II
Calendar No. 46
119THCONGRESS
1
STSESSION S. 1096
To prohibit brand name drug companies from compensating generic drug
companies to delay the entry of a generic drug into the market, and
to prohibit biological product manufacturers from compensating bio-
similar and interchangeable companies to delay the entry of biosimilar
biological products and interchangeable biological products.
IN THE SENATE OF THE UNITED STATES
MARCH24, 2025
Ms. K
LOBUCHAR(for herself, Mr. GRASSLEY, Mr. DURBIN, Mr. CRAMER, Mr.
B
LUMENTHAL, Ms. ERNST, Mr. WELCH, Mr. KELLY, and Mr. BOOKER)
introduced the following bill; which was read twice and referred to the
Committee on the Judiciary
A
PRIL10, 2025
Reported by Mr. G
RASSLEY, with an amendment
[Strike out all after the enacting clause and insert the part printed in italic]
A BILL
To prohibit brand name drug companies from compensating
generic drug companies to delay the entry of a generic
drug into the market, and to prohibit biological product
manufacturers from compensating biosimilar and inter-
changeable companies to delay the entry of biosimilar
biological products and interchangeable biological prod-
ucts.
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6652 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 2
•S 1096 RS
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION1.SHORTTITLE. 3
ThisActmaybecitedasthe‘‘PreserveAccesstoAf-4
fordableGenericsandBiosimilarsAct’’. 5
SEC.2.CONGRESSIONAL FINDINGS ANDDECLARATION OF 6
PURPOSES. 7
(a)FINDINGS.—Congressfindsthefollowing: 8
(1)In1984,theDrugPriceCompetitionand 9
PatentTermRestorationAct(PublicLaw98–417) 10
(referredtointhisActasthe‘‘1984Act’’),wasen-11
actedwiththeintentoffacilitatingtheearlyentry 12
ofgenericdrugswhilepreservingincentivesforinno-13
vation. 14
(2)Prescriptiondrugsmakeupapproximately 15
11percentofthenationalhealthcarespending. 16
(3)Initially,the1984Actwassuccessfulinfa-17
cilitatinggenericcompetitiontothebenefitofcon-18
sumersandhealthcarepayers.Although91percent 19
ofallprescriptionsdispensedintheUnitedStates 20
aregenericdrugs,theyaccountforonly18percent 21
ofallexpenditures. 22
(4)Genericdrugscostsubstantiallylessthan 23
brandnamedrugs,withdiscountsoffthebrand 24
priceaveraging80to85percent. 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 3
•S 1096 RS
(5)Federaldollarscurrentlyaccountforover 1
40percentofthe$449,700,000,000spentonretail 2
prescriptiondrugsannually. 3
(6)(A)Inrecentyears,theintentofthe1984 4
Acthasbeensubvertedbycertainsettlementagree-5
mentsinwhichbrandnamecompaniestransfer 6
valuetotheirpotentialgenericcompetitorstosettle 7
claimsthatthegenericcompanyisinfringingthe 8
brandedcompany’spatents. 9
(B)These‘‘reversepayment’’settlementagree-10
ments— 11
(i)allowabrandedcompanytoshareits 12
monopolyprofitswiththegenericcompanyasa 13
waytoprotectthebrandedcompany’smonop-14
oly;and 15
(ii)haveundulydelayedthemarketingof 16
low-costgenericdrugscontrarytofreecompeti-17
tion,theinterestsofconsumers,andtheprin-18
ciplesunderlyingantitrustlaw. 19
(C)Becauseofthepricedisparitybetween 20
brandnameandgenericdrugs,suchagreementsare 21
moreprofitableforboththebrandandgenericman-22
ufacturersthancompetitionandwillbecomeincreas-23
inglycommonunlessprohibited. 24
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 4
•S 1096 RS
(D)Theseagreementsresultinconsumerslos-1
ingthebenefitsthatthe1984Actwasintendedto 2
provide. 3
(7)In2010,theBiologicsPriceCompetition 4
andInnovationAct(PublicLaw111–148)(referred 5
tointhisActasthe‘‘BPCIA’’),wasenactedwith 6
theintentoffacilitatingtheearlyentryofbiosimilar 7
andinterchangeablefollow-onversionsofbranded 8
biologicalproductswhilepreservingincentivesforin-9
novation. 10
(8)Biologicaldrugsplayanimportantrolein 11
treatingmanyseriousillnesses,fromcancerstoge-12
neticdisorders.Theyarealsoexpensive,rep-13
resentingmorethanhalfofallprescriptiondrug 14
spending. 15
(9)Competitionfrombiosimilarandinter-16
changeablebiologicalproductspromisestolower 17
drugcostsandincreasepatientaccesstobiological 18
medicines.But‘‘reversepayment’’settlementagree-19
mentsalsothreatentodelaytheentryofbiosimilar 20
andinterchangeablebiologicalproducts,whichwould 21
underminethegoalsofBPCIA. 22
(b)PURPOSES.—ThepurposesofthisActare— 23
(1)toenhancecompetitioninthepharma-24
ceuticalmarketbystoppinganticompetitiveagree-25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 5
•S 1096 RS
mentsbetweenbrandnameandgenericdrugand 1
biosimilarbiologicalproductmanufacturersthat 2
limit,delay,orotherwisepreventcompetitionfrom 3
genericdrugsandbiosimilarbiologicalproducts;and 4
(2)tosupportthepurposeandintentofanti-5
trustlawbyprohibitinganticompetitivepracticesin 6
thepharmaceuticalindustrythatharmconsumers. 7
SEC.3.UNLAWFUL COMPENSATION FORDELAY. 8
(a)INGENERAL.—TheFederalTradeCommission 9
Act(15U.S.C.44etseq.)isamendedbyinsertingafter 10
section26(15U.S.C.57c–2)thefollowing: 11
‘‘SEC.27.PRESERVING ACCESSTOAFFORDABLE GENERICS 12
ANDBIOSIMILARS. 13
‘‘(a)PROHIBITION.— 14
‘‘(1)INGENERAL.—Itshallbeaviolationof 15
thissectionforapartytoenterinto,orbeapartici-16
pantto,anagreement,resolvingorsettling,ona 17
finalorinterimbasis,apatentclaiminconnection 18
withthesaleofadrugproductorbiologicalproduct, 19
thathasanticompetitiveeffects. 20
‘‘(2)TREATMENT.—Aviolationofthissection 21
shallbetreatedasanunfairmethodofcompetition 22
inviolationofsection5(a)(1). 23
‘‘(3)PRESUMPTION.— 24
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 6
•S 1096 RS
‘‘(A)INGENERAL.—Subjecttosubpara-1
graph(B),anagreementdescribedinpara-2
graph(1)shallbepresumedtohaveanti-3
competitiveeffectsforpurposesofsuchpara-4
graphif— 5
‘‘(i)anANDAfilerorabiosimilarbi-6
ologicalproductapplicationfilerreceives 7
anythingofvalue,includinganexclusiveli-8
cense;and 9
‘‘(ii)theANDAfilerorbiosimilarbio-10
logicalproductapplicationfileragreesto 11
limitorforgoresearch,development,man-12
ufacturing,marketing,orsalesofthe 13
ANDAproductorbiosimilarbiological 14
product,asapplicable,foranyperiodof 15
time. 16
‘‘(B)EXCEPTION.—Subparagraph(A) 17
shallnotapplyifthepartiestosuchagreement 18
demonstratebyapreponderanceoftheevidence 19
