,,ii ,cal5d> ,no4 #acj #aaf? ,,congress 
#a/ ,session  ,s4 #abbd  ,,9 ,,! ,,s5ate
 ,,( ,,! ,,unit$ ,,/ates  ,april #bi1   
#bjai,ms4 ,klobu*> 7= h]self & ,mr4     
,grassley7 introduc$ ! foll[+ bill2 :i* 
0 read twice & ref]r$ to ! ,committee on
 ! ,judici>y  ,june #bh 7legislative    
day1 ,june #bg71 #bjai,report$ by ,mr4  
,graham1 ) an am5dm5t & an am5dm5t to ! 
title,strike out all aft] ! enact+      
clause & ins]t ! "p pr9t$ 9 italic  ,a  
,,bill  ,to enable ! ,f$]al ,trade      
,commission to det] fil+ ( %am citiz5   
petitions to cov] an attempt to int]f]e 
) approval ( a compet+ g5]ic drug or    
biosimil>1 to fo/] competition1 &       
facilitate ! effici5t review ( petitions
 fil$ 9 good fai? to raise legitimate   
public hea? conc]ns1 & = o!r purposes4  
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,/op ,significant & ,"t-wa/+ ,abuse   
,limit+ ,legitimate ,innovation ( ,new  
,g5]ics ,act or ! ,/op ,,/all+ ,act4    
#b4 ,f$]al ,trade ,commission en=cem5t  
aga9/ %am petitions  7a7 ,def9itions ,9 

?is section3  7#a7 ,commission ,! t]m   
,commission means ! ,f$]al ,trade       
,commission4  7#b7 ,cov]$ application ,!
 t]m cov]$ application means an         
application fil$ pursuant to subsection 
7b77#b7 or 7j7 ( section #eje ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee7 or section #cea7k7 ( !  
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7k774  7#c7 ,cov]$        
petition ,! t]m cov]$ petition means a  
petition1 or a supplem5t to a petition1 
fil$ "u section #eje7q7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7q774  7#d7 ,p]son ,! t]m 
p]son-- 7,a7 means an individual or     
entity2 &  7,b7 includes-- 7i7 a        
director1 (fic]1 employee1 ag5t1        
repres5tative1 successor1 & assign ( an 
entity2  7ii7 a jo9t v5ture1 subsidi>y1 
p>tn]%ip1 division1 gr\p1 & affiliate   
controll$ by an entity2 &  7iii7 a      
director1 (fic]1 employee1 ag5t1        
repres5tative1 successor1 & assign ( a  
jo9t v5ture1 subsidi>y1 p>tn]%ip1       

division1 gr\p1 & affiliate controll$ by
 an entity4  7#e7 ,s]ies ( cov]$        
petitions ,! t]m s]ies ( cov]$ petitions
 means any gr\p ( m ?an #a cov]$        
petition4  7#f7 ,%am ,! t]m %am means a 
cov]$ petition t is objectively baseless
 & t attempts to use a gov]nm5tal       
process1 z oppos$ to ! outcome ( t      
process1 to int]f]e ) ! bus9ess ( a     
competitor1 or a s]ies ( cov]$ petitions
 t attempts to use a gov]nm5tal process1
 z oppos$ to ! outcome ( t process1 to  
int]f]e ) ! bus9ess ( a competitor4  7b7
 ,violation ,a p]son submitt+ or caus+ !
 submission ( a cov]$ petition or a     
s]ies ( cov]$ petitions t is a %am %all 
be liable = engag+ 9 an unfair me?od (  
competition "u section #e7;a77#a7 ( !   
,f$]al ,trade ,commission ,act 7#ae     
,u4,s4,c4 #de7;a77#a774  7c7 ,civil     
action  7#a7 ,9 g5]al ,if ! ,commission 
has reason to believe t ! submission ( a
 cov]$ petition or a s]ies ( cov]$      
petitions con/itutes a violation (      
section #e7;a77#a7 ( ! ,f$]al ,trade    

