Federal Circuit Clarifies Scope of § 271(e) Safe Harbor in Classen v. Elan
In Classen Immunotherapies, Inc. v. Elan Pharms., Inc., the Federal Circuit determined that an NDA-holder’s post-approval activities fall within the scope of the § 271(e) safe harbor. 2015 U.S. App. LEXIS 7854 (Fed. Circ. May 13, 2015). Specifically, 35 U.S.C. § 271(e)(1) exempts activities reasonably relating to developing clinical data on an approved drug and submitting that…