,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #aejc  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,m>* #e1 #bjai,ms4    
,kelly ( ,ill9ois introduc$ ! foll[+    
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce  ,a ,,bill  ,to am5d !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
reg>d+ ! li/ "u section #eje7;j77#g7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act1 
& = o!r purposes4  #a4 ,%ort title ,?is 
,act may be cit$ z ! ,orange ,book      
,transp>5cy ,act ( #bjai4  #b4 ,orange  
,book  7a7 ,pat5ts ,clause 7iii7 (      
section #eje7;j77#g77;,a7 ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j77#g77 is am5d$ to read
 z foll[s3  7iii7  7,i7 ,:5 pat5t       
in=mation submitt$ "u subsection 7b7 or 
7c7 respect+ a drug includ$ on ! li/ is 
to be publi%$ by ! ,secret>y1 !         
,secret>y %all1 9 revisions made "u     
clause 7ii71 include su* in=mation = su*
 drug4  7,,ii7 ,! ,secret>y-- 7aa7 %all 
include on ! li/1 f su* pat5t in=mation 
respect+ a drug1 drug sub/ance 7includ+ 

active +r$i5t7 pat5ts1 drug product     
7includ+ =mulation & composition7       
pat5ts1 & me?od ( use pat5ts2 &  7bb7   
may *oose to include on ! li/ additional
 pat5t in=mation respect+ ! drug4       
7,,iii7 ,! ,secret>y %all n include on !
 li/ any pat5t to ! ext5t su* pat5t     
claims a device t is us$ = ! deliv]y ( !
 drug4 ,not)/&+ ! prec$+ s5t5ce1 !      
,secret>y may require 7"u o!r applicable
 provisions ( law7 ! hold] ( ! approv$  
application = a drug to submit1 =       
purposes o!r ?an ! li/ "u ?is p>agraph1 
pat5t in=mation respect+ a device t is  
us$ = ! deliv]y ( ! drug4  4  7b7 ,li/+ 
( exclusivities ,subp>agraph 7,a7 (     
section #eje7;j77#g7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77#g77 is am5d$ by add+ at ! end 
! foll[+3  7iv7 ,= ea* drug includ$ on !
 li/1 ! ,secret>y %all specify ea*      
exclusivity p]iod t is applicable & has 
n conclud$ "u--  7,i7 clause 7iii7 or   
7iv7 ( subsection 7c77#c77;,e7 ( ?is    
section2  7,,ii7 clause 7iv7 or 7v7 (   

p>agraph 7#e77;,b7 ( ?is subsection2    
7,,iii7 clause 7iii7 or 7iv7 ( p>agraph 
7#e77;,f7 ( ?is subsection2  7,,iv7     
section #eje;,a2  7,v7 section #eje;,e2 
or  7,,vi7 section #ebg7;a74  4  7c7    
,removal ( invalid pat5ts  7#a7 ,9 g5]al
 ,section #eje7;j77#g7 ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cee7;j77#g77 is am5d$ by add+ at ! end 
! foll[+3  7,d7  7i7 ,! hold] ( an      
application approv$ "u subsection 7c7 = 
a drug on ! li/ %all promptly notify !  
,secret>y 9 writ+ if ei!r ( ! foll[+    
occurs3  7,i7 ,! ,pat5t ,trial &        
,appeals ,bo>d issues a decision t a    
pat5t = su* drug is invalid4  7,,ii7 ,a 
c\rt issues a decision f :i* no appeal  
may be tak5 t a pat5t = su* drug is     
invalid4  7ii7 ,! hold] ( an approv$    
application %all include 9 any          
notification "u clause 7i7 a copy ( !   
decision describ$ 9 subclause 7,i7 or   
7,,ii7 ( clause 7i74  7iii7 ,! ,secret>y
 %all remove f ! li/ any pat5t t is     
det]m9$ to be invalid 9 a decision      

describ$ 9 subclause 7,i7 or 7,,ii7 (   
clause 7i7--  7,i7 promptly2 b  7,,ii7 n
 be=e ! expiration ( any #ahj-;day      
exclusivity p]iod "u clause 7iv7 or 7v7 
( p>agraph 7#e77;,b7 t relies on a      
c]tification describ$ 9 p>agraph        
7#b77;,a77vii77,,iv7 t su* pat5t 0      
invalid4  4  7#b7 ,applicability        
,subp>agraph 7,d7 ( section #eje7;j77#g7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee7;j77#g771 z    
add$ by p>agraph 7#a71 applies only )   
respect to a decision describ$ 9 su*    
subp>agraph t is issu$ on or aft] ! date
 ( enactm5t ( ?is ,act4  7d7 ,review &  
report ,n lat] ?an "o ye> aft] ! date ( 
enactm5t ( ?is ,act1 ! ,secret>y (      
,heal? & ,human ,s]vices1 act+ ?r\gh !  
,commission] ( ,food & ,drugs1 %all--   
7#a7 review ! types ( pat5t in=mation t 
%\ld be includ$ on ! li/ "u section     
#ejg7;j77#g7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7;j77#g772 &  7#b7 report to !      
,congress on ! results ( su* review1    

includ+ any recomm5dations ab\t ! types 
( pat5t in=mation t %\ld be includ$ on  
or remov$ f su* li/4