,,ii #aac? ,,congress #a/ ,session ,s4 #bad ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,febru>y #d1 #bjac ,ms4 ,klobu*> 7= h]self1 ,mr4 ,grassley1 ,mr4 ,durb91 ,mr4 ,frank51 & ,mr4 ,johnson ( ,s\? ,dakota7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ! ,judici>y ,a ,,bill ,to prohibit br& "n drug companies f comp5sat+ g5]ic drug companies to delay ! entry ( a g5]ic drug into ! m>ket4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,pres]ve ,access to ,af=dable ,g5]ics ,act4 #b4 ,congressional f9d+s & decl>ation ( purposes 7a7 ,f9d+s ,congress f9ds ! foll[+3 7#a7 ,9 #aihd1 ! ,drug ,price ,competition & ,pat5t ,t]m ,re/oration ,act 7,public ,law #ih-dag7 7ref]r$ to 9 ?is ,act z ! #aihd ,act71 0 enact$ ) ! int5t ( facilitat+ ! e>ly entry ( g5]ic drugs :ile pres]v+ inc5tives = innovation4 7#b7 ,prescription drugs make up #aj p]c5t ( ! national heal? c>e sp5d+ b = ! pa/ decade h be5 "o ( ! fa/e/ gr[+ segm5ts ( heal? c>e exp5ditures4 7#c7 ,until rec5tly1 ! #aihd ,act 0 successful 9 facilitat+ g5]ic competition to ! b5efit ( consum]s & heal? c>e pay]s--al?\gh #fg p]c5t ( all prescriptions disp5s$ 9 ! ,unit$ ,/ates are g5]ic drugs1 !y acc\nt = only #bj p]c5t ( all exp5ditures4 7#d7 ,g5]ic drugs co/ sub/antially less ?an br& "n drugs1 ) disc\nts (f ! br& price sometimes exce$+ #ij p]c5t4 7#e7 ,f$]al doll>s curr5tly acc\nt = an e/imat$ #ce p]c5t ( ! #bfc1jjj1jjj1jjj sp5t on prescription drugs1 & ?is %>e is expect$ to rise to #db p]c5t by #bjba4 7#f7 7,a7 ,9 rec5t ye>s1 ! int5t ( ! #aihd ,act has be5 subv]t$ by c]ta9 settlem5t agreem5ts betwe5 br& companies & _! pot5tial g5]ic competitors t make rev]se paym5ts :i* are paym5ts by ! br& company to ! g5]ic company4 7,b7 ,^! settlem5t agreem5ts h unduly delay$ ! m>ket+ ( l[-co/ g5]ic drugs contr>y to free competition1 ! int]e/s ( consum]s1 & ! pr9ciples und]ly+ antitru/ law4 7,c7 ,because ( ! price disp>ity betwe5 br& "n & g5]ic drugs1 su* agreem5ts are m pr(itable = bo? ! br& & g5]ic manufactur]s ?an competition1 & w become increas+ly common unless prohibit$4 7,d7 ,^! agreem5ts result 9 consum]s los+ ! b5efits t ! #aihd ,act 0 int5d$ to provide4 7b7 ,purposes ,! purposes ( ?is ,act are-- 7#a7 to enhance competition 9 ! ph>maceutical m>ket by /opp+ anticompetitive agreem5ts betwe5 br& "n & g5]ic drug manufactur]s t limit1 delay1 or o!rwise prev5t competition f g5]ic drugs2 & 7#b7 to support ! purpose & int5t ( antitru/ law by prohibit+ anticompetitive practices 9 ! ph>maceutical indu/ry t h>m consum]s4 #c4 ,unlawful comp5sation = delay ,! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #dd et seq47 is am5d$ by-- 7#a7 r$esignat+ section #bh z section #bi2 & 7#b7 ins]t+ be=e section #bi1 z r$esignat$1 ! foll[+3 #bh4 ,pres]v+ access to af=dable g5]ics 7a7 ,9 g5]al 7#a7 ,en=cem5t proce$+ ,! ,f$]al ,trade ,commission may initiate a proce$+ to en=ce ! provisions ( ?is section aga9/ ! p>ties to any agreem5t resolv+ or settl+1 on a f9al or int]im basis1 a pat5t infr+em5t claim1 9 connection ) ! sale ( a drug product4 7#b7 ,presumption 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 9 su* a proce$+1 an agreem5t %all be presum$ to h anticompetitive effects & be unlawful if-- 7i7 an ,,&a fil] receives any?