,,ii ,cal5d> ,no4 #acb #aaf? ,,congress 
#a/ ,session  ,s4 #adaf  ,,9 ,,! ,,s5ate
 ,,( ,,! ,,unit$ ,,/ates  ,may #i1      
#bjai,mr4 ,cornyn 7= himself1 ,mr4      
,blum5?al1 ,mrs4 ,capito1 ,mrs4 ,murray1
 ,mr4 ,scott ( ,florida1 ,mr4 ,k5n$y1   
,mr4 ,hawley1 & ,mr4 ,durb97 introduc$ !
 foll[+ bill2 :i* 0 read twice & ref]r$ 
to ! ,committee on ! ,judici>y  ,june   
#bh 7legislative day1 ,june #bg71       
#bjai,report$ by ,mr4 ,graham1 ) an     
amendment,strike out all aft] ! enact+  
clause & ins]t ! "p pr9t$ 9 italic  ,a  
,,bill  ,to am5d ! ,f$]al ,trade        
,commission ,act to prohibit            
anticompetitive behaviors by drug       
product manufactur]s1 & = o!r purposes4 
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,af=dable ,prescriptions = ,pati5ts   
,act ( #bjai4  #b4 ,product hopp+2 pat5t
 ?icket+  7a7 ,9 g5]al ,! ,f$]al ,trade 
,commission ,act 7#ae ,u4,s4,c4 #da et  
seq47 is am5d$ by ins]t+ aft] section   
#bf 7#ae ,u4,s4,c4 #eg;c-#b7 ! foll[+3  
#bg4 ,product hopp+2 pat5t ?icket+  7a7 

,def9itions ,9 ?is section3 7#a7        
,abbreviat$ new drug application ,! t]m 
abbreviat$ new drug application means an
 application "u subsection 7b77#b7 or   
7j7 ( section #eje ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee74  7#b7 ,biosimil> biological      
product ,! t]m biosimil> biological     
product means a biological product      
lic5s$ "u section #cea7k7 ( ! ,public   
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7k774  7#c7 ,biosimil> biological   
product lic5se application ,! t]m       
biosimil> biological product lic5se     
application means an application        
submitt$ "u section #cea7k7 ( ! ,public 
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7k774  7#d7 ,competition w9d[ ,! t]m
 competition w9d[ means-- 7,a7 ) respect
 to a li/$ drug1 ! p]iod betwe5--  7i7 !
 date t is ! e>li] (-- 7,i7 #h ye>s be=e
 any pat5t or m>ket+ exclusivity grant$ 
"u *apt] ,v ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4 #cea et   
seq47 ) respect to su* li/$ drug        

expires2 &  7,,ii7 ! date on :i* ! fir/ 
abbreviat$ new drug application t       
ref]5ces su* li/$ drug is fil$2 &  7ii7 
! lat] (-- 7,i7 ! date t is #ahj days   
aft] ! fir/ abbreviat$ new drug         
application t ref]5ces su* li/$ drug is 
fil$2 &  7,,ii7 ! date t is #a ye> aft] 
! date on :i* ! g5]ic drug t is !       
subject ( ! abbreviat$ new drug         
application describ$ 9 subclause 7,i7   
ent]s ! m>ketplace2 or  7,b7 ) respect  
to a ref]5ce product1 ! p]iod betwe5--  
7i7 ! date t is ! e>li] (--  7,i7 #f    
ye>s be=e any pat5t or m>ket+           
exclusivity 7includ+ any ext5sion ( su* 
exclusivity7 grant$ "u section #cea ( ! 
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7 or section #ebg ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;cc7 ) respect to su*
 ref]5ce product expires2 &  7,,ii7 !   
date on :i* ! fir/ biosimil> biological 
product lic5se application t ref]5ces   
su* ref]5ce product is fil$2 &  7ii7 !  
lat] (-- 7,i7 ! date t is #ahj days aft]

 ! date on :i* ! fir/ biosimil>         
biological product lic5se application t 
ref]5ces su* ref]5ce product ent]s !    
m>ketplace2 &  7,,ii7 ! date t is #a ye>
 aft] ! date on :i* ! biosimil>         
biological product t is ! subject ( !   
biosimil> biological product lic5se     
application describ$ 9 subclause 7,i7   
ent]s ! m>ketplace4  7#e7 ,expect$      
rev5ue ,! t]m expect$ rev5ue1 ) respect 
to a foll[-on product1 means ! f9ancial 
value repres5t$ by ! numb] ( individuals
 9 ! t>get population multipli$ by !    
f9ancial rev5ue g5]at$ by ea* memb] ( ! 
t>get population ov] ! #c-ye> p]iod     
beg9n+--  7,a7 on ! day t #c g5]ic drugs
 ref]5c+ ! same li/$ drug or #b or m    
biosimil> biological products ref]5c+ ! 
same ref]5ce product w\ld h be5 widely  
available 9 ! m>ket2 or  7,b7 if #c or m
 g5]ic drugs ref]5c+ ! same li/$ drug or
 #b or m biosimil> biological products  
ref]5c+ ! same ref]5ce product are      
already widely available 9 ! m>ket1 !   
day t ! foll[-on product ent]s ! m>ket4 