,commission ,act 7#ae ,u4,s4,c4         
#de7;a77#a771 ! ,commission may comm5ce 
a civil action to recov] a civil p5alty 
& seek o!r appropriate relief 9 a       
di/rict c\rt ( ! ,unit$ ,/ates aga9/ any
 p]son t submitt$ or caus$ to be        
submitt$ su* cov]$ petition or su* s]ies
 ( cov]$ petitions1 includ+ successors  
or assigns4  7#b7 ,presumption ,9 a     
civil action "u p>agraph 7#a71 a cov]$  
petition %all be presum$ to be "p ( a   
s]ies ( cov]$ petitions t is a %am "u   
subsection 7b7 ( ?is section if !       
,secret>y ( ,heal? & ,human ,s]vices has
 det]m9$ t ! cov]$ petition 0 submitt$ )
 ! prim>y purpose ( delay+ ! approval ( 
a cov]$ application & 0 "p ( a s]ies (  
cov]$ petitions1 & has ref]r$ su*       
det]m9ation to ! ,f$]al ,trade          
,commission 9 writ+1 ) a reason$ basis =
 ! det]m9ation4  7#c7 ,exception ,!     
presumption 9 p>agraph 7#b7 %all n apply
 if ! def5dant e/abli%es1 by a          
prepond]ance ( ! evid5ce1 t ! s]ies (   
cov]$ petitions t includes ! cov]$      

petition ref]r$ to ! ,commission by !   
,secret>y ( ,heal? & ,human ,s]vices is 
n a %am4  7#d7 ,civil p5alty ,9 an      
action "u p>agraph 7#a71 any p]son t has
 be5 f\nd liable = a violation ( section
 #e7;a77#a7 ( ! ,f$]al ,trade           
,commission ,act 7#ae ,u4,s4,c4         
#de7;a77#a77 %all be subject to a civil 
p5alty = ea* violation ( n m ?an !      
great] (--  7,a7 any rev5ue e>n$ f !    
sale by su* p]son ( any drug product1   
ref]5c$ 9 a cov]$ application t 0 !     
subject ( a cov]$ petition or a s]ies ( 
cov]$ petitions t is a %am1 dur+ ! p]iod
 9 :i* ! cov]$ petition or s]ies ( cov]$
 petitions 0 "u review by ! ,secret>y ( 
,heal? & ,human ,s]vices2 or  7,b7      
#ej1jjj = ea* cal5d> day t ea* cov]$    
petition t is a %am or t 0 "p ( a s]ies 
( cov]$ petitions t is a %am 0 "u review
 by ! ,secret>y ( ,heal? & ,human       
,s]vices4  7#e7 ,antitru/ laws ,no?+ 9  
?is section %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
 #ab7;a771 & ( section #e ( ! ,f$]al    
,trade ,commission ,act 7#ae ,u4,s4,c4  
#de7 to ! ext5t t x applies to unfair   
me?ods ( competition4  7#f7 ,rule (     
con/ruction ,! civil p5alty provid$ 9   
?is subsection is 9 addition to1 & n 9  
lieu (1 any o!r rem$ies provid$ by      
,f$]al law1 includ+ "u section #af ( !  
,clayton ,act 7#ae ,u4,s4,c4 #bf7 or "u 
section #ac7;b7 ( ! ,f$]al ,trade       
,commission ,act 7#ae ,u4,s4,c4         
#ec7;b774 ,no?+ 9 ?is p>agraph %all be  
con/ru$ to affect any au?ority ( !      
,commission "u any o!r provision ( law4 
7d7 ,applicability ,?is section %all    
apply to any cov]$ petition submitt$ on 
or aft] ! date ( enactm5t ( ?is ,act4   
#c4 ,sev]ability ,if any provision ( ?is
 ,act or ! application ( su* provision  
to any p]son or circum/ance is held to  
be uncon/itutional1 ! rema9d] ( ?is ,act
 & ! application ( ! provisions ( su*   
,act to any p]son or circum/ance %all n 
be affect$4  #a4 ,%ort title ,?is ,act  

