The REMEDY Act reforms the process for brand-name drug companies to select a single, unchangeable patent to trigger the thirty-month exclusivity period against generic drug applications.
Richard Durbin
Senator
IL
The REMEDY Act aims to reform how brand-name drug companies use patent listings to delay generic competition. This legislation requires companies to designate a single, unchangeable "covered patent" to trigger the thirty-month exclusivity period against generic applications. Consequently, the automatic 30-month delay will only start if a patent infringement lawsuit is filed specifically concerning that designated patent for newer drugs. This measure seeks to prevent the manipulation of patent listings that extends market exclusivity beyond intended limits.
REMEDY Act Limits Drug Companies to One Patent for Generic Delay, Speeding Up Access to Affordable Meds
The REMEDY Act—officially the Reforming Evergreening and Manipulation that Extends Drug Years Act—is taking a direct shot at one of the biggest roadblocks to affordable prescription drugs: the strategic patent delays used by brand-name manufacturers. This section of the bill focuses on how brand-name companies can use patent infringement lawsuits to trigger a 30-month delay on the FDA approval of generic versions. The core change is simple but powerful: for any drug approved after this law takes effect, the brand-name company must now designate just one patent—the “covered patent”—that can trigger that 30-month exclusivity clock. Once they pick it, they can’t change it.
Cutting the Line on Patent Games
Right now, brand-name companies can sometimes list dozens of patents for a single drug, and a lawsuit over any of them can hit the pause button on a generic competitor for two and a half years. This practice, often called “evergreening,” allows companies to string out patent protections long after the main patent has expired, keeping prices high. The REMEDY Act changes the rules of the game for new drugs. Moving forward, the 30-month delay will only kick in if the brand-name manufacturer sues the generic maker specifically over that single, designated “covered patent.” If they try to sue over Patent #12 or Patent #37, the generic approval process keeps moving. This is a huge win for generic manufacturers and, ultimately, for consumers.
Why One Patent Matters to Your Wallet
Think of this change as forcing drug companies to pick their best player for the final round. By restricting the delay trigger to one patent, the law makes the path to generic competition much clearer and faster. For example, if you rely on a medication for a chronic condition, a faster generic entry means the price could drop significantly months or even years sooner than under the current system. The bill also includes a crucial safeguard: if a court rules that the designated “covered patent” is invalid, the 30-month delay ends immediately, preventing companies from dragging out a lost cause just to buy more time. This provision (SEC. 2) is designed to increase transparency and make it much harder for pharmaceutical companies to use legal maneuvers to artificially extend their market monopoly, accelerating the timeline for cheaper alternatives to hit the shelves.