,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #cgji  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,decemb] #aa1         
#bjac,mr4 ,ru% 7= himself1 ,mr4 ,van    
,holl51 & ,mr4 ,waxman7 introduc$ !     
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce1 & 9    
addition to ! ,committee on ! ,judici>y1
 = a p]iod to be subsequ5tly det]m9$ by 
! ,speak]1 9 ea* case = consid]ation (  
su* provisions z fall )9 ! jurisdiction 
( ! committee conc]n$  ,a ,,bill  ,to   
prohibit br& "n drug companies f        
comp5sat+ g5]ic drug companies to delay 
! entry ( a g5]ic drug into ! m>ket1 & =
 o!r purposes4  #a4 ,%ort title ,?is    
,act may be cit$ z ! ,protect+ ,consum] 
,access to ,g5]ic ,drugs ,act ( #bjac4  
#b4 ,unfair & deceptive acts & practices
 relat$ to new drug applications  7a7   
,conduct prohibit$ ,x %all be unlawful =
 any p]son to directly or indirectly be 
a p>ty to any agreem5t resolv+ or settl+
 a pat5t infr+em5t claim 9 :i*-- 7#a7 an
 ,,&a fil] receives any?+ ( value2 &    

7#b7 ! ,,&a fil] agrees n to rese>*1    
develop1 manufacture1 m>ket1 or sell1 = 
any p]iod ( "t1 ! drug t is to be       
manufactur$ "u ! ,,&a involv$ & is !    
subject ( ! pat5t infr+em5t claim4  7b7 
,exceptions ,not)/&+ subsection 7a77#a71
 subsection 7a7 does n prohibit a       
resolution or settlem5t ( a pat5t       
infr+em5t claim 9 :i* ! value receiv$ by
 ! ,,&a fil] includes no m ?an-- 7#a7 ! 
"r to m>ket ! drug t is to be           
manufactur$ "u ! ,,&a involv$ & is !    
subject ( ! pat5t infr+em5t claim1 be=e 
! expiration (-- 7,a7 ! pat5t t is !    
basis = ! pat5t infr+em5t claim2 or     
7,b7 any o!r /atutory exclusivity t w\ld
 prev5t ! m>ket+ ( su* drug2 &  7#b7 !  
waiv] ( a pat5t infr+em5t claim =       
damages bas$ on prior m>ket+ ( su* drug4
  7c7 ,en=cem5t ,a violation (          
subsection 7a7 %all be treat$ z an      
unfair & deceptive act or practice & an 
unfair me?od ( competition 9 or affect+ 
int]/ate comm]ce prohibit$ "u section #e
 ( ! ,f$]al ,trade ,commission ,act 7#ae

 ,u4,s4,c4 #de74 ,! ,f$]al ,trade       
,commission %all en=ce ?is ,act 9 ! same
 mann]1 by ! same means1 & ) ! same     
jurisdiction z ?\gh all applicable t]ms 
& provisions ( ! ,f$]al ,trade          
,commission ,act 7 incorporat$ into &   
made a "p ( ?is ,act4  7d7 ,def9itions  
,9 ?is section3 7#a7 ,agreem5t ,! t]m   
agreem5t means any?+ t w\ld con/itute an
 agreem5t = purposes ( section #e ( !   
,f$]al ,trade ,commission ,act 7#ae     
,u4,s4,c4 #de74  7#b7 ,agreem5t resolv+ 
or settl+ ,! t]m agreem5t resolv+ or    
settl+1 9 ref]5ce to a pat5t infr+em5t  
claim1 includes any agreem5t t is       
cont+5t ^u1 provides a cont+5t condition
 =1 or is o!rwise relat$ to ! resolution
 or settlem5t ( ! claim4  7#c7 ,,&a ,!  
t]m ,,&a means an abbreviat$ new drug   
application = ! approval ( a new drug "u
 section #eje7;j7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j774  7#d7 ,,&a fil] ,! t]m ,,&a  
fil] means a p>ty t has fil$ an ,,&a ) !
 ,food & ,drug ,adm9i/ration4  7#e7     

