,,ii #aafth ,,congress #ast ,session ,s4 #cdd ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,february #f1 #bjai,mr4 ,tillis 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 and the ,securities ,exchange ,act of #aicd to prevent the inter partes review process for challenging patents from diminishing competition in the pharmaceutical industry and with respect to drug innovation1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,hatch-,waxman ,integrity ,act of #bjai4 #b4 ,preventing the inter partes review process for challenging patents from diminishing competition in the pharmaceutical industry and with respect to drug innovation 7a7 ,brand name drugs ,section #eje7;b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#b77 is amended-- 7#a7 in subparagraph 7,a77iv71 by striking and at the end2 7#b7 in subparagraph 7,b71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following3 7,c7 in each certification required under subparagraph 7,a7 with respect to a patent1 a certification that-- 7i7 neither the applicant nor any party in privity with1 related to1 or cooperating with the applicant has filed1 or will file1 a petition to institute an inter partes review or a post-grant review of that patent under chapter #ca or #cb1 respectively1 of title #ce1 ,united ,states ,code2 and 7ii7 in making the certification required under subparagraph 7,a71 the applicant is not relying in whole or in part on any decision issued by the ,patent ,trial and ,appeal ,board in an inter partes review or a post-grant review instituted under chapter #ca or #cb1 respectively1 of title #ce1 ,united ,states ,code4 4 7b7 ,generic drugs ,section #eje7;j77#b77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#b77;,a77 is amended-- 7#a7 in clause 7vii77,,iv71 by striking and at the end2 7#b7 in clause 7viii71 by striking the period at the end and inserting 2 and2 7#c7 by inserting after clause 7viii71 as amended by paragraph 7#b71 the following3 7ix7 in each certification required under clause 7vii7 with respect to a patent1 a certification that-- 7,i7 neither the applicant nor any party in privity with1 related to1 or cooperating with the applicant has filed1 or will file1 a petition to institute an inter partes review or a post-grant review of that patent under chapter #ca or #cb1 respectively1 of title #ce1 ,united ,states ,code2 and 7,,ii7 in making the certification required under clause 7vii71 the applicant is not relying in whole or in part on any decision issued by the ,patent ,trial and ,appeal ,board in an inter partes review or a post-grant review instituted under chapter #ca or #cb1 respectively1 of title #ce1 ,united ,states ,code4 2 and 7#d7 in the flush text following clause 7ix71 as added by paragraph 7#c71 by striking 7viii7 and inserting 7ix74 7c7 ,biosimilar drugs2 evaluation by the ,secretary ,section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 is amended-- 7#a7 in paragraph 7#b77;,a77iii7-- 7,a7 by redesignating subclauses 7,i7 and 7,,ii7 as items 7aa7 and 7bb71 respectively1 and adjusting the margins accordingly2 7,b7 in the matter preceding item 7aa71 as so redesignated1 by striking ,an application and inserting the following3 7,i7 ,in general ,an application 2 7,c7 in subclause 7,i71 as so designated-- 7i7 in item 7aa71 as so redesignated1 by striking and at the end2 7ii7 in item 7bb71 as so redesignated1 by striking the period at the end and inserting 2 and2 and 7iii7 by adding at the end the following3 7cc7 shall1 with respect to a patent described in subclause 7,,ii71 include a certification that neither the applicant nor any party in privity with1 related to1 or cooperating with the applicant has filed1 or will file1 a petition to institute an inter partes review or a post-grant review of the patent under chapter #ca or #cb1 respectively1 of title #ce1 ,united ,states ,code4 2 and 7,d7 by adding at the end the following3 7,,ii7 ,patent described ,a patent is described in this subclause if-- 7aa7 the patent covers the reference product or a method for using the reference product2 and 7bb7 7,,aa7 the reference product described in item 7aa7 is marked under section #bhg7;a7 of title #ce1 ,united ,states ,code2 or 7,,bb7 there is otherwise public notice regarding the applicability of the reference product described in item 7aa74 2 and 7#b7 in paragraph 7#c7-- 7,a7 in subparagraph 7,a77ii71 by striking and at the end2 7,b7 in subparagraph 7,b71 by striking the period at the end and inserting 2 and2 and 7,c7 by adding at the end the following3 7,c7 the ,secretary determines that the application fully complies with the requirements under paragraph 7#b77;,a77iii74 4 #c4 ,preventing the manipulative and deceptive use of inter partes review ,section #aj7;b7 of the ,securities ,exchange ,act of #aicd 7#ae ,u4,s4,c4 #gh;j7b77 is amended-- 7#a7 by inserting 7#a7 after 7b72 and 7#b7 by adding at the end the following3 7#b7 ,for purposes of paragraph 7#a71 a person shall be considered to be using a manipulative or deceptive device if-- 7,a7 the person1 or an affiliate of the person1 files a petition to institute an inter partes review under chapter #ca of title #ce1 ,united ,states ,code1 with respect to a patent2 and 7,b7 the person1 or an affiliate of the person1 during the #ahj-;day period beginning on the date that is #ij days before the date on which the person files the petition described in subparagraph 7,a71 engages in a short sale of any publicly traded security of the owner of the patent that is the subject of the petition4 4