Where an ANDA specification does not "directly address the issue of infringement," the court, in determining infringement of such ANDA under the Hatch-Waxman Act, is not limited to the "the ANDA process and compounds . . . to the exclusion of the reality of the contemplated ANDA product‘s use." Rather, "the Court must look to the whole of the product, which means considering its ultimate useable state, as well as the ANDA-contemplated process and compound."
PDL Biopharma, Inc. v. Sun Pharm. Indus. Ltd., 2-07-cv-01788 (NJD March 31, 2009, Opinion)