EU Law of Competition and Trade in the Pharmaceutical Sector

855 Pages·2019·6.982 MB·English

by  Pablo Figueroa (editor), Alejandro Guerrero (editor)

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EU LAW OF COMPETITION AND TRADE IN
THE PHARMACEUTICAL SECTOR
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ELGAR COMPETITION LAW AND PRACTICE
SeriesEditors:AidanRobertsonQC,BrickCourtChambers,London,UKandElizabeth
Morony,Partner,CliffordChanceLLP,London,UK
TheElgarCompetitionLawandPracticeseries,isalibraryofworksbyleadingpractitioners,
competitionofficialsandscholarscoveringdiscreteareasofsubstantivelawandprocedurein
thefieldofcompetitionandantitrust.Eachtitleisbothanalyticalanddescriptivein
approach,highlightingandunpickingthelegal(andeconomic)issuesthataremostcritical
andrelevanttopractice.Designedtobedetailed,focusedreferenceworks,thebooksinthis
seriesofferanin-depthtreatmentandanauthoritativestatementonthelaw,economicsand
practiceinkeytopicswithinthefield,fromVerticalAgreementstoAntitrustDamages,from
CompetitionandIPtoCompetitioninEnergyMarkets,andfromLeniencyandFinestoArticle
101andArticle102.
Presentedinaformatthatallowsforeaseofnavigationtoaparticularpointoflaw,each
titleintheseriesiswrittenbyspecialistsintheirrespectivefields,oftenwithinsighteither
fromprivatepracticeorfromanenforcementperspective.
Underthedirectionandserieseditorshipoftwoleadingfiguresincompetitionlaw
practice,theElgarCompetitionLawandPracticeserieswillbeaforumforthehighestquality
workincompetitionlaw,andwillformanimportantreferencelibraryforallpracticingin
thefield.
Titlesintheseriesinclude:
CompetitionDamagesActionsintheEU
LawandPractice
DavidAshtonandDavidHenry
Evidence,ProofandJudicialReviewinEUCompetitionLaw
FernandoCastillodelaTorreandEricGippiniFournier
CompetitionDamagesActionsintheEU
LawandPractice,SecondEdition
DavidAshton
EULawofCompetitionandTradeinthePharmaceuticalSector
EditedbyPabloFigueroaandAlejandroGuerrero
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EU LAW OF COMPETITION
AND TRADE IN THE
PHARMACEUTICAL
SECTOR
Editedby
PABLO FIGUEROA
GarridoAbogados,SpainandQueenMaryUniversity,London,UK
ALEJANDRO GUERRERO
Gibson,Dunn&CrutcherLLP,Belgium
ELGAR COMPETITION LAW AND PRACTICE
Cheltenham, UK + Northampton, MA, USA
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©TheEditorsandContributorsSeverally2019
Allrightsreserved.Nopartofthispublicationmaybereproduced,storedinaretrievalsystemor
transmittedinanyformorbyanymeans,electronic,mechanicalorphotocopying,recording,or
otherwisewithoutthepriorpermissionofthepublisher.
Publishedby
EdwardElgarPublishingLimited
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EdwardElgarPublishing,Inc.
