,,ii  #aah? ,,congress  #a/ ,session    
,s4 #bghj  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,septemb] #ac1         
#bjbc,ms4 ,hassan 7= h]self & ,mr4      
,braun7 introduc$ ! foll[+ bill2 :i* 0  
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to require sponsors ( drug  
applications & hold]s ( approv$         
applications to provide c]ta9           
submissions & communications to ! ,food 
& ,drug ,adm9i/ration & ! ,unit$ ,/ates 
,pat5t & ,tradem>k ,(fice4  #a4 ,%ort   
title ,?is ,act may be cit$ z !         
,m$ication ,af=dability & ,pat5t        
,integrity ,act4  #b4 ,disclosure (     
in=mation  7a7 ,9 g5]al  7#a7 ,9 g5]al  
,section #eje7;b7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;b77 is am5d$ by add+ at ! end !   
foll[+3  7#g7 7,a7 ,) respect to any    
application submitt$ "u ?is subsection  
or approv$ "u subsection 7c71 ! sponsor 
( ! application or hold] ( ! approv$    
application %all1 = any applicable      

pat5t-- 7i7 c]tify to ! ,food & ,drug   
,adm9i/ration t ! in=mation describ$ 9  
subp>agraph 7,b7 t is submitt$ to !     
,secret>y is complete & consi/5t ) !    
in=mation su* sponsor or hold] provid$  
to ! ,unit$ ,/ates ,pat5t & ,tradem>k   
,(fice & any communications su* sponsor 
or hold] _h ) ! ,unit$ ,/ates ,pat5t &  
,tradem>k ,(fice2 &  7ii7 7,i7 submit to
 ! ,unit$ ,/ates ,pat5t & ,tradem>k     
,(fice any in=mation mat]ial to         
pat5tability ) respect to su* applicable
 pat5t t ! sponsor or hold] submits to !
 ,food & ,drug ,adm9i/ration1 & any     
communications ) ! ,food & ,drug        
,adm9i/ration t are relat$ to su*       
submissions2 &  7,,ii7 c]tify to !      
,unit$ ,/ates ,pat5t & ,tradem>k ,(fice 
t ! in=mation provid$ "u subclause 7,i7 
is complete & consi/5t ) ! in=mation su*
 sponsor or hold] provid$ to ! ,food &  
,drug ,adm9i/ration & any communications
 su* sponsor or hold] _h ) ! ,food &    
,drug ,adm9i/ration4  7,b7 ,! in=mation 
describ$ 9 ?is subp>agraph is-- 7i7 any 

/atem5t or *>act]ization ( analytical or
 cl9ical data disclos$ by ! sponsor ( ! 
application or hold] ( ! approv$        
application "u ?is section to ! ,unit$  
,/ates ,pat5t & ,tradem>k ,(fice t has  
be51 or w be1 submitt$ to ! ,food &     
,drug ,adm9i/ration to support !        
approval ( an application "u ?is        
section2  7ii7 any /atem5t or           
*>act]ization ) respect to an applicable
 pat5t1 includ+ any /atem5t or          
*>act]ization ( prior art1 submitt$ by !
 sponsor ( ! application or hold] ( !   
approv$ application to ! ,unit$ ,/ates  
,pat5t & ,tradem>k ,(fice 9 support (   
pat5tability2 &  7iii7 o!r in=mation1 z 
! ,secret>y or ! ,secret>y ( ,comm]ce   
may require4  7,c7 ,9 ?is p>agraph1 !   
t]m applicable pat5t means-- 7i7 a pat5t
 t-- 7,i7 claims a drug t is ! subject (
 an application describ$ 9 subp>agraph  
7,a71 includ+ any pat5t t claims1 )     
respect to su* a drug1 a =mulation or   
composition1 me?od ( use1 or me?od (    
manufactur+2 &  7,,ii7 is issu$1        

