,,ii  #aah? ,,congress  #a/ ,session    
,s4 #aabh  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,m>* #cj1 #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 e/abli% special rules    
relat+ to in=mation provid$ ) respect to
 drug applications conc]n+ me?od ( use  
pat5ts4  #a4 ,%ort title ,?is ,act may  
be cit$ z ! ,ensur+ ,access to ,g5]ic   
,m$ications ,act4  #b4 ,special rules   
relat+ to me?od ( use pat5ts ,section   
#eje ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is  
am5d$ by add+ at ! end ! foll[+3  7z7   
,cause ( action relat+ to drug use codes
  7#a7 ,9 g5]al ,9 ! case ( an          
application "u subsection 7b77#b7 or 7j7
 ( ?is section or section #cea7k7 ( !   
,public ,heal? ,s]vice ,act ) respect to
 :i* ! applicant seek+ approval includes
 9 ! application a /atem5t t a pat5t    
claim+ a me?od ( use does n claim a use 

= ! drug t is ! subject ( su*           
application1 z describ$ 9 subsection    
7b77#b77;,b7 or 7j77#b77;,a77viii71 or 9
 ! case ( an application "u su* section 
#cea7k71 z o!rwise requir$ by !         
,secret>y1 ! sponsor ( ! application "u 
subsection 7b77#b7 or 7j7 or su* section
 #cea7k7 describ$ 9 p>agraph 7#b7 may   
file a civil action 9 an appropriate    
di/rict c\rt ( ! ,unit$ ,/ates aga9/ !  
hold] ( ! approv$ application = !       
applicable ref]5ce drug or ref]5ce      
product seek+ a c\rt ord] requir+ !     
hold] to correct or delete in=mation    
relat+ to a use code submitt$ by ! hold]
 ( ! ref]5ce drug or ref]5ce product )  
respect to su* pat5t claim+ a me?od (   
use1 on ! gr\nd t su* use code-- 7,a7   
does n correspond to a pat5t t claims ! 
ref]5ce drug or ref]5ce product = :i* ! 
application 0 approv$2  7,b7 does n     
correspond to a pat5t t claims an       
approv$ me?od ( us+ ! ref]5ce drug or   
ref]5ce product2 or  7,c7 is ov]ly broad
 or o!rwise inaccurate or inappropriate4

  7#b7 ,rule ( con/ruction ,no?+ 9 ?is  
subsection %all be con/ru$ to affect !  
application ( subsection                
7j77#e77;,c77ii74  7#c7 ,def9ition ,=   
purposes ( p>agraph 7#a71 ! t]m use code
 means ! in=mation relat+ to a pat5t    
claim+ a me?od ( us+ a drug t is approv$
 "u section #eje ( ?is ,act or "u       
section #cea ( ! ,public ,heal? ,s]vice 
,act1 z applicable1 bas$ ^u in=mation   
submitt$ by ! drug sponsor or hold] ( ! 
approv$ application or lic5sure pursuant
 to section #cad4ec7;c77#b77;ii77,p77#c7
 ( title #ba1 ,code ( ,f$]al            
,regulations 7or any successor          
regulations74  4