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SENT ii NNS If IN the DT certification NN referred VVD to TO at IN the DT beginning NN of IN this DT subparagraph NN concerns VVZ a DT patent NN other JJ than IN a DT patent NN that WDT claims VVZ a DT process NN for IN manufacturing VVG the DT listed JJ drug NN for IN which WDT patent NN information NN was VBD submitted VVN under IN subsection NN c NN 2 CD , , the DT approval NN shall MD be VB made VVN effective JJ on IN the DT date NN that WDT is VBZ 45 CD days NNS after IN the DT date NN on IN which WDT the DT notice NN provided VVN under IN subsection NN b NN 3 CD is VBZ received VVN , , unless IN a DT civil JJ action NN for IN infringement NN of IN the DT patent NN , , accompanied VVN by IN a DT motion NN for IN preliminary JJ injunction NN to TO enjoin VV the DT applicant NN from IN engaging VVG in IN the DT commercial JJ manufacture NN or CC sale NN of IN the DT drug NN , , is VBZ filed VVN on IN or CC before IN such JJ date NN , , in IN which WDT case NN the DT approval NN shall MD be VB made VVN effective JJ I NN on IN the DT date NN of IN a DT court NN action NN declining VVG to TO grant VV a DT preliminary JJ injunction NN . SENT or CC II NP if IN the DT court NN has VHZ granted VVN a DT preliminary JJ injunction NN prohibiting VVG the DT applicant NN from IN engaging VVG in IN the DT commercial JJ manufacture NN or CC sale NN of IN the DT drug NN aa NN on IN issuance NN by IN a DT court NN of IN a DT determination NN that IN the DT patent NN is VBZ invalid JJ or CC is VBZ not RB infringed VVN . SENT bb NP on IN issuance NN by IN a DT court NN of IN an DT order NN revoking VVG the DT preliminary JJ injunction NN or CC permitting VVG the DT applicant NN to TO engage VV in IN the DT commercial JJ manufacture NN or CC sale NN of IN the DT drug NN . SENT or CC cc NN on IN the DT date NN specified VVN in IN a DT court NN order NN under IN section NN 271 CD e NN 4 LS A DT of IN title NN 35 CD , , United NP States NPS Code NP , , if IN the DT court NN determines VVZ that IN the DT patent NN is VBZ infringed VVN . SENT Each DT of IN the DT parties NNS shall MD reasonably RB cooperate VV in IN expediting VVG a DT civil JJ action NN under IN this DT clause NN . SENT If IN the DT notice NN under IN subsection NN b NN 3 CD contains VVZ an DT address NN for IN the DT receipt NN of IN expedited JJ notification NN of IN a DT civil JJ action NN under IN this DT clause NN , , the DT plaintiff NN shall MD , , on IN the DT date NN on IN which WDT the DT complaint NN is VBZ filed VVN , , simultaneously RB cause VV a DT notification NN of IN the DT civil JJ action NN to TO be VB delivered VVN to TO that DT address NN by IN the DT next JJ business NN day NN . SENT . SENT 2 CD FAILURE NN TO TO BRING VV INFRINGEMENT NN ACTION NN Subsection NN c SYM of IN section NN 505 CD of IN the DT Federal NP Food NP , , Drug NP , , and CC Cosmetic JJ Act NP 21 CD U NP . SENT S NP . SENT C SYM . SENT 355 CD c SYM 3 CD is VBZ amended VVN by IN adding VVG at IN the DT end NN the DT following NN . SENT 5 CD If IN , , in IN connection NN with IN an DT application NN under IN subsection NN b NN 2 CD , , the DT applicant NN provides VVZ an DT owner NN of IN a DT patent NN notice NN under IN subsection NN b NN 3 CD with IN respect NN to TO the DT patent NN , , and CC the DT owner NN of IN the DT patent NN fails VVZ to TO bring VV a DT civil JJ action NN against IN the DT applicant NN for IN infringement NN of IN the DT patent NN on IN or CC before IN the DT date NN that WDT is VBZ 45 CD days NNS after IN the DT date NN on IN which WDT the DT notice NN is VBZ received VVN , , the DT owner NN of IN the DT patent NN shall MD be VB barred VVN from IN bringing VVG a DT civil JJ action NN for IN infringement NN