,i #aaf? ,,congress #a/ ,session ,h4 ,r4 #acdd ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,febru>y #be1 #bjai,mr4 ,doggett 7= himself1 ,mr4 ,blum5au]1 ,mr4 ,c>twright1 ,ms4 ,judy ,*u ( ,cali=nia1 ,mr4 ,cumm+s1 ,ms4 ,de,lauro1 ,mr4 ,de,saulnier1 ,mr4 ,grijalva1 ,ms4 ,hill ( ,cali=nia1 ,ms4 ,kaptur1 ,mr4 ,khanna1 ,ms4 ,moore1 ,mrs4 ,napolitano1 ,ms4 ,ocasio-,cortez1 ,ms4 ,norton1 ,ms4 ,p+ree1 ,mr4 ,pocan1 ,ms4 ,wat]s1 ,mr4 ,wel*1 & ,mr4 ,langev97 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,ways & ,means1 & 9 addition to ! ,committees on ,en]gy & ,comm]ce1 & ! ,judici>y1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to prohibit br& "n drug companies f comp5sat+ g5]ic drug companies to delay ! entry ( a g5]ic drug into ! m>ket1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,competitive ,deals ,result+ 9 ,unlea%$ ,g5]ics & ,sav+s ,act ( #bjai or ! ,competitive ,,drugs ,act ( #bjai 4 #b4 ,clawback ( rese>* & developm5t tax b5efits = manufactur]s engag+ 9 pay-=-delay 7a7 ,9 g5]al ,section #da ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new subsection3 7i7 ,recapture 7#a7 ,9 g5]al ,if ! ,f$]al ,trade ,commission det]m9es "u section #bg ( ! ,f$]al ,trade ,commission ,act t ! taxpay] violat$ section #e ( su* ,act 9 connection ) ! sale ( a drug product 7z def9$ 9 su* section71 !n ! tax "u ?is *apt] = ! taxable ye> :i* includes ! date ( su* det]m9ation %all be increas$ by ! sum ( ! product = ea* ( ! #b relevant ye>s (-- 7,a7 ! aggregate decrease 9 ! cr$its all[$ "u section #ch = su* relevant ye> :i* w\ld h result$ solely f r$uc+ to z]o any cr$it det]m9$ "u ?is section1 multipli$ by 7,b7 ! sales ratio = su* drug product = su* relevant ye>4 7#b7 ,relevant ye> ,= purposes ( ?is subsection1 ! t]m relevant ye> means1 ) respect to any det]m9ation by ! ,f$]al ,trade ,commission describ$ 9 p>agraph 7#a71 a taxable ye> 9 :i* ! aggregate decrease 9 ! cr$its all[$ "u section #ch :i* w\ld h result$ solely f r$uc+ to z]o any cr$it det]m9$ "u ?is section is "o ( ! two highe/ su* decreases dur+ ! #aj-ye> p]iod end+ ) ! la/ taxable ye> t end$ be=e ! date ( su* det]m9ation4 7#c7 ,sales ratio ,= purposes ( ?is subsection1 ! t]m sales ratio means1 ) respect to a drug product sold by a taxpay] 9 a taxable ye>1 ! ratio (-- 7,a7 ! rev5ue f sales ( su* drug product by su* taxpay] dur+ su* taxable ye>1 to 7,b7 ! total rev5ue f sales ( all drug products by su* taxpay] dur+ su* taxable ye>4 7#d7 ,cons5t decrees deem$ to be violations ,if a taxpay] ent]s into a cons5t decree ) respect to any proce$+ initiat$ by ! ,f$]al ,trade ,commission "u section #bg ( ! ,f$]al ,trade ,commission ,act1 su* cons5t decree %all be treat$ = purposes ( ?is subsection z if ! ,commission _h det]m9$ "u su* section t ! taxpay] violat$ section #e ( su* ,act 9 connection ) ! sale ( ! drug product to :i* su* proce$+ relates4 7#e7 ,recapture n tak5 into acc\nt 9 det]m9+ maximum p5alty ,! increase 9 tax "u ?is subsection %all n be treat$ z a p5alty = purposes ( section #bg7;f7 ( ! ,f$]al ,trade ,commission ,act4 4 7b7 ,effective date ,! am5dm5t made by ?is section %all apply to taxable ye>s end+ aft] ! date ( ! enactm5t ( ?is ,act4 #c4 ,tax on receipt ( pay-=-delay paym5ts2 d5ial ( d$uction = pay-=-delay paym5ts 7a7 ,receipt ( paym5t ,! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ aft] *apt] #cf ! foll[+ new *apt]3 #cg ,pay-=-,delay ,sec4 #deja4 ,imposition ( tax4 #deja4 ,imposition ( tax ,!re is h]eby impos$1 on ea* taxpay] :o is p>ty to an agreem5t t is det]m9$ by ! ,f$]al ,trade ,commission "u section #bg ( ! ,f$]al ,trade ,commission ,act to be a violation ( section #e ( su* ,act1 a tax equal to #ej p]c5t ( ! am\nt paid to su* taxpay] "u su* agreem5t4 4 7b7 ,d5ial ( d$uction ,section #afb7;c7 is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#d7 ,pay-=-delay paym5ts ,no d$uction %all be all[$ "u subsection 7a7 = any paym5t "u an agreem5t t is det]m9$ by ! ,f$]al ,trade ,commission "u section #bg ( ! ,f$]al ,trade ,commission ,act to be a violation ( section #e ( su* ,act4 4 7c7 ,con=m+ am5dm5t ,! table ( *apt]s = ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ aft] ! item relat+ to *apt] #cf ! foll[+ new item3 ,*apt] #cg--,pay-=-,delay 4 #d4 ,unlawful comp5sation = delay 7a7 ,9 g5]al ,! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #dd et seq47 is am5d$ by ins]t+ aft] section #bf 7#ae ,u4,s4,c4 #eg;c-#b7 ! foll[+3 #bg4 ,pres]v+ access to af=dable g5]ics 7a7 ,9 g5]al 7#a7 ,en=cem5t proce$+ ,! ,commission may initiate a proce$+ 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 ,violation 7,a7 ,9 g5]al ,subject to subp>agraph 7,b71 9 su* a proce$+1 an agreem5t %all be an unfair me?od ( competition 9 or affect+ comm]ce & be a violation ( section #e if pursuant to ! agreem5t-- 7i7 an ,,&a fil] receives any?+ ( value1 includ+ an exclusive or non-exclusive lic5se1 an agreem5t reg>d+ ! m>ket+ ( a product1 or any o!r comm]cial opportunity or b5efit2 & 7ii7 ! ,,&a fil] agrees to limit or =go rese>*1 developm5t1 manufactur+1 m>ket+1 or sales ( ! ,,&a product = any p]iod ( "t4 7,b7 ,exception ,subp>agraph 7,a7 %all n apply if ! p>ties to su* agreem5t demon/rate by cle> & conv9c+ evid5ce t-- 7i7 ! value describ$ 9 subp>agraph 7,a77i7 is comp5sation solely = o!r goods or s]vices t ! ,,&a fil] has promis$ to provide2 or 7ii7 ! procompetitive b5efits ( ! agreem5t outweigh ! anticompetitive effects ( ! agreem5t4 7b7 ,limitations ,9 det]m9+ :e!r ! settl+ p>ties h met _! burd5 "u subsection 7a77#b77;,b71 ! fact f9d] may n presume-- 7#a7 t entry ( ! ,,&a product into int]/ate comm]ce w\ld n h occurr$ until ! expiration ( ! relevant pat5t or /atutory exclusivity2 or 7#b7 t ! agreem5t's provision = entry ( ! ,,&a product into int]/ate comm]ce prior to ! expiration ( ! relevant pat5t or /atutory exclusivity means t ! agreem5t is procompetitive4 7c7 ,exclusions ,no?+ 9 ?is section %all prohibit a resolution or settlem5t ( a pat5t infr+em5t claim 9 :i* ! consid]ation grant$ to ! ,,&a fil] z "p ( ! resolution or settlem5t includes "o or m ( ! foll[+ & no?