7#f7 ,foll[-on product ,! t]m foll[-on  
product means a drug approv$ ?r\gh an   
application or supplem5t to an          
application submitt$ "u section #eje7;b7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee7;c77 or a      
biological product lic5s$ ?r\gh an      
application or supplem5t to an          
application submitt$ "u section #cea7;a7
 ( ! ,public ,heal? ,s]vice ,act 7#db   
,u4,s4,c4 #bfb7;a77 = a *ange1          
modification1 or re=mulation to ! same  
manufactur]'s previ\sly approv$ drug or 
biological product4  7#g7 ,g5]ic drug ,!
 t]m g5]ic drug means a drug approv$ "u 
subsection 7b77#b7 or 7j7 ( section #eje
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee74  7#h7 ,li/$  
drug ,! t]m li/$ drug means a drug li/$ 
"u section #eje7;j77#g7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j77#g774  7#i7 ,pat5t   
family ,! t]m pat5t family means a gr\p 
( relat$ pat5ts t cont9ue ! priority    
date ( ! und]ly+ composition ( matt]    

pat5t1 all ( :i* claim ! same drug or   
biological product or a use ( ! same    
drug or biological product4  7#aj7      
,pat5t portfolio ,! t]m pat5t portfolio 
means a gr\p ( relat$ pat5ts cov]+ !    
same or simil> te*nical cont5t4  7#aa7  
,pat5t ?icket+  7,a7 ,9 g5]al ,! t]m    
pat5t ?icket+ means an action tak5 to   
limit competition by a pat5tee ) respect
 to a drug approv$ "u section #eje7;c7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cee7;c77 or a          
biological product lic5s$ "u section    
#cea7;a7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;a77 9 :i*--  7i7  
7,i7 ! pat5tee obta9s pat5ts 9 ! same   
pat5t family or pat5t portfolio-- 7aa7 t
 claim ! drug or biological product or a
 use ( ! drug or biological product1 a  
=m ( ! drug or biological product1 a    
me?od ( use ( ! drug or biological      
product1 or a me?od ( manufacture ( a   
drug or biological product2 &  7bb7 ^:  
effective fil+ date does n prec$e ! date
 ( fil+ ! application "u section        

#eje7;b7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 
or section #cea7;a7 ( ! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a772  
or  7,,ii7 ! und]ly+ composition ( matt]
 pat5t is f\nd invalid & ! pat5tee      
obta9s pat5ts 9 ! same pat5t family or  
pat5t portfolio t claim ! drug or       
biological product or a use ( ! drug or 
biological product1 a =m ( ! drug or    
biological product1 a me?od ( use ( !   
drug or biological product1 or a me?od (
 manufacture ( ! drug or biological     
product2  7ii7 an abbreviat$ new drug   
application ref]5c+ su* approv$ drug or 
a biosimil> biological product lic5se   
application ref]5c+ su* lic5s$          
biological product c\ld n be m>ket$ )\t 
practic+ "o or m ( ! inv5tions claim$ 9 
! additional pat5ts describ$ 9 subclause
 7,i7 or 7,,ii7 ( clause 7i72 &  7iii7 !
 ,commission det]m9es t ! pat5tee       
improp]ly limit$ competition by obta9+  
pat5ts describ$ 9 subclause 7,i7 or     
7,,ii7 ( clause 7i74  7,b7 ,factors to  

consid] ,! ,commission may e/abli% t an 
action describ$ 9 subp>agraph 7,a7      
improp]ly limits competition if !       
,commission e/abli%es a reasonable numb]
 ( ! foll[+ factors 9 a mann] t is      
suffici5t to demon/rate anticompetitive 
int5t3  7i7 ,! additional pat5ts        
describ$ 9 subp>agraph 7,a77i7 7ref]r$  
to 9 ?is subp>agraph z ! additional     
pat5ts7 /em f few pat5t families4  7ii7 
,! additional pat5ts h common           
specifications4  7iii7 ,! additional    
pat5ts did n issue on an application )  
respect to :i* a requirem5t = re/riction
 "u section #aba ( title #ce1 ,unit$    
,/ates ,code1 has be5 made1 or on an    
application fil$ z a result ( su* a     
requirem5t4  7iv7 ,! additional pat5ts h
 ov]lapp+ or id5tical claims4  7v7 ,!   
additional pat5ts h be5 grant$ to !     
pat5tee on =mulations or compositions ( 
! product & n us$4  7vi7 ,"o or m ( !   
additional pat5ts h be5 invalidat$ 9 an 
int] p>tes review conduct$ "u *apt] #ca 
( title #ce1 ,unit$ ,/ates ,code1 or a  

po/-grant proce$+ conduct$ "u *apt] #cb 
( t title4  7vii7 ,litigation )         
applicants "u section #cea7k7 ( !       
,public ,heal? ,s]vice ,act has be5     
ext5d$ bas$ on ! additional pat5ts4     
7viii7 ,! applications ) respect to !   
additional pat5ts describ$ 9 subclause  
7,i7 or 7,,ii7 ( subp>agraph 7,a77i7 are
 submitt$ n m ?an #cf mon?s be=e !      
expiration ( ! und]ly+ composition (    
matt] pat5t4  7ix7 ,a public or int]nal 
/atem5t1 a %>ehold] call1 or ano!r      
demon/ration ( purpose t ! pat5tee      
int5d$ to use ! numb] ( pat5ts or l5g? (
 ext5d$ pat5t protection 9 ord] to      
unduly limit competition4  7#ab7        
,ref]5ce product ,! t]m ref]5ce product 
has ! mean+ giv5 ! t]m 9 section        
#cea7;i7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;i774  7#ac7 ,t>get
 population ,! t]m t>get population1 )  
respect to a drug1 means ! population ( 
individuals t-- 7,a7 w\ld exp]i5ce a    
significant heal? improvem5t f a        
foll[-on product2 &  7,b7 w\ld h b\ght !

