LEADER 01981nam 2200349z- 450 001 9910671107803321 005 20180410221905.0 035 $a(CKB)5470000001388918 035 $a(EXLCZ)995470000001388918 100 $a20220406c2016uuuu -u- - 101 0 $aeng 200 00$aANDA litigation $estrategies and tactics for pharmaceutical patent litigators /$fKenneth L. Dorsney, editor-in-chief 210 $cAmerican Bar Association 311 $a1-63425-458-9 327 $aThe 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. 517 $aANDA litigation 606 $aBiotechnology$zUnited States$xPatents 606 $aDrugs$zUnited States$xPatents 606 $aPatent suits$zUnited States 606 $aPharmacy$xLaw and legislation$zUnited States 610 $aAbbreviated New Drug Application. 615 0$aBiotechnology$xPatents. 615 0$aDrugs$xPatents. 615 0$aPatent suits 615 0$aPharmacy$xLaw and legislation 676 $a346.7304/86 702 $aDorsney$b Kenneth L. 712 02$aAmerican Bar Association.$bSection of Intellectual Property Law, 906 $aBOOK 912 $a9910671107803321 996 $aANDA litigation$93049757 997 $aUNINA