Critics of “evergreening,” a tactic used by brand-name drug companies to extend a patent or regulatory monopoly, say the practice is getting worse.
Chip Davis, president and CEO of the Association for Accessible Medicine (AAM), says the frequency of evergreening tactics has gone up, along with the creativity of delay strategies.
“As patents on a product’s main ingredient and methods of use are getting close to expiring, what brand-name drug companies will do is make nominal changes. For example, they’ll change it from a tablet to a capsule or may say our dosing went from 20 mg to 30 mg and then secure a patent on the new dosing formula or formation.”
When the drug company receives the patent extension, it will use its sales force to switch patients to the new formulation, says Davis.
There are high-profile cases, he notes, including renting the sovereign immunity of the Saint Regis Mohawk Tribe to block competition. In an effort to delay competition when one of Humira’s principal initial patents expired in 2016, manufacturer Abbvie filed more than 75 late-stage patents.
Davis says these tactics deny patients access to safe, effective, and affordable alternatives. “It’s negative to patients and their providers because more options are better than fewer. More options lead to the price coming down as opposed to a monopoly where the brand manufacturer has unbridled discretion to take 9.9% price increases once or twice a year, which is what’s going on, particularly in the specialty medicines area.”
An AAM paper published in February, Ensuring the Future of Accessible Medicines in the U.S., calls for ensuring that there are no “artificial barriers” to launching a new generic or biosimilar competitor.
Davis says that there’s no magic single solution to evergreening because the number of different systemic ways drug companies are using to prevent competition from coming to the market is growing. "So we have to have multiple proposed solutions to deal with them.”
AAM has an array of policy proposals including ensuring that generic companies can gain access to the number of samples needed for generic development and for filing applications with the FDA.
Up next: FDA and PhRMA respond