US
Us Congress Senate Bill SB1096

Us Congress 2025-2026 Regular Session

Us Congress Senate Bill SB1096 Compare Versions

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11 II
2-Calendar No. 46
32 119THCONGRESS
43 1
54 STSESSION S. 1096
65 To prohibit brand name drug companies from compensating generic drug
76 companies to delay the entry of a generic drug into the market, and
87 to prohibit biological product manufacturers from compensating bio-
98 similar and interchangeable companies to delay the entry of biosimilar
109 biological products and interchangeable biological products.
1110 IN THE SENATE OF THE UNITED STATES
1211 MARCH24, 2025
1312 Ms. K
1413 LOBUCHAR(for herself, Mr. GRASSLEY, Mr. DURBIN, Mr. CRAMER, Mr.
1514 B
1615 LUMENTHAL, Ms. ERNST, Mr. WELCH, Mr. KELLY, and Mr. BOOKER)
1716 introduced the following bill; which was read twice and referred to the
1817 Committee on the Judiciary
19-A
20-PRIL10, 2025
21-Reported by Mr. G
22-RASSLEY, with an amendment
23-[Strike out all after the enacting clause and insert the part printed in italic]
2418 A BILL
2519 To prohibit brand name drug companies from compensating
2620 generic drug companies to delay the entry of a generic
2721 drug into the market, and to prohibit biological product
2822 manufacturers from compensating biosimilar and inter-
2923 changeable companies to delay the entry of biosimilar
3024 biological products and interchangeable biological prod-
3125 ucts.
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3526 Be it enacted by the Senate and House of Representa-1
3627 tives of the United States of America in Congress assembled, 2
37-SECTION1.SHORTTITLE. 3
38-ThisActmaybecitedasthe‘‘PreserveAccesstoAf-4
39-fordableGenericsandBiosimilarsAct’’. 5
40-SEC.2.CONGRESSIONAL FINDINGS ANDDECLARATION OF 6
41-PURPOSES. 7
42-(a)FINDINGS.—Congressfindsthefollowing: 8
43-(1)In1984,theDrugPriceCompetitionand 9
44-PatentTermRestorationAct(PublicLaw98–417) 10
45-(referredtointhisActasthe‘‘1984Act’’),wasen-11
46-actedwiththeintentoffacilitatingtheearlyentry 12
47-ofgenericdrugswhilepreservingincentivesforinno-13
48-vation. 14
49-(2)Prescriptiondrugsmakeupapproximately 15
50-11percentofthenationalhealthcarespending. 16
51-(3)Initially,the1984Actwassuccessfulinfa-17
52-cilitatinggenericcompetitiontothebenefitofcon-18
53-sumersandhealthcarepayers.Although91percent 19
54-ofallprescriptionsdispensedintheUnitedStates 20
55-aregenericdrugs,theyaccountforonly18percent 21
56-ofallexpenditures. 22
57-(4)Genericdrugscostsubstantiallylessthan 23
58-brandnamedrugs,withdiscountsoffthebrand 24
59-priceaveraging80to85percent. 25
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30+•S 1096 IS
31+SECTION 1. SHORT TITLE. 1
32+This Act may be cited as the ‘‘Preserve Access to Af-2
33+fordable Generics and Biosimilars Act’’. 3
34+SEC. 2. CONGRESSIONAL FINDINGS AND DECLARATION OF 4
35+PURPOSES. 5
36+(a) F
37+INDINGS.—Congress finds the following: 6
38+(1) In 1984, the Drug Price Competition and 7
39+Patent Term Restoration Act (Public Law 98–417) 8
40+(referred to in this Act as the ‘‘1984 Act’’), was en-9
41+acted with the intent of facilitating the early entry 10
42+of generic drugs while preserving incentives for inno-11
43+vation. 12
44+(2) Prescription drugs make up approximately 13
45+11 percent of the national health care spending. 14
46+(3) Initially, the 1984 Act was successful in fa-15
47+cilitating generic competition to the benefit of con-16
48+sumers and health care payers. Although 91 percent 17
49+of all prescriptions dispensed in the United States 18
50+are generic drugs, they account for only 18 percent 19
51+of all expenditures. 20
52+(4) Generic drugs cost substantially less than 21
53+brand name drugs, with discounts off the brand 22
54+price averaging 80 to 85 percent. 23
55+(5) Federal dollars currently account for over 24
56+40 percent of the $449,700,000,000 spent on retail 25
57+prescription drugs annually. 26
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62-•S 1096 RS
63-(5)Federaldollarscurrentlyaccountforover 1
64-40percentofthe$449,700,000,000spentonretail 2
65-prescriptiondrugsannually. 3
66-(6)(A)Inrecentyears,theintentofthe1984 4
67-Acthasbeensubvertedbycertainsettlementagree-5
68-mentsinwhichbrandnamecompaniestransfer 6
69-valuetotheirpotentialgenericcompetitorstosettle 7
70-claimsthatthegenericcompanyisinfringingthe 8
71-brandedcompany’spatents. 9
72-(B)These‘‘reversepayment’’settlementagree-10
73-ments— 11
74-(i)allowabrandedcompanytoshareits 12
75-monopolyprofitswiththegenericcompanyasa 13
76-waytoprotectthebrandedcompany’smonop-14
77-oly;and 15
78-(ii)haveundulydelayedthemarketingof 16
79-low-costgenericdrugscontrarytofreecompeti-17
80-tion,theinterestsofconsumers,andtheprin-18
81-ciplesunderlyingantitrustlaw. 19
82-(C)Becauseofthepricedisparitybetween 20
83-brandnameandgenericdrugs,suchagreementsare 21
84-moreprofitableforboththebrandandgenericman-22
85-ufacturersthancompetitionandwillbecomeincreas-23
86-inglycommonunlessprohibited. 24
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60+•S 1096 IS
61+(6)(A) In recent years, the intent of the 1984 1
62+Act has been subverted by certain settlement agree-2
63+ments in which brand name companies transfer 3
64+value to their potential generic competitors to settle 4
65+claims that the generic company is infringing the 5
66+branded company’s patents. 6
67+(B) These ‘‘reverse payment’’ settlement agree-7
68+ments— 8
69+(i) allow a branded company to share its 9
70+monopoly profits with the generic company as a 10
71+way to protect the branded company’s monop-11
72+oly; and 12
73+(ii) have unduly delayed the marketing of 13
74+low-cost generic drugs contrary to free competi-14
75+tion, the interests of consumers, and the prin-15
76+ciples underlying antitrust law. 16
77+(C) Because of the price disparity between 17
78+brand name and generic drugs, such agreements are 18
79+more profitable for both the brand and generic man-19
80+ufacturers than competition and will become increas-20
81+ingly common unless prohibited. 21
82+(D) These agreements result in consumers los-22
83+ing the benefits that the 1984 Act was intended to 23
84+provide. 24
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90-(D)Theseagreementsresultinconsumerslos-1
91-ingthebenefitsthatthe1984Actwasintendedto 2
92-provide. 3
93-(7)In2010,theBiologicsPriceCompetition 4
94-andInnovationAct(PublicLaw111–148)(referred 5
95-tointhisActasthe‘‘BPCIA’’),wasenactedwith 6
96-theintentoffacilitatingtheearlyentryofbiosimilar 7
97-andinterchangeablefollow-onversionsofbranded 8
98-biologicalproductswhilepreservingincentivesforin-9
99-novation. 10
100-(8)Biologicaldrugsplayanimportantrolein 11
101-treatingmanyseriousillnesses,fromcancerstoge-12
102-neticdisorders.Theyarealsoexpensive,rep-13
103-resentingmorethanhalfofallprescriptiondrug 14
104-spending. 15
105-(9)Competitionfrombiosimilarandinter-16
106-changeablebiologicalproductspromisestolower 17
107-drugcostsandincreasepatientaccesstobiological 18
108-medicines.But‘‘reversepayment’’settlementagree-19
109-mentsalsothreatentodelaytheentryofbiosimilar 20
110-andinterchangeablebiologicalproducts,whichwould 21
111-underminethegoalsofBPCIA. 22
112-(b)PURPOSES.—ThepurposesofthisActare— 23
113-(1)toenhancecompetitioninthepharma-24
114-ceuticalmarketbystoppinganticompetitiveagree-25
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87+•S 1096 IS
88+(7) In 2010, the Biologics Price Competition 1
89+and Innovation Act (Public Law 111–148) (referred 2
90+to in this Act as the ‘‘BPCIA’’), was enacted with 3
91+the intent of facilitating the early entry of biosimilar 4
92+and interchangeable follow-on versions of branded 5
93+biological products while preserving incentives for in-6
94+novation. 7
95+(8) Biological drugs play an important role in 8
96+treating many serious illnesses, from cancers to ge-9
97+netic disorders. They are also expensive, rep-10
98+resenting more than half of all prescription drug 11
99+spending. 12
100+(9) Competition from biosimilar and inter-13
101+changeable biological products promises to lower 14
102+drug costs and increase patient access to biological 15
103+medicines. But ‘‘reverse payment’’ settlement agree-16
104+ments also threaten to delay the entry of biosimilar 17
105+and interchangeable biological products, which would 18
106+undermine the goals of BPCIA. 19
107+(b) P
108+URPOSES.—The purposes of this Act are— 20
109+(1) to enhance competition in the pharma-21
110+ceutical market by stopping anticompetitive agree-22
111+ments between brand name and generic drug and 23
112+biosimilar biological product manufacturers that 24
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118-mentsbetweenbrandnameandgenericdrugand 1
119-biosimilarbiologicalproductmanufacturersthat 2
120-limit,delay,orotherwisepreventcompetitionfrom 3
121-genericdrugsandbiosimilarbiologicalproducts;and 4
122-(2)tosupportthepurposeandintentofanti-5
123-trustlawbyprohibitinganticompetitivepracticesin 6
124-thepharmaceuticalindustrythatharmconsumers. 7
125-SEC.3.UNLAWFUL COMPENSATION FORDELAY. 8
126-(a)INGENERAL.—TheFederalTradeCommission 9
127-Act(15U.S.C.44etseq.)isamendedbyinsertingafter 10
128-section26(15U.S.C.57c–2)thefollowing: 11
129-‘‘SEC.27.PRESERVING ACCESSTOAFFORDABLE GENERICS 12
130-ANDBIOSIMILARS. 13
131-‘‘(a)PROHIBITION.— 14
132-‘‘(1)INGENERAL.—Itshallbeaviolationof 15
133-thissectionforapartytoenterinto,orbeapartici-16
134-pantto,anagreement,resolvingorsettling,ona 17
135-finalorinterimbasis,apatentclaiminconnection 18
136-withthesaleofadrugproductorbiologicalproduct, 19
137-thathasanticompetitiveeffects. 20
138-‘‘(2)TREATMENT.—Aviolationofthissection 21
139-shallbetreatedasanunfairmethodofcompetition 22
140-inviolationofsection5(a)(1). 23
141-‘‘(3)PRESUMPTION.— 24