that— 20
‘‘(i)thevaluedescribedinsubpara-21
graph(A)(i)iscompensationsolelyfor 22
othergoodsorservicesthattheANDA 23
filerorbiosimilarbiologicalproductappli-24
cationfilerhaspromisedtoprovide;or 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 7
•S 1096 RS
‘‘(ii)theprocompetitivebenefitsofthe 1
transferofvaluedescribedinsubpara-2
graph(A)(i)andtheagreementbythe 3
ANDAfilerorbiosimilarbiologicalproduct 4
applicationfilertolimitorforgoresearch, 5
development,manufacturing,marketing,or 6
salesoftheANDAproductorbiosimilar 7
biologicalproductdescribedinsubpara-8
graph(A)(ii)outweightheanticompetitive 9
effectsofthetransferofvaluedescribedin 10
subparagraph(A)(i)andtheagreementby 11
theANDAfilerorbiosimilarbiological 12
productapplicationfilertolimitorforgo 13
research,development,manufacturing, 14
marketing,orsalesoftheANDAproduct 15
orbiosimilarbiologicalproductdescribed 16
insubparagraph(A)(ii). 17
‘‘(4)CIVILACTION.—Inadditiontoanypro-18
ceedingundersection5,iftheCommissionhasrea-19
sontobelievethatapartyhasviolatedthissection, 20
theCommissionmaybring,initsownnamebyany 21
ofitsattorneysdesignatedbyitforsuchpurpose,a 22
civilactionagainstthepartyinadistrictcourtof 23
theUnitedStatestoseektorecoveranyoftherem-24
ediesofcivilpenalty,mandatoryinjunctions,and 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 8
•S 1096 RS
suchotherandfurtherequitablereliefasthecourt 1
deemsappropriate. 2
‘‘(5)CIVILPENALTY.— 3
‘‘(A)INGENERAL.—Eachpartythatvio-4
latesorassistsintheviolationofparagraph(1) 5
shallforfeitandpaytotheUnitedStatesacivil 6
penaltysufficienttodeterviolationsofpara-7
graph(1),butinnoeventgreaterthan3times 8
thevaluereceivedbythepartythatisreason-9
ablyattributabletotheviolationofparagraph 10
(1).Ifnosuchvaluehasbeenreceivedbythe 11
NDAholder,thebiologicalproductlicensehold-12
er,theANDAfiler,orthebiosimilarbiological 13
productapplicationfiler,thepenaltytothe 14
NDAholder,thebiologicalproductlicensehold-15
er,theANDAfiler,orthebiosimilarbiological 16
productapplicationfilershallbesufficientto 17
deterviolations,butinnoeventshallbegreater 18
than3timesthevaluegiventoanANDAfiler 19
orbiosimilarbiologicalproductapplicationfiler 20
reasonablyattributabletotheviolationofthis 21
section. 22
‘‘(B)AMOUNT.—Indeterminingthe 23
amountofthecivilpenaltydescribedinsub-24
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 9
•S 1096 RS
paragraph(A),thecourtshalltakeintoac-1
count— 2
‘‘(i)thenature,circumstances,extent, 3
andgravityoftheviolation; 4
‘‘(ii)withrespecttotheviolator,the 5
degreeofculpability,anyhistoryofprior 6
suchconduct,includingotheragreements 7
resolvingorsettlingapatentinfringement 8
claim,theabilitytopay,anyeffectonthe 9
abilitytocontinuedoingbusiness,profits 10
earnedbytheNDAholder,thebiological 11
productlicenseholder,theANDAfiler,or 12
thebiosimilarbiologicalproductapplica-13
tionfiler,compensationreceivedbythe 14
ANDAfilerorbiosimilarbiologicalproduct 15
applicationfiler,andtheamountofcom-16
merceaffected;and 17
‘‘(iii)othermattersthatjusticere-18
quires. 19
‘‘(C)REMEDIESINADDITION.—Remedies 20
providedinthisparagraphareinadditionto, 21
andnotinlieuof,anyotherremedyprovided 22
byFederallaw.Nothinginthissectionshallbe 23
construedtolimitanyauthorityoftheCommis-24
sionunderanyotherprovisionoflaw. 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 10
•S 1096 RS
‘‘(b)EXCLUSIONS.—Nothinginthissectionshallpro-1
hibitaresolutionorsettlementofapatentinfringement 2
claiminwhichtheconsiderationthattheANDAfileror 3
biosimilarbiologicalproductapplicationfiler,respectively, 4
receivesaspartoftheresolutionorsettlementincludes 5
onlyoneormoreofthefollowing: 6
‘‘(1)Therighttomarketandsecurefinalap-7
provalintheUnitedStatesfortheANDAproduct 8
orbiosimilarbiologicalproductatadate,whether 9
certainorcontingent,priortotheexpirationof— 10
‘‘(A)anypatentthatisthebasisforthe 11
patentinfringementclaim;or 12
‘‘(B)anypatentrightorotherstatutory 13
exclusivitythatwouldpreventthemarketingof 14
suchANDAproductorbiosimilarbiological 15
product. 16
‘‘(2)Apaymentforreasonablelitigationex-17
pensesnottoexceed— 18
‘‘(A)forcalendaryear2025,$7,500,000; 19
or 20
‘‘(B)forcalendaryear2026andeachsub-21
sequentcalendaryear,theamountdetermined 22
fortheprecedingcalendaryearadjustedtore-23
flectthepercentageincrease(ifany)inthe 24
ProducerPriceIndexforLegalServicespub-25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 11
•S 1096 RS
lishedbytheBureauofLaborStatisticsofthe 1
DepartmentofLaborforthemostrecentcal-2
endaryear. 3
‘‘(3)Acovenantnottosueonanyclaimthat 4
theANDAproductorbiosimilarbiologicalproduct 5
infringesaUnitedStatespatent. 6
‘‘(c)ANTITRUSTLAWS.—Excepttotheextentthis 7
sectionestablishesanadditionalbasisofliability,nothing 8
inthissectionshallmodify,impair,limit,orsupersedethe 9
applicabilityoftheantitrustlawsasdefinedinsubsection 10
(a)ofthefirstsectionoftheClaytonAct(15U.S.C. 11
12(a)),andofsection5ofthisActtotheextentthatsec-12
tion5appliestounfairmethodsofcompetition.Nothing 13
inthissectionshallmodify,impair,limit,orsupersedethe 14
rightofanANDAfilerorbiosimilarbiologicalproduct 15
applicationfilertoassertclaimsorcounterclaimsagainst 16
anyperson,undertheantitrustlawsorotherlawsrelating 17
tounfaircompetition. 18
‘‘(d)DEFINITIONS.—Inthissection: 19
‘‘(1)AGREEMENT.—Theterm‘agreement’ 20
meansanythingthatwouldconstituteanagreement 21
undersection1oftheShermanAct(15U.S.C.1) 22
orsection5ofthisAct. 23
‘‘(2)AGREEMENT RESOLVINGORSETTLINGA 24
PATENTINFRINGEMENT CLAIM.—Theterm‘agree-25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 12
•S 1096 RS
mentresolvingorsettlingapatentinfringement 1
claim’includesanyagreementthatisenteredinto 2
within30daysoftheresolutionorthesettlementof 3
theclaim,oranyotheragreementthatiscontingent 4
upon,providesacontingentconditionfor,orisoth-5
erwiserelatedtotheresolutionorsettlementofthe 6
claim. 7
‘‘(3)ANDA.—Theterm‘ANDA’meansanab-8
breviatednewdrugapplicationfiledundersection 9
505(j)oftheFederalFood,Drug,andCosmeticAct 10
(21U.S.C.355(j))oranewdrugapplicationsub-11
mittedpursuanttosection505(b)(2)oftheFederal 12
Food,Drug,andCosmeticAct(21U.S.C. 13
