#aaith ,,congress  #b;d ,session  ,s4   
#ajda  ,,an ,,act  ,to amend title #ce1 
,united ,states ,code1 to address the   
infringement of patents that claim      
biological products1 and for other      
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,affordable         
,prescriptions for ,patients ,act4  #b4 
,patent infringement  7a7 ,in general   
,section #bga7;e7 of title #ce1 ,united 
,states ,code1 is amended-- 7#a7 in     
paragraph 7#b71 in the flush text       
following subparagraph 7,c77ii71 by     
adding at the end the following3 ,with  
respect to a submission described in    
subparagraph 7,c77ii71 the act of       
infringement shall extend to any patent 
that claims the biological product1 a   
method of using the biological product1 
or a method or product used to          
manufacture the biological product42 and
  7#b7 by adding at the end the         
following3  7#g7 7,a7 ,subject to       
subparagraphs 7,c71 7,d71 and 7,e71 if  
the sponsor of an approved application  

for a reference product1 as defined in  
section #cea7;i7 of the ,public ,health 
,service ,act 7#db ,u4,s4,c4 #bfb7;i77  
7referred to in this paragraph as the   
reference product sponsor71 brings an   
action for infringement under this      
section against an applicant for        
approval of a biological product under  
section #cea7k7 of such ,act that       
references that reference product       
7referred to in this paragraph as the   
subsection 7k7 applicant71 the reference
 product sponsor may assert in the      
action a total of not more than #bj     
patents of the type described in        
subparagraph 7,b71 not more than #aj of 
which shall have issued after the date  
specified in section #cea7l77#g77;,a7 of
 such ,act4  7,b7 ,the patents described
 in this subparagraph are patents that  
satisfy each of the following           
requirements3 7i7 ,patents that claim   
the biological product that is the      
subject of an application under section 
#cea7k7 of the ,public ,health ,service 

,act 7#db ,u4,s4,c4 #bfb7k77 7or a use  
of that product7 or a method or product 
used in the manufacture of such         
biological product4  7ii7 ,patents that 
are included on the list of patents     
described in paragraph 7#c77;,a7 of     
section #cea7l7 of the ,public ,health  
,service ,act 7#db ,u4,s4,c4 #bfb7l771  
including as provided under paragraph   
7#g7 of such section #cea7l74  7iii7    
,patents that-- 7,i7 have an actual     
filing date of more than #d years after 
the date on which the reference product 
is approved2 or  7,,ii7 include a claim 
to a method in a manufacturing process  
that is not used by the reference       
product sponsor4  7,c7 ,the court in    
which an action described in            
subparagraph 7,a7 is brought may        
increase the number of patents limited  
under that subparagraph-- 7i7 if the    
request to increase that number is made 
without undue delay2 and  7ii7 7,i7 if  
the interest of justice so requires2 or 
7,,ii7 for good cause shown1 which--    

7aa7 shall be established if the        
subsection 7k7 applicant fails to       
provide information required by section 
#cea7k77#b77;,a7 of the ,public ,health 
,service ,act 7#db4 ,u4,s4,c4           
#bfb7k77#b77;,a77 that would enable the 
reference product sponsor to form a     
reasonable belief with respect to       
whether a claim of infringement under   
this section could reasonably be        
asserted2 and  7bb7 may be established--
 7,,aa7 if there is a material change to
 the biological product 7or process with
 respect to the biological product7 of  
the subsection 7k7 applicant that is the
 subject of the application2 7,,bb7 if1 
with respect to a patent on the         
supplemental list described in section  
#cea7l77#g7 of the ,public ,health      
,service ,act 7#db ,u4,s4,c4            
#bfb7l77#g771 the patent would have     
issued before the date specified in     
section #cea7l77#g77;,a7 of such ,act   
but for the failure of the ,office to   
issue the patent or a delay in the      

issuance of the patent1 as described in 
paragraph 7#a7 of section #aed7;b7 and  
subject to the limitations under        
paragraph 7#b7 of such section #aed7;b72
 or 7,,cc7 for another reason that shows
 good cause1 as determined appropriate  
by the court4  7,d7 ,in determining     
whether good cause has been shown for   
the purposes of subparagraph            
7,c77ii77,,ii71 a court may consider    
whether the reference product sponsor   
has provided a reasonable description of
 the identity and relevance of any      
information beyond the subsection 7k7   
application that the court believes is  
necessary to enable the court to form a 
belief with respect to whether a claim  
of infringement under this section could
 reasonably be asserted4  7,e7 ,the     
limitation imposed under subparagraph   
7,a7-- 7i7 shall apply only if the      
subsection 7k7 applicant completes all  
actions required under paragraphs       
7#b77;,a71 7#c77;,b77ii71 7#e71         
7#f77;,c77i71 7#g71 and 7#h77;,a7 of    

section #cea7l7 of the ,public ,health  
,service ,act 7#db ,u4,s4,c4 #bfb7l772  
and  7ii7 shall not apply with respect  
to any patent that claims1 with respect 
to a biological product1 a method for   
using that product in therapy1          
diagnosis1 or prophylaxis1 such as an   
indication or method of treatment or    
other condition of use4  4  7b7         
,applicability ,the amendments made by  
subsection 7a7 shall apply with respect 
to an application submitted under       
section #cea7k7 of the ,public ,health  
,service ,act 7#db ,u4,s4,c4 #bfb7k77 on
 or after the date of enactment of this 
,act4  ,passed the ,senate ,july #ba1   
#bjbf4,secretary