 foll[-on product solely because ( !    
significant heal? improvem5t t ^?       
individuals w\ld exp]i5ce4  7#ad7       
,ultimate p>5t entity ,! t]m ultimate   
p>5t entity has ! mean+ giv5 ! t]m 9    
section #hja4a ( title #af1 ,code (     
,f$]al ,regulations1 or any successor   
regulation4  7#ae7 ,und]ly+ composition 
( matt] pat5t ,! t]m und]ly+ composition
 ( matt] pat5t means a pat5t ) respect  
to ! molecules1 comp\nds1 or new        
=mulations ( ! active +r$i5t ( a drug or
 biological product4  7b7 ,prohibitions 
7#a7 ,pat5t ?icket+  7,a7 ,prima facie  
,except z provid$ 9 subp>agraph 7,b71 an
 action by a drug manufactur] t         
con/itutes pat5t ?icket+ %all be        
consid]$ to be an unfair me?od (        
competition 9 or affect+ comm]ce 9      
violation ( section #e7;a74  7,b7       
,rebuttal  7i7 ,9 g5]al ,subject to     
subp>agraph 7,c71 an action t con/itutes
 pat5t ?icket+ %all n be consid]$ to be 
an unfair me?od ( competition 9 or      
affect+ comm]ce 9 violation ( section   

#e7;a7 if ! manufactur] describ$ 9 t    
p>agraph demon/rates to ! ,commission or
 a di/rict c\rt ( ! ,unit$ ,/ates1 z    
applicable1 by a prepond]ance ( !       
evid5ce 9 a proce$+ initiat$ by !       
,commission "u subsection 7c77#a77;,a71 
or 9 a suit br\ght "u subp>agraph 7,b7  
or 7,c7 ( subsection 7c77#a71 t !       
anticompetitive effects ( ! action d n  
outweigh ! pro-competitive effects ( !  
action4  7ii7 ,evid5ce ,9 mak+ a        
demon/ration "u clause 7i7 t !          
anticompetitive effects ( pat5t ?icket+ 
d n outweigh ! pro-competitive effects (
 t behavior1 a manufactur] describ$ 9   
subp>agraph 7,a7--  7,i7 may pres5t     
evid5ce t-- 7aa7 ! inv5tions claim$ 9 ! 
additional pat5ts describ$ 9 subclauses 
7,i7 & 7,,ii7 ( subsection              
7a77#aa77;,a77i7 result$ 9-- 7,,aa7     
cl9ically mean+ful & significant        
!rapeutic or safety b5efits2 7,,bb7     
significantly improv$ product purity or 
pot5cy2 7,,cc7 significant ga9$         
effici5cies 9 manufactur+2 or 7,,dd7 o!r

 improv$ product attributes hav+        
sub/antial b5efits = consum]s or        
pati5ts2  7bb7 a g5]ic drug or biosimil>
 biological product c\ld be m>ket$      
comm]cially )\t incorporat+ !           
improvem5ts claim$ 9 ! additional pat5ts
 describ$ 9 item 7aa72 or  7cc7 = ea* ( 
! lat] fil$ pat5ts1 ! manufactur] _h    
sub/antial f9ancial reason1 ap>t f !    
f9ancial effects ( r$uc$ competition1 to
 file ea* ( ! pat5ts2 &  7,,ii7 9 mak+ a
 demon/ration "u subclause 7,i71 %all   
submit to ! ,commission or ! c\rt1 z    
applicable1 all rese>* & developm5t1    
manufactur+1 m>ket+1 & o!r co/s         
associat$ ) approval ( ! orig9al drug "u
 section #eje7;c7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;c77 or lic5sure ( ! orig9al       
biological product "u section #cea7;a7 (
 ! ,public ,heal? ,s]vice ,act 7#db     
,u4,s4,c4 #bfb7;a771 :i*--  7aa7 %all   
include-- 7,,aa7 any docum5ts relat+ to 
! co/s & b5efits ( ! lat] fil$ pat5ts ) 
respect to pati5ts :o use ! drug2 &     

7,,bb7 any applications = pat5ts t 7    
fil$ & reject$2 &  7bb7 %all n be       
con/ru$ to limit ! in=mation t !        
,commission or ! c\rt1 z applicable1 may
 o!rwise obta9 9 any proce$+ or action  
in/itut$ ) respect to a violation ( ?is 
section4  7,c7 ,response ,! ,commission 
may rebut any evid5ce pres5t$ by a drug 
manufactur] "u subp>agraph 7,b7 by      
e/abli%+ by a prepond]ance ( ! evid5ce t
 ! h>m to consum]s f ! action t is !    
subject ( t pres5tation is great] ?an ! 
b5efits to consum]s f t action4  7#b7   
,product hopp+  7,a7 ,prima facie       
,except z provid$ 9 subp>agraph 7,b71   
any ( ! foll[+ actions by a manufactur] 
( a ref]5ce product or li/$ drug %all be
 consid]$ to be an unfair me?od (       
competition 9 or affect+ comm]ce 9      
violation ( section #e7;a73  7i7 ,if1   
dur+ ! p]iod beg9n+ on ! date on :i* !  
manufactur] ( ! ref]5ce drug receives   
notice t an applicant has submitt$ to ! 
,commission] ( ,food & ,drugs an        
abbreviat$ new drug application or      