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115+•S 1096 IS
116+limit, delay, or otherwise prevent competition from 1
117+generic drugs and biosimilar biological products; and 2
118+(2) to support the purpose and intent of anti-3
119+trust law by prohibiting anticompetitive practices in 4
120+the pharmaceutical industry that harm consumers. 5
121+SEC. 3. UNLAWFUL COMPENSATION FOR DELAY. 6
122+(a) I
123+NGENERAL.—The Federal Trade Commission 7
124+Act (15 U.S.C. 44 et seq.) is amended by inserting after 8
125+section 26 (15 U.S.C. 57c–2) the following: 9
126+‘‘SEC. 27. PRESERVING ACCESS TO AFFORDABLE GENERICS 10
127+AND BIOSIMILARS. 11
128+‘‘(a) P
129+ROHIBITION.— 12
130+‘‘(1) I
131+N GENERAL.—It shall be a violation of 13
132+this section for a party to enter into, or be a partici-14
133+pant to, an agreement, resolving or settling, on a 15
134+final or interim basis, a patent claim in connection 16
135+with the sale of a drug product or biological product, 17
136+that has anticompetitive effects. 18
137+‘‘(2) T
138+REATMENT.—A violation of this section 19
139+shall be treated as an unfair method of competition 20
140+in violation of section 5(a)(1). 21
141+‘‘(3) P
142+RESUMPTION.— 22
143+‘‘(A) I
144+N GENERAL.—Subject to subpara-23
145+graph (B), an agreement described in para-24
146+graph (1) shall be presumed to have anti-25
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145-‘‘(A)INGENERAL.—Subjecttosubpara-1
146-graph(B),anagreementdescribedinpara-2
147-graph(1)shallbepresumedtohaveanti-3
148-competitiveeffectsforpurposesofsuchpara-4
149-graphif— 5
150-‘‘(i)anANDAfilerorabiosimilarbi-6
151-ologicalproductapplicationfilerreceives 7
152-anythingofvalue,includinganexclusiveli-8
153-cense;and 9
154-‘‘(ii)theANDAfilerorbiosimilarbio-10
155-logicalproductapplicationfileragreesto 11
156-limitorforgoresearch,development,man-12
157-ufacturing,marketing,orsalesofthe 13
158-ANDAproductorbiosimilarbiological 14
159-product,asapplicable,foranyperiodof 15
160-time. 16
161-‘‘(B)EXCEPTION.—Subparagraph(A) 17
162-shallnotapplyifthepartiestosuchagreement 18
163-demonstratebyapreponderanceoftheevidence 19
164-that— 20
165-‘‘(i)thevaluedescribedinsubpara-21
166-graph(A)(i)iscompensationsolelyfor 22
167-othergoodsorservicesthattheANDA 23
168-filerorbiosimilarbiologicalproductappli-24
169-cationfilerhaspromisedtoprovide;or 25
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149+•S 1096 IS
150+competitive effects for purposes of such para-1
151+graph if— 2
152+‘‘(i) an ANDA filer or a biosimilar bi-3
153+ological product application filer receives 4
154+anything of value, including an exclusive li-5
155+cense; and 6
156+‘‘(ii) the ANDA filer or biosimilar bio-7
157+logical product application filer agrees to 8
158+limit or forgo research, development, man-9
159+ufacturing, marketing, or sales of the 10
160+ANDA product or biosimilar biological 11
161+product, as applicable, for any period of 12
162+time. 13
163+‘‘(B) E
164+XCEPTION.—Subparagraph (A) 14
165+shall not apply if the parties to such agreement 15
166+demonstrate by a preponderance of the evidence 16
167+that— 17
168+‘‘(i) the value described in subpara-18
169+graph (A)(i) is compensation solely for 19
170+other goods or services that the ANDA 20
171+filer or biosimilar biological product appli-21
172+cation filer has promised to provide; or 22
173+‘‘(ii) the procompetitive benefits of the 23
174+transfer of value described in subpara-24
175+graph (A)(i) and the agreement by the 25
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173-‘‘(ii)theprocompetitivebenefitsofthe 1
174-transferofvaluedescribedinsubpara-2
175-graph(A)(i)andtheagreementbythe 3
176-ANDAfilerorbiosimilarbiologicalproduct 4
177-applicationfilertolimitorforgoresearch, 5
178-development,manufacturing,marketing,or 6
179-salesoftheANDAproductorbiosimilar 7
180-biologicalproductdescribedinsubpara-8
181-graph(A)(ii)outweightheanticompetitive 9
182-effectsofthetransferofvaluedescribedin 10
183-subparagraph(A)(i)andtheagreementby 11
184-theANDAfilerorbiosimilarbiological 12
185-productapplicationfilertolimitorforgo 13
186-research,development,manufacturing, 14
187-marketing,orsalesoftheANDAproduct 15
188-orbiosimilarbiologicalproductdescribed 16
189-insubparagraph(A)(ii). 17
190-‘‘(4)CIVILACTION.—Inadditiontoanypro-18
191-ceedingundersection5,iftheCommissionhasrea-19
192-sontobelievethatapartyhasviolatedthissection, 20
193-theCommissionmaybring,initsownnamebyany 21
194-ofitsattorneysdesignatedbyitforsuchpurpose,a 22
195-civilactionagainstthepartyinadistrictcourtof 23
196-theUnitedStatestoseektorecoveranyoftherem-24
197-ediesofcivilpenalty,mandatoryinjunctions,and 25
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178+•S 1096 IS
179+ANDA filer or biosimilar biological product 1
180+application filer to limit or forgo research, 2
181+development, manufacturing, marketing, or 3
182+sales of the ANDA product or biosimilar 4
183+biological product described in subpara-5
184+graph (A)(ii) outweigh the anticompetitive 6
185+effects of the transfer of value described in 7
186+subparagraph (A)(i) and the agreement by 8
187+the ANDA filer or biosimilar biological 9
188+product application filer to limit or forgo 10
189+research, development, manufacturing, 11
190+marketing, or sales of the ANDA product 12
191+or biosimilar biological product described 13
192+in subparagraph (A)(ii). 14
193+‘‘(4) C
194+IVIL ACTION.—In addition to any pro-15
195+ceeding under section 5, if the Commission has rea-16
196+son to believe that a party has violated this section, 17
197+the Commission may bring, in its own name by any 18
198+of its attorneys designated by it for such purpose, a 19
199+civil action against the party in a district court of 20
200+the United States to seek to recover any of the rem-21
201+edies of civil penalty, mandatory injunctions, and 22
202+such other and further equitable relief as the court 23
203+deems appropriate. 24
204+‘‘(5) C
205+IVIL PENALTY.— 25
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201-suchotherandfurtherequitablereliefasthecourt 1
202-deemsappropriate. 2
203-‘‘(5)CIVILPENALTY.— 3
204-‘‘(A)INGENERAL.—Eachpartythatvio-4
205-latesorassistsintheviolationofparagraph(1) 5
206-shallforfeitandpaytotheUnitedStatesacivil 6
207-penaltysufficienttodeterviolationsofpara-7
208-graph(1),butinnoeventgreaterthan3times 8
209-thevaluereceivedbythepartythatisreason-9
210-ablyattributabletotheviolationofparagraph 10
211-(1).Ifnosuchvaluehasbeenreceivedbythe 11
208+•S 1096 IS
209+‘‘(A) IN GENERAL.—Each party that vio-1
210+lates or assists in the violation of paragraph (1) 2
211+shall forfeit and pay to the United States a civil 3
212+penalty sufficient to deter violations of para-4
213+graph (1), but in no event greater than 3 times 5
214+the value received by the party that is reason-6
215+ably attributable to the violation of paragraph 7
216+(1). If no such value has been received by the 8
217+NDA holder, the biological product license hold-9
218+er, the ANDA filer, or the biosimilar biological 10
219+product application filer, the penalty to the 11
212220 NDA holder, the biological product license hold-12
213221 er, the ANDA filer, or the biosimilar biological 13
214-productapplicationfiler,thepenaltytothe 14
215-NDAholder,thebiologicalproductlicensehold-15
216-er,theANDAfiler,orthebiosimilarbiological 16
217-productapplicationfilershallbesufficientto 17
218-deterviolations,butinnoeventshallbegreater 18
219-than3timesthevaluegiventoanANDAfiler 19
220-orbiosimilarbiologicalproductapplicationfiler 20
221-reasonablyattributabletotheviolationofthis 21
222-section. 22
223-‘‘(B)AMOUNT.—Indeterminingthe 23
224-amountofthecivilpenaltydescribedinsub-24
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222+product application filer shall be sufficient to 14
223+deter violations, but in no event shall be greater 15
224+than 3 times the value given to an ANDA filer 16
225+or biosimilar biological product application filer 17
226+reasonably attributable to the violation of this 18
227+section. 19
228+‘‘(B) A
229+MOUNT.—In determining the 20
230+amount of the civil penalty described in sub-21
231+paragraph (A), the court shall take into ac-22
232+count— 23
233+‘‘(i) the nature, circumstances, extent, 24
234+and gravity of the violation; 25
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228-paragraph(A),thecourtshalltakeintoac-1
229-count— 2
230-‘‘(i)thenature,circumstances,extent, 3
231-andgravityoftheviolation; 4
232-‘‘(ii)withrespecttotheviolator,the 5
233-degreeofculpability,anyhistoryofprior 6
234-suchconduct,includingotheragreements 7
235-resolvingorsettlingapatentinfringement 8
236-claim,theabilitytopay,anyeffectonthe 9
237-abilitytocontinuedoingbusiness,profits 10
238-earnedbytheNDAholder,thebiological 11
239-productlicenseholder,theANDAfiler,or 12
240-thebiosimilarbiologicalproductapplica-13
241-tionfiler,compensationreceivedbythe 14
242-ANDAfilerorbiosimilarbiologicalproduct 15
243-applicationfiler,andtheamountofcom-16
244-merceaffected;and 17
245-‘‘(iii)othermattersthatjusticere-18
246-quires. 19
247-‘‘(C)REMEDIESINADDITION.—Remedies 20
248-providedinthisparagraphareinadditionto, 21
249-andnotinlieuof,anyotherremedyprovided 22
250-byFederallaw.Nothinginthissectionshallbe 23
251-construedtolimitanyauthorityoftheCommis-24
252-sionunderanyotherprovisionoflaw. 25
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237+•S 1096 IS
238+‘‘(ii) with respect to the violator, the 1
239+degree of culpability, any history of prior 2
240+such conduct, including other agreements 3
241+resolving or settling a patent infringement 4
242+claim, the ability to pay, any effect on the 5
243+ability to continue doing business, profits 6
244+earned by the NDA holder, the biological 7
245+product license holder, the ANDA filer, or 8
246+the biosimilar biological product applica-9
