,i #aafth ,,congress #ast ,session ,h4 ,r4 #bcgd ,,in ,,the ,,house ,,of ,,representatives ,april #bi1 #bjai,mr4 ,jeffries 7for himself1 ,mr4 ,sensenbrenner1 ,mr4 ,nadler1 ,mr4 ,collins of ,georgia1 ,mr4 ,cicilline1 and ,mr4 ,welch7 introduced the following bill2 which was referred to the ,committee on the ,judiciary ,a ,,bill ,to enable the ,federal ,trade ,commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar1 to foster competition and facilitate the efficient review of petitions filed in good faith to raise legitimate public heath concerns1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,stop ,significant and ,time-wasting ,abuse ,limiting ,legitimate ,innovation of ,new ,generics ,act or the ,stop ,,stalling ,act4 #b4 ,federal ,trade ,commission enforcement against sham petitions 7a7 ,definitions ,in this section3 7#a7 ,commission ,the term ,commission means the ,federal ,trade ,commission4 7#b7 ,covered application ,the term covered application means an application filed pursuant to subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k774 7#c7 ,covered petition ,the term covered petition means a petition1 or a supplement to a petition1 filed under section #eje7q7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7q774 7#d7 ,person ,the term person means-- 7,a7 an individual or entity2 7,b7 its directors1 officers1 employees1 agents1 representatives1 successors1 and assigns2 and 7,c7 the joint ventures1 subsidiaries1 partnerships1 divisions1 groups1 and affiliates it controls1 and the respective directors1 officers1 employees1 agents1 representatives1 successors1 and assigns of each4 7#e7 ,series of covered petitions ,the term series of covered petitions means any group of more than one covered petition4 7#f7 ,sham ,the term 8sham0 means a covered petition that is objectively baseless and that attempts to use a governmental process1 as opposed to the outcome of that process1 to interfere with the business of a competitor1 or a series of covered petitions1 that attempts to use a governmental process1 as opposed to the outcome of that process1 to interfere with the business of a competitor4 7b7 ,violation 7#a7 ,in general ,a person submitting or causing the submission of a covered petition or a series of covered petitions that is a sham shall be liable for engaging in an unfair method of competition under section #e7;a77#a7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#a774 7c7 ,civil action 7#a7 ,in general ,if the ,commission has reason to believe that the submission of a covered petition or a series of covered petitions constitutes a violation of section #e7;a77#a7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#a771 the ,commission may commence a civil action to recover a civil penalty and seek other appropriate relief in a district court of the ,united ,states against any person that submitted or caused to be submitted such covered petition or such series of covered petitions1 including successors or assigns4 7#b7 ,presumption ,in a civil action under paragraph 7#a71 a covered petition shall be presumed to be part of a series of covered petitions that is a sham under subsection 7b7 of this section if the ,secretary of ,health and ,human ,services has determined that the covered petition was submitted with the primary purpose of delaying the approval of a covered application1 was part of a series of covered petitions1 and has referred such determination to the ,federal ,trade ,commission in writing1 with a reasoned basis for the determination4 7#c7 ,exception ,the presumption in paragraph 7#b7 shall not apply if the defendant establishes1 by a preponderance of the evidence1 that the series of covered petitions that includes the covered petition referred to the ,commission by the ,secretary of ,health and ,human ,services is not a sham4 7#d7 ,civil penalty ,in an action under paragraph 7#a71 any person that has been found liable for a violation of section #e7;a77#a7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#a77 shall be subject to a civil penalty for each violation of not more than the greater of-- 7,a7 any revenue earned from the sale by such person of any drug product1 referenced in a covered application that was the subject of a covered petition or a series of covered petitions that is a sham1 during the period in which the covered petition or series of covered petitions was under review by the ,secretary of ,health and ,human ,services2 or 7,b7 #ej1jjj for each calendar day that each covered petition that is a sham or that was part of a series of covered petitions that is a sham was under review by the ,secretary of ,health and ,human ,services4 7#e7 ,antitrust laws ,nothing in this section shall modify1 impair1 limit1 or supersede the applicability of the antitrust laws as defined in subsection 7a7 of the first section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 and of section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent that it applies to unfair methods of competition4 7#f7 ,rule of construction ,the civil penalty provided in this subsection is in addition to1 and not in lieu of1 any other remedies provided by ,federal law1 including under section #af of the ,clayton ,act 7#ae ,u4,s4,c4 #bf7 or under section #ac7;b7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #ec7;b774 ,nothing in this paragraph shall be construed to affect any authority of the ,commission under any other provision of law4 7d7 ,applicability ,this section shall apply to any covered petition submitted on or after the date of enactment of this ,act4 #c4 ,severability ,if any provision of this ,act1 an amendment made by this ,act1 or the application of such provision or amendment to any person or circumstance is held to be unconstitutional1 the remainder of this ,act1 the amendments made by this ,act1 and the application of the provisions of such ,act or amendments to any person or circumstance shall not be affected4