,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #dhej  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,octob] #bc1 #bjai,ms4
 ,spanb]g] 7= h]self & ,mr4 ,re$7       
introduc$ ! 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   
provide = c]ta9 additional requirem5ts )
 respect to pat5t disclosures4  #a4     
,%ort title ,?is ,act may be cit$ z !   
,biologic ,pat5t ,transp>5cy ,act4  #b4 
,pat5t disclosure requirem5ts  7a7 ,9   
g5]al ,section #cea ( ! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4 #bfb7 is    
am5d$ by add+ at ! end ! foll[+3  7o7   
,additional requirem5ts ) respect to    
pat5ts  7#a7 ,approv$ application hold] 
li/+ requirem5ts  7,a7 ,9 g5]al ,beg9n+ 
on ! date ( enactm5t ( ! ,biologic      
,pat5t ,transp>5cy ,act1 )9 #cj days (  
approval ( an application "u subsection 

7a7 or 7k71 ! hold] ( su* approv$       
application %all submit to ! ,secret>y a
 li/ ( ea* pat5t requir$ to be disclos$ 
7z describ$ 9 p>agraph 7#c774  7,b7     
,previ\sly approv$ or lic5s$ biological 
products  7i7 ,products approv$ "u      
section #cea ( ! ,,phsa ,n lat] ?an #cj 
days aft] ! date ( enactm5t ( !         
,biologic ,pat5t ,transp>5cy ,act1 !    
hold] ( a biological product lic5se t 0 
approv$ "u subsection 7a7 or 7k7 be=e ! 
date ( enactm5t ( su* ,act %all submit  
to ! ,secret>y a li/ ( ea* pat5t requir$
 to be disclos$ 7z describ$ 9 p>agraph  
7#c774  7ii7 ,products approv$ "u       
section #eje ( ! ,,ffdca ,n lat] ?an #cj
 days aft] ,m>* #bc1 #bjbj1 ! hold] ( an
 approv$ application = a biological     
product "u section #eje ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act t is     
deem$ to be a lic5se = ! biological     
product "u ?is section on ,m>* #bc1     
#bjbj1 %all submit a li/ ( ea* pat5t    
requir$ to be disclos$ 7z describ$ 9    
p>agraph 7#c774  7,c7 ,updates ,! hold] 

( a biological product lic5se approv$ "u
 subsection 7a7 or 7k7 %all submit to ! 
,secret>y a li/ t includes--  7i7 any   
pat5t fir/ requir$ to be disclos$ 7z    
describ$ 9 p>agraph 7#c77 aft] !        
submission "u subp>agraph 7,a7 or 7,b71 
z applicable1 )9 #cj days ( ! e>li] (-- 
7,i7 ! date ( issuance ( su* pat5t by ! 
,unit$ ,/ates ,pat5t & ,tradem>k ,(fice2
 or  7,,ii7 ! date ( approval ( a       
supplem5tal application = ! biological  
product2 &  7ii7 any pat5t1 or any claim
 ) respect to a pat5t1 includ$ on ! li/ 
pursuant to ?is p>agraph ) respect to ! 
biological product subsequ5tly det]m9$  
to be invalid or un5=ceable1 )9 #cj days
 ( a det]m9ation ( pat5t invalidity4    
7#b7 ,publication ( in=mation  7,a7 ,9  
g5]al ,)9 #a ye> ( ! date ( enactm5t ( !
 ,biologic ,pat5t ,transp>5cy ,act1 !   
,secret>y %all publi% & make available  
to ! public a s+le1 easily se>*able1 li/
 t includes-- 7i7 ! (ficial & propriet>y
 "n ( ea* biological product lic5s$ "u  
subsection 7a7 or 7k71 & ( ea*          