+ else3 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 paym5t1 n to exce$ #g1ejj1jjj1 if bas$ on reasonable litigation exp5ses4 7#c7 ,a cov5ant n to sue 7includ+ any agreem5t to dismiss7 on any claim t ! ,,&a product infr+es a ,unit$ ,/ates pat5t4 7d7 ,judicial review 7#a7 ,9 g5]al ,any p>ty t is subject to a f9al ord] ( ! ,commission1 issu$ 9 an adm9i/rative adjudicative proce$+ "u ! au?ority ( subsection 7a77#a71 may1 )9 #cj days aft] ! issuance ( su* ord]1 petition = review ( su* ord] 9-- 7,a7 ! ,unit$ ,/ates ,c\rt ( ,appeals = ! ,di/rict ( ,columbia ,circuit2 or 7,b7 ! ,unit$ ,/ates ,c\rt ( ,appeals = ! circuit 9 :i* any p>ty subject to su* f9al ord] is incorporat$ on ! date t ! petition = review is fil$4 7#b7 ,treatm5t ( f9d+s ,9 a proce$+ = judicial review ( a f9al ord] ( ! ,commission1 ! f9d+s ( ! ,commission z to ! facts1 if support$ by evid5ce1 %all be conclusive4 7e7 ,con/ruction 7#a7 ,antitru/ laws & consum] protection laws ,no?+ 9 ?is section %all be con/ru$ to modify1 impair1 or sup]s$e ! op]ation (-- 7,a7 ! antitru/ laws z def9$ 9 subsection 7a7 ( ! fir/ section ( ! ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 or any ,/ate law sub/antially simil> to any ( su* antitru/ laws2 or 7,b7 section #e ( ?is ,act or any sub/antially simil> ,/ate law4 7#b7 ,claims & c\nt]claims ,no?+ 9 ?is section %all modify1 impair1 or sup]s$e ! "r ( an ,,&a fil] to ass]t a claim or c\nt]claim aga9/ any p]son "u any law ref]r$ to 9 p>agraph 7#a74 7f7 ,p5alties 7#a7 ,=feiture ,ea* p>ty t violates subsection 7a77#b77;,a7 %all =feit & pay to ! ,unit$ ,/ates a civil p5alty suffici5t to det] su* violation1 b 9 no ev5t great] ?an #c times ! value receiv$ by ! p>ty t is reasonably attributable to su* violation4 ,su* p5alty %all accrue to ! ,unit$ ,/ates & may be recov]$ 9 a civil action br\ght by ! ,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>ty t commits su* violation4 ,9 su* actions1 ! ,unit$ ,/ates di/rict c\rts are emp[]$ to grant m&atory injunctions & su* o!r & fur!r equitable relief z ! c\rts det]m9e to be appropriate4 7#b7 ,cease & desi/ 7,a7 ,9 g5]al ,if ! ,commission has issu$ a cease & desi/ ord] ) respect to a p>ty 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>ty at any "t be=e ! expiration ( #a 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$+ ) respect to a violation describ$ 9 subsection 7a77#b77;,a7 by a p>ty %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 ( ! violation1 includ+ ! am\nt ( comm]ce affect$2 7,b7 ) respect to ! violator1 9 addition to ! value receiv$1 ! degree ( culpability1 any hi/ory ( violations1 ! ability to pay1 & any effect on ! ability to cont9ue do+ bus9ess2 & 7,c7 o!r matt]s t ju/ice requires4 7#d7 ,rem$ies 9 addition ,rem$ies provid$ 9 ?is subsection are 9 addition to any o!r rem$y provid$ by ,f$]al or ,/ate law4 ,no?