,,ii  #aah? ,,congress  #a/ ,session    
,s4 #aej  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,janu>y #cj1 #bjbc ,mr4
 ,cornyn 7= himself1 ,mr4 ,blum5?al1    
,mr4 ,grassley1 ,mr4 ,durb91 ,mr4 ,cruz1
 & ,ms4 ,klobu*>7 introduc$ ! foll[+    
bill2 :i* 0 read twice & ref]r$ to !    
,committee on ! ,judici>y  ,a ,,bill    
,to am5d ! ,f$]al ,trade ,commission    
,act to prohibit product hopp+1 & = o!r 
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,af=dable ,prescriptions = 
,pati5ts ,act ( #bjbc4  #b4 ,product    
hopp+  7a7 ,9 g5]al ,! ,f$]al ,trade    
,commission ,act 7#ae ,u4,s4,c4 #da et  
seq47 is am5d$ by ins]t+ aft] section   
#bf 7#ae ,u4,s4,c4 #eg;c-#b7 ! foll[+3  
#bg4 ,product hopp+  7a7 ,def9itions ,9 
?is section3 7#a7 ,abbreviat$ new drug  
application ,! t]m abbreviat$ new drug  
application means any application "u    
subsection 7j7 ( section #eje ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee7 or an application "u    
subsection 7b77#b7 ( su* section #eje t 

seeks a !rapeutic equival5ce rat+ to !  
ref]5ce product4  7#b7 ,biosimil>       
biological product ,! t]m biosimil>     
biological product means a biological   
product lic5s$ "u section #cea7k7 ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7k774  7#c7 ,biosimil>    
biological product lic5se application ,!
 t]m biosimil> biological product lic5se
 application means an application       
submitt$ "u section #cea7k7 ( ! ,public 
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7k774  7#d7 ,foll[-on product ,! t]m
 foll[-on product-- 7,a7 means a drug   
approv$ ?r\gh an application or         
supplem5t to an application submitt$ "u 
section #eje7;b7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;b77 or a biological product lic5s$
 ?r\gh an application or supplem5t to an
 application submitt$ "u section        
#cea7;a7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;a77 = a *ange or  
modification to1 or re=mulation (1 !    
same manufactur]'s previ\sly approv$    

drug or biological product t has an     
indication t is id5tical or sub/antively
 simil> to an indication ( ! same       
manufactur]'s previ\sly approv$ drug or 
biological product2 &  7,b7 excludes su*
 an application or supplem5t to an      
application = a *ange1 modification1 or 
re=mulation ( a drug or biological      
product t is reque/$ by ! ,secret>y or  
necess>y to comply ) law1 includ+       
sections #eje;,a & #eje;,b ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee;a1 #cee;c74  7#e7 ,g5]ic 
drug ,! t]m g5]ic drug means any drug   
approv$ "u an application submitt$ "u   
subsection 7j7 ( section #eje ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee7 or an application "u    
subsection 7b77#b7 ( su* section #eje t 
seeks a !rapeutic equival5ce rat+ to !  
ref]5ce product4  7#f7 ,li/$ drug ,! t]m
 li/$ drug means a drug li/$ "u section 
#eje7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7;j77#g774  7#g7 ,manufactur] ,! t]m

 manufactur] means ! hold]1 lic5see1 or 
assignee (--  7,a7 an approv$           
application = a drug "u section #eje7;c7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee7;c772 or  7,b7 
a biological product lic5se "u section  
#cea7;a7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;a774  7#h7        
,ref]5ce product ,! t]m ref]5ce product 
has ! mean+ giv5 ! t]m 9 section        
#cea7;i7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;i774  7#i7        
,ultimate p>5t entity ,! t]m ultimate   
p>5t entity has ! mean+ giv5 ! t]m 9    
section #hja4a ( title #af1 ,code (     
,f$]al ,regulations1 or any successor   
regulation4  7b7 ,prohibition on product
 hopp+  7#a7 ,prima facie ,a manufactur]
 ( a ref]5ce product or li/$ drug %all  
be consid]$ to h engag$ 9 an unfair     
me?od ( competition 9 or affect+ comm]ce
 9 violation ( section #e7;a7 if        
compla9t c\nsel or ! ,commission        
demon/rates 9 an action or proce$+      
initiat$ by ! ,commission "u subsection 

