US pharmaceutical giant Johnson & Johnson (J&J) is to be investigated by South Africa's Competition Commission over the high price of its tuberculosis medicine, bedaquiline, and attempts to extend its patent through a controversial practice known as "evergreening".
What is this?
Evergreening is when brand-name pharmaceutical companies patent "new inventions" that are in reality minor modifications of old drugs.
These could include new forms of release, new dosages, new combinations or variations. Big Pharma refers to this as "lifecycle management" and it effectively means drug manufacturers can make "trivial changes to medicines or their use in order to keep their monopoly in the market", said The Guardian.
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This practice is widespread across the industry and has increased over time. A research paper published in 2018 titled "May Your Drug Price Be Evergreen" in the Journal of Law and the Biosciences found that 78% of the drugs in the US associated with new patents between 2005 and 2015 were not new drugs but existing ones. "Once companies start down the road of extending protection, they show a tendency to return to the well, with the majority adding more than one extension and 50% becoming serial offenders," said the study.
In one high-profile example, AbbVie's arthritis treatment, Humira – the world's most popular drug – was revealed to have more than 100 patents, Reuters reported. Critics allege that these “patent thickets” delay the launch of rival generic medicines even after exclusivity periods have elapsed for the original patent, explained the Financial Times.
In the case of bedaquiline – the world's leading treatment for multi-drug resistant tuberculosis (TB) – J&J was able to extend its patent, which expired in July in many low- and middle-income countries (LMICs), to 2027 because of so-called secondary patents on tweaks to the drug's formulation that improve its absorption in the body.
Why is it so controversial?
Evergreening helps Big Pharma protect some of its most prized assets but "since branded drugs are winning lengthy and lucrative IP [intellectual property] extensions, generics are taking longer to reach the market and prices around the industry continue to rise", reported industry news site Fierce Pharma.
South Africa has one of the highest TB rates in the world, and "even though TB is curable – it is the country's leading cause of death", said The Guardian. That is why the country's Fix the Patent Laws campaign has argued such practices have "acted as a barrier to equitable and affordable access to medicines for HIV, tuberculosis, mental health, diabetes and cancer".
Russell Rensburg, the director of the Rural Health Advocacy Project at Wits University in Johannesburg, put it more bluntly, claiming countering "these kinds of exploitative practices" is "essential to addressing health inequity".
Are things finally changing?
Having long flown under the radar, the issue of patent evergreening is attracting wider attention from regulators and lawmakers.
Delivering what Science magazine called a "key victory" for advocates of affordable access to bedaquiline, in March 2023 the Indian Patent Office rejected J&J's attempt to win a secondary patent to extend its exclusivity until 2027.
Had it accepted the patent, "public and family budgets would have remained burdened by unjustifiable high costs of the drug", said the People's Dispatch.
Then this summer, J&J announced a deal in conjunction with the UN-affiliated Stop TB Partnership not to enforce some of its patents on the drug, in a move that makes generic versions available in many low- and middle-income countries, lowering costs. But South Africa has an open tender system so cannot legally buy medicine through the wider system, meaning it "doesn't appear to be benefiting from the slide in prices", reported Managing IP.
In a statement, J&J said it was a "longstanding and committed partner in South Africa's fight against multidrug-resistant tuberculosis" and that all patients in the country who require bedaquiline have access to it thanks to the company's collaboration with the government and other partners.
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