,i  #aafth ,,congress  #ast ,session    
,h4 ,r4 #aejc  ,,in ,,the ,,house ,,of  
,,representatives  ,march #e1 #bjai,ms4 
,kelly of ,illinois introduced the      
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,a ,,bill  ,to amend the ,federal ,food1
 ,drug1 and ,cosmetic ,act regarding the
 list under section #eje7;j77#g7 of the 
,federal ,food1 ,drug1 and ,cosmetic    
,act1 and for other purposes4  #a4      
,short title ,this ,act may be cited as 
the ,orange ,book ,transparency ,act of 
#bjai4  #b4 ,orange ,book  7a7 ,patents 
,clause 7iii7 of section                
#eje7;j77#g77;,a7 of the ,federal ,food1
 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #cee7;j77#g77 is amended to   
read as follows3  7iii7  7,i7 ,when     
patent information submitted under      
subsection 7b7 or 7c7 respecting a drug 
included on the list is to be published 
by the ,secretary1 the ,secretary shall1
 in revisions made under clause 7ii71   
include such information for such drug4 

7,,ii7 ,the ,secretary-- 7aa7 shall     
include on the list1 from such patent   
information respecting a drug1 drug     
substance 7including active ingredient7 
patents1 drug product 7including        
formulation and composition7 patents1   
and method of use patents2 and  7bb7 may
 choose to include on the list          
additional patent information respecting
 the drug4  7,,iii7 ,the ,secretary     
shall not include on the list any patent
 to the extent such patent claims a     
device that is used for the delivery of 
the drug4 ,notwithstanding the preceding
 sentence1 the ,secretary may require   
7under other applicable provisions of   
law7 the holder of the approved         
application for a drug to submit1 for   
purposes other than the list under this 
paragraph1 patent information respecting
 a device that is used for the delivery 
of the drug4  4  7b7 ,listing of        
exclusivities ,subparagraph 7,a7 of     
section #eje7;j77#g7 of the ,federal    
,food1 ,drug1 and ,cosmetic ,act 7#ba   

,u4,s4,c4 #cee7;j77#g77 is amended by   
adding at the end the following3  7iv7  
,for each drug included on the list1 the
 ,secretary shall specify each          
exclusivity period that is applicable   
and has not concluded under--  7,i7     
clause 7iii7 or 7iv7 of subsection      
7c77#c77;,e7 of this section2  7,,ii7   
clause 7iv7 or 7v7 of paragraph         
7#e77;,b7 of this subsection2  7,,iii7  
clause 7iii7 or 7iv7 of paragraph       
7#e77;,f7 of this subsection2  7,,iv7   
section #eje;,a2  7,v7 section #eje;,e2 
or  7,,vi7 section #ebg7;a74  4  7c7    
,removal of invalid patents  7#a7 ,in   
general ,section #eje7;j77#g7 of the    
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is    
amended by adding at the end the        
following3  7,d7  7i7 ,the holder of an 
application approved under subsection   
7c7 for a drug on the list shall        
promptly notify the ,secretary in       
writing if either of the following      
occurs3  7,i7 ,the ,patent ,trial and   

,appeals ,board issues a decision that a
 patent for such drug is invalid4       
7,,ii7 ,a court issues a decision from  
which no appeal may be taken that a     
patent for such drug is invalid4  7ii7  
,the holder of an approved application  
shall include in any notification under 
clause 7i7 a copy of the decision       
described in subclause 7,i7 or 7,,ii7 of
 clause 7i74  7iii7 ,the ,secretary     
shall remove from the list any patent   
that is determined to be invalid in a   
decision described in subclause 7,i7 or 
7,,ii7 of clause 7i7--  7,i7 promptly2  
but  7,,ii7 not before the expiration of
 any #ahj-;day exclusivity period under 
clause 7iv7 or 7v7 of paragraph         
7#e77;,b7 that relies on a certification
 described in paragraph                 
7#b77;,a77vii77,,iv7 that such patent   
was invalid4  4  7#b7 ,applicability    
,subparagraph 7,d7 of section           
#eje7;j77#g7 of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7;j77#g771 as added by paragraph   

7#a71 applies only with respect to a    
decision described in such subparagraph 
that is issued on or after the date of  
enactment of this ,act4  7d7 ,review and
 report ,not later than one year after  
the date of enactment of this ,act1 the 
,secretary of ,health and ,human        
,services1 acting through the           
,commissioner of ,food and ,drugs1      
shall--  7#a7 review the types of patent
 information that should be included on 
the list under section #ejg7;j77#g7 of  
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cee7;j77#g772 and 
7#b7 report to the ,congress on the     
results of such review1 including any   
recommendations about the types of      
patent information that should be       
included on or removed from such list4