355(b)(2)). 14
‘‘(4)ANDAFILER.—Theterm‘ANDAfiler’ 15
meansapartythatownsorcontrolsanANDAfiled 16
withtheSecretaryofHealthandHumanServicesor 17
hastheexclusiverightsundersuchANDAtodis-18
tributetheANDAproduct. 19
‘‘(5)ANDA PRODUCT.—Theterm‘ANDA 20
product’meanstheproducttobemanufactured 21
undertheANDAthatisthesubjectofthepatent 22
infringementclaim. 23
‘‘(6)BIOLOGICALPRODUCT.—Theterm‘bio-24
logicalproduct’hasthemeaninggivensuchtermin 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 13
•S 1096 RS
section351(i)(1)ofthePublicHealthServiceAct 1
(42U.S.C.262(i)(1)). 2
‘‘(7)BIOLOGICALPRODUCTLICENSEAPPLICA-3
TION.—Theterm‘biologicalproductlicenseapplica-4
tion’meansanapplicationundersection351(a)of 5
thePublicHealthServiceAct(42U.S.C.262(a)). 6
‘‘(8)BIOLOGICALPRODUCT LICENSEHOLD-7
ER.—Theterm‘biologicalproductlicenseholder’ 8
means— 9
‘‘(A)theholderofanapprovedbiological 10
productlicenseapplicationforabiologicalprod-11
uct; 12
‘‘(B)apersonowningorcontrollingen-13
forcementofanypatentsthatclaimthebiologi-14
calproductthatisthesubjectofsuchapproved 15
application;or 16
‘‘(C)thepredecessors,subsidiaries,divi-17
sions,groups,andaffiliatescontrolledby,con-18
trolling,orundercommoncontrolwithanyof 19
theentitiesdescribedinsubparagraphs(A)and 20
(B)(suchcontroltobepresumedbydirector 21
indirectshareownershipof50percentorgreat-22
er),aswellasthelicensees,licensors,succes-23
sors,andassignsofeachoftheentities. 24
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 14
•S 1096 RS
‘‘(9)BIOSIMILARBIOLOGICALPRODUCT.—The 1
term‘biosimilarbiologicalproduct’meanstheprod-2
ucttobemanufacturedunderthebiosimilarbiologi-3
calproductapplicationthatisthesubjectofthepat-4
entinfringementclaim. 5
‘‘(10)BIOSIMILARBIOLOGICALPRODUCTAPPLI-6
CATION.—Theterm‘biosimilarbiologicalproductap-7
plication’meansanapplicationundersection351(k) 8
ofthePublicHealthServiceAct(42U.S.C.262(k)) 9
forlicensureofabiologicalproductasbiosimilarto, 10
orinterchangeablewith,areferenceproduct. 11
‘‘(11)BIOSIMILARBIOLOGICALPRODUCTAPPLI-12
CATIONFILER.—Theterm‘biosimilarbiological 13
productapplicationfiler’meansapartythatownsor 14
controlsabiosimilarbiologicalproductapplication 15
filedwiththeSecretaryofHealthandHumanServ-16
icesorhastheexclusiverightsundersuchapplica-17
tiontodistributethebiosimilarbiologicalproduct. 18
‘‘(12)DRUGPRODUCT.—Theterm‘drugprod-19
uct’hasthemeaninggivensuchterminsection 20
314.3(b)oftitle21,CodeofFederalRegulations(or 21
anysuccessorregulation). 22
‘‘(13)MARKET.—Theterm‘market’meansthe 23
promotion,offeringforsale,selling,ordistribution 24
ofadrugproduct. 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 15
•S 1096 RS
‘‘(14)NDA.—Theterm‘NDA’meansanew 1
drugapplicationfiledundersection505(b)ofthe 2
FederalFood,Drug,andCosmeticAct(21U.S.C. 3
355(b)). 4
‘‘(15)NDAHOLDER.—Theterm‘NDAholder’ 5
means— 6
‘‘(A)theholderofanapprovedNDAappli-7
cationforadrugproduct; 8
‘‘(B)apersonowningorcontrollingen-9
forcementofthepatentlistedintheApproved 10
DrugProductsWithTherapeuticEquivalence 11
Evaluations(commonlyknownasthe‘FDAOr-12
angeBook’)inconnectionwiththeNDA;or 13
‘‘(C)thepredecessors,subsidiaries,divi-14
sions,groups,andaffiliatescontrolledby,con-15
trolling,orundercommoncontrolwithanyof 16
theentitiesdescribedinsubparagraphs(A)and 17
(B)(suchcontroltobepresumedbydirector 18
indirectshareownershipof50percentorgreat-19
er),aswellasthelicensees,licensors,succes-20
sors,andassignsofeachoftheentities. 21
‘‘(16)PARTY.—Theterm‘party’meansany 22
person,partnership,corporation,orotherlegalenti-23
ty. 24
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 16
•S 1096 RS
‘‘(17)PATENT INFRINGEMENT.—Theterm 1
‘patentinfringement’meansinfringementofany 2
patentorofanyfiledpatentapplication,including 3
anyextension,reissue,renewal,division,continu-4
ation,continuationinpart,reexamination,patent 5
termrestoration,patentsofaddition,andextensions 6
thereof. 7
‘‘(18)PATENTINFRINGEMENT CLAIM.—The 8
term‘patentinfringementclaim’meansanyallega-9
tionmadetoanANDAfilerorbiosimilarbiological 10
productapplicationfiler,whetherornotincludedin 11
acomplaintfiledwithacourtoflaw,thatitsANDA 12
orANDAproduct,orbiosimilarbiologicalproduct 13
applicationorbiosimilarbiologicalproduct,mayin-14
fringeanypatentheldby,orexclusivelylicensedto, 15
theNDAholderorbiologicalproductlicenseholder 16
ofthedrugproductorbiologicalproduct,asapplica-17
ble. 18
‘‘(19)STATUTORY EXCLUSIVITY.—Theterm 19
‘statutoryexclusivity’meansthoseprohibitionson 20
thesubmissionortheapprovalofdrugapplications 21
underclauses(ii)through(iv)ofsection 22
505(c)(3)(E),clauses(ii)through(iv)ofsection 23
505(j)(5)(F),section527,section505A,orsection 24
505EoftheFederalFood,Drug,andCosmeticAct 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 17
•S 1096 RS
(21U.S.C.355(c)(3)(E),360cc,355a,355f),oron 1
thesubmissionorlicensingofbiologicalproductap-2
plicationsundersection351(k)(7)orparagraph(2) 3
or(3)ofsection351(m)ofthePublicHealthServ-4
iceAct(42U.S.C.262)orundersection527ofthe 5
FederalFood,Drug,andCosmeticAct(21U.S.C. 6
360cc).’’. 7
(b)EFFECTIVEDATE.—Section27oftheFederal 8
TradeCommissionAct,asaddedbythissection,shall 9
applytoallagreementsdescribedinsection27(a)(1)of 10
thatActenteredintoonorafterthedateofenactment 11
ofthisAct. 12
SEC.4.CERTIFICATION OFAGREEMENTS. 13
(a)NOTICEOFALLAGREEMENTS.—Section1111(7) 14
oftheMedicarePrescriptionDrug,Improvement,and 15
ModernizationActof2003(21U.S.C.355note)is 16
amendedbyinserting‘‘,ortheownerofapatentforwhich 17
aclaimofinfringementcouldreasonablybeasserted 18
againstanypersonformaking,using,offeringtosell,sell-19
ing,orimportingintotheUnitedStatesabiologicalprod-20
uctthatisthesubjectofabiosimilarbiologicalproduct 21
application’’beforetheperiodattheend. 22
(b)CERTIFICATIONOFAGREEMENTS.—Section1112 23
oftheMedicarePrescriptionDrug,Improvement,and 24
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 18
•S 1096 RS
ModernizationActof2003(21U.S.C.355note)is 1
amendedbyaddingattheendthefollowing: 2
‘‘(d)CERTIFICATION.—TheChiefExecutiveOfficer 3
orthecompanyofficialresponsiblefornegotiatingany 4
agreementundersubsection(a)or(b)thatisrequiredto 5