+ 9 ?is p>agraph %all be con/ru$ to affect any au?ority ( ! ,commission "u any o!r provision ( law4 7g7 ,def9itions ,9 ?is section3 7#a7 ,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 be=e or aft] ! resolution or ! settlem5t ( a pat5t infr+em5t claim1 or any o!r agreem5t t c be %[n to be cont+5t ^u1 to provide a cont+5t condition =1 or to be o!rwise relat$ to ! resolution or settlem5t ( ! claim4 7#b7 ,,&a ,! t]m ,,&a means an abbreviat$ new drug application fil$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 or a new drug application fil$ "u section #eje7;b77#b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#b774 7#c7 ,,&a fil] ,! t]m ,,&a fil] means a p>ty t owns or controls an ,,&a fil$ ) ! ,commission] ( ,food & ,drugs or has ! exclusive rights "u su* ,,&a to di/ribute ! ,,&a product4 7#d7 ,,&a product ,! t]m ,,&a product means ! product to be manufactur$ "u ! ,,&a t is ! subject ( ! pat5t infr+em5t claim4 7#e7 ,drug product ,! t]m drug product has ! mean+ giv5 su* t]m 9 section #cad4c7;b7 ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation74 7#f7 ,,nda ,! t]m ,,nda means a new drug application fil$ "u section #eje7;b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b774 7#g7 ,pat5t infr+em5t claim ,! t]m pat5t infr+em5t claim means any allegation made to an ,,&a fil]1 :e!r or n includ$ 9 a compla9t fil$ ) a c\rt1 t ! ,,&a fil]'s ,,&a or ,,&a product may infr+e any ( ! foll[+ held by1 or exclusively lic5s$ to1 ! ,,nda hold] ( ! drug product3 7,a7 ,any pat5t4 7,b7 ,any fil$ pat5t application4 7,c7 ,any ext5sion1 reissue1 r5ewal1 division1 cont9uation1 cont9uation 9 "p1 or reexam9ation ( a pat5t4 7,d7 ,any pat5t t]m re/oration1 pat5ts ( addition1 or ext5sions !re(4 7,e7 ,any o!r pat5t int]e/4 7#h7 ,/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 section #eje;,a 7p$iatric exclusivity71 or section #eje;,e 7qualifi$ infecti\s disease product exclusivity7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#c77;,e71 #cfj;cc1 #cee;a1 #cee;f74 4 7b7 ,applicability ,section #bg ( ! ,f$]al ,trade ,commission ,act1 z add$ by ?is section1 %all apply to any agreem5t describ$ 9 section #bg7;a77#b77;,a7 ( t ,act ent]$ into aft] ,june #ag1 #bjac4 ,section #bg7;f7 ( ! ,f$]al ,trade ,commission ,act1 z add$ by ?is section1 %all apply to agreem5ts ent]$ into on or aft] ! date ( enactm5t ( ?is ,act4 #e4 ,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 aft] 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 ) prim>y responsibility = negotiat+ any agreem5t "u subsection 7a7 or 7b7 t is requir$ to be fil$ "u subsection 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]tification-- 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+4 4 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 by ins]t+ aft] subp>agraph 7,e7 ! foll[+ new subp>agraph3 7,f7 "u section #bg2 4 #g4 ,/atute ( limitations ,! ,f$]al ,trade ,commission %all comm5ce any en=cem5t proce$+ describ$ 9 section #bg ( ! ,f$]al ,trade ,commission ,act1 z add$ by section #c1 except = an action describ$ 9 section #bg7;f77#b7 ( su* ,act1 n lat] ?an #f ye>s aft] ! date on :i* ! p>ties to ! agreem5t file ! o!r agreem5ts "u section #aaab7;c77#b7 or ! c]tification requir$ by section #aaab7;d7 ( ! ,m$ic>e ,prescription ,drug ,improvem5t & ,mod]nization ,act ( #bjjc 7#ba ,u4,s4,c4 #cee note74