WilliamPrattHouse
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Acataloguerecordforthisbook
isavailablefromtheBritishLibrary
LibraryofCongressControlNumber:2019930679
Thisbookisavailableelectronicallyinthe
Lawsubjectcollection
DOI10.4337/9781785362613
ISBN9781785362606(cased)
ISBN9781785362613(eBook)
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CONTENTS
Extendedcontents vii
Listoffigures xv
Listoftables xvi
Listofcontributors xvii
Tableofcases xix
Tableoflegislation xxxviii
1 Competitionlawandpharma:aneconomicperspective 1
BenoîtDurand
2 Reversepayments:anEUandUSperspective 35
FrankMaier-Rigaud,NathanBlalockandOliverGannon
3 Article101TFEU:horizontalcooperationagreementsinthepharmaceuticalsector 109
SoledadBlancoThomas,LiliaLuchianovandThomasWeck
4 ThecompetitiveassessmentofIPlicensingagreementsinthepharmaceuticalsector 175
PierreMoullet
5 Article102TFEU:patentfilingsasanabuseofdominantpositionafterAstraZeneca:
thepatent–antitrustinterfaceunderanewperspective 219
FranciscoHernández
6 Mergersinthepharmaceuticalsector 247
PabloFigueroaandAlejandroGuerrero
7 Mergersinthemedicaldevicessector 269
JanHeithecker
8 Antitrustpracticesinpharmaceuticalpublicprocurement 311
AntonioMiñoLópez
9 EUtradelawandpharmaceuticals 377
PascaleHecker
10 Thepharmaceuticalsectorandparalleltrade 405
EdurneNavarroVaronaandCristinaCaballeroCandelario
11 FreemovementandcompetitionintheEuropeanmarketforpharmaceuticals 431
PedroCarodeSousa
12 IPlawandpharmaceuticals:patentsandsupplementaryprotectioncertificatesinthe
pharmaceuticalsector 459
RaisAmils
13 TheEUregulatoryframeworkformedicinalproductsforhumanuse 503
MarcMartensandNicolasCarbonnelle
14 AntitrustandthepharmaceuticalindustryintheUnitedStates 552
GeorgeA.Hay
v
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CONTENTS
15 UKcompetitionandtradeinthepharmasector 578
PaulaRiedel
16 Competitionlawandpharma:China 615
AndrewL.Foster
17 Competitionlawandpharma:Spain 657
HelmutBrokelmannandMariarosariaGanino
18 Theapplicationofcompetitionlawinthepharmaceuticalsector:challengesforBRICS 687
MariaIoannidouandIoannisKokkoris
19 Producthopping:theUSapproach 716
MichaelA.Carrier
20 Marketingdatainthepharmaceuticalsector:acompetitionlawconsideration 733
PedroCallol
Index 761
vi
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EXTENDED CONTENTS
Listoffigures xv
Listoftables xvi
Listofcontributors xvii
Tableofcases xix
Tableoflegislation xxxviii
1 Competitionlawandpharma:aneconomicperspective
BenoîtDurand
1. INTRODUCTION 1.1
2. ANR&DINTENSIVEINDUSTRY 1.21
3. THEDETERMINANTSOFR&DINTENSITYINTHEPHARMACEUTICALINDUSTRY 1.24
4. COMPETITIONANDTHEPATENTSYSTEM 1.28
5. DELAYINGTHEENTRYOFGENERICS 1.35
A. Strategicuseofthepatentsystem 1.41
B. Producthopping 1.48
C. Disparagingthegenericversion 1.52
6. THEEFFECTSOFPARALLELTRADE 1.55
A. ThedevelopmentofparallelimportsintheEEA 1.60
B. Theeffectofparallelimportsonprices 1.65