of IN the DT patent NN in IN connection NN with IN the DT development NN , , manufacture VV , , use VV , , offer VVP to TO sell VV , , or CC sale NN of IN the DT drug NN for IN which WDT the DT application NN was VBD filed VVN or CC approved VVN under IN subsection NN b NN 2 CD . SENT . SENT c SYM EFFECTIVE JJ DATE NN The DT amendments NNS made VVN by IN subsections NNS a DT and CC b NN shall MD be VB effective JJ with IN respect NN to TO any DT certification NN under IN subsection NN b NN 2 CD A DT iv NN or CC j NN 2 CD A NP vii NP IV NP of IN section NN 505 CD of IN the DT Federal NP Food NP , , Drug NP , , and CC Cosmetic JJ Act NP 21 CD U NP . SENT S NP . SENT C SYM . SENT 355 CD made VVN after IN the DT date NN of IN enactment NN of IN this DT Act NP in IN an DT application NN filed VVN under IN subsection NN b NN 2 CD or CC j NN of IN that DT section NN , , including VVG with IN respect NN to TO patent NN information NN that WDT was VBD submitted VVN to TO the DT Secretary NP before IN such JJ date NN under IN subsection NN c NN 2 CD of IN such JJ Act NP . SENT SEC NP . SENT 8 CD . SENT EXCLUSIVITY NN FOR IN ACCELERATED JJ GENERIC JJ DRUG NN APPLICANTS NNS . SENT a DT IN IN GENERAL NP Section NP 505 CD j NN 5 CD of IN the DT Federal NP Food NP , , Drug NP , , and CC Cosmetic JJ Act NP 21 CD U NP . SENT S NP . SENT C SYM . SENT 355 CD j NN 5 CD is VBZ amended VVN 1 CD in IN subparagraph NN B NP iv NP A NP in IN the DT text NN preceding VVG subclause NN I PP , , by IN inserting VVG the DT earlier RBR of IN after IN not RB earlier JJR than IN one CD hundred CD and CC eighty CD days NNS after IN . SENT B NP by IN striking VVG or CC at IN the DT end NN of IN subclause NN I PP . SENT C SYM by IN striking JJ subclause NN II NP and CC all DT that WDT follows VVZ through IN the DT end NN . SENT and CC D NP by IN adding VVG after IN subclause NN I PP the DT following NN . SENT II NP the DT date NN of IN a DT final JJ decision NN of IN a DT court NN from IN which WDT no DT appeal NN has VHZ been VBN or CC can MD be VB taken VVN , , other JJ than IN a DT petition NN to TO the DT Supreme NP Court NP for IN a DT writ NN of IN certiorari NN holding NN that IN the DT patent NN that WDT is VBZ the DT subject NN of IN the DT certification NN is VBZ invalid JJ or CC not RB infringed VVN , , or CC III NP the DT date NN of IN a DT settlement NN order NN or CC consent NN decree NN signed VVN by IN a DT Federal NP judge NN that WDT enters VVZ a DT final JJ judgment NN and CC includes VVZ a DT finding NN that IN the DT patent NN that WDT is VBZ the DT subject NN of IN the DT certification NN is VBZ invalid JJ or CC not RB infringed VVN . SENT . SENT and CC 2 CD by IN inserting VVG after IN subparagraph NN D NP the DT following NN . SENT E SYM Forfeiture NN of IN 180 CD Day NP Period NP i NP IN IN GENERAL NP Except IN as RB provided VVN in IN clause NN ii NNS , , if IN a DT forfeiture NN event NN occurs VVZ with IN respect NN to TO a DT first JJ application NN I PP the DT 180 CD day NN period NN under IN subparagraph NN B NP iv NP shall MD be VB forfeited VVN by IN the DT first JJ applicant NN . SENT and CC II NP any DT subsequent JJ application NN shall MD become VV effective JJ as RB provided VVN under IN clause NN i NP , , ii NP , , or CC iii NNS of IN subparagraph NN B NN , , and CC clause NN iv NN of IN subparagraph NN B NP shall MD not RB apply VV to TO the DT subsequent JJ application NN . SENT ii NN FORFEITURE NN TO TO FIRST CD SUBSEQUENT JJ APPLICANT NN If IN the DT subsequent JJ application NN that WDT is VBZ the DT first JJ to TO be VB made VVN effective JJ under IN clause NN i NP was VBD the DT first JJ among IN a DT number NN of IN subsequent JJ applications NNS to TO be VB filed VVN I PP that IN first JJ subsequent JJ application NN