7c7 t1 dur+ ! p]iod beg9n+ on ! date on 
:i* ! manufactur] ( ! ref]5ce product or
 li/$ drug fir/ receives notice t an    
applicant has submitt$ to ! ,commission]
 ( ,food & ,drugs an abbreviat$ new drug
 application or biosimil> biological    
product lic5se application ref]5c+ !    
ref]5ce product or li/$ drug & end+ on !
 date t is ! e>li] ( #ahj days aft] !   
date on :i* ! g5]ic drug or biosimil>   
biological product t is ! subject ( !   
abbreviat$ new drug application or      
biosimil> biological product lic5se     
application or ano!r g5]ic drug or      
biosimil> biological product ref]5c+ !  
li/$ drug or ref]5ce product is fir/    
m>ket$ or #c ye>s aft] ! date on :i* !  
foll[-on product is fir/ m>ket$1 !      
manufactur] engag$ 9 ei!r ( ! foll[+    
actions3 7,a7 ,! manufactur] engag$ 9 a 
h>d swit*1 :i* %all be e/abli%$ by      
demon/rat+ t ! manufactur] engag$ 9 ei!r
 ( ! foll[+ actions3  7i7 ,^u ! reque/ (
 ! manufactur] ( ! li/$ drug or ref]5ce 
product1 ! ,commission] ( ,food & ,drugs

 )drew ! approval ( ! application = !   
li/$ drug or ref]5ce product or plac$ ! 
li/$ drug or ref]5ce product on !       
discont9u$ products li/ & ! manufactur] 
m>ket$ or sold a foll[-on product4  7ii7
 ,! manufactur] ( ! li/$ drug or ref]5ce
 product--  7,i7  7aa7 )drew1 discont9u$
 ! manufacture (1 or ann\nc$ )drawal (1 
discont9uance ( ! manufacture (1 or     
int5t to )draw ! application ) respect  
to ! drug or ref]5ce product 9 a mann] t
 imp$es competition f a g5]ic drug or a 
biosimil> biological product1 :i* may be
 e/abli%$ by objective circum/ances1    
unless su* actions 7 tak5 by !          
manufactur] pursuant to a reque/ ( !    
,commission] ( ,food & ,drugs2 or  7bb7 
de/roy$ ! inv5tory ( ! li/$ drug or     
ref]5ce product 9 a mann] t imp$es      
competition f a g5]ic drug or a         
biosimil> biological product1 :i* may be
 e/abli%$ by objective circum/ances2 &  
7,,ii7 m>ket$ or sold a foll[-on        
product4  7,b7 ,! manufactur] engag$ 9 a
 s(t swit*1 :i* %all be e/abli%$ by     

demon/rat+ t ! manufactur] engag$ 9 bo? 
( ! foll[+ actions3  7i7 ,! manufactur] 
took actions ) respect to ! li/$ drug or
 ref]5ce product o!r ?an ^? describ$ 9  
subp>agraph 7,a7 t unfairly disadvantage
 ! li/$ drug or ref]5ce product relative
 to ! foll[-on product describ$ 9 clause
 7ii7 9 a mann] t imp$es competition f a
 g5]ic drug or a biosimil> biological   
product1 :i* may be e/abli%$ by         
objective circum/ances4  7ii7 ,!        
manufactur] m>ket$ or sold a foll[-on   
product4  7#b7 ,exclusions ,no?+ 9 ?is  
section %all prohibit actions t consi/  
solely (-- 7,a7 tru?ful1 non-mislead+   
promotional m>ket+2 or  7,b7 ceas+      
promotional m>ket+ = ! li/$ drug or     
ref]5ce product4  7#c7 ,ju/ification    
7,a7 ,9 g5]al ,subject to p>agraph 7#d71
 ! actions describ$ 9 p>agraph 7#a7 by a
 manufactur] ( a li/$ drug or ref]5ce   
product %all n be consid]$ to be an     
unfair me?od ( competition 9 or affect+ 
comm]ce if ! manufactur] demon/rates to 
! ,commission or a di/rict c\rt ( !     