assign$1 or lic5s$ to ! sponsor ( !     
application or hold] ( ! approv$        
application describ$ 9 subp>agraph 7,a72
  7ii7 an application = a pat5t describ$
 9 clause 7i77,i7 t is s\ght by !       
sponsor ( ! application or hold] ( !    
approv$ application describ$ 9          
subp>agraph 7,a72 or  7iii7 su* o!r     
pat5t or application = a pat5t z !      
,secret>y det]m9es appropriate4  7,d7   
7i7 ,except z provid$ 9 clause 7ii71    
subp>agraph 7,a7 %all apply ) respect to
 any orig9al application submitt$ "u ?is
 subsection on or aft] ! date ( enactm5t
 ( ! ,m$ication ,af=dability & ,pat5t   
,integrity ,act & to any am5dm5ts or    
supplem5ts to su* orig9al application4  
7ii7 ,9 ! case ( an application submitt$
 be=e ! date ( enactm5t ( ! ,m$ication  
,af=dability & ,pat5t ,integrity ,act1 !
 requirem5ts ( subp>agraph 7,a7 apply ) 
respect to-- 7,i7 any applicable pat5t  
issu$ on or aft] su* date ( enactm5t2 & 
7,,ii7 9 ! case ( an applicable pat5t   
issu$ be=e su* date ( enactm5t1 only to 

submissions & communications describ$ 9 
clauses 7i7 & 7ii7 ( subp>agraph 7,a7   
made on or aft] su* date ( enactm5t4  4 
7#b7 ,condition = approval ,section     
#eje7;d77#f7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#eje7;d77#f77 is am5d$ by ins]t+ 1 or ! 
sponsor fail$ to comply ) a requirem5t (
 subsection 7b77#g77;,a77i7 aft]        
subsection 7b74  7b7 ,biological product
 applications ,section #cea7;a77#b7 ( ! 
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;a77#b77 is am5d$ by add+
 at ! end ! foll[+3  7,f7 7i7 ,) respect
 to any application submitt$ "u ?is     
subsection or biological product lic5s$ 
"u ?is subsection1 ! sponsor ( !        
application or hold] ( ! lic5sure %all1 
= any applicable pat5t-- 7,i7 c]tify to 
! ,food & ,drug ,adm9i/ration t !       
in=mation describ$ 9 clause 7ii7 t is   
submitt$ to ! ,secret>y is complete &   
consi/5t ) ! in=mation su* sponsor or   
hold] provid$ to ! ,unit$ ,/ates ,pat5t 
& ,tradem>k ,(fice & any communications 

su* sponsor or hold] _h ) ! ,unit$      
,/ates ,pat5t & ,tradem>k ,(fice2 &     
7,,ii7 7aa7 submit to ! ,unit$ ,/ates   
,pat5t & ,tradem>k ,(fice any in=mation 
mat]ial to pat5tability ) respect to su*
 applicable pat5t t ! sponsor or hold]  
submits to ! ,food & ,drug              
,adm9i/ration1 & any communications ) ! 
,food & ,drug ,adm9i/ration t are relat$
 to su* submissions2 &  7bb7 c]tify to !
 ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice
 t ! in=mation provid$ "u item 7aa7 is  
complete & consi/5t ) ! in=mation su*   
sponsor or hold] provid$ to ! ,food &   
,drug ,adm9i/ration & any communications
 su* sponsor or hold] _h ) ! ,food &    
,drug ,adm9i/ration4  7ii7 ,! in=mation 
describ$ 9 ?is clause is-- 7,i7 any     
/atem5t or *>act]ization ( analytical or
 cl9ical data disclos$ by ! sponsor ( ! 
application or hold] ( ! approv$        
application "u ?is section to ! ,unit$  
,/ates ,pat5t & ,tradem>k ,(fice t has  
be51 or w be1 submitt$ to ! ,food &     
,drug ,adm9i/ration to support !        