may be cit$ z ! ,/op ,significant &     
,"t-wa/+ ,abuse ,limit+ ,legitimate     
,innovation ( ,new ,g5]ics ,act or !    
,/op ,,/all+ ,act4  #b4 ,f$]al trade    
commission en=cem5t aga9/ %am petitions 
7a7 ,def9itions ,9 ?is section3  7#a7   
,commission ,! t]m ,commission means !  
,f$]al ,trade ,commission4  7#b7 ,cov]$ 
application ,! t]m cov]$ application    
means an application fil$ pursuant to   
subsection 7b77#b7 or 7j7 ( section #eje
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee7 or section    
#cea7k7 ( ! ,public ,heal? ,s]vice ,act 
7#db ,u4,s4,c4 #bfb7k774  7#c7 ,cov]$   
petition ,! t]m cov]$ petition means a  
petition1 or a supplem5t to a petition1 
fil$ "u section #eje7q7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7q774  7#d7 ,p]son ,! t]m 
p]son-- 7,a7 means an individual or     
entity2 &  7,b7 includes-- 7i7 a        
successor & an assign ( an entity2 &    
7ii7 a jo9t v5ture1 subsidi>y1 p>tn]%ip1
 division1 gr\p1 & affiliate controll$  

by an entity1 &  7iii7 a successor & an 
assign ( a jo9t v5ture1 subsidi>y1      
p>tn]%ip1 division1 gr\p1 & affiliate   
controll$ by an entity4  7#e7 ,s]ies (  
cov]$ petitions ,! t]m s]ies ( cov]$    
petitions means any gr\p ( m ?an #a     
cov]$ petition relat+ to ! same cov]$   
application4  7#f7 ,%am ,! t]m %am means
 a cov]$ petition t is objectively      
baseless & t attempts to use a          
gov]nm5tal process1 z oppos$ to !       
outcome ( t process1 to int]f]e ) !     
bus9ess ( a competitor1 or a s]ies (    
cov]$ petitions t attempts to use a     
gov]nm5tal process1 z oppos$ to !       
outcome ( t process1 to int]f]e ) !     
bus9ess ( a competitor4  7b7 ,violation 
,a p]son submitt+ or caus+ ! submission 
( a cov]$ petition or a s]ies ( cov]$   
petitions t is a %am %all be liable =   
engag+ 9 an unfair me?od ( competition  
"u section #e7;a77#a7 ( ! ,f$]al ,trade 
,commission ,act 7#ae ,u4,s4,c4         
#de7;a77#a774  7c7 ,civil action  7#a7  
,9 g5]al ,if ! ,commission has reason to

 believe t ! submission ( a cov]$       
petition or a s]ies ( cov]$ petitions   
con/itutes a violation ( section        
#e7;a77#a7 ( ! ,f$]al ,trade ,commission
 ,act 7#ae ,u4,s4,c4 #de7;a77#a771 !    
,commission may comm5ce a civil action  
to recov] a civil p5alty & seek o!r     
appropriate relief 9 a di/rict c\rt ( ! 
,unit$ ,/ates aga9/ any p]son t submitt$
 or caus$ to be submitt$ su* cov]$      
petition or su* s]ies ( cov]$ petitions1
 includ+ successors or assigns4  7#b7   
,presumption ,9 a civil action "u       
p>agraph 7#a71 a cov]$ petition %all be 
presum$ to be "p ( a s]ies ( cov]$      
petitions t is a %am "u subsection 7b7 (
 ?is section if--  7,a7 ! ,secret>y (   
,heal? & ,human ,s]vices-- 7i7 has      
det]m9$ t ! cov]$ petition 0 submitt$ ) 
! prim>y purpose ( delay+ ! approval ( a
 cov]$ application2 &  7ii7 has ref]r$  
su* det]m9ation to ! ,f$]al ,trade      
,commission 9 writ+1 includ+ a reason$  
basis = ! det]m9ation2 &  7,b7 ! cov]$  
petition 0 "p ( a s]ies ( cov]$         

