AstraZeneca, Johnson & Johnson and Gilead lead a crowded field of drug makers who excessively extend patent protections to limit the market entry of competing products in an anti-competitive practice called “evergreening,” a primary driver of high drug prices. This is one finding of many according to a public database created by the Center for Innovation (C4i) at UC Law SF.
The searchable database is the first of its kind to comprehensively track the patent protections filed by pharmaceutical companies. Using patent data from 2005-2018 on brand-name drugs listed in the Federal Drug Administration’s Orange Book, the database reveals the extent of the evergreening strategy used by pharma to prolong patents, often for trivial reasons, and delay the entry of competition, especially generics. The strategy helps drug companies maintain market share and contributes to high drug prices.
AstraZeneca led the field in filing for patent protections — and the monopoly profits that go with them — with six drugs that rank among the top 20 drugs for the number of protections received. These protections combined to extend AstraZeneca’s market control by more than 90 years for drugs that treat prevalent diseases, such as diabetes and gastroesophageal reflux disease (GERD).
Additional findings exposed by the database include:
- Some of the most common medicines to receive extensions include widely prescribed medications such as insulin, HIV medications, drugs that treat pain, and those that treat opioid addiction.
- Johnson & Johnson’s Janssen Global HIV drug Prezista ranked second in number of protections, receiving 167 protections from 14 unique patents to delay competitor entry for 16 years. Gilead’s HIV drug Truvada ranked fourth in the top 20 with 120 protections (extending for more than 17 years), and its HIV drug Viread came in fifth with 118 protections (extending for more than 16 years).
- Many patent protections have been secured for trivial reasons. These changes are far less expensive for the companies to develop than discovering a new drug, suggesting that a financial market reward — rather than a patent — should be sufficient to incentivize innovation.
- AstraZeneca’s behavior includes actions where the company introduced new versions of its drugs in an evergreen practice called product hopping. AstraZeneca now appears to be evergreening their evergreens. For example, Prilosec product-hopped to Nexium and then protections were piled onto Nexium.
- Nine other companies have drugs that appear in the top 20, highlighting the broad use of evergreening practices across the industry.
- Even lower numbers of protections can extend market protection significantly. For example, Indivior’s widely prescribed Suboxone, which treats opioid addiction, obtained 11 protections and added more than 16 years to its market dominance. An earlier version of Suboxone even secured an Orphan Drug designation, which is supposed to be designed for drugs that serve a small volume of patients with no possibility of recouping investment, despite the fact that Suboxone became one of the company’s best-selling drugs in 2019.
- Significantly, insulin, which treats diabetes, is commonly evergreened but is no longer being regulated as a small molecule drug as of March 2020. This means it is now covered under the Federal Drug Administration’s Purple Book of biosimilar drugs, making the drug companies’ questionable patent behaviors surrounding these widely used drugs harder to detect in the future.
“Competition is the backbone of the U.S. economy, but that’s not what we are seeing in the drug industry,” said Professor Robin Feldman, Director of the Center for Innovation. “The database clearly shows how the industry takes advantage of the patent system by blocking competition to protect their prices and revenue.”
Drug patents are intended as time-limited government grants of market protection to incentivize drug companies so the companies will innovate new, life-saving medicines. After a limited period of time in which drug companies can earn a profit, competitors should be able to enter, driving drug prices down to competitive levels.
“These drug tweaks may be enough to get these companies past the patent office, but they may not mean much in terms of a benefit to patients,” Feldman said. “Thus, society is lavishing expensive rewards on minimal improvements.”
The Evergreen Drug Patent Search database is based on findings in Feldman’s paper, “May Your Drug Price be Evergreen,” which was published in the peer-reviewed Oxford Journal of Law and the Biosciences and has been updated with additional data. It was created by a painstaking process of combing through 160,000 data points to examine every instance in which a pharmaceutical company added a new drug patent or exclusivity.
More information about the drug patent database can be found online at https://sites.uchastings.edu/evergreensearch/. The Evergreen Drug Patent Search was supported, in part, by Arnold Ventures, a philanthropic foundation.