The fight to end evergreening

HEALTH

Exclusive drug patents mean big money for pharmaceutical companies. What happens when they extend patents indefinitely?

This year, top pharmaceutical companies are finding themselves on the edge of a cliff.

2023 marks a patent cliff for many popular prescription drugs, meaning companies’ exclusive patent rights will expire and introduce competition into the market.

Because patents give exclusive rights to produce a certain drug, they permit companies to keep prices artificially high. When patents expire, companies sometimes turn to a practice called evergreening: making minor modifications to drug formulae to extend their monopolies for continued profit. For people in low-income countries in need of care, this spells disaster.

Tuberculosis (TB) is particularly expensive to treat.

The cost of treating TB

Evergreen patents have kept the cost of common TB medications staggeringly

high, rendering them inaccessible in many low-income countries.

$175

$1700

Terizidone

Pretomanid

Delamanid

$130

Bedaquiline

$340

According to the World Health Organization, 1.6 million people died from TB worldwide in 2021, making it the second leading infectious killer after COVID-19. The TB burden remains high in large part due to lack of access to medicines – only about 1 in 3 people with drug resistant TB accessed treatment in 2021. Because prices are so high, many low- and middle-income governments use older, less effective and more toxic drugs to treat TB because they are cheaper.

Johnson & Johnson recently came under fire for attempting to evergreen bedaquiline, a widely-used drug to treat TB. Following a campaign led by author John Green, the company walked back its patent extension plans.

TB activists around the world have long opposed J&J’s bedaquiline patent. Activists from four countries in particular with high TB burdens filed oppositions to J&J’s patent:

Ukraine filed its opposition to bedaquiline's patent in 2020. The burden of TB in Ukraine has been chronically high even before its war with Russia; since the invasion, nearly 400 health facilities have been terribly destroyed, including three TB hospitals. Many health care workers have been injured or killed.

Brazil also filed an opposition in 2020. TB rates in the country increased in 2021 for the first time in 20 years, particularly in lower-income regions.

Thailand has filed multiple oppositions to the bedaquiline patent. In 2021, the country dropped from the WHO's list of highest-TB burden countries.

India has filed the greatest number of oppositions to J&J's bedaquiline patent. The country has the highest burden of TB in the world, with two deaths occuring every three minutes from the disease.

Researchers estimate that introducing generics could lower bedaquiline’s price by 94%, and delamanid’s by 98%.

With new light shed on patent manipulation and its impact on drug pricing, evergreening could be a practice of the past.

See GitHub repository for this project.