,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #cjib  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,decemb] #ah1 #bjai,ms4
 ,smi? 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 am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act ) respect to !  
#ahj-;day exclusivity p]iod1 & = o!r    
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,exp&+ ,access to ,l[-,co/ 
,g5]ics ,act ( #bjai4  #b4 #ahj-;day    
exclusivity p]iod  7a7 ,9 g5]al ,section
 #eje7;j77#e77;,b77iv7 ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cee7;j77#e77;,b77iv77 is am5d$--  7#a7 
9 subclause 7,i71 by /rik+ effective on 
! date t is #ahj days aft] & all t      
foll[s ?r\gh ! p]iod at ! end & ins]t+ !
 foll[+3 8effective--  7aa7 except z    
provid$ 9 item 7bb71 on ! date t is #ahj
 days aft] ! date ( ! fir/ comm]cial    
m>ket+ ( ! drug 7includ+ ! comm]cial    
m>ket+ ( ! li/$ drug7 by any fir/       

applicant2 or  7bb7 if1 9 an infr+em5t  
action br\ght 9 a di/rict c\rt solely   
aga9/ ! applicant = ! application       
describ$ 9 ?is subclause 7or any        
affiliate ( ! applicant71 or an action 9
 a di/rict c\rt = a decl>atory judgm5t  
br\ght by t applicant1 ) respect to ea* 
pat5t to :i* a fir/ applicant _h        
submitt$ & lawfully ma9ta9$ a           
c]tification "u p>agraph                
7#b77;,a77vii77,,iv71 ! di/rict c\rt    
decides t ea* pat5t is invalid or n     
infr+$ 7includ+ any sub/antive          
det]m9ation t !re is no cause ( action =
 pat5t infr+em5t or invalidity71 & !    
applicant = ! application describ$ 9 ?is
 subclause meets ! requirem5ts "u       
subclause 7,,iii71 imm$iately ^u !      
di/rict c\rt ent]+ su* decision = su*   
applicant4  2 &  7#b7 by add+ at ! end !
 foll[+3  7,,iii7 ,applicant requirem5ts
 ,! requirem5ts "u ?is subclause are t !
 applicant = ! application describ$ 9   
subclause 7,i7--  7aa7 does n /ay !     
action describ$ 9 item 7bb7 ( su*       

subclause2  7bb7 does n agree to be b\nd
 by a judgm5t z to ano!r applicant2 &   
7cc7 does n reque/ jo9d] "u section     
#db4abb ( title #cg1 ,code ( ,f$]al     
,regulations 7or any correspond+ simil> 
regulation or rul+71 = any petition t ! 
applicant may h fil$ ) respect to !     
application4  4  7b7 ,applicability ,!  
am5dm5ts made by subsection 7a7 %all    
apply only ) respect to an application  
fil$ "u section #eje7;j7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j77 aft] ! date (       
enactm5t ( ?is ,act t id5tifies a li/$  
drug = :i* no c]tification "u p>agraph  
7#b77;,a77vii77,,iv7 ( su* section 0    
made be=e su* date ( enactm5t4