,,ii  #aai? ,,congress  #a/ ,session    
,s4 #ajie  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,m>* #bd1 #bjbe,ms4    
,klobu*> 7= h]self1 ,mr4 ,grassley1 ,mr4
 ,durb91 ,mr4 ,blum5?al1 ,mr4 ,cruz1    
,mr4 ,wel*1 & ,mr4 ,book]7 introduc$ !  
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ! ,judici>y  ,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 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$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7q774  7#d7 ,p]son ,! t]m 
p]son-- 7,a7 means an individual or     
entity2 &  7,b7 includes-- 7i7 a        
successor or an assign ( an entity2     
7ii7 a jo9t v5ture1 subsidi>y1 p>tn]%ip1
 division1 gr\p1 or affiliate controll$ 
by an entity2 &  7iii7 a successor or an
 assign ( a jo9t v5ture1 subsidi>y1     
p>tn]%ip1 division1 gr\p1 or 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-- 7,a7 a cov]$ petition t-- 7i7 is
 objectively baseless2 &  7ii7 attempts 
to use a gov]nm5tal process1 z oppos$ to
 ! outcome ( t process1 to int]f]e ) !  
bus9ess ( a competitor2 or  7,b7 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]$ petitions4
  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 ! ,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
 dur+ :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 ,review ( ref]ral ,no   
ref]ral by ! ,secret>y ( ,heal? & ,human
 ,s]vices "u p>agraph 7#b77;,a7 %all be 
subject to judicial review1 except z a  
?ird-p>ty claim ass]t$ by ! def5dant "u 
section #gjf7b77;,a7 ( title #e1 ,unit$ 
,/ates ,code1 aga9/ ! ,secret>y ( ,heal?
 & ,human ,s]vices or ! ,dep>tm5t (     
,heal? & ,human ,s]vices1 z "p ( a civil

 action comm5c$ "u p>agraph 7#a74  7#f7 
,antitru/ laws ,no?+ 9 ?is section %all 
modify1 impair1 limit1 or sup]s$e !     
applicability ( ! antitru/ laws1 z def9$
 9 subsection 7a7 ( ! fir/ section ( !  
,clayton ,act 7#ae ,u4,s4,c4 #ab71 & (  
section #e ( ! ,f$]al ,trade ,commission
 ,act 7#ae ,u4,s4,c4 #de7 to ! ext5t t x
 applies to unfair me?ods ( competition4
  7#g7 ,rule ( con/ruction ,! civil     
p5alty provid$ 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  7d7 ,applicability 
,?is section %all apply to any cov]$    
petition submitt$ on or aft] ! date (   
enactm5t ( ?is ,act4  7e7 ,rule (       
con/ruction ,no?+ 9 ?is ,act %all be    
con/ru$ to limit any au?ority ( !       
,commission "u any o!r provision ( law4 
#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