Mahesh Kumar A./AP Photo
A doctor examines a man suffering from tuberculosis during a visit at the government TB hospital in Hyderabad, India, March 13, 2018.
Across most of the rich world, tuberculosis is a minor health problem, with estimated cases of about 8,000 per year in the United States, and about 300 in Denmark. That, of course, is thanks to public-health and sanitation measures, plus the development and rollout of antibiotics that effectively kill the tuberculosis bacteria, many decades ago.
However, in many middle-income and poor countries tuberculosis remains a major problem. The World Health Organization estimates that about a quarter of all people alive have a latent TB infection (though only a minority develop an active case). In 2021, it killed about 1.6 million people—the second-deadliest disease in the world, behind only COVID-19. Worse, several countries have developed a large number of drug-resistant TB cases, because the bacteria has evolved to counter previous antibiotics.
So it’s great news that the Indian government has shot down an attempt from Johnson & Johnson to extend the patent on the best treatment for drug-resistant TB, which is called bedaquiline. This will enable the production of a generic version of the drug at a greatly reduced cost. It’s not only a benefit for poorer nations with a heavy TB burden, but a lesson the rest of the world can take.
The decision is the result of a challenge filed with the Indian Patent Office by two activists, Nandita Venkatesan and Phumeza Tisle, who are TB survivors from India and South Africa, respectively, with the backing of Médecins Sans Frontières. They argued that Johnson & Johnson’s patent extension argument was spurious, since they didn’t make any real changes to the drug. They just fiddled slightly with the formulation, without a real effect on its mechanism of action.
As legal analysts Renu Bala Rampal and Soujanya Sikha explain in detail, the patent office agreed with the challengers’ arguments. It concluded that Janssen Pharmaceuticals (the subsidiary of Johnson & Johnson that developed the drug) was engaged in patent evergreening—that is, trying to get a longer legal monopoly on the drug through technical trickery. This is a common practice around the world, the U.S. very much included.
That’s great news for India, where over 40 percent of the population is TB-positive, and which has the largest number of drug-resistant TB infections in the world. A generic bedaquiline will reportedly cost something like $8 per month per patient in poor countries, as compared to $46 today. While it can cause serious side effects, they are typically less severe than those caused by other last-ditch treatments (Venkatesan lost her hearing from such treatment), and bedaquiline doesn’t have to be taken as long either.
Tuberculosis cases are concentrated in poor neighborhoods, and this will make the finicky business of tracking down new cases and directing people to appropriate treatment much easier for India, which is still quite poor. “Small differences in getting a lower price go a huge way in decision-making at a country level,” said David Branigan, TB project officer at Treatment Action Group, which advocates for the elimination of TB, HIV, and hepatitis C. “Also, it goes a long way to … free up funds for other areas of the TB response that are underfunded.”
“Small differences in getting a lower price go a huge way in decision-making at a country level.”
This is also great news for rich countries. If huge numbers of TB cases are allowed to fester indefinitely, then sooner or later the bacteria will evolve resistance to bedaquiline along with all other drugs, and from there possibly spread to Europe or America where it will be much more difficult to treat. Cutting down TB cases as far as possible where they still proliferate would greatly reduce this risk. Eliminating the disease entirely, which would be difficult but probably not impossible, would be even better.
The case against Johnson & Johnson gets even stronger when we realize that most of the drug development costs for bedaquiline were shouldered by governments, principally the United States. A study estimated that government investment in basic research and clinical trials, plus tax breaks and deductions, amounted to a sum between 1.6 and 5.1 times that spent by Janssen, depending on the accounting assumptions used. So not only did the company get the normal legal period of monopoly profits from the drug—much of it coming from some of the poorest people on Earth—they didn’t even front most of the cash and work to develop it in the first place. Time to share!
Moreover, this high-profile triumph over patent evergreening should give governments around the world the momentum needed to deny the pharmaceutical industry monopoly patent extension for the most trivial of changes. That includes most prominently the U.S., where many of the innovations take place.
But it’s not all good news. India has some of the largest generic pharmaceutical manufacturers in the world, which ought to put it in ideal position to export around the world. But Johnson & Johnson already got their patent evergreening scheme to work elsewhere. “That patent was already accepted in 15 other high-TB countries,” said Branigan. That’s a big obstacle to getting generic bedaquiline where it needs to go.
The last couple of years have been a brutal lesson in the importance of public health. All possible pressure, from outside groups to the U.S government (which should expect more for its investment), should be brought to bear to get Johnson & Johnson to give up its patent at least for these 15 countries. Given how poor they are, it’s not even that much money at stake.