shall MD be VB treated VVN as IN the DT first JJ application NN under IN this DT subparagraph NN including VVG clause NN i NP and CC as IN the DT previous JJ application NN under IN subparagraph NN B NP iv NP . SENT and CC II NP any DT other JJ subsequent JJ applications NNS shall MD become VV effective JJ as RB provided VVN under IN clause NN i NP , , ii NP , , or CC iii NNS of IN subparagraph NN B NN , , but CC clause NN iv NN of IN subparagraph NN B NN shall MD apply VV to TO any DT such JJ subsequent JJ application NN . SENT iii NN AVAILABILITY NN The DT 180 CD day NN period NN under IN subparagraph NN B NP iv NP shall MD be VB available JJ to TO a DT first JJ applicant NN submitting VVG an DT application NN for IN a DT drug NN with IN respect NN to TO any DT patent NN without IN regard NN to TO whether IN an DT application NN has VHZ been VBN submitted VVN for IN the DT drug NN under IN this DT subsection NN containing VVG such PDT a DT certification NN with IN respect NN to TO a DT different JJ patent NN . SENT iv NN APPLICABILITY NN The DT 180 CD day NN period NN described VVN in IN subparagraph NN B NP iv NP shall MD apply VV to TO an DT application NN only RB if IN a DT civil JJ action NN is VBZ brought VVN against IN the DT applicant NN for IN infringement NN of IN a DT patent NN that WDT is VBZ the DT subject NN of IN the DT certification NN . SENT v NN DEFINITIONS NNS In IN this DT subparagraph NN . SENT I PP APPLICATION NN The DT term NN application NN means VVZ an DT application NN for IN approval NN of IN a DT drug NN under IN this DT subsection NN containing VVG a DT certification NN under IN paragraph NN 2 CD A NP vii NP IV NP with IN respect NN to TO a DT patent NN . SENT II NP FIRST NP APPLICATION NN The DT term NN first JJ application NN means VVZ the DT first JJ application NN to TO be VB filed VVN for IN approval NN of IN the DT drug NN . SENT III NP FORFEITURE NN EVENT NN The DT term NN forfeiture NN event NN , , with IN respect NN to TO an DT application NN under IN this DT subsection NN , , means VVZ the DT occurrence NN of IN any DT of IN the DT following NN . SENT aa NN FAILURE NN TO TO MARKET NN The DT applicant NN fails VVZ to TO market VV the DT drug NN by IN the DT later RBR of IN AA NN the DT date NN that WDT is VBZ 60 CD days NNS after IN the DT date NN on IN which WDT the DT approval NN of IN the DT application NN for IN the DT drug NN is VBZ made VVN effective JJ under IN clause NN iii NNS of IN subparagraph NN B NN unless IN the DT Secretary NP extends VVZ the DT date NN because IN of IN extraordinary JJ or CC unusual JJ circumstances NNS . SENT or CC BB NP if IN 1 CD or CC more JJR civil JJ actions NNS have VHP been VBN brought VVN against IN the DT applicant NN for IN infringement NN of IN a DT patent NN subject NN to TO a DT certification NN under IN paragraph NN 2 CD A NP vii NP IV NP or CC 1 CD or CC more JJR civil JJ actions NNS have VHP been VBN brought VVN by IN the DT applicant NN for IN a DT declaratory JJ judgment NN that IN such PDT a DT patent NN is VBZ invalid JJ or CC not RB infringed VVN , , the DT date NN that WDT is VBZ 60 CD days NNS after IN the DT date NN of IN a DT final JJ decision NN from IN which WDT no DT appeal NN has VHZ been VBN or CC can MD be VB taken VVN , , other JJ than IN a DT petition NN to TO the DT Supreme NP Court NP for IN a DT writ NN of IN certiorari NN in IN the DT last JJ of IN those DT civil JJ actions NNS to TO be VB decided VVN unless IN the DT Secretary NP extends VVZ the DT date NN because IN of IN extraordinary JJ or CC unusual JJ circumstances NNS . SENT bb NP WITHDRAWAL NN OF IN APPLICATION NN The DT applicant NN withdraws VVZ the DT application NN . SENT cc NN AMENDMENT NN OF IN CERTIFICATION NN The DT applicant NN , , voluntarily RB or