,,ii  #aai? ,,congress  #a/ ,session    
,s4 #bfeh  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,augu/ #a1 #bjbe ,ms4  
,hassan 7= h]self & ,mr4 ,hawley7       
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 is1 to ! be/ k ( ! sponsor or 
hold]1 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 in=mation !  
,food & ,drug ,adm9i/ration provid$ 9   
response2 &  7,,ii7 c]tify to ! ,unit$  
,/ates ,pat5t & ,tradem>k ,(fice t !    
submission "u subclause 7,i71 to ! be/ k
 ( ! sponsor or hold]1 includes all     
in=mation mat]ial to pat5tability1 & is 
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 limit$ to 
in=mation t is mat]ial to pat5tability1 
z def9$ 9 regulations promulgat$ by !   
,unit$ ,/ates ,pat5t & ,tradem>k ,(fice1
 & t is--  7i7 any /atem5t or           
*>act]ization ( analytical data set =? 9
 ! *emi/ry1 manufactur+1 & controls     
section ( a new drug application        
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 or  7iii7 o!r in=mation1 z
 ! ,secret>y or ! ,secret>y ( ,comm]ce  
may by regulation 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 or ! ,secret>y ( ,comm]ce may 
by regulation require4  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$ication  
,af=dability & ,pat5t ,integrity ,act1 !
 requirem5ts ( subp>agraph 7,a7 apply   
only ) respect to--  7,i7 any applicable
 pat5t issu$ 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  7,e7 ,! ,unit$    
,/ates ,pat5t & ,tradem>k ,(fice %all1 z
 necess>y1 update its applicable        
regulations or e/abli% new proc$ures to 
ensure t any in=mation t ! sponsor or   
hold] ( ! application has submitt$ to or
 receiv$ f ! ,food & ,drug ,adm9i/ration
 & t is submitt$ to ! ,unit$ ,/ates     
,pat5t & ,tradem>k ,(fice to fulfill !  
requirem5ts ( subp>agraph 7,a71 & t w\ld
 n o!rwise be submitt$ to ! ,unit$      
,/ates ,pat5t & ,tradem>k ,(fice1 %all  
rema9 subject to application protections
 = trade secret or confid5tial in=mation

 or f9ancial in=mation z if ! in=mation 
7 held by ! ,food & ,drug ,adm9i/ration4
  4  7#b7  ,inclusion ( c]tifications 9 
application  ,section #eje7;b77#a77;,a7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7;b77#a77;,a77  
is am5d$--  7,a7 9 clause 7vii71 by     
/rik+ & at ! end2  7,b7 9 clause        
7viii77,,ii71 by /rik+ ! p]iod & ins]t+ 
2 &2 &  7,c7 by add+ at ! end ! foll[+3 
7ix7 ) respect to ea* pat5t li/$ 9 !    
application pursuant to clause 7viii7 t 
is an applicable pat5t 7z def9$ 9       
p>agraph 7#g77;,c771 ! c]tifications    
requir$ "u clauses 7i7 & 7ii77,,ii7 (   
p>agraph 7#g77;,a74  4  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
 is1 to ! be/ k ( ! sponsor or hold]1   
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/ration
 provid$ 9 response2 &  7bb7 c]tify to !
 ,unit$ ,/ates ,pat5t & ,tradem>k ,(fice
 t ! submission "u item 7aa71 to ! be/ k
 ( ! sponsor or hold]1 includes all     
in=mation mat]ial to pat5tability & is  
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 limit$ to      

in=mation t is mat]ial to pat5tability1 
z def9$ 9 regulations promulgat$ by !   
,unit$ ,/ates ,pat5t & ,tradem>k ,(fice1
 & t is--  7,i7 any /atem5t or          
*>act]ization ( analytical data set =? 9
 ! *emi/ry1 manufactur+1 & controls     
section 9 a biological product lic5se   
application 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 or  7,,iii7 o!r in=mation1
 z ! ,secret>y or ! ,secret>y ( ,comm]ce
 may by regulation require4  7iii7 ,9   
?is subp>agraph1 ! t]m applicable pat5t 

means--  7,i7 a pat5t t-- 7aa7 claims a 
biological product t is ! subject ( an  
application describ$ 9 clause 7i71      
includ+ any pat5t t claims1 ) respect to
 su* biological product1 a =mulation or 
composition1 me?od ( use1 or me?od (    
manufactur+2 &  7bb7 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 or ,secret>y (     
,comm]ce may by regulation require4     
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$ication   
,af=dability & ,pat5t ,integrity ,act1 !
 requirem5ts ( clause 7i7 apply only )  
respect to--  7aa7 any applicable pat5t 
issu$ 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  7,i7 ,any in=mation t ! sponsor ( !
 application or hold] ( ! lic5sure has  
submitt$ to or receiv$ f ! ,food & ,drug
 ,adm9i/ration t is submitt$ to ! ,unit$
 ,/ates ,pat5t & ,tradem>k (fice to     
fulfill ! requirem5ts ( clause 7i7 %all 
rema9 subject to application protections
 = trade secret or confid5tial in=mation
 or f9ancial in=mation z if ! in=mation 
7 held by ! ,food & ,drug ,adm9i/ration4
  7,,ii7 ,! ,unit$ ,/ates ,pat5t &      
,tradem>k ,(fice %all1 z necess>y1      
update its applicable regulations or    
create new proc$ures to ensure          

compliance ) subclause 7,i7 = in=mation 
submitt$ "u ?is subp>agraph4  4  7c7    
,en=cem5t  7#a7  ,,fda en=cem5t         
,section #cja7q77#a7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cca7q77#a77 is am5d$--  7,a7 9 clause  
7,b71 by /rik+ 2 or & ins]t+ a          
semicolon2  7,b7 9 clause 7,c71 by /rik+
 ! p]iod & ins]t+ 2 or2 &  7,c7 by add+ 
at ! end ! foll[+3  7,d7 to submit !    
c]tification requir$ "u 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;,c7 ( 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