biosimil> biological product lic5se     
application & end+ on ! date t is #ahj  
days aft] ! date on :i* t g5]ic drug or 
biosimil> biological product fir/ ent]s1
 or c\ld ent]1 ! m>ket1 or is d5i$--    
7,i7 ^u ! reque/ ( ! manufactur] ( !    
li/$ drug or ref]5ce product1 !         
,commission] ( ,food & ,drugs--  7aa7   
)draws ! approval ( ! application = !   
li/$ drug or ref]5ce product2 or  7bb7  
places ! li/$ drug or ref]5ce product on
 ! discont9u$ products li/2 or  7,,ii7 !
 manufactur] ( ! li/$ drug or ref]5ce   
product ann\nces discont9uance (1 or    
int5t to )draw1 ! application = !       
ref]5ce product4  7ii7 ,! manufactur] ( 
a previ\sly approv$ drug or biological  
product m>kets or sells a foll[-on      
product dur+ ! competition w9d[4  7,b7  
,rebuttal  7i7 ,9 g5]al ,subject to     
subp>agraph 7,c71 an action describ$ 9  
subp>agraph 7,a7 %all n be consid]$ to  
be an unfair me?od ( competition 9 or   
affect+ comm]ce if--  7,i7 ) respect to 
an action describ$ 9 subp>agraph        

7,a77i71 ! manufactur] ( ! li/$ drug or 
ref]5ce product demon/rates to !        
,commission or a di/rict c\rt ( ! ,unit$
 ,/ates1 z applicable1 by a prepond]ance
 ( ! evid5ce 9 a proce$+ initiat$ by !  
,commission "u subsection 7c77#a77;,a71 
or 9 a suit br\ght "u subp>agraph 7,b7  
or 7,c7 ( subsection 7c77#a71 t !       
manufactur] remov$ su* drug f ! m>ket = 
significant & docum5t$ safety reasons2  
or  7,,ii7 ) respect to an action       
describ$ 9 subp>agraph 7,a77ii7-- 7aa7 !
 manufactur] demon/rates to !           
,commission or a di/rict c\rt ( ! ,unit$
 ,/ates1 z applicable1 by a prepond]ance
 ( ! evid5ce 9 a proce$+ initiat$ by !  
,commission "u subsection 7c77#a77;,a71 
or 9 a suit br\ght "u subp>agraph 7,b7  
or 7,c7 ( subsection 7c77#a71 t-- 7,,aa7
 ! foll[-on product describ$ 9 su*      
subp>agraph 7,a77ii7 7ref]r$ to 9 ?is   
subclause z ! foll[-on product7 provides
 a cl9ically mean+ful & significant     
additional heal? b5efit to ! t>get      
population beyond t provid$ by !        

previ\sly approv$ drug or biological    
product2 7,,bb7 ! foll[-on product 0 !  
available means t 0 lea/ likely to r$uce
 competition2 & 7,,cc7 ! manufactur] _h 
sub/antive f9ancial reasons1 ap>t f !   
f9ancial effects ( r$uc$ competition1 to
 introduce ! foll[-on product to !      
m>ket2 &  7bb7 9 mak+ ! demon/ration    
requir$ "u item 7aa71 ! manufactur]     
provides to ! ,commission-- 7,,aa7 all  
rese>* & developm5t1 manufactur+1       
m>ket+1 & o!r relat$ co/s associat$ ) ! 
drug or biological product previ\sly    
approv$ "u section #eje7;c7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;c77 or section #cea7;a7 
( ! ,public ,heal? ,s]vice ,act 7#db    
,u4,s4,c4 #bfb7;a77 & ! foll[-on        
product1 includ+ all docum5ts1 memos1 or
 o!r bus9ess docum5ts t expla91 m5tion1 
or o!rwise ju/ify ! decision ( !        
manufactur] to develop & manufacture !  
foll[-on product2 & 7,,bb7 ! rev5ue     
obta9$ by ! manufactur] ) respect to !  
drug or biological product previ\sly    

approv$ "u section #eje7;c7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;c77 or section #cea7;a7 
( ! ,public ,heal? ,s]vice ,act 7#db    
,u4,s4,c4 #bfb7;a77 & ! expect$ rev5ue (
 ! manufactur] ) respect to ! previ\sly 
approv$ drug or biological product & !  
foll[-on product4  7ii7 ,rule (         
con/ruction ,no?+ 9 clause 7i7 may be   
con/ru$ to limit ! in=mation t !        
,commission may o!rwise obta9 9 any     
proce$+ or action in/itut$ ) respect to 
a violation ( ?is section4  7,c7        
,response ,! ,commission may rebut any  
evid5ce pres5t$ by a drug manufactur] "u
 subp>agraph 7,b7 by e/abli%+ by a      
prepond]ance ( ! evid5ce t--  7i7 ! h>m 
to consum]s ( ! drug or biological      
product t is ! subject ( ! product f !  
action t is ! subject ( t pres5tation is
 great] ?an ! b5efits to consum]s ( !   
drug or biological product t is !       
subject ( *all5g$ action2 or  7ii7 a    
prim>y purpose ( ! manufactur] 9 pursu+ 
! *all5g$ action 0 to block or o!rwise  