CC as IN a DT result NN of IN a DT settlement NN or CC defeat NN in IN patent NN litigation NN , , amends VVZ the DT certification NN from IN a DT certification NN under IN paragraph NN 2 CD A NP vii NP IV NP to TO a DT certification NN under IN paragraph NN 2 CD A NP vii NP III NP . SENT dd NP FAILURE NN TO TO OBTAIN VV APPROVAL NN The DT applicant NN fails VVZ to TO obtain VV tentative JJ approval NN of IN an DT application NN within IN 30 CD months NNS after IN the DT date NN on IN which WDT the DT application NN is VBZ filed VVN , , unless IN the DT failure NN is VBZ caused VVN by IN AA NN a DT change NN in IN the DT requirements NNS for IN approval NN of IN the DT application NN imposed VVN after IN the DT date NN on IN which WDT the DT application NN is VBZ filed VVN . SENT or CC BB NP other JJ extraordinary JJ circumstances NNS warranting VVG an DT exception NN , , as RB determined VVN by IN the DT Secretary NP . SENT ee JJ FAILURE NN TO TO CHALLENGE VV PATENT NN In IN a DT case NN in IN which WDT , , after IN the DT date NN on IN which WDT the DT applicant NN submitted VVD the DT application NN , , new JJ patent NN information NN is VBZ submitted VVN under IN subsection NN c NN 2 CD for IN the DT listed VVN drug NN for IN a DT patent NN for IN which WDT certification NN is VBZ required VVN under IN paragraph NN 2 CD A NP , , the DT applicant NN fails VVZ to TO submit VV , , not RB later RBR than IN the DT date NN that WDT is VBZ 60 CD days NNS after IN the DT date NN on IN which WDT the DT Secretary NP publishes VVZ the DT new JJ patent NN information NN under IN paragraph NN 7 CD A DT iii NN unless IN the DT Secretary NP extends VVZ the DT date NN because IN of IN extraordinary JJ or CC unusual JJ circumstances NNS AA NN a DT certification NN described VVN in IN paragraph NN 2 CD A NP vii NP IV NP with IN respect NN to TO the DT patent NN to TO which WDT the DT new JJ patent NN information NN relates VVZ . SENT or CC BB NP a DT statement NN that IN any DT method NN of IN use NN claim NN of IN that DT patent NN does VVZ not RB claim VV a DT use NN for IN which WDT the DT applicant NN is VBZ seeking VVG approval NN under IN this DT subsection NN in IN accordance NN with IN paragraph NN 2 CD A DT viii NN . SENT ff NNS UNLAWFUL JJ CONDUCT NN The DT Federal NP Trade NP Commission NP determines VVZ that IN the DT applicant NN engaged VVN in IN unlawful JJ conduct NN with IN respect NN to TO the DT application NN in IN violation NN of IN section NN 1 CD of IN the DT Sherman NP Act NP . SENT IV NP SUBSEQUENT JJ APPLICATION NN The DT term NN subsequent JJ application NN means VVZ an DT application NN for IN approval NN of IN a DT drug NN that WDT is VBZ filed VVN subsequent JJ to TO the DT filing NN of IN a DT first JJ application NN for IN approval NN of IN that DT drug NN . SENT . SENT b SYM APPLICABILITY NN The DT amendment NN made VVN by IN subsection NN a DT shall MD apply VV only RB with IN respect NN to TO an DT application NN filed VVN under IN section NN 505 CD j NN of IN the DT Federal NP Food NP , , Drug NP , , and CC Cosmetic JJ Act NP 21 CD U NP . SENT S NP . SENT C SYM . SENT 355 CD j NN after IN the DT date NN of IN enactment NN of IN this DT Act NP for IN a DT listed VVN drug NN for IN which WDT no DT certification NN under IN section NN 505 CD j NN 2 LS A DT vii NP IV NP of IN that DT Act NP was VBD made VVN before IN the DT date NN of IN enactment NN of IN this DT Act NP , , except IN that DT if IN a DT forfeiture NN event NN described VVN in IN section NN 505 CD j NN 5 CD E NN v NN III NP ff NN of IN that DT Act NP as RB amended VVD by IN this DT section NN occurs VVZ in IN the DT case NN of IN an DT applicant NN , , the DT applicant NN shall MD forfeit VV the DT 180 CD day NN period NN under IN section NN 