,unit$ ,/ates1 z applicable1 9 an       
action1 suit or proce$+ initiat$ by !   
,commission "u subsection 7c77#a7 t--   
7i7 ! manufactur] w\ld h tak5 ! actions 
reg>dless ( :e!r a g5]ic drug t ref]5ces
 ! li/$ drug or biosimil> biological    
product t ref]5ces ! ref]5ce product _h 
already ent]$ ! m>ket2 &  7ii7 7,i7 )   
respect to a h>d swit* "u p>agraph      
7#a77;,a71 ! manufactur] took ! action =
 reasons relat+ to ! safety risk to     
pati5ts ( ! li/$ drug or ref]5ce        
product2  7,,ii7 ) respect to an action 
describ$ 9 p>agraph                     
7#a77;,a77ii77,i77aa71 !re is a supply  
disruption t-- 7aa7 is outside ( !      
control ( ! manufactur]2  7bb7 prev5ts !
 production or di/ribution ( !          
applicable li/$ drug or ref]5ce product2
 &  7cc7 _c be rem$i$ by reasonable     
ef=ts2 or  7,,iii7 ) respect to a s(t   
swit* "u p>agraph 7#a77;,b71 !          
manufactur] _h legitimate               
pro-competitive reasons1 ap>t f !       
f9ancial effects ( r$uc$ competition1 to

 take ! action4  7,b7 ,rule (           
con/ruction ,no?+ 9 subp>agraph 7,a7 may
 be con/ru$ to limit ! in=mation t !    
,commission may o!rwise obta9 9 any     
proce$+ or action in/itut$ ) respect to 
a violation ( ?is section4  7#d7        
,response ,) respect to a ju/ification  
(f]$ by a manufactur] "u p>agraph 7#c71 
! ,commission may-- 7,a7 rebut any      
evid5ce pres5t$ by a manufactur] dur+ t 
ju/ification2 or  7,b7 e/abli% by a     
prepond]ance ( ! evid5ce t-- 7i7 on     
balance1 ! pro-competitive b5efits f !  
conduct describ$ 9 subp>agraph 7,a7 or  
7,b7 ( p>agraph 7#a71 z applicable1 d n 
outweigh any anticompetitive effects ( !
 conduct1 ev5 9 consid]ation ( !        
ju/ification s (f]$2 or  7ii7  7,i7 !   
conduct describ$ 9 p>agraph 7#a7 is n   
reasonably necess>y to address or a*ieve
 ! ju/ifications describ$ 9 clause 7ii7 
( p>agraph 7#c77;,a72 or  7,,ii7 !      
ju/ifications describ$ 9 clause 7ii7 (  
p>agraph 7#c77;,a7 c\ld be reasonably   
address$ or a*iev$ ?r\gh less           