biological product application approv$  
"u section #eje ( ! ,f$]al ,food1 ,drug1
 & ,cosmetic ,act & deem$ to be a lic5se
 = ! biological product "u ?is section  
on ,m>* #bc1 #bjbj2  7ii7 ) respect to  
ea* biological product describ$ 9 clause
 7i71 ea* pat5t submitt$ 9 accordance ) 
p>agraph 7#a72  7iii7 ! date ( lic5sure 
& application numb] = ea* su* biological
 product2  7iv7 ! m>ket+ /atus1 dosage  
=m1 r\te ( adm9i/ration1 /r5g?1 &1 if   
applicable1 ref]5ce product1 = ea* su*  
biological product2  7v7 ! lic5sure     
/atus = ea* su* biological product1     
includ+ :e!r ! lic5se at ! "t ( li/+ is 
approv$1 )drawn1 or revok$2  7vi7 any   
p]iod ( any exclusivity "u subsection   
7k77#g77;,a7 or subsection 7k77#g77;,b7 
( ?is section or section #ebg ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act1 & any  
ext5sion ( su* p]iod 9 accordance )     
subsection 7m7 ( ?is section ) respect  
to ea* su* biological product1 & ! date 
on :i* su* exclusivity expires2  7vii7  
in=mation reg>d+ any det]m9ation relat$ 

to biosimil>ity or int]*angeability =   
ea* su* biological product2 &  7viii7   
in=mation reg>d+ approv$ indications =  
ea* su* biological product1 9 su* mann] 
z ! ,secret>y det]m9es appropriate4     
7,b7 ,updates ,e #cj days aft] !        
publication ( ! fir/ li/ "u subp>agraph 
7,a71 ! ,secret>y %all revise ! li/ to  
include--  7i7  7,i7 ea* biological     
product lic5s$ "u subsection 7a7 or 7k7 
dur+ ! #cj-;day p]iod2 &  7,,ii7 )      
respect to ea* biological product       
describ$ 9 subclause 7,i71 ! in=mation  
describ$ 9 clauses 7i7 ?r\gh 7viii7 (   
subp>agraph 7,a72 &  7ii7 any updates to
 in=mation previ\sly publi%$ 9          
accordance ) subp>agraph 7,a74  7#c7    
,pat5ts requir$ to be disclos$ ,9 ?is   
section1 a pat5t requir$ to be disclos$ 
is any pat5t = :i* ! hold] ( a          
biological product lic5se approv$ "u    
subsection 7a7 or 7k71 or a biological  
product application approv$ "u section  
#eje ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act & deem$ to be a lic5se = 

a biological product "u ?is section on  
,m>* #bc1 #bjbj1 believes a claim (     
pat5t infr+em5t c\ld reasonably be      
ass]t$ by ! hold]1 or by a pat5t own] t 
has grant$ an exclusive lic5se to !     
hold] ) respect to ! biological product 
t is ! subject ( su* lic5se1 if a p]son 
n lic5s$ by ! hold] engag$ 9 ! mak+1    
us+1 (f]+ to sell1 sell+1 or import+    
into ! ,unit$ ,/ates ( ! biological     
product t is ! subject ( su* lic5se4  4 
7b7 ,disclosure ( pat5ts ,section       
#cea7l77#c77;,a77i7 ( ! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4             
#bfb7l77#c77;,a77i77 is am5d$ by ins]t+ 
includ$ 9 ! li/ provid$ by ! ref]5ce    
product sponsor "u subsection 7o77#a7   
aft] a li/ ( pat5ts4  7c7 ,re/riction on
 claims ( pat5t infr+em5t ,section      
#bga7;e7 ( title #ce1 ,unit$ ,/ates     
,code1 is am5d$ by add+ at ! end !      
foll[+3  7#g7 ,! own] ( a pat5t t %\ld h
 be5 includ$ 9 ! li/ describ$ 9 section 
#cea7o77#a7 ( ! ,public ,heal? ,s]vice  
,act 7#db ,u4,s4,c4 #bfb7o77#a771       

includ+ any updates requir$ "u          
subp>agraph 7,c7 ( t section1 b 0 n     
timely includ$ 9 su* li/1 may n br+ an  
action "u ?is section = infr+em5t ( !   
pat5t4  4  7d7 ,regulations ,! ,secret>y
 ( ,heal? & ,human ,s]vices may         
promulgate regulations to c>ry out      
subsection 7o7 ( section #cea ( !       
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb71 z add$ by subsection   
7a74  7e7 ,rule ( con/ruction ,no?+ 9   
?is ,act1 includ+ an am5dm5t made by ?is
 ,act1 %all be con/ru$ to require or    
all[ ! ,secret>y ( ,heal? & ,human      
,s]vices to delay ! lic5s+ ( a          
biological product "u section #cea ( !  
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb74