[co-author: Katie Ning]
Previously, it was recommended that regulatory attorneys consult patent attorneys when preparing labels covering branded pharmaceuticals.[1] In so doing, the label would closely reflect limitations in the asserted patent claims to best insure that actions for infringement, particularly inducement of infringement of method-of-treatment patents are successful, and situations like those in Bayer Schering Pharma AG v. Lupin, Ltd.[2] could be avoided. There, Bayer’s inducement action was dismissed where the claimed method simultaneously treated three separate medical conditions but the approved label only mentioned one. The lack of conformity between the label and the patent claims proved fatal. Here, it is recommended that regulatory attorneys and patent attorneys carefully review ANDAs to uncover admissions by generic filers that would assist patentees in proving infringement, especially under the doctrine of equivalents.
As one example, a generic company could specify the “function” of a component in a purposed formulation and that would assist the patentee attorney satisfying the function prong of the tripart test for infringement doctrine of equivalents. See, e.g., Par Pharmaceutical, Inc. v. Hospira, Inc.[3]; Shire Development, LLC v. Mylan Pharmaceuticals, Inc.[4] Similarly, any statements by the generic that its purposed product was designed to “mimic” certain claimed properties of the branded version would similarly assist the patentee. See generally Wyeth v. Sandoz, Inc.[5]
An ANDA, of course, must characterize the proposed generic product, its formulation or use, where applicable. However, little need for an infringement inquiry is required where an ANDA “define[s] the compound in a manner that directly addresses the question of infringement.” Abbott Laboratories v. Torpharm, Inc.[6] The critical effect of statements by a generic in its ANDA is best illustrated in the Federal Circuit’s decision in Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals, Inc.,[7] where the court stated:
[I]f an ANDA specification defines a compound such that it meets the limitations of an asserted claim, then there is almost never a genuine issue of material fact that the claim is infringed.[8]
There, statements in Teva’s ANDA indicating that it could market a product within the scope of the patent claims trumped its promise not to do so. In other words, “[s]imply saying ‘But I won’t do it’ is not enough to avoid infringement.”[9]
A damaging characterization by generic was clearly exemplified in Intendis GMBH v. Glenmark Pharmaceuticals Inc., USA,[10] where the issue was whether Glenmark’s isopropyl myristate excipients...