h9d] ! entry into ! m>ket ( a g5]ic drug
 or biosimil> biological product4  7c7  
,en=cem5t  7#a7 ,9 g5]al ,if !          
,commission has reason to believe t any 
drug manufactur] has violat$1 is        
violat+1 or is ab\t to violate ?is      
section1 ! ,commission may take any ( ! 
foll[+ actions3  7,a7 ,in/itute a       
proce$+-- 7i7 t1 except z provid$ 9     
p>agraph 7#b71 complies ) ! requirem5ts 
"u section #e7;b72 &  7ii7 9 :i* !      
,commission may impose on ! manufactur] 
any p5alty t ! ,commission may impose = 
a violation ( section #e4  7,b7 ,9 !    
same mann] & to ! same ext5t z provid$ 9
 section #ac7;b71 br+ suit 9 a di/rict  
c\rt ( ! ,unit$ ,/ates to tempor>ily    
enjo9 ! action ( ! drug manufactur]4    
7,c7 7i7 ,br+ suit 9 a di/rict c\rt ( ! 
,unit$ ,/ates to p]man5tly enjo9 !      
action ( ! drug manufactur]4  7ii7 ,9 a 
suit br\ght "u clause 7i71 ! ,commission
 may seek-- 7,i7 any ( ! rem$ies        
describ$ 9 p>agraph 7#c72 &  7,,ii7 any 
o!r equitable rem$y1 includ+ ancill>y   

equitable relief4  7#b7 ,judicial review
  7,a7 ,9 g5]al ,not)/&+ any provision (
 section #e1 any drug manufactur] t is  
subject to a f9al ord] ( ! ,commission t
 is issu$ 9 a proce$+ initiat$ "u       
p>agraph 7#a77;,a7 may1 n lat] ?an #cj  
days aft] ! date on :i* ! ,commission   
issues ! ord]1 petition = review ( !    
ord] 9--  7i7 ! ,unit$ ,/ates ,c\rt (   
,appeals = ! ,di/rict ( ,columbia       
,circuit2 or  7ii7 ! c\rt ( appeals ( ! 
,unit$ ,/ates = ! circuit 9 :i* !       
ultimate p>5t entity ( ! manufactur] is 
incorporat$1 z ( ! date on :i* !        
manufactur] obta9s ! und]ly+ composition
 ( matt] pat5t ) respect to ! proce$+ or
 files a new drug application "u section
 #eje7;b7 ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 
or biological product lic5se application
 "u section #cea7;a7 ( ! ,public ,heal? 
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77 t 
is ! subject ( ! proce$+1 z applicable4 
7,b7 ,treatm5t ( f9d+s ,9 a review ( an 
ord] issu$ by ! ,commission conduct$ by 

a c\rt ( appeals ( ! ,unit$ ,/ates "u   
subp>agraph 7,a71 ! factual f9d+s ( !   
,commission %all be conclusive if ^?    
facts are support$ by ! evid5ce4  7#c7  
,equitable rem$ies  7,a7 ,disgorgem5t   
7i7 ,9 g5]al ,9 a suit br\ght "u        
p>agraph 7#a77;,c71 ! ,commission may   
seek1 & ! c\rt may ord]1 disgorgem5t (  
any unju/ enri*m5t t a p]son obta9$ z a 
result ( ! violation t gives rise to !  
suit 9 :i* ! ,commission seeks ! claim4 
7ii7 ,calculation ,any disgorgem5t t is 
ord]$ ) respect to a p]son "u clause 7i7
 %all be (fset by any am\nt ( re/itution
 t ! p]son is ord]$ to pay "u           
subp>agraph 7,b74  7iii7 ,limitations   
p]iod ,! ,commission may br+ a claim =  
disgorgem5t "u ?is subp>agraph n lat]   
?an #e ye>s aft] ! late/ date on :i* !  
p]son aga9/ :i* ! claim is br\ght       
receives any unju/ enri*m5t f ! effects 
( ! violation t gives rise to ! suit 9  
:i* ! ,commission seeks ! claim4  7,b7  
,re/itution  7i7 ,9 g5]al ,9 a suit     
br\ght "u p>agraph 7#a77;,c71 !         

,commission may seek1 & ! c\rt may ord]1
 re/itution ) respect to ! violation t  
gives rise to ! suit 9 :i* ! ,commission
 seeks ! claim4  7ii7 ,limitations p]iod
 ,! ,commission may br+ a claim =       
re/itution "u ?is subp>agraph n lat] ?an
 #e ye>s aft] ! late/ date on :i* !     
p]son aga9/ :i* ! claim is br\ght       
receives any unju/ enri*m5t f ! effects 
( ! violation t gives rise to ! suit 9  
:i* ! ,commission seeks ! claim4  7#d7  
,rules ( con/ruction ,no?+ 9 ?is        
subsection may be con/ru$ z-- 7,a7      
requir+ ! ,commission to br+ a suit     
seek+ a tempor>y injunction "u p>agraph 
7#a77;,b7 be=e br++ a suit seek+ a      
p]man5t injunction "u p>agraph          
7#a77;,c72 or  7,b7 affect+ any o!r     
au?ority ( ! ,commission "u ?is ,act to 
seek relief or obta9 a rem$y ) respect  
to a violation ( ?is ,act4  4  7b7      
,applicability ,section #bg ( ! ,f$]al  
,trade ,commission ,act1 z add$ by      
subsection 7a71 %all apply ) respect to 
any--  7#a7 conduct t occurs on or aft] 