247+tion filer, compensation received by the 10
248+ANDA filer or biosimilar biological product 11
249+application filer, and the amount of com-12
250+merce affected; and 13
251+‘‘(iii) other matters that justice re-14
252+quires. 15
253+‘‘(C) R
254+EMEDIES IN ADDITION .—Remedies 16
255+provided in this paragraph are in addition to, 17
256+and not in lieu of, any other remedy provided 18
257+by Federal law. Nothing in this section shall be 19
258+construed to limit any authority of the Commis-20
259+sion under any other provision of law. 21
260+‘‘(b) E
261+XCLUSIONS.—Nothing in this section shall pro-22
262+hibit a resolution or settlement of a patent infringement 23
263+claim in which the consideration that the ANDA filer or 24
264+biosimilar biological product application filer, respectively, 25
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256-‘‘(b)EXCLUSIONS.—Nothinginthissectionshallpro-1
257-hibitaresolutionorsettlementofapatentinfringement 2
258-claiminwhichtheconsiderationthattheANDAfileror 3
259-biosimilarbiologicalproductapplicationfiler,respectively, 4
260-receivesaspartoftheresolutionorsettlementincludes 5
261-onlyoneormoreofthefollowing: 6
262-‘‘(1)Therighttomarketandsecurefinalap-7
263-provalintheUnitedStatesfortheANDAproduct 8
264-orbiosimilarbiologicalproductatadate,whether 9
265-certainorcontingent,priortotheexpirationof— 10
266-‘‘(A)anypatentthatisthebasisforthe 11
267-patentinfringementclaim;or 12
268-‘‘(B)anypatentrightorotherstatutory 13
269-exclusivitythatwouldpreventthemarketingof 14
270-suchANDAproductorbiosimilarbiological 15
271-product. 16
272-‘‘(2)Apaymentforreasonablelitigationex-17
273-pensesnottoexceed— 18
274-‘‘(A)forcalendaryear2025,$7,500,000; 19
275-or 20
276-‘‘(B)forcalendaryear2026andeachsub-21
277-sequentcalendaryear,theamountdetermined 22
278-fortheprecedingcalendaryearadjustedtore-23
279-flectthepercentageincrease(ifany)inthe 24
280-ProducerPriceIndexforLegalServicespub-25
281-VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
267+•S 1096 IS
268+receives as part of the resolution or settlement includes 1
269+only one or more of the following: 2
270+‘‘(1) The right to market and secure final ap-3
271+proval in the United States for the ANDA product 4
272+or biosimilar biological product at a date, whether 5
273+certain or contingent, prior to the expiration of— 6
274+‘‘(A) any patent that is the basis for the 7
275+patent infringement claim; or 8
276+‘‘(B) any patent right or other statutory 9
277+exclusivity that would prevent the marketing of 10
278+such ANDA product or biosimilar biological 11
279+product. 12
280+‘‘(2) A payment for reasonable litigation ex-13
281+penses not to exceed— 14
282+‘‘(A) for calendar year 2025, $7,500,000; 15
283+or 16
284+‘‘(B) for calendar year 2026 and each sub-17
285+sequent calendar year, the amount determined 18
286+for the preceding calendar year adjusted to re-19
287+flect the percentage increase (if any) in the 20
288+Producer Price Index for Legal Services pub-21
289+lished by the Bureau of Labor Statistics of the 22
290+Department of Labor for the most recent cal-23
291+endar year. 24
292+VerDate Sep 11 2014 00:09 Mar 29, 2025 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1096.IS S1096
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283-•S 1096 RS
284-lishedbytheBureauofLaborStatisticsofthe 1
285-DepartmentofLaborforthemostrecentcal-2
286-endaryear. 3
287-‘‘(3)Acovenantnottosueonanyclaimthat 4
288-theANDAproductorbiosimilarbiologicalproduct 5
289-infringesaUnitedStatespatent. 6
290-‘‘(c)ANTITRUSTLAWS.—Excepttotheextentthis 7
291-sectionestablishesanadditionalbasisofliability,nothing 8
292-inthissectionshallmodify,impair,limit,orsupersedethe 9
293-applicabilityoftheantitrustlawsasdefinedinsubsection 10
294-(a)ofthefirstsectionoftheClaytonAct(15U.S.C. 11
295-12(a)),andofsection5ofthisActtotheextentthatsec-12
296-tion5appliestounfairmethodsofcompetition.Nothing 13
297-inthissectionshallmodify,impair,limit,orsupersedethe 14
298-rightofanANDAfilerorbiosimilarbiologicalproduct 15
299-applicationfilertoassertclaimsorcounterclaimsagainst 16
300-anyperson,undertheantitrustlawsorotherlawsrelating 17
301-tounfaircompetition. 18
302-‘‘(d)DEFINITIONS.—Inthissection: 19
303-‘‘(1)AGREEMENT.—Theterm‘agreement’ 20
304-meansanythingthatwouldconstituteanagreement 21
305-undersection1oftheShermanAct(15U.S.C.1) 22
306-orsection5ofthisAct. 23
307-‘‘(2)AGREEMENT RESOLVINGORSETTLINGA 24
308-PATENTINFRINGEMENT CLAIM.—Theterm‘agree-25
309-VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
294+•S 1096 IS
295+‘‘(3) A covenant not to sue on any claim that 1
296+the ANDA product or biosimilar biological product 2
297+infringes a United States patent. 3
298+‘‘(c) A
299+NTITRUSTLAWS.—Except to the extent this 4
300+section establishes an additional basis of liability, nothing 5
301+in this section shall modify, impair, limit, or supersede the 6
302+applicability of the antitrust laws as defined in subsection 7
303+(a) of the first section of the Clayton Act (15 U.S.C. 8
304+12(a)), and of section 5 of this Act to the extent that sec-9
305+tion 5 applies to unfair methods of competition. Nothing 10
306+in this section shall modify, impair, limit, or supersede the 11
307+right of an ANDA filer or biosimilar biological product 12
308+application filer to assert claims or counterclaims against 13
309+any person, under the antitrust laws or other laws relating 14
310+to unfair competition. 15
311+‘‘(d) D
312+EFINITIONS.—In this section: 16
313+‘‘(1) A
314+GREEMENT.—The term ‘agreement’ 17
315+means anything that would constitute an agreement 18
316+under section 1 of the Sherman Act (15 U.S.C. 1) 19
317+or section 5 of this Act. 20
318+‘‘(2) A
319+GREEMENT RESOLVING OR SETTLING A 21
320+PATENT INFRINGEMENT CLAIM .—The term ‘agree-22
321+ment resolving or settling a patent infringement 23
322+claim’ includes any agreement that is entered into 24
323+within 30 days of the resolution or the settlement of 25
324+VerDate Sep 11 2014 00:09 Mar 29, 2025 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S1096.IS S1096
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311-•S 1096 RS
312-mentresolvingorsettlingapatentinfringement 1
313-claim’includesanyagreementthatisenteredinto 2
314-within30daysoftheresolutionorthesettlementof 3
315-theclaim,oranyotheragreementthatiscontingent 4
316-upon,providesacontingentconditionfor,orisoth-5
317-erwiserelatedtotheresolutionorsettlementofthe 6
318-claim. 7
319-‘‘(3)ANDA.—Theterm‘ANDA’meansanab-8
320-breviatednewdrugapplicationfiledundersection 9
321-505(j)oftheFederalFood,Drug,andCosmeticAct 10
322-(21U.S.C.355(j))oranewdrugapplicationsub-11
323-mittedpursuanttosection505(b)(2)oftheFederal 12
324-Food,Drug,andCosmeticAct(21U.S.C. 13
325-355(b)(2)). 14
326-‘‘(4)ANDAFILER.—Theterm‘ANDAfiler’ 15
327-meansapartythatownsorcontrolsanANDAfiled 16
328-withtheSecretaryofHealthandHumanServicesor 17
329-hastheexclusiverightsundersuchANDAtodis-18
330-tributetheANDAproduct. 19
331-‘‘(5)ANDA PRODUCT.—Theterm‘ANDA 20
332-product’meanstheproducttobemanufactured 21
333-undertheANDAthatisthesubjectofthepatent 22
334-infringementclaim. 23
335-‘‘(6)BIOLOGICALPRODUCT.—Theterm‘bio-24
336-logicalproduct’hasthemeaninggivensuchtermin 25
337-VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
326+•S 1096 IS
327+the claim, or any other agreement that is contingent 1
328+upon, provides a contingent condition for, or is oth-2
329+erwise related to the resolution or settlement of the 3
330+claim. 4
331+‘‘(3) ANDA.—The term ‘ANDA’ means an ab-5
332+breviated new drug application filed under section 6
333+505(j) of the Federal Food, Drug, and Cosmetic Act 7
334+(21 U.S.C. 355(j)) or a new drug application sub-8
335+mitted pursuant to section 505(b)(2) of the Federal 9
336+Food, Drug, and Cosmetic Act (21 U.S.C. 10
337+355(b)(2)). 11
338+‘‘(4) ANDA
339+FILER.—The term ‘ANDA filer’ 12
340+means a party that owns or controls an ANDA filed 13
341+with the Secretary of Health and Human Services or 14
342+has the exclusive rights under such ANDA to dis-15
343+tribute the ANDA product. 16
344+‘‘(5) ANDA
345+PRODUCT.—The term ‘ANDA 17
346+product’ means the product to be manufactured 18
347+under the ANDA that is the subject of the patent 19
348+infringement claim. 20
349+‘‘(6) B
350+IOLOGICAL PRODUCT .—The term ‘bio-21
351+logical product’ has the meaning given such term in 22
352+section 351(i)(1) of the Public Health Service Act 23
353+(42 U.S.C. 262(i)(1)). 24
354+VerDate Sep 11 2014 00:09 Mar 29, 2025 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S1096.IS S1096
338355 ssavage on LAPJG3WLY3PROD with BILLS 13
339-•S 1096 RS
340-section351(i)(1)ofthePublicHealthServiceAct 1
341-(42U.S.C.262(i)(1)). 2
342-‘‘(7)BIOLOGICALPRODUCTLICENSEAPPLICA-3
343-TION.—Theterm‘biologicalproductlicenseapplica-4
344-tion’meansanapplicationundersection351(a)of 5
345-thePublicHealthServiceAct(42U.S.C.262(a)). 6
346-‘‘(8)BIOLOGICALPRODUCT LICENSEHOLD-7
347-ER.—Theterm‘biologicalproductlicenseholder’ 8
348-means— 9
349-‘‘(A)theholderofanapprovedbiological 10
350-productlicenseapplicationforabiologicalprod-11
351-uct; 12
352-‘‘(B)apersonowningorcontrollingen-13
353-forcementofanypatentsthatclaimthebiologi-14
354-calproductthatisthesubjectofsuchapproved 15
355-application;or 16
356-‘‘(C)thepredecessors,subsidiaries,divi-17
357-sions,groups,andaffiliatescontrolledby,con-18
358-trolling,orundercommoncontrolwithanyof 19
359-theentitiesdescribedinsubparagraphs(A)and 20
360-(B)(suchcontroltobepresumedbydirector 21
361-indirectshareownershipof50percentorgreat-22
362-er),aswellasthelicensees,licensors,succes-23
363-sors,andassignsofeachoftheentities. 24
364-VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
365-ssavage on LAPJG3WLY3PROD with BILLS 14
366-•S 1096 RS
367-‘‘(9)BIOSIMILARBIOLOGICALPRODUCT.—The 1
