,,ii ,calendar ,no4 #acb #aafth ,,congress #ast ,session ,s4 #adaf ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #i1 #bjai,mr4 ,cornyn 7for himself1 ,mr4 ,blumenthal1 ,mrs4 ,capito1 ,mrs4 ,murray1 ,mr4 ,scott of ,florida1 ,mr4 ,kennedy1 ,mr4 ,hawley1 and ,mr4 ,durbin7 introduced the following bill2 which was read twice and referred to the ,committee on the ,judiciary ,june #bh 7legislative day1 ,june #bg71 #bjai,reported by ,mr4 ,graham1 with an amendment,strike out all after the enacting clause and insert the part printed in italic ,a ,,bill ,to amend the ,federal ,trade ,commission ,act to prohibit anticompetitive behaviors by drug product manufacturers1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,affordable ,prescriptions for ,patients ,act of #bjai4 #b4 ,product hopping2 patent thicketing 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 hopping2 patent thicketing 7a7 ,definitions ,in this section3 7#a7 ,abbreviated new drug application ,the term abbreviated new drug application means an application under subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee74 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 ,competition window ,the term competition window means-- 7,a7 with respect to a listed drug1 the period between-- 7i7 the date that is the earlier of-- 7,i7 #h years before any patent or marketing exclusivity granted under chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 with respect to such listed drug expires2 and 7,,ii7 the date on which the first abbreviated new drug application that references such listed drug is filed2 and 7ii7 the later of-- 7,i7 the date that is #ahj days after the first abbreviated new drug application that references such listed drug is filed2 and 7,,ii7 the date that is #a year after the date on which the generic drug that is the subject of the abbreviated new drug application described in subclause 7,i7 enters the marketplace2 or 7,b7 with respect to a reference product1 the period between-- 7i7 the date that is the earlier of-- 7,i7 #f years before any patent or marketing exclusivity 7including any extension of such exclusivity7 granted under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 or section #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7 with respect to such reference product expires2 and 7,,ii7 the date on which the first biosimilar biological product license application that references such reference product is filed2 and 7ii7 the later of-- 7,i7 the date that is #ahj days after the date on which the first biosimilar biological product license application that references such reference product enters the marketplace2 and 7,,ii7 the date that is #a year after the date on which the biosimilar biological product that is the subject of the biosimilar biological product license application described in subclause 7,i7 enters the marketplace4 7#e7 ,expected revenue ,the term expected revenue1 with respect to a follow-on product1 means the financial value represented by the number of individuals in the target population multiplied by the financial revenue generated by each member of the target population over the #c-year period beginning-- 7,a7 on the day that #c generic drugs referencing the same listed drug or #b or more biosimilar biological products referencing the same reference product would have been widely available in the market2 or 7,b7 if #c or more generic drugs referencing the same listed drug or #b or more biosimilar biological products referencing the same reference product are already widely available in the market1 the day that the follow-on product enters the market4 7#f7 ,follow-on product ,the term follow-on product 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;c77 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 change1 modification1 or reformulation to the same manufacturer's previously approved drug or biological product4 7#g7 ,generic drug ,the term generic drug means a drug approved under subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee74 7#h7 ,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#i7 ,patent family ,the term patent family means a group of related patents that continue the priority date of the underlying composition of matter patent1 all of which claim the same drug or biological product or a use of the same drug or biological product4 7#aj7 ,patent portfolio ,the term patent portfolio means a group of related patents covering the same or similar technical content4 7#aa7 ,patent thicketing 7,a7 ,in general ,the term patent thicketing means an action taken to limit competition by a patentee with respect to a drug approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 or a biological product licensed under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 in which-- 7i7 7,i7 the patentee obtains patents in the same patent family or patent portfolio-- 7aa7 that claim the drug or biological product or a use of the drug or biological product1 a form of the drug or biological product1 a method of use of the drug or biological product1 or a method of manufacture of a drug or biological product2 and 7bb7 whose effective filing date does not precede the date of filing the application under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 or section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a772 or 7,,ii7 the underlying composition of matter patent is found invalid and the patentee obtains patents in the same patent family or patent portfolio that claim the drug or biological product or a use of the drug or biological product1 a form of the drug or biological product1 a method of use of the drug or biological product1 or a method of manufacture of the drug or biological product2 7ii7 an abbreviated new drug application referencing such approved drug or a biosimilar biological product license application referencing such licensed biological product could not be marketed without practicing one or more of the inventions claimed in the additional patents described in subclause 