01981nam 2200349z- 450 991067110780332120180410221905.0(CKB)5470000001388918(EXLCZ)99547000000138891820220406c2016uuuu -u- -engANDA litigation strategies and tactics for pharmaceutical patent litigators /Kenneth L. Dorsney, editor-in-chiefAmerican Bar Association1-63425-458-9 The statutory and regulatory scheme -- The drug approval process--an overview -- Notice and prefiling considerations -- The litigation timeline -- Initiating litigation -- Use of reissue proceedings in Hatch-Waxman litigation -- Inter partes review in ANDA litigation -- Examining subject-matter jurisdiction over declaratory judgment claims filed in combination with patent infringement claims under section 271(e)(2)(a) -- Responding to the complaint -- Discovery -- Experts -- Claim construction -- Summary judgment -- Remedies -- Settlement -- Antitrust -- Pretrial preparation -- Trial -- Posttrial -- Appeals to the Court of Appeals for the Federal Circuit -- Hatch-Waxman practice in the Supreme Court of the United States -- Managing an ANDA litigation -- Pharmaceutical regulation and litigation in foreign countries.ANDA litigationBiotechnologyUnited StatesPatentsDrugsUnited StatesPatentsPatent suitsUnited StatesPharmacyLaw and legislationUnited StatesAbbreviated New Drug Application.BiotechnologyPatents.DrugsPatents.Patent suitsPharmacyLaw and legislation346.7304/86Dorsney Kenneth L.American Bar Association.Section of Intellectual Property Law,BOOK9910671107803321ANDA litigation3049757UNINA