befiledundersubsection(c),within30daysaftersuch 6
filing,shallexecuteandfilewiththeAssistantAttorney 7
GeneralandtheCommissionacertificationasfollows:‘I 8
declarethatthefollowingistrue,correct,andcomplete 9
tothebestofmyknowledge:Thematerialsfiledwiththe 10
FederalTradeCommissionandtheDepartmentofJustice 11
undersection1112ofsubtitleBoftitleXIoftheMedi-12
carePrescriptionDrug,Improvement,andModernization 13
Actof2003,withrespecttotheagreementreferencedin 14
thiscertification— 15
‘‘(1)representthecomplete,final,andexclusive 16
agreementbetweentheparties; 17
‘‘(2)includeanyancillaryagreementsthatare 18
contingentupon,provideacontingentconditionfor, 19
orareotherwiserelatedto,thereferencedagree-20
ment;and 21
‘‘(3)includewrittendescriptionsofanyoral 22
agreements,representations,commitments,orprom-23
isesbetweenthepartiesthatareresponsivetosub-24
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 19
•S 1096 RS
section(a)or(b)ofsuchsection1112andhavenot 1
beenreducedtowriting.’’’. 2
SEC.5.NOTIFICATION OFAGREEMENTS. 3
Section1112oftheMedicarePrescriptionDrug,Im-4
provement,andModernizationActof2003(21U.S.C. 5
355note),asamendedbysection4(b),isfurtheramended 6
byaddingattheendthefollowing: 7
‘‘(e)RULEOFCONSTRUCTION.— 8
‘‘(1)INGENERAL.—Anagreementthatisre-9
quiredundersubsection(a)or(b)shallinclude 10
agreementsresolvinganyoutstandingdisputes,in-11
cludingagreementsresolvingorsettlingaPatent 12
TrialandAppealBoardproceeding. 13
‘‘(2)DEFINITION.—Forpurposesofsubpara-14
graph(A),theterm‘PatentTrialandAppealBoard 15
proceeding’meansaproceedingconductedbythe 16
PatentTrialandAppealBoardoftheUnitedStates 17
PatentandTrademarkOffice,includinganinter 18
partesreviewinstitutedunderchapter31oftitle35, 19
UnitedStatesCode,apost-grantreviewinstituted 20
underchapter32ofthattitle(includingapro-21
ceedinginstitutedpursuanttothetransitionalpro-22
gramforcoveredbusinessmethodpatents,asde-23
scribedinsection18oftheLeahy-SmithAmerica 24
InventsAct(35U.S.C.321note)),andaderivation 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 20
•S 1096 RS
proceedinginstitutedundersection135ofthat 1
title.’’. 2
SEC.6.FORFEITURE OF180-DAYEXCLUSIVITY PERIOD. 3
Section505(j)(5)(D)(i)(V)oftheFederalFood, 4
Drug,andCosmeticAct(21U.S.C.355(j)(5)(D)(i)(V)) 5
isamendedbyinserting‘‘section27oftheFederalTrade 6
CommissionActor’’after‘‘thattheagreementhasvio-7
lated’’. 8
SEC.7.COMMISSION LITIGATION AUTHORITY. 9
Section16(a)(2)oftheFederalTradeCommission 10
Act(15U.S.C.56(a)(2))isamended— 11
(1)insubparagraph(D),bystriking‘‘or’’after 12
thesemicolon; 13
(2)insubparagraph(E)— 14
(A)bymovingthemargin2emstothe 15
left;and 16
(B)byinserting‘‘or’’afterthesemicolon; 17
and 18
(3)insertingaftersubparagraph(E)thefol-19
lowing: 20
‘‘(F)undersection27,’’. 21
SEC.8.REPORT ONADDITIONAL EXCLUSION. 22
(1)INGENERAL.—Notlaterthan1yearafter 23
thedateofenactmentofthisAct,theFederalTrade 24
CommissionshallsubmittotheCommitteeonthe 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 21
•S 1096 RS
JudiciaryoftheSenateandtheCommitteeonthe 1
JudiciaryoftheHouseofRepresentativesarec-2
ommendation,andtheCommission’sbasisforsuch 3
recommendation,regardingapotentialamendment 4
toincludeinsection27(b)oftheFederalTrade 5
CommissionAct(asaddedbysection3)anaddi-6
tionalexclusionforconsiderationgrantedbyan 7
NDAholdertoaANDAfilerorbyabiologicalprod-8
uctlicenseholdertoabiosimilarbiologicalproduct 9
applicationfileraspartoftheresolutionorsettle-10
ment,arelease,waiver,orlimitationofaclaimfor 11
damagesorothermonetaryrelief. 12
(2)DEFINITIONS.—Inthissection,theterms 13
‘‘ANDAfiler’’,‘‘biologicalproductlicenseholder’’, 14
‘‘biosimilarbiologicalproductapplicationfiler’’,and 15
‘‘NDAholder’’havethemeaningsgivensuchterms 16
insection27(d)oftheFederalTradeCommission 17
Act(asaddedbysection3). 18
SEC.9.STATUTE OFLIMITATIONS. 19
TheFederalTradeCommissionshallcommenceany 20
enforcementproceedingdescribedinsection27ofthe 21
FederalTradeCommissionAct,asaddedbysection3,not 22
laterthan6yearsafterthedateonwhichthepartiesto 23
theagreementfilethecertificationundersection1112(d) 24
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6401 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 22
•S 1096 RS
oftheMedicarePrescriptionDrugImprovementandMod-1
ernizationActof2003(21U.S.C.355note). 2
SEC.10.SEVERABILITY. 3
IfanyprovisionofthisAct,anamendmentmadeby 4
thisAct,ortheapplicationofsuchprovisionoramend-5
menttoanypersonorcircumstanceisheldtobeunconsti-6
tutional,theremainderofthisAct,theamendmentsmade 7
bythisAct,andtheapplicationoftheprovisionsofsuch 8
Actoramendmentstoanypersonorcircumstanceshall 9
notbeaffected. 10
SECTION 1. SHORT TITLE. 11
This Act may be cited as the ‘‘Preserve Access to Af-12
fordable Generics and Biosimilars Act’’. 13
SEC. 2. CONGRESSIONAL FINDINGS AND DECLARATION OF 14
PURPOSES. 15
(a) F
INDINGS.—Congress finds the following: 16
(1) In 1984, the Drug Price Competition and 17
Patent Term Restoration Act of 1984 (Public Law 18
98–417) (referred to in this Act as the ‘‘1984 Act’’), 19
was enacted with the intent of facilitating the early 20
entry of generic drugs while preserving incentives for 21
innovation. 22
(2) Prescription drugs make up approximately 23
11 percent of the national health care spending. 24
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 23
•S 1096 RS
(3) Initially, the 1984 Act was successful in fa-1
cilitating generic competition to the benefit of con-2
sumers and health care payers. Although 91 percent 3
of all prescriptions dispensed in the United States are 4
generic drugs, they account for only 18 percent of all 5
expenditures. 6
(4) Generic drugs cost substantially less than 7
brand name drugs, with discounts off the brand price 8
averaging 80 to 85 percent. 9
(5) Federal dollars currently account for over 40 10
percent of the $449,700,000,000 spent on retail pre-11
scription drugs annually. 12
(6)(A) In recent years, the intent of the 1984 Act 13
has been subverted by certain settlement agreements 14
in which brand name companies transfer value to 15
their potential generic competitors to settle claims 16
