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...
Transcript of 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...
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Hatch-Waxman Act .........................9
Medicare Prescription Drug, Improvement, and Modernization
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5. 2015 ............................................... 102
6. 2015 .................................................... 104
7. FTC ................................................................................. 120
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10. ........................................... 240
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12. B.II. ..................................................... 247
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14. Lundbeck ............................................................... 285
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19. 2015 ..................................... 358
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TIFA
TPPpatent
linkage 2016 8 4
14 15
25
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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
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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
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patent linkage
30
2015 11 5
Trans-Pacific Strategic Economic Partnership Agreement, TPP
18 18.51
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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.
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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
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4
2015
2016 8 4
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5
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6
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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
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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).
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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).
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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
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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
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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
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(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
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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)
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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.
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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).
75 Kelly, supra note 14, at 425.
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.
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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
81 Kelly, supra note 14, at 427.
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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
84 Kelly, supra note 14, at 427.
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
86 Kelly, supra note 14, at 427.
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).
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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.
92 Kelly, supra note 14, at 429.
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.
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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).
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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).
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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
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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).
116 Kelly, supra note 14, at 429.
117 Mova Parmaceuticals, Corp. v. Shalala, 140 F.3d 1060 (D.C. Cir. 1998).
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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.
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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.
133 Kelly, supra note 14, at 440.
-
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).
139 21 U.S.C. 355(j)(5)(D)(i)(I).
140
2015 245Kelly, supra note 14, at 440.
141 9 200-201Kelly, supra note 14, at 440-441.
142 21 U.S.C. 355(j)(5)(D)(i)(II).
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
FTC Assistant Attorney General
Antitrust Agencies147
148:
1. 1112 (a)-Generic-Brand Agreements
MMA 1112 (a) FFDCA 505 (j)(2)(A)(vii)(IV)
48 8 4 certification
ANDA
abrand name drug
b ANDA
c ANDA ANDA
FFDCA 505 (j)(5)(B)(iv) 180 180
1112 (c)
1112 (a)(1)
ANDA
2. 1112 (b)-Generic-Generic Agreements
147 MMA Title XI 1112 48 19 :
20
92 2
148 FEDERAL TRADE COMMISSION, Pharmaceutical Agreement Filings Overview (2004),
https://www.ftc.gov/tips-advice/competition-guidance/industry-guidance/health-
care/pharmaceutical-agreement-filings, last visited on Aug. 5, 2016.
-
40
MMA 1112 (b)a listed drug
FFDCA 505 (j)(2)(A)(vii)(IV)certification ANDA
ANDA
FFDCA 505 (j)(5)(B)(iv) 180
1112 c
1112 (b)(1)
ANDA
3. MMA 1112(c)(1) 1112(a)(b)
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
ANDA
1112(a)(1) 1112(b)(1)149
MMA 2004 1 7
150
FTC
149 FEDERAL TRADE COMMISSION, supra note 148, at 2.
150 MMA Title XI 1113.
-
41
151 MMA 1115
FTC 152
equitable relief153
1984 HWA
45 HWA
30 180
HWA
154 FDA
P4 180 HWA
FFDCA505(b)(2) ANDA
FDA
Acknowledgment Letter
155156
151 MMA Title XI 1115(a).
152 MMA Title XI 1115(b); Kelly, supra note 14, at 441.
153 FEDERAL TRADE COMMISSION, supra note 148, at 3.
154 21 U.S.C.355(b)(3)(C)355(j)(2)(B)(iii)(1984).
155 21 C.F.R.314.52(f)314.95(f)314.101(1994).
156 9 92
-
42
MMA
MMA ANDA
P4 FDA 20
157
158
FDA
45
1984 HWA
HWA FFDCA Act
/
45
159 ANDA P4
160
180
P4
157 Kelly, supra note 14, at 440.
158 9 88
159 8 73
160 9 158
-
43
HWA 161
MMA
MMA
Declaratory Judgment162
45
Declaratory Judgment Act
163 P4
164
165
MMA
FDA 166 P4
167
45
168
161 9 158159
162 21 U.S.C. 355(j)(5)(C)(i).
163 28 U.S.C. 2201(a).
164 21 U.S.C. 355(j)(5)(C)(i)(I).
165 35 U.S.C. 271(e)(5).
166 21 U.S.C. 355(j)(5)(C)(i)(III).
167 21 U.S.C. 355(j)(5)(C)(i)(III); Kelly, supra note 14, at 441.
168 9 163-166
-
44
HWA
180 P4
45 30
30 180
2003 MMA
30
MMA
169
Preserve Access to Affordable Generics Act, S.2019
169 :
39 4 3712010 12
-
45
Prescription Drug Affordability Act of 2015, H.R.3513
170
HWA
MMA
2004 5 18 U.S.-Australia Free
Trade Agreement USAFTA171
USAFTA
170
Mr. Cummings, H.R.3513 - PRESCRIPTION DRUG
AFFORDABILITY ACT OF 2015, https://www.congress.gov/bill/114th-congress/house-
bill/3513/text?q=%7B%22search%22%3A%5B%22Fair+Prescription+Drug+Competition+Act%2
C+S.438%22%5D%7D&resultIndex=3, last visited on July. 8, 2016 Activas
Sen. Klobuchar, Amy [D-MN], S.2019 - Preserve Access to Affordable Generics Act,
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2C+S.316%22%5D%7D&resultIndex=2, last visited on July. 8, 2016.