anticompetitive means4  7c7 ,en=cem5t   
7#a7 ,9 g5]al ,if ! ,commission has     
reason to believe t any manufactur] has 
violat$1 is violat+1 or is ab\t to      
violate ?is section1 or a rule          
promulgat$ "u ?is section1 ! ,commission
 may take any ( ! foll[+ actions3 7,a7  
,in/itute a proce$+ "u section #e7;b74  
7,b7 ,9 ! same mann] & to ! same ext5t z
 provid$ 9 section #ac7;b71 br+ suit 9 a
 di/rict c\rt ( ! ,unit$ ,/ates to      
tempor>ily enjo9 ! action ( !           
manufactur]4  7,c7 ,br+ suit 9 a di/rict
 c\rt ( ! ,unit$ ,/ates1 9 :i* !        
,commission may seek--  7i7 to p]man5tly
 enjo9 ! action ( ! manufactur]2  7ii7  
any ( ! rem$ies describ$ 9 p>agraph     
7#c72 &  7iii7 any o!r equitable rem$y1 
includ+ ancill>y equitable relief4  7#b7
 ,judicial review  7,a7 ,9 g5]al        
,not)/&+ any provision ( section #e1 any
 manufactur] t is subject to a f9al     
cease & desi/ ord] issu$ 9 a proce$+ to 
en=ce ?is section1 or a rule promulgat$ 
"u ?is section1 may1 n lat] ?an #cj days

 aft] ! date on :i* ! ,commission issues
 ! ord]1 petition = review ( ! ord] 9-- 
7i7 ! ,unit$ ,/ates ,c\rt ( ,appeals = !
 ,di/rict ( ,columbia ,circuit2 or  7ii7
 ! c\rt ( appeals ( ! ,unit$ ,/ates = ! 
circuit 9 :i* ! ultimate p>5t entity ( !
 manufactur] is incorporat$4  7,b7      
,treatm5t ( f9d+s ,9 a review ( a f9al  
cease & desi/ ord] conduct$ by a c\rt ( 
appeals ( ! ,unit$ ,/ates "u subp>agraph
 7,a71 ! factual f9d+s ( ! ,commission  
%all be conclusive if ^? facts are      
support$ by ! evid5ce4  7#c7 ,equitable 
rem$ies  7,a7 ,disgorgem5t  7i7 ,9 g5]al
 ,9 a suit br\ght "u p>agraph 7#a77;,c71
 ! ,commission may seek1 & ! c\rt may   
ord]1 disgorgem5t ( any unju/ enri*m5t t
 a p]son obta9$ z a result ( ! violation
 t gives rise to ! suit4  7ii7          
,calculation ,any disgorgem5t t is ord]$
 ) respect to a p]son "u clause 7i7 %all
 be (fset by any am\nt ( re/itution     
ord]$ "u subp>agraph 7,b74  7iii7       
,limitations p]iod ,! ,commission may   
seek disgorgem5t "u ?is subp>agraph n   

lat] ?an #e ye>s aft] ! late/ date on   
:i* ! p]son f :i* ! disgorgem5t is s\ght
 receives any unju/ enri*m5t f ! effects
 ( ! violation t gives rise to ! suit 9 
:i* ! ,commission seeks ! disgorgem5t4  
7,b7 ,re/itution  7i7 ,9 g5]al ,9 a suit
 br\ght "u p>agraph 7#a77;,c71 !        
,commission may seek1 & ! c\rt may ord]1
 re/itution ) respect to ! violation t  
gives rise to ! suit4  7ii7 ,limitations
 p]iod ,! ,commission may seek          
re/itution "u ?is subp>agraph n lat] ?an
 #e ye>s aft] ! late/ date on :i* !     
p]son f :i* ! re/itution is s\ght       
receives any unju/ enri*m5t f ! effects 
( ! violation t gives rise to ! suit 9  
:i* ! ,commission seeks ! re/itution4   
7#d7 ,rules ( con/ruction ,no?+ 9 ?is   
subsection may be con/ru$ z-- 7,a7      
requir+ ! ,commission to br+ a suit     
seek+ a tempor>y injunction "u p>agraph 
7#a77;,b7 be=e br++ a suit seek+ a      
p]man5t injunction "u p>agraph          
7#a77;,c72 or  7,b7 affect+ ! au?ority (
 ! ,f$]al ,trade ,commission "u any o!r 

