,,ii #aahth ,,congress #ast ,session ,s4 #bghj ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #ac1 #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 require sponsors of drug applications and holders of approved applications to provide certain submissions and communications to the ,food and ,drug ,administration and the ,united ,states ,patent and ,trademark ,office4 #a4 ,short title ,this ,act may be cited as the ,medication ,affordability and ,patent ,integrity ,act4 #b4 ,disclosure of information 7a7 ,in general 7#a7 ,in general ,section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 is amended by adding at the end the following3 7#g7 7,a7 ,with respect to any application submitted under this subsection or approved under subsection 7c71 the sponsor of the application or holder of the approved application shall1 for any applicable patent-- 7i7 certify to the ,food and ,drug ,administration that the information described in subparagraph 7,b7 that is submitted to the ,secretary is complete and consistent with the information such sponsor or holder provided to the ,united ,states ,patent and ,trademark ,office and any communications such sponsor or holder had with the ,united ,states ,patent and ,trademark ,office2 and 7ii7 7,i7 submit to the ,united ,states ,patent and ,trademark ,office any information material to patentability with respect to such applicable patent that the sponsor or holder submits to the ,food and ,drug ,administration1 and any communications with the ,food and ,drug ,administration that are related to such submissions2 and 7,,ii7 certify to the ,united ,states ,patent and ,trademark ,office that the information provided under subclause 7,i7 is complete and consistent with the information such sponsor or holder provided to the ,food and ,drug ,administration and any communications such sponsor or holder had with the ,food and ,drug ,administration4 7,b7 ,the information described in this subparagraph is-- 7i7 any statement or characterization of analytical or clinical data disclosed by the sponsor of the application or holder of the approved application under this section to the ,united ,states ,patent and ,trademark ,office that has been1 or will be1 submitted to the ,food and ,drug ,administration to support the approval of an application under this section2 7ii7 any statement or characterization with respect to an applicable patent1 including any statement or characterization of prior art1 submitted by the sponsor of the application or holder of the approved application to the ,united ,states ,patent and ,trademark ,office in support of patentability2 and 7iii7 other information1 as the ,secretary or the ,secretary of ,commerce may require4 7,c7 ,in this paragraph1 the term applicable patent means-- 7i7 a patent that-- 7,i7 claims a drug that is the subject of an application described in subparagraph 7,a71 including any patent that claims1 with respect to such a drug1 a formulation or composition1 method of use1 or method of manufacturing2 and 7,,ii7 is issued1 assigned1 or licensed to the sponsor of the application or holder of the approved application described in subparagraph 7,a72 7ii7 an application for a patent described in clause 7i77,i7 that is sought by the sponsor of the application or holder of the approved application described in subparagraph 7,a72 or 7iii7 such other patent or application for a patent as the ,secretary determines appropriate4 7,d7 7i7 ,except as provided in clause 7ii71 subparagraph 7,a7 shall apply with respect to any original application submitted under this subsection on or after the date of enactment of the ,medication ,affordability and ,patent ,integrity ,act and to any amendments or supplements to such original application4 7ii7 ,in the case of an application submitted before the date of enactment of the ,medication ,affordability and ,patent ,integrity ,act1 the requirements of subparagraph 7,a7 apply with respect to-- 7,i7 any applicable patent issued on or after such date of enactment2 and 7,,ii7 in the case of an applicable patent issued before such date of enactment1 only to submissions and communications described in clauses 7i7 and 7ii7 of subparagraph 7,a7 made on or after such date of enactment4 4 7#b7 ,condition for approval ,section #eje7;d77#f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #eje7;d77#f77 is amended by inserting 1 or the sponsor failed to comply with a requirement of subsection 7b77#g77;,a77i7 after subsection 7b74 7b7 ,biological product applications ,section #cea7;a77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77#b77 is amended by adding at the end the following3 7,f7 7i7 ,with respect to any application submitted under this subsection or biological product licensed under this subsection1 the sponsor of the application or holder of the licensure shall1 for any applicable patent-- 7,i7 certify to the ,food and ,drug ,administration that the information described in clause 7ii7 that is submitted to the ,secretary is complete and consistent with the information such sponsor or holder provided to the ,united ,states ,patent and ,trademark ,office and any communications such sponsor or holder had with the ,united ,states ,patent and ,trademark ,office2 and 7,,ii7 7aa7 submit to the ,united ,states ,patent and ,trademark ,office any information material to patentability with respect to such applicable patent that the sponsor or holder submits to the ,food and ,drug ,administration1 and any communications with the ,food and ,drug ,administration that are related to such submissions2 and 7bb7 certify to the ,united ,states ,patent and ,trademark ,office that the information provided under item 7aa7 is complete and consistent with the information such sponsor or holder provided to the ,food and ,drug ,administration and any communications such sponsor or holder had with the ,food and ,drug ,administration4 7ii7 ,the information described in this clause is-- 7,i7 any statement or characterization of analytical or clinical data disclosed by the sponsor of the application or holder of the approved application under this section to the ,united ,states ,patent and ,trademark ,office that has been1 or will be1 submitted to the ,food and ,drug ,administration to support the approval of an application under this section2 7,,ii7 any statement or characterization with respect to an applicable patent1 including any statement or characterization of prior art1 submitted by the sponsor of the application or holder of the approved application to the ,united ,states ,patent and ,trademark ,office in support of patentability2 and 7,,iii7 other information1 as the ,secretary or the ,secretary of ,commerce may require4 7iii7 ,in this subparagraph1 the term applicable patent means-- 7,i7 a patent-- 7aa7 with respect to which a reference product sponsor could reasonably assert a claim of patent infringement1 if a person not licensed by the reference product sponsor engaged in the making1 using1 offering to sell1 selling1 or importing into the ,united ,states of a biological product that relies on such patent2 and 7bb7 that is issued1 assigned1 or exclusively licensed to the sponsor of the application or holder of the licensure described in clause 7i72 7,,ii7 an application for a patent described in subclause 7,i77aa7 that is sought by the sponsor of the application or holder of the licensure described in clause 7i72 or 7,,iii7 such other patent or application for a patent as the ,secretary determines appropriate4 7iv7 7,i7 ,except as provided in subclause 7,,ii71 clause 7i7 shall apply with respect to any original application submitted under this subsection on or after the date of enactment of the ,medication ,affordability and ,patent ,integrity ,act and to any amendments or supplements to such original application4 7,,ii7 ,in the case of an application submitted under this subsection before the date of enactment of the ,medication ,affordability and ,patent ,integrity ,act1 the requirements of clause 7i7 apply with respect to-- 7aa7 any applicable patent issued on or after such date of enactment2 and 7bb7 in the case of an applicable patent issued before such date of enactment1 only to submissions and communications described in subclauses 7,i7 and 7,,ii7 of clause 7i7 made on or after such date of enactment4 7v7 ,notwithstanding subparagraph 7,c71 the ,secretary may not approve an application for a biological product if the sponsor of such application is out of compliance with the requirements of clause 7i77,i7 with respect to such application4 4 7c7 ,enforcement 7#a7 ,,fda enforcement ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended by adding at the end the following3 7jjj7 ,a failure to comply with a requirement of section #eje7;b77#g7 of this ,act or section #cea7;a77#b77;,f7 of the ,public ,health ,service ,act4 4 7#b7 ,defense against patent infringement actions 7,a7 ,in general ,chapter #bh of title #ce1 ,united ,states ,code1 is amended by adding at the end the following3 #bgd4 ,non-disclosure defense to infringement of drug patent ,a person shall be entitled to a defense under section #bhb7;b7 in an action asserting infringement of an applicable patent 7as defined in paragraph 7#g77;,b7 of section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 or subparagraph 7,f77ii7 of section #cea7;a77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77#b777 if the owner or predecessor owner of the applicable patent violated paragraph 7#g77;,a7 of such section #eje7;b7 or subparagraph 7,f77i7 of such section #cea7;a77#b7 with respect to the applicable patent by negligently or intentionally failing to disclose any information required to be disclosed pursuant to such paragraph 7#g77;,a7 or such subparagraph 7,f77i74 4 7,b7 ,technical and conforming amendment ,the table of sections for chapter #bh of title #ce1 ,united ,states ,code1 is amended by adding at the end the following3 #bgd4 ,non-disclosure defense to infringement of drug patent4 4