368-term‘biosimilarbiologicalproduct’meanstheprod-2
369-ucttobemanufacturedunderthebiosimilarbiologi-3
370-calproductapplicationthatisthesubjectofthepat-4
371-entinfringementclaim. 5
372-‘‘(10)BIOSIMILARBIOLOGICALPRODUCTAPPLI-6
373-CATION.—Theterm‘biosimilarbiologicalproductap-7
374-plication’meansanapplicationundersection351(k) 8
375-ofthePublicHealthServiceAct(42U.S.C.262(k)) 9
376-forlicensureofabiologicalproductasbiosimilarto, 10
377-orinterchangeablewith,areferenceproduct. 11
378-‘‘(11)BIOSIMILARBIOLOGICALPRODUCTAPPLI-12
379-CATIONFILER.—Theterm‘biosimilarbiological 13
380-productapplicationfiler’meansapartythatownsor 14
381-controlsabiosimilarbiologicalproductapplication 15
382-filedwiththeSecretaryofHealthandHumanServ-16
383-icesorhastheexclusiverightsundersuchapplica-17
384-tiontodistributethebiosimilarbiologicalproduct. 18
385-‘‘(12)DRUGPRODUCT.—Theterm‘drugprod-19
386-uct’hasthemeaninggivensuchterminsection 20
387-314.3(b)oftitle21,CodeofFederalRegulations(or 21
388-anysuccessorregulation). 22
389-‘‘(13)MARKET.—Theterm‘market’meansthe 23
390-promotion,offeringforsale,selling,ordistribution 24
391-ofadrugproduct. 25
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393-ssavage on LAPJG3WLY3PROD with BILLS 15
394-•S 1096 RS
395-‘‘(14)NDA.—Theterm‘NDA’meansanew 1
396-drugapplicationfiledundersection505(b)ofthe 2
397-FederalFood,Drug,andCosmeticAct(21U.S.C. 3
398-355(b)). 4
399-‘‘(15)NDAHOLDER.—Theterm‘NDAholder’ 5
400-means— 6
401-‘‘(A)theholderofanapprovedNDAappli-7
402-cationforadrugproduct; 8
403-‘‘(B)apersonowningorcontrollingen-9
404-forcementofthepatentlistedintheApproved 10
405-DrugProductsWithTherapeuticEquivalence 11
406-Evaluations(commonlyknownasthe‘FDAOr-12
407-angeBook’)inconnectionwiththeNDA;or 13
408-‘‘(C)thepredecessors,subsidiaries,divi-14
409-sions,groups,andaffiliatescontrolledby,con-15
410-trolling,orundercommoncontrolwithanyof 16
411-theentitiesdescribedinsubparagraphs(A)and 17
412-(B)(suchcontroltobepresumedbydirector 18
413-indirectshareownershipof50percentorgreat-19
414-er),aswellasthelicensees,licensors,succes-20
415-sors,andassignsofeachoftheentities. 21
416-‘‘(16)PARTY.—Theterm‘party’meansany 22
417-person,partnership,corporation,orotherlegalenti-23
418-ty. 24
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420-ssavage on LAPJG3WLY3PROD with BILLS 16
421-•S 1096 RS
422-‘‘(17)PATENT INFRINGEMENT.—Theterm 1
423-‘patentinfringement’meansinfringementofany 2
424-patentorofanyfiledpatentapplication,including 3
425-anyextension,reissue,renewal,division,continu-4
426-ation,continuationinpart,reexamination,patent 5
427-termrestoration,patentsofaddition,andextensions 6
428-thereof. 7
429-‘‘(18)PATENTINFRINGEMENT CLAIM.—The 8
430-term‘patentinfringementclaim’meansanyallega-9
431-tionmadetoanANDAfilerorbiosimilarbiological 10
432-productapplicationfiler,whetherornotincludedin 11
433-acomplaintfiledwithacourtoflaw,thatitsANDA 12
434-orANDAproduct,orbiosimilarbiologicalproduct 13
435-applicationorbiosimilarbiologicalproduct,mayin-14
436-fringeanypatentheldby,orexclusivelylicensedto, 15
437-theNDAholderorbiologicalproductlicenseholder 16
438-ofthedrugproductorbiologicalproduct,asapplica-17
439-ble. 18
440-‘‘(19)STATUTORY EXCLUSIVITY.—Theterm 19
441-‘statutoryexclusivity’meansthoseprohibitionson 20
442-thesubmissionortheapprovalofdrugapplications 21
443-underclauses(ii)through(iv)ofsection 22
444-505(c)(3)(E),clauses(ii)through(iv)ofsection 23
445-505(j)(5)(F),section527,section505A,orsection 24
446-505EoftheFederalFood,Drug,andCosmeticAct 25
447-VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
448-ssavage on LAPJG3WLY3PROD with BILLS 17
449-•S 1096 RS
450-(21U.S.C.355(c)(3)(E),360cc,355a,355f),oron 1
451-thesubmissionorlicensingofbiologicalproductap-2
452-plicationsundersection351(k)(7)orparagraph(2) 3
453-or(3)ofsection351(m)ofthePublicHealthServ-4
454-iceAct(42U.S.C.262)orundersection527ofthe 5
455-FederalFood,Drug,andCosmeticAct(21U.S.C. 6
456-360cc).’’. 7
457-(b)EFFECTIVEDATE.—Section27oftheFederal 8
458-TradeCommissionAct,asaddedbythissection,shall 9
459-applytoallagreementsdescribedinsection27(a)(1)of 10
460-thatActenteredintoonorafterthedateofenactment 11
461-ofthisAct. 12
462-SEC.4.CERTIFICATION OFAGREEMENTS. 13
463-(a)NOTICEOFALLAGREEMENTS.—Section1111(7) 14
464-oftheMedicarePrescriptionDrug,Improvement,and 15
465-ModernizationActof2003(21U.S.C.355note)is 16
466-amendedbyinserting‘‘,ortheownerofapatentforwhich 17
467-aclaimofinfringementcouldreasonablybeasserted 18
468-againstanypersonformaking,using,offeringtosell,sell-19
469-ing,orimportingintotheUnitedStatesabiologicalprod-20
470-uctthatisthesubjectofabiosimilarbiologicalproduct 21
471-application’’beforetheperiodattheend. 22
472-(b)CERTIFICATIONOFAGREEMENTS.—Section1112 23
473-oftheMedicarePrescriptionDrug,Improvement,and 24
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476-•S 1096 RS
477-ModernizationActof2003(21U.S.C.355note)is 1
478-amendedbyaddingattheendthefollowing: 2
479-‘‘(d)CERTIFICATION.—TheChiefExecutiveOfficer 3
480-orthecompanyofficialresponsiblefornegotiatingany 4
481-agreementundersubsection(a)or(b)thatisrequiredto 5
482-befiledundersubsection(c),within30daysaftersuch 6
483-filing,shallexecuteandfilewiththeAssistantAttorney 7
484-GeneralandtheCommissionacertificationasfollows:‘I 8
485-declarethatthefollowingistrue,correct,andcomplete 9
486-tothebestofmyknowledge:Thematerialsfiledwiththe 10
487-FederalTradeCommissionandtheDepartmentofJustice 11
488-undersection1112ofsubtitleBoftitleXIoftheMedi-12
489-carePrescriptionDrug,Improvement,andModernization 13
490-Actof2003,withrespecttotheagreementreferencedin 14
491-thiscertification— 15
492-‘‘(1)representthecomplete,final,andexclusive 16
493-agreementbetweentheparties; 17
494-‘‘(2)includeanyancillaryagreementsthatare 18
495-contingentupon,provideacontingentconditionfor, 19
496-orareotherwiserelatedto,thereferencedagree-20
497-ment;and 21
498-‘‘(3)includewrittendescriptionsofanyoral 22
499-agreements,representations,commitments,orprom-23
500-isesbetweenthepartiesthatareresponsivetosub-24
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503-•S 1096 RS
504-section(a)or(b)ofsuchsection1112andhavenot 1
505-beenreducedtowriting.’’’. 2
506-SEC.5.NOTIFICATION OFAGREEMENTS. 3
507-Section1112oftheMedicarePrescriptionDrug,Im-4
508-provement,andModernizationActof2003(21U.S.C. 5
509-355note),asamendedbysection4(b),isfurtheramended 6
510-byaddingattheendthefollowing: 7
511-‘‘(e)RULEOFCONSTRUCTION.— 8
512-‘‘(1)INGENERAL.—Anagreementthatisre-9
513-quiredundersubsection(a)or(b)shallinclude 10
514-agreementsresolvinganyoutstandingdisputes,in-11
515-cludingagreementsresolvingorsettlingaPatent 12
516-TrialandAppealBoardproceeding. 13
517-‘‘(2)DEFINITION.—Forpurposesofsubpara-14
518-graph(A),theterm‘PatentTrialandAppealBoard 15
519-proceeding’meansaproceedingconductedbythe 16
520-PatentTrialandAppealBoardoftheUnitedStates 17
521-PatentandTrademarkOffice,includinganinter 18
522-partesreviewinstitutedunderchapter31oftitle35, 19
523-UnitedStatesCode,apost-grantreviewinstituted 20
524-underchapter32ofthattitle(includingapro-21
525-ceedinginstitutedpursuanttothetransitionalpro-22
526-gramforcoveredbusinessmethodpatents,asde-23
527-scribedinsection18oftheLeahy-SmithAmerica 24
528-InventsAct(35U.S.C.321note)),andaderivation 25
529-VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
530-ssavage on LAPJG3WLY3PROD with BILLS 20
531-•S 1096 RS
532-proceedinginstitutedundersection135ofthat 1
533-title.’’. 2
534-SEC.6.FORFEITURE OF180-DAYEXCLUSIVITY PERIOD. 3
535-Section505(j)(5)(D)(i)(V)oftheFederalFood, 4
536-Drug,andCosmeticAct(21U.S.C.355(j)(5)(D)(i)(V)) 5
537-isamendedbyinserting‘‘section27oftheFederalTrade 6
538-CommissionActor’’after‘‘thattheagreementhasvio-7
539-lated’’. 8
540-SEC.7.COMMISSION LITIGATION AUTHORITY. 9
541-Section16(a)(2)oftheFederalTradeCommission 10
542-Act(15U.S.C.56(a)(2))isamended— 11
543-(1)insubparagraph(D),bystriking‘‘or’’after 12
544-thesemicolon; 13
545-(2)insubparagraph(E)— 14
546-(A)bymovingthemargin2emstothe 15
547-left;and 16
548-(B)byinserting‘‘or’’afterthesemicolon; 17
549-and 18
550-(3)insertingaftersubparagraph(E)thefol-19
551-lowing: 20
552-‘‘(F)undersection27,’’. 21
553-SEC.8.REPORT ONADDITIONAL EXCLUSION. 22
554-(1)INGENERAL.—Notlaterthan1yearafter 23
555-thedateofenactmentofthisAct,theFederalTrade 24
556-CommissionshallsubmittotheCommitteeonthe 25
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558-ssavage on LAPJG3WLY3PROD with BILLS 21
559-•S 1096 RS
560-JudiciaryoftheSenateandtheCommitteeonthe 1
561-JudiciaryoftheHouseofRepresentativesarec-2
562-ommendation,andtheCommission’sbasisforsuch 3
563-recommendation,regardingapotentialamendment 4
564-toincludeinsection27(b)oftheFederalTrade 5
565-CommissionAct(asaddedbysection3)anaddi-6
566-tionalexclusionforconsiderationgrantedbyan 7
567-NDAholdertoaANDAfilerorbyabiologicalprod-8
568-uctlicenseholdertoabiosimilarbiologicalproduct 9
569-applicationfileraspartoftheresolutionorsettle-10
570-ment,arelease,waiver,orlimitationofaclaimfor 11
571-damagesorothermonetaryrelief. 12
572-(2)DEFINITIONS.—Inthissection,theterms 13
573-‘‘ANDAfiler’’,‘‘biologicalproductlicenseholder’’, 14
574-‘‘biosimilarbiologicalproductapplicationfiler’’,and 15
575-‘‘NDAholder’’havethemeaningsgivensuchterms 16
576-insection27(d)oftheFederalTradeCommission 17
577-Act(asaddedbysection3). 18
578-SEC.9.STATUTE OFLIMITATIONS. 19
579-TheFederalTradeCommissionshallcommenceany 20
580-enforcementproceedingdescribedinsection27ofthe 21
581-FederalTradeCommissionAct,asaddedbysection3,not 22
582-laterthan6yearsafterthedateonwhichthepartiesto 23
583-theagreementfilethecertificationundersection1112(d) 24
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585-ssavage on LAPJG3WLY3PROD with BILLS 22
586-•S 1096 RS
587-oftheMedicarePrescriptionDrugImprovementandMod-1
588-ernizationActof2003(21U.S.C.355note). 2
589-SEC.10.SEVERABILITY. 3
590-IfanyprovisionofthisAct,anamendmentmadeby 4
591-thisAct,ortheapplicationofsuchprovisionoramend-5
592-menttoanypersonorcircumstanceisheldtobeunconsti-6
593-tutional,theremainderofthisAct,theamendmentsmade 7
594-bythisAct,andtheapplicationoftheprovisionsofsuch 8
595-Actoramendmentstoanypersonorcircumstanceshall 9
596-notbeaffected. 10
597-SECTION 1. SHORT TITLE. 11
598-This Act may be cited as the ‘‘Preserve Access to Af-12
599-fordable Generics and Biosimilars Act’’. 13
600-SEC. 2. CONGRESSIONAL FINDINGS AND DECLARATION OF 14
601-PURPOSES. 15
602-(a) F
603-INDINGS.—Congress finds the following: 16
604-(1) In 1984, the Drug Price Competition and 17
605-Patent Term Restoration Act of 1984 (Public Law 18
606-98–417) (referred to in this Act as the ‘‘1984 Act’’), 19
607-was enacted with the intent of facilitating the early 20
608-entry of generic drugs while preserving incentives for 21
609-innovation. 22
610-(2) Prescription drugs make up approximately 23
611-11 percent of the national health care spending. 24
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615-(3) Initially, the 1984 Act was successful in fa-1
616-cilitating generic competition to the benefit of con-2
617-sumers and health care payers. Although 91 percent 3
618-of all prescriptions dispensed in the United States are 4
619-generic drugs, they account for only 18 percent of all 5
620-expenditures. 6
621-(4) Generic drugs cost substantially less than 7
622-brand name drugs, with discounts off the brand price 8
623-averaging 80 to 85 percent. 9
624-(5) Federal dollars currently account for over 40 10
625-percent of the $449,700,000,000 spent on retail pre-11
626-scription drugs annually. 12
627-(6)(A) In recent years, the intent of the 1984 Act 13
628-has been subverted by certain settlement agreements 14
629-in which brand name companies transfer value to 15
630-their potential generic competitors to settle claims 16
631-that the generic company is infringing the branded 17
632-company’s patents. 18
633-(B) These ‘‘reverse payment’’ settlement agree-19
634-ments— 20
635-(i) allow a branded company to share its 21
636-monopoly profits with the generic company as a 22
637-way to protect the branded company’s monopoly; 23
638-and 24
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642-(ii) have unduly delayed the marketing of 1
643-low-cost generic drugs contrary to free competi-2
644-tion, the interests of consumers, and the prin-3
645-ciples underlying antitrust law. 4
646-(C) Because of the price disparity between brand 5
647-name and generic drugs, such agreements are more 6
648-profitable for both the brand and generic manufactur-7
649-ers than competition and will become increasingly 8
650-common unless prohibited. 9
651-(D) These agreements result in consumers losing 10
652-the benefits that the 1984 Act was intended to pro-11
653-vide. 12
654-(7) In 2010, the Biologics Price Competition and 13
655-Innovation Act of 2009 (Public Law 111–148) (re-14
656-ferred to in this Act as the ‘‘BPCIA’’), was enacted 15
657-with the intent of facilitating the early entry of bio-16
658-similar and interchangeable follow-on versions of 17
659-branded biological products while preserving incen-18
660-tives for innovation. 19
661-(8) Biological drugs play an important role in 20
662-treating many serious illnesses, from cancers to ge-21
663-netic disorders. They are also expensive, representing 22
664-more than half of all prescription drug spending. 23
665-(9) Competition from biosimilar and inter-24
666-changeable biological products promises to lower drug 25
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670-costs and increase patient access to biological medi-1
671-cines. But ‘‘reverse payment’’ settlement agreements 2
672-also threaten to delay the entry of biosimilar and 3
673-interchangeable biological products, which would un-4
674-dermine the goals of the BPCIA. 5
675-(b) P
676-URPOSES.—The purposes of this Act are— 6
677-(1) to enhance competition in the pharma-7
678-ceutical market by stopping anticompetitive agree-8
679-ments between brand name and generic drug and bio-9
680-similar biological product manufacturers that limit, 10
681-delay, or otherwise prevent competition from generic 11
682-drugs and biosimilar biological products; and 12
683-(2) to support the purpose and intent of anti-13
684-trust law by prohibiting anticompetitive practices in 14
685-the pharmaceutical industry that harm consumers. 15
686-SEC. 3. UNLAWFUL COMPENSATION FOR DELAY. 16
687-(a) I
688-NGENERAL.—The Federal Trade Commission Act 17
689-(15 U.S.C. 41 et seq.) is amended by inserting after section 18
690-26 (15 U.S.C. 57c–2) the following: 19
691-‘‘SEC. 27. PRESERVING ACCESS TO AFFORDABLE GENERICS 20
692-AND BIOSIMILARS. 21
693-‘‘(a) P
694-ROHIBITION.— 22
695-‘‘(1) I
696-N GENERAL.—It shall be a violation of this 23
697-section for a party to enter into, or be a participant 24
698-to, an agreement, resolving or settling, on a final or 25
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702-interim basis, a patent claim in connection with the 1
703-sale of a drug product or biological product, that has 2
704-anticompetitive effects. 3
705-‘‘(2) T
706-REATMENT.—A violation of this section 4
707-shall be treated as an unfair method of competition 5
708-in violation of section 5(a)(1). 6
709-‘‘(3) P
710-RESUMPTION.— 7
711-‘‘(A) I
712-N GENERAL.—Subject to subpara-8
713-graph (B), an agreement described in paragraph 9
714-(1) shall be presumed to have anticompetitive ef-10
715-fects for purposes of such paragraph if— 11
716-‘‘(i) an ANDA filer or a biosimilar bi-12
717-ological product application filer receives 13
718-anything of value, including an exclusive li-14
719-cense; and 15
720-‘‘(ii) the ANDA filer or biosimilar bio-16
721-logical product application filer agrees to 17
722-limit or forgo research, development, manu-18
723-facturing, marketing, or sales of the ANDA 19
724-product or biosimilar biological product, as 20
725-applicable, for any period of time. 21
726-‘‘(B) E
727-XCEPTION.—Subparagraph (A) shall 22
728-not apply if the parties to such agreement dem-23
729-onstrate by a preponderance of the evidence 24
730-that— 25
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734-‘‘(i) the value described in subpara-1
735-graph (A)(i) is compensation solely for 2
736-other goods or services that the ANDA filer 3
737-or biosimilar biological product application 4
738-filer has promised to provide; or 5
739-‘‘(ii) the procompetitive benefits of the 6
740-transfer of value described in subparagraph 7
741-(A)(i) and the agreement by the ANDA filer 8
742-or biosimilar biological product application 9
743-filer to limit or forgo research, development, 10
744-manufacturing, marketing, or sales of the 11
745-ANDA product or biosimilar biological 12
746-product described in subparagraph (A)(ii) 13
747-outweigh the anticompetitive effects of the 14
748-transfer of value described in subparagraph 15
749-(A)(i) and the agreement by the ANDA filer 16
750-or biosimilar biological product application 17
751-filer to limit or forgo research, development, 18
752-manufacturing, marketing, or sales of the 19
753-ANDA product or biosimilar biological 20
754-product described in subparagraph (A)(ii). 21
755-‘‘(4) C
756-IVIL ACTION.—In addition to any pro-22
757-ceeding under section 5, if the Commission has reason 23
758-to believe that a party has violated this section, the 24
759-Commission may bring, in its own name by any of 25
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763-its attorneys designated by it for such purpose, a civil 1
764-action against the party in a district court of the 2
765-United States to seek to recover any of the remedies 3
766-of civil penalty, mandatory injunctions, and such 4
767-other and further equitable relief as the court deems 5
768-appropriate. 6
769-‘‘(5) C
770-IVIL PENALTY.— 7
771-‘‘(A) I
772-N GENERAL.—Each party that vio-8
773-lates or assists in the violation of paragraph (1) 9
774-shall forfeit and pay to the United States a civil 10
775-penalty sufficient to deter violations of para-11
776-graph (1), but in no event greater than 3 times 12
777-the value received by the party that is reasonably 13
778-attributable to the violation of paragraph (1). If 14
779-no such value has been received by the NDA 15
780-holder, the biological product license holder, the 16
781-ANDA filer, or the biosimilar biological product 17
782-application filer, the penalty to the NDA holder, 18
783-the biological product license holder, the ANDA 19
784-filer, or the biosimilar biological product appli-20
785-cation filer shall be sufficient to deter violations, 21
786-but in no event shall be greater than 3 times the 22
787-value given to an ANDA filer or biosimilar bio-23
788-logical product application filer reasonably at-24
789-tributable to the violation of this section. 25
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793-‘‘(B) AMOUNT.—In determining the amount 1
794-of the civil penalty described in subparagraph 2
795-(A), the court shall take into account— 3
796-‘‘(i) the nature, circumstances, extent, 4
797-and gravity of the violation; 5
798-‘‘(ii) with respect to the violator, the 6
799-degree of culpability, any history of prior 7
800-such conduct, including other agreements re-8
801-solving or settling a patent infringement 9
802-claim, the ability to pay, any effect on the 10
803-ability to continue doing business, profits 11
804-earned by the NDA holder, the biological 12
805-product license holder, the ANDA filer, or 13
806-the biosimilar biological product applica-14
807-tion filer, compensation received by the 15
808-ANDA filer or biosimilar biological product 16