petitions4  7#c7 ,exception ,!          
presumption 9 p>agraph 7#b7 %all n apply
 if ! def5dant e/abli%es1 by a          
prepond]ance ( ! evid5ce1 t ! s]ies (   
cov]$ petitions t includes ! cov]$      
petition ref]r$ to ! ,commission by !   
,secret>y ( ,heal? & ,human ,s]vices is 
n a %am4  7#d7 ,civil p5alty ,9 an      
action "u p>agraph 7#a71 any p]son t has
 be5 f\nd liable = a violation ( section
 #e7;a77#a7 ( ! ,f$]al ,trade           
,commission ,act 7#ae ,u4,s4,c4         
#de7;a77#a77 %all be subject to a civil 
p5alty = ea* violation ( n m ?an !      
great] (--  7,a7 any rev5ue e>n$ f !    
sale by su* p]son ( any drug product1   
ref]5c$ 9 a cov]$ application t 0 !     
subject ( a cov]$ petition or a s]ies ( 
cov]$ petitions t is a %am1 dur+ ! p]iod
 9 :i* ! cov]$ petition or s]ies ( cov]$
 petitions 0 "u review by ! ,secret>y ( 
,heal? & ,human ,s]vices2 or  7,b7      
#ej1jjj = ea* cal5d> day t ea* cov]$    
petition t is a %am or t 0 "p ( a s]ies 
( cov]$ petitions t is a %am 0 "u review

 by ! ,secret>y ( ,heal? & ,human       
,s]vices4  7#e7 ,antitru/ laws ,no?+ 9  
?is section %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
 #ab7;a771 & ( section #e ( ! ,f$]al    
,trade ,commission ,act 7#ae ,u4,s4,c4  
#de7 to ! ext5t t x applies to unfair   
me?ods ( competition4  7#f7 ,rule (     
con/ruction ,! civil p5alty provid$ 9   
?is subsection is 9 addition to1 & n 9  
lieu (1 any o!r rem$ies provid$ by      
,f$]al law1 includ+ "u section #af ( !  
,clayton ,act 7#ae ,u4,s4,c4 #bf7 or "u 
section #ac7;b7 ( ! ,f$]al ,trade       
,commission ,act 7#ae ,u4,s4,c4         
#ec7;b774 ,no?+ 9 ?is p>agraph %all be  
con/ru$ to affect any au?ority ( !      
,commission "u any o!r provision ( law4 
7d7 ,applicability ,?is section %all    
apply to any cov]$ petition submitt$ on 
or aft] ! date ( enactm5t ( ?is ,act4   
#c4 ,sev]ability ,if any provision ( ?is
 ,act or ! application ( su* provision  

to any p]son or circum/ance is held to  
be uncon/itutional1 ! rema9d] ( ?is ,act
 & ! application ( ! provisions ( su*   
,act to any p]son or circum/ance %all n 
be affect$4 ,am5d ! title s z to read3  
,a bill to enable ! ,f$]al ,trade       
,commission to det] fil+ ( %am citiz5   
petitions to cov] an attempt to int]f]e 
) approval ( a compet+ g5]ic drug or    
biosimil>1 to fo/] competition1 &       
facilitate ! effici5t review ( petitions
 fil$ 9 good fai? to raise legitimate   
public heal? conc]ns1 & = o!r purposes44
 ,june #bh 7legislative day1 ,june #bg71
 #bjai,report$ ) an am5dm5t & an am5dm5t
 to ! title