,,ii #aahth ,,congress #ast ,session ,s4 #aej ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,january #cj1 #bjbc ,mr4 ,cornyn 7for himself1 ,mr4 ,blumenthal1 ,mr4 ,grassley1 ,mr4 ,durbin1 ,mr4 ,cruz1 and ,ms4 ,klobuchar7 introduced the following bill2 which was read twice and referred to the ,committee on the ,judiciary ,a ,,bill ,to amend the ,federal ,trade ,commission ,act to prohibit product hopping1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,affordable ,prescriptions for ,patients ,act of #bjbc4 #b4 ,product hopping 7a7 ,in general ,the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq47 is amended by inserting after section #bf 7#ae ,u4,s4,c4 #eg;c-#b7 the following3 #bg4 ,product hopping 7a7 ,definitions ,in this section3 7#a7 ,abbreviated new drug application ,the term abbreviated new drug application means any application under subsection 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or an application under subsection 7b77#b7 of such section #eje that seeks a therapeutic equivalence rating to the reference product4 7#b7 ,biosimilar biological product ,the term biosimilar biological product means a biological product licensed under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k774 7#c7 ,biosimilar biological product license application ,the term biosimilar biological product license application means an application submitted under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k774 7#d7 ,follow-on product ,the term follow-on product-- 7,a7 means a drug approved through an application or supplement to an application submitted under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 or a biological product licensed through an application or supplement to an application submitted under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 for a change or modification to1 or reformulation of1 the same manufacturer's previously approved drug or biological product that has an indication that is identical or substantively similar to an indication of the same manufacturer's previously approved drug or biological product2 and 7,b7 excludes such an application or supplement to an application for a change1 modification1 or reformulation of a drug or biological product that is requested by the ,secretary or necessary to comply with law1 including sections #eje;,a and #eje;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;a1 #cee;c74 7#e7 ,generic drug ,the term generic drug means any drug approved under an application submitted under subsection 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or an application under subsection 7b77#b7 of such section #eje that seeks a therapeutic equivalence rating to the reference product4 7#f7 ,listed drug ,the term listed drug means a drug listed under section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g774 7#g7 ,manufacturer ,the term manufacturer means the holder1 licensee1 or assignee of-- 7,a7 an approved application for a drug under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c772 or 7,b7 a biological product license under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a774 7#h7 ,reference product ,the term reference product has the meaning given the term in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i774 7#i7 ,ultimate parent entity ,the term ultimate parent entity has the meaning given the term in section #hja4a of title #af1 ,code of ,federal ,regulations1 or any successor regulation4 7b7 ,prohibition on product hopping 7#a7 ,prima facie ,a manufacturer of a reference product or listed drug shall be considered to have engaged in an unfair method of competition in or affecting commerce in violation of section #e7;a7 if complaint counsel or the ,commission demonstrates in an action or proceeding initiated by the ,commission under subsection 7c7 that1 during the period beginning on the date on which the manufacturer of the reference product or listed drug first receives notice that an applicant has submitted to the ,commissioner of ,food and ,drugs an abbreviated new drug application or biosimilar biological product license application referencing the reference product or listed drug and ending on the date that is the earlier of #ahj days after the date on which the generic drug or biosimilar biological product that is the subject of the abbreviated new drug application or biosimilar biological product license application or another generic drug or biosimilar biological product referencing the listed drug or reference product is first marketed or #c years after the date on which the follow-on product is first marketed1 the manufacturer engaged in either of the following actions3 7,a7 ,the manufacturer engaged in a hard switch1 which shall be established by demonstrating that the manufacturer engaged in either of the following actions3 7i7 ,upon the request of the manufacturer of the listed drug or reference product1 the ,commissioner of ,food and ,drugs withdrew the approval of the application for the listed drug or reference product or placed the listed drug or reference product on the discontinued products list and the manufacturer marketed or sold a follow-on product4 7ii7 ,the manufacturer of the listed drug or reference product-- 7,i7 7aa7 withdrew1 discontinued the manufacture of1 or announced withdrawal of1 discontinuance of the manufacture of1 or intent to withdraw the application with respect to the drug or reference product in a manner that impedes competition from a generic drug or a biosimilar biological product1 which may be established by objective circumstances1 unless such actions were taken by the manufacturer pursuant to a request of the ,commissioner of ,food and ,drugs2 or 7bb7 destroyed the inventory of the listed drug or reference product in a manner that impedes competition from a generic drug or a biosimilar biological product1 which may be established by objective circumstances2 and 7,,ii7 marketed or sold a follow-on product4 7,b7 ,the manufacturer engaged in a soft switch1 which shall be established by demonstrating that the manufacturer engaged in both of