809-application filer, and the amount of com-17
810-merce affected; and 18
811-‘‘(iii) other matters that justice re-19
812-quires. 20
813-‘‘(C) R
814-EMEDIES IN ADDITION .—Remedies 21
815-provided in this paragraph are in addition to, 22
816-and not in lieu of, any other remedy provided by 23
817-Federal law. Nothing in this section shall be con-24
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821-strued to limit any authority of the Commission 1
822-under any other provision of law. 2
823-‘‘(b) E
824-XCLUSIONS.—Nothing in this section shall pro-3
825-hibit a resolution or settlement of a patent infringement 4
826-claim in which the consideration that the ANDA filer or 5
827-biosimilar biological product application filer, respectively, 6
828-receives as part of the resolution or settlement includes only 7
829-one or more of the following: 8
830-‘‘(1) The right to market and secure final ap-9
831-proval in the United States for the ANDA product or 10
832-biosimilar biological product at a date, whether cer-11
833-tain or contingent, prior to the expiration of— 12
834-‘‘(A) any patent that is the basis for the 13
835-patent infringement claim; or 14
836-‘‘(B) any patent right or other statutory ex-15
837-clusivity that would prevent the marketing of 16
838-such ANDA product or biosimilar biological 17
839-product. 18
840-‘‘(2) A payment for reasonable litigation ex-19
841-penses not to exceed— 20
842-‘‘(A) for calendar year 2025, $7,500,000; or 21
843-‘‘(B) for calendar year 2026 and each subse-22
844-quent calendar year, the amount determined for 23
845-the preceding calendar year adjusted to reflect 24
846-the percentage increase (if any) in the Producer 25
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850-Price Index for Legal Services published by the 1
851-Bureau of Labor Statistics of the Department of 2
852-Labor for the most recent calendar year. 3
853-‘‘(3) A covenant not to sue on any claim that the 4
854-ANDA product or biosimilar biological product in-5
855-fringes a United States patent. 6
856-‘‘(c) A
857-NTITRUSTLAWS.—Except to the extent this sec-7
858-tion establishes an additional basis of liability, nothing in 8
859-this section shall modify, impair, limit, or supersede the 9
860-applicability of the antitrust laws as defined in subsection 10
861-(a) of the first section of the Clayton Act (15 U.S.C. 12(a)), 11
862-and of section 5 of this Act to the extent that section 5 ap-12
863-plies to unfair methods of competition. Nothing in this sec-13
864-tion shall modify, impair, limit, or supersede the right of 14
865-an ANDA filer or biosimilar biological product application 15
866-filer to assert claims or counterclaims against any person, 16
867-under the antitrust laws or other laws relating to unfair 17
868-competition. 18
869-‘‘(d) D
870-EFINITIONS.—In this section: 19
871-‘‘(1) A
872-GREEMENT.—The term ‘agreement’ means 20
873-anything that would constitute an agreement under 21
874-section 1 of the Sherman Act (15 U.S.C. 1) or section 22
875-5 of this Act. 23
876-‘‘(2) A
877-GREEMENT RESOLVING OR SETTLING A 24
878-PATENT INFRINGEMENT CLAIM .—The term ‘agreement 25
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882-resolving or settling a patent infringement claim’ in-1
883-cludes any agreement that is entered into within 30 2
884-days of the resolution or the settlement of the claim, 3
885-or any other agreement that is contingent upon, pro-4
886-vides a contingent condition for, or is otherwise re-5
887-lated to the resolution or settlement of the claim. 6
888-‘‘(3) ANDA.—The term ‘ANDA’ means an abbre-7
889-viated new drug application filed under section 505(j) 8
890-of the Federal Food, Drug, and Cosmetic Act (21 9
891-U.S.C. 355(j)) or a new drug application submitted 10
892-pursuant to section 505(b)(2) of the Federal Food, 11
893-Drug, and Cosmetic Act (21 U.S.C. 355(b)(2)). 12
894-‘‘(4) ANDA
895-FILER.—The term ‘ANDA filer’ 13
896-means a party that owns or controls an ANDA filed 14
897-with the Secretary of Health and Human Services or 15
898-has the exclusive rights under such ANDA to dis-16
899-tribute the ANDA product. 17
900-‘‘(5) ANDA
901-PRODUCT.—The term ‘ANDA prod-18
902-uct’ means the product to be manufactured under the 19
903-ANDA that is the subject of the patent infringement 20
904-claim. 21
905-‘‘(6) B
906-IOLOGICAL PRODUCT.—The term ‘biologi-22
907-cal product’ has the meaning given such term in sec-23
908-tion 351(i)(1) of the Public Health Service Act (42 24
909-U.S.C. 262(i)(1)). 25
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356+•S 1096 IS
913357 ‘‘(7) BIOLOGICAL PRODUCT LICENSE APPLICA -1
914358 TION.—The term ‘biological product license applica-2
915359 tion’ means an application under section 351(a) of 3
916360 the Public Health Service Act (42 U.S.C. 262(a)). 4
917361 ‘‘(8) B
918-IOLOGICAL PRODUCT LICENSE HOLDER .— 5
919-The term ‘biological product license holder’ means— 6
920-‘‘(A) the holder of an approved biological 7
921-product license application for a biological prod-8
922-uct; 9
923-‘‘(B) a person owning or controlling en-10
924-forcement of any patents that claim the biologi-11
925-cal product that is the subject of such approved 12
926-application; or 13
927-‘‘(C) the predecessors, subsidiaries, divi-14
928-sions, groups, and affiliates controlled by, con-15
929-trolling, or under common control with any of 16
930-the entities described in subparagraphs (A) and 17
931-(B) (such control to be presumed by direct or in-18
932-direct share ownership of 50 percent or greater), 19
933-as well as the licensees, licensors, successors, and 20
934-assigns of each of the entities. 21
362+IOLOGICAL PRODUCT LICENSE HOLD -5
363+ER.—The term ‘biological product license holder’ 6
364+means— 7
365+‘‘(A) the holder of an approved biological 8
366+product license application for a biological prod-9
367+uct; 10
368+‘‘(B) a person owning or controlling en-11
369+forcement of any patents that claim the biologi-12
370+cal product that is the subject of such approved 13
371+application; or 14
372+‘‘(C) the predecessors, subsidiaries, divi-15
373+sions, groups, and affiliates controlled by, con-16
374+trolling, or under common control with any of 17
375+the entities described in subparagraphs (A) and 18
376+(B) (such control to be presumed by direct or 19
377+indirect share ownership of 50 percent or great-20
378+er), as well as the licensees, licensors, succes-21
379+sors, and assigns of each of the entities. 22
935380 ‘‘(9) B
936-IOSIMILAR BIOLOGICAL PRODUCT .—The 22
937-term ‘biosimilar biological product’ means the prod-23
938-uct to be manufactured under the biosimilar biologi-24
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381+IOSIMILAR BIOLOGICAL PRODUCT .—The 23
382+term ‘biosimilar biological product’ means the prod-24
383+uct to be manufactured under the biosimilar biologi-25
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942387 cal product application that is the subject of the pat-1
943388 ent infringement claim. 2
944389 ‘‘(10) B
945390 IOSIMILAR BIOLOGICAL PRODUCT APPLI -3
946391 CATION.—The term ‘biosimilar biological product ap-4
947392 plication’ means an application under section 351(k) 5
948393 of the Public Health Service Act (42 U.S.C. 262(k)) 6
949394 for licensure of a biological product as biosimilar to, 7
950395 or interchangeable with, a reference product. 8
951396 ‘‘(11) B
952397 IOSIMILAR BIOLOGICAL PRODUCT APPLI -9
953-CATION FILER.—The term ‘biosimilar biological prod-10
954-uct application filer’ means a party that owns or 11
398+CATION FILER.—The term ‘biosimilar biological 10
399+product application filer’ means a party that owns or 11
955400 controls a biosimilar biological product application 12
956401 filed with the Secretary of Health and Human Serv-13
957-ices or has the exclusive rights under such application 14
958-to distribute the biosimilar biological product. 15
402+ices or has the exclusive rights under such applica-14
403+tion to distribute the biosimilar biological product. 15
959404 ‘‘(12) D
960-RUG PRODUCT.—The term ‘drug product’ 16
961-has the meaning given such term in section 314.3(b) 17
962-of title 21, Code of Federal Regulations (or any suc-18
963-cessor regulation). 19
405+RUG PRODUCT.—The term ‘drug prod-16
406+uct’ has the meaning given such term in section 17
407+314.3(b) of title 21, Code of Federal Regulations (or 18
408+any successor regulation). 19
964409 ‘‘(13) M
965410 ARKET.—The term ‘market’ means the 20
966-promotion, offering for sale, selling, or distribution of 21
967-a drug product. 22
968-‘‘(14) NDA.—The term ‘NDA’ means a new drug 23
969-application filed under section 505(b) of the Federal 24
970-Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)). 25
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974-‘‘(15) NDA HOLDER.—The term ‘NDA holder’ 1
975-means— 2
976-‘‘(A) the holder of an approved NDA appli-3
977-cation for a drug product; 4
978-‘‘(B) a person owning or controlling en-5
979-forcement of the patent listed in the Approved 6
980-Drug Products With Therapeutic Equivalence 7
981-Evaluations (commonly known as the ‘FDA Or-8
982-ange Book’) in connection with the NDA; or 9
983-‘‘(C) the predecessors, subsidiaries, divi-10
984-sions, groups, and affiliates controlled by, con-11
985-trolling, or under common control with any of 12
986-the entities described in subparagraphs (A) and 13
987-(B) (such control to be presumed by direct or in-14
988-direct share ownership of 50 percent or greater), 15
989-as well as the licensees, licensors, successors, and 16
990-assigns of each of the entities. 17
411+promotion, offering for sale, selling, or distribution 21
412+of a drug product. 22
413+‘‘(14) NDA.—The term ‘NDA’ means a new 23
414+drug application filed under section 505(b) of the 24
