,i  #aac? ,,congress  #b;d ,session  ,h4
 ,r4 #dbhg  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,m>* #bd1 #bjad ,mr4  
,ca/ro ( ,texas 7= himself & ,mr4 ,=bes7
 introduc$ ! foll[+ bill2 :i* 0 ref]r$  
to ! ,committee on ! ,judici>y  ,a      
,,bill  ,to advance ! public heal? by   
enc\rag+ indep5d5t innovators to pursue 
drug repurpos+ rese>* & develop new     
treatm5ts & cures by provid+ appropriate
 intellectual prop]ty protections = ^?  
innovations1 & = o!r purposes4  #a4     
,%ort title ,?is ,act may be cit$ z !   
,indep5d5t ,innovator & ,repurpos+ ,act4
  #b4 ,ext5sion ( pat5t t]m = me?od (   
us+ biological product  7a7 ,ext5sion = 
regulatory delay ,! t]m ( a pat5t claim+
 a me?od ( us+ a biological product %all
 be ext5d$ = #e ye>s f ! orig9al        
expiration date ( ! pat5t1 :i* %all     
include any pat5t t]m adju/m5t grant$ "u
 section #aed7;b7 ( title #ce1 ,unit$   
,/ates ,code1 if--  7#a7 an application 
= an ext5sion is submitt$ by ! own] (   
record ( ! pat5t or its ag5t 9          

accordance ) ! requirem5ts ( subsection 
7b72 &  7#b7 ! t]m ( ! pat5t--  7,a7 has
 n expir$ be=e ! application is s       
submitt$2 &  7,b7 has n be5 ext5d$ "u   
subsection 7c7 ( ?is section or section 
#aef ( title #ce1 ,unit$ ,/ates ,code4  
7b7 ,application = ext5sion ,to obta9 an
 ext5sion ( ! t]m ( a pat5t "u ?is      
section1 ! own] ( record ( ! pat5t or   
its ag5t %all submit an application to !
 ,director4 ,! application %all conta9--
  7#a7 ! id5tity ( ! biological product2
  7#b7 ! id5tity ( ! pat5t = :i* an     
ext5sion is be+ s\ght & ! id5tity ( ea* 
claim ( su* pat5t t claims ! me?od ( us+
 ! biological product2  7#c7 in=mation  
demon/rat+ to ! ,director t--  7,a7 !   
pat5t 0 issu$ to an indep5d5t innovator2
  7,b7 ! own] ( record is--  7i7 !      
indep5d5t innovator2 or  7ii7 a qualifi$
 small bus9ess 9 :i* ! indep5d5t        
innovator has an own]%ip int]e/2  7,c7  
an application "u section #cea7;a7 ( !  
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;a77 = comm]cial m>ket+ (

 ! biological product = a me?od ( use   
claim$ 9 ! pat5t has be5 fil$2 &  7,d7 a
 p]iod ( n less ?an #aj ye>s elaps$     
betwe5 ! orig9al date ( submission ( an 
application = an exemption "u section   
#eje7;i7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 
= inve/igat+ su* me?od ( use & ! date on
 :i* ! ,food & ,drug ,adm9i/ration      
approv$ ! application describ$ 9        
subp>agraph 7,c72 &  7#d7 a brief       
description ( ! activities und]tak5 by !
 own] ( record ( ! pat5t1 or ! ag5t (   
su* own]1 dur+ su* p]iod ) respect to ! 
biological product & ! significant dates
 applicable to su* activities to ! ext5t
 su* in=mation is possess$ by su* own]4 
7c7 ,det]m9ation ( ext5sion  7#a7 ,9    
g5]al ,a det]m9ation t a pat5t is       
eligible = ext5sion %all be made by !   
,director solely on ! basis ( !         
repres5tations conta9$ 9 ! application =
 ! ext5sion4 ,if ! ,director det]m9es t 
a pat5t is eligible = ext5sion "u       
subsection 7a7 & t ! requirem5ts (      

subsection 7b7 h be5 compli$ )1 !       
,director %all issue to ! applicant = ! 
ext5sion ( ! t]m ( ! pat5t a c]tificate 
( ext5sion1 "u seal1 = #e ye>s4 ,su*    
c]tificate %all be record$ 9 ! (ficial  
file ( ! pat5t & %all be consid]$ z "p (
 ! orig9al pat5t4  7#b7 ,int]im ext5sion
 ,if ! t]m ( a pat5t = :i* an           
application has be5 submitt$ "u         
subsection 7b7 w\ld expire be=e a       
c]tificate ( ext5sion is issu$ or d5i$  
"u p>agraph 7#a7 respect+ ! application1
 ! ,director %all ext5d1 until su*      
det]m9ation is made1 ! t]m ( ! pat5t =  
p]iods ( up to "o ye> if ! ,director    
det]m9es t ! pat5t is eligible =        
ext5sion4  7d7 ,def9itions ,9 ?is       
section3  7#a7 ,biological product ,!   
t]m biological product has ! mean+ giv5 
to su* t]m 9 section #cea7;i77#a7 ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;i77#a774  7#b7 ,director
 ,! t]m ,director means ! ,"u ,secret>y 
( ,comm]ce = ,intellectual ,prop]ty &   
,director ( ! ,unit$ ,/ates ,pat5t &    

,tradem>k ,(fice4  7#c7 ,indep5d5t      
innovator  7,a7 ,! t]m indep5d5t        
innovator means any p]son or entity t-- 
7i7 obta9s a me?od ( use pat5t = a      
biological product2 &  7ii7 is n1 at !  
"t ( inv5tion or pat5t fil+1 affiliat$ )
 ! hold] ( a m>ket+ application approv$ 
"u section #cea7;a7 ( ! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77 = 
! comm]cial m>ket+ ( su* biological     
product4  7,b7 ,= purposes ( subp>agraph
 7,a7 & p>agraph 7#d71 ! t]m affiliat$  
ref]s to any relation%ip ( employm5t1   
control1 or common own]%ip1 :e!r direct 
or indirect1 includ+ ?r\gh "o or m      
int]m$i>ies4  7#d7 ,qualifi$ small      
bus9ess ,! t]m qualifi$ small bus9ess   
means any entity ) few] ?an #ejj        
employees1 includ+ employees (          
affiliates1 & :i* is n affiliat$ ) !    
hold] ( ! m>ket+ application approv$ "u 
section #cea7;a7 ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4 sec4        
#bfb7;a77 = ! comm]cial m>ket+ ( su*    
biological product4  7e7 ,effective date

 ,?is section %all take effect on ! date
 ( ! enactm5t ( ?is ,act & %all apply to
 any unexpir$ pat5t issu$ be=e1 on1 or  
aft] t effective date4