the following actions3 7i7 ,the manufacturer took actions with respect to the listed drug or reference product other than those described in subparagraph 7,a7 that unfairly disadvantage the listed drug or reference product relative to the follow-on product described in clause 7ii7 in a manner that impedes competition from a generic drug or a biosimilar biological product1 which may be established by objective circumstances4 7ii7 ,the manufacturer marketed or sold a follow-on product4 7#b7 ,exclusions ,nothing in this section shall prohibit actions that consist solely of-- 7,a7 truthful1 non-misleading promotional marketing2 or 7,b7 ceasing promotional marketing for the listed drug or reference product4 7#c7 ,justification 7,a7 ,in general ,subject to paragraph 7#d71 the actions described in paragraph 7#a7 by a manufacturer of a listed drug or reference product shall not be considered to be an unfair method of competition in or affecting commerce if the manufacturer demonstrates to the ,commission or a district court of the ,united ,states1 as applicable1 in an action1 suit or proceeding initiated by the ,commission under subsection 7c77#a7 that-- 7i7 the manufacturer would have taken the actions regardless of whether a generic drug that references the listed drug or biosimilar biological product that references the reference product had already entered the market2 and 7ii7 7,i7 with respect to a hard switch under paragraph 7#a77;,a71 the manufacturer took the action for reasons relating to the safety risk to patients of the listed drug or reference product2 7,,ii7 with respect to an action described in paragraph 7#a77;,a77ii77,i77aa71 there is a supply disruption that-- 7aa7 is outside of the control of the manufacturer2 7bb7 prevents the production or distribution of the applicable listed drug or reference product2 and 7cc7 cannot be remedied by reasonable efforts2 or 7,,iii7 with respect to a soft switch under paragraph 7#a77;,b71 the manufacturer had legitimate pro-competitive reasons1 apart from the financial effects of reduced competition1 to take the action4 7,b7 ,rule of construction ,nothing in subparagraph 7,a7 may be construed to limit the information that the ,commission may otherwise obtain in any proceeding or action instituted with respect to a violation of this section4 7#d7 ,response ,with respect to a justification offered by a manufacturer under paragraph 7#c71 the ,commission may-- 7,a7 rebut any evidence presented by a manufacturer during that justification2 or 7,b7 establish by a preponderance of the evidence that-- 7i7 on balance1 the pro-competitive benefits from the conduct described in subparagraph 7,a7 or 7,b7 of paragraph 7#a71 as applicable1 do not outweigh any anticompetitive effects of the conduct1 even in consideration of the justification so offered2 or 7ii7 7,i7 the conduct described in paragraph 7#a7 is not reasonably necessary to address or achieve the justifications described in clause 7ii7 of paragraph 7#c77;,a72 or 7,,ii7 the justifications described in clause 7ii7 of paragraph 7#c77;,a7 could be reasonably addressed or achieved through less anticompetitive means4 7c7 ,enforcement 7#a7 ,in general ,if the ,commission has reason to believe that any manufacturer has violated1 is violating1 or is about to violate this section1 or a rule promulgated under this section1 the ,commission may take any of the following actions3 7,a7 ,institute a proceeding under section #e7;b74 7,b7 ,in the same manner and to the same extent as provided in section #ac7;b71 bring suit in a district court of the ,united ,states to temporarily enjoin the action of the manufacturer4 7,c7 ,bring suit in a district court of the ,united ,states1 in which the ,commission may seek-- 7i7 to permanently enjoin the action of the manufacturer2 7ii7 any of the remedies described in paragraph 7#c72 and 7iii7 any other equitable remedy1 including ancillary equitable relief4 7#b7 ,judicial review 7,a7 ,in general ,notwithstanding any provision of section #e1 any manufacturer that is subject to a final cease and desist order issued in a proceeding to enforce this section1 or a rule promulgated under this section1 may1 not later than #cj days after the date on which the ,commission issues the order1 petition for review of the order in-- 7i7 the ,united ,states ,court of ,appeals for the ,district of ,columbia ,circuit2 or 7ii7 the court of appeals of the ,united ,states for the circuit in which the ultimate parent entity of the manufacturer is incorporated4 7,b7 ,treatment of findings ,in a review of a final cease and desist order conducted by a court of appeals of the ,united ,states under subparagraph 7,a71 the factual findings of the ,commission shall be conclusive if those facts are supported by the evidence4 7#c7 ,equitable remedies 7,a7 ,disgorgement 7i7 ,in general ,in a suit brought under paragraph 7#a77;,c71 the ,commission may seek1 and the court may order1 disgorgement of any unjust enrichment that a person obtained as a result of the violation that gives rise to the suit4 7ii7 ,calculation ,any disgorgement that is ordered with respect to a person under clause 7i7 shall be offset by any amount of restitution ordered under subparagraph 7,b74 7iii7 ,limitations period ,the ,commission may seek disgorgement under this subparagraph not later than #e years after the latest date on which the person from which the disgorgement is sought receives any unjust enrichment from the effects of the violation that gives rise to the suit in which the ,commission seeks the disgorgement4 7,b7 ,restitution 7i7 ,in general ,in a suit brought under paragraph 7#a77;,c71 the ,commission may seek1 and the court may order1 restitution with respect to the violation that gives rise to the suit4 7ii7 ,limitations period ,the ,commission may seek restitution under this subparagraph not later than #e years after the latest date on which the person from which the restitution is sought receives any unjust enrichment from the effects of the violation that gives rise to the suit in which the ,commission seeks the restitution4 