+ ( value2 & 7ii7 ! ,,&a fil] agrees to limit or =ego rese>*1 developm5t1 manufactur+1 m>ket+1 or sales ( ! ,,&a product = any p]iod ( "t4 7,b7 ,exception ,! presumption 9 subp>agraph 7,a7 %all n apply if ! p>ties to su* agreem5t demon/rate by cle> & conv9c+ evid5ce t ! procompetitive b5efits ( ! agreem5t outweigh ! anticompetitive effects ( ! agreem5t4 7b7 ,competitive factors ,9 det]m9+ :e!r ! settl+ p>ties h met _! burd5 "u subsection 7a77#b77;,b71 ! fact f9d] %all consid]-- 7#a7 ! l5g? ( "t rema9+ until ! end ( ! life ( ! relevant pat5t1 comp>$ ) ! agre$ ^u entry date = ! ,,&a product2 7#b7 ! value to consum]s ( ! competition f ! ,,&a product all[$ "u ! agreem5t2 7#c7 ! =m & am\nt ( consid]ation receiv$ by ! ,,&a fil] 9 ! agreem5t resolv+ or settl+ ! pat5t infr+em5t claim2 7#d7 ! rev5ue ! ,,&a fil] w\ld h receiv$ by w9n+ ! pat5t litigation2 7#e7 ! r$uction 9 ! ,,nda hold]'s rev5ues if x _h lo/ ! pat5t litigation2 7#f7 ! "t p]iod betwe5 ! date ( ! agreem5t convey+ value to ! ,,&a fil] & ! date ( ! settlem5t ( ! pat5t infr+em5t claim2 & 7#g7 any o!r factor t ! fact f9d]1 9 its discretion1 deems relevant to its det]m9ation ( competitive effects "u ?is subsection4 7c7 ,limitations ,9 det]m9+ :e!r ! settl+ p>ties h met _! burd5 "u subsection 7a77#b77;,b71 ! fact f9d] %all n presume-- 7#a7 t entry w\ld n h occurr$ until ! expiration ( ! relevant pat5t or /atutory exclusivity2 or 7#b7 t ! agreem5t's provision = entry ( ! ,,&a product prior to ! expiration ( ! relevant pat5t or /atutory exclusivity means t ! agreem5t is pro-competitive1 al?\gh su* evid5ce may be relevant to ! fact f9d]'s det]m9ation "u ?is section4 7d7 ,exclusions ,no?+ 9 ?is section %all prohibit a resolution or settlem5t ( a pat5t infr+em5t claim 9 :i* ! consid]ation grant$ by ! ,,nda hold] to ! ,,&a fil] z "p ( ! resolution or settlem5t includes only "o or m ( ! foll[+3 7#a7 ,! "r to m>ket ! ,,&a product 9 ! ,unit$ ,/ates prior to ! expiration (-- 7,a7 any pat5t t is ! basis = ! pat5t infr+em5t claim2 or 7,b7 any pat5t "r or o!r /atutory exclusivity t w\ld prev5t ! m>ket+ ( su* drug4 7#b7 ,a paym5t = reasonable litigation exp5ses n to exce$ #g1ejj1jjj4 7#c7 ,a cov5ant n to sue on any claim t ! ,,&a product infr+es a ,unit$ ,/ates pat5t4 7e7 ,regulations & en=cem5t 7#a7 ,regulations ,! ,f$]al ,trade ,commission may issue1 9 accordance ) section #eec ( title #e1 ,unit$ ,/ates ,code1 regulations implem5t+ & int]pret+ ?is section4 ,^! regulations may exempt c]ta9 types ( agreem5ts describ$ 9 subsection 7a7 if ! ,commission det]m9es su* agreem5ts w fur!r m>ket competition & b5efit consum]s4 ,judicial review ( any su* regulation %all be 9 ! ,unit$ ,/ates ,di/rict ,c\rt = ! ,di/rict ( ,columbia pursuant to section #gjf ( title #e1 ,unit$ ,/ates ,code4 7#b7 ,en=cem5t ,a violation ( ?is section %all be treat$ z a violation ( section #e4 7#c7 ,judicial review ,any p]son1 p>tn]%ip or corporation t is subject to a f9al ord] ( ! ,commission1 issu$ 9 an adm9i/rative adjudicative proce$+ "u ! au?ority ( subsection 7a77#a71 may1 )9 #cj days ( ! issuance ( su* ord]1 petition = review ( su* ord] 9 ! ,unit$ ,/ates ,c\rt ( ,appeals = ! ,di/rict ( ,columbia ,circuit or ! ,unit$ ,/ates ,c\rt ( ,appeals = ! circuit 9 :i* ! ultimate p>5t entity1 z def9$ at #af ,,cfr #hja4a7;a77#c71 ( ! ,,nda hold] is incorporat$ z ( ! date t ! ,,nda is fil$ ) ! ,secret>y ( ! ,food & ,drug ,adm9i/ration1 or ! ,unit$ ,/ates ,c\rt ( ,appeals = ! circuit 9 :i* ! ultimate p>5t entity ( ! ,,&a fil] is incorporat$ z ( ! date t ! ,,&a is fil$ ) ! ,secret>y ( ! ,food & ,drug ,adm9i/ration4 ,9 su* a review proce$+1 ! f9d+s ( ! ,commission z to ! facts1 if support$ by evid5ce1 %all be conclusive4 7f7 ,antitru/ laws ,no?+ 9 ?is section %all be con/ru$ to modify1 impair or sup]s$e ! applicability ( ! antitru/ laws z def9$ 9 subsection 7a7 ( ! #a/ section ( ! ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a77 & ( section #e ( ?is ,act to ! ext5t t section #e applies to unfair me?ods ( competition4 ,no?+ 9 ?is section %all modify1 impair1 limit or sup]s$e ! "r ( an ,,&a fil] to ass]t claims or c\nt]claims aga9/ any p]son1 "u ! antitru/ laws or o!r laws relat+ to unfair competition4 7g7 ,p5alties 7#a7 ,=feiture ,ea* p]son1 p>tn]%ip or corporation t violates or assi/s 9 ! violation ( ?is section %all =feit & pay to ! ,unit$ ,/ates a civil p5alty suffici5t to det] violations ( ?is section1 b 9 no ev5t great] ?an #c times ! value receiv$ by ! p>ty t is reasonably attributable to a violation ( ?is section4 ,if no su* value has be5 receiv$ by ! ,,nda hold]1 ! p5alty to ! ,,nda hold] %all be suffici5t to det] violations1 b 9 no ev5t great] ?an #c times ! value giv5 to ! ,,&a fil] reasonably attributable to ! violation ( ?is section4 ,su* p5alty %all accrue to ! ,unit$ ,/ates & may be recov]$ 9 a civil action br\ght by ! ,f$]al ,trade ,commission1 9 its own "n by any ( its attorneys designat$ by x = su* purpose1 9 a di/rict c\rt ( ! ,unit$ ,/ates aga9/ any p]son1 p>tn]%ip or corporation t violates ?is section4 ,9 su* actions1 ! ,unit$ ,/ates di/rict c\rts are emp[]$ to grant m&atory injunctions & su* o!r & fur!r equitable relief z !y deem appropriate4 7#b7 ,cease & desi/ 7,a7 ,9 g5]al ,if ! ,commission has issu$ a cease & desi/ ord] ) respect to a p]son1 p>tn]%ip or corporation 9 an adm9i/rative adjudicative proce$+ "u ! au?ority ( subsection 7a77#a71 an action br\ght pursuant to p>agraph 7#a7 may be comm5c$ aga9/ su* p]son1 p>tn]%ip or corporation at any "t be=e ! expiration ( "o ye> aft] su* ord] becomes f9al pursuant to section #e7;g74 7,b7 ,exception ,9 an action "u subp>agraph 7,a71 ! f9d+s ( ! ,commission z to ! mat]ial facts 9 ! adm9i/rative adjudicative proce$+ ) respect to su* p]son's1 p>tn]%ip's or corporation's violation ( ?is section %all be conclusive unless-- 7i7 ! t]ms ( su* cease & desi/ ord] expressly provide t ! ,commission's f9d+s %all n be conclusive2 or 7ii7 ! ord] became f9al by reason ( section #e7;g77#a71 9 :i* case su* f9d+ %all be conclusive if support$ by evid5ce4 7#c7 ,civil p5alty ,9 det]m9+ ! am\nt ( ! civil p5alty describ$ 9 ?is section1 ! c\rt %all take into