藥品專利連結制度與競爭法規範之研究 · i 105 年委託研究報告2 pg10502-0235...

105 2

105 12

I

105 2

PG10502-0235

105 4 105 12

73

105 12

III

............................................................................................................... VII

................................................................................................................ IX

............................................................................................................ XI

Abstract .............................................................................................................. XIII

...................................................................................................1

..................................................................................1

..................................................................................4

..........................................................................7

.............................................................7

Hatch-Waxman Act .........................9

Medicare Prescription Drug, Improvement, and Modernization

Act2003 .................................... 24

.................................................................................... 44

V

................................................... 99

................ 355

VI

.................................................................................. 383

........................................................................................................................ i

............................................................................................................ lvi

........................................................................... lvi

........................................................................ lxxii

....................................................................... lxxvi

...................................................................... lxxvii

VII

1. ........................................................................ 53

2. ........................................................................ 69

3. ...................................................................... 80

4. ........................................................................ 96

5. 2015 ............................................... 102

6. 2015 .................................................... 104

7. FTC ................................................................................. 120

8. ................................................................ 127

9. .......................... 222

10. ........................................... 240

11. .................................................................... 243

12. B.II. ..................................................... 247

13. .......................................................... 271

14. Lundbeck ............................................................... 285

15. ................................. 316

16. ......................................... 326

17. ...................................................................... 331

18. ............................................. 357

19. 2015 ..................................... 358

IX

1. .......................................................................... 134

2. ......................................................... 246

XI

TIFA

TPPpatent

linkage 2016 8 4

14 15

25

XIII

Abstract

In response to the negotiation of the Trade and Investment Framework

Agreement (TIFA) between Taiwan and the U.S. and Taiwans active pursuit

of the opportunity to join the Trans-Pacific Partnership (TPP), Taiwan

intends to adopt a patent linkage system and a draft amendment of the

Pharmaceutical Affairs Act (hereinafter as PAA) has been passed by the

Executive Yuan on August 4, 2016. The patent linkage system prescribed in the said

amendment overall is modeled after the U.S. patent linkage system, with slight

differences only on the terms of Automatic Stay and Exclusivity periods (where the

terms prescribed in the draft amendment of PAA are both shorter than their U.S.

counterparts). However, since patent linkage systems have aroused a considerable

number of competition law issues, this study will survey competition law issues related

to patent linkage systems in countries where patent linkage systems are in operation,

such as the U.S., Australia, Korea, and Canada, as well as introduces existing

situations of the drug markets in various countries, looking at areas such as impact of

insurance systems, competition between generic drugs and patented brand-name drugs,

and the controversy over market delimitation in pharmaceutical industries, as a basis

for analysis of possible impact after the patent linkage system is introduced in Taiwan.

In addition, although the European Union does not employ a patent linkage system,

cases of reverse payment settlement related to patent linkage have already occurred.

Therefore, this study will also survey and analyze E.U.s pharmaceutical market

condition and related reverse payment settlement cases.

Competition law issues related to patent linkage system majorly include

agreement of reverse payment agreements, improper listing and sham litigations. In

addition, market definition is the important basis of Fair Trade Act for market

XIV

competition analysis. After refering relevant enforcement in other countries, market

definition theory, and experts opinions, this study suggests that in the cases the

brand-name drug manufacturers intend to delay the entry of generic drugs by entering

into agreement with generic drug manufacturers, or by manipulating the patent linkage

system, the product market should only include the brand-name drug in dispute and

all corresponding generic drugs with the same major components. As for reverse

payment agreements, unless the reverse payment agreement at issue involves any

tranditional cartel, such as express market division, it is inappropriate to directly

determine such agreement as a concerted action under Article 14 and 15 of the

Fair Trade Act. Instead, the better choice would be reviewing reverse payment

agreement under Article 25 of the Fair Trade Act, and making the point of the size of

payment made by the brand-name drug manufacturer to the generic drug

manufacturers, and the entry timing of the generic drug under the agreement at issue.

Keywords: Patent Linkage, Pharmaceutical Affair Act, Generic Drugs, Reverse

Payment, Fair Trade Act

1

patent linkage

30

2015 11 5

Trans-Pacific Strategic Economic Partnership Agreement, TPP

18 18.51

2

1

Trade and

Investment Framework Agreement, TIFA

1 Office of United States Trade Representativ, TPP, Article 18.51 I-II, UNITED STATES TRADE

REPRESENTATIVE WEBSITE, https://medium.com/the-trans-pacific-partnership/intellectual-property-

3479efdc7adf#.ta3rsbw4x. (last visit: Jul.17, 2016)

1. If a Party permits, as a condition of approving the marketing of a pharmaceutical product,

persons, other than the person originally submitting the safety and efficacy information, to rely on

evidence or information concerning the safety and efficacy of a product that was previously

approved, such as evidence of prior marketing approval by the Party or in another territory, that

Party shall provide:

(a) a system to provide notice to a patent holder57 or to allow for a patent holder to be notified prior

to the marketing of such a pharmaceutical product, that such other person is seeking to market

that product during the term of an applicable patent claiming the approved product or its approved

method of use;

(b) adequate time and opportunity for such a patent holder to seek, prior to the marketing58 of an

allegedly infringing product, available remedies in subparagraph (c); and

(c) procedures, such as judicial or administrative proceedings, and expeditious remedies, such as

preliminary injunctions or equivalent effective provisional measures, for the timely resolution of

disputes concerning the validity or infringement of an applicable patent claiming an approved

pharmaceutical product or its approved method of use.

2. As an alternative to paragraph 1, a Party shall instead adopt or maintain a system other than

judicial proceedings that precludes, based upon patent-related information submitted to the

marketing approval authority by a patent holder or the applicant for marketing approval, or based

on direct coordination between the marketing approval authority and the patent office, the

issuance of marketing approval to any third person seeking to market a pharmaceutical product

subject to a patent claiming that product, unless by consent or acquiescence of the patent holder.

3

TPP2

8 TIFA

3 104

2016 8 4

4

2 2009-20102012-

2013: http://www.ndc.gov.tw/Content_List.aspx?n=20336701F40BF6FC

: 2016 7 1

3

https://www.moea.gov.tw/Mns/otn/content/Content.aspx?menu_id =14117:2016

7 1

4 2016 8 4

http://www.fda.gov.tw/TC/newsContent.aspx?id=21156&chk=ccad567b-d0ab-450d-93f7-

9b0509ffc998#.WCxVusloBZp: 2016 8 9

4

2015

2016 8 4

7

1984 Drug Price

Competition and Patent Restoration Act Hatch-Waxman Act HWA

Generic Drugs

HWA Patent Linkage

Patent Term Restoration5Data

Exclusivity6Brand Drug

7

Reference Listed Drug

Originator

5 21 U.S.C. 355(c)(3)(E)(ii).

6 21 U.S.C. 355(v)(2)(A)(i)(I)&(II).

7

2010 3

2012 10 3

8

Generic Manufacturer

8

9Orange Book

Patent

Certification

10 HWA Paragraph IV

HWA

45 45-day period

HWA 30 Automatic 30-

Month Stay

8

2012 136

103 2014 12 4

9 2015

26-28

10

2011 21

9

180 180-day Exclusivity

HWA

HWA 2003 U.S. Food and Drug

Administration FDA 2015 11

12 2003

HWA

HWA

1984 HWA 2003

Hatch-Waxman Act

1906 Pure Food and Drug Act

13

11 Proposed 21 C.F.R. 3142015 9 88

12 U.S. GOVERNMENT PUBLISHING OFFICE, Electronic Code of Federal Regulations, Jun. 29, 2016,

http://www.ecfr.gov/cgi-bin/text-

idx?SID=c8016d46cef71e07be6c4324554366f7&mc=true&node=pt21.5.314&rgn=div5#se21.5.31

4_1107, last visited on Dec. 23, 2016.

