,,ii  #aacth ,,congress  #b;d ,session  
,s4 #baej  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,march #bd1    
#bjad,mr4 ,blumenthal 7for himself and  
,mr4 ,hatch7 introduced the following   
bill2 which was read twice and referred 
to the ,committee on the ,judiciary  ,a 
,,bill  ,to advance the public health by
 encouraging independent innovators to  
pursue drug repurposing research and    
develop new treatments and cures by     
providing appropriate intellectual      
property protections for those          
innovations1 and for other purposes4    
#a4 ,short title ,this ,act may be cited
 as the ,independent ,innovator and     
,repurposing ,act4  #b4 ,extension of   
patent term for method of using         
biological product  7a7 ,extension for  
regulatory delay ,the term of a patent  
claiming a method of using a biological 
product shall be extended for #e years  
from the original expiration date of the
 patent1 which shall include any patent 
term adjustment granted under section   

#aed7;b7 of title #ce1 ,united ,states  
,code1 if-- 7#a7 an application for an  
extension is submitted by the owner of  
record of the patent or its agent in    
accordance with the requirements of     
subsection 7b72 and  7#b7 the term of   
the patent-- 7,a7 has not expired before
 the application is so submitted2 and   
7,b7 has not been extended under        
subsection 7c7 of this section or       
section #aef of title #ce1 ,united      
,states ,code4  7b7 ,application for    
extension ,to obtain an extension of the
 term of a patent under this section1   
the owner of record of the patent or its
 agent shall submit an application to   
the ,director4 ,the application shall   
contain-- 7#a7 the identity of the      
biological product2  7#b7 the identity  
of the patent for which an extension is 
being sought and the identity of each   
claim of such patent that claims the    
method of using the biological product2 
7#c7 information demonstrating to the   
,director that-- 7,a7 the patent was    

issued to an independent innovator2     
7,b7 the owner of record is-- 7i7 the   
independent innovator2 or  7ii7 a       
qualified small business in which the   
independent innovator has an ownership  
interest2  7,c7 an application under    
section #cea7;a7 of the ,public ,health 
,service ,act 7#db ,u4,s4,c4 #bfb7;a77  
for commercial marketing of the         
biological product for a method of use  
claimed in the patent has been filed2   
and  7,d7 a period of not less than #aj 
years elapsed between the original date 
of submission of an application for an  
exemption under section #eje7;i7 of the 
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7;i77 for       
investigating such method of use and the
 date on which the ,food and ,drug      
,administration approved the application
 described in subparagraph 7,c72 and    
7#d7 a brief description of the         
activities undertaken by the owner of   
record of the patent1 or the agent of   
such owner1 during such period with     

respect to the biological product and   
the significant dates applicable to such
 activities to the extent such          
information is possessed by such owner4 
7c7 ,determination of extension  7#a7   
,in general ,a determination that a     
patent is eligible for extension shall  
be made by the ,director solely on the  
basis of the representations contained  
in the application for the extension4   
,if the ,director determines that a     
patent is eligible for extension under  
subsection 7a7 and that the requirements
 of subsection 7b7 have been complied   
with1 the ,director shall issue to the  
applicant for the extension of the term 
of the patent a certificate of          
extension1 under seal1 for #e years4    
,such certificate shall be recorded in  
the official file of the patent and     
shall be considered as part of the      
original patent4  7#b7 ,interim         
extension ,if the term of a patent for  
which an application has been submitted 
under subsection 7b7 would expire before

 a certificate of extension is issued or
 denied under paragraph 7#a7 respecting 
the application1 the ,director shall    
extend1 until such determination is     
made1 the term of the patent for periods
 of up to one year if the ,director     
determines that the patent is eligible  
for extension4  7d7 ,definitions ,in    
this section3 7#a7 ,biological product  
,the term biological product has the    
meaning given to such term in section   
#cea7;i77#a7 of the ,public ,health     
,service ,act 7#db ,u4,s4,c4            
#bfb7;i77#a774  7#b7 ,director ,the term
 ,director means the ,under ,secretary  
of ,commerce for ,intellectual ,property
 and ,director of the ,united ,states   
,patent and ,trademark ,office4  7#c7   
,independent innovator  7,a7 ,the term  
independent innovator means any person  
or entity that-- 7i7 obtains a method of
 use patent for a biological product2   
and  7ii7 is not1 at the time of        
invention or patent filing1 affiliated  
with the holder of a marketing          

application approved under section      
#cea7;a7 of the ,public ,health ,service
 ,act 7#db ,u4,s4,c4 #bfb7;a77 for the  
commercial marketing of such biological 
product4  7,b7 ,for purposes of         
subparagraph 7,a7 and paragraph 7#d71   
the term affiliated refers to any       
relationship of employment1 control1 or 
common ownership1 whether direct or     
indirect1 including through one or more 
intermediaries4  7#d7 ,qualified small  
business ,the term qualified small      
business means any entity with fewer    
than #ejj employees1 including employees
 of affiliates1 and which is not        
affiliated with the holder of the       
marketing application approved under    
section #cea7;a7 of the ,public ,health 
,service ,act 7#db ,u4,s4,c4 sec4       
#bfb7;a77 for the commercial marketing  
of such biological product4  7e7        
,effective date ,this section shall take
 effect on the date of the enactment of 
this ,act and shall apply to any        
unexpired patent issued before1 on1 or  

after that effective date4