that the generic company is infringing the branded 17
company’s patents. 18
(B) These ‘‘reverse payment’’ settlement agree-19
ments— 20
(i) allow a branded company to share its 21
monopoly profits with the generic company as a 22
way to protect the branded company’s monopoly; 23
and 24
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 24
•S 1096 RS
(ii) have unduly delayed the marketing of 1
low-cost generic drugs contrary to free competi-2
tion, the interests of consumers, and the prin-3
ciples underlying antitrust law. 4
(C) Because of the price disparity between brand 5
name and generic drugs, such agreements are more 6
profitable for both the brand and generic manufactur-7
ers than competition and will become increasingly 8
common unless prohibited. 9
(D) These agreements result in consumers losing 10
the benefits that the 1984 Act was intended to pro-11
vide. 12
(7) In 2010, the Biologics Price Competition and 13
Innovation Act of 2009 (Public Law 111–148) (re-14
ferred to in this Act as the ‘‘BPCIA’’), was enacted 15
with the intent of facilitating the early entry of bio-16
similar and interchangeable follow-on versions of 17
branded biological products while preserving incen-18
tives for innovation. 19
(8) Biological drugs play an important role in 20
treating many serious illnesses, from cancers to ge-21
netic disorders. They are also expensive, representing 22
more than half of all prescription drug spending. 23
(9) Competition from biosimilar and inter-24
changeable biological products promises to lower drug 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 25
•S 1096 RS
costs and increase patient access to biological medi-1
cines. But ‘‘reverse payment’’ settlement agreements 2
also threaten to delay the entry of biosimilar and 3
interchangeable biological products, which would un-4
dermine the goals of the BPCIA. 5
(b) P
URPOSES.—The purposes of this Act are— 6
(1) to enhance competition in the pharma-7
ceutical market by stopping anticompetitive agree-8
ments between brand name and generic drug and bio-9
similar biological product manufacturers that limit, 10
delay, or otherwise prevent competition from generic 11
drugs and biosimilar biological products; and 12
(2) to support the purpose and intent of anti-13
trust law by prohibiting anticompetitive practices in 14
the pharmaceutical industry that harm consumers. 15
SEC. 3. UNLAWFUL COMPENSATION FOR DELAY. 16
(a) I
NGENERAL.—The Federal Trade Commission Act 17
(15 U.S.C. 41 et seq.) is amended by inserting after section 18
26 (15 U.S.C. 57c–2) the following: 19
‘‘SEC. 27. PRESERVING ACCESS TO AFFORDABLE GENERICS 20
AND BIOSIMILARS. 21
‘‘(a) P
ROHIBITION.— 22
‘‘(1) I
N GENERAL.—It shall be a violation of this 23
section for a party to enter into, or be a participant 24
to, an agreement, resolving or settling, on a final or 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 26
•S 1096 RS
interim basis, a patent claim in connection with the 1
sale of a drug product or biological product, that has 2
anticompetitive effects. 3
‘‘(2) T
REATMENT.—A violation of this section 4
shall be treated as an unfair method of competition 5
in violation of section 5(a)(1). 6
‘‘(3) P
RESUMPTION.— 7
‘‘(A) I
N GENERAL.—Subject to subpara-8
graph (B), an agreement described in paragraph 9
(1) shall be presumed to have anticompetitive ef-10
fects for purposes of such paragraph if— 11
‘‘(i) an ANDA filer or a biosimilar bi-12
ological product application filer receives 13
anything of value, including an exclusive li-14
cense; and 15
‘‘(ii) the ANDA filer or biosimilar bio-16
logical product application filer agrees to 17
limit or forgo research, development, manu-18
facturing, marketing, or sales of the ANDA 19
product or biosimilar biological product, as 20
applicable, for any period of time. 21
‘‘(B) E
XCEPTION.—Subparagraph (A) shall 22
not apply if the parties to such agreement dem-23
onstrate by a preponderance of the evidence 24
that— 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 27
•S 1096 RS
‘‘(i) the value described in subpara-1
graph (A)(i) is compensation solely for 2
other goods or services that the ANDA filer 3
or biosimilar biological product application 4
filer has promised to provide; or 5
‘‘(ii) the procompetitive benefits of the 6
transfer of value described in subparagraph 7
(A)(i) and the agreement by the ANDA filer 8
or biosimilar biological product application 9
filer to limit or forgo research, development, 10
manufacturing, marketing, or sales of the 11
ANDA product or biosimilar biological 12
product described in subparagraph (A)(ii) 13
outweigh the anticompetitive effects of the 14
transfer of value described in subparagraph 15
(A)(i) and the agreement by the ANDA filer 16
or biosimilar biological product application 17
filer to limit or forgo research, development, 18
manufacturing, marketing, or sales of the 19
ANDA product or biosimilar biological 20
product described in subparagraph (A)(ii). 21
‘‘(4) C
IVIL ACTION.—In addition to any pro-22
ceeding under section 5, if the Commission has reason 23
to believe that a party has violated this section, the 24
Commission may bring, in its own name by any of 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00027 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 28
•S 1096 RS
its attorneys designated by it for such purpose, a civil 1
action against the party in a district court of the 2
United States to seek to recover any of the remedies 3
of civil penalty, mandatory injunctions, and such 4
other and further equitable relief as the court deems 5
appropriate. 6
‘‘(5) C
IVIL PENALTY.— 7
‘‘(A) I
N GENERAL.—Each party that vio-8
lates or assists in the violation of paragraph (1) 9
shall forfeit and pay to the United States a civil 10
penalty sufficient to deter violations of para-11
graph (1), but in no event greater than 3 times 12
the value received by the party that is reasonably 13
attributable to the violation of paragraph (1). If 14
no such value has been received by the NDA 15
holder, the biological product license holder, the 16