13 9 29
http://www.ecfr.gov/cgi-bin/text-idx?SID=c8016d46cef71e07be6c4324554366f7&mc=true&node=pt21.5.314&rgn=div5#se21.5.314_1107http://www.ecfr.gov/cgi-bin/text-idx?SID=c8016d46cef71e07be6c4324554366f7&mc=true&node=pt21.5.314&rgn=div5#se21.5.314_1107http://www.ecfr.gov/cgi-bin/text-idx?SID=c8016d46cef71e07be6c4324554366f7&mc=true&node=pt21.5.314&rgn=div5#se21.5.314_1107

10

premarket approvalnotification system

14 1938 Food, Drug, and

Cosmetic Actt FFDCA

New Drug Application NDA

FDA FDA

FDA 60 reject

15 1962 Kefauver-Harris

Kefauver-Harris Drug Amendments

premarket approval

systempreclinical

clinical FDA

FDA 16 1938-1962 NDA

NDA

17 FDA

1962 FDA Drug

Efficacy Study Implementation: DESI

NDA FDA NDA

14 Colleen Kelly, The Balance Between Innovation and Competition: The Hatch-Waxman Act, the 2003

Amendments, and Beyond, 66 FOOD DRUG L.J. 417, 418 (2011).

15 Kelly, supra note 14, at 418.

16 Id. at 420.

17 9 31

11

1969 FDA Abbreviated New

Drug Application: ANDADuplicates

Drug Product ANDA

bioavailabilitybioequivalence

NDA 1962

1962 18

FDA 1982 Paper-NDA:

NDA

FDA

Generic Drugs

HWA 19

Hatch-Waxman Act1984

1984 Drug

Price Competition and Patent Term Restoration Act of 1984Hatch-Waxman

Act HWA FFDCA 20

18 7 3

19 9 33-34

20 Anna B. Laakmann, The Hatch-Waxman Acts Side Effects: Precautions for Biosimilars, 47 LOY.

L.A. L. REV. 917 (2014).

12

rely on

FDA

FDA

21

HWA

FFDCA505(b)(1)(b)(2)(j)22

FFDCA505(b)(1)

New Molecular

Entity

FFDCA505(b)(1)

Full Report

FFDCA505(b)(1)

21 9 39

22 21 U.S.C. 355(b)(1)(b)(2)(j).

13

Full NDA23

FFDCA505(b)(2)

FFDCA505(b)(2)

NDA

24

FDA NDA

New Chemical Entity, NCENew Molecular

Entity, NME25 FDA

Dosage FormFormulationActive Ingredient

Bio-inequivalence

23 FOOD AND DRUG ADMINISTRATION (U.S.), Small Business Assistance: Frequently Asked Questions

for New Drug Product Exclusivity, What is a full new drug application 505(b)(1)? , Feb. 11,

2016,

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069962.ht

m, last visited on Jun. 28, 2016.

24 10 20

25 9 41
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069962.htmhttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069962.htm

14

ProdrugMetabolic26

27

FFDCA505(j)ANDA

FDA ANDA

NDA ANDA

Active

Pharmaceutical Ingredient, APIDosage FormRoute of

Administration

Pharmaceutical Equivalence28 FDA

29

FFDCA505(j)(8):

26 41

27 10 21

28 18 FDA

-http://www.fda.gov.tw/upload/133/Content/2014033109011129474.pdf

:2016.6.28

29 10 18

15

a.

Therapeutic Ingredient

30

b.

a

31

b

32

30 21 U.S. Code 355 (j)(8)(A)(i):The term bioavailability means the rate and extent to which the

active ingredient or therapeutic ingredient is absorbed from a drug and becomes available at the site

of drug action.iiFor a drug that is not intended to be absorbed into the bloodstream, the Secretary

may assess bioavailability by scientifically valid measurements intended to reflect the rate and

extent to which the active ingredient or therapeutic ingredient becomes available at the site of drug

action.

31 21 U.S. Code 355 (j)(8)(B)(i): The rate and extent of absorption of the drug do not show a

significant difference from the rate and extent of absorption of the listed drug when administered

at the same molar dose of the therapeutic ingredient under similar experimental conditions in either

a single dose or multiple doses; or

32 21 U.S. Code 355 (j)(8)(B)(ii) :The extent of absorption of the drug does not show a significant

difference from the extent of absorption of the listed drug when administered at the same molar

dose of the therapeutic ingredient under similar experimental conditions in either a single dose or

16

FFDCA505(b)(1)(G) NDA

FDA

Approved Drug Products with Therapeutic Equivalence Evaluations

Orange Book NDA

33

FDA 34

FDA

aaiPharma Inc. v. Thompson 35

FDA

36

multiple doses and the difference from the listed drug in the rate of absorption of the drug is

intentional, is reflected in its proposed labeling, is not essential to the attainment of effective body

drug concentrations on chronic use, and is considered medically insignificant for the drug.

33 7 5-6 8 6

34 JOHN R. THOMAS, PHARMACEUTICAL PATENT LAW 15 (2nd ed. 2010)

8 7

35 aaiPharma Inc. v. Thompson, 296 F.3d 227 (4th Cir. 2002).

36 9 58-59

17

HWA

:37

FDA

38

39 HWA

Patent InformationFDA

40

HWA Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk

41

FFDCA505(j)(2)(A)(vii)HWA 42

ANDA

FDA

Patent Certification43:

(1) Paragraph I

37 21 U.S.C. 355(b)(1)(G)(c)(2)Id. at 56.

38 21 C.F.R. 314.53(c)(1994).

39 21 C.F.R. 314.53(b).

40 21 C.F.R. 314.53(c)(2003).

41 9 6063

42 76

43 7 6

18

(2) Paragraph II

(3) Paragrph III

(4) Paragraph IV

ANDA

FDA

(1)-(3)

(1)(2)

FDA (3)

FDA tentative approval

final approval44(4)

: Paragraph IV Certification:P4

180

45

HWA

HWA

(3)46

8 Section viii Statements

No Relevant Patent

FFDCA505(j)(2)(A)(viii)

44 8 9

45 21 U.S.C. 355(j)(5)(B)(iv).

46 8 10

19

:

47

FDA 48

Preliminary

Injunction OrderTemporary Restraining Order

49

50

P4

P4 HWA

FFDCA 505(b)(3)(B)505(j)(2)(B)(ii)(1984)

:

P4

47 11

48 10 25

49 21 C.F.R. 314.107(b)(3)(v).

50 9 78

20

51

45

45 45-day period

45 P4

FDA

52 P4

FDA

53

FDA 30 Automatic 30-

Month Stay54

30

FDA 30 55

30

FDA ANDA 1

2

330

51 21 U.S.C. 355(b)(3)(C)355(j)(2)(B)(iii)(1984); 9 86-87

52

2010 123

53 21 C.F.R. 314.107(f)(2)-(3) (1994).

54 9 130

55 21 U.S. Code 355(j)(5)(B)(iii).

21

56

30

57

58

59

30 FDA ANDA

60 30

180

HWA FFDCA505(j)(5)(B)(iv)

ANDA P4

56 7 8

57 8

58 21 U.S. Code 355(c)(3)(C)355(j)(5)(B); 9 132

59 :

see Winter v. Natural Resources Defense Council, Inc., 129 S.