7,i7 or 7,,ii7 of clause 7i72 and 7iii7 the ,commission determines that the patentee improperly limited competition by obtaining patents described in subclause 7,i7 or 7,,ii7 of clause 7i74 7,b7 ,factors to consider ,the ,commission may establish that an action described in subparagraph 7,a7 improperly limits competition if the ,commission establishes a reasonable number of the following factors in a manner that is sufficient to demonstrate anticompetitive intent3 7i7 ,the additional patents described in subparagraph 7,a77i7 7referred to in this subparagraph as the additional patents7 stem from few patent families4 7ii7 ,the additional patents have common specifications4 7iii7 ,the additional patents did not issue on an application with respect to which a requirement for restriction under section #aba of title #ce1 ,united ,states ,code1 has been made1 or on an application filed as a result of such a requirement4 7iv7 ,the additional patents have overlapping or identical claims4 7v7 ,the additional patents have been granted to the patentee on formulations or compositions of the product and not used4 7vi7 ,one or more of the additional patents have been invalidated in an inter partes review conducted under chapter #ca of title #ce1 ,united ,states ,code1 or a post-grant proceeding conducted under chapter #cb of that title4 7vii7 ,litigation with applicants under section #cea7k7 of the ,public ,health ,service ,act has been extended based on the additional patents4 7viii7 ,the applications with respect to the additional patents described in subclause 7,i7 or 7,,ii7 of subparagraph 7,a77i7 are submitted not more than #cf months before the expiration of the underlying composition of matter patent4 7ix7 ,a public or internal statement1 a shareholder call1 or another demonstration of purpose that the patentee intended to use the number of patents or length of extended patent protection in order to unduly limit competition4 7#ab7 ,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#ac7 ,target population ,the term target population1 with respect to a drug1 means the population of individuals that-- 7,a7 would experience a significant health improvement from a follow-on product2 and 7,b7 would have bought the follow-on product solely because of the significant health improvement that those individuals would experience4 7#ad7 ,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 7#ae7 ,underlying composition of matter patent ,the term underlying composition of matter patent means a patent with respect to the molecules1 compounds1 or new formulations of the active ingredient of a drug or biological product4 7b7 ,prohibitions 7#a7 ,patent thicketing 7,a7 ,prima facie ,except as provided in subparagraph 7,b71 an action by a drug manufacturer that constitutes patent thicketing shall be considered to be an unfair method of competition in or affecting commerce in violation of section #e7;a74 7,b7 ,rebuttal 7i7 ,in general ,subject to subparagraph 7,c71 an action that constitutes patent thicketing shall not be considered to be an unfair method of competition in or affecting commerce in violation of section #e7;a7 if the manufacturer described in that paragraph demonstrates to the ,commission or a district court of the ,united ,states1 as applicable1 by a preponderance of the evidence in a proceeding initiated by the ,commission under subsection 7c77#a77;,a71 or in a suit brought under subparagraph 7,b7 or 7,c7 of subsection 7c77#a71 that the anticompetitive effects of the action do not outweigh the pro-competitive effects of the action4 7ii7 ,evidence ,in making a demonstration under clause 7i7 that the anticompetitive effects of patent thicketing do not outweigh the pro-competitive effects of that behavior1 a manufacturer described in subparagraph 7,a7-- 7,i7 may present evidence that-- 7aa7 the inventions claimed in the additional patents described in subclauses 7,i7 and 7,,ii7 of subsection 7a77#aa77;,a77i7 resulted in-- 7,,aa7 clinically meaningful and significant therapeutic or safety benefits2 7,,bb7 significantly improved product purity or potency2 7,,cc7 significant gained efficiencies in manufacturing2 or 7,,dd7 other improved product attributes having substantial benefits for consumers or patients2 7bb7 a generic drug or biosimilar biological product could be marketed commercially without incorporating the improvements claimed in the additional patents described in item 7aa72 or 7cc7 for each of the later filed patents1 the manufacturer had substantial financial reason1 apart from the financial effects of reduced competition1 to file each of the patents2 and 7,,ii7 in making a demonstration under subclause 7,i71 shall submit to the ,commission or the court1 as applicable1 all research and development1 manufacturing1 marketing1 and other costs associated with approval of the original drug under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 or licensure of the original biological product under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a771 which-- 7aa7 shall include-- 7,,aa7 any documents relating to the costs and benefits of the later filed patents with respect to patients who use the drug2 and 7,,bb7 any applications for patents that were filed and rejected2 and 7bb7 shall not be construed to limit the information that the ,commission or the court1 as applicable1 may otherwise obtain in any proceeding or action instituted with respect to a violation of this section4 7,c7 ,response ,the ,commission may rebut any evidence presented by a drug manufacturer under subparagraph 7,b7 by establishing by a preponderance of the evidence that the harm to consumers from the action that is the subject of that presentation is greater than the benefits to consumers from that action4 7#b7 ,product hopping 7,a7 ,prima facie ,except as provided in subparagraph 7,b71 any of the following actions by a manufacturer of a reference product or listed drug shall be considered to be an unfair method of competition in or affecting commerce in violation of section #e7;a73 7i7 ,if1 during the period beginning on the date on which the manufacturer of the reference drug 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 and ending on the date that is #ahj days after the date on which that generic drug or biosimilar biological product first enters1 or could enter1 the market1 or is denied-- 7,i7 upon the request of the manufacturer of the listed drug or reference product1 the ,commissioner of ,food and ,drugs-- 7aa7 withdraws the approval of the application for the listed drug or reference product2 or 7bb7 places the listed drug or reference product on the discontinued products list2 or 7,,ii7 the manufacturer of the listed drug or reference product announces discontinuance of1 or intent to withdraw1 the application for the reference product4 7ii7 ,the manufacturer of a previously approved drug or biological product markets or sells a follow-on product during the competition window4 7,b7 ,rebuttal 7i7 ,in general ,subject to subparagraph 7,c71 an action described in subparagraph 7,a7 shall not be considered to be an unfair method of competition in or affecting commerce if-- 7,i7 with respect to an action described in subparagraph 7,a77i71 the manufacturer of the listed drug or reference product demonstrates to the ,commission or a district court of the ,united ,states1 as applicable1 by a preponderance of the evidence in a proceeding initiated by the ,commission under subsection 7c77#a77;,a71 or in a suit brought under subparagraph 7,b7 or 7,c7 of subsection 7c77#a71 that the manufacturer removed such drug from the market for significant and documented safety reasons2 or 7,,ii7 with respect to an action described in subparagraph 7,a77ii7-- 7aa7 the manufacturer demonstrates to the ,commission or a district court of the ,united ,states1 as applicable1 by a preponderance of the evidence in a proceeding initiated by the ,commission under subsection 7c77#a77;,a71 or in a suit brought under subparagraph 7,b7 or 7,c7 of subsection 7c77#a71 that-- 7,,aa7 the follow-on product described in such subparagraph 7,a77ii7 7referred to in this subclause as the follow-on product7 provides a clinically meaningful and significant additional health benefit to the target population beyond that provided by the previously approved drug or biological product2 7,,bb7 the follow-on product was the available means that was least likely to reduce competition2 and 7,,cc7 the manufacturer had substantive financial reasons1 apart from the financial effects of reduced competition1 to introduce the follow-on product to the market2 and 7bb7 in making the demonstration required under item 7aa71 the manufacturer provides to the ,commission-- 7,,aa7 all research and development1 manufacturing1 marketing1 and other related costs associated with the drug or biological product previously approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 or section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 and the follow-on product1 including all documents1 memos1 or other business documents that explain1 mention1 or otherwise justify the decision of the manufacturer to develop and manufacture the follow-on product2 and 7,,bb7 the revenue obtained by the manufacturer with respect to the drug or biological product previously approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77 or section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 and the expected revenue of the manufacturer with respect to the previously approved drug or biological product and the follow-on product4 7ii7 ,rule of construction ,nothing in clause 7i7 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,c7 ,response ,the ,commission may rebut any evidence presented by a drug manufacturer under subparagraph 7,b7 by establishing by a preponderance of the evidence that-- 7i7 the harm to consumers of the drug or biological product that is the subject of the product from the action that is the subject of that presentation is greater than the benefits to consumers of the drug or biological product that is the subject of challenged action2 or 7ii7 a primary purpose of the manufacturer in pursuing the challenged action was to block or otherwise hinder the entry into the market of a generic drug or biosimilar biological product4 7c7 ,enforcement 7#a7 ,in general ,if the ,commission has reason to believe that any drug manufacturer has violated1 is violating1 or is about to violate this section1 the ,commission may take any of the following actions3 7,a7 ,institute a proceeding-- 7i7 that1 except as provided in paragraph 7#b71 complies with the requirements under section #e7;b72 and 7ii7 in which the ,commission may impose on the manufacturer any penalty that the ,commission may impose for a violation of section #e4 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 drug manufacturer4 7,c7 7i7 ,bring suit in a district court of the ,united ,states to permanently enjoin the action of the drug manufacturer4 7ii7 ,in a suit brought under clause 7i71 the ,commission may seek-- 7,i7 any of the remedies described in paragraph 7#c72 and 7,,ii7 any other equitable remedy1 including ancillary equitable relief4 7#b7 ,judicial review 7,a7 ,in general ,notwithstanding any provision of section #e1 any drug manufacturer that is subject to a final order of the ,commission that is issued in a proceeding initiated under paragraph 7#a77;,a7 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 incorporated1 as of the date on which the manufacturer obtains the underlying composition of matter patent with respect to the proceeding or files a new drug application under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 or biological product license application under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 that is the subject of the proceeding1 as applicable4 7,b7 ,treatment of findings ,in a review of an order issued by the ,commission 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 suit in which the ,commission seeks the claim4 7ii7 ,calculation ,any