C. Theeffectofparallelimportsoninnovation 1.70
7. THEDEMANDANDPRICINGOFPHARMACEUTICALPRODUCTS 1.78
A. Demandforpharmaceuticals:institutionaldetails 1.80
B. Countervailingbuyerpowerinthepharmaceuticalindustry 1.84
C. In-hospitalandout-of-hospitalpricing 1.93
2 Reversepayments:anEUandUSperspective
FrankMaier-Rigaud,NathanBlalockandOliverGannon
1. INTRODUCTION 2.1
A. Overviewofrecentinvestigationsbycompetitionauthorities 2.6
B. Existenceofbeneficialreversepaymentsettlements 2.10
C. Effects-basedanalysisofrestrictionsisrequiredintheassessmentofreverse
paymentsettlements 2.12
2. SETTLEMENTASTHEOUTCOMEOFIMPERFECTINFORMATION 2.15
3. WHATAREREVERSEPAYMENTSETTLEMENTS? 2.19
4. THEINCENTIVESOFORIGINATORSANDGENERICCOMPANIESTOSETTLE 2.23
A. Originatorsfacenumerousthreatstoprofitspriortopatentexpiration 2.25
B. Optionsforgenericcompanies 2.46
5. FACT-SPECIFICINQUIRYREQUIREDTODETERMINEANTICOMPETITIVENESSOF
REVERSEPAYMENTSETTLEMENTS 2.51
A. Howdogenericcompaniesandoriginatorsevaluatethedecisiontoenterinto
reversepaymentsettlements?Aneconomicassessment 2.51
B. Howarethecompetitiveeffectsofpatentsettlementswithoutvaluetransfers
evaluated? 2.60
C. Howarethecompetitiveeffectsofareversepaymentsettlementevaluated
withvaluetransfers? 2.64
6. THEEUROPEANAPPROACH 2.77
A. OverviewoftheregulatoryassessmentinEurope 2.77
B. ThePharmaceuticalSectorInquiry 2.84
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EXTENDEDCONTENTS
C. Annualmonitoringreports 2.87
D. Reversepaymentinvestigations 2.94
E. Summaryofprecedentcases 2.129
7. THEUSAPPROACHPOST-ACTAVIS 2.132
A. TheActavisruling 2.132
B. DifferentlegalassessmentspriortotheSupremeCourtjudgment 2.134
C. TheSupremeCourtActavisrulingcomparedwiththeEUapproach 2.137
D. TheFTC’smonitoringofreversepaymentsettlements 2.140
E. TheeffectsoftheActavisrulingonreversepaymentsettlementlawsuits 2.143
8. CONCLUSION 2.153
3 Article101TFEU:horizontalcooperationagreementsinthepharmaceuticalsector
SoledadBlancoThomas,LiliaLuchianovandThomasWeck
1. INTRODUCTION 3.1
2. THEAPPLICABLEEUCOMPETITIONRULES 3.6
A. Article101TFEU 3.10
B. ApplicableEUregulations,guidelinesandnoticesrelevantfortheassessmentof
horizontalcooperation 3.26
C. Safeharbours,deminimisnoticeandblockexemptions 3.28
D. Ancillaryrestraints 3.44
E. Individualassessment 3.46
3. THERELEVANCEOFSECTORINQUIRIESANDOTHERSTUDIESONCOMPETITIONIN
THEPHARMACEUTICALSECTOR 3.51
A. EUCommission’ssectorinquiries 3.52
B. Nationalsectorinquiriesandstudies 3.60
4. SPECIFICISSUESOFHORIZONTALAGREEMENTSINTHEPHARMACEUTICALSECTOR 3.69
A. Preliminaryconcepts 3.73
B. Patentsettlementagreements 3.95
C. Co-promotionagreements 3.180
D. Marketsharingagreements 3.205
E. Co-marketingagreements 3.217
F. Agreementsconcerningtheuseofthepatentsystem 3.227
G. Otherhorizontalagreements 3.236
5. COMPETITIONINNEWPHARMACEUTICALAREAS:BIOLOGICALANDBIOSIMILAR
MEDICINES 3.262
4 ThecompetitiveassessmentofIPlicensingagreementsinthepharmaceuticalsector
PierreMoullet
