S. 2620 — REMEDY Act

This section requires the holder of an approved new drug application (NDA) to select, upon first listing patents under subsection (c)(2) for drugs approved on or after enactment, one such patent as the "covered patent" eligible for the 30-month stay on abbreviated new drug application (ANDA) approval—a stay that delays Food and Drug Administration (FDA) approval of generics pending patent infringement litigation—and prohibits changing that selection. For such drugs, the section limits the 30-month stay trigger under subsections (c)(3)(C) and (j)(5)(B)(iii) to infringement suits on the covered patent (from any listed patent previously eligible), with conforming changes to (c)(3)(E)(ii) and (j)(5)(F)(ii). (Thus, this restricts brand-name companies' use of multiple secondary patents to extend market exclusivity.)