Federal Circuit Relaxes Limits Of Safe Harbor For Post-Approval Studies

Classen Immunotherapies, Inc. v. Elan Pharms., Inc., (Fed. Cir. May 13, 2015)

Affirming the U.S. District Court for the District of Maryland, the U.S. Court of Appeals for the Federal Circuit recently held the "safe harbor" provision of 35 U.S.C. § 271(e)(1) exempted infringement of Elan Pharmaceuticals' post-approval clinical study and supplemental new drug application (sNDA) for its muscle relaxant, Skelaxin® (metaxalone). Classen Immunotherapies, Inc. v. Elan Pharms., Inc., 2015 WL 2216154 (Fed. Cir. May 13, 2015)

Classen sued Elan for infringement of U.S. Patent 6,584,472 (the '472 patent), which claims a method for accessing and analyzing data on a commercially available drug to identify a new use of that drug, and then commercializing that use. Elan conducted a post-approval bioavailability (BA) study on the food effects of Skelaxin. The results of the study showed the BA of Skelaxin increased when taken with food. Elan submitted a citizen petition asking