Ct. 365 (2008) 8 22-23

60 7 8

22

180 180 -day Exclusivity

FDA

ANDA 61

180

duopoly

20-30%62

85%63

HWA

180

waive ANDA

Boehringer Ingelheim Corp. v. Shalala 64

ANDA

61 10 28

62 FEDERAL TRADE COMMISSION, Pay-for-Delay: How Drug Company Pay-Offs Cost Consumers

Billions, Jan. 2010, at 8, available at

https://www.ftc.gov/sites/default/files/documents/reports/pay-delay-how-drug-company-pay-offs-

cost-consumers-billions-federal-trade-commission-staff-study/100112payfordelayrpt.pdf.

63 Jon Leibowitz , Statement of Federal Trade Commission Chairman Jon Leibowitz Pay-for-Delay

Press Conference, Jan. 1, 2010, at 1, available at

https://www.ftc.gov/sites/default/files/documents/reports/pay-delay-how-drug-company-pay-offs-

cost-consumers-billions-federal-trade-commission-staff-study/100113stmtleibowitzpfd.pdf.

64 Boehringer Ingelheim Corp. v. Shalala, 993 F.Supp. 1 (D.D.C. 1997).
https://www.ftc.gov/sites/default/files/documents/reports/pay-delay-how-drug-company-pay-offs-cost-consumers-billions-federal-trade-commission-staff-study/100112payfordelayrpt.pdfhttps://www.ftc.gov/sites/default/files/documents/reports/pay-delay-how-drug-company-pay-offs-cost-consumers-billions-federal-trade-commission-staff-study/100112payfordelayrpt.pdf

23

ANDA ANDA

FDA

ANDA

ANDA

FDA 1999 2002

65

ANDA FDA

45

66

6768

HWA 271 (e)(2)69

65 9 199-200

66 35 U.S.C. 271(e)(1).

67 U.S. Const. art. III, 2.

68 9 101

69 35 U.S.C. 271(e)(2)

24

Eli Lilly & Co. v. Medtronic, Inc.

Artificial Act of Infringement70

71

HWA

Injunctive Relief

HWA 72

Medicare Prescription Drug, Improvement, and Modernization Act2003

HWA 50

70 Eli Lilly & Co. v. Medtronic, Inc., 110 S. Ct. 2683(S. Ct.1990).

71 9 102

72 Id. at 103.

25

73 1.6 53%74

FTC 50%

75%

75

HWA

HWA 76

77

2003

Medicare Prescription Drug, Improvement, and Modernization Act of 2003

MMA MMA

30 180

MMA

73 PETER BARTON HUTT, RICHARD A. MERRILL & LEWIS A. GROSSMAN, FOOD AND DRUG LAW: CASE

AND MATERIALS 577, 764(3rd ed., 2007).

74 Mary W. Bourke & M. Edward Danberg, Current Trends in Hatch-Waxman Patent Litigation: A

System Still in Flux, in PHARMACEUTICAL LAW 2006: ACROSS THE PRODUCT LIFE CYCLE 939,

950 (Practicing Law Inst. ed., 2006).


76 Natalie M. Derzko, The Impact of Recent Reforms of the Hatch-Waxman Scheme on Orange Book

Strategic Behavior and Pharmaceutical Innovation, 45 IDEA -- J.L. & TECH. 165, 168 (2004).

77 Legislative and Regulatory Responses to the FTC Study on Barriers to Entry in the Pharmaceutical

Marketplace: Hearing Before the S. Comm. on the Judiciary, Statement of Daniel E. Troy, Chief

Counsel, FDA, 108th Cong. 1 (2003), available at https://www.gpo.gov/fdsys/pkg/CHRG-

108shrg91212/html/CHRG-108shrg91212.htm; Kelly, supra note 14, at 425-427.

26

30

1984 HWA

FDA

NDA NDA

HWA

78NDA FDA

30

79

FDA HWA

30

HWA ANDA

30

Late-listed

P4 45

HWA 30 80

30 81

Improper Listing

78 21 U.S.C. 355(b)(1)(G).

79 8 60

80 65


27

NDA

aaiPharma Inc. v. Thompson aaiPharma NDA

Eli Lilly & Company Eli Lilly NDA

NDA

FDA HWA

NDA NDA FDA

82 NDA NDA

30

83

FDA

coatingnew formulaCrystalline

FormsImprovement Patents84

30 85

Evergreening SmithKline v. Apotex

SmithKline Beecham SmithKline Beecham Corporation

Paxil

82 21 U.S.C. 355(d)(6)355(e)(4).

83 8 36-38


85 7 10

28

Apotex 9 5

30 86 Apotex ANDA

87

FDA

FDA/

88

Evergreening

MisrepresentationFraud In re Buspirone

Patent & Antitrust Listigation 89Bristol-Myers

P4

:Bristol-Myers

Buspirone

FDA

Bristol-Myers Noerr-Pennington

PetitionRedress

90 FDA

Patent Scope


87 7 9

88 THOMAS, supra note 34, at 417 8 64

89 In re Buspirone Patent & Antitrust Listigation, 185 F. Supp. 2d 363 (S.D.N.Y. 2002).

90 Esther H. Steinhauer, Is Noerr-Pennington Immunity Still a Viable Defense Against Antitrust Claims

Arising From Hatch-Waxman Litigation, 61 FOOD DRUG L.J. 679, 681 (2006).

29

91 Bristol-Myers

92

FTC Evergreening

HWA

2002 30

ANDA 40

93FTC

ANDA 30

ANDA

94 FTC FDA

12product-by-process

patents3patents that constitute double-patenting

95

91 Id. at 684.


93 FEDERAL TRADE COMMISION, Generic Drug Entry Prior To Patent Expiration: An FTC Study, July

2002, at iii-iv, available at

https://www.google.com.tw/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0ahUKEwjoq

ZHD7anOAhXFGJQKHXa-B-

AQFggcMAA&url=https%3A%2F%2Fwww.ftc.gov%2Fsites%2Fdefault%2Ffiles%2Fdocuments

%2Freports%2Fgeneric-drug-entry-prior-patent-expiration-ftc-

study%2Fgenericdrugstudy_0.pdf&usg=AFQjCNF-5BYomIvmYwNSAIoLxSErdjWvYw.

94 Id. at ii.

95 Id. at 54-55.

30

MMA

30 FDA

Code of Federal Regulation Title 21, Part 314:

Applications for FDA Approval to Market a New Drug

1:

2:3

4method-of use patent5

96 2003 6 18 patent-

by-patent97

MMA FDA

HWA

FTC

ANDAFFDCA505(b)(2)

30

P4 30

MMA 30

98

99

96 8 30-32

97 32

98 21 U.S.C. 355(j)(5)(B)(iii)(I).

99 21 U.S.C. 355(j)(5)(B)(iii)(II).

31

100

MMA FDA

Processing

101Polymorphic

FDA

102

Method-

of -Use-PatentsClaim-

by-Claim103

Use Code

8 104

MMA

MMA NDA

Signed Declarations105

106

KnowinglyWillful

100 Kelly, supra note 14, at 438-440.

101 68 Fed. Reg. 36676.

102 68 Fed. Reg. 36676.

103 9 61

104 61Kelly, supra note 14, at 432.

105 68 Fed. Reg. 36686, 36707 - 36712.

106 Barry J. Marenberg, FDA Issues Final Rule on Patent Listing Requirements and 30-Month Stays of

Approval Following Submission of Abbreviated New Drug Applications, 23 BIOTECHNOLOGY L.

REP. 48, 49 (2004).

