,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #afag  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #bb1 #bjai,mrs4   
,murray 7= h]self & ,mr4 ,cornyn7       
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act ) respect to !  
li/+ ( pat5ts 9 ! ,orange ,book4  #a4   
,%ort title ,?is ,act may be cit$ z !   
,second ,look at ,drug ,pat5ts ,act (   
#bjai4  #b4 ,am5dm5ts  7a7 ,9 g5]al     
,section #eje ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is 
am5d$-- 7#a7 9 subsection 7b77#a71 at ! 
end ( ! fif? s5t5ce1 by ins]t+ subject  
to subsection 7j77#g77;,a77iii77,,ii7   
be=e ! p]iod2 &  7#b7 9 subsection      
7j77#g77;,a77iii7-- 7,a7 by /rik+ ,:5   
pat5t & ins]t+ 7,i7 ,:5 pat5t2  7,b7 by 
ins]t+ 1 subject to subclauses 7,,ii7 & 
7,,iii71 aft] 1 include2 &  7,c7 by add+
 at ! end ! foll[+3  7,,ii7 ,! ,secret>y
 %all include pat5t in=mation on ! li/  

pursuant to subclause 7,i7 if ! foll[+  
conditions are met3 7aa7 ,if ! pat5t has
 be5 issu$ z ( ! date on :i* !          
application is approv$ "u subsection    
7c71 ! sponsor1 )9 #cj days ( ! date (  
su* approval1 %all submit to ! ,"u      
,secret>y ( ,comm]ce = ,intellectual    
,prop]ty & ,director ( ! ,unit$ ,/ates  
,pat5t & ,tradem>k ,(fice 7ref]r$ to 9  
?is clause z ! ,director7 a notification
 t ! sponsor has includ$ 9 its          
application in=mation ab\t ! pat5t z    
requir$ "u subsection 7b77#a74  7bb7 ,if
 ! pat5t is issu$ aft] ! date on :i* !  
application is approv$ "u subsection    
7c71 ! sponsor1 n lat] ?an #cj days aft]
 ! date on :i* ! pat5t is issu$1 %all   
submit to ! ,director ! notification    
describ$ 9 item 7aa74  7cc7 ,^u receipt 
( a notification "u item 7aa7 or 7bb71 z
 applicable1 ! ,director %all publi%1 n 
lat] ?an #cj days ( su* receipt1 9 !    
,(ficial ,gazette ( ! ,unit$ ,/ates     
,pat5t & ,tradem>k ,(fice1 & on an      
int]net website t ! ,director %all      

e/abli%1 ma9ta91 & op]ate1 a            
notification ) respect to ! pat5t1      
reque/+ t any p]son t is eligible to    
file a reque/ describ$ 9 section        
#caa7;b7 ( title #ce1 ,unit$ ,/ates     
,code1 file su* a reque/4  7,,iii7 ,a   
pat5t includ$ on ! li/ z describ$ 9     
subclause 7,,ii7 %all be designat$ z be+
 provisionally includ$ on su* li/ until 
ei!r ( ! foll[+ conditions is met3 7aa7 
,! ,pat5t ,trial & ,appeal ,bo>d ( !    
,unit$ ,/ates ,pat5t & ,tradem>k ,(fice 
7ref]r$ to 9 ?is clause z ! ,bo>d7      
issues a f9al writt5 decision ) respect 
to an int] p>tes review ( all claims ( !
 pat5t conduct$ "u *apt] #ca ( title    
#ce1 ,unit$ ,/ates ,code1 & ! ,director 
issues & publi%es a c]tificate confirm+ 
^? claims to be pat5table4  7bb7        
,not)/&+ ! fil+ deadl9es provid$ "u     
section #cba7;c7 ( title #ce1 ,unit$    
,/ates ,code1 no p]son files a petition 
= int] p>tes review ( any claim ( !     
pat5t1 ) respect to a pat5t describ$ 9  
subclause 7,,ii77aa71 n lat] ?an #cjj   

days aft] ! date on :i* ! application is
 approv$ "u subsection 7c71 or1 )       
respect to a pat5t describ$ 9 subclause 
7,,ii77bb71 n lat] ?an #ae mon?s aft] ! 
date on :i* ! application is s approv$4 
7,,iv7 ,) respect to a pat5t t is       
includ$ on ! li/ z describ$ 9 subclause 
7,,ii71 is designat$ z provisionally    
includ$ on su* li/ "u subclause 7,,iii71
 &1 aft] an int] p>tes review ( ! pat5t 
conduct$ "u *apt] #ca ( title #ce1      
,unit$ ,/ates ,code1 is subject to a    
f9al writt5 decision ( ! ,bo>d & a      
c]tificate issu$ & publi%$ by !         
,director cancel+ "o or m claims ( !    
pat5t f9ally det]m9$ to be unpat5table1 
! hold] ( ! approv$ application1 n lat] 
?an #cj days aft] ! date on :i* !       
,director publi%es ! c]tificate1 %all   
submit to ! ,secret>y-- 7aa7 if t       
decision & c]tificate relate to all     
claims ( ! pat5t1 a reque/ to remove !  
pat5t f ! li/2 &  7bb7 if t decision &  
c]tificate d n relate to all claims ( ! 
pat5t1 a reque/ to remove ! pat5t       

in=mation relat+ to ! claim or claims to
 :i* t decision & c]tificate relate f ! 
li/4  7,v7 ,if1 z ( ! date on :i* a drug
 is approv$ "u subsection 7c71 a        
compla9t has be5 fil$ 9 a di/rict c\rt (
 ! ,unit$ ,/ates *all5g+ ! validity ( a 
pat5t1 a pat5t submitt$ "u subsection   
7b7 or 7c7 respect+ su* drug includ$ on 
! li/ %all be includ$ on ! li/ until !  
date on :i* ! c\rt invalidates ! pat5t1 
if applicable4  7,,vi7 ,no?+ 9 ?is      
clause %all affect ! availability to a  
fir/ applicant ( an exclusivity p]iod   
pursuant to clause 7iv7 or 7v7 (        
p>agraph 7#e77;,b71 provid$ t1 at ! "t t
 ! fir/ applicant submits an application
 "u ?is subsection conta9+ a            
c]tification describ$ 9 p>agraph        
7#b77;,a77vii77,,iv71 in=mation ab\t !  
pat5t is includ$ on ! li/ or is includ$ 
on ! li/ on a provisional basis4  4  7b7
 ,effective date ,! am5dm5ts made by    
subsection 7a7 %all apply only ) respect
 to pat5ts issu$ aft] ! date ( enactm5t 
( ?is ,act4