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418+Federal Food, Drug, and Cosmetic Act (21 U.S.C. 1
419+355(b)). 2
420+‘‘(15) NDA
421+HOLDER.—The term ‘NDA holder’ 3
422+means— 4
423+‘‘(A) the holder of an approved NDA appli-5
424+cation for a drug product; 6
425+‘‘(B) a person owning or controlling en-7
426+forcement of the patent listed in the Approved 8
427+Drug Products With Therapeutic Equivalence 9
428+Evaluations (commonly known as the ‘FDA Or-10
429+ange Book’) in connection with the NDA; or 11
430+‘‘(C) the predecessors, subsidiaries, divi-12
431+sions, groups, and affiliates controlled by, con-13
432+trolling, or under common control with any of 14
433+the entities described in subparagraphs (A) and 15
434+(B) (such control to be presumed by direct or 16
435+indirect share ownership of 50 percent or great-17
436+er), as well as the licensees, licensors, succes-18
437+sors, and assigns of each of the entities. 19
991438 ‘‘(16) P
992-ARTY.—The term ‘party’ means any per-18
993-son, partnership, corporation, or other legal entity. 19
439+ARTY.—The term ‘party’ means any 20
440+person, partnership, corporation, or other legal enti-21
441+ty. 22
994442 ‘‘(17) P
995-ATENT INFRINGEMENT.—The term ‘pat-20
996-ent infringement’ means infringement of any patent 21
997-or of any filed patent application, including any ex-22
998-tension, reissue, renewal, division, continuation, con-23
999-tinuation in part, reexamination, patent term res-24
1000-toration, patents of addition, and extensions thereof. 25
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1004-‘‘(18) PATENT INFRINGEMENT CLAIM .—The term 1
1005-‘patent infringement claim’ means any allegation 2
1006-made to an ANDA filer or biosimilar biological prod-3
1007-uct application filer, whether or not included in a 4
1008-complaint filed with a court of law, that its ANDA 5
1009-or ANDA product, or biosimilar biological product 6
1010-application or biosimilar biological product, may in-7
1011-fringe any patent held by, or exclusively licensed to, 8
1012-the NDA holder or biological product license holder of 9
1013-the drug product or biological product, as applicable. 10
443+ATENT INFRINGEMENT .—The term 23
444+‘patent infringement’ means infringement of any 24
445+patent or of any filed patent application, including 25
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449+any extension, reissue, renewal, division, continu-1
450+ation, continuation in part, reexamination, patent 2
451+term restoration, patents of addition, and extensions 3
452+thereof. 4
453+‘‘(18) P
454+ATENT INFRINGEMENT CLAIM .—The 5
455+term ‘patent infringement claim’ means any allega-6
456+tion made to an ANDA filer or biosimilar biological 7
457+product application filer, whether or not included in 8
458+a complaint filed with a court of law, that its ANDA 9
459+or ANDA product, or biosimilar biological product 10
460+application or biosimilar biological product, may in-11
461+fringe any patent held by, or exclusively licensed to, 12
462+the NDA holder or biological product license holder 13
463+of the drug product or biological product, as applica-14
464+ble. 15
1014465 ‘‘(19) S
1015-TATUTORY EXCLUSIVITY.—The term ‘stat-11
1016-utory exclusivity’ means those prohibitions on the 12
1017-submission or the approval of drug applications 13
1018-under clauses (ii) through (iv) of section 505(c)(3)(E), 14
1019-clauses (ii) through (iv) of section 505(j)(5)(F), sec-15
1020-tion 527, section 505A, or section 505E of the Federal 16
1021-Food, Drug, and Cosmetic Act (21 U.S.C. 17
1022-355(c)(3)(E), 355(j)(5)(F), 360cc, 355a, 355f), or on 18
1023-the submission or licensing of biological product ap-19
1024-plications under section 351(k)(7) or paragraph (2) 20
1025-or (3) of section 351(m) of the Public Health Service 21
1026-Act (42 U.S.C. 262) or under section 527 of the Fed-22
1027-eral Food, Drug, and Cosmetic Act (21 U.S.C. 23
1028-360cc).’’. 24
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1032-(b) EFFECTIVEDATE.—Section 27 of the Federal 1
1033-Trade Commission Act, as added by this section, shall 2
1034-apply to all agreements described in section 27(a)(1) of that 3
1035-Act entered into on or after the date of enactment of this 4
1036-Act. 5
1037-SEC. 4. CERTIFICATION OF AGREEMENTS. 6
466+TATUTORY EXCLUSIVITY .—The term 16
467+‘statutory exclusivity’ means those prohibitions on 17
468+the submission or the approval of drug applications 18
469+under clauses (ii) through (iv) of section 19
470+505(c)(3)(E), clauses (ii) through (iv) of section 20
471+505(j)(5)(F), section 527, section 505A, or section 21
472+505E of the Federal Food, Drug, and Cosmetic Act 22
473+(21 U.S.C. 355(c)(3)(E), 360cc, 355a, 355f), or on 23
474+the submission or licensing of biological product ap-24
475+plications under section 351(k)(7) or paragraph (2) 25
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478+•S 1096 IS
479+or (3) of section 351(m) of the Public Health Serv-1
480+ice Act (42 U.S.C. 262) or under section 527 of the 2
481+Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3
482+360cc).’’. 4
483+(b) E
484+FFECTIVEDATE.—Section 27 of the Federal 5
485+Trade Commission Act, as added by this section, shall 6
486+apply to all agreements described in section 27(a)(1) of 7
487+that Act entered into on or after the date of enactment 8
488+of this Act. 9
489+SEC. 4. CERTIFICATION OF AGREEMENTS. 10
1038490 (a) N
1039-OTICE OFALLAGREEMENTS.—Section 1111(7) 7
1040-of the Medicare Prescription Drug, Improvement, and Mod-8
1041-ernization Act of 2003 (21 U.S.C. 355 note) is amended 9
1042-by inserting ‘‘, or the owner of a patent for which a claim 10
1043-of infringement could reasonably be asserted against any 11
1044-person for making, using, offering to sell, selling, or import-12
1045-ing into the United States a biological product that is the 13
1046-subject of a biosimilar biological product application’’ be-14
1047-fore the period at the end. 15
491+OTICE OFALLAGREEMENTS.—Section 1111(7) 11
492+of the Medicare Prescription Drug, Improvement, and 12
493+Modernization Act of 2003 (21 U.S.C. 355 note) is 13
494+amended by inserting ‘‘, or the owner of a patent for which 14
495+a claim of infringement could reasonably be asserted 15
496+against any person for making, using, offering to sell, sell-16
497+ing, or importing into the United States a biological prod-17
498+uct that is the subject of a biosimilar biological product 18
499+application’’ before the period at the end. 19
1048500 (b) C
1049-ERTIFICATION OFAGREEMENTS.—Section 1112 16
1050-of the Medicare Prescription Drug, Improvement, and Mod-17
1051-ernization Act of 2003 (21 U.S.C. 355 note) is amended 18
1052-by adding at the end the following: 19
501+ERTIFICATION OFAGREEMENTS.—Section 1112 20
502+of the Medicare Prescription Drug, Improvement, and 21
503+Modernization Act of 2003 (21 U.S.C. 355 note) is 22
504+amended by adding at the end the following: 23
1053505 ‘‘(d) C
1054-ERTIFICATION.—The Chief Executive Officer or 20
1055-the company official responsible for negotiating any agree-21
1056-ment under subsection (a) or (b) that is required to be filed 22
1057-under subsection (c), within 30 days after such filing, shall 23
1058-execute and file with the Assistant Attorney General and 24
1059-the Commission a certification as follows: ‘I declare that 25
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1062-•S 1096 RS
1063-the following is true, correct, and complete to the best of 1
1064-my knowledge: The materials filed with the Federal Trade 2
1065-Commission and the Department of Justice under section 3
1066-1112 of subtitle B of title XI of the Medicare Prescription 4
1067-Drug, Improvement, and Modernization Act of 2003, with 5
1068-respect to the agreement referenced in this certification— 6
1069-‘‘(1) represent the complete, final, and exclusive 7
1070-agreement between the parties; 8
1071-‘‘(2) include any ancillary agreements that are 9
1072-contingent upon, provide a contingent condition for, 10
1073-or are otherwise related to, the referenced agreement; 11
1074-and 12
1075-‘‘(3) include written descriptions of any oral 13
1076-agreements, representations, commitments, or prom-14
1077-ises between the parties that are responsive to sub-15
1078-section (a) or (b) of such section 1112 and have not 16
1079-been reduced to writing.’’’. 17
1080-SEC. 5. NOTIFICATION OF AGREEMENTS. 18
1081-Section 1112 of the Medicare Prescription Drug, Im-19
1082-provement, and Modernization Act of 2003 (21 U.S.C. 355 20
1083-note), as amended by section 4(b), is further amended by 21
1084-adding at the end the following: 22
506+ERTIFICATION.—The Chief Executive Officer 24
507+or the company official responsible for negotiating any 25
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509+ssavage on LAPJG3WLY3PROD with BILLS 18
510+•S 1096 IS
511+agreement under subsection (a) or (b) that is required to 1
512+be filed under subsection (c), within 30 days after such 2
513+filing, shall execute and file with the Assistant Attorney 3
514+General and the Commission a certification as follows: ‘I 4
515+declare that the following is true, correct, and complete 5
516+to the best of my knowledge: The materials filed with the 6
517+Federal Trade Commission and the Department of Justice 7
518+under section 1112 of subtitle B of title XI of the Medi-8
519+care Prescription Drug, Improvement, and Modernization 9
520+Act of 2003, with respect to the agreement referenced in 10
521+this certification— 11
522+‘‘(1) represent the complete, final, and exclusive 12
523+agreement between the parties; 13
524+‘‘(2) include any ancillary agreements that are 14
525+contingent upon, provide a contingent condition for, 15
526+or are otherwise related to, the referenced agree-16
527+ment; and 17