32

107MMA FFDCA

FFDCA505(b)(2)/ANDA

Counterclaim Provision

108 Caraco Pharmaceutical Laboratories, Ltd, et al. v. Novo Nordisk A/S. et al.

109Caraco

Novo 110

111

30

MMA

30

ANDA/ FFDCA505(b)(2)

30

ANDA/ FFDCA505(b)(2) FDA

ANDAFFDCA505(b)(2) 30

112MMA

107 68 Fed. Reg. at 36686.

108 21 U.S.C. 355(c)(3)(D)(ii)355(j)(5)(C)(ii).

109 Caraco Pharmaceutical Laboratories, Ltd, et al. v. Novo Nordisk A/S. et al., 132 S. Ct. 1670 (S. Ct.

2012).

110 8 54-55

111 9 26-28Kelly, supra note 14, at 432.

112 8 65-66

33

180

1984 HWA

ANDA P4

180 HWA

FDA

1Successful Defense

1132

114

115116

FDA D.C. Circuit

D.C. District Court

Mova Parmaceuticals, Corp. v. Shalala 117

HWA FDA

180 HWA

First-to-File ANDA P4

113 59 Fed. Reg. 50338 (Oct. 3, 1994).

114 21 C.F.R. 314.107(e)(1)(1999).

115 59 Fed. Reg. 50353 (Oct. 3, 1994).


117 Mova Parmaceuticals, Corp. v. Shalala, 140 F.3d 1060 (D.C. Cir. 1998).

34

180 Mylan Pharmaceuticals, Inc. v.

Shalala 118 FDA HWA a decision of a

court119 180

FDA

Mova Parmaceuticals, Corp. v. Shalala 180

P4

180 120

Reverse Payment AgreementFTC

Pay-for-Delay121 ANDA

P4

122

: 1

2 ANDA P4

118 Mylan Pharmaceuticals, Inc. v. Shalala, 81 F. Supp. 2d 30 (D.D.C. 2000).

119 21 U.S.C. 355(j)(5)(B)(iv).

120 8 71

121 9 196

122 12 1

2008 1 56

35

Authorized Generic, AG3

123

180 Mylan Pharmaceuticals, Inc. v. Shalala

FDA

124 HWA

FTC 1992-2000 125

ANDA P4 73%

126 20

127

123 THE CONGRESS OF THE UNITED STATES CONGRESSIONAL BUDGET OFFICE, How Increased

Competition from Generic Drugs Has Affected Price and Returns in the Pharmaceutical Industry

(Jul., 1998), available at https://www.cbo.gov/sites/default/files/105th-congress-1997-

1998/reports/pharm.pdf 7 11

124 9 197

125 Legislative and Regulatory Responses to the FTC Study on Barriers to Entry in the

Pharmaceutical Marketplace: Hearing Before the S. Comm. on the Judiciary, statement of Daniel

E. Troy, Chief Counsel, FDA 108th Cong. 14, 19 (2003), available at

https://www.gpo.gov/fdsys/pkg/CHRG-108shrg91212/html/CHRG-108shrg91212.htm.

126 FEDERAL TRADE COMMISSION, supra note 93, at 6.

127 Id. at 7.

36

175 1 3,200

4 10 128FTC 180

129

Federal Trade Commission FTCDepartment

of Justice DOJ130

MMA

180

180 MMA HWA

Court Decision

131

132

133

128 Id. at 31.

129 THE CONGRESS OF THE UNITED STATES CONGRESSIONAL BUDGET OFFICE, supra note 123, at 46.

130 FEDERAL TRADE COMMISSION, supra note 93, at vi, viii; THE CONGRESS OF THE UNITED STATES

CONGRESSIONAL BUDGET OFFICE, supra note 123, at 46 ; Kelly, supra note 14, at 431.

131 21 U.S.C. 355(j)(5)(B)(iv).

132 Mary W. Bourke & M. Edward Danberg, supra note 74, at 972.


37

MMA

ANDA P4

180

134

forfeit

135

ANDA P4 MMA

136

MMA ANDAP4

180 Forfeiture Event

137:

1. ANDA 75 ANDA 30

2. ANDA 75 :

(1)

134 148 Cong. Rec. S7348 (Jul. 25, 2002) (statement of Senator Hatch).

135 21 U.S.C. 355(j)(5)(D)(iii).

136 21 U.S.C. 355(j)(5)(B)(iv)(II)(bb).

137 21 U.S.C. 355(j)(5)(D)(i) 7 9

38

(2)

(3) /138

139

180 140

MMA 180

5 141

:

1. ANDA 142

2. amend P4

143

3. 30 tentative

144

4. /

FTC 145

5. P4 146

138 21 U.S.C. 355(j)(5)(D)(i)(I).

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143 21 U.S.C. 355(j)(5)(D)(i)(III).

144 21 U.S.C. 355(j)(5)(D)(i)(IV).

145 21 U.S.C. 355(j)(5)(D)(i)(V).

146 21 U.S.C. 355(j)(5)(D)(i)(VI).

39

FDA

MMA

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MMA 1112(c)(2)

1112(a)(b) 1112(a)(b)1112(a)(b)

1112(a)(b)

MMA 1112(c)(3) 1112(a)(b)

MMA 1113 1112

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150 MMA Title XI 1113.

41

151 MMA 1115

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information, to rely on evidence or information concerning the safety or efficacy of a product that

was previously approved, such as evidence of prior marketing approval by the Party or in another

territory:

(a) that Party shall provide measures in its marketing approval process to prevent those other persons

from:

(i) marketing a product, where that product is claimed in a patent; or

(ii) marketing a product for an approved use, where that approved use is claimed in a patent, during the

term of that patent, unless by consent or acquiescence of the patent owner; and

(b) if the Party permits a third person to request marketing approval to enter the market with:

(i) a product during the term of a patent identified as claiming the product; or

(ii) a product for an approved use, during the term of a patent identified as claiming that approved use,

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55 179 2

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grounds that it is not marketing, and does not propose to market, the therapeutic goods in a manner,

or in circumstances, that would infringe a valid claim of a patent that has been granted in relation

to the therapeutic goods; or

(b) a certificate to the effect that:

(i) a patent has been granted in relation to the therapeutic goods; and

(ii) the applicant proposes to market the therapeutic goods before the end of the term of

the patent; and

(iii) the applicant has given the patentee notice of the application for registration or listing

of the therapeutic goods under section 23.

The certificate must be signed by, or on behalf of, the applicant and must be in a form approved by

the Secretary.

178 173 3

179 4

49

TGA

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: 1

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3

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180 TGA26 C (1) - (3)

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182 TGA26 C (4) 180 40 180 39

50

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183TGA

1 184

2

185

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183 TGA26 C (5) 180 39

184 TGA26 C (5A)(6)(7) 180 40

185 TGA26 D (1) 173 5

186 TGA26 D (3) 180 40-41

51

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a pharmaceutical product, persons, other than the person originally submitting safety or efficacy

information, to rely on that information or on evidence of safety or efficacy information of a product

that was previously approved, such as evidence of prior marketing approval in the territory of the

Party or in another territory, that Party shall:

(a) provide that the patent owner shall be notified of the identity of any such other person that requests

marketing approval to enter the market during the term of a patent notified to the approving

authority as covering that product or its approved method of use; and

(b) implement measures in its marketing approval process to prevent such other persons from marketing

a product without the consent or acquiescence of the patent owner during the term of a patent

notified to the approving authority as covering that product or its approved method of use.;

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217 2015 3 13 50 4 6

218 2015 3 13 50 4 4

219 2015 3 13 50 4 5

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220 135221

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2

221 2013 135 :

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222 2015 3 13 50 5 2

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256 Article 1709.5: Each Party shall provide that:

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right to prevent other persons from making, using or selling the subject matter of the patent, without

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287 180 37



290 PM(NOC) Regulations8 (6) 180 35-36

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92

8

48 9 48 12

48 15

48 16

48 18

45

309 2016

1 27

271 (e (2)

(A)(B)

310 271 (e)(4)

309 48 12 2 1

310 (2) It shall be an act of infringement to submit--

93

(2)(A)

(B)

(C)

(D)

285 (2)

311

(A) an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act [21 USCS Sect.