acc\nt-- 7,a7 ! nature1 circum/ances1 ext5t1 & gravity ( ! violation2 7,b7 ) respect to ! violator1 ! degree ( culpability1 any hi/ory ( violations1 ! ability to pay1 any effect on ! ability to cont9ue do+ bus9ess1 pr(its e>n$ by ! ,,nda hold]1 comp5sation receiv$ by ! ,,&a fil]1 & ! am\nt ( comm]ce affect$2 & 7,c7 o!r matt]s t ju/ice requires4 7#d7 ,rem$ies 9 addition ,rem$ies provid$ 9 ?is subsection are 9 addition to1 & n 9 lieu (1 any o!r rem$y provid$ by ,f$]al law4 ,no?+ 9 ?is p>agraph %all be con/ru$ to affect any au?ority ( ! ,commission "u any o!r provision ( law4 7h7 ,def9itions ,9 ?is section3 7#a7 ,agreem5t ,! t]m agreem5t means any?+ t w\ld con/itute an agreem5t "u section #a ( ! ,%]man ,act 7#ae ,u4,s4,c4 #a7 or section #e ( ?is ,act4 7#b7 ,agreem5t resolv+ or settl+ a pat5t infr+em5t claim ,! t]m agreem5t resolv+ or settl+ a pat5t infr+em5t claim includes any agreem5t t is ent]$ into )9 #cj days ( ! resolution or ! settlem5t ( ! claim1 or any o!r agreem5t t is cont+5t ^u1 provides a cont+5t condition =1 or is o!rwise relat$ to ! resolution or settlem5t ( ! claim4 7#c7 ,,&a ,! t]m ,,&a means an abbreviat$ new drug application1 z def9$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j774 7#d7 ,,&a fil] ,! t]m ,,&a fil] means a p>ty :o has fil$ an ,,&a ) ! ,food & ,drug ,adm9i/ration4 7#e7 ,,&a product ,! t]m ,,&a product means ! product to be manufactur$ "u ! ,,&a t is ! subject ( ! pat5t infr+em5t claim4 7#f7 ,drug product ,! t]m drug product means a f9i%$ dosage =m 7e4g41 tablet1 capsule1 or solution7 t conta9s a drug sub/ance1 g5]ally1 b n necess>ily1 9 association ) #a or m o!r +r$i5ts1 z def9$ 9 section #cad4c7;b7 ( title #ba1 ,code ( ,f$]al ,regulations4 7#g7 ,,nda ,! t]m ,,nda means a new drug application1 z def9$ "u section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b774 7#h7 ,,nda hold] ,! t]m ,,nda hold] means-- 7,a7 ! p>ty t receiv$ ,,fda approval to m>ket a drug product pursuant to an ,,nda2 7,b7 a p>ty own+ or controll+ en=cem5t ( ! pat5t li/$ 9 ! ,approv$ ,drug ,products ,) ,!rapeutic ,equival5ce ,evaluations 7commonly kn[n z ! ,,fda ,orange ,book7 9 connection ) ! ,,nda2 or 7,c7 ! pr$ecessors1 subsidi>ies1 divisions1 gr\ps1 & affiliates controll$ by1 controll+1 or "u common control ) any ( ! entities describ$ 9 subp>agraphs 7,a7 & 7,b7 7su* control to be presum$ by direct or indirect %>e own]%ip ( #ej p]c5t or great]71 z well z ! lic5sees1 lic5sors1 successors1 & assigns ( ea* ( ! entities4 7#i7 ,pat5t infr+em5t ,! t]m pat5t infr+em5t means infr+em5t ( any pat5t or ( any fil$ pat5t application1 ext5sion1 reissue1 r5ewal1 division1 cont9uation1 cont9uation 9 "p1 reexam9ation1 pat5t t]m re/oration1 pat5ts ( addition & ext5sions !re(4 7#aj7 ,pat5t infr+em5t claim ,! t]m pat5t infr+em5t claim means any allegation made to an ,,&a fil]1 :e!r or n includ$ 9 a compla9t fil$ ) a c\rt ( law1 t its ,,&a or ,,&a product may infr+e any pat5t held by1 or exclusively lic5s$ to1 ! ,,nda hold] ( ! drug product4 7#aa7 ,/atutory exclusivity ,! t]m /atutory exclusivity means ^? prohibitions on ! approval ( drug applications "u clauses 