,,ii  #aahth ,,congress  #ast ,session  
,s4 #egd  ,,in ,,the ,,senate ,,of ,,the
 ,,united ,,states  ,march #a1 #bjbc,ms4
 ,hassan 7for herself and ,mr4 ,braun7  
introduced the following bill2 which was
 read twice and referred to the         
,committee on ,health1 ,education1      
,labor1 and ,pensions  ,a ,,bill  ,to   
amend the ,federal ,food1 ,drug1 and    
,cosmetic ,act to prevent the use of    
patents1 trade secrets1 or other        
intellectual property to inhibit        
competition4  #a4 ,short title ,this    
,act may be cited as the ,increasing    
,prescription ,drug ,competition ,act4  
#b4 ,preventing the use of patents1     
trade secrets1 or other intellectual    
property on risk evaluation and         
mitigation strategies to inhibit        
competition ,section #eje-a of the      
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee-a7 is amended  
by adding at the end the following3  7n7
 ,additional requirements  7#a7 ,patents
 claiming ,,rems ,if an application     

under subsection 7b77#b7 or 7j7 of      
section #eje includes a certification   
under subsection 7b77#b77;,a7 or        
7j77#b77;,a77vii7 of section #eje with  
respect to a patent that claims an      
aspect of the elements to assure safe   
use of a risk evaluation and mitigation 
strategy requirements under subsection  
7f7 for the applicable listed drug1 such
 certification shall have no effect on  
the effective date of the approval of   
the application1 notwithstanding        
subparagraphs 7,b7 and 7,c7 of section  
#eje7;c77#c7 and clauses 7ii7 and 7iii7 
of section #eje7;j77#e77;,b74 ,this     
paragraph shall apply to all            
applications submitted to the ,secretary
 under subsection 7b77#b7 or 7j7 of     
section #eje before1 on1 or after the   
date of enactment of the ,increasing    
,prescription ,drug ,competition ,act4  
7#b7 ,damages ,in the event that the    
sponsor of another application under    
section #eje of this ,act or section    
#cea of the ,public ,health ,service    

,act infringes a patent1 trade secret1  
or any other intellectual property held 
by the sponsor or holder to comply with 
risk evaluation and mitigation strategy 
requirements under this section1 the    
sponsor or holder of the approved       
application shall not seek1 or claim    
entitlement to1 any remedy other than   
damages arising from the infringement4  
7#c7 ,clarifications ,nothing in this   
section shall be construed as-- 7,a7    
prohibiting the sponsor or holder of an 
approved application from allowing the  
sponsor of another application under    
section #eje of this ,act or section    
#cea of the ,public ,health ,service    
,act to use the patent1 trade secret1 or
 any other intellectual property other  
than as described in this subsection2   
7,b7 preventing a sponsor of an         
application under section #eje of this  
,act or section #cea of the ,public     
,health ,service ,act from using a      
different1 comparable aspect of the     
elements to assure safe use as          

authorized under this section2  7,c7 in 
any way negating the applicability of a 
risk evaluation and mitigation strategy 
with elements to assure safe use1 as    
otherwise required under this section2  
or  7,d7 limiting the application of any
 provision of the antitrust laws 7as    
defined in subsection 7a7 of the first  
section of the ,clayton ,act 7#ae       
,u4,s4,c4 #ab7;a774  4