,,ii  #aac? ,,congress  #b;d ,session   
,s4 #cjjd  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,decemb] #aa1 #bjad    
,mr4 ,hat* 7= himself & ,mr4 ,b5net7    
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to promote ! developm5t (   
mean+ful treatm5ts = pati5ts4  #a4      
,%ort title  ,?is ,act may be cit$ z !  
,dormant ,!rapies ,act ( #bjad4  #b4    
,table ( cont5ts  ,! table ( cont5ts =  
?is ,act is z foll[s3  ,sec4 #a4 ,%ort  
title4 ,sec4 #b4 ,table ( cont5ts4 ,sec4
 #c4 ,def9itions4 ,sec4 #d4 ,captur+ lo/
 opportunities & creat+ new cures =     
pati5ts4 ,sec4 #e4 ,implem5tation &     
effect4  #c4  ,def9itions  ,9 ?is ,act3 
7#a7 ,! t]m biological product has !    
mean+ giv5 to t t]m 9 section #cea ( !  
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb74  7#b7 ,! t]m ,director 
means ! ,"u ,secret>y ( ,comm]ce =      
,intellectual ,prop]ty & ,director ( !  
,unit$ ,/ates ,pat5t & ,tradem>k ,(fice4

  7#c7 ,! t]m dormant !rapy means a     
m$ic9e designat$ z a dormant !rapy "u   
section #d7;a74  7#d7 ,! t]m drug has ! 
mean+ giv5 to t t]m 9 section #bja ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cba74  7#e7 ,! t]m      
m$ic9e means a biological product or a  
drug4  7#f7 ,! t]m protection p]iod1 )  
respect to a dormant !rapy1 means !     
p]iod t-- 7,a7 beg9s on ! date on :i* ! 
,secret>y fir/ approves an application  
"u section #eje7;b7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;b77 or section #cea7;a7 ( !       
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;a77 = ! dormant !rapy = 
any indication2 &  7,b7 ends on ! date t
 is #ae ye>s aft] ! date ( su* approval4
  7#g7 ,! t]m ,secret>y means !         
,secret>y ( ,heal? & ,human ,s]vices4   
7#h7 ,! t]m sponsor1 ) respect to a     
dormant !rapy1 is ! p]son :o takes      
responsibility = ! designation &        
developm5t ( ! dormant !rapy4 ,! sponsor
 may be a s+le entity or an entity      

collaborat+ ) "o or m o!r entities4  #d4
  ,captur+ lo/ opportunities & creat+   
new cures = pati5ts  7a7  ,designation z
 a dormant !rapy  ,! ,secret>y %all     
designate a m$ic9e z a dormant !rapy    
if--  7#a7 ! sponsor ( ! m$ic9e submits 
a reque/ = su* designation meet+ !      
requirem5ts "u subsection 7b71 & !      
reque/ has n be5 )drawn "u subsection   
7d77#a72 &  7#b7 ! ,secret>y det]m9es   
t--  7,a7 ! m$ic9e is be+ inve/igat$ or 
is int5d$ to be inve/igat$ = an         
indication to address "o or m unmet     
m$ical ne$s2  7,b7 a suitable cl9ical   
plan = su* inve/igations ( ! m$ic9e has 
be5 develop$ by ! sponsor2  7,c7 !      
sponsor int5ds to file an application   
pursuant to section #eje7;b7 ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;b77 or section #cea7;a7 
( ! ,public ,heal? ,s]vice ,act 7#db    
,u4,s4,c4 #bfb7;a77 = approval or lic5s+
 ( ! m$ic9e = an indication describ$ 9  
subp>agraph 7,a72 &  7,d7 at ! "t !     
reque/ = designation is made1 ! m$ic9e =

 :i* designation is be+ reque/$ conta9s1
 9 ! case ( a drug an active moiety t is
 n ! same z1 & 9 ! case ( a biological  
product an active moiety t is n highly  
simil> to1 an active moiety 9 a m$ic9e =
 :i* an application "u section #eje ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7 or section #cea ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bfb7 has be5 submitt$4  7b7  
,requirem5ts = reque/ = designation z   
dormant !rapy  ,a reque/ "u subsection  
7a77#a7 ) respect to a m$ic9e may be    
made only by ! sponsor ( ! m$ic9e & %all
 conta9 ea* ( ! foll[+3  7#a7 ,a li/+ ( 
all ,unit$ ,/ates pat5ts & applications 
= pat5ts "u :i* ! sponsor has rights & t
 may be reasonably con/ru$ to provide   
protection = ! m$ic9e4  7#b7 ,a waiv] ( 
pat5t rights to ! ext5t requir$ "u      
subsection 7c7 to take effect1 if at    
all1 z provid$ "u subsection 7c77#c74   
7#c7 ,su* additional in=mation z !      
,secret>y may require by regulation 9   
ord] to det]m9e eligibility =           

