Law360, New York ( September 29, 2015, 10:37 AM EDT) -- After receipt of a so-called Paragraph IV Notice from a generic company, a patentee — the brand company — has 45 days in which to file suit to secure a 30-month stay of U.S. Food and Drug Administration approval of the generic's abbreviated new drug application. Not much time! But who does the brand sue? The applicable statute, 35 U.S.C. § 271(e)(2)(A), envisions suit against the ANDA "submitter." Yet this is complicated where multiple organizations are involved in the "submission." Can suit be instituted against those that merely "aid and abet," i.e., induce, the ANDA filing? These considerations are significant because relief under § 271(e)(4) (A)-(C) is available only against named defendants. On Sept. 24, the Federal Circuit, in Shire LLC v. Amneal Pharmaceuticals LLC, Nos. 2014-1736, 2014-1737, 2014-1738, 2014-1730, 2014-1741, Slip. Op. (Fed. Cir. September 4, 2015). clarified the law on whether entities who merely assist an ANDA filer are liable for inducing infringement. The prior holdings — both district court and Federal Circuit — were somewhat inconsistent on this issue....