505 CD j NN 5 CD B NN iv NN of IN that DT Act NP without IN regard NN to TO when WRB the DT applicant NN made VVD a DT certification NN under IN section NN 505 CD j NN 2 LS A DT vii NP IV NP of IN that DT Act NP . SENT SEC NP . SENT 9 CD . SENT BIOEQUIVALENCE NN . SENT a DT IN IN GENERAL NP The DT amendments NNS to TO part NN 320 CD of IN title NN 21 CD , , Code NP of IN Federal NP Regulations NNS , , promulgated VVD by IN the DT Commissioner NP of IN Food NP and CC Drugs NPS on IN July NP 17 CD , , 1991 CD 57 CD Fed NP . SENT Reg NP . SENT 17997 CD April NP 28 CD , , 1992 CD , , shall MD continue VV in IN effect NN as IN an DT exercise NN of IN authorities NNS under IN sections NNS 501 CD , , 502 CD , , 505 CD , , and CC 701 CD of IN the DT Federal NP Food NP , , Drug NP , , and CC Cosmetic JJ Act NP 21 CD U NP . SENT S NP . SENT C SYM . SENT 351 CD , , 352 CD , , 355 CD , , 371 CD . SENT b SYM EFFECT NN Subsection NN a DT does VVZ not RB affect VV the DT authority NN of IN the DT Commissioner NP of IN Food NP and CC Drugs NP to TO amend VV part NN 320 CD of IN title NN 21 CD , , Code NP of IN Federal NP Regulations NNS . SENT c SYM EFFECT NN OF IN SECTION NN This DT section NN shall MD not RB be VB construed VVN to TO alter VV the DT authority NN of IN the DT Secretary NP of IN Health NP and CC Human NP Services NPS to TO regulate VV biological JJ products NNS under IN the DT Federal NP Food NP , , Drug NP , , and CC Cosmetic JJ Act NP 21 CD U NP . SENT S NP . SENT C SYM . SENT 301 CD et NP seq NP . SENT . SENT Any DT such JJ authority NN shall MD be VB exercised VVN under IN that DT Act NP as IN in IN effect NN on IN the DT day NN before IN the DT date NN of IN enactment NN of IN this DT Act NP . SENT SEC NP . SENT 10 CD . SENT FILING NN OF IN PATENT NN INFORMATION NN WITH IN THE DT FOOD NN AND CC DRUG NN ADMINISTRATION NN . SENT a DT FILING NN AFTER IN APPROVAL NN OF IN AN DT APPLICATION NN 1 CD IN IN GENERAL NP Section NP 505 CD of IN the DT Federal NP Food NP , , Drug NP , , and CC Cosmetic JJ Act NP 21 CD U NP . SENT S NP . SENT C SYM . SENT 355 CD as RB amended VVN by IN section NN 9 CD a DT 2 CD B NP ii NP is VBZ amended VVN in IN subsection NN c NN by IN striking JJ paragraph NN 2 CD and CC inserting VVG the DT following NN . SENT 2 CD PATENT NN INFORMATION NN A NP IN IN GENERAL NP Not RB later RBR than IN the DT date NN that WDT is VBZ 30 CD days NNS after IN the DT date NN of IN an DT order NN approving VVG an DT application NN under IN subsection NN b NN unless IN the DT Secretary NP extends VVZ the DT date NN because IN of IN extraordinary JJ or CC unusual JJ circumstances NNS , , the DT holder NN of IN the DT application NN shall MD file VV with IN the DT Secretary NP the DT patent NN information NN described VVN in IN subparagraph NN C NP with IN respect NN to TO any DT patent JJ i NP I NN that WDT claims VVZ the DT drug NN for IN which WDT the DT application NN was VBD approved VVN . SENT or CC II NP that WDT claims VVZ an DT approved VVN method NN of IN using VVG the DT drug NN . SENT and CC ii NNS with IN respect NN to TO which WDT a DT claim NN of IN patent NN infringement NN could MD reasonably RB be VB asserted VVN if IN a DT person NN not RB licensed VVD by IN the DT owner NN engaged VVN in IN the DT manufacture NN , , use NN , , or CC sale NN of IN the DT drug NN . SENT B SYM SUBSEQUENTLY RB ISSUED VVN PATENTS NNS In IN a DT case NN in IN which WDT a DT patent NN described VVN in IN subparagraph NN A DT is VBZ issued VVN after IN the DT date NN of IN an DT order NN approving VVG an DT application NN under IN subsection NN b NN , , the DT holder NN of IN the DT application NN shall MD file VV with IN the DT Secretary NP the DT patent NN information NN described VVN in IN subparagraph NN C NP not RB later