,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #fdhe  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,decemb] #e1 #bjbe,mr4
 ,cl9e 7= himself & ,ms4 ,l(gr57        
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ! ,judici>y  ,a ,,bill 
,to am5d title #ce1 ,unit$ ,/ates ,code1
 to provide = a safe h>bor f infr+em5t (
 a me?od ( use pat5t relat+ to drugs or 
biological products4  #a4 ,%ort title   
,?is ,act may be cit$ z ! ,sk9ny        
,labels1 ,big ,sav+s ,act4  #b4 ,safe   
h>bor f infr+em5t ( a me?od ( use pat5t 
7a7 ,9 g5]al ,section #bga ( title #ce1 
,unit$ ,/ates ,code1 is am5d$--  7#a7 by
 r$esignat+ subsections 7h7 & 7i7 z     
subsections 7k7 & 7l71 respectively2 &  
7#b7 by ins]t+ aft] subsection 7g7 !    
foll[+3  7h7  7#a7 ,! foll[+ %all n be  
acts ( direct1 induc$1 or contributory  
infr+em5t ( a me?od ( use claim 9 a     
pat5t includ$ 9 ! li/ describ$ 9 section
 #eje7;j77#g7 or section #eab7n77#d7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cee7;j77#g71            

#cfj;b7n77#d77 9 an action or c\nt]claim
 "u ?is section3 7,a7 ,submitt+ or seek+
 approval ( an application "u section   
#eje7;j7 or section #eab7;b77#b7 ( !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;j71 #cfj;b7b77#b771
 or submitt+ or seek+ approval ( an     
application describ$ 9 section          
#eje7;b77#b7 ( su* ,act 7#ba ,u4,s4,c4  
#cee7;b77#b771 provid$ t su* application
 includes a /atem5t "u1 z applicable1   
section #eje7;j77#b77;,a77viii71 section
 #eab7n77#a77;,i71 or section           
#eje7;b77#b77;,b7 ( su* ,act 7#ba       
,u4,s4,c4 #cee7;j77#b77;,a77viii71      
#cfj;b7n77#a77;,i71 #cee7;b77#b77;,b77 =
 ! me?od ( use claims 9 ! pat5t ) !     
label+ propos$ 9 su* application4  7,b7 
,promot+ or comm]cially m>ket+ a drug   
product ) ! label+ approv$ 9 an         
application describ$ 9 subp>agraph 7,a74
  7,c7 ,describ+ a drug product approv$ 
9 an application submitt$ "u section    
#eje7;j7 or section #eab7;b77#b7 ( su*  
,act 7#ba ,u4,s4,c4 #cee7;j71           

#cfj;b7b77#b77 or approv$ 9 an          
application describ$ 9 section          
#eje7;b77#b7 ( su* ,act 7#ba ,u4,s4,c4  
#cee7;b77#b77 z a g5]ic (1 or           
!rapeutically equival5t to1 ! li/$ drug 
ref]5c$ 9 su* application1 z applicable4
  7#b7 ,subp>agraphs 7,a7 ?r\gh 7,c7 (  
p>agraph 7#a7 %all apply only if !      
label+1 promotion1 or comm]cial m>ket+  
does n ref]5ce ! condition or conditions
 ( use claim$ 9 ! pat5t t 0 id5tifi$ by 
! pat5t own] or assignee to ! ,secret>y 
"u section #cad4ec ( title #ba1 ,code ( 
,f$]al ,regulations 7or a successor     
regulation7 & t 0 subject to ! /atem5t  
"u section #eje7;j77#b77;,a77viii71     
section #eab7n77#a77;,i71 or section    
#eje7;b77#b77;,b7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77#b77;,a77viii71                
#cfj;b7n77#a77;,i71 #cee7;b77#b77;,b771 
z applicable4  7i7 7#a7 ,! foll[+ %all n
 be acts ( direct1 induc$1 or           
contributory infr+em5t ( a pat5t claim  
cov]+ a me?od ( us+ ! ref]5ce product 9 

an action or c\nt]claim "u ?is section3 
7,a7 ,submitt+ or seek+ approval ( an   
application "u section #cea7k7 ( !      
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7k774  7,b7 ,describ+ a   
biological product approv$ 9 an         
application describ$ 9 subp>agraph 7,a7 
z biosimil> to1 or int]*angeable )1 !   
ref]5ce product1 z applicable1 ) !      
label+ approv$ 9 su* application1 :5 !  
biological product has n be5 approv$ = !
 pat5t$ condition or conditions ( use4  
7,c7 ,promot+ or comm]cially m>ket+ a   
biological product ) ! label+ approv$ 9 
an application describ$ 9 subp>agraph   
7,a74  7#b7 ,subp>agraphs 7,a7 ?r\gh    
7,c7 ( p>agraph 7#a7 %all apply only if 
! label+1 promotion1 or comm]cial m>ket+
 does n ref]5ce ! condition or          
conditions ( use claim$ 9 ! pat5t &     
specifically reflect$ 9 ! prescrib+     
in=mation4  7j7 ,z us$ 9 ?is section3   
7#a7 ,! t]ms biological product1        
biosimil>1 int]*angeable1 & ref]5ce     
product h ! mean+s giv5 su* t]ms 9      

section #cea7;i7 ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i774  
7#b7 ,! t]m comm]cial m>ket+ has ! mean+
 giv5 su* t]m 9 section #cad4c ( title  
#ba1 ,code ( ,f$]al ,regulations 7or a  
successor regulation74  7#c7 ,! t]m     
label+ has ! mean+ giv5 su* t]m 9       
section #bja7m7 ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act 7#ba ,u4,s4,c4        
#cba7m774  7#d7 ,! t]m promot+-- 7,a7 is
 )9 ! mean+ ( ! t]m us$ 9 section #bjb4a
 ( title #ba1 ,code ( ,f$]al            
,regulations 7or a successor            
regulation72 &  7,b7 includes ! use (   
promotional label+ & adv]tis+1 z        
describ$ 9 p>agraphs 7#a7 & 7#b7 (      
section #bjb4a7l7 ( title #ba1 ,code (  
,f$]al ,regulations 7or successor       
regulations74  4  7b7 ,application ,?is 
,act & ! am5dm5ts made by ?is ,act %all 
apply to--  7#a7 conduct t occurs be=e1 
on1 or aft] ! date ( enactm5t ( ?is     
,act2 &  7#b7 all judicial or o!r       
proce$+s p5d+ z ( su* date ( enactm5t4