! date ( enactm5t ( ?is ,act2 &  7#b7   
action or proce$+ t is comm5c$ on or    
aft] ! date ( enactm5t ( ?is ,act4  7c7 
,antitru/ laws ,no?+ 9 ?is section1 or !
 am5dm5ts made by ?is section1 %all     
modify1 impair1 limit1 or sup]s$e !     
applicability ( ! antitru/ laws z def9$ 
9 subsection 7a7 ( ! fir/ section ( !   
,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 &
 ( section #e ( ! ,f$]al ,trade         
,commission ,act 7#ae ,u4,s4,c4 #de7 to 
! ext5t t x applies to unfair me?ods (  
competition4  7d7 ,rulemak+ ,! ,f$]al   
,trade ,commission may issue rules "u   
section #eec ( title #e1 ,unit$ ,/ates  
,code1 to c>ry out section #bg ( !      
,f$]al ,trade ,commission ,act1 z add$  
by subsection 7a71 includ+ by def9+ any 
t]ms us$ 9 su* section #bg4  #a4 ,%ort  
title ,?is ,act may be cit$ z !         
,af=dable ,prescriptions = ,pati5ts ,act
 ( #bjai4  #b4 ,product hopp+  7a7 ,9   
g5]al ,! ,f$]al ,trade ,commission ,act 
7#ae ,u4,s4,c4 #da et seq47 is am5d$ by 
ins]t+ aft] section #bf 7#ae ,u4,s4,c4  

#eg;c-#b7 ! foll[+3  #bg4 ,product hopp+
  7a7 ,def9itions ,9 ?is section3 7#a7  
,abbreviat$ new drug application ,! t]m 
abbreviat$ new drug application means an
 application "u subsection 7b77#b7 or   
7j7 ( section #eje ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee74  7#b7 ,biosimil> biological      
product ,! t]m biosimil> biological     
product means a biological product      
lic5s$ "u section #cea7k7 ( ! ,public   
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7k774  7#c7 ,biosimil> biological   
product lic5se application ,! t]m       
biosimil> biological product lic5se     
application means an application        
submitt$ "u section #cea7k7 ( ! ,public 
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7k774  7#d7 ,foll[-on product ,! t]m
 foll[-on product-- 7,a7 means a drug   
approv$ ?r\gh an application or         
supplem5t to an application submitt$ "u 
section #eje7;b7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;b77 or a biological product lic5s$

 ?r\gh an application or supplem5t to an
 application submitt$ "u section        
#cea7;a7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;a77 = a *ange1    
modification1 or re=mulation to ! same  
manufactur]'s previ\sly approv$ drug or 
biological product t treats ! same      
m$ical condition2 &  7,b7 excludes su*  
an application or supplem5t to an       
application = a *ange1 modification1 or 
re=mulation ( a drug or biological      
product t is reque/$ by ! ,secret>y or  
necess>y to comply ) law1 includ+       
sections #eje;,a & #eje;,b ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee;a1 #cee;c74  7#e7 ,g5]ic 
drug ,! t]m g5]ic drug means a drug     
approv$ "u an application submitt$ "u   
subsection 7b77#b7 or 7j7 ( section #eje
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee74  7#f7 ,li/$  
drug ,! t]m li/$ drug means a drug li/$ 
"u section #eje7;j77#g7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j77#g774  7#g7          

,manufactur] ,! t]m manufactur] means ! 
hold]1 lic5see1 or assignee (-- 7,a7 an 
approv$ application = a drug "u section 
#eje7;c7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c772
 or  7,b7 a biological product lic5se "u
 section #cea7;a7 ( ! ,public ,heal?    
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a774  
7#h7 ,ref]5ce product ,! t]m ref]5ce    
product has ! mean+ giv5 ! t]m 9 section
 #cea7;i7 ( ! ,public ,heal? ,s]vice    
,act 7#db ,u4,s4,c4 #bfb7;i774  7#i7    
,ultimate p>5t entity ,! t]m ultimate   
p>5t entity has ! mean+ giv5 ! t]m 9    
section #hja4a ( title #af1 ,code (     
,f$]al ,regulations1 or any successor   
regulation4  7b7 ,prohibition on product
 hopp+  7#a7 ,prima facie ,except z     
provid$ 9 p>agraph 7#b71 a manufactur] (
 a ref]5ce product or li/$ drug %all be 
consid]$ to h engag$ 9 an unfair me?od (
 competition 9 or affect+ comm]ce 9     
violation ( section #e7;a7 if !         
,commission demon/rates by a            
prepond]ance ( ! evid5ce 9 a proce$+    

initiat$ by ! ,commission "u subsection 
7c77#a77;,a71 or 9 a suit br\ght "u     
subp>agraph 7,b7 or 7,c7 ( subsection   
7c77#a71 t1 dur+ ! p]iod beg9n+ on !    
date on :i* ! manufactur] ( ! ref]5ce   
product or li/$ drug fir/ receives      
notice t an applicant has submitt$ to ! 
,commission] ( ,food & ,drugs an        
abbreviat$ new drug application or      
biosimil> biological product lic5se     
application & end+ on ! date t is #ahj  
days aft] ! date on :i* t g5]ic drug or 
biosimil> biological product is fir/    
m>ket$1 ! manufactur] engag$ 9 ei!r ( ! 
foll[+ actions3  7,a7 ,! manufactur]    
engag$ 9 a h>d swit*1 :i* %all be       
e/abli%$ by demon/rat+ t ! manufactur]  
engag$ 9 ei!r ( ! foll[+ actions3  7i7  
,^u ! reque/ ( ! manufactur] ( ! li/$   
drug or ref]5ce product1 ! ,commission] 
( ,food & ,drugs )drew ! approval ( !   
application = ! li/$ drug or ref]5ce    
product or plac$ ! li/$ drug or ref]5ce 
product on ! discont9u$ products li/ & !
 manufactur] m>ket$ or sold a foll[-on  

