Johnson (J&J) must stop trying to extend its monopoly on the tuberculosis (TB) drug bedaquiline in all countries with a high burden of TB, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) ahead of J&J’s annual shareholders meeting this week. It’s critical that the US pharmaceutical corporation stop using secondary patents to prevent other manufacturers from supplying more affordable, quality-assured generic versions of this lifesaving drug to everyone, everywhere who needs it, said MSF.

Access to affordable generic versions of bedaquiline is currently being blocked by J&J’s secondary patents in at least 25 of the 43 countries with a high burden of TB or drug-resistant TB (DR-TB). Secondary patents are often granted for small changes to already-patented medicines and are used by pharmaceutical companies to extend their monopolies on drugs. Bedaquiline is the backbone of the more effective, and patient-friendly treatment regimens that are now being recommended by the World Health Organization for DR-TB.

“We are deeply concerned that the persistent 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,” said Christophe Perrin, TB pharmacist with MSF’s Access Campaign. “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.”

While J&J’s patent on the base compound of bedaquiline expires in 2023 in most countries, it has resorted to “patent evergreening” by filing additional patents for small changes to extend its monopoly on the drug until 2027 in many high-TB-burden countries. However, in a landmark decision last month, the Indian Patent Office rejected one such evergreening attempt by J&J by denying the corporation a secondary patent in the country, which would have extended its monopoly for four more years. As a result of the ruling in India, manufacturers in the country will be able to produce and supply affordable, quality-assured generic versions of bedaquiline once the primary patent expires in July 2023.

Bedaquiline currently accounts for 35-40 percent of the price of shorter—and 35-70 percent of longer—TB regimens. It is the main cost driver in the WHO-recommended, six-month, all-oral BPaLM regimen (comprised of bedaquiline, pretomanid, linezolid and moxifloxacin), with bedaquiline accounting for $272 out of the total $570 price for the treatment combination. J&J currently prices the drug at $1.50 per day for an adult treatment. However, with scale-up and generic competition, the price of bedaquiline would be expected to drop, bringing it closer to its target price of $0.50 per day as estimated by researchers.

“The introduction of the new six-month BPaLM regimen in Sierra Leone has been a groundbreaking milestone,” said Dr. Manisha Kumar, MSF medical coordinator in Sierra Leone. “Being the first country to routinely offer this shorter and more effective DR-TB treatment outside the setting of a clinical trial is revolutionary, especially considering that many people here struggle to access care due to distance, bad roads, and high transportation costs. Adherence to longer treatment regimens and stigma also continue to pose significant challenges. With the lower pill burden and shorter duration of BPaLM, more people with DR-TB can be cured faster and with less suffering.”

TB was the leading infectious disease killer until the COVID-19 pandemic. The number of people newly diagnosed with TB, including DR-TB, in 2020 fell by 18 percent from the previous year due to disruptions to health systems and services caused by the pandemic, with only a partial recovery in 2021. In 2021, only one in three people with DR-TB received treatment for the disease.

“Too many lives have been lost to this killer disease,” Perrin said. “J&J must give up its secondary patents to make way for the supply of affordable generics. People with TB deserve urgent access to shorter, safer, and affordable treatments.”

MSF is the largest non-governmental provider of TB treatment worldwide and has been involved in TB care for 30 years, often working alongside national health authorities to treat people in a wide variety of settings, including chronic conflict zones, prisons, refugee camps, and rural areas. As of September 2021—across 60 programs in 41 countries—MSF treated 17,000 people with TB and 2,300 people with DR-TB.