ANDA filer, or the biosimilar biological product 17
application filer, the penalty to the NDA holder, 18
the biological product license holder, the ANDA 19
filer, or the biosimilar biological product appli-20
cation filer shall be sufficient to deter violations, 21
but in no event shall be greater than 3 times the 22
value given to an ANDA filer or biosimilar bio-23
logical product application filer reasonably at-24
tributable to the violation of this section. 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 29
•S 1096 RS
‘‘(B) AMOUNT.—In determining the amount 1
of the civil penalty described in subparagraph 2
(A), the court shall take into account— 3
‘‘(i) the nature, circumstances, extent, 4
and gravity of the violation; 5
‘‘(ii) with respect to the violator, the 6
degree of culpability, any history of prior 7
such conduct, including other agreements re-8
solving or settling a patent infringement 9
claim, the ability to pay, any effect on the 10
ability to continue doing business, profits 11
earned by the NDA holder, the biological 12
product license holder, the ANDA filer, or 13
the biosimilar biological product applica-14
tion filer, compensation received by the 15
ANDA filer or biosimilar biological product 16
application filer, and the amount of com-17
merce affected; and 18
‘‘(iii) other matters that justice re-19
quires. 20
‘‘(C) R
EMEDIES IN ADDITION .—Remedies 21
provided in this paragraph are in addition to, 22
and not in lieu of, any other remedy provided by 23
Federal law. Nothing in this section shall be con-24
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 30
•S 1096 RS
strued to limit any authority of the Commission 1
under any other provision of law. 2
‘‘(b) E
XCLUSIONS.—Nothing in this section shall pro-3
hibit a resolution or settlement of a patent infringement 4
claim in which the consideration that the ANDA filer or 5
biosimilar biological product application filer, respectively, 6
receives as part of the resolution or settlement includes only 7
one or more of the following: 8
‘‘(1) The right to market and secure final ap-9
proval in the United States for the ANDA product or 10
biosimilar biological product at a date, whether cer-11
tain or contingent, prior to the expiration of— 12
‘‘(A) any patent that is the basis for the 13
patent infringement claim; or 14
‘‘(B) any patent right or other statutory ex-15
clusivity that would prevent the marketing of 16
such ANDA product or biosimilar biological 17
product. 18
‘‘(2) A payment for reasonable litigation ex-19
penses not to exceed— 20
‘‘(A) for calendar year 2025, $7,500,000; or 21
‘‘(B) for calendar year 2026 and each subse-22
quent calendar year, the amount determined for 23
the preceding calendar year adjusted to reflect 24
the percentage increase (if any) in the Producer 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00030 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 31
•S 1096 RS
Price Index for Legal Services published by the 1
Bureau of Labor Statistics of the Department of 2
Labor for the most recent calendar year. 3
‘‘(3) A covenant not to sue on any claim that the 4
ANDA product or biosimilar biological product in-5
fringes a United States patent. 6
‘‘(c) A
NTITRUSTLAWS.—Except to the extent this sec-7
tion establishes an additional basis of liability, nothing in 8
this section shall modify, impair, limit, or supersede the 9
applicability of the antitrust laws as defined in subsection 10
(a) of the first section of the Clayton Act (15 U.S.C. 12(a)), 11
and of section 5 of this Act to the extent that section 5 ap-12
plies to unfair methods of competition. Nothing in this sec-13
tion shall modify, impair, limit, or supersede the right of 14
an ANDA filer or biosimilar biological product application 15
filer to assert claims or counterclaims against any person, 16
under the antitrust laws or other laws relating to unfair 17
competition. 18
‘‘(d) D
EFINITIONS.—In this section: 19
‘‘(1) A
GREEMENT.—The term ‘agreement’ means 20
anything that would constitute an agreement under 21
section 1 of the Sherman Act (15 U.S.C. 1) or section 22
5 of this Act. 23
‘‘(2) A
GREEMENT RESOLVING OR SETTLING A 24
PATENT INFRINGEMENT CLAIM .—The term ‘agreement 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00031 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 32
•S 1096 RS
resolving or settling a patent infringement claim’ in-1
cludes any agreement that is entered into within 30 2
days of the resolution or the settlement of the claim, 3
or any other agreement that is contingent upon, pro-4
vides a contingent condition for, or is otherwise re-5
lated to the resolution or settlement of the claim. 6
‘‘(3) ANDA.—The term ‘ANDA’ means an abbre-7
viated new drug application filed under section 505(j) 8
of the Federal Food, Drug, and Cosmetic Act (21 9
U.S.C. 355(j)) or a new drug application submitted 10
pursuant to section 505(b)(2) of the Federal Food, 11
Drug, and Cosmetic Act (21 U.S.C. 355(b)(2)). 12
‘‘(4) ANDA
FILER.—The term ‘ANDA filer’ 13
means a party that owns or controls an ANDA filed 14
with the Secretary of Health and Human Services or 15
has the exclusive rights under such ANDA to dis-16
tribute the ANDA product. 17
‘‘(5) ANDA
PRODUCT.—The term ‘ANDA prod-18
uct’ means the product to be manufactured under the 19
ANDA that is the subject of the patent infringement 20
claim. 21
‘‘(6) B
IOLOGICAL PRODUCT.—The term ‘biologi-22
cal product’ has the meaning given such term in sec-23
tion 351(i)(1) of the Public Health Service Act (42 24
U.S.C. 262(i)(1)). 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00032 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 33
•S 1096 RS
‘‘(7) BIOLOGICAL PRODUCT LICENSE APPLICA -1
TION.—The term ‘biological product license applica-2
tion’ means an application under section 351(a) of 3
the Public Health Service Act (42 U.S.C. 262(a)). 4
‘‘(8) B
IOLOGICAL PRODUCT LICENSE HOLDER .— 5
The term ‘biological product license holder’ means— 6
‘‘(A) the holder of an approved biological 7
product license application for a biological prod-8
uct; 9
‘‘(B) a person owning or controlling en-10