RBR than IN the DT date NN that WDT is VBZ 30 CD days NNS after IN the DT date NN on IN which WDT the DT patent NN is VBZ issued VVN unless IN the DT Secretary NP extends VVZ the DT date NN because IN of IN extraordinary JJ or CC unusual JJ circumstances NNS . SENT C SYM PATENT NN INFORMATION NN The DT patent NN information NN required VVN to TO be VB filed VVN under IN subparagraph NN A NP or CC B NP includes VVZ i NP the DT patent NN number NN . SENT ii NP the DT expiration NN date NN of IN the DT patent NN . SENT iii NNS with IN respect NN to TO each DT claim NN of IN the DT patent NN I NN whether IN the DT patent NN claims VVZ the DT drug NN or CC claims VVZ a DT method NN of IN using VVG the DT drug NN . SENT and CC II NP whether IN the DT claim NN covers VVZ aa NN a DT drug NN substance NN . SENT bb NP a DT drug NN formulation NN . SENT cc NN a DT drug NN composition NN . SENT or CC dd NP a DT method NN of IN use NN . SENT iv JJS if IN the DT patent NN claims VVZ a DT method NN of IN use NN , , the DT approved VVN use NN covered VVN by IN the DT claim NN . SENT v NN the DT identity NN of IN the DT owner NN of IN the DT patent NN including VVG the DT identity NN of IN any DT agent NN of IN the DT patent NN owner NN . SENT and CC vi NP a DT declaration NN that IN the DT applicant NN , , as RB of IN the DT date NN of IN the DT filing NN , , has VHZ provided VVN complete JJ and CC accurate JJ patent NN information NN for IN all DT patents NNS described VVN in IN subparagraph NN A NP . SENT D SYM PUBLICATION NN On IN filing NN of IN patent NN information NN required VVN under IN subparagraph NN A NP or CC B NP , , the DT Secretary NP shall MD i NP immediately RB publish VV the DT information NN described VVN in IN clauses NNS i NP through IN iv NP of IN subparagraph NP C NP . SENT and CC ii NNS make VVP the DT information NN described VVN in IN clauses NNS v NN and CC vi NP of IN subparagraph NP C NP available JJ to TO the DT public NN on IN request NN . SENT E SYM CIVIL JJ ACTION NN FOR IN CORRECTION NN OR CC DELETION NN OF IN PATENT NN INFORMATION NN i NP IN IN GENERAL NP A DT person NN that WDT has VHZ filed VVN an DT application NN under IN subsection NN b NN 2 CD or CC j NN for IN a DT drug NN may MD bring VV a DT civil JJ action NN against IN the DT holder NN of IN the DT approved VVN application NN for IN the DT drug NN seeking VVG an DT order NN requiring VVG that IN the DT holder NN of IN the DT application NN amend VV the DT application NN I PP to TO correct VV patent NN information NN filed VVN under IN subparagraph NN A NP . SENT or CC II NP to TO delete VV the DT patent NN information NN in IN its PP$ entirety NN for IN the DT reason NN that IN aa NN the DT patent NN does VVZ not RB claim VV the DT drug NN for IN which WDT the DT application NN was VBD approved VVN . SENT or CC bb NP the DT patent NN does VVZ not RB claim VV an DT approved VVN method NN of IN using VVG the DT drug NN . SENT ii NN LIMITATIONS NNS Clause NN i NP does VVZ not RB authorize VV I PP a DT civil JJ action NN to TO correct VV patent NN information NN filed VVN under IN subparagraph NN B NN . SENT or CC II NP an DT award NN of IN damages NNS in IN a DT civil JJ action NN under IN clause NN i NP . SENT F SYM NO DT CLAIM NN FOR IN PATENT NN INFRINGEMENT NN An DT owner NN of IN a DT patent NN with IN respect NN to TO which WDT a DT holder NN of IN an DT application NN fails VVZ to TO file VV information NN on IN or CC before IN the DT date NN required VVN under IN subparagraph NN A NP or CC B NP shall MD be VB barred VVN from IN bringing VVG a DT civil JJ action NN for IN infringement NN of IN the DT patent NN against IN a DT person NN that IN i NP has VHZ filed VVN an DT application NN under IN subsection NN b NN 2 CD or CC j NN . SENT or