,,ii  #aafth ,,congress  #ast ,session  
,s4 #abji  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,april #aa1    
#bjai ,mr4 ,cassidy 7for himself and    
,mr4 ,durbin7 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 approval of abbreviated new drug     
applications4  #a4 ,short title  ,this  
,act may be cited as the ,reforming     
,evergreening and ,manipulation that    
,extends ,drug ,years ,act or the       
,,remedy ,act4  #b4 ,amendments to      
,,anda approval provision  7a7 ,in      
general ,section #eje of the ,federal   
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee7 is amended--  7#a7 in   
subsection 7c77#c77;,c71 by inserting in
 the case of a certification with       
respect to a patent that claims a drug  
substance 7and not in the case of a     
certification with respect to a patent  

that claims a drug product or method of 
use for a drug1 except that1 in the case
 of a patent that claims a drug         
substance and a drug product or method  
of use1 this subparagraph shall apply1  
but only to the extent the patent claims
 a drug substance71 after immediately   
unless12 and  7#b7 in subsection        
7j77#e77;,b77iii71 by inserting in the  
case of a certification with respect to 
a patent that claims a drug substance   
7and not in the case of a certification 
with respect to a patent that claims a  
drug product or method of use for a     
drug1 except that1 in the case of a     
patent that claims a drug substance and 
a drug product or method of use1 this   
clause shall apply1 but only to the     
extent the patent claims a drug         
substance71 after immediately unless14  
7b7 ,orange book updates with respect to
 invalidated patents  7#a7 ,in general  
,section #eje7;j77#g77;,a7 of the       
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7;j77#g77;,a77  

is amended by adding at the end the     
following3  7iv7 ,in the case of a      
listed drug for which the list under    
clause 7i7 includes a patent that claims
 the drug or a use for such drug1 and   
where the ,under ,secretary of ,commerce
 for ,intellectual ,property and        
,director of the ,united ,states ,patent
 and ,trademark ,office has cancelled   
any claim of the patent relating to such
 drug or such use pursuant to a         
determination by the ,patent ,trial and 
,appeal ,board in an inter partes review
 conducted under chapter #ca of title   
#ce1 ,united ,states ,code1 or a        
post-grant review conducted under       
chapter #cb of that title1 and any such 
cancellation1 if appealed1 has been     
upheld upon appeal1 the holder of the   
applicable approved application shall   
notify the ,secretary of such           
cancellation1 and the revisions required
 under clause 7iii7 shall include       
striking the patent from the list with  
respect to such drug4  4  7#b7 ,no      

effect on first applicant exclusivity   
period ,section                         
#eje7;j77#e77;,b77iv77,i7 is amended by 
adding at the end the following3 ,this  
subclause shall apply even if a patent  
is stricken from the list under         
paragraph 7#g77;,a71 pursuant to the    
second sentence of clause 7iii7 of such 
paragraph1 provided that1 at the time   
that the first applicant submitted an   
application under this subsection       
containing a certification described in 
paragraph 7#b77;,a77vii77,,iv71 the     
patent that was the subject of such     
certification was included in such list 
with respect to the listed drug44