designation "u subsection 7a74  7c7     
,waiv] ( pat5t rights expir+ aft] !     
protection p]iod ends  7#a7  ,pat5t     
waiv]  7,a7  ,9 g5]al  ,subject to      
subp>agraph 7,b71 ! reque/ "u ?is       
subsection %all include a waiv] ( ! "r  
to en=ce or o!rwise ass]t any pat5t     
describ$ 9 subsection 7b77#a7 7or any   
pat5t issu$ on ! basis ( an application 
describ$ 9 subsection 7b77#a771 :i* may 
expire aft] ! end ( ! protection p]iod =
 ! dormant !rapy1 aga9/ any applicable  
product describ$ 9 p>agraph 7#b74 ,!    
waiv] %all be made by ! own] ( ! pat5t  
or application = pat5t1 z ! case may be4
  7,b7  ,limitations on pat5t waiv]     
,any pat5t waiv] provid$ pursuant to ?is
 section1 %\ld x become effective--  7i7
 %all h no effect dur+ ! protection     
p]iod = ! m$ic9e to :i* ! waiv] relates2
 &  7ii7 %all h no effect ) respect to !
 subject matt] ( a claim$ inv5tion 9 a  
pat5t t does n provide any protection = 
su* m$ic9e ) respect to an applicable   
product describ$ 9 p>agraph 7#b74  7#b7 

,applicable products describ$  ,an      
applicable product is describ$ 9 ?is    
p>agraph only if--  7,a7 x is approv$ or
 lic5s$ pursuant to an application t--  
7i7 is fil$ "u section #eje7;b77#b7 or  
#eje7;j7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7;b77#b71 7j77 or section #cea7k7 ( 
! ,public ,heal? ,s]vice ,act 7#db      
,u4,s4,c4 #bfb7k772 &  7ii7 ref]5ces or 
o!rwise relies ^u ! approval or lic5sure
 ( ! dormant !rapy to :i* ! waiv]       
relates2 &  7,b7 ! approval or lic5sure 
( ! product occurs aft] ! expiration ( !
 protection p]iod applicable to ! m$ic9e
 to :i* ! reque/ "u subsection 7a77#a7  
relates4  7#c7  ,effective date ( waiv] 
,a waiv] "u subsection 7b77#b7 ) respect
 to a pat5t %all take effect1 if at all1
 on ! date ! ,director publi%es ! notice
 requir$ "u subsection 7e77#b77;,f7     
relat+ to ! pat5t4  7d7  ,)drawal (     
reque/ = designation1 revocation by !   
secret>y  7#a7  ,9 g5]al  ,! sponsor ( a
 m$ic9e may )draw a reque/ = designation

 "u subsection 7a77#a7 ) respect to a   
m$ic9e unless ! m$ic9e has be5 approv$  
or lic5s$ "u section #eje ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7 or section #cea ( !     
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb74 ,! ,secret>y %all d5y a
 designation reque/ or revoke any       
designation grant$ if at any "t !       
,secret>y f9ds t ! sponsor is n 9       
compliance ) subsection 7c77#a7 or      
7g77#a74  7#b7  ,effects ( )drawal (    
reque/ or revocation ( designation  ,if 
! sponsor ( a m$ic9e )draws a reque/ "u 
subsection 7b7 or ! ,secret>y d5ies a   
designation reque/ or revokes a         
designation ) respect to ! m$ic9e--     
7,a7 any pat5t waiv] submitt$ "u ?is    
section ) respect to ! m$ic9e1 b n yet  
effective1 is cancel$ & deem$ a nullity2
  7,b7 any pat5t waiv] t has tak5 effect
 "u ?is section ) respect to ! m$ic9e   
%all rema9 9 effect2  7,c7 any pat5t t]m
 ext5sion grant$ by ! ,director "u      
subsection 7e77#b7 ) respect to ! m$ic9e