provision ( law4  4  7b7 ,applicability 
,section #bg ( ! ,f$]al ,trade          
,commission ,act1 z add$ by subsection  
7a71 %all apply ) respect to any--  7#a7
 conduct t occurs on or aft] ! date (   
enactm5t ( ?is ,act2 &  7#b7 action or  
proce$+ t is comm5c$ on or aft] ! date (
 enactm5t ( ?is ,act4  7c7 ,antitru/    
laws ,except to ! ext5t subsection 7a7  
e/abli%es an additional basis =         
liability "u ! ,f$]al ,trade ,commission
 ,act 7#ae ,u4,s4,c4 #da et seq471 no?+ 
9 ?is section1 or ! am5dm5ts made by ?is
 section1 %all modify1 impair1 limit1 or
 sup]s$e ! applicability ( ! antitru/   
laws z def9$ 9 subsection 7a7 ( ! fir/  
section ( ! ,clayton ,act 7#ae ,u4,s4,c4
 #ab71 or ( section #e ( ! ,f$]al ,trade
 ,commission ,act 7#ae ,u4,s4,c4 #de7 to
 ! ext5t t x applies to unfair me?ods ( 
competition4  7d7 ,rulemak+ ,! ,f$]al   
,trade ,commission may issue rules "u   
section #eec ( title #e1 ,unit$ ,/ates  
,code1 to def9e any t]ms us$ 9 section  
#bg ( ! ,f$]al ,trade ,commission ,act1 

z add$ by subsection 7a7 7o!r ?an t]ms t
 are def9$ 9 subsection 7a7 ( su*       
section #bg74  #c4 ,title #ce am5dm5ts  
7a7 ,9 g5]al ,section #bga7;e7 ( title  
#ce1 ,unit$ ,/ates ,code1 is am5d$--    
7#a7 9 p>agraph 7#b77;,c71 9 ! flu% text
 foll[+ clause 7ii71 by add+ at ! end ! 
foll[+3 ,) respect to a submission      
describ$ 9 clause 7ii71 ! act (         
infr+em5t %all ext5d to any pat5t t     
claims ! biological product1 a me?od (  
us+ ! biological product1 or a me?od or 
product us$ to manufacture ! biological 
product42 &  7#b7 by add+ at ! end !    
foll[+3  7#g7 7,a7 ,subject to          
subp>agraphs 7,c71 7,d71 & 7,e71 if !   
sponsor ( an approv$ application = a    
ref]5ce product1 z def9$ 9 section      
#cea7;i7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;i77 7ref]r$ to 9  
?is p>agraph z ! ref]5ce product        
sponsor71 br+s an action = infr+em5t "u 
?is section aga9/ an applicant =        
approval ( a biological product "u      
section #cea7k7 ( su* ,act t ref]5ces t 

ref]5ce product 7ref]r$ to 9 ?is        
p>agraph z ! subsection 7k7 applicant71 
! ref]5ce product sponsor may ass]t 9 ! 
action a total ( n m ?an #bj pat5ts ( ! 
type describ$ 9 subp>agraph 7,b71 n m   
?an #aj ( :i* %all h issu$ aft] ! date  
specifi$ 9 section #cea7l77#g77;,a7 (   
su* ,act4  7,b7 ,! pat5ts describ$ 9 ?is
 subp>agraph are pat5ts t satisfy ea* ( 
! foll[+ requirem5ts3 7i7 ,pat5ts t     
claim ! biological product t is !       
subject ( an application "u section     
#cea7k7 ( ! ,public ,heal? ,s]vice ,act 
7#db ,u4,s4,c4 #bfb7k77 7or a use ( t   
product7 or a me?od or product us$ 9 !  
manufacture ( su* biological product4   
7ii7 ,pat5ts t are includ$ on ! li/ (   
pat5ts describ$ 9 p>agraph 7#c77;,a7 (  
section #cea7l7 ( ! ,public ,heal?      
,s]vice ,act 7#db ,u4,s4,c4 #bfb7l771   
includ+ z provid$ "u p>agraph 7#g7 ( su*
 section #cea7l74  7iii7 ,pat5ts t--    
7,i7 h an actual fil+ date ( m ?an #d   
ye>s aft] ! date on :i* ! ref]5ce       
product is approv$2 or  7,,ii7 include a

