#aafth ,,congress  #ast ,session  ,h4   
,r4 #aejc  ,,an ,,act  ,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 ,submission of patent
 information for brand name drugs       
,paragraph 7#a7 of section #eje7;b7 of  
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cee7;b77 is       
amended to read as follows3  7b7  7#a7  
,any person may file with the ,secretary
 an application with respect to any drug
 subject to the provisions of subsection
 7a74 ,such persons shall submit to the 
,secretary as part of the application-- 
7,a7 full reports of investigations     
which have been made to show whether or 
not such drug is safe for use and       
whether such drug is effective in use2  
7,b7 a full list of the articles used as

 components of such drug2  7,c7 a full  
statement of the composition of such    
drug2  7,d7 a full description of the   
methods used in1 and the facilities and 
controls used for1 the manufacture1     
processing1 and packing of such drug2   
7,e7 such samples of such drug and of   
the articles used as components thereof 
as the ,secretary may require2  7,f7    
specimens of the labeling proposed to be
 used for such drug2  7,g7 any          
assessments required under section      
#eje;,b2 and  7,h7 patent information1  
with respect to each patent for which a 
claim of patent infringement could      
reasonably be asserted if a person not  
licensed by the owner engaged in the    
manufacture1 use1 or sale of the drug1  
and consistent with the following       
requirements3 7i7 ,the applicant shall  
file with the application the patent    
number and the expiration date of--     
7,i7 any patent which claims the drug   
for which the applicant submitted the   
application and is a drug substance     

7including active ingredient7 patent or 
a drug product 7including formulation   
and composition7 patent2 and  7,,ii7 any
 patent which claims the method of using
 such drug4  7ii7 ,if an application is 
filed under this subsection for a drug  
and a patent of the type described in   
clause 7i7 which claims such drug or a  
method of using such drug is issued     
after the filing date but before        
approval of the application1 the        
applicant shall amend the application to
 include such patent information4  ,upon
 approval of the application1 the       
,secretary shall publish the information
 submitted under subparagraph 7,h74 ,the
 ,secretary shall1 in consultation with 
the ,director of the ,national          
,institutes of ,health and with         
representatives of the drug             
manufacturing industry1 review and      
develop guidance1 as appropriate1 on the
 inclusion of women and minorities in   
clinical trials required by subparagraph
 7,a74  4  7b7 ,conforming changes to   

requirements for subsequent submission  
of patent information ,section          
#eje7;c77#b7 of the ,federal ,food1     
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7;j77#g77 is amended--  7#a7 by    
inserting after the patent number and   
the expiration date of any patent which 
the following3 fulfills the criteria in 
subsection 7b7 and2  7#b7 by inserting  
after the first sentence the following3 
,patent information that is not the type
 of patent information required by      
subsection 7b7 shall not be submitted42 
and  7#c7 by inserting after could not  
file patent information under subsection
 7b7 because no patent the following3 of
 the type required to be submitted in   
subsection 7b74  7c7 ,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 7ii71 7iii71 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 7ii71 7iii71 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  7d7    
,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 notify 
within #ad days the ,secretary in       
writing if either of the following      
occurs3 7,i7 ,the ,patent ,trial and    
,appeals ,board issues a decision from  
which no appeal has been or can be taken
 that a patent for such drug is invalid4
  7,,ii7 ,a court issues a decision from

 which no appeal has been or can 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 paragraph      
7#e77;,b77iv7 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  7e7 ,review and
 report ,not later than #a 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 solicit public comment     
regarding 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 transmit to the ,congress an       
evaluation of such comments1 including  
any recommendations about the types of  
patent information that should be       
included on or removed from such list4  
#c4 ,,gao report to ,congress  7a7 ,in  
general ,not later than #a year after   
the date of enactment of this ,act1 the 
,comptroller ,general of the ,united    
,states 7referred to in this section as 
the ,comptroller ,general7 shall submit 
to the ,committee on ,energy and        
,commerce of the ,house of              

,representatives a report on the patents
 included in the list published under   
section #eje7;j77#g7 of the ,federal    
,food1 ,drug and ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee7;j77#g771 including an   
analysis and evaluation of the types of 
patents included in such list and the   
claims such patents make about the      
products they claim4  7b7 ,contents ,the
 ,comptroller ,general shall include in 
the report under subsection 7a7-- 7#a7  
data on the number of--  7,a7 patents   
included in the list published under    
paragraph 7#g7 of section #eje7;j7 of   
the ,federal ,food1 ,drug and ,cosmetic 
,act 7#ba ,u4,s4,c4 #cee7;j771 that     
claim the active ingredient or          
formulation of a drug in combination    
with a device that is used for delivery 
of the drug1 together comprising the    
finished dosage form of the drug2 and   
7,b7 claims in each patent that claim a 
device that is used for the delivery of 
the drug1 but do not claim such device  
in combination with an active ingredient

 or formulation of a drug2  7#b7 data on
 the date of inclusion in the list under
 paragraph 7#g7 of such section #eje7;j7
 for all patents under such list1 as    
compared to patents that claim a method 
of using the drug in combination with a 
device2  7#c7 an analysis regarding the 
impact of including on the list under   
paragraph 7#g7 of such section #eje7;j7 
certain types of patent information for 
drug product applicants and approved    
application holders1 including an       
analysis of whether--  7,a7 the listing 
of the patents described in paragraph   
7#a77;,a7 delayed the market entry of   
one or more drugs approved under such   
section #eje7;j72 and  7,b7 not listing 
the patents described in paragraph      
7#a77;,a7 would delay the market entry  
of one or more such drugs2 and  7#d7    
recommendations about which kinds of    
patents relating to devices described in
 paragraph 7#a77;,a7 should be submitted
 to the ,secretary of ,health and ,human
 ,services for inclusion on the list    

under paragraph 7#g7 of such section    
#eje7;j7 and which patents should not be
 required to be so submitted4  ,passed  
the ,house of ,representatives ,may #h1 
#bjai4;,clerk4