forcement of any patents that claim the biologi-11
cal product that is the subject of such approved 12
application; or 13
‘‘(C) the predecessors, subsidiaries, divi-14
sions, groups, and affiliates controlled by, con-15
trolling, or under common control with any of 16
the entities described in subparagraphs (A) and 17
(B) (such control to be presumed by direct or in-18
direct share ownership of 50 percent or greater), 19
as well as the licensees, licensors, successors, and 20
assigns of each of the entities. 21
‘‘(9) B
IOSIMILAR BIOLOGICAL PRODUCT .—The 22
term ‘biosimilar biological product’ means the prod-23
uct to be manufactured under the biosimilar biologi-24
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00033 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 34
•S 1096 RS
cal product application that is the subject of the pat-1
ent infringement claim. 2
‘‘(10) B
IOSIMILAR BIOLOGICAL PRODUCT APPLI -3
CATION.—The term ‘biosimilar biological product ap-4
plication’ means an application under section 351(k) 5
of the Public Health Service Act (42 U.S.C. 262(k)) 6
for licensure of a biological product as biosimilar to, 7
or interchangeable with, a reference product. 8
‘‘(11) B
IOSIMILAR BIOLOGICAL PRODUCT APPLI -9
CATION FILER.—The term ‘biosimilar biological prod-10
uct application filer’ means a party that owns or 11
controls a biosimilar biological product application 12
filed with the Secretary of Health and Human Serv-13
ices or has the exclusive rights under such application 14
to distribute the biosimilar biological product. 15
‘‘(12) D
RUG PRODUCT.—The term ‘drug product’ 16
has the meaning given such term in section 314.3(b) 17
of title 21, Code of Federal Regulations (or any suc-18
cessor regulation). 19
‘‘(13) M
ARKET.—The term ‘market’ means the 20
promotion, offering for sale, selling, or distribution of 21
a drug product. 22
‘‘(14) NDA.—The term ‘NDA’ means a new drug 23
application filed under section 505(b) of the Federal 24
Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)). 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00034 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 35
•S 1096 RS
‘‘(15) NDA HOLDER.—The term ‘NDA holder’ 1
means— 2
‘‘(A) the holder of an approved NDA appli-3
cation for a drug product; 4
‘‘(B) a person owning or controlling en-5
forcement of the patent listed in the Approved 6
Drug Products With Therapeutic Equivalence 7
Evaluations (commonly known as the ‘FDA Or-8
ange Book’) in connection with the NDA; or 9
‘‘(C) the predecessors, subsidiaries, divi-10
sions, groups, and affiliates controlled by, con-11
trolling, or under common control with any of 12
the entities described in subparagraphs (A) and 13
(B) (such control to be presumed by direct or in-14
direct share ownership of 50 percent or greater), 15
as well as the licensees, licensors, successors, and 16
assigns of each of the entities. 17
‘‘(16) P
ARTY.—The term ‘party’ means any per-18
son, partnership, corporation, or other legal entity. 19
‘‘(17) P
ATENT INFRINGEMENT.—The term ‘pat-20
ent infringement’ means infringement of any patent 21
or of any filed patent application, including any ex-22
tension, reissue, renewal, division, continuation, con-23
tinuation in part, reexamination, patent term res-24
toration, patents of addition, and extensions thereof. 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00035 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 36
•S 1096 RS
‘‘(18) PATENT INFRINGEMENT CLAIM .—The term 1
‘patent infringement claim’ means any allegation 2
made to an ANDA filer or biosimilar biological prod-3
uct application filer, whether or not included in a 4
complaint filed with a court of law, that its ANDA 5
or ANDA product, or biosimilar biological product 6
application or biosimilar biological product, may in-7
fringe any patent held by, or exclusively licensed to, 8
the NDA holder or biological product license holder of 9
the drug product or biological product, as applicable. 10
‘‘(19) S
TATUTORY EXCLUSIVITY.—The term ‘stat-11
utory exclusivity’ means those prohibitions on the 12
submission or the approval of drug applications 13
under clauses (ii) through (iv) of section 505(c)(3)(E), 14
clauses (ii) through (iv) of section 505(j)(5)(F), sec-15
tion 527, section 505A, or section 505E of the Federal 16
Food, Drug, and Cosmetic Act (21 U.S.C. 17
355(c)(3)(E), 355(j)(5)(F), 360cc, 355a, 355f), or on 18
the submission or licensing of biological product ap-19
plications under section 351(k)(7) or paragraph (2) 20
or (3) of section 351(m) of the Public Health Service 21
Act (42 U.S.C. 262) or under section 527 of the Fed-22
eral Food, Drug, and Cosmetic Act (21 U.S.C. 23
360cc).’’. 24
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00036 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 37
•S 1096 RS
(b) EFFECTIVEDATE.—Section 27 of the Federal 1
Trade Commission Act, as added by this section, shall 2
apply to all agreements described in section 27(a)(1) of that 3
Act entered into on or after the date of enactment of this 4
Act. 5
SEC. 4. CERTIFICATION OF AGREEMENTS. 6
(a) N
OTICE OFALLAGREEMENTS.—Section 1111(7) 7
of the Medicare Prescription Drug, Improvement, and Mod-8
ernization Act of 2003 (21 U.S.C. 355 note) is amended 9
by inserting ‘‘, or the owner of a patent for which a claim 10
of infringement could reasonably be asserted against any 11
person for making, using, offering to sell, selling, or import-12
ing into the United States a biological product that is the 13
subject of a biosimilar biological product application’’ be-14
fore the period at the end. 15
(b) C
ERTIFICATION OFAGREEMENTS.—Section 1112 16
of the Medicare Prescription Drug, Improvement, and Mod-17
ernization Act of 2003 (21 U.S.C. 355 note) is amended 18
by adding at the end the following: 19
‘‘(d) C
ERTIFICATION.—The Chief Executive Officer or 20
the company official responsible for negotiating any agree-21
ment under subsection (a) or (b) that is required to be filed 22
under subsection (c), within 30 days after such filing, shall 23
