- with readers working within the Pharmaceuticals & BioTech industries
A central feature of the Hatch Waxman Act is the "30-month stay," a carefully crafted compromise between the interests of innovator pharmaceutical companies and generics. The innovator is required to list in the FDA's "Orange Book" all patents covering its drug product or an approved method of use. Then, if a generic applicant challenges any of those listed patents as invalid or not infringed, the innovator has 45 days to sue for patent infringement. If it does so, a 30-month stay on FDA approval of the generic is triggered, allowing for the resolution of patent issues before a generic launches. The stay helps innovators by preventing infringing competition, and helps generics avoid the specter of money damages. The 30-month stay attaches to any Orange Book patent challenged by a generic in its application to FDA.
On July 31, 2025, U.S. Senators Durbin and Cassidy introduced bill S. 4878, the "Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act," which would amend the Hatch Waxman Act to limit the innovator to only one Orange-Book listed patent that can be eligible for the 30-month stay, which patent the innovator must designate in advance. If a generic applicant decided not to challenge the elected patent, or if an infringement claim based on that patent were summarily adjudicated by a court, then the 30-month stay would be lost. Notably, S. 4878 does not purport to limit the number or types of patents that an innovator can obtain or list in the Orange Book.
If enacted, S. 4878 would present significant challenges for innovators in their patent prosecution and "selection" strategies. Also, S. 4878 would likely change Hatch-Waxman Act litigation, increasing injunction practice and influencing decision making on certification strategy by generics and enforcement by innovators.
We will continue to monitor the status of S. 4878
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