,,ib ,union ,cal5d> ,no4 #be #aaf? ,,congress #a/ ,session ,h4 ,r4 #aejc ,report ,no4 #aaf-dg ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,m>* #e1 #bjai ,ms4 ,kelly ( ,ill9ois introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,may #b1 #bjai ,additional sponsors3 ,mr4 ,ruiz1 ,mr4 ,ru%1 ,mr4 ,pallone1 ,mrs4 ,d+ell1 ,ms4 ,e%oo1 ,mr4 ,k5n$y1 ,ms4 ,matsui1 ,mrs4 ,craig1 ,ms4 ,cl>ke ( ,new ,york1 ,mr4 ,van ,drew1 ,mr4 ,wald51 ,ms4 ,s*ak[sky1 & ,ms4 ,muc>sel-,p[ell ,may #b1 #bjai ,report$ ) an am5dm5t1 committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union1 & ord]$ to be pr9t$ ,/rike out all aft] ! enact+ clause & ins]t ! "p pr9t$ 9 italic ,= text ( introduc$ bill1 see copy ( bill z introduc$ on ,m>* #e1 #bjai ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act reg>d+ ! li/ "u section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,orange ,book ,transp>5cy ,act ( #bjai4 #b4 ,orange ,book 7a7 ,submission ( pat5t in=mation = br& "n drugs ,p>agraph 7#a7 ( section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 is am5d$ to read z foll[s3 7b7 7#a7 ,any p]son may file ) ! ,secret>y an application ) respect to any drug subject to ! provisions ( subsection 7a74 ,su* p]sons %all submit to ! ,secret>y z "p ( ! application-- 7,a7 full reports ( inve/igations :i* h be5 made to %[ :e!r or n su* drug is safe = use & :e!r su* drug is effective 9 use2 7,b7 a full li/ ( ! articles us$ z compon5ts ( su* drug2 7,c7 a full /atem5t ( ! composition ( su* drug2 7,d7 a full description ( ! me?ods us$ 91 & ! facilities & controls us$ =1 ! manufacture1 process+1 & pack+ ( su* drug2 7,e7 su* samples ( su* drug & ( ! articles us$ z compon5ts !re( z ! ,secret>y may require2 7,f7 specim5s ( ! label+ propos$ to be us$ = su* drug2 7,g7 any assessm5ts requir$ "u section #eje;,b2 & 7,h7 pat5t in=mation1 ) respect to ea* pat5t = :i* a claim ( pat5t infr+em5t c\ld reasonably be ass]t$ if a p]son n lic5s$ by ! own] engag$ 9 ! manufacture1 use1 or sale ( ! drug1 & consi/5t ) ! foll[+ requirem5ts3 7i7 ,! applicant %all file ) ! application ! pat5t numb] & ! expiration date (-- 7,i7 any pat5t :i* claims ! drug = :i* ! applicant submitt$ ! application & is a drug sub/ance 7includ+ active +r$i5t7 pat5t or a drug product 7includ+ =mulation & composition7 pat5t2 & 7,,ii7 any pat5t :i* claims ! me?od ( us+ su* drug4 7ii7 ,if an application is fil$ "u ?is subsection = a drug & a pat5t ( ! type describ$ 9 clause 7i7 :i* claims su* drug or a me?od ( us+ su* drug is issu$ aft] ! fil+ date b be=e approval ( ! application1 ! applicant %all am5d ! application to include su* pat5t in=mation4 ,^u approval ( ! application1 ! ,secret>y %all publi% ! in=mation submitt$ "u subp>agraph 7,h74 ,! ,secret>y %all1 9 consultation ) ! ,director ( ! ,national ,in/itutes ( ,heal? & ) repres5tatives ( ! drug manufactur+ indu/ry1 review & develop guidance1 z appropriate1 on ! inclusion ( wom5 & m9orities 9 cl9ical trials requir$ by subp>agraph 7,a74 4 7b7 ,con=m+ *anges to requirem5ts = subsequ5t submission ( pat5t in=mation ,section #eje7;c77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is am5d$-- 7#a7 by ins]t+ aft] ! pat5t numb] & ! expiration date ( any pat5t :i* ! foll[+3 fulfills ! crit]ia 9 subsection 7b7 &2 7#b7 by ins]t+ aft] ! fir/ s5t5ce ! foll[+3 ,pat5t in=mation t is n ! type ( pat5t in=mation requir$ by subsection 7b7 %all n be submitt$42 & 7#c7 by ins]t+ aft] c\ld n file pat5t in=mation "u subsection 7b7 because no pat5t ! foll[+3 ( ! type requir$ to be submitt$ 9 subsection 7b74 7c7 ,li/+ ( exclusivities ,subp>agraph 7,a7 ( section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is am5d$ by add+ at ! end ! foll[+3 7iv7 ,= ea* drug includ$ on ! li/1 ! ,secret>y %all specify ea* exclusivity p]iod t is applicable & has n conclud$ "u-- 7,i7 clause 7ii71 7iii71 or 7iv7 ( subsection 7c77#c77;,e7 ( ?is section2 7,,ii7 clause 7iv7 or 7v7 ( p>agraph 7#e77;,b7 ( ?is subsection2 7,,iii7 clause 7ii71 7iii71 or 7iv7 ( p>agraph 7#e77;,f7 ( ?is subsection2 7,,iv7 section #eje;,a2 7,v7 section #eje;,e2 or 7,,vi7 section #ebg7;a74 4 7d7 ,removal ( invalid pat5ts 7#a7 ,9 g5]al ,section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is am5d$ by add+ at ! end ! foll[+3 7,d7 7i7 ,! hold] ( an application approv$ "u subsection 7c7 = a drug on ! li/ %all notify )9 #ad days ! ,secret>y 9 writ+ if ei!r ( ! foll[+ occurs3 7,i7 ,! ,pat5t ,trial & ,appeals ,bo>d issues a decision f :i* no appeal has be5 or c be tak5 t a pat5t = su* drug is invalid4 7,,ii7 ,a c\rt issues a decision f :i* no appeal has be5 or c be tak5 t a pat5t = su* drug is invalid4 7ii7 ,! hold] ( an approv$ application %all include 9 any notification "u clause 7i7 a copy ( ! decision describ$ 9 subclause 7,i7 or 7,,ii7 ( clause 7i74 7iii7 ,! ,secret>y %all remove f ! li/ any pat5t t is det]m9$ to be invalid 9 a decision describ$ 9 subclause 7,i7 or 7,,ii7 ( clause 7i7-- 7,i7 promptly2 b 7,,ii7 n be=e ! expiration ( any #ahj-;day exclusivity p]iod "u p>agraph 7#e77;,b77iv7 t relies on a c]tification describ$ 9 p>agraph 7#b77;,a77vii77,,iv7 t su* pat5t 0 invalid4 4 7#b7 ,applicability ,subp>agraph 7,d7 ( section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g771 z add$ by p>agraph 7#a71 applies only ) respect to a decision describ$ 9 su* subp>agraph t is issu$ on or aft] ! date ( enactm5t ( ?is ,act4 7e7 ,review & report ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs1 %all-- 7#a7 solicit public comm5t reg>d+ ! types ( pat5t in=mation t %\ld be includ$ on ! li/ "u section #ejg7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g772 & 7#b7 transmit to ! ,congress an evaluation ( su* comm5ts1 includ+ any recomm5dations ab\t ! types ( pat5t in=mation t %\ld be includ$ on or remov$ f su* li/4 #c4 ,,gao report to ,congress 7a7 ,9 g5]al ,n lat] ?an "o ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 7ref]r$ to 9 ?is section z ! ,comptroll] ,g5]al7 %all submit to ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report on ! pat5ts includ$ 9 ! li/ publi%$ "u section #eje7;j77#g7 ( ! ,f$]al ,food1 ,drug & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g771 includ+ an analysis & evaluation ( ! types ( pat5ts includ$ 9 su* li/ & ! claims su* pat5ts make ab\t ! products !y claim4 7b7 ,cont5ts ,! ,comptroll] ,g5]al %all include 9 ! report "u subsection 7a7-- 7#a7 data on ! numb] (-- 7,a7 pat5ts includ$ 9 ! li/ publi%$ "u p>agraph 7#g7 ( section #eje7;j7 ( ! ,f$]al ,food1 ,drug & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j771 t claim ! active +r$i5t or =mulation ( a drug 9 comb9ation ) a device t is us$ = deliv]y ( ! drug1 toge!r compris+ ! f9i%$ dosage =m ( ! drug2 & 7,b7 claims 9 ea* pat5t t claim a device t is us$ = ! deliv]y ( ! drug1 b d n claim su* device 9 comb9ation ) an active +r$i5t or =mulation ( a drug2 7#b7 data on ! date ( inclusion 9 ! li/ "u p>agraph 7#g7 ( su* section #eje7;j7 = all pat5ts "u su* li/1 z comp>$ to pat5ts t claim a me?od ( us+ ! drug 9 comb9ation ) a device2 7#c7 an analysis reg>d+ ! impact ( includ+ on ! li/ "u p>agraph 7#g7 ( su* section #eje7;j7 c]ta9 types ( pat5t in=mation = drug product applicants & approv$ application hold]s1 includ+ an analysis ( :e!r-- 7,a7 ! li/+ ( ! pat5ts describ$ 9 p>agraph 7#a77;,a7 delay$ ! m>ket entry ( "o or m drugs approv$ "u su* section #eje7;j72 & 7,b7 n li/+ ! pat5ts describ$ 9 p>agraph 7#a77;,a7 w\ld delay ! m>ket entry ( "o or m su* drugs2 & 7#d7 recomm5dations ab\t :i* k9ds ( pat5ts relat+ to devices describ$ 9 p>agraph 7#a77;,a7 %\ld be submitt$ to ! ,secret>y ( ,heal? & ,human ,s]vices = inclusion on ! li/ "u p>agraph 7#g7 ( su* section #eje7;j7 & :i* pat5ts %\ld n be requir$ to be s submitt$4 ,may #b1 #bjai ,report$ ) an am5dm5t1 committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union1 & ord]$ to be pr9t$