 %all be cancel$1 except t ! ,director  
%all ma9ta9 ! pat5t t]m ext5sion = "o   
pat5t1 to be select$ by ! sponsor ( !   
m$ic9e1 = ! p]iod ( ext5sion t w\ld h   
be5 applicable "u section #aef ( title  
#ce1 ,unit$ ,/ates ,code2 &  7,d7 !     
designation1 if made1 o!rwise %all be   
treat$ z nev] hav+ be5 reque/$ or made  
or hav+ effect4  7#c7  ,basis =         
revocation  ,! ,secret>y may revoke a   
designation made "u subsection 7a71 b   
only bas$ ^u a f9d+ by ! ,secret>y "u   
p>agraph 7#a74  7e7  ,gu>ante$          
protections = dormant !rapies  7#a7     
,applications fil$ dur+ ! protection    
p]iod  ,dur+ ! protection p]iod = a     
dormant !rapy1 not)/&+ any o!r provision
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cja et seq47 or !  
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bja et seq47--  7,a7 abs5t a 
"r ( ref]5ce f ! hold] ( su* approv$    
application = ! dormant !rapy1 !        
,secret>y %all n approve an application 
fil$ pursuant to section #eje7;b77#b7 or

 section #eje7;j7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;b77#b71 7j77 or section #cea7k7 ( 
! ,public ,heal? ,s]vice ,act 7#db      
,u4,s4,c4 #bfb7k77 ref]5c+ or o!rwise   
rely+ on ! approval ( ! dormant !rapy2  
7,b7 ! ,secret>y %all n approve--  7i7  
an application fil$ pursuant to su*     
section #eje7;b77#b7 or #eje7;j7 t      
ref]5ces or o!rwise relies on ! approval
 ( a m$ic9e t is n ! dormant !rapy1 0   
approv$ subsequ5t to ! approval ( !     
dormant !rapy1 & conta9s ! same active  
moiety z ! active moiety 9 ! dormant    
!rapy 7or if ! dormant !rapy conta9s m  
?an "o active moiety1 all ( ! active    
moieties are ! same72 or  7ii7 an       
application fil$ pursuant to su* section
 #cea7k7 t ref]5ces or o!rwise relies on
 ! lic5sure ( a m$ic9e t is n ! dormant 
!rapy1 0 lic5s$ subsequ5t to ! lic5sure 
( ! dormant !rapy1 & conta9s an active  
moiety t is highly simil> to ! active   
moiety 9 ! dormant !rapy 7or if !       
dormant !rapy conta9s m ?an "o active   

moiety1 all ( ! active moieties are     
highly simil>72 &  7,c7 ! ,secret>y %all
 n approve an application fil$ pursuant 
to section #eje7;b77#a7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;b77#a77 = a drug t      
conta9s ! same active moiety z ! active 
moiety 9 ! qualify+ m$ic9e 7or if !     
qualify+ m$ic9e conta9s m ?an "o active 
moiety1 all ( ! active moieties are !   
same71 or an application fil$ pursuant  
to section #cea7;a7 ( ! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77 = 
a biological product t conta9s an active
 moiety t is highly simil> to ! active  
moiety 9 ! qualify+ m$ic9e 7or if !     
qualify+ m$ic9e conta9s m ?an "o active 
moiety1 all ( ! active moieties are     
highly simil>71 unless ! in=mation      
provid$ to support approval ( su*       
application is comp>able 9 scope &      
ext5t1 includ+ ) respect to design &    
ext5t ( precl9ical & cl9ical te/+1 to ! 
in=mation provid$ to support approval ( 
! application = ! qualify+ m$ic9e "u    

section #eje7;b7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;b77 or section #cea7;a7 ( !       
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;a774  7#b7  ,pat5t t]m  
alignm5t ) data package protection p]iod
  7,a7  ,9 g5]al  ,not)/&+ any provision
 ( title #ce1 ,unit$ ,/ates ,code1 a    
sponsor ( a m$ic9e designat$ z a dormant
 !rapy "u subsection 7a77#a71 ^u !      
approval or lic5sure !re( "u section    
#eje ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or  
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb71 & 9 lieu (   
fil+ a pat5t t]m ext5sion application "u
 section #aef7;d7 ( su* title #ce1 %all 
be entitl$ to pat5t t]m ext5sions 9     
accordance ) ?is p>agraph4  7,b7        
,submission ( f9al li/+ ( pat5ts &      
applications = pat5ts foll[+ approval or
 lic5sure  7i7  ,submission  ,! sponsor 
( ! dormant !rapy1 )9 a p]iod to be set 
by ! ,director ( n less ?an #b mon?s    
beg9n+ on ! date ! ,secret>y approves or