171 OFFICE OF UNITED STATES TRADE REPRESENTATIVE, USAFTA, https://ustr.gov/trade-
agreements/free-trade-agreements/australian-fta/final-text, last visited on Jul. 17, 2016.
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46
17 17.10 4 172
173
2004 8 13
the US Free Trade Implementation Act 2004
1989 Therapeutic Goods Act 1989 TGA 26B-
26D 2005 1 1
172 Article 17.10. Where a Party permits, as a condition of approving the marketing of a
pharmaceutical product, persons, other than the person originally submitting the safety or efficacy
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,
the Party shall provide for the patent owner to be notified of such request and the identity of any
such other person.., OFFICE OF UNITED STATES TRADE REPRESENTATIVE, supra note 171.
173 17
3 2005 3 3
-
47
174
interlocutory injunction
Australian Register of Therapeutic Goods175
2013
USAFTA 176
174 200 2015
4 95
175 AUSTRALIA GOVERNMENT-DEPARTMENT OF HEARLTH, Australian Register of Therapeutic
Goods, http://www.tga.gov.au/australian-register-therapeutic-goods, last visited on Jul. 17,
2016 174 96
176 Harris, T., Nicol, D., Gruen, N., 2013 Pharmaceutical Patents Review Report, Canberra, available
at https://www.ipaustralia.gov.au/sites/g/files/net856/f/2013-05-27_ppr_final_report.pdf
174 96
-
48
TGA
177: 1
acting in good faith
non-infringement certificate1782
TPA
11
55 179 2
177 (1)The certificate required under this subsection is either:
(a) a certificate to the effect that the applicant, acting in good faith, believes on reasonable
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
TGA
: 1
23
180
3
181 2
TGA 1
23
182
180 TGA26 C (1) - (3)
2013 39?
21 3
2009 3 39
181 7 48
182 TGA26 C (4) 180 40 180 39
-
50
Attorney General
183TGA
1 184
2
185
TGA
TGA
186
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
187
State
Territory
188
189
National Health
Act National Health Pharmaceutical Benefits
RegulationsPharmaceutical Benefits Scheme PBS
190Generic Medicines
Industry Association Pty Ltd
187 TGA26 D (4) 180 41
188 TGA26 C (8).
189 TGA26 D (5) 180 40
190 26
(2012-2013)
http://www.nhi.gov.tw/Resource/webdata/23978_1_1020715%E5%9C%8B%E9%9A%9B%E8%9
7%A5%E5%83%B9%E6%94%BF%E7%AD%96%E8%88%87%E7%AE%A1%E7%90%86%E5
%88%B6%E5%BA%A6%E8%AE%80%E6%9B%B8%E6%9C%83%E6%9C%83%E8%AD%B0
%E8%B3%87%E6%96%99.pdf2016 7 17
-
52
2010
PBS Clopidogrel PBS 6 4 4
191 PBS
2013
192
5
Trans-Pacific Partnership TPP
Patent Trial and Appeal Board PTAB
Korean Intellectual Property Tribunal KIPT
191 Generic Medicines Industry Association Pty Ltd, Key Facts You Need to Know about Generic
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192 T., Nicol, D., Gruen, N., supra note 176 174 96
-
53
1.
20
45
()
30
180
FTC
193DOJ
194
2007 6 30 United States-Korea
Free Trade Agreement KORUS FTA195
193 Federal Trade Commission FTC
194 Department of Justice DOJ
195 OFFICE OF UNITED STATES TRADE REPRESENTATIVE, U.S. - Korea Free Trade Agreement, ,
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2016.
-
54
2012 3 15 18.9.5 196
:rely on
197
2012 3 15
regulatory stay of
the approval of generic productexclusivity rights
The Ministry of Food and
196 KORUS FTA Article 18.9.5 Where a Party permits, as a condition of approving the marketing of
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.;
OFFICE OF UNITED STATES TRADE REPRESENTATIVE, supra note 195.
197 Mee-Sung SHIM, Kevin Kyumin LEE and Eun Sun CHOIDraft Legislation of Pharmaceutical
Affairs Act for Korean Patent-Regulatory Approval Linkage System, Sep 2014, at 1-2, available
at http://www.kimchang.com/newsletter/20140508/img/KC_IP_Newsletter_Spring_2014.pdf.
166 2014 10 24 4
-
55
Drug Safety MFDS 2014 3 21 Korea
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198 MFDS 2015 3 15
199
KPAA 31 23 50 2
:
200 87 201 30
198 2015
5 27
199 2015 3
http://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%95%BD%EC%82%AC%EB%B2%95
: 2016 8 8
200
https://www.tipo.gov.tw/dl.asp?fileName=62418342560.docx: 2016 7 25
201 2013 87 :
1
2
1. 79 1
2. 81 1
3. 81-2 2
4. 81-3 1
-
56
MFDS
Green List
123
456
7202
MFDS
drug substancedosage formcomposition
pharmaceutical use
203
204 MFDS KPAA
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3 2
4
5 3
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203 2015 3 13 50 2 4
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at 1-2Ki Young Kim, Hyunsuk Jin, Samuel SungMok Lee, The Korean Drug Approval-Patent
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visited on Jul.17, 2016.