approval ( an application "u ?is        
section2  7,,ii7 any /atem5t or         
*>act]ization ) respect to an applicable
 pat5t1 includ+ any /atem5t or          
*>act]ization ( prior art1 submitt$ by !
 sponsor ( ! application or hold] ( !   
approv$ application to ! ,unit$ ,/ates  
,pat5t & ,tradem>k ,(fice 9 support (   
pat5tability2 &  7,,iii7 o!r in=mation1 
z ! ,secret>y or ! ,secret>y ( ,comm]ce 
may require4  7iii7 ,9 ?is subp>agraph1 
! t]m applicable pat5t means-- 7,i7 a   
pat5t-- 7aa7 ) respect to :i* a ref]5ce 
product sponsor c\ld reasonably ass]t a 
claim ( pat5t infr+em5t1 if a p]son n   
lic5s$ by ! ref]5ce product sponsor     
engag$ 9 ! mak+1 us+1 (f]+ to sell1     
sell+1 or import+ into ! ,unit$ ,/ates (
 a biological product t relies on su*   
pat5t2 &  7bb7 t is issu$1 assign$1 or  
exclusively lic5s$ to ! sponsor ( !     
application or hold] ( ! lic5sure       
describ$ 9 clause 7i72  7,,ii7 an       
application = a pat5t describ$ 9        
subclause 7,i77aa7 t is s\ght by !      

sponsor ( ! application or hold] ( !    
lic5sure describ$ 9 clause 7i72 or      
7,,iii7 su* o!r pat5t or application = a
 pat5t z ! ,secret>y det]m9es           
appropriate4  7iv7 7,i7 ,except z       
provid$ 9 subclause 7,,ii71 clause 7i7  
%all apply ) respect to any orig9al     
application submitt$ "u ?is subsection  
on or aft] ! date ( enactm5t ( !        
,m$ication ,af=dability & ,pat5t        
,integrity ,act & to any am5dm5ts or    
supplem5ts to su* orig9al application4  
7,,ii7 ,9 ! case ( an application       
submitt$ "u ?is subsection be=e ! date (
 enactm5t ( ! ,m$ication ,af=dability & 
,pat5t ,integrity ,act1 ! requirem5ts ( 
clause 7i7 apply ) respect to-- 7aa7 any
 applicable pat5t issu$ on or aft] su*  
date ( enactm5t2 &  7bb7 9 ! case ( an  
applicable pat5t issu$ be=e su* date (  
enactm5t1 only to submissions &         
communications describ$ 9 subclauses    
7,i7 & 7,,ii7 ( clause 7i7 made on or   
aft] su* date ( enactm5t4  7v7 ,not)/&+ 
subp>agraph 7,c71 ! ,secret>y may n     

approve an application = a biological   
product if ! sponsor ( su* application  
is out ( compliance ) ! requirem5ts (   
clause 7i77,i7 ) respect to su*         
application4  4  7c7 ,en=cem5t  7#a7    
,,fda en=cem5t ,section #cja ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cca7 is am5d$ by add+ at !   
end ! foll[+3  7jjj7 ,a failure to      
comply ) a requirem5t ( section         
#eje7;b77#g7 ( ?is ,act or section      
#cea7;a77#b77;,f7 ( ! ,public ,heal?    
,s]vice ,act4  4  7#b7 ,def5se aga9/    
pat5t infr+em5t actions  7,a7 ,9 g5]al  
,*apt] #bh ( title #ce1 ,unit$ ,/ates   
,code1 is am5d$ by add+ at ! end !      
foll[+3  #bgd4 ,non-disclosure def5se to
 infr+em5t ( drug pat5t ,a p]son %all be
 entitl$ to a def5se "u section #bhb7;b7
 9 an action ass]t+ infr+em5t ( an      
applicable pat5t 7z def9$ 9 p>agraph    
7#g77;,b7 ( section #eje7;b7 ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;b77 or subp>agraph      
7,f77ii7 ( section #cea7;a77#b7 ( !     

,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;a77#b777 if ! own] or   
pr$ecessor own] ( ! applicable pat5t    
violat$ p>agraph 7#g77;,a7 ( su* section
 #eje7;b7 or subp>agraph 7,f77i7 ( su*  
section #cea7;a77#b7 ) respect to !     
applicable pat5t by neglig5tly or       
int5tionally fail+ to disclose any      
in=mation requir$ to be disclos$        
pursuant to su* p>agraph 7#g77;,a7 or   
su* subp>agraph 7,f77i74  4  7,b7       
,te*nical & con=m+ am5dm5t ,! table (   
sections = *apt] #bh ( title #ce1 ,unit$
 ,/ates ,code1 is am5d$ by add+ at ! end
 ! foll[+3  #bgd4 ,non-disclosure def5se
 to infr+em5t ( drug pat5t4  4