,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #ciia  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,july #be1 #bjai,mr4  
,johnson ( ,georgia 7= himself & ,mrs4  
,roby7 introduc$ ! foll[+ bill2 :i* 0   
ref]r$ to ! ,committee on ! ,judici>y   
,a ,,bill  ,to am5d title #ce1 ,unit$   
,/ates ,code1 to cl>ify & improve !     
process = subsection 7k7 applicants to  
resolve pat5t infr+em5t claims =        
biological products 7commonly kn[n z !  
pat5t dance71 & = o!r purposes4  #a4    
,%ort title ,?is ,act may be cit$ z !   
,af=dable ,prescriptions = ,pati5ts     
,?r\gh ,improvem5ts to ,pat5t           
,litigation ,act ( #bjai4  #b4 ,title   
#ce am5dm5ts  7a7 ,9 g5]al ,section     
#bga7;e7 ( title #ce1 ,unit$ ,/ates     
,code1 is am5d$--  7#a7 9 p>agraph      
7#b77;,c71 9 ! flu% text foll[+ clause  
7ii71 by add+ at ! end ! foll[+3 ,)     
respect to a submission describ$ 9      
clause 7ii71 ! act ( infr+em5t %all     
ext5d to any pat5t t claims ! biological
 product1 a me?od ( us+ ! biological    

product1 or a me?od or product us$ to   
manufacture ! biological product42 &    
7#b7 by add+ at ! end ! foll[+3  7#g7   
7,a7 ,subject to subp>agraphs 7,c71     
7,d71 & 7,e71 if ! sponsor ( an approv$ 
application = a ref]5ce product1 z def9$
 9 section #cea7;i7 ( ! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i77   
7ref]r$ to 9 ?is p>agraph z ! ref]5ce   
product sponsor71 br+s an action =      
infr+em5t "u ?is section aga9/ an       
applicant = approval ( a biological     
product "u section #cea7k7 ( su* ,act t 
ref]5ces t ref]5ce product 7ref]r$ to 9 
?is p>agraph z ! subsection 7k7         
applicant71 ! ref]5ce product sponsor   
may ass]t 9 ! action a total ( n m ?an  
#bj pat5ts ( ! type describ$ 9          
subp>agraph 7,b71 n m ?an #aj ( :i* %all
 h issu$ aft] ! date specifi$ 9 section 
#cea7l77#g77;,a7 ( su* ,act4  7,b7 ,!   
pat5ts describ$ 9 ?is subp>agraph are   
pat5ts t satisfy ea* ( ! foll[+         
requirem5ts3  7i7 ,pat5ts t claim !     
biological product t is ! subject ( an  

application "u section #cea7k7 ( !      
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7k77 7or a use ( t        
product7 or a me?od or product us$ 9 !  
manufacture ( su* biological product4   
7ii7 ,pat5ts t are includ$ on ! li/ (   
pat5ts describ$ 9 section               
#cea7l77#c77;,a7 ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4             
#bfb7l77#c77;,a771 includ+ z provid$ "u 
section #cea7l77#g7 ( su* ,act4  7iii7  
,pat5ts t-- 7,i7 h an actual fil+ date (
 m ?an #d ye>s aft] ! date on :i* !     
ref]5ce product is approv$2 or  7,,ii7  
include a claim to a me?od 9 a          
manufactur+ process t is n us$ by !     
ref]5ce product sponsor4  7,c7 ,! c\rt 9
 :i* an action describ$ 9 subp>agraph   
7,a7 is br\ght may increase ! numb] (   
pat5ts limit$ "u t subp>agraph--  7i7 if
 ! reque/ to increase t numb] is made   
)\t undue delay2 &  7ii7 7,i7 if !      
int]e/ ( ju/ice s requires2 or  7,,ii7 =
 good cause %[n1 :i*-- 7aa7 %all be     
e/abli%$ if ! subsection 7k7 applicant  

fails to provide in=mation requir$ "u   
p>agraph 7#b77;,a7 t w\ld enable !      
ref]5ce product sponsor to =m a         
reasonable belief ) respect to :e!r a   
claim ( infr+em5t "u ?is section c\ld   
reasonably be ass]t$2 &  7bb7 may be    
e/abli%$-- 7,,aa7 if !re is a mat]ial   
*ange to ! biological product 7or       
process ) respect to ! biological       
product7 ( ! subsection 7k7 applicant t 
is ! subject ( ! application2 7,,bb7 if1
 ) respect to a pat5t on ! supplem5tal  
li/ describ$ 9 section #cea7l77#g77;,a7 
( ,public ,heal? ,s]vice ,act 7#db      
,u4,s4,c4 #bfb7l77#g77;,a771 ! pat5t    
w\ld h issu$ be=e ! date specifi$ 9 su* 
section #cea7l77#g77;,a7 b = ! failure (
 ! ,(fice to issue ! pat5t or a delay 9 
! issuance ( ! pat5t1 z describ$ 9      
p>agraph 7#a7 ( section #aed7;b7 &      
subject to ! limitations "u p>agraph    
7#b7 ( su* section #aed7;b72 or 7,,cc7 =
 ano!r reason t %[s good cause1 z       
det]m9$ appropriate by ! c\rt4  7,d7 ,9 
det]m9+ :e!r good cause has be5 %[n = ! 

purposes ( subp>agraph 7,c77ii77,,ii71 a
 c\rt may consid] :e!r ! ref]5ce product
 sponsor has provid$ a reasonable       
description ( ! id5tity & relevance (   
any in=mation beyond ! subsection 7k7   
application t ! c\rt believes is        
necess>y to enable ! c\rt to =m a belief
 ) respect to :e!r a claim ( infr+em5t  
"u ?is section c\ld reasonably be       
ass]t$4  7,e7 ,! limitation impos$ "u   
subp>agraph 7,a7-- 7i7 %all apply only  
if ! subsection 7k7 applicant completes 
all actions requir$ "u p>agraphs        
7#b77;,a71 7#c77;,b77ii71 7#e71         
7#f77;,c77i71 7#g71 & 7#h77;,a7 (       
section #cea7l7 ( ! ,public ,heal?      
,s]vice ,act 7#db ,u4,s4,c4 #bfb7l772 & 
7ii7 %all n apply ) respect to any pat5t
 t claims1 ) respect to a biological    
product1 a me?od = us+ t product 9      
!rapy1 diagnosis1 or prophylaxis1 su* z 
an indication or me?od ( treatm5t or o!r
 condition ( use4  4  7b7 ,applicability
 ,! am5dm5ts made by subsection 7a7 %all
 apply ) respect to an application      

submitt$ "u section #cea7k7 ( ! ,public 
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7k77 on or aft] ! date ( enactm5t ( 
?is ,act4