disgorgement that is ordered with respect to a person under clause 7i7 shall be offset by any amount of restitution that the person is ordered to pay under subparagraph 7,b74 7iii7 ,limitations period ,the ,commission may bring a claim for disgorgement under this subparagraph not later than #e years after the latest date on which the person against which the claim is brought receives any unjust enrichment from the effects of the violation that gives rise to the suit in which the ,commission seeks the claim4 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 suit in which the ,commission seeks the claim4 7ii7 ,limitations period ,the ,commission may bring a claim for restitution under this subparagraph not later than #e years after the latest date on which the person against which the claim is brought receives any unjust enrichment from the effects of the violation that gives rise to the suit in which the ,commission seeks the claim4 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 any other authority of the ,commission under this ,act to seek relief or obtain a remedy with respect to a violation of this ,act4 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 ,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 #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 7d7 ,rulemaking ,the ,federal ,trade ,commission may issue rules under section #eec of title #e1 ,united ,states ,code1 to carry out section #bg of the ,federal ,trade ,commission ,act1 as added by subsection 7a71 including by defining any terms used in such section #bg4 #a4 ,short title ,this ,act may be cited as the ,affordable ,prescriptions for ,patients ,act of #bjai4 #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 an application under subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee74 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 change1 modification1 or reformulation to the same manufacturer's previously approved drug or biological product that treats the same medical condition2 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 a drug approved under an application submitted under subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee74 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 ,except as provided in paragraph 7#b71 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 the ,commission demonstrates by a preponderance of the evidence in a proceeding initiated by the ,commission under subsection 7c77#a77;,a71 or in a suit brought under subparagraph 7,b7 or 7,c7 of subsection 7c77#a71 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 and ending on the date that is #ahj days after the date on which that generic drug or biosimilar biological 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 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 as established by objective circumstances2 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 product that is highly similar to1 and has no clinically meaningful difference with respect to safety1 purity1 and potency from1 the reference product1 which may be established by objective circumstances4 7ii7 ,the manufacturer marketed or sold a follow-on product4 7#b7 ,justification 7,a7 ,in general ,subject to paragraph 7#c71 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-- 7i7 the manufacturer demonstrates to the ,commission or a district court of the ,united ,states1 as applicable1 by a preponderance of the evidence in a proceeding initiated by the ,commission under subsection 7c77#a77;,a71 or in a suit brought under subparagraph 7,b7 or 7,c7 of subsection 7c77#a71 that-- 7,i7 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 7,,ii7 7aa7 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 7bb7 with respect to an action described in item 7aa7 or 7bb7 of paragraph 7#a77;,a77ii77,i71 there is a supply disruption that-- 7,,aa7 is outside of the control of the manufacturer2 7,,bb7 prevents the production or distribution of the applicable listed drug or reference product2 and 7,,cc7 cannot be remedied by reasonable efforts2 or 7cc7 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#c7 ,response ,with respect to a justification offered by a manufacturer under paragraph 7#b71 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 that1 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 offered4 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 the ,commission may take any of the following actions3 7,a7 ,institute a proceeding-- 7i7 that1 except as provided in paragraph 7#b71 complies with the requirements under section #e7;b72 and 7ii7 in which the ,commission may impose on the manufacturer any penalty that the ,commission may impose for a violation of section #e4 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 order of the ,commission that is issued in a proceeding instituted under paragraph 7#a77;,a7 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 an order issued by the ,commission 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 any other authority of the ,commission under this ,act to seek relief or obtain a remedy with respect to a violation of this ,act4 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 ,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 #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 7d7 ,rulemaking ,the ,federal ,trade ,commission may issue rules under section #eec of title #e1 ,united ,states ,code1 to carry out section #bg of the ,federal ,trade ,commission ,act1 as added by subsection 7a71 including by defining any terms used in such section #bg 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 section #cea7l77#c77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l77#c77;,a771 including as provided under section #cea7l77#g7 of such ,act4 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 under section #cea7l77#b77;,a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7l77#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 ,june #bh 7legislative day1 ,june #bg71 #bjai,reported with an amendment