,i #aafth ,,congress #ast ,session ,h4 ,r4 #adii ,,in ,,the ,,house ,,of ,,representatives ,march #e1 #bjai,mr4 ,rush 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 manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market1 and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,protecting ,consumer ,access to ,generic ,drugs ,act of #bjai4 #b4 ,unlawful agreements 7a7 ,agreements prohibited ,subject to subsections 7b7 and 7c71 it shall be unlawful for an ,,nda or ,,bla holder and a subsequent filer to enter into1 or carry out1 an agreement resolving or settling a covered patent infringement claim on a final or interim basis if under such agreement-- 7#a7 a subsequent filer directly or indirectly receives from such holder anything of value1 including an exclusive license2 and 7#b7 the subsequent filer agrees to limit or forego research on1 or development1 manufacturing1 marketing1 or sales1 for any period of time1 of the covered product that is the subject of the application described in subparagraph 7,a7 or 7,b7 of subsection 7f77#h74 7b7 ,exclusion ,it shall not be unlawful under subsection 7a7 if a party to an agreement described in such subsection demonstrates by clear and convincing evidence that the value described in subsection 7a77#a7 is compensation solely for other goods or services that the subsequent filer has promised to provide4 7c7 ,limitation ,nothing in this section shall prohibit an agreement resolving or settling a covered patent infringement claim in which the consideration granted by the ,,nda or ,,bla holder to the subsequent filer as part of the resolution or settlement includes only one or more of the following3 7#a7 ,the right to market the covered product that is the subject of the application described in subparagraph 7,a7 or 7,b7 of subsection 7f77#h7 in the ,united ,states before the expiration of-- 7,a7 any patent that is the basis of the covered patent infringement claim2 or 7,b7 any patent right or other statutory exclusivity that would prevent the marketing of such covered product4 7#b7 ,a payment for reasonable litigation expenses not to exceed #g1ejj1jjj in the aggregate4 7#c7 ,a covenant not to sue on any claim that such covered product infringes a patent4 7d7 ,enforcement by ,federal ,trade ,commission 7#a7 ,general application ,the requirements of this section apply1 according to their terms1 to an ,,nda or ,,bla holder or subsequent filer that is-- 7,a7 a person1 partnership1 or corporation over which the ,commission has authority pursuant to section #e7;a77#b7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#b772 or 7,b7 a person1 partnership1 or corporation over which the ,commission would have authority pursuant to such section but for the fact that such person1 partnership1 or corporation is not organized to carry on business for its own profit or that of its members4 7#b7 ,unfair or deceptive acts or practices enforcement authority 7,a7 ,in general ,a violation of this section shall be treated as an unfair or deceptive act or practice in violation of section #e7;a77#a7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#a774 7,b7 ,powers of ,commission ,except as provided in subparagraph 7,c7 and paragraphs 7#a77;,b7 and 7#c7-- 7i7 the ,commission shall enforce this section in the same manner1 by the same means1 and with the same jurisdiction1 powers1 and duties as though all applicable terms and provisions of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq47 were incorporated into and made a part of this section2 and 7ii7 any ,,nda or ,,bla holder or subsequent filer that violates this section shall be subject to the penalties and entitled to the privileges and immunities provided in the ,federal ,trade ,commission ,act4 7,c7 ,judicial review ,in the case of a cease and desist order issued by the ,commission under section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 for violation of this section1 a party to such order may obtain judicial review of such order as provided in such section #e1 except that-- 7i7 such review may only be obtained in-- 7,i7 the ,united ,states ,court of ,appeals for the ,district of ,columbia ,circuit2 7,,ii7 the ,united ,states ,court of ,appeals for the circuit in which the ultimate parent entity1 as defined in section #hja4a7;a77#c7 of title #af1 ,code of ,federal ,regulations1 or any successor thereto1 of the ,,nda or ,,bla holder is incorporated as of the date that the application described in subparagraph 7,a7 or 7,b7 of subsection 7f77#h7 is submitted to the ,commissioner of ,food and ,drugs2 or 7,,iii7 the ,united ,states ,court of ,appeals for the circuit in which the ultimate parent entity1 as so defined1 of the subsequent filer is incorporated as of the date that the application described in subparagraph 7,a7 or 7,b7 of subsection 7f77#h7 is submitted to the ,commissioner of ,food and ,drugs2 and 7ii7 the petition for review shall be filed in the court not later than #cj days after such order is served on the party seeking review4 7#c7 ,additional enforcement authority 7,a7 ,civil penalty ,the ,commission may commence a civil action to recover a civil penalty in a district court of the ,united ,states against any ,,nda or ,,bla holder or subsequent filer that violates this section4 7,b7 ,special rule for recovery of penalty if cease and desist order issued 7i7 ,in general ,if the ,commission has issued a cease and desist order in a proceeding under section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 