 lic5ses ! dormant !rapy1 %all submit to
 ! ,director--  7,i7 ! li/+ ( pat5ts &  
applications = pat5ts provid$ to !      
,secret>y "u subsection 7b77#a72  7,,ii7
 any revisions to su* li/+ z may be     
requir$ = compliance ) subsection       
7b77#a72 &  7,,iii7 any docum5tation !  
,director may require f ! pat5tee or    
pat5t applicant 7z ! case may be7 ( !   
waiv] ( pat5t rights requir$ "u         
subsection 7b77#b74  7ii7  ,failure to  
provide suffici5t docum5tation ( waiv]  
,if ! ,director det]m9es t ! sponsor has
 n compli$ ) ! waiv] requirem5ts "u     
subsection 7c71 aft] provid+ ! sponsor !
 opportunity to rem$y any insuffici5cy1 
! ,director %all s notify ! ,secret>y t 
! pat5t waiv] requirem5ts = designation 
h n be5 satisfi$4  7,c7  ,ext5sion (    
pat5ts  7i7  ,9 g5]al  ,unless !        
,director has notifi$ ! ,secret>y ( a   
det]m9ation "u subp>agraph 7,b77ii71 =  
ea* pat5t id5tifi$ 9 a submission       
pursuant to subp>agraph 7,b77i71 & = ea*
 pat5t issu+ bas$ ^u an application =   

pat5t s id5tifi$1 ! ,director %all1 )9 !
 #c-mon? p]iod beg9n+ on ! date ( !     
submission1 ext5d ! pat5t to expire at !
 end ( ! protection p]iod = ! dormant   
!rapy1 if ! pat5t w\ld o!rwise expire   
be=e ! end ( ! protection p]iod4 ,if !  
,director has s notifi$ ! ,secret>y "u  
subp>agraph 7,b77ii71 ! ,director %all  
ext5d "o su* pat5t1 select$ by !        
sponsor1 = ! p]iod t w\ld h be5         
applicable _h an application = ext5sion 
be5 fil$ "u section #aef ( title #ce1   
,unit$ ,/ates ,code1 ) respect to su*   
pat5t4  7ii7  ,application ( c]ta9      
provisions  ,dur+ ! p]iod ( an ext5sion 
"u clause 7i7--  7,i7 ! rights "u !     
pat5t %all be limit$ 9 ! mann] provid$  
"u section #aef7;b7 ( title #ce1 ,unit$ 
,/ates ,code2 &  7,,ii7 ! t]ms product &
 approv$ product 9 su* section #aef7;b7 
%all be deem$ to include =ms ( ! active 
moiety ( ! dormant !rapy & highly simil>
 active moieties t might be approv$ or  
lic5s$ by ! ,secret>y bas$ ^u an        
application fil$ "u section #eje7;b77#b7

 or #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7;b77#b71 7j77 or "u section #cea7k7
 ( ! ,public ,heal? ,s]vice ,act 7#db   
,u4,s4,c4 #bfb7k77 t ref]5ces or o!rwise
 relies ^u ! dormant !rapy4  7,d7       
,int]im pat5t ext5sions  ,not)/&+ any   
provision ( title #ce1 ,unit$ ,/ates    
,code1 ) respect to any pat5t li/$ 7or  
pat5t issu+ on an application li/$7 "u  
subsection 7b77#a7 t w\ld o!rwise expire
 be=e ! sponsor c\ld make a submission  
"u subp>agraph 7,b71 ! ,director1 ^u    
application ( ! pat5tee1 %all grant to !
 pat5tee an int]im ext5sion ( su* pat5t1
 subject to ! limitations 9 section     
#aef7;d77#e77;,f7 ( su* title #ce1 = su*
 p]iod z may be necess>y to p]mit !     
sponsor to submit ! li/+ "u subp>agraph 
7,b7 &1 if ! pat5t is !re9 li/$1 to     
ext5d ! pat5t z provid$ "u subp>agraph  
7,c74 ,! ,director may require1 = any   
pat5t ext5d$ "u ?is subp>agraph1 t !    
sponsor ( ! dormant !rapy to :i* ! pat5t
 relates provide p]iodic c]tifications t

