Pharmaceutical companies are taking advantage of the drug patent system to keep prices of essential medications high, according to a new report — and that includes blockbuster weight-loss drugs and other expensive medications set for government price negotiations this year.
The new findings illustrate how drugmakers file dozens of patents to cover minor modifications in the same drug in order to extend their market exclusivity, delaying the entry of cheaper generic medications and generating billions of dollars in extra revenue.
“We want to expose how the patent system has become a tool to drive the business model and financial gain,” said Tahir Amin, CEO of Initiative for Medicines, Access & Knowledge, a research and policy advocacy organization focused on patent laws that published the report. “It’s a corruption of the patent system.”
A standard drug patent lasts twenty years from the date it is first filed, though the time a drug company holds market exclusivity is often roughly half that, due to the lengthy regulatory approval process required before a drug can be sold. To compensate for regulatory delays, drug companies can request up to five years of additional protection thanks to the 1984 Hatch-Waxman Act — the same law that aimed to streamline the entry of generic drugs into the market.
Experts like Amin argue that drugmakers are abusing these extensions by filing hundreds of additional patents for anything from minor drug updates to particular manufacturing processes, thus prolonging their market monopoly. A 2023 study published in Yale Law and Policy Review found that of the 236 top-selling drugs, 91 percent that received patent extensions preserved their monopolies well past the expiration of their Hatch-Waxman extensions thanks to these add-on patents.
In their new report, Amin and his team examined the patent histories of four widely popular and pricey prescription drugs: the blood thinner Eliquis; the…
Auteur: Helen Santoro