7ii7 ?r\gh 7iv7 ( section #eje7;c77#c77;,e7 7#e- & #c-ye> data exclusivity71 section #ebg 7orphan drug exclusivity71 or section #eje;,a 7p$iatric exclusivity7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act4 4 #d4 ,notice & c]tification ( agreem5ts 7a7 ,notice ( all agreem5ts ,section #aaab7;c77#b7 ( ! ,m$ic>e ,prescription ,drug1 ,improvem5t1 & ,mod]nization ,act ( #bjjc 7#ba ,u4,s4,c4 #cee note7 is am5d$ by-- 7#a7 /rik+ ! ,commission ! & ins]t+ ! foll[+3 8! ,commission-- 7#a7 ! 2 7#b7 /rik+ ! p]iod & ins]t+ 2 &2 & 7#c7 ins]t+ at ! end ! foll[+3 7#b7 any o!r agreem5t ! p>ties ent] into )9 #cj days ( ent]+ into an agreem5t cov]$ by subsection 7a7 or 7b74 4 7b7 ,c]tification ( agreem5ts ,section #aaab ( su* ,act is am5d$ by add+ at ! end ! foll[+3 7d7 ,c]tification ,! ,*ief ,executive ,(fic] or ! company (ficial responsible = negotiat+ any agreem5t requir$ to be fil$ "u subsection 7a71 7b71 or 7c7 %all execute & file ) ! ,assi/ant ,attorney ,g5]al & ! ,commission a c]tification z foll[s3 ,i decl>e t ! foll[+ is true1 correct1 & complete to ! be/ ( my k3 ,! mat]ials fil$ ) ! ,f$]al ,trade ,commission & ! ,dep>tm5t ( ,ju/ice "u section #aaab ( subtitle ,b ( title ,,xi ( ! ,m$ic>e ,prescription ,drug1 ,improvem5t1 & ,mod]nization ,act ( #bjjc1 ) respect to ! agreem5t ref]5c$ 9 ?is c]tification3 7#a7 repres5t ! complete1 f9al1 & exclusive agreem5t betwe5 ! p>ties2 7#b7 include any ancill>y agreem5ts t are cont+5t ^u1 provide a cont+5t condition =1 or are o!rwise relat$ to1 ! ref]5c$ agreem5t2 & 7#c7 include writt5 descriptions ( any oral agreem5ts1 repres5tations1 commitm5ts1 or promises betwe5 ! p>ties t are responsive to subsection 7a7 or 7b7 ( su* section #aaab & h n be5 r$uc$ to writ+44 4 #e4 ,=feiture ( #ahj-;day exclusivity p]iod ,section #eje7;j77#e77;,d77i77,v7 ( ! ,f$]al ,food1 ,drug & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,d77i77,v77 is am5d$ by ins]t+ section #bh ( ! ,f$]al ,trade ,commission ,act or aft] t ! agreem5t has violat$4 #f4 ,commission litigation au?ority ,section #af7;a77#b7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #ef7;a77#b77 is am5d$-- 7#a7 9 subp>agraph 7,d71 by /rik+ or aft] ! semicolon2 7#b7 9 subp>agraph 7,e71 by ins]t+ or aft] ! semicolon2 & 7#c7 ins]t+ aft] subp>agraph 7,e7 ! foll[+3 7,f7 "u section #bh2 4 #g4 ,/atute ( limitations ,! ,commission %all comm5ce any en=cem5t proce$+ describ$ 9 section #bh ( ! ,f$]al ,trade ,commission ,act1 z add$ by section #c1 except = an action describ$ 9 section #bh7;g77#b7 ( ! ,f$]al ,trade ,commission ,act1 n lat] ?an #c ye>s aft] ! date on :i* ! p>ties to ! agreem5t file ! ,notice ( ,agreem5t z provid$ by sections #aaab7;c77#b7 & 7d7 ( ! ,m$ic>e ,prescription ,drug ,improvem5t & ,mod]nization ,act ( #bjjc 7#ba ,u4,s4,c4 #cee note74 #h4 ,sev]ability ,if any provision ( ?is ,act1 an am5dm5t made by ?is ,act1 or ! application ( su* provision or am5dm5t to any p]son or circum/ance is held to be uncon/itutional1 ! rema9d] ( ?is ,act1 ! am5dm5ts made by ?is ,act1 & ! application ( ! provisions ( su* ,act or am5dm5ts to any p]son or circum/ance %all n be affect$ !reby4