355(j)] or described in section 505(b)(2) of such Act [21 USCS Sect. 355(b)(2)] for a drug claimed

in a patent or the use of which is claimed in a patent, or

(B) an application under section 512 of such Act [21 USCS Sect. 360b] or under the Act of March 4,

1913 (21 U.S.C. 151-158) for a drug or veterinary biological product which is not primarily

manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other

processes involving site specific genetic manipulation techniques and which is claimed in a patent

or the use of which is claimed in a patent, if the purpose of such submission is to obtain approval

under such Act to engage in the commercial manufacture, use, or sale of a drug or veterinary

biological product claimed in a patent or the use of which is claimed in a patent before the expiration

of such patent.

311 For an act of infringement described in paragraph (2)-

(A) the court shall order the effective date of any approval of the drug or veterinary biological product

involved in the infringement to be a date which is not earlier than the date of the expiration of the

patent which has been infringed,

(B) injunctive relief may be granted against an infringer to prevent the commercial manufacture, use,

or sale of an approved drug or veterinary biological product, and

(C) damages or other monetary relief may be awarded against an infringer only if there has been

commercial manufacture, use, or sale of an approved drug or veterinary biological product., and

94

50 5 2

1.

126 2. 135

60 1

(D) the court shall order a permanent injunction prohibiting any infringement of the patent by the

biological product involved in the infringement until a date which is not earlier than the date of the

expiration of the patent that has been infringed under paragraph (2)(C), provided the patent is the

subject of a final court decision, as defined in section 351(k)(6) of the Public Health Service Act,

in an action for infringement of the patent under section 351(l)(6) of such Act, and the biological

product has not yet been approved because of section 351(k)(7) of such Act.

The remedies prescribed by subparagraphs (A), (B), (C), and (D) are the only remedies which may

be granted by a court for an act of infringement described in paragraph (2), except that a court may

award attorney fees under section 285 35 USCS Sect. 285].

95

312

2016 4 13

60 1 1

1.2.

313

60 1 2

247

60 1

312 105 4 13 TPP

http://www.tipo.gov.tw/ct.asp?xItem=585578&ctNode=7127&mp=12016

7 30

313

96

314

4.

20 20

45

45

30 15

180 12

FTCDOJ

314

99

DOJ FTC

Clayton Act

Sherman Act FTC Federal Trade Commision

Act 5 unfair methods of competition

315Dual EnforcementDOJ

FTC Robison-Patman Act

price fixingbasic

metals DOJ FTC

FTC 316

2015

315 ROBERT PITOFSKY, TRADE REGULATION: CASES AND MATERIALS, 54(6th ed. 2010).

316 Id. at 68.

100

GDP 53914 GDP 23.8

31392 GDP 17.8%

6.8%317

FDA 1938 FFDCA

2012 The Food

and Drug Administration Safety and Innovation Act FDASIA

1992

Prescription Drug User Fee Act PDUFA

FDA

FDASIA Generics

Drug User Fee ActGDUFA

318

2015

Precision Medicine Initiative

2016 National

Cancer Moonshot

319

BMI

317

20162016 7 65

318 65-66

319 67

101

2015

3334 2014

7.6%

94.3% 77.5%

2015 Turing Daraprim

13.5 750 50

702 21%

2020 881 2015-2020

CAGR 4.6%

320

2015 740.6

22.2%

406

321

IMS Health 2015

439 391

302 238

212 322

15

320 67

321 70

322 68

102

Sanofii Lantus SoloSTAR C

323

5. 2015

2015

2015

2015

1 Harvoni Gilead Sciences C

143 793.8

2 Humira AbbVie

106 35.9

3 Enbrel Amgen

66 11.9

4 Crestor AstraZeneca

63 10.5

5 Lantus

SoloSTAR Sanofi 58 20.8

6 Remicade Johnson & Johnson

50 11.1

7 Advair

Diskus GlaxoSmithKline 47 0

8 Abilify Otsuka America 44 -42.1

9 Copaxone Teva

44 10.0

323 71

103

10 Januvia Merck 42 20.0

11 Neulasta Amgen

41 7.9

12 Lyrica Pfizer

38 22.6

13 Lantus Aventis 38 8.6

14 Rituxan Genetech/Biogen

/

36 2.9

15 Nexium AstraZenenca 35 -39.7

15 2015 851

25.5%324

Otsuka America Ability

2014 10

2015 4

42.1% 2014 3

2015 8 AstraZeneca Nexium

2014 5 Pfizer OTC

39.7% 2014 5 2015

15 AstraZeneca 15

2014 2.2%325

324 70

325 72-74

104

6. 2015

2015

2015

2015

%

1 Gilead Sciences 276 51.8

2 Johnson & Johnson 215 10.5

3 Merck 208 10.1

4 Novartis 203 -2.6

5 Pfizer 196 7.5

6 AstraZeneca 193 -2.2

7 Teva 191 9.7

8 Amgen 184 9.9

9 Roche 179 3.7

10 Sanofi 177 17.3

11 Allergan 169 3.8

12 AbbVie 166 24.7

13 Eli Lilly 140 15.5

14 Novo Nordisk 133 25.0

15 GlaxoSmithKline 114 1.6

NovartisAstraZeneca

Gilead Sciences Harvoni

Solvadi 2015 276

15 2744 10% 2013

105

51.8%326

2015

2320 25% 15%

FDA

45

21

327

328

Originator Pharmaceutical Sector R&D

new molecular entity NMENew

Chemical Entity NCE

326 73-74

327 72-73

328 74-75

106

329NDA

FDA

cGMP 330

10-15

8 331 4% R&D

17%332

FDA Phase I

to Approval NMEnon-new

molecular entities non-NME 6.2%11.5% 22.6%

R&D 333

329 Henry Grabowski & John Vernon, Effective Patent Life in Pharmaceuticals, 19 INTL J. TECH.

MGMT. 98 (2000).

330 Patricia M. Danzon, Competition and Antitrust Issues in the Pharmaceutical Industry, Central

Regional de Competencia para Amrica Latina publication, at 8, available at

http://www.crcal.org/guias-y-estudios/estudios/estudios-de-sector/doc_download/30-competition-

and-antitrust-issues-in-the-pharmaceutical-industry.

331 Joseph A. DiMasi et al., The Price of Innovation: New Estimates of Drug Development Costs, 22 J.

HEALTH ECON. 151 (2003); Tufts Center for the Study of Drug Development, Post-Approval R&D

Raises Total Drug Development Costs to $897 Million, IMPACT REPORT, VOL.5, NO. 3 (2003).

332 Danzon, supra note 330, at 5.

333 BIO , Biomedtracker , Amplion , Clinical Development Success Rates 2006-2015, at 20, available

at,

https://www.bio.org/sites/default/files/Clinical%20Development%20Success%20Rates%202006-

2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdfHenry Grabowski, John

Vernon & Joseph DiMasi, Returns on Research and Development for 1990s New Drug

Introductions, 20 PHARMACOECON. SUPPL. 3, 1129 (2002).