CC ii NP manufactures VVZ , , uses VVZ , , offers VVZ to TO sell VV , , or CC sells VVZ a DT drug NN approved VVN under IN an DT application NN under IN subsection NN b NN 2 CD or CC j NN . SENT . SENT 2 CD TRANSITION NN PROVISION NN A DT FILING NN OF IN PATENT NN INFORMATION NN Each DT holder NN of IN an DT application NN for IN approval NN of IN a DT new JJ drug NN under IN section NN 505 CD b SYM of IN the DT Federal NP Food NP , , Drug NP , , and CC Cosmetic JJ Act NP 21 CD U NP . SENT S NP . SENT C SYM . SENT 355 CD b SYM that DT has VHZ been VBN approved VVN before IN the DT date NN of IN enactment NN of IN this DT Act NP shall MD amend VV the DT application NN to TO include VV the DT patent NN information NN required VVN under IN the DT amendment NN made VVN by IN paragraph NN 1 CD not RB later RBR than IN the DT date NN that WDT is VBZ 30 CD days NNS after IN the DT date NN of IN enactment NN of IN this DT Act NP unless IN the DT Secretary NP of IN Health NP and CC Human NP Services NPS extends VVZ the DT date NN because IN of IN extraordinary JJ or CC unusual JJ circumstances NNS . SENT B SYM NO DT CLAIM NN FOR IN PATENT NN INFRINGEMENT NN An DT owner NN of IN a DT patent NN with IN respect NN to TO which WDT a DT holder NN of IN an DT application NN under IN subsection NN b NN of IN section NN 505 CD of IN the DT Federal NP Food NP , , Drug NP , , and CC Cosmetic JJ Act NP 21 CD U NP . SENT S NP . SENT C SYM . SENT 355 CD fails VVZ to TO file VV information NN on IN or CC before IN the DT date NN required VVN under IN subparagraph NN A DT shall MD be VB barred VVN from IN bringing VVG a DT civil JJ action NN for IN infringement NN of IN the DT patent NN against IN a DT person NN that IN i NP has VHZ filed VVN an DT application NN under IN subsection NN b NN 2 CD or CC j NN of IN that DT section NN . SENT or CC ii NP manufactures VVZ , , uses VVZ , , offers VVZ to TO sell VV , , or CC sells VVZ a DT drug NN approved VVN under IN an DT application NN under IN subsection NN b NN 2 CD or CC j NN of IN that DT section NN . SENT b SYM FILING NN WITH IN AN DT APPLICATION NN Section NP 505 CD of IN the DT Federal NP Food NP , , Drug NP , , and CC Cosmetic JJ Act NP 21 CD U NP . SENT S NP . SENT C SYM . SENT 355 CD is VBZ amended VVN 1 CD in IN subsection NN b NN 2 CD A NP in IN subparagraph NP A NP , , by IN striking VVG and CC at IN the DT end NN . SENT B NP in IN subparagraph NP B NP , , by IN striking VVG the DT period NN at IN the DT end NN and CC inserting VVG . SENT and NP . SENT and CC C NP by IN adding VVG at IN the DT end NN the DT following NN . SENT C SYM with IN respect NN to TO a DT patent NN that IN claims NNS both CC the DT drug NN and CC a DT method NN of IN using VVG the DT drug NN or CC claims VVZ more JJR than IN 1 CD method NN of IN using VVG the DT drug NN for IN which WDT the DT application NN is VBZ filed VVN i NP a DT certification NN under IN subparagraph NN A DT iv NN on IN a DT claim NN by IN claim NN basis NN . SENT and CC ii NNS a DT statement NN under IN subparagraph NN B NN regarding VVG the DT method NN of IN use NN claim NN . SENT . SENT and CC 2 CD in IN subsection NN j NN 2 CD A DT , , by IN inserting VVG after IN clause NN viii NNS the DT following NN . SENT With IN respect NN to TO a DT patent NN that IN claims NNS both CC the DT drug NN and CC a DT method NN of IN using VVG the DT drug NN or CC claims VVZ more JJR than IN 1 CD method NN of IN using VVG the DT drug NN for IN which WDT the DT application NN is VBZ filed VVN , , the DT application NN shall MD contain VV a DT certification NN under IN clause NN vii NP IV NP on IN a DT claim NN by IN claim NN basis NN and CC a DT statement NN under IN clause NN viii NNS regarding VVG the DT method NN of IN use NN claim NN . SENT . SENT END NN