7#d7 ,rules of construction ,nothing in this subsection may be construed as-- 7,a7 requiring the ,commission to bring a suit seeking a temporary injunction under paragraph 7#a77;,b7 before bringing a suit seeking a permanent injunction under paragraph 7#a77;,c72 or 7,b7 affecting the authority of the ,federal ,trade ,commission under any other provision of law4 4 7b7 ,applicability ,section #bg of the ,federal ,trade ,commission ,act1 as added by subsection 7a71 shall apply with respect to any-- 7#a7 conduct that occurs on or after the date of enactment of this ,act2 and 7#b7 action or proceeding that is commenced on or after the date of enactment of this ,act4 7c7 ,antitrust laws ,except to the extent subsection 7a7 establishes an additional basis for liability under the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq471 nothing in this section1 or the amendments made by this section1 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 #ab71 or 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 7d7 ,rulemaking ,the ,federal ,trade ,commission may issue rules under section #eec of title #e1 ,united ,states ,code1 to define any terms used in section #bg of the ,federal ,trade ,commission ,act1 as added by subsection 7a7 7other than terms that are defined in subsection 7a7 of such section #bg74 #c4 ,title #ce amendments 7a7 ,in general ,section #bga7;e7 of title #ce1 ,united ,states ,code1 is amended-- 7#a7 in paragraph 7#b77;,c71 in the flush text following clause 7ii71 by adding at the end the following3 ,with respect to a submission described in clause 7ii71 the act of infringement shall extend to any patent that claims the biological product1 a method of using the biological product1 or a method or product used to manufacture the biological product42 and 7#b7 by adding at the end the following3 7#g7 7,a7 ,subject to subparagraphs 7,c71 7,d71 and 7,e71 if the sponsor of an approved application for a reference product1 as defined in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i77 7referred to in this paragraph as the reference product sponsor71 brings an action for infringement under this section against an applicant for approval of a biological product under section #cea7k7 of such ,act that references that reference product 7referred to in this paragraph as the subsection 7k7 applicant71 the reference product sponsor may assert in the action a total of not more than #bj patents of the type described in subparagraph 7,b71 not more than #aj of which shall have issued after the date specified in section #cea7l77#g77;,a7 of such ,act4 7,b7 ,the patents described in this subparagraph are patents that satisfy each of the following requirements3 7i7 ,patents that claim the biological product that is the subject of an application under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 7or a use of that product7 or a method or product used in the manufacture of such biological product4 7ii7 ,patents that are included on the list of patents described in paragraph 7#c77;,a7 of section #cea7l7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l771 including as provided under paragraph 7#g7 of such section #cea7l74 7iii7 ,patents that-- 7,i7 have an actual filing date of more than #d years after the date on which the reference product is approved2 or 7,,ii7 include a claim to a method in a manufacturing process that is not used by the reference product sponsor4 7,c7 ,the court in which an action described in subparagraph 7,a7 is brought may increase the number of patents limited under that subparagraph-- 7i7 if the request to increase that number is made without undue delay2 and 7ii7 7,i7 if the interest of justice so requires2 or 7,,ii7 for good cause shown1 which-- 7aa7 shall be established if the subsection 7k7 applicant fails to provide information required section #cea7k77#b77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#b77;,a77 that would enable the reference product sponsor to form a reasonable belief with respect to whether a claim of infringement under this section could reasonably be asserted2 and 7bb7 may be established-- 7,,aa7 if there is a material change to the biological product 7or process with respect to the biological product7 of the subsection 7k7 applicant that is the subject of the application2 7,,bb7 if1 with respect to a patent on the supplemental list described in section #cea7l77#g77;,a7 of ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l77#g77;,a771 the patent would have issued before the date specified in such section #cea7l77#g77;,a7 but for the failure of the ,office to issue the patent or a delay in the issuance of the patent1 as described in paragraph 7#a7 of section #aed7;b7 and subject to the limitations under paragraph 7#b7 of such section #aed7;b72 or 7,,cc7 for another reason that shows good cause1 as determined appropriate by the court4 7,d7 ,in determining whether good cause has been shown for the purposes of subparagraph 7,c77ii77,,ii71 a court may consider whether the reference product sponsor has provided a reasonable description of the identity and relevance of any information beyond the subsection 7k7 application that the court believes is necessary to enable the court to form a belief with respect to whether a claim of infringement under this section could reasonably be asserted4 7,e7 ,the limitation imposed under subparagraph 7,a7-- 7i7 shall apply only if the subsection 7k7 applicant completes all actions required under paragraphs 7#b77;,a71 7#c77;,b77ii71 7#e71 7#f77;,c77i71 7#g71 and 7#h77;,a7 of section #cea7l7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l772 and 7ii7 shall not apply with respect to any patent that claims1 with respect to a biological product1 a method for using that product in therapy1 diagnosis1 or prophylaxis1 such as an indication or method of treatment or other condition of use4 4 7b7 ,applicability ,the amendments made by subsection 7a7 shall apply with respect to an application submitted under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 on or after the date of enactment of this ,act4