product4  7ii7 ,! manufactur] ( ! li/$  
drug or ref]5ce product-- 7,i7 7aa7     
ann\nc$ )drawal (1 discont9uance ( !    
manufacture (1 or int5t to )draw !      
application ) respect to ! drug or      
ref]5ce product 9 a mann] t imp$es      
competition f a g5]ic drug or a         
biosimil> biological product1 z e/abli%$
 by objective circum/ances2 or  7bb7    
de/roy$ ! inv5tory ( ! li/$ drug or     
ref]5ce product 9 a mann] t imp$es      
competition f a g5]ic drug or a         
biosimil> biological product1 :i* may be
 e/abli%$ by objective circum/ances2 &  
7,,ii7 m>ket$ or sold a foll[-on        
product4  7,b7 ,! manufactur] engag$ 9 a
 s(t swit*1 :i* %all be e/abli%$ by     
demon/rat+ t ! manufactur] engag$ 9 bo? 
( ! foll[+ actions3  7i7 ,! manufactur] 
took actions ) respect to ! li/$ drug or
 ref]5ce product o!r ?an ^? describ$ 9  
subp>agraph 7,a7 t unfairly disadvantage
 ! li/$ drug or ref]5ce product relative
 to ! foll[-on product describ$ 9 clause
 7ii7 9 a mann] t imp$es competition f a

 g5]ic drug or a biosimil> biological   
product t is highly simil> to1 & has no 
cl9ically mean+ful diff]5ce ) respect to
 safety1 purity1 & pot5cy f1 ! ref]5ce  
product1 :i* may be e/abli%$ by         
objective circum/ances4  7ii7 ,!        
manufactur] m>ket$ or sold a foll[-on   
product4  7#b7 ,ju/ification  7,a7 ,9   
g5]al ,subject to p>agraph 7#c71 !      
actions describ$ 9 p>agraph 7#a7 by a   
manufactur] ( a li/$ drug or ref]5ce    
product %all n be consid]$ to be an     
unfair me?od ( competition 9 or affect+ 
comm]ce if--  7i7 ! manufactur]         
demon/rates to ! ,commission or a       
di/rict c\rt ( ! ,unit$ ,/ates1 z       
applicable1 by a prepond]ance ( !       
evid5ce 9 a proce$+ initiat$ by !       
,commission "u subsection 7c77#a77;,a71 
or 9 a suit br\ght "u subp>agraph 7,b7  
or 7,c7 ( subsection 7c77#a71 t--  7,i7 
! manufactur] w\ld h tak5 ! actions     
reg>dless ( :e!r a g5]ic drug t ref]5ces
 ! li/$ drug or biosimil> biological    
product t ref]5ces ! ref]5ce product _h 

already ent]$ ! m>ket2 &  7,,ii7 7aa7 ) 
respect to a h>d swit* "u p>agraph      
7#a77;,a71 ! manufactur] took ! action =
 reasons relat+ to ! safety risk to     
pati5ts ( ! li/$ drug or ref]5ce        
product2  7bb7 ) respect to an action   
describ$ 9 item 7aa7 or 7bb7 ( p>agraph 
7#a77;,a77ii77,i71 !re is a supply      
disruption t-- 7,,aa7 is outside ( !    
control ( ! manufactur]2 7,,bb7 prev5ts 
! production or di/ribution ( !         
applicable li/$ drug or ref]5ce product2
 & 7,,cc7 _c be rem$i$ by reasonable    
ef=ts2 or  7cc7 ) respect to a s(t swit*
 "u p>agraph 7#a77;,b71 ! manufactur] _h
 legitimate pro-competitive reasons1    
ap>t f ! f9ancial effects ( r$uc$       
competition1 to take ! action4  7,b7    
,rule ( con/ruction ,no?+ 9 subp>agraph 
7,a7 may be con/ru$ to limit ! in=mation
 t ! ,commission may o!rwise obta9 9 any
 proce$+ or action in/itut$ ) respect to
 a violation ( ?is section4  7#c7       
,response ,) respect to a ju/ification  
(f]$ by a manufactur] "u p>agraph 7#b71 

! ,commission may--  7,a7 rebut any     
evid5ce pres5t$ by a manufactur] dur+ t 
ju/ification2 or  7,b7 e/abli% by a     
prepond]ance ( ! evid5ce t1 on balance1 
! pro-competitive b5efits f ! conduct   
describ$ 9 subp>agraph 7,a7 or 7,b7 (   
p>agraph 7#a71 z applicable1 d n        
outweigh any anticompetitive effects ( !
 conduct1 ev5 9 consid]ation ( !        
ju/ification s (f]$4  7c7 ,en=cem5t     
7#a7 ,9 g5]al ,if ! ,commission has     
reason to believe t any manufactur] has 
violat$1 is violat+1 or is ab\t to      
violate ?is section1 ! ,commission may  
take any ( ! foll[+ actions3  7,a7      
,in/itute a proce$+-- 7i7 t1 except z   
provid$ 9 p>agraph 7#b71 complies ) !   
requirem5ts "u section #e7;b72 &  7ii7 9
 :i* ! ,commission may impose on !      
manufactur] any p5alty t ! ,commission  
may impose = a violation ( section #e4  
7,b7 ,9 ! same mann] & to ! same ext5t z
 provid$ 9 section #ac7;b71 br+ suit 9 a
 di/rict c\rt ( ! ,unit$ ,/ates to      
tempor>ily enjo9 ! action ( !           