,pat5t infr+em5t ,! t]m pat5t infr+em5t 
means infr+em5t ( any pat5t or ( any    
fil$ pat5t application1 ext5sion1       
reissuance1 r5ewal1 division1           
cont9uation1 cont9uation 9 "p1          
reexam9ation1 pat5t t]m re/oration1     
pat5t ( addition1 or ext5sion !re(4     
7#f7 ,pat5t infr+em5t claim ,! t]m pat5t
 infr+em5t claim means any allegation   
made to an ,,&a fil]1 :e!r or n includ$ 
9 a compla9t fil$ ) a c\rt ( law1 t its 
,,&a or drug to be manufactur$ "u su*   
,,&a may infr+e any pat5t4  #c4 ,,ftc   
,rulemak+ ,! ,f$]al ,trade ,commission  
may1 by rule promulgat$ "u section #eec 
( title #e1 ,unit$ ,/ates ,code1 exempt 
c]ta9 agreem5ts describ$ 9 section #b if
 ! ,commission f9ds su* agreem5ts to be 
9 fur!rance ( m>ket competition & = !   
b5efit ( consum]s4 ,consi/5t ) !        
au?ority ( ! ,commission1 su* rules may 
include int]pretive rules & g5]al       
/atem5ts ( policy ) respect to !        
practices prohibit$ "u section #b4  #d4 
,=feiture ( #ahj-;day exclusivity p]iod 

"u ! ,,ffdca ,section                   
#eje7;j77#e77;,d77i7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77#e77;,d77i77 is am5d$ 9        
subclause 7,v7 by ins]t+ section #b ( ! 
,protect+ ,consum] ,access to ,g5]ic    
,drugs ,act ( #bjac or aft] t ! agreem5t
 has violat$4  #e4 ,notice &            
c]tification ( agreem5ts  7a7 ,notice ( 
all agreem5ts ,section #aaab7;c77#b7 ( !
 ,m$ic>e ,prescription ,drug1           
,improvem5t1 & ,mod]nization ,act (     
#bjjc 7#ba ,u4,s4,c4 #caee note7 is     
am5d$ by-- 7#a7 /rik+ ! ,commission ! & 
ins]t+ ! ,commission 7#a7 !2 &  7#b7    
ins]t+ be=e ! p]iod at ! end ! foll[+3 2
 & 7#b7 a description ( ! subject matt] 
( any o!r agreem5t ! p>ties ent] into )9
 #cj days ( an ent]+ into an agreem5t   
cov]$ by subsection 7a7 or 7b74  7b7    
,c]tification ( agreem5ts ,section #aaab
 ( su* ,act is am5d$ by add+ at ! end ! 
foll[+3  7d7 ,c]tification ,! ,*ief     
,executive ,(fic] or ! company (ficial  
responsible = negotiat+ any agreem5t    

requir$ to be fil$ "u subsection 7a71   
7b71 or 7c7 %all execute & file ) !     
,assi/ant ,attorney ,g5]al & !          
,commission a c]tification z foll[s3 ,i 
decl>e "u p5alty ( p]jury t ! foll[+ is 
true & correct3 ,! mat]ials fil$ ) !    
,f$]al ,trade ,commission & ! ,dep>tm5t 
( ,ju/ice "u section #aaab ( subtitle ,b
 ( title ,,xi ( ! ,m$ic>e ,prescription 
,drug1 ,improvem5t1 & ,mod]nization ,act
 ( #bjjc1 ) respect to ! agreem5t       
ref]5c$ 9 ?is c]tification3 7#a7        
repres5t ! complete1 f9al1 & exclusive  
agreem5t betwe5 ! p>ties2 7#b7 include  
any ancill>y agreem5ts t are cont+5t ^u1
 provide a cont+5t condition =1 or are  
o!rwise relat$ to1 ! ref]5c$ agreem5t2 &
 7#c7 include writt5 descriptions ( any 
oral agreem5ts1 repres5tations1         
commitm5ts1 or promises betwe5 ! p>ties 
t are responsive to subsection 7a7 or   
7b7 ( su* section #aaab & h n be5 r$uc$ 
to writ+44  4