107

R&D

WTO TRIPS

20 patent term

extension 5

4-6 1-2

6 334

data exclusivity period

orphan drugsmarket exclusivity

5 12

7 335

oligopolies

336


335 Id. at 6-7.

336 Id. at 7.

108

standard-of-care

337

co-payment

338

drug

formulary

tier

337 Id. at 8.

338 Id. at 9.

109

339

Pharmacy Benefit Managers PBMPBM

health plan

PBM

PBM

PBMM

dispensing fees

PBM340

PBM

341

Congressional Budget Office 1998

342

343

339 Rahul Guha, Andrew M. Lacy, Sally Woodhouse, Analyzing Competition in the Pharmaceutical

Industry, ECONOMICS COMMITTEE NEWSLETTER, VOL.8, NO.1, at 6 (2008).

340 Danzon, supra note 330, at 9-10.

341 Guha, Andrew M. Lacy, Sally Woodhouse, supra note 339, at 6.

342 THE CONGRESS OF THE UNITED STATES CONGRESSIONAL BUDGET OFFICE, supra note 123 ; Id. at 6.


110

FDA route of administration

performance characteristics

344

345

copycat

346

ANDA

347348

chemical drugs

344Center for Drug Evaluation and Research, Generic Drugs, available at

http://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistence/ucm12

7615.pdf.


346 United States v. Generix Drug Corp., 460 U.S. 453, 455, n.1 (1983).

347 David Reiffen & Michael R. Ward, Generic Drug Industry Dynamics, Federal Trade Commission,

BUREAU OF ECONOMICS WORKING PAPER NO. 248 (Feb. 2002), available at

https://www.ftc.gov/reports/generic-drug-industry-dynamics.

348 Danzon, supra note 330, at 12-15.

111

biosimilarbiologic drugs

349 R&D

350 2015 3 Sandoz

Zarxiofilgrastim-sndz351

maximum allowable cost MACMAC

MAC

352

MAC

70%

PBM 353PBM

349 Id. at 6.

350 Id. at 13.

351 317 66


353 Id. at 15-16.

112

PBM

354

355

10-30%

80-90%356

357

PBM

net price

358



356 Id. at 16.


358 Id. at 7-8.

113

price-

elastic359

IMS HealthVerispan

PBM

non-price benefits

IMS HealthVerispan

IMS

HealthVerispan

relevant product market

360

2000-

2010 FTC 229 22


360 Guha, Andrew M. Lacy, Sally Woodhouse, supra note 339, at 7-8.

114

361

362

supracompetitive

prices FTC

12%363

FTC v. Indiana Federation

of Dentist 364

365

per se illegal

quick look

361 Anish Vaishnav, Survey: Product Market Definition in Pharmaceutical Antitrust Case : Evaluating

Cross-Price Elasticity of Demand, 2011 COLUM. BUS. L. REV. 586, 587 (2011).

362 M. Howard Morse, Product Market Definition in the Pharmaceutical Industry, 71 ANTITRUST L.J.

633, 633 (2003).

363 Vaishnav, supra note 361 , at 587.

364 FTC v. Indiana Fed'n of Dentists, 476 U.S. 447 (1986); George Farah & Laura Alexander,

Prominent Market Definition Issues in Pharmaceutical Antitrust Cases, ANTITRUST L. J. 30

ANTITRUST ABA 45, 46, available at

http://www.cohenmilstein.com/sites/default/files/media.4444.pdf.

365 Id. at 46-47.

115

rule

of reason

366

market powermonopoly power

geographic marketproduct market367relevant

market Robert Pitofsky

368

2

7

2010 Horizontal Merger Guildelines

369 7

370

line of commercepart

of commerce371


367 Brown Shoe Co., Inc. v. United States, 370 U.S. 294, 324 (1962).

368 Robert Pitofsky, New Definitions of Relevant Market and the Assault on Antitrust, 90 COLUM. L.

REV.1805, 1806-07 (1990).

369 U.S. DEP'T OF JUSTICE & FED. TRADE COMM'N, Horizontal Merger Guidelines (2010), avaialbe at

http://www.ftc.gov/os/2010/08/100819hmg.pdf.

370 supra note 367, at 324, 335; Farah & Alexander, supra note 364, at 46.

371 United States v. Grinnell Corp., 384 U.S. 563, 573 (1966).

116

2 372

FTC

FTC

FTC

FTC

FTC

constrain

interchangeable

373

100%

372 Vaishnav, supra note 361 , at 590-592.

373 Morse, supra note 362, at 649, n59.

117

FTC

Abbott Labs. & Geneva Pharm.,

Inc.374Hoechst Marion Roussel, Inc. & Andrx Corp.375

efficacy

Hoechst

Marion Roussel, Inc. & Andrx Corp.FTC complaint

diltiazem

376

FTC Schering Administrative Law

Judge Schering-Plough Upsher-

Smith Upsher-Smith

Schering-Plough K-Dur 20 K-Dur 20

374 FEDERAL TRADE COMMISSION, Abbott Labs. & Geneva Pharm., Inc., FTC DOCKET NOS. C-3945,

3946 (May 26, 2000), available at http://www.ftc.gov/os/2000/05/c3945complaint.htm; FEDERAL

TRADE COMMISSION, Press Release, FTC Charges Drug Manufacturers with Stifling Competition

in Two Prescription Drug Markets (Mar. 16, 2000), http://www.ftc.gov/opa/2000/03/hoechst.htm,

last visited on Dec. 25, 2016.

375 FEDERAL TRADE COMMISSION, Hoechst Marion Roussel, Inc. & Andrx Corp., FTC DOCKET NO.

9293 (Apr. 25, 2000) , available at

https://www.ftc.gov/sites/default/files/documents/cases/2000/04/000425cclid.pdf; FEDERAL TRADE

COMMISSION, Press Release, FTC Charges Drug Manufacturers with Stifling Competition in Two

Prescription Drug Markets (Mar. 16, 2000), available at https://www.ftc.gov/news-events/press-

releases/2000/03/ftc-charges-drug-manufacturers-stifling-competition-two.

376 Morse, supra note 362 at 650-651.

118

FTC K-Dur 20

20 mEqmilliequivalent

377

K-Dur 20

Schering-Plough 100%

378

FTC

K-Dur 20 FTC

K-Dur 20

10 mEq K-Dur 20 FTC

FTC

379

380

377 FEDERAL TRADE COMMISSION, In the Matter of Schering-Plough Corporation, et al., Docket No.

9297, Opinion of the Commission, available at

https://www.ftc.gov/sites/default/files/documents/cases/2003/12/031218commissionopinion.pdf.

378 Morse, supra note 362 at 651.

379 FEDERAL TRADE COMMISSION, In the Matter of Schering-Plough Corp., Upsher-Smith Labs. &

Am. Home Prods. Corp., FTC DOCKET NO. 9297 (FTC June 27, 2002), at 12, 16, 19, 7879,

8795, available at

https://www.ftc.gov/sites/default/files/documents/cases/2002/06/020627id.pdf.

380 Schering-Plough Corp. v. FTC, 402 F.3d 1056 (11th Cir. 2005).

119

2002 Biovail 381

Tiazac FTC

Tiazac

Tiazac Biovail

FTC

Biovail 100%

382

FTC

innovation383

381 FEDERAL TRADE COMMISSION, Biovail Corp., FTC DOCKET NO. C-4060 (Oct. 4, 2002),

https://www.ftc.gov/news-events/press-releases/2002/10/announced-action-october-4-2002, last

visited on Oct. 8, 2016; FEDERAL TRADE COMMISSION, Press Release, WrongfulOrange

Book Listing Raises Red Flag with FTC; Leads to Consent Order with Biovail Corp.

