,,ii  #aafth ,,congress  #ast ,session  
,s4 #afag  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,may #bb1      
#bjai,mrs4 ,murray 7for herself and ,mr4
 ,cornyn7 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      
listing of patents in the ,orange ,book4
  #a4 ,short title ,this ,act may be    
cited as the ,second ,look at ,drug     
,patents ,act of #bjai4  #b4 ,amendments
  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 7b77#a71 at the end  
of the fifth sentence1 by inserting     
subject to subsection                   
7j77#g77;,a77iii77,,ii7 before the      
period2 and  7#b7 in subsection         
7j77#g77;,a77iii7-- 7,a7 by striking    
,when patent and inserting 7,i7 ,when   
patent2  7,b7 by inserting 1 subject to 

subclauses 7,,ii7 and 7,,iii71 after 1  
include2 and  7,c7 by adding at the end 
the following3  7,,ii7 ,the ,secretary  
shall include patent information on the 
list pursuant to subclause 7,i7 if the  
following conditions are met3 7aa7 ,if  
the patent has been issued as of the    
date on which the application is        
approved under subsection 7c71 the      
sponsor1 within #cj days of the date of 
such approval1 shall submit to the      
,under ,secretary of ,commerce for      
,intellectual ,property and ,director of
 the ,united ,states ,patent and        
,trademark ,office 7referred to in this 
clause as the ,director7 a notification 
that the sponsor has included in its    
application information about the patent
 as required under subsection 7b77#a74  
7bb7 ,if the patent is issued after the 
date on which the application is        
approved under subsection 7c71 the      
sponsor1 not later than #cj days after  
the date on which the patent is issued1 
shall submit to the ,director the       

notification described in item 7aa74    
7cc7 ,upon receipt of a notification    
under item 7aa7 or 7bb71 as applicable1 
the ,director shall publish1 not later  
than #cj days of such receipt1 in the   
,official ,gazette of the ,united       
,states ,patent and ,trademark ,office1 
and on an internet website that the     
,director shall establish1 maintain1 and
 operate1 a notification with respect to
 the patent1 requesting that any person 
that is eligible to file a request      
described in section #caa7;b7 of title  
#ce1 ,united ,states ,code1 file such a 
request4  7,,iii7 ,a patent included on 
the list as described in subclause      
7,,ii7 shall be designated as being     
provisionally included on such list     
until either of the following conditions
 is met3 7aa7 ,the ,patent ,trial and   
,appeal ,board of the ,united ,states   
,patent and ,trademark ,office 7referred
 to in this clause as the ,board7 issues
 a final written decision with respect  
to an inter partes review of all claims 

of the patent conducted under chapter   
#ca of title #ce1 ,united ,states ,code1
 and the ,director issues and publishes 
a certificate confirming those claims to
 be patentable4  7bb7 ,notwithstanding  
the filing deadlines provided under     
section #cba7;c7 of title #ce1 ,united  
,states ,code1 no person files a        
petition for inter partes review of any 
claim of the patent1 with respect to a  
patent described in subclause           
7,,ii77aa71 not later than #cjj days    
after the date on which the application 
is approved under subsection 7c71 or1   
with respect to a patent described in   
subclause 7,,ii77bb71 not later than #ae
 months after the date on which the     
application is so approved4  7,,iv7     
,with respect to a patent that is       
included on the list as described in    
subclause 7,,ii71 is designated as      
provisionally included on such list     
under subclause 7,,iii71 and1 after an  
inter partes review of the patent       
conducted under chapter #ca of title    

#ce1 ,united ,states ,code1 is subject  
to a final written decision of the      
,board and a certificate issued and     
published by the ,director canceling one
 or more claims of the patent finally   
determined to be unpatentable1 the      
holder of the approved application1 not 
later than #cj days after the date on   
which the ,director publishes the       
certificate1 shall submit to the        
,secretary-- 7aa7 if that decision and  
certificate relate to all claims of the 
patent1 a request to remove the patent  
from the list2 and  7bb7 if that        
decision and certificate do not relate  
to all claims of the patent1 a request  
to remove the patent information        
relating to the claim or claims to which
 that decision and certificate relate   
from the list4  7,v7 ,if1 as of the date
 on which a drug is approved under      
subsection 7c71 a complaint has been    
filed in a district court of the ,united
 ,states challenging the validity of a  
patent1 a patent submitted under        

subsection 7b7 or 7c7 respecting such   
drug included on the list shall be      
included on the list until the date on  
which the court invalidates the patent1 
if applicable4  7,,vi7 ,nothing in this 
clause shall affect the availability to 
a first applicant of an exclusivity     
period pursuant to clause 7iv7 or 7v7 of
 paragraph 7#e77;,b71 provided that1 at 
the time that the first applicant       
submits an application under this       
subsection containing a certification   
described in paragraph                  
7#b77;,a77vii77,,iv71 information about 
the patent is included on the list or is
 included on the list on a provisional  
basis4  4  7b7 ,effective date ,the     
amendments made by subsection 7a7 shall 
apply only with respect to patents      
issued after the date of enactment of   
this ,act4