,,ii  #aafth ,,congress  #ast ,session  
,s4 #cjib  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,december #ah1 
#bjai,ms4 ,smith 7for herself and ,mr4  
,braun7 introduced the following bill2  
which was read twice and referred to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions  ,a ,,bill  ,to   
amend the ,federal ,food1 ,drug1 and    
,cosmetic ,act with respect to the      
#ahj-;day exclusivity period1 and for   
other purposes4  #a4 ,short title ,this 
,act may be cited as the ,expanding     
,access to ,low-,cost ,generics ,act of 
#bjai4  #b4 #ahj-;day exclusivity period
  7a7 ,in general ,section              
#eje7;j77#e77;,b77iv7 of the ,federal   
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee7;j77#e77;,b77iv77 is     
amended--  7#a7 in subclause 7,i71 by   
striking effective on the date that is  
#ahj days after and all that follows    
through the period at the end and       
inserting the following3 8effective--   
7aa7 except as provided in item 7bb71 on

 the date that is #ahj days after the   
date of the first commercial marketing  
of the drug 7including the commercial   
marketing of the listed drug7 by any    
first applicant2 or  7bb7 if1 in an     
infringement action brought in a        
district court solely against the       
applicant for the application described 
in this subclause 7or any affiliate of  
the applicant71 or an action in a       
district court for a declaratory        
judgment brought by that applicant1 with
 respect to each patent to which a first
 applicant had submitted and lawfully   
maintained a certification under        
paragraph 7#b77;,a77vii77,,iv71 the     
district court decides that each patent 
is invalid or not infringed 7including  
any substantive determination that there
 is no cause of action for patent       
infringement or invalidity71 and the    
applicant for the application described 
in this subclause meets the requirements
 under subclause 7,,iii71 immediately   
upon the district court entering such   

decision for such applicant4  2 and     
7#b7 by adding at the end the following3
  7,,iii7 ,applicant requirements ,the  
requirements under this subclause are   
that the applicant for the application  
described in subclause 7,i7--  7aa7 does
 not stay the action described in item  
7bb7 of such subclause2  7bb7 does not  
agree to be bound by a judgment as to   
another applicant2 and  7cc7 does not   
request joinder under section #db4abb of
 title #cg1 ,code of ,federal           
,regulations 7or any corresponding      
similar regulation or ruling71 for any  
petition that the applicant may have    
filed with respect to the application4  
4  7b7 ,applicability ,the amendments   
made by subsection 7a7 shall apply only 
with respect to an application filed    
under section #eje7;j7 of the ,federal  
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee7;j77 after the date of   
enactment of this ,act that identifies a
 listed drug for which no certification 
under paragraph 7#b77;,a77vii77,,iv7 of 

such section was made before such date  
of enactment4