Concerning its Drug Tiazac (Apr. 23, 2002), https://www.ftc.gov/news-events/press-

releases/2002/04/wrongful-orange-book-listing-raises-red-flag-ftc-leads-consent, last visited on

Oct. 8, 2016.


383 Id. at 633-634.
https://www.ftc.gov/news-events/press-releases/2002/10/announced-action-october-4-2002https://www.ftc.gov/news-events/press-releases/2002/04/wrongful-orange-book-listing-raises-red-flag-ftc-leads-consenthttps://www.ftc.gov/news-events/press-releases/2002/04/wrongful-orange-book-listing-raises-red-flag-ftc-leads-consent

120

FTC

FTC FTC

consent order384

FTC

385

FTC

mechanism of action

chemical compoundfrequency of dosagestrength

of dosage

386

FTC

387

7. FTC

2003 Pfizer Pfizer Inc. 6 Pharmacia

Pharmacia Corp.FTC R&D

384 Id. at 642-643.

385 Id. at. 634.

386 Id. at 643-644.

387 Id. at 644-648.

121

Pharmacia

Pfizer Viagra 95%

388

Glaxo-SmithKline 18.2 FTC

irritable bowel syndrome

389

2002 Amgen Amgen Inc. 1.6 Immunex

Immunex Corp. FTC FTC

cytokine TNF

IL-1

390

388 FEDERAL TRADE COMMISSION, Pfizer Inc. & Pharmacia Corp., FTC DOCKET NO. C-4075 (May 30,

2003), available at http://www.ftc.gov/os/2003/04/pfizercmp.htm; FEDERAL TRADE COMMISSION,

Pfizer, Pharmacia Will Divest Assets to Settle FTC Charges, Press Release (Apr. 14, 2003),

https://www.ftc.gov/news-events/press-releases/2003/04/pfizer-pharmacia-will-divest-assets-settle-

ftc-charges, last visited on Oct. 8, 2016; FEDERAL TRADE COMMISSION, Analysis of Proposed

Consent Order to Aid Public Comment, FTC DOCKET NO. C-4075(Apr.14,2003), available at

https://www.ftc.gov/sites/default/files/documents/cases/2003/04/pfizeranalysis.htm.

389 FEDERAL TRADE COMMISSION, In the Matter of Glaxo Wellcome plc, and SmithKline Beecham plc,

FTC Docket No. C-3990 ( Jan. 30, 2001), available at

https://www.ftc.gov/enforcement/cases-proceedings/0010088/glaxo-wellcome-plc-smithkline-

beecham-plc-matter; FEDERAL TRADE COMMISSION, Press Release, Resolving Competitive

Concerns, FTC Agreement Clears $182 Billion Merger of SmithKline Beecham and Glaxo

Wellcome (Dec. 18, 2000), http://www.ftc.gov/opa/2000/12/skb.htm, last visited on Oct. 8, 2016.

390 FEDERAL TRADE COMMISSION, Amgen Inc. & Immunex Corp., FTC Docket No. C-4053 (Sept. 3,

2002), available at
https://www.ftc.gov/news-events/press-releases/2003/04/pfizer-pharmacia-will-divest-assets-settle-ftc-chargeshttps://www.ftc.gov/news-events/press-releases/2003/04/pfizer-pharmacia-will-divest-assets-settle-ftc-chargeshttp://www.ftc.gov/opa/2000/12/skb.htm

122

2003 2 Baxter Baxter Corp. Wyeth Wyeth

Corp. FTC

FTC Propofol

anethetic

out-patient

surgery FTC FTC

FTC

equivalents391

FTC Pfizer

Pharmacia FTC

overactive bladderextended-release drugs

https://www.ftc.gov/sites/default/files/documents/cases/2002/07/amgenoma.pdf; FEDERAL

TRADE COMMISSION, Press Release, Resolving Anticompetitive Concerns, FTC Clears $16 Billion

Acquisition of Immunex Corp. by AmgenInc.(Jul. 12, 2002), https://www.ftc.gov/news-

events/press-releases/2002/07/resolving-anticompetitive-concerns-ftc-clears-16-billion, last visited

on Oct.8, 2016.

https://www.ftc.gov/news-events/press-releases/2002/07/resolving-anticompetitive-concerns-ftc-clears-16-billionhttps://www.ftc.gov/news-events/press-releases/2002/07/resolving-anticompetitive-concerns-ftc-clears-16-billion

123

392

2002 8 Biovail Elan FTC

30mg

60mg FTC

Biovail Elan

Adalat CC

393

FTC

FTC

392 FEDERAL TRADE COMMISSION, supra note 388; FEDERAL TRADE COMMISSION, Pfizer, Pharmacia

Will Divest Assets to Settle FTC Charges, Press Release (Apr. 14, 2003),

https://www.ftc.gov/news-events/press-releases/2003/04/pfizer-pharmacia-will-divest-assets-settle-

ftc-charges, last visited on Oct. 8, 2016.

393 FEDERAL TRADE COMMISSION, Biovail Corp. & Elan Corp., FTC DOCKET NO. C-4057 (Aug. 15,

2002), available at https://zh.scribd.com/document/1192402/US-Federal-Trade-Commission-

biovalcmp; FEDERAL TRADE COMMISSION, Press Release, Consent Order Resolves Charges that

Biovail and Elan Agreement Unreasonably Restrained Competition in Market for Generic Anti-

Hypertension Drug (Jun. 27, 2002), https://www.ftc.gov/news-events/press-

releases/2002/06/consent-order-resolves-charges-biovail-and-elan-agreement, last visited on Oct.

8, 2016.
https://www.ftc.gov/news-events/press-releases/2003/04/pfizer-pharmacia-will-divest-assets-settle-ftc-chargeshttps://www.ftc.gov/news-events/press-releases/2003/04/pfizer-pharmacia-will-divest-assets-settle-ftc-chargeshttps://www.ftc.gov/news-events/press-releases/2002/06/consent-order-resolves-charges-biovail-and-elan-agreementhttps://www.ftc.gov/news-events/press-releases/2002/06/consent-order-resolves-charges-biovail-and-elan-agreement

124

FTC 394

Biovail-Elan

FTC

FTC

395

Times-Picayune Publishing Co. v. United States 396

cross elasticity of demand

397

Ec =

Ec>0


395 Id. 362 at 647-648.

396 Times-Picayune Pub. Co. v. United States, 345 U.S. 594, 612, n31 (1953).

397 2014 9 214

125

Ec

126

practical indicia

quantitative

qualitative

402

403

United States v. E. I. du Pont de Nemours & Co.404

405


403 In re Cardizem CD Antitrust Litigation, 200 F.R.D. 297, 311 (E.D. Mich. 2001)

; Geneva Pharms. Tech. Corp. v. Barr Labs., Inc., 201 F. Supp. 2d 236, 268 (S.D.N.Y. 2002)(quoting

In re Cardizem CD Antitrust Litigation).

404 supra note 401, at 404.


127

406

consumer system

407

third party

payermanaged care

8.

