,,ii  #aah? ,,congress  #a/ ,session    
,s4 #egd  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,m>* #a1 #bjbc,ms4     
,hassan 7= h]self & ,mr4 ,braun7        
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to prev5t ! use 
( pat5ts1 trade secrets1 or o!r         
intellectual prop]ty to inhibit         
competition4  #a4 ,%ort title ,?is ,act 
may be cit$ z ! ,increas+ ,prescription 
,drug ,competition ,act4  #b4 ,prev5t+ !
 use ( pat5ts1 trade secrets1 or o!r    
intellectual prop]ty on risk evaluation 
& mitigation /rategies to inhibit       
competition ,section #eje-a ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee-a7 is am5d$ by add+ at ! 
end ! foll[+3  7n7 ,additional          
requirem5ts  7#a7 ,pat5ts claim+ ,,rems 
,if an application "u subsection 7b77#b7
 or 7j7 ( section #eje includes a       
c]tification "u subsection 7b77#b77;,a7 

or 7j77#b77;,a77vii7 ( section #eje )   
respect to a pat5t t claims an aspect ( 
! elem5ts to assure safe use ( a risk   
evaluation & mitigation /rategy         
requirem5ts "u subsection 7f7 = !       
applicable li/$ drug1 su* c]tification  
%all h no effect on ! effective date ( !
 approval ( ! application1 not)/&+      
subp>agraphs 7,b7 & 7,c7 ( section      
#eje7;c77#c7 & clauses 7ii7 & 7iii7 (   
section #eje7;j77#e77;,b74 ,?is p>agraph
 %all apply to all applications submitt$
 to ! ,secret>y "u subsection 7b77#b7 or
 7j7 ( section #eje be=e1 on1 or aft] ! 
date ( enactm5t ( ! ,increas+           
,prescription ,drug ,competition ,act4  
7#b7 ,damages ,9 ! ev5t t ! sponsor (   
ano!r application "u section #eje ( ?is 
,act or section #cea ( ! ,public ,heal? 
,s]vice ,act infr+es a pat5t1 trade     
secret1 or any o!r intellectual prop]ty 
held by ! sponsor or hold] to comply )  
risk evaluation & mitigation /rategy    
requirem5ts "u ?is section1 ! sponsor or
 hold] ( ! approv$ application %all n   

seek1 or claim entitlem5t to1 any rem$y 
o!r ?an damages aris+ f ! infr+em5t4    
7#c7 ,cl>ifications ,no?+ 9 ?is section 
%all be con/ru$ z-- 7,a7 prohibit+ !    
sponsor or hold] ( an approv$           
application f all[+ ! sponsor ( ano!r   
application "u section #eje ( ?is ,act  
or section #cea ( ! ,public ,heal?      
,s]vice ,act to use ! pat5t1 trade      
secret1 or any o!r intellectual prop]ty 
o!r ?an z describ$ 9 ?is subsection2    
7,b7 prev5t+ a sponsor ( an application 
"u section #eje ( ?is ,act or section   
#cea ( ! ,public ,heal? ,s]vice ,act f  
us+ a diff]5t1 comp>able aspect ( !     
elem5ts to assure safe use z au?oriz$ "u
 ?is section2  7,c7 9 any way negat+ !  
applicability ( a risk evaluation &     
mitigation /rategy ) elem5ts to assure  
safe use1 z o!rwise requir$ "u ?is      
section2 or  7,d7 limit+ ! application (
 any provision ( ! antitru/ laws 7z     
def9$ 9 subsection 7a7 ( ! fir/ section 
( ! ,clayton ,act 7#ae ,u4,s4,c4        
#ab7;a774  4