About one-quarter of U.S. adults report delaying filling prescription medications, skipping doses, or cutting pills due to cost according to Kaiser Family Foundation’s 2022 Health Care Debt Survey. A convoluted web of factors drives high prescription drug prices in America, but drug maker’s abuse of the patent system is a significant contributor to the difficult reality Americans face. When manufacturers are able to monopolize profits and arbitrarily hike prices with no competition, the system begins to incentivize finding loopholes to safeguard market control instead of incentivizing pharmaceutical innovation.
Drug patents are intended to help companies recoup their research and development costs by allowing them to exclusively sell a drug for a set period of time, usually 20 years. After the patent expires, other companies are allowed to enter the market with generic or biosimilar versions that offer price competition. But drugmakers have several tactics to circumvent market competition, including “pay for delay” schemes, authorized generics, restricting access to samples needed for bioequivalence testing, and patent extension tactics known as “evergreening.”
Evergreening is a tactic where brand name drug manufacturers can extend monopoly protection of a drug by patenting peripheral ingredients, variations of existing products, or even dosage forms with little to no therapeutic advantage.
For example, take manufacturer AbbVie’s best-selling anti-inflammatory biologic, Humira, which accounted for more than a third of AbbVie’s total revenue in 2021. A majority of its 311 patents were filed after Humira was already on the market. One of its patents for treating ankylosing spondylitis (AS) was set to expire in 2016, and in 2014, AbbVie applied for another patent to treat AS at the specific Humira dose of 40 milligrams. This 2014 patent’s approval gave Humira 11 years of patent protection after 2016.
Since the end of 2016, when AbbVie’s original patent was set to expire, Humira’s price has gone up 60%, costing over $80K a year.
Between 2016 and 2019, five biosimilars to Humira were approved by the FDA. Yet none of them were able to enter the market until this year because of AbbVie manipulating patent extensions and aggressively suing competitor firms for patent breaches. One analysis estimated these delays cost Medicare an additional $2.19 billion between 2016 and 2019 alone. These are costs coming out of taxpayer wallets.
When pressed previously, AbbVie lawyers have insisted the company is acting within legal parameters. At a 2014 Goldman Sachs Healthcare Conference, AbbVie’s executive VP of finance said Humira’s patent strategy was designed to make it harder for new biosimilars to follow behind.
According to a report released by the House Oversight and Government Reform Committee, AbbVie dedicated a large portion of its research budget to suppressing competition. This included investing in a “Humira ‘enhancements’ program to protect against biosimilar competition.” According to their findings of AbbVie’s internal documents, delaying biosimilar entry for the last five years cost the U.S. healthcare system an astronomical $19 billion.
This strategy is not exclusive to AbbVie or Humira. A 2019 analysis of the 10 best selling drugs found that these drugs held more than 69 patents on average with 37.4 years of patent protection. One of the fundamental issues allowing the U.S.’s patent system to be exploited this way is that it does not require proof of a product being improved, but merely proof that it is different enough from a similar patented invention that it would not be obvious to “a person skilled in the art.”
It would take a much longer article to decipher the many vulnerabilities in our healthcare system that have landed us in our disturbing reality where 1 in 4 Americans aren’t filling prescriptions as prescribed due to their cost.
One point is clear though: conversations advocating for equitable healthcare access will be insufficient without acknowledging how our existing laws are exploited by pharmaceutical companies to prioritize a culture of litigating loopholes over actual innovation and care.
Pooja Dhupati is a student at UACOM-P Class of 2026. After graduating from the University of Southern California with a B.A. in Sociology, she earned her Master’s in Public Health with an emphasis in Health Services and Policy from USC. Afterwards, she enjoyed working for a small children’s health advocacy nonprofit in Downtown Los Angeles and then for Wisconsin’s Division of Public Health through the CDC Foundation. Back home in Phoenix for medical school, she’s excited to combine her background in health policy and community advocacy with her medical education. Since moving back to AZ, she loves competing in dog sports with her tiny L.A. shelter dog, Mitai!