In re Cardizem CD Antitrust Litigation 408

consumer patient

409

406 Id. at 597, n43.

407 Id. at 598.

408 In Re Cardizem CD Antitrust Litigation, 105 F. Supp. 2d 618 (E.D. Mich. 2000).


128

FDA 1997

Direct-to-Consumer DTC410

18

90% DTC 411

2002 FDA

89% DTC

412

DTC

DTC

101413

410 Ziad F. Gellad & Kenneth W. Lyles, Direct-to-Consumer Advertising of Pharmaceuticals, 120 AM.

J.MED. 475, 476 (2007), available at

http://psychrights.org/research/Digest/CriticalThinkRxCites/gellad.pdf.

411 Kathryn J. Aikin, John L. Swasy & Amie C. Braman, Patient and Physician Attitudes and Behaviors

Associated With DTC Promotion of Prescription Drugs - Summary of FDA Survey Research

Results, 2 (2004), available at

http://www.fda.gov/downloads/drugs/scienceresearch/researchareas/drugmarketingadvertisingandc

ommunicationsresearch/ucm152860.pdf.

412 Gellad & Kenneth W. Lyles, supra note 410, at 478.

413 Meredith B. Rosenthal, Ernst R. Berndt, Julie M. Donohue, Arnold M. Epstein & Richard G.

Frank, Demand Effects of Recent Changes in Prescription Drug Promotion, 6 FRONTIERS HEALTH

POL'Y RES. 1, 16 (2003), available at http://www.nber.org/chapters/c9862.pdf.

129

414

415

In re Schering-Plough Corp.416

417

418


415 United States v. Ciba Geigy Corp., 508 F. Supp. 1118, 1126 (D.N.J. 1976)

; FTC v. Lundbeck, Inc. NOS. 08-6379 (JNE/JJG), 08-6381 (JNE/JJG), 2010 WL 3810015, at 15-19,

21 (D. Minn. Aug. 31, 2010).

416 In re Schering-Plough Corp., No. 9297, 2002 WL 1488085, at 62 (F.T.C. June 27, 2002).


418 U.S. DEPARTMENT OF JUSTICE (DRUG ENFORCEMENT ADMIN. OFFICE OF DIVERSION CONTROL),

Practitioner's Manual: Section V - Valid Prescription Requirements,

http://www.deadiversion.usdoj.gov/pubs/manuals/pract/section5.htm, last visited on Oct. 9, 2016.

130

419

420healthcare community

421

entity

422

423

Barr Laboratories, Inc. v. Abbot Laboratories

424

419 Rosenthal, Ernst R. Berndt, Julie M. Donohue, supra note 413, at 6.


421 U.S. DEPARTMENT OF JUSTICE (DRUG ENFORCEMENT ADMIN. OFFICE OF DIVERSION CONTROL),

supra note 418.

422 Rosenthal, Ernst R. Berndt, Julie M. Donohue, supra note 413, at 4.


424 Barr Lab., Inc. v. Abbott Lab., 978 F.2d 98 (3d Cir. 1992).

131

425

therapeutic interchange

426

427

428

429

425 Id. at 109; Morse, supra note 362 at 662.

426 William H. Shrank, et. al., State Generic Substitution Laws Can Lower Drug Outlays Under

Medicaid, 29 HEALTH AFFAIRS 1383, 1384 (2010).

427 FEDERAL TRADE COMMISSION, Pharmacy Benefit Managers: Ownership of Mail-Order Pharmacies

i (2005), at 81, available at https://www.ftc.gov/reports/pharmacy-benefit-managers-ownership-

mail-order-pharmacies-federal-trade-commission-report.

428 Daniel R. Levinson (Dep't of Health and Human Servs., Office of Inspector Gen.), Generic Drug

Utilization in State Medicaid Programs, at ii (2006), available at https://oig.hhs.gov/oei/reports/oei-

05-05-00360.pdf.


132

PBM

PBM

claim adjudication

430

PBM

95%

431

PBM

Pharmacy & Therapeutics committees

P&T

432

PBM PBM

433

PBM

PBM

434

430 Id. at 603-606.

431 U.S. DEPARTMENT OF JUSTICE & FEDERAL TRADE COMMISSION, Improving Health Care: A Dose

of Competition ch. 7, 11-12 (2004), available at

https://www.ftc.gov/sites/default/files/documents/reports/improving-health-care-dose-competition-

report-federal-trade-commission-and-department-justice/040723healthcarerpt.pdf.

432 Id. at 10.

433 Id. at 13.


133

435

PBM

436

437

PBM P&T

P&T

distributionconsumption438


436 U.S. National Library of Medicine, Definition of Managed Care,

http://www.nlm.nih.gov/medlineplus/managedcare.html, last visited on Oct. 9, 2016.



134

439

1.

440

441

439 Id. at 612-614.

440 Id. at 612-613.

441 Cong. Budget Office, How the Medicaid Rebate on Prescription Drugs Affects Pricing in the

Pharmaceutical Industry 1 (1996) (quoting F.M. Scherer, Pricing, Profits, and Technological

PBM

135

442

interchangeability

Fed. Trade Comm'n v. Lundbeck, Inc.443

neonatologists

Indocin IV NeoProfen

444

Indocin

IV NeoProfen

445

446 FTC

Progress in the Pharmaceutical Industry, 7 J. ECON. PERSP. 97, 99 (1993)); FEDERAL TRADE

COMMISSION, supra note 427, at 44.


443 Fed. Trade Comm'n v. Lundbeck, Inc., NOS. 08-6379 (JNE/JJG), 08-6381 (JNE/JJG), 2010 WL

3810015, at 16-21 (D. Minn. Aug. 31, 2010).

444 FTC v. Lundbeck, Inc., NO. 10-3458/3459, at 5-6 (8th Cir. Aug. 19, 2011).


3810015, at 16-21 (D. Minn. Aug. 31, 2010).


3810015, at 16-18 (D. Minn. Aug. 31, 2010).

136

Patent Ductus Arteriosus, PDA447

448

449

450

PBM

PBM P&T

451

447 FTC v. Lundbeck, Inc., NO. 10-3458/3459 , at 6 (8th Cir. Aug. 19, 2011).


449 Fed. Trade Comm'n v. Lundbeck, Inc., NOS. 08-6379 (JNE/JJG), 08-6381 (JNE/JJG), 2010

WL 3810015, at 18-19 (D. Minn. Aug. 31, 2010).


451 Christopher L. Sagers, Richardm. Brunell, W. Joseph Bruckner, Brief for American Antitrust

Institute as Amicus Curiae Supporting Appellants, 20, n5(Jan. 3, 2011), available at

https://www.ftc.gov/sites/default/files/documents/cases/2011/01/110103lundbeckbriefamerican.pdf

; FTC v. Lundbeck, Inc., NOS. 10-3548, 10-3549, 2010 WL 3810015, at 16-21 (D. Minn. 2011)

appeal docketed, NOS. 08-6379 (JNE/JJG), 08-6381 (JNE/JJG) (8th Cir. Jan 3, 2001), available at

http://www.antitrustinstitute.org/sites/default/files/AAI%20Amicus%20Brief_0.pdf.

137

452

non-price

453

454

telescoping demand

DTC

455


453 Sagers, supra note 451, at 8; U.S. DEP'T OF JUSTICE & FED. TRADE COMM'N, supra note 369, 1,

Overview, at 2.

454 Sagers, supra note 451, at 2,4; Vaishnav, supra note 361 , at 615-616.

455 Gellad & Kenneth W. Lyles, supra note 410, at 478.

138

85%

decouple

456

457

50 United States v. E. I. du Pont de Nemours

& Co.458

characteristic

competing commodities

459

utility



458 supra note 401, at 404.

459 Id. at 380-381.

139

460

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藥品專利連結制度與競爭法規範之研究 · i 105 年委託研究報告2 pg10502-0235...