1. INTRODUCTION 4.1
2. COMPETITIONENFORCEMENTININNOVATIVEINDUSTRIES 4.7
A. Staticv.dynamiccompetition 4.7
B. RelationshipsbetweencompetitionandIPlaw 4.12
3. APPLICATIONOFARTICLE101TFEUTOTECHNOLOGYLICENSINGAGREEMENTS 4.19
A. WithintheTTBER 4.20
B. OutsidetheTTBER 4.42
5 Article102TFEU:patentfilingsasanabuseofdominantpositionafterAstraZeneca:the
patent–antitrustinterfaceunderanewperspective
FranciscoHernández
1. INTRODUCTION 5.1
2. THEAPPLICATIONOFARTICLE102TFEUTOPATENTRIGHTS:THETRADITIONAL
APPROACH 5.14
3. THENEWANTITRUSTACTIVISMINTHEPHARMACEUTICALMARKETS 5.27
A. ThePharmaceuticalSectorInquiry,FinalReport 5.28
B. ThejudgmentoftheCourtofJusticeinAstraZeneca 5.36
C. ThePfizercase 5.45
4. EUROPEANCOMPETITIONLAWINTHETWENTY-FIRSTCENTURY:THEFRAMEWORK
FORANEWPATENT–ANTITRUSTINTERFACE 5.54
viii
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EXTENDEDCONTENTS
5. THEAPPLICATIONOFARTICLE102TOPATENTFILINGSUPTODATE:THEWEAKNESS
OFTHEASTRAZENECAAPPROACH 5.76
6. CONCLUSION:THEPHARMACEUTICALMARKETEXPERIENCE–ANEWFRAMEFOR
THEIP–ANTITRUSTINTERFACEINEUROPE? 5.92
6 Mergersinthepharmaceuticalsector
PabloFigueroaandAlejandroGuerrero
1. INTRODUCTION 6.1
2. MARKETDEFINITION 6.2
A. Productmarketdefinitionforfinisheddosepharmaceuticalproducts 6.4
B. Marketsupstreamanddownstreamfromfinishedpharmaceuticals 6.31
3. GEOGRAPHICMARKETDEFINITION 6.40
A. Finishedpharmaceuticals 6.40
B. Marketsupstreamoffinishedpharmaceuticals 6.42
C. Marketsdownstreamoffinishedpharmaceuticals 6.43
4. COMPETITIVEANALYSISINTHEPHARMACEUTICALSECTOR 6.45
A. Preliminaryconsiderations 6.45
B. TheCommission’sapproachtoaffectedmarkets 6.47
C. Keycompetitivedriversinthepharmaceuticalmarkets 6.48
D. Remediesandcommitmentsinmergercontrol 6.61
5. CONCLUSIONS 6.67
7 Mergersinthemedicaldevicessector
JanHeithecker
1. INTRODUCTIONANDOVERVIEW 7.1
2. MARKETDEFINITION 7.6
A. Introductionandoverview 7.6
B. In-vitrodiagnosticsdevices 7.13
C. Diagnosticimagingdevices 7.25
D. Orthopaedicdevices 7.33
E. Cardiovasculardevices 7.43
F. Othermedicalcapitalgoods 7.50
G. Consumablemedicaldevices 7.61
H. Geographicmarketdefinition 7.78
3. COMPETITIVEASSESSMENT 7.83
A. Introductionandoverview 7.83
B. Horizontalconcerns 7.89
C. Non-horizontalconcerns 7.106
8 Antitrustpracticesinpharmaceuticalpublicprocurement
AntonioMiñoLópez
1. INTRODUCTION 8.1
2. BIDRIGGING:CONCEPTANDESSENTIALFEATURES 8.6
A. Concept:paradigmofcartels 8.6
B. Restrictionbyobject 8.10
C. Unifyingpurposeandstability 8.17
D. Massiveharmfulpotential 8.20
E. Thenonbisinidemprinciple 8.22
F. Publicpoliciesinducingparallelbehaviour:theEthiconcase 8.27
3. TYPESOFCOLLUSIVEPRACTICESINTHEPUBLICPROCUREMENTOFDRUGSAND
RELATEDMARKETS 8.32
A. Introduction 8.32
B. Informationexchange 8.39
C. Pricefixing 8.42
4. ABUSEOFDOMINANTPOSITION 8.124
A. Introduction 8.124
B. Marketdefinition 8.127
C. Dominantposition 8.144
D. Abusivepractices 8.153
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