Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Appeal Nos. 2024-1965, -1966, -2082, -2083 (Fed. Cir. Jan. 29, 2025) Our Case of the Week is a 31-page decision that touches on a variety of issues, including...more
The provisions of U.S. regulatory law regarding FDA approval for less than all the indications for which an innovator drug was approved under 21 U.S.C. ยง 355(j)(2)(A)(viii) (the so-called "skinny label) has in the recent past...more