,,ii  #aaith ,,congress  #ast ,session  
,s4 #dc  ,,in ,,the ,,senate ,,of ,,the 
,,united ,,states  ,january #i1         
#bjbe,mr4 ,hickenlooper 7for himself1   
,mr4 ,welch1 ,mr4 ,cotton1 and ,ms4     
,collins7 introduced the following bill2
 which was read twice and referred to   
the ,committee on the ,judiciary  ,a    
,,bill  ,to amend title #ce1 ,united    
,states ,code1 to provide for a safe    
harbor from infringement of a method of 
use patent relating to drugs or         
biological products4  #a4 ,short title  
,this ,act may be cited as the ,skinny  
,labels1 ,big ,savings ,act4  #b4 ,safe 
harbor from infringement of a method of 
use patent  7a7 ,in general ,section    
#bga of title #ce1 ,united ,states      
,code1 is amended-- 7#a7 by             
redesignating subsections 7h7 and 7i7 as
 subsections 7k7 and 7l71 respectively2 
and  7#b7 by inserting after subsection 
7g7 the following3  7h7 7#a7 ,the       
following shall not be acts of direct1  
induced1 or contributory infringement of

 a method of use claim in a patent      
included in the list described in       
section #eje7;j77#g7 or section         
#eab7n77#d7 of the ,federal ,food1      
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7;j77#g71 #cfj;b7n77#d77 in an     
action or counterclaim under this       
section3 7,a7 ,submitting or seeking    
approval of an application under section
 #eje7;j7 or section #eab7;b77#b7 of the
 ,federal ,food1 ,drug1 and ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee7;j71           
#cfj;b7b77#b771 or submitting or seeking
 approval of an application described in
 section #eje7;b77#b7 of such ,act 7#ba 
,u4,s4,c4 #cee7;b77#b771 provided that  
such application includes a statement   
under1 as applicable1 section           
#eje7;j77#b77;,a77viii71 section        
#eab7n77#a77;,i71 or section            
#eje7;b77#b77;,b7 of such ,act 7#ba     
,u4,s4,c4 #cee7;j77#b77;,a77viii71      
#cfj;b7n77#a77;,i71 #cee7;b77#b77;,b77  
for the method of use claims in the     
patent with the labeling proposed in    

such application4  7,b7 ,promoting or   
commercially marketing a drug product   
with the labeling approved in an        
application described in subparagraph   
7,a74  7,c7 ,describing a drug product  
approved in an application submitted    
under section #eje7;j7 or section       
#eab7;b77#b7 of such ,act 7#ba ,u4,s4,c4
 #cee7;j71 #cfj;b7b77#b77 or approved in
 an application described in section    
#eje7;b77#b7 of such ,act 7#ba ,u4,s4,c4
 #cee7;b77#b77 as a generic of1 or      
therapeutically equivalent to1 the      
listed drug referenced in such          
application1 as applicable4  7#b7       
,subparagraphs 7,a7 through 7,c7 of     
paragraph 7#a7 shall apply only if the  
labeling1 promotion1 or commercial      
marketing does not reference the        
condition or conditions of use claimed  
in the patent that was identified by the
 patent owner or assignee to the        
,secretary under section #cad4ec of     
title #ba1 ,code of ,federal            
,regulations 7or a successor regulation7

 and that was subject to the statement  
under section #eje7;j77#b77;,a77viii71  
section #eab7n77#a77;,i71 or section    
#eje7;b77#b77;,b7 of the ,federal ,food1
 ,drug1 and ,cosmetic ,act 7#ba         
,u4,s4,c4 #cee7;j77#b77;,a77viii71      
#cfj;b7n77#a77;,i71 #cee7;b77#b77;,b771 
as applicable4  7i7 7#a7 ,the following 
shall not be acts of direct1 induced1 or
 contributory infringement of a patent  
claim covering a method of using the    
reference product in an action or       
counterclaim under this section3 7,a7   
,submitting or seeking approval of an   
application under section #cea7k7 of the
 ,public ,health ,service ,act 7#db     
,u4,s4,c4 #bfb7k774  7,b7 ,describing a 
biological product approved in an       
application described in subparagraph   
7,a7 as biosimilar to1 or               
interchangeable with1 the reference     
product1 as applicable1 with the        
labeling approved in such application1  
when the biological product has not been
 approved for the patented condition or 

conditions of use4  7,c7 ,promoting or  
commercially marketing a biological     
product with the labeling approved in an
 application described in subparagraph  
7,a74  7#b7 ,subparagraphs 7,a7 through 
7,c7 of paragraph 7#a7 shall apply only 
if the labeling1 promotion1 or          
commercial marketing does not reference 
the condition or conditions of use      
claimed in the patent and specifically  
reflected in the prescribing            
information4  7j7 ,as used in this      
section3 7#a7 ,the terms biological     
product1 biosimilar1 interchangeable1   
and reference product have the meanings 
given such terms in section #cea7;i7 of 
the ,public ,health ,service ,act 7#db  
,u4,s4,c4 #bfb7;i774  7#b7 ,the term    
commercial marketing has the meaning    
given such term in section #cad4c of    
title #ba1 ,code of ,federal            
,regulations 7or a successor            
regulation74  7#c7 ,the term labeling   
has the meaning given such term in      
section #bja7m7 of the ,federal ,food1  

,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cba7m774  7#d7 ,the term promoting--  
7,a7 is within the meaning of the term  
used in section #bjb4a of title #ba1    
,code of ,federal ,regulations 7or a    
successor regulation72 and  7,b7        
includes the use of promotional labeling
 and advertising1 as described in       
paragraphs 7#a7 and 7#b7 of section     
#bjb4a7l7 of title #ba1 ,code of        
,federal ,regulations 7or successor     
regulations74  4  7b7 ,application ,this
 ,act and the amendments made by this   
,act shall apply to-- 7#a7 conduct that 
occurs before1 on1 or after the date of 
enactment of this ,act2 and  7#b7 all   
judicial or other proceedings pending as
 of such date of enactment4