United States Federal Circuit
Classen Immuniotherapies, Inc. v. Elan Pharms., Inc., 14-1671
In an infringement action, the district court's summary judgment that defendant did not infringe the patent, based on the safe harbor provision of 35 U.S.C. section 271(e)(1), is affirmed where the court correctly decided that section 271(e)(1) exempts defendant's activities reasonably relating to developing clinical data on its approved drug Skelaxin and submitting that information to the Food and Drug Administration (FDA) in a citizen petition and a supplemental new drug application (sNDA).
Appellate Information
- Decided 05/13/2015
- Published 05/13/2015
Judges
- LOURIE
Court
- United States Federal Circuit