,,ii  #aaf? ,,congress  #a/ ,session    
,s4 #cdd  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,febru>y #f1 #bjai,mr4 
,tillis introduc$ ! foll[+ bill2 :i* 0  
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act & ! ,securities 
,ex*ange ,act ( #aicd to prev5t ! int]  
p>tes review process = *all5g+ pat5ts f 
dim9i%+ competition 9 ! ph>maceutical   
indu/ry & ) respect to drug innovation1 
& = o!r purposes4  #a4 ,%ort title ,?is 
,act may be cit$ z ! ,hat*-,waxman      
,integrity ,act ( #bjai4  #b4 ,prev5t+ !
 int] p>tes review process = *all5g+    
pat5ts f dim9i%+ competition 9 !        
ph>maceutical indu/ry & ) respect to    
drug innovation  7a7 ,br& "n drugs      
,section #eje7;b77#b7 ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;b77#b77 is am5d$-- 7#a7 9         
subp>agraph 7,a77iv71 by /rik+ & at !   
end2  7#b7 9 subp>agraph 7,b71 by /rik+ 
! p]iod at ! end & ins]t+ 2 &2 &  7#c7  

by add+ at ! end ! foll[+3  7,c7 9 ea*  
c]tification requir$ "u subp>agraph 7,a7
 ) respect to a pat5t1 a c]tification   
t--  7i7 nei!r ! applicant nor any p>ty 
9 privity )1 relat$ to1 or coop]at+ ) ! 
applicant has fil$1 or w file1 a        
petition to in/itute an int] p>tes      
review or a po/-grant review ( t pat5t  
"u *apt] #ca or #cb1 respectively1 (    
title #ce1 ,unit$ ,/ates ,code2 &  7ii7 
9 mak+ ! c]tification requir$ "u        
subp>agraph 7,a71 ! applicant is n rely+
 9 :ole or 9 "p on any decision issu$ by
 ! ,pat5t ,trial & ,appeal ,bo>d 9 an   
int] p>tes review or a po/-grant review 
in/itut$ "u *apt] #ca or #cb1           
respectively1 ( title #ce1 ,unit$ ,/ates
 ,code4  4  7b7 ,g5]ic drugs ,section   
#eje7;j77#b77;,a7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77#b77;,a77 is am5d$--  7#a7 9   
clause 7vii77,,iv71 by /rik+ & at ! end2
  7#b7 9 clause 7viii71 by /rik+ ! p]iod
 at ! end & ins]t+ 2 &2  7#c7 by ins]t+ 
aft] clause 7viii71 z am5d$ by p>agraph 

7#b71 ! foll[+3  7ix7 9 ea* c]tification
 requir$ "u clause 7vii7 ) respect to a 
pat5t1 a c]tification t--  7,i7 nei!r ! 
applicant nor any p>ty 9 privity )1     
relat$ to1 or coop]at+ ) ! applicant has
 fil$1 or w file1 a petition to in/itute
 an int] p>tes review or a po/-grant    
review ( t pat5t "u *apt] #ca or #cb1   
respectively1 ( title #ce1 ,unit$ ,/ates
 ,code2 &  7,,ii7 9 mak+ ! c]tification 
requir$ "u clause 7vii71 ! applicant is 
n rely+ 9 :ole or 9 "p on any decision  
issu$ by ! ,pat5t ,trial & ,appeal ,bo>d
 9 an int] p>tes review or a po/-grant  
review in/itut$ "u *apt] #ca or #cb1    
respectively1 ( title #ce1 ,unit$ ,/ates
 ,code4  2 &  7#d7 9 ! flu% text foll[+ 
clause 7ix71 z add$ by p>agraph 7#c71 by
 /rik+ 7viii7 & ins]t+ 7ix74  7c7       
,biosimil> drugs2 evaluation by !       
,secret>y ,section #cea7k7 ( ! ,public  
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7k77 is am5d$--  7#a7 9 p>agraph    
7#b77;,a77iii7-- 7,a7 by r$esignat+     
subclauses 7,i7 & 7,,ii7 z items 7aa7 & 

7bb71 respectively1 & adju/+ ! m>g9s    
accord+ly2  7,b7 9 ! matt] prec$+ item  
7aa71 z s r$esignat$1 by /rik+ ,an      
application & ins]t+ ! foll[+3  7,i7 ,9 
g5]al ,an application  2  7,c7 9        
subclause 7,i71 z s designat$-- 7i7 9   
item 7aa71 z s r$esignat$1 by /rik+ & at
 ! end2  7ii7 9 item 7bb71 z s          
r$esignat$1 by /rik+ ! p]iod at ! end & 
ins]t+ 2 &2 &  7iii7 by add+ at ! end ! 
foll[+3  7cc7 %all1 ) respect to a pat5t
 describ$ 9 subclause 7,,ii71 include a 
c]tification t nei!r ! applicant nor any
 p>ty 9 privity )1 relat$ to1 or        
coop]at+ ) ! applicant has fil$1 or w   
file1 a petition to in/itute an int]    
p>tes review or a po/-grant review ( !  
pat5t "u *apt] #ca or #cb1 respectively1
 ( title #ce1 ,unit$ ,/ates ,code4  2 & 
7,d7 by add+ at ! end ! foll[+3  7,,ii7 
,pat5t describ$ ,a pat5t is describ$ 9  
?is subclause if--  7aa7 ! pat5t cov]s !
 ref]5ce product or a me?od = us+ !     
ref]5ce product2 &  7bb7 7,,aa7 !       
ref]5ce product describ$ 9 item 7aa7 is 

m>k$ "u section #bhg7;a7 ( title #ce1   
,unit$ ,/ates ,code2 or 7,,bb7 !re is   
o!rwise public notice reg>d+ !          
applicability ( ! ref]5ce product       
describ$ 9 item 7aa74  2 &  7#b7 9      
p>agraph 7#c7-- 7,a7 9 subp>agraph      
7,a77ii71 by /rik+ & at ! end2  7,b7 9  
subp>agraph 7,b71 by /rik+ ! p]iod at ! 
end & ins]t+ 2 &2 &  7,c7 by add+ at !  
end ! foll[+3  7,c7 ! ,secret>y det]m9es
 t ! application fully complies ) !     
requirem5ts "u p>agraph 7#b77;,a77iii74 
4  #c4 ,prev5t+ ! manipulative &        
deceptive use ( int] p>tes review       
,section #aj7;b7 ( ! ,securities        
,ex*ange ,act ( #aicd 7#ae ,u4,s4,c4    
#gh;j7b77 is am5d$-- 7#a7 by ins]t+ 7#a7
 aft] 7b72 &  7#b7 by add+ at ! end !   
foll[+3  7#b7 ,= purposes ( p>agraph    
7#a71 a p]son %all be consid]$ to be us+
 a manipulative or deceptive device if--
  7,a7 ! p]son1 or an affiliate ( !     
p]son1 files a petition to in/itute an  
int] p>tes review "u *apt] #ca ( title  
#ce1 ,unit$ ,/ates ,code1 ) respect to a

 pat5t2 &  7,b7 ! p]son1 or an affiliate
 ( ! p]son1 dur+ ! #ahj-;day p]iod      
beg9n+ on ! date t is #ij days be=e !   
date on :i* ! p]son files ! petition    
describ$ 9 subp>agraph 7,a71 engages 9 a
 %ort sale ( any publicly trad$ security
 ( ! own] ( ! pat5t t is ! subject ( !  
petition4  4