 claim to a me?od 9 a manufactur+       
process t is n us$ by ! ref]5ce product 
sponsor4  7,c7 ,! c\rt 9 :i* an action  
describ$ 9 subp>agraph 7,a7 is br\ght   
may increase ! numb] ( pat5ts limit$ "u 
t subp>agraph-- 7i7 if ! reque/ to      
increase t numb] is made )\t undue      
delay2 &  7ii7  7,i7 if ! int]e/ (      
ju/ice s requires2 or  7,,ii7 = good    
cause %[n1 :i*--  7aa7 %all be e/abli%$ 
if ! subsection 7k7 applicant fails to  
provide in=mation requir$ section       
#cea7k77#b77;,a7 ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4             
#bfb7k77#b77;,a77 t w\ld enable !       
ref]5ce product sponsor to =m a         
reasonable belief ) respect to :e!r a   
claim ( infr+em5t "u ?is section c\ld   
reasonably be ass]t$2 &  7bb7 may be    
e/abli%$-- 7,,aa7 if !re is a mat]ial   
*ange to ! biological product 7or       
process ) respect to ! biological       
product7 ( ! subsection 7k7 applicant t 
is ! subject ( ! application2 7,,bb7 if1
 ) respect to a pat5t on ! supplem5tal  

li/ describ$ 9 section #cea7l77#g77;,a7 
( ,public ,heal? ,s]vice ,act 7#db      
,u4,s4,c4 #bfb7l77#g77;,a771 ! pat5t    
w\ld h issu$ be=e ! date specifi$ 9 su* 
section #cea7l77#g77;,a7 b = ! failure (
 ! ,(fice to issue ! pat5t or a delay 9 
! issuance ( ! pat5t1 z describ$ 9      
p>agraph 7#a7 ( section #aed7;b7 &      
subject to ! limitations "u p>agraph    
7#b7 ( su* section #aed7;b72 or 7,,cc7 =
 ano!r reason t %[s good cause1 z       
det]m9$ appropriate by ! c\rt4  7,d7 ,9 
det]m9+ :e!r good cause has be5 %[n = ! 
purposes ( subp>agraph 7,c77ii77,,ii71 a
 c\rt may consid] :e!r ! ref]5ce product
 sponsor has provid$ a reasonable       
description ( ! id5tity & relevance (   
any in=mation beyond ! subsection 7k7   
application t ! c\rt believes is        
necess>y to enable ! c\rt to =m a belief
 ) respect to :e!r a claim ( infr+em5t  
"u ?is section c\ld reasonably be       
ass]t$4  7,e7 ,! limitation impos$ "u   
subp>agraph 7,a7-- 7i7 %all apply only  
if ! subsection 7k7 applicant completes 

all actions requir$ "u p>agraphs        
7#b77;,a71 7#c77;,b77ii71 7#e71         
7#f77;,c77i71 7#g71 & 7#h77;,a7 (       
section #cea7l7 ( ! ,public ,heal?      
,s]vice ,act 7#db ,u4,s4,c4 #bfb7l772 & 
7ii7 %all n apply ) respect to any pat5t
 t claims1 ) respect to a biological    
product1 a me?od = us+ t product 9      
!rapy1 diagnosis1 or prophylaxis1 su* z 
an indication or me?od ( treatm5t or o!r
 condition ( use4  4  7b7 ,applicability
 ,! am5dm5ts made by subsection 7a7 %all
 apply ) respect to an application      
submitt$ "u section #cea7k7 ( ! ,public 
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7k77 on or aft] ! date ( enactm5t ( 
?is ,act4