for violation of this section-- 7,i7 the ,commission may commence a civil action under subparagraph 7,a7 to recover a civil penalty against any party to such order at any time before the expiration of the #a-year period beginning on the date on which such order becomes final under section #e7;g7 of such ,act 7#ae ,u4,s4,c4 #de7;g772 and 7,,ii7 in such civil action1 the findings of the ,commission as to the material facts in such proceeding shall be conclusive1 unless-- 7aa7 the terms of such order expressly provide that the ,commission's findings shall not be conclusive2 or 7bb7 such order became final by reason of section #e7;g77#a7 of such ,act 7#ae ,u4,s4,c4 #de7;g77#a771 in which case such findings shall be conclusive if supported by evidence4 7ii7 ,relationship to penalty for violation of an order ,the penalty provided in clause 7i7 for violation of this section is separate from and in addition to any penalty that may be incurred for violation of an order of the ,commission under section #e7l7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7l774 7,c7 ,amount of penalty 7i7 ,in general ,the amount of a civil penalty imposed in a civil action under subparagraph 7,a7 on a party to an agreement described in subsection 7a7 shall be sufficient to deter violations of this section1 but in no event greater than-- 7,i7 if such party is the ,,nda or ,,bla holder1 the greater of-- 7aa7 #c times the value received by such ,,nda or ,,bla holder that is reasonably attributable to the violation of this section2 or 7bb7 #c times the value given to the subsequent filer reasonably attributable to the violation of this section2 and 7,,ii7 if such party is the subsequent filer1 #c times the value received by such subsequent filer that is reasonably attributable to the violation of this section4 7ii7 ,factors for consideration ,in determining such amount1 the court shall take into account-- 7,i7 the nature1 circumstances1 extent1 and gravity of the violation2 7,,ii7 with respect to the violator1 the degree of culpability1 any history of violations1 the ability to pay1 any effect on the ability to continue doing business1 profits earned by the ,,nda or ,,bla holder1 compensation received by the subsequent filer1 and the amount of commerce affected2 and 7,,iii7 other matters that justice requires4 7,d7 ,injunctions and other equitable relief ,in a civil action under subparagraph 7,a71 the ,united ,states district courts are empowered to grant mandatory injunctions and such other and further equitable relief as they deem appropriate4 7#d7 ,remedies in addition ,remedies provided in this subsection are in addition to1 and not in lieu of1 any other remedy provided by ,federal law4 7#e7 ,preservation of authority of ,commission ,nothing in this section shall be construed to affect any authority of the ,commission under any other provision of law4 7e7 ,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 such section #e applies to unfair methods of competition4 ,nothing in this section shall modify1 impair1 limit1 or supersede the right of a subsequent filer to assert claims or counterclaims against any person1 under the antitrust laws or other laws relating to unfair competition4 7f7 ,definitions ,in this section3 7#a7 ,agreement resolving or settling a covered patent infringement claim ,the term agreement resolving or settling a covered patent infringement claim means any agreement that-- 7,a7 resolves or settles a covered patent infringement claim2 or 7,b7 is contingent upon1 provides for a contingent condition for1 or is otherwise related to the resolution or settlement of a covered patent infringement claim4 7#b7 ,commission ,the term ,commission means the ,federal ,trade ,commission4 7#c7 ,covered patent infringement claim ,the term covered patent infringement claim means an allegation made by the ,,nda or ,,bla holder to a subsequent filer1 whether or not included in a complaint filed with a court of law1 that-- 7,a7 the submission of the application described in clause 7i7 or 7ii7 of paragraph 7#e77;,a71 or the manufacture1 use1 offering for sale1 sale1 or importation into the ,united ,states of a covered product that is the subject of such an application1 infringes any patent owned by1 or exclusively licensed to1 the ,,nda or ,,bla holder of the covered product2 or 7,b7 the covered product to be manufactured under such application uses a covered product as claimed in a published patent application4 7#d7 ,covered product ,the term covered product means-- 7,a7 a new drug 7as defined in section #bja7p7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7p7772 or 7,b7 a biological product 7as defined in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i7774 7#e7 ,,nda or ,,bla holder ,the term ,,nda or ,,bla holder means-- 7,a7 the holder of-- 7i7 an approved new drug application filed under section #eje7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 for a covered product2 or 7ii7 an application approved under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 with respect to a biological product2 7,b7 a person owning or controlling enforcement of the patent on-- 7i7 the list published under section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 in connection with the application described in subparagraph 7,a77i72 or 7ii7 the equivalent list published under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 comprised of patents associated with applications filed under section #cea7;a7 of such ,act 7#db ,u4,s4,c4 #bfb7;a772 or 7,c7 the predecessors1 subsidiaries1 divisions1 groups1 and affiliates controlled by1 controlling1 or under common control with any entity described in subparagraph 7,a7 or 7,b7 7such control to be presumed by direct or indirect share ownership of #ej percent or greater71 as well as the licensees1 licensors1 successors1 and assigns of each of the entities4 7#f7 ,patent ,the term patent means a patent issued by the ,united ,states ,patent and ,trademark ,office4 7#g7 ,statutory exclusivity ,the term statutory exclusivity means those prohibitions on the approval of drug applications under clauses 7ii7 through 7iv7 of section #eje7;c77#c77;,e7 7#e- and #c-year data exclusivity71 section #eje7;j77#e77;,b77iv7 7#ahj-;day exclusivity71 section #ebg 7orphan drug exclusivity71 section #eje;,a 7pediatric exclusivity71 or section #eje;,e 7qualified infectious disease product exclusivity7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#c77;,e71 #cee7;j77#e77;,b77iv71 #cfj;cc1 #cee;a1 #cee;f71 or section #cea7k77#f7 7interchangeable biological product exclusivity7 or section #cea7k77#g7 7biological product reference product exclusivity7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#f71 7#g774 7#h7 ,subsequent filer ,the term subsequent filer means-- 7,a7 in the case of a drug1 a party that owns or controls an abbreviated new drug application filed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 or a new drug application filed under section #eje7;b77#b7 of such ,act 7#ba ,u4,s4,c4 #cee7;b77#b77 or has the exclusive rights to distribute the covered product that is the subject of such application2 or 7,b7 in the case of a biological product1 a party that owns or controls an application filed with the ,food and ,drug ,administration under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 or has the exclusive rights to distribute the biological product that is the subject of such application4 7g7 ,effective date ,this section shall apply to all agreements described in subsection 7a7 entered into after ,june #ag1 #bjac1 except that a civil penalty may only be obtained under subsection 7d77#c77;,a7 with respect to such an agreement entered into on or after the date of enactment of this ,act4 #c4 ,notice and certification of agreements 7a7 ,notice of all agreements ,section #aaaa7g7 of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc 7#ba ,u4,s4,c4 #cee note7 is amended by inserting or the owner of a patent for which a claim of infringement could reasonably be asserted against any person for making1 using1 offering to sell1 selling1 or importing into the ,united ,states a biological product that is the subject of a biosimilar biological product application before the period at the end4 7b7 ,certification of agreements ,section #aaab of such ,act 7#ba ,u4,s4,c4 #cee note7 is amended by adding at the end the following3 7d7 ,certification ,the ,chief ,executive ,officer or the company official responsible for negotiating any agreement under subsection 7a7 or 7b7 that is required to be filed under subsection 7c7 shall1 within #cj days of such filing1 execute and file with the ,assistant ,attorney ,general and the ,commission a certification as follows3 ,i declare that the following is true1 correct1 and complete to the best of my knowledge3 ,the materials filed with the ,federal ,trade ,commission and the ,department of ,justice under section #aaab of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc1 with respect to the agreement referenced in this certification-- 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 were entered into within #cj days of1 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 writing4 4 4 #d4 ,forfeiture of #ahj-;day exclusivity period ,section #eje7;j77#e77;,d77i77,v7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,d77i77,v77 is amended by inserting section #b of the ,protecting ,consumer ,access to ,generic ,drugs ,act of #bjai or after that the agreement has violated4 #e4 ,commission litigation authority ,section #af7;a77#b7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #ef7;a77#b77 is amended-- 7#a7 in subparagraph 7,d71 by striking or after the semicolon2 7#b7 in subparagraph 7,e71 by inserting or after the semicolon2 and 7#c7 by inserting after subparagraph 7,e7 the following3 7,f7 under section #b7;d77#c77;,a7 of the ,protecting ,consumer ,access to ,generic ,drugs ,act of #bjai2 4 #f4 ,statute of limitations 7a7 ,in general ,except as provided in subsection 7b71 the ,commission shall commence any administrative proceeding or civil action to enforce section #b of this ,act not later than #f years after the date on which the parties to the agreement file the ,notice of ,agreement as provided by section #aaab7;c77#b7 and 7d7 of the ,medicare ,prescription ,drug ,improvement and ,modernization ,act of #bjjc 7#ba ,u4,s4,c4 #cee note74 7b7 ,civil action after issuance of cease and desist order ,if the ,commission has issued a cease and desist order under section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 for violation of section #b of this ,act and the proceeding for the issuance of such order was commenced within the period required by subsection 7a7 of this section1 such subsection does not prohibit the commencement1 after such period1 of a civil action under section #b7;d77#c77;,a7 against a party to such order or a civil action under subsection 7l7 of such section #e for violation of such order4