 developm5t ( ! dormant !rapy is        
cont9u+4 ,! ,director may t]m9ate any   
int]im ext5sion = :i* a requir$         
c]tification has n be5 made4  7,e7      
,notice ( ext5sion  ,= ea* pat5t t is   
ext5d$ "u ?is p>agraph1 ! ,director %all
 publi% a notice ( su* ext5sion & issue 
a c]tificate ( ext5sion describ$ 9      
section #aef7;e77#a7 ( title #ce1 ,unit$
 ,/ates ,code4  7,f7  ,notice ( waiv]   
,= ea* pat5t id5tifi$ 9 a submission "u 
subp>agraph 7,b77i71 & ea* pat5t issu+  
bas$ ^u an application = pat5t s        
id5tifi$1 t expires aft] ! end ( !      
protection p]iod = ! dormant !rapy1 !   
,director %all publi% a notice t ! pat5t
 is subject to ! limit$ waiv] ( ! "r to 
en=ce describ$ 9 subsection 7c77#a74    
7f7  ,c]ta9 ,,fda protections           
inapplicable  ,if a m$ic9e has be5      
designat$ z a dormant !rapy "u          
subsection 7a71 ! protections o!rwise   
applicable ) respect to su* m$ic9e "u   
sections #eje;,a1 #eje;,e1 & #ebg ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   

7#ba ,u4,s4,c4 #cee;a1 #cee;f1 #cfj;cc7 
%all n apply4 ,! prec$+ s5t5ce %all n be
 con/ru$ to affect any protections      
applicable ) respect to a m$ic9e1       
includ+ a m$ic9e designat$ "u section   
#ebf ( su* ,act 7#ba ,u4,s4,c4 #cfj;bb7 
= a r>e disease or condition1 "u        
provisions o!r ?an su* sections #eje;,a1
 #eje;,e1 & #ebg4  7g7  ,developm5t     
c]tifications  7#a7  ,9 g5]al  ,!       
,secret>y %all require t ! sponsor ( a  
dormant !rapy provide a c]tification t !
 cl9ical plan "u subsection 7a77#b77;,b7
 has be5 complet$1 &1 t ! initial m>ket+
 approval or lic5sure = ! qualify+      
m$ic9e 0 bas$ on ! inve/igations set =? 
9 su* cl9ical plan 7includ+             
modifications to ! initial plan approv$ 
by ! ,food & ,drug ,adm9i/ration74      
,prior to receiv+ su* c]tifications1 !  
,secret>y %all require p]iodic          
c]tifications t ! cl9ical plan "u       
subsection 7a77#b77;,b7 is cont9u+4     
7#b7  ,det]m9ation ( noncompliance  ,if 
! ,secret>y concludes t ! sponsor has n 

compli$ ) p>agraph 7#a71 aft] provid+ ! 
sponsor ! opportunity to rem$y any      
insuffici5cy1 ! ,secret>y %all1 =       
purposes ( subsection 7d77#a71 det]m9e t
 ! sponsor is n 9 compliance ) !        
c]tification requirem5t "u p>agraph     
7#a74  7h7  ,collaboration  ,no?+ 9 ?is 
section %all be con/ru$ z prev5t+ a     
sponsor f collaborat+ ) o!r entities 9  
develop+ a dormant !rapy or apply+ = a  
dormant !rapy designation4  #e4         
,implem5tation & effect  7a7 ,effective 
date ,subject to ! provisions ( ?is     
section1 ?is ,act %all take effect on ! 
date ( enactm5t4  7b7 ,implem5t+        
regulations ,! ,secret>y1 9 consultation
 ) ! ,secret>y ( ,comm]ce1 %all         
promulgate su* regulations & f9alize su*
 guidance z necess>y to implem5t !      
provisions ( section #d4 ,su*           
regulations or guidance %all take effect
 #ah mon?s aft] ! date ( enactm5t ( ?is 
,act4  7c7 ,limitation on det]m9ations &
 designations ,not)/&+ any provision (  
section #d1 ! ,secret>y may n make a    

det]m9ation on a reque/ = designation by
 a manufactur] or sponsor "u section    
#d7;a7 prior to ! effective date ( !    
regulations "u subsection 7b7 or #cj    
mon?s aft] ! date ( enactm5t ( ?is ,act1
 :i*ev] occurs fir/1 & ! ,secret>y may n
 designate a m$ic9e "u section #d7;a7   
unless ! requirem5t "u section          
#d7;a77#b77;,d7 is met = su* m$ic9e z ( 
! effective date ( ! regulations "u     
subsection 7b7 or #cj mon?s aft] ! date 
( enactm5t ( ?is ,act1 :i*ev] occurs    
fir/4