,i #aacth ,,congress #ast ,session ,h4 ,r4 #cgji ,,in ,,the ,,house ,,of ,,representatives ,december #aa1 #bjac,mr4 ,rush 7for himself1 ,mr4 ,van ,hollen1 and ,mr4 ,waxman7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on the ,judiciary1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,protecting ,consumer ,access to ,generic ,drugs ,act of #bjac4 #b4 ,unfair and deceptive acts and practices related to new drug applications 7a7 ,conduct prohibited ,it shall be unlawful for any person to directly or indirectly be a party to any agreement resolving or settling a patent infringement claim in which-- 7#a7 an ,,anda filer receives anything of value2 and 7#b7 the ,,anda filer agrees not to research1 develop1 manufacture1 market1 or sell1 for any period of time1 the drug that is to be manufactured under the ,,anda involved and is the subject of the patent infringement claim4 7b7 ,exceptions ,notwithstanding subsection 7a77#a71 subsection 7a7 does not prohibit a resolution or settlement of a patent infringement claim in which the value received by the ,,anda filer includes no more than-- 7#a7 the right to market the drug that is to be manufactured under the ,,anda involved and is the subject of the patent infringement claim1 before the expiration of-- 7,a7 the patent that is the basis for the patent infringement claim2 or 7,b7 any other statutory exclusivity that would prevent the marketing of such drug2 and 7#b7 the waiver of a patent infringement claim for damages based on prior marketing of such drug4 7c7 ,enforcement ,a violation of subsection 7a7 shall be treated as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce prohibited under section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de74 ,the ,federal ,trade ,commission shall enforce this ,act in the same manner1 by the same means1 and with the same jurisdiction as though all applicable terms and provisions of the ,federal ,trade ,commission ,act were incorporated into and made a part of this ,act4 7d7 ,definitions ,in this section3 7#a7 ,agreement ,the term agreement means anything that would constitute an agreement for purposes of section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de74 7#b7 ,agreement resolving or settling ,the term agreement resolving or settling1 in reference to a patent infringement claim1 includes any agreement that is contingent upon1 provides a contingent condition for1 or is otherwise related to the resolution or settlement of the claim4 7#c7 ,,anda ,the term ,,anda means an abbreviated new drug application for the approval of a new drug under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j774 7#d7 ,,anda filer ,the term ,,anda filer means a party that has filed an ,,anda with the ,food and ,drug ,administration4 7#e7 ,patent infringement ,the term patent infringement means infringement of any patent or of any filed patent application1 extension1 reissuance1 renewal1 division1 continuation1 continuation in part1 reexamination1 patent term restoration1 patent of addition1 or extension thereof4 7#f7 ,patent infringement claim ,the term patent infringement claim means any allegation made to an ,,anda filer1 whether or not included in a complaint filed with a court of law1 that its ,,anda or drug to be manufactured under such ,,anda may infringe any patent4 #c4 ,,ftc ,rulemaking ,the ,federal ,trade ,commission may1 by rule promulgated under section #eec of title #e1 ,united ,states ,code1 exempt certain agreements described in section #b if the ,commission finds such agreements to be in furtherance of market competition and for the benefit of consumers4 ,consistent with the authority of the ,commission1 such rules may include interpretive rules and general statements of policy with respect to the practices prohibited under section #b4 #d4 ,forfeiture of #ahj-;day exclusivity period under the ,,ffdca ,section #eje7;j77#e77;,d77i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,d77i77 is amended in subclause 7,v7 by inserting section #b of the ,protecting ,consumer ,access to ,generic ,drugs ,act of #bjac or after that the agreement has violated4 #e4 ,notice and certification of agreements 7a7 ,notice of all agreements ,section #aaab7;c77#b7 of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc 7#ba ,u4,s4,c4 #caee note7 is amended by-- 7#a7 striking the ,commission the and inserting the ,commission 7#a7 the2 and 7#b7 inserting before the period at the end the following3 2 and 7#b7 a description of the subject matter of any other agreement the parties enter into within #cj days of an entering into an agreement covered by subsection 7a7 or 7b74 7b7 ,certification of agreements ,section #aaab of such ,act is amended by adding at the end the following3 7d7 ,certification ,the ,chief ,executive ,officer or the company official responsible for negotiating any agreement required to be filed under subsection 7a71 7b71 or 7c7 shall execute and file with the ,assistant ,attorney ,general and the ,commission a certification as follows3 ,i declare under penalty of perjury that the following is true and correct3 ,the materials filed with the ,federal ,trade ,commission and the ,department of ,justice under section #aaab of subtitle ,b of title ,,xi of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc1 with respect to the agreement referenced in this certification3 7#a7 represent the complete1 final1 and exclusive agreement between the parties2 7#b7 include any ancillary agreements that are contingent upon1 provide a contingent condition for1 or are otherwise related to1 the referenced agreement2 and 7#c7 include written descriptions of any oral agreements1 representations1 commitments1 or promises between the parties that are responsive to subsection 7a7 or 7b7 of such section #aaab and have not been reduced to writing44 4