528+‘‘(3) include written descriptions of any oral 18
529+agreements, representations, commitments, or prom-19
530+ises between the parties that are responsive to sub-20
531+section (a) or (b) of such section 1112 and have not 21
532+been reduced to writing.’’’. 22
533+SEC. 5. NOTIFICATION OF AGREEMENTS. 23
534+Section 1112 of the Medicare Prescription Drug, Im-24
535+provement, and Modernization Act of 2003 (21 U.S.C. 25
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538+•S 1096 IS
539+355 note), as amended by section 4(b), is further amended 1
540+by adding at the end the following: 2
1085541 ‘‘(e) R
1086-ULE OFCONSTRUCTION.— 23
542+ULE OFCONSTRUCTION.— 3
1087543 ‘‘(1) I
1088-N GENERAL.—An agreement that is re-24
1089-quired under subsection (a) or (b) shall include agree-25
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1092-•S 1096 RS
1093-ments resolving any outstanding disputes, including 1
1094-agreements resolving or settling a Patent Trial and 2
1095-Appeal Board proceeding. 3
544+N GENERAL.—An agreement that is re-4
545+quired under subsection (a) or (b) shall include 5
546+agreements resolving any outstanding disputes, in-6
547+cluding agreements resolving or settling a Patent 7
548+Trial and Appeal Board proceeding. 8
1096549 ‘‘(2) D
1097-EFINITION.—For purposes of subpara-4
1098-graph (A), the term ‘Patent Trial and Appeal Board 5
1099-proceeding’ means a proceeding conducted by the Pat-6
1100-ent Trial and Appeal Board of the United States Pat-7
1101-ent and Trademark Office, including an inter partes 8
1102-review instituted under chapter 31 of title 35, United 9
1103-States Code, a post-grant review instituted under 10
1104-chapter 32 of that title (including a proceeding insti-11
1105-tuted pursuant to the transitional program for cov-12
1106-ered business method patents, as described in section 13
1107-18 of the Leahy-Smith America Invents Act (35 14
1108-U.S.C. 321 note)), and a derivation proceeding insti-15
1109-tuted under section 135 of that title.’’. 16
1110-SEC. 6. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD. 17
1111-Section 505(j)(5)(D)(i)(V) of the Federal Food, Drug, 18
1112-and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) is amend-19
1113-ed by inserting ‘‘section 27 of the Federal Trade Commis-20
1114-sion Act or’’ after ‘‘that the agreement has violated’’. 21
1115-SEC. 7. COMMISSION LITIGATION AUTHORITY. 22
1116-Section 16(a)(2) of the Federal Trade Commission Act 23
1117-(15 U.S.C. 56(a)(2)) is amended— 24
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1120-•S 1096 RS
1121-(1) in subparagraph (D), by striking ‘‘or’’ after 1
1122-the semicolon; 2
1123-(2) in subparagraph (E)— 3
1124-(A) by moving the margin 2 ems to the left; 4
1125-and 5
1126-(B) by inserting ‘‘or’’ after the semicolon; 6
1127-and 7
1128-(3) by inserting after subparagraph (E) the fol-8
1129-lowing: 9
1130-‘‘(F) under section 27,’’. 10
1131-SEC. 8. REPORT ON ADDITIONAL EXCLUSION. 11
550+EFINITION.—For purposes of subpara-9
551+graph (A), the term ‘Patent Trial and Appeal Board 10
552+proceeding’ means a proceeding conducted by the 11
553+Patent Trial and Appeal Board of the United States 12
554+Patent and Trademark Office, including an inter 13
555+partes review instituted under chapter 31 of title 35, 14
556+United States Code, a post-grant review instituted 15
557+under chapter 32 of that title (including a pro-16
558+ceeding instituted pursuant to the transitional pro-17
559+gram for covered business method patents, as de-18
560+scribed in section 18 of the Leahy-Smith America 19
561+Invents Act (35 U.S.C. 321 note)), and a derivation 20
562+proceeding instituted under section 135 of that 21
563+title.’’. 22
564+SEC. 6. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD. 23
565+Section 505(j)(5)(D)(i)(V) of the Federal Food, 24
566+Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) 25
567+VerDate Sep 11 2014 00:09 Mar 29, 2025 Jkt 059200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\S1096.IS S1096
568+ssavage on LAPJG3WLY3PROD with BILLS 20
569+•S 1096 IS
570+is amended by inserting ‘‘section 27 of the Federal Trade 1
571+Commission Act or’’ after ‘‘that the agreement has vio-2
572+lated’’. 3
573+SEC. 7. COMMISSION LITIGATION AUTHORITY. 4
574+Section 16(a)(2) of the Federal Trade Commission 5
575+Act (15 U.S.C. 56(a)(2)) is amended— 6
576+(1) in subparagraph (D), by striking ‘‘or’’ after 7
577+the semicolon; 8
578+(2) in subparagraph (E)— 9
579+(A) by moving the margin 2 ems to the 10
580+left; and 11
581+(B) by inserting ‘‘or’’ after the semicolon; 12
582+and 13
583+(3) inserting after subparagraph (E) the fol-14
584+lowing: 15
585+‘‘(F) under section 27,’’. 16
586+SEC. 8. REPORT ON ADDITIONAL EXCLUSION. 17
1132587 (1) I
1133-N GENERAL.—Not later than 1 year after 12
1134-the date of enactment of this Act, the Federal Trade 13
1135-Commission shall submit to the Committee on the Ju-14
1136-diciary of the Senate and the Committee on the Judi-15
1137-ciary of the House of Representatives a recommenda-16
1138-tion, and the Commission’s basis for such rec-17
1139-ommendation, regarding a potential amendment to 18
1140-include in section 27(b) of the Federal Trade Com-19
1141-mission Act (as added by section 3) an additional ex-20
1142-clusion for consideration granted by an NDA holder 21
1143-to a ANDA filer or by a biological product license 22
1144-holder to a biosimilar biological product application 23
1145-filer as part of the resolution or settlement, a release, 24
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1148-•S 1096 RS
1149-waiver, or limitation of a claim for damages or other 1
1150-monetary relief. 2
588+N GENERAL.—Not later than 1 year after 18
589+the date of enactment of this Act, the Federal Trade 19
590+Commission shall submit to the Committee on the 20
591+Judiciary of the Senate and the Committee on the 21
592+Judiciary of the House of Representatives a rec-22
593+ommendation, and the Commission’s basis for such 23
594+recommendation, regarding a potential amendment 24
595+to include in section 27(b) of the Federal Trade 25
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597+ssavage on LAPJG3WLY3PROD with BILLS 21
598+•S 1096 IS
599+Commission Act (as added by section 3) an addi-1
600+tional exclusion for consideration granted by an 2
601+NDA holder to a ANDA filer or by a biological prod-3
602+uct license holder to a biosimilar biological product 4
603+application filer as part of the resolution or settle-5
604+ment, a release, waiver, or limitation of a claim for 6
605+damages or other monetary relief. 7
1151606 (2) D
1152-EFINITIONS.—In this section, the terms 3
1153-‘‘ANDA filer’’, ‘‘biological product license holder’’, 4
1154-‘‘biosimilar biological product application filer’’, and 5
1155-‘‘NDA holder’’ have the meanings given such terms in 6
1156-section 27(d) of the Federal Trade Commission Act 7
1157-(as added by section 3). 8
1158-SEC. 9. STATUTE OF LIMITATIONS. 9
1159-The Federal Trade Commission shall commence any 10
1160-enforcement proceeding described in section 27 of the Fed-11
1161-eral Trade Commission Act, as added by section 3, not later 12
1162-than 6 years after the date on which the parties to the agree-13
1163-ment file the certification under section 1112(d) of the 14
1164-Medicare Prescription Drug, Improvement, and Moderniza-15
1165-tion Act of 2003 (21 U.S.C. 355 note). 16
1166-SEC. 10. SEVERABILITY. 17
1167-If any provision of this Act, an amendment made by 18
1168-this Act, or the application of such provision or amendment 19
1169-to any person or circumstance is held to be unconstitu-20
1170-tional, the remainder of this Act, the amendments made by 21
1171-this Act, and the application of the provisions of such Act 22
1172-or amendments to any person or circumstance shall not be 23
1173-affected. 24
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1176-46
1177-119
1178-TH
1179-CONGRESS
1180-1
1181-ST
1182-S
1183-ESSION
1184-
1185-S. 1096 A BILL
1186-To prohibit brand name drug companies from com-
1187-pensating generic drug companies to delay the
1188-entry of a generic drug into the market, and to
1189-prohibit biological product manufacturers from
1190-compensating biosimilar and interchangeable
1191-companies to delay the entry of biosimilar bio-
1192-logical products and interchangeable biological
1193-products.
1194-A
1195-PRIL
1196-10, 2025
1197-Reported with an amendment
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607+EFINITIONS.—In this section, the terms 8
608+‘‘ANDA filer’’, ‘‘biological product license holder’’, 9
609+‘‘biosimilar biological product application filer’’, and 10
610+‘‘NDA holder’’ have the meanings given such terms 11
611+in section 27(d) of the Federal Trade Commission 12
612+Act (as added by section 3). 13
613+SEC. 9. STATUTE OF LIMITATIONS. 14
614+The Federal Trade Commission shall commence any 15
615+enforcement proceeding described in section 27 of the 16
616+Federal Trade Commission Act, as added by section 3, not 17
617+later than 6 years after the date on which the parties to 18
618+the agreement file the certification under section 1112(d) 19
619+of the Medicare Prescription Drug Improvement and Mod-20
620+ernization Act of 2003 (21 U.S.C. 355 note). 21
621+SEC. 10. SEVERABILITY. 22
622+If any provision of this Act, an amendment made by 23
623+this Act, or the application of such provision or amend-24
624+ment to any person or circumstance is held to be unconsti-25
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627+•S 1096 IS
628+tutional, the remainder of this Act, the amendments made 1
629+by this Act, and the application of the provisions of such 2
630+Act or amendments to any person or circumstance shall 3
631+not be affected. 4
632+Æ
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