Safe Harbor Provision Exempts Post-Approval Activities That Are Not "Routine" From Infringement

Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., No. 2014-1671, 2015 U.S. App. LEXIS 7854 (Fed. Cir. May 13, 2015) (Reyna, CJ.).  Click Here for a copy of the opinion.

Elan marketed and sold metaxalone tablets as a branded muscle relaxant called Skelaxin, after obtaining approval for its new drug application ("NDA").  Subsequently, the FDA proposed to change the designation of metaxalone from "non bioproblem" to "bioproblem" based on clinical studies conducted by a third party.  (A "bioproblem" drug requires in vivo bioavailability and bioequivalence data for generic drug approval.)  In response, Elan initiated its own clinical study and observed a significant effect of food on the metaxalone's bioavailability.  Elan submitted a citizen petition requesting that the FDA require both fed and fasting bioavailability data for generic metaxalone, before approving any abbreviated new drug applications ("ANDAs") that reference Elan's NDA.  Elan also submitted