manufactur]4  7,c7 ,br+ suit 9 a di/rict
 c\rt ( ! ,unit$ ,/ates1 9 :i* !        
,commission may seek-- 7i7 to p]man5tly 
enjo9 ! action ( ! manufactur]2  7ii7   
any ( ! rem$ies describ$ 9 p>agraph     
7#c72 &  7iii7 any o!r equitable rem$y1 
includ+ ancill>y equitable relief4  7#b7
 ,judicial review  7,a7 ,9 g5]al        
,not)/&+ any provision ( section #e1 any
 manufactur] t is subject to a f9al ord]
 ( ! ,commission t is issu$ 9 a proce$+ 
in/itut$ "u p>agraph 7#a77;,a7 may1 n   
lat] ?an #cj days aft] ! date on :i* !  
,commission issues ! ord]1 petition =   
review ( ! ord] 9--  7i7 ! ,unit$ ,/ates
 ,c\rt ( ,appeals = ! ,di/rict (        
,columbia ,circuit2 or  7ii7 ! c\rt (   
appeals ( ! ,unit$ ,/ates = ! circuit 9 
:i* ! ultimate p>5t entity ( !          
manufactur] is incorporat$4  7,b7       
,treatm5t ( f9d+s ,9 a review ( an ord] 
issu$ by ! ,commission conduct$ by a    
c\rt ( appeals ( ! ,unit$ ,/ates "u     
subp>agraph 7,a71 ! factual f9d+s ( !   
,commission %all be conclusive if ^?    

facts are support$ by ! evid5ce4  7#c7  
,equitable rem$ies  7,a7 ,disgorgem5t   
7i7 ,9 g5]al ,9 a suit br\ght "u        
p>agraph 7#a77;,c71 ! ,commission may   
seek1 & ! c\rt may ord]1 disgorgem5t (  
any unju/ enri*m5t t a p]son obta9$ z a 
result ( ! violation t gives rise to !  
suit4  7ii7 ,calculation ,any           
disgorgem5t t is ord]$ ) respect to a   
p]son "u clause 7i7 %all be (fset by any
 am\nt ( re/itution ord]$ "u subp>agraph
 7,b74  7iii7 ,limitations p]iod ,!     
,commission may seek disgorgem5t "u ?is 
subp>agraph n lat] ?an #e ye>s aft] !   
late/ date on :i* ! p]son f :i* !       
disgorgem5t is s\ght receives any unju/ 
enri*m5t f ! effects ( ! violation t    
gives rise to ! suit 9 :i* ! ,commission
 seeks ! disgorgem5t4  7,b7 ,re/itution 
7i7 ,9 g5]al ,9 a suit br\ght "u        
p>agraph 7#a77;,c71 ! ,commission may   
seek1 & ! c\rt may ord]1 re/itution )   
respect to ! violation t gives rise to !
 suit4  7ii7 ,limitations p]iod ,!      
,commission may seek re/itution "u ?is  

subp>agraph n lat] ?an #e ye>s aft] !   
late/ date on :i* ! p]son f :i* !       
re/itution is s\ght receives any unju/  
enri*m5t f ! effects ( ! violation t    
gives rise to ! suit 9 :i* ! ,commission
 seeks ! re/itution4  7#d7 ,rules (     
con/ruction ,no?+ 9 ?is subsection may  
be con/ru$ z-- 7,a7 requir+ !           
,commission to br+ a suit seek+ a       
tempor>y injunction "u p>agraph         
7#a77;,b7 be=e br++ a suit seek+ a      
p]man5t injunction "u p>agraph          
7#a77;,c72 or  7,b7 affect+ any o!r     
au?ority ( ! ,commission "u ?is ,act to 
seek relief or obta9 a rem$y ) respect  
to a violation ( ?is ,act4  4  7b7      
,applicability ,section #bg ( ! ,f$]al  
,trade ,commission ,act1 z add$ by      
subsection 7a71 %all apply ) respect to 
any--  7#a7 conduct t occurs on or aft] 
! date ( enactm5t ( ?is ,act2 &  7#b7   
action or proce$+ t is comm5c$ on or    
aft] ! date ( enactm5t ( ?is ,act4  7c7 
,antitru/ laws ,no?+ 9 ?is section1 or !
 am5dm5ts made by ?is section1 %all     

modify1 impair1 limit1 or sup]s$e !     
applicability ( ! antitru/ laws z def9$ 
9 subsection 7a7 ( ! fir/ section ( !   
,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 &
 ( section #e ( ! ,f$]al ,trade         
,commission ,act 7#ae ,u4,s4,c4 #de7 to 
! ext5t t x applies to unfair me?ods (  
competition4  7d7 ,rulemak+ ,! ,f$]al   
,trade ,commission may issue rules "u   
section #eec ( title #e1 ,unit$ ,/ates  
,code1 to c>ry out section #bg ( !      
,f$]al ,trade ,commission ,act1 z add$  
by subsection 7a71 includ+ by def9+ any 
t]ms us$ 9 su* section #bg 7o!r ?an t]ms
 t are def9$ 9 subsection 7a7 ( su*     
section #bg74  #c4 ,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   

section #cea7l77#b77;,a7 ( ! ,public    
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7l77#b77;,a77 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 (       
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