execute and file with the Assistant Attorney General and 24
the Commission a certification as follows: ‘I declare that 25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00037 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 38
•S 1096 RS
the following is true, correct, and complete to the best of 1
my knowledge: The materials filed with the Federal Trade 2
Commission and the Department of Justice under section 3
1112 of subtitle B of title XI of the Medicare Prescription 4
Drug, Improvement, and Modernization Act of 2003, with 5
respect to the agreement referenced in this certification— 6
‘‘(1) represent the complete, final, and exclusive 7
agreement between the parties; 8
‘‘(2) include any ancillary agreements that are 9
contingent upon, provide a contingent condition for, 10
or are otherwise related to, the referenced agreement; 11
and 12
‘‘(3) include written descriptions of any oral 13
agreements, representations, commitments, or prom-14
ises between the parties that are responsive to sub-15
section (a) or (b) of such section 1112 and have not 16
been reduced to writing.’’’. 17
SEC. 5. NOTIFICATION OF AGREEMENTS. 18
Section 1112 of the Medicare Prescription Drug, Im-19
provement, and Modernization Act of 2003 (21 U.S.C. 355 20
note), as amended by section 4(b), is further amended by 21
adding at the end the following: 22
‘‘(e) R
ULE OFCONSTRUCTION.— 23
‘‘(1) I
N GENERAL.—An agreement that is re-24
quired under subsection (a) or (b) shall include agree-25
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00038 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 39
•S 1096 RS
ments resolving any outstanding disputes, including 1
agreements resolving or settling a Patent Trial and 2
Appeal Board proceeding. 3
‘‘(2) D
EFINITION.—For purposes of subpara-4
graph (A), the term ‘Patent Trial and Appeal Board 5
proceeding’ means a proceeding conducted by the Pat-6
ent Trial and Appeal Board of the United States Pat-7
ent and Trademark Office, including an inter partes 8
review instituted under chapter 31 of title 35, United 9
States Code, a post-grant review instituted under 10
chapter 32 of that title (including a proceeding insti-11
tuted pursuant to the transitional program for cov-12
ered business method patents, as described in section 13
18 of the Leahy-Smith America Invents Act (35 14
U.S.C. 321 note)), and a derivation proceeding insti-15
tuted under section 135 of that title.’’. 16
SEC. 6. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD. 17
Section 505(j)(5)(D)(i)(V) of the Federal Food, Drug, 18
and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) is amend-19
ed by inserting ‘‘section 27 of the Federal Trade Commis-20
sion Act or’’ after ‘‘that the agreement has violated’’. 21
SEC. 7. COMMISSION LITIGATION AUTHORITY. 22
Section 16(a)(2) of the Federal Trade Commission Act 23
(15 U.S.C. 56(a)(2)) is amended— 24
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00039 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 40
•S 1096 RS
(1) in subparagraph (D), by striking ‘‘or’’ after 1
the semicolon; 2
(2) in subparagraph (E)— 3
(A) by moving the margin 2 ems to the left; 4
and 5
(B) by inserting ‘‘or’’ after the semicolon; 6
and 7
(3) by inserting after subparagraph (E) the fol-8
lowing: 9
‘‘(F) under section 27,’’. 10
SEC. 8. REPORT ON ADDITIONAL EXCLUSION. 11
(1) I
N GENERAL.—Not later than 1 year after 12
the date of enactment of this Act, the Federal Trade 13
Commission shall submit to the Committee on the Ju-14
diciary of the Senate and the Committee on the Judi-15
ciary of the House of Representatives a recommenda-16
tion, and the Commission’s basis for such rec-17
ommendation, regarding a potential amendment to 18
include in section 27(b) of the Federal Trade Com-19
mission Act (as added by section 3) an additional ex-20
clusion for consideration granted by an NDA holder 21
to a ANDA filer or by a biological product license 22
holder to a biosimilar biological product application 23
filer as part of the resolution or settlement, a release, 24
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00040 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS 41
•S 1096 RS
waiver, or limitation of a claim for damages or other 1
monetary relief. 2
(2) D
EFINITIONS.—In this section, the terms 3
‘‘ANDA filer’’, ‘‘biological product license holder’’, 4
‘‘biosimilar biological product application filer’’, and 5
‘‘NDA holder’’ have the meanings given such terms in 6
section 27(d) of the Federal Trade Commission Act 7
(as added by section 3). 8
SEC. 9. STATUTE OF LIMITATIONS. 9
The Federal Trade Commission shall commence any 10
enforcement proceeding described in section 27 of the Fed-11
eral Trade Commission Act, as added by section 3, not later 12
than 6 years after the date on which the parties to the agree-13
ment file the certification under section 1112(d) of the 14
Medicare Prescription Drug, Improvement, and Moderniza-15
tion Act of 2003 (21 U.S.C. 355 note). 16
SEC. 10. SEVERABILITY. 17
If any provision of this Act, an amendment made by 18
this Act, or the application of such provision or amendment 19
to any person or circumstance is held to be unconstitu-20
tional, the remainder of this Act, the amendments made by 21
this Act, and the application of the provisions of such Act 22
or amendments to any person or circumstance shall not be 23
affected. 24
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00041 Fmt 6652 Sfmt 6203 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS Calendar No.
46
119
TH
CONGRESS
1
ST
S
ESSION
S. 1096 A BILL
To prohibit brand name drug companies from com-
pensating generic drug companies to delay the
entry of a generic drug into the market, and to
prohibit biological product manufacturers from
compensating biosimilar and interchangeable
companies to delay the entry of biosimilar bio-
logical products and interchangeable biological
products.
A
PRIL
10, 2025
Reported with an amendment
VerDate Sep 11 2014 19:02 Apr 11, 2025 Jkt 059200 PO 00000 Frm 00042 Fmt 6651 Sfmt 6651 E:\BILLS\S1096.RS S1096
ssavage on LAPJG3WLY3PROD with BILLS