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57
205
20612
KPAA 50 2 4 3
207
208
209
2015
12
34
Korean Intellectual Property Tribunal KIPT
5
6
patent certification MFDS210
4
205 2015 3 13 50 3 1
206 2015 3 13 50 2 5
207 2015 3 13 50 3 4
208 2015 3 13 50 3 3
209 2015 3 13 50 3 5 Kim, Hyunsuk Jin, Samuel
SungMok Lee, supra note 204, at 2.
210 Proposed Amendments to the Pharmaceutical Affairs Act, Article 50-4 (1),(2014); Enforcement
Regulation on the Safety of Pharmaceuticals, etc., Article 4(1) Subparagraph 10.
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58
Korean Intellectual
Property Office KIPO KIPT
211 KIPO
12 212
213
2012 KIPO
KIPT
2014 KPAA 4
KPAA 31 23
9
21412
3
211 174 99
212 YAKUP.COM, Why the Commissioner of the KIPO Meet CEOs of Pharmaceutical Companies?,
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Jeong, Seung Joo, Patent-Drug Approval Linkage in Korea Under Korea-U.S. FTA - Based on
Comparative Study on U.S. Hatch-Waxman Act and Canadian Patented Medicines (Notice of
Compliance) Regulation (Sep. 12, 2013). MIPLC Master Thesis Series (2012/13), available at
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213 Young Sun Cho, Hyunsuk Jin, Overview and implications of the drug patent-approval linkage
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214 2015 3 13 50 4 1
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59
4
20
215
KPAA Enforcement Regulations of
KPAA12
bioequivalence
3
216 20
MFDS 217
MFDS
218
MFDS MFDS
219
45 9
45 KIPT 126
215 2015 3 13 50 4 12
216 Enforcement Regulations of Korea Pharmaceutical Affairs Act, Decree No. 162 (Oct. 18, 2012),
Article 30quarter, Paragraph 1.
217 2015 3 13 50 4 6
218 2015 3 13 50 4 4
219 2015 3 13 50 4 5
-
60
220 135221
2221
2 KPAA 50-5 2
MFDS 223 MFDS
220 2013 126 :
1
2
221 2013 135 :
1
2 1
222 2015 3 13 50 5 2
223 2015 3 13 50 5 1
-
61
1KIPT 162 224 189 225
2KIPT
224 2013 162 :
1
2 1
1.
2.
2-2
3.
4. 138
5.
6.
3
4 3
5 3 20
6
225 2013 189 :
1 186 1
2 1
3 1
-
62
162 189
3KIPT 43
3
226
MFDS
227
MFDS KPAA 50 6 1
1 KPAA 50 5 1 45
2
3 KPAA 50 5 2
4
5 KPAA 50 4
6
7 KPAA 50 5 4
8
226 2015 3 13 50 5 4
227 2015 3 13 50 5 5
-
63
106 1 228 106 2 1 229 107
9 230 KPAA 50 6
2 7
178 231
MFDS 123
232233
234235
228 2013 189 : 106 :
1
229 2013 106-2 :
1
https://www.tipo.gov.tw/dl.asp?fileName=62418342560.docx:2016.7.25
230 2015 3 13 50 6 1
231 2013 178 :
1
2 1 451 453
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:2016.7.25
232 2015 3 13 50 11 1
233 2015 3 13 50 11 3
234 Young, Hyunsuk Jin, supra note 213, at 3.
235 2015 3 13 50 11 2
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64
suspendremove
236
KPAA 50 6 3 9
Korea Fair Trade Commission
KFTC
50 7 Monopoly Regulation
Fair Trade Act of Korea 3 2 1 19 1
23 1
KPAA 237
238KPAA
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236 2015 3 13 50 6 3 1-810
237 Young, Hyunsuk Jin, supra note 213, at 3.
238 Id. at 4.
239 2013 133 :
1
3
2
-
65
134240135
1. 25 29 32 36 1 3 42 3 1
4
2. 33 1 44
3. 33 1
4. 25
5.
6. 47 2
7. 52 1
8. 53 1
2
3 1 4
4 1
240 2013 134 :
1 92
1. 89
2. 89
3.
4.
5. 90 3
6.
-
66
241 KPAA 50 4
MFDS
efficacy
242
9 243
2 244
MFDS
MFDS 245 MFDS
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1. 92-2
2.
3. 92-3 3
3 1 2 133 2 4
4
1. 1 3
2. 2 1 92-2
241 2015 3 13 50 7 2 SHIM, supra note 197, at 3.
242 2015 3 13 50 7 1 50 9 1
243 2015 3 13 50 9 2
244 2015 3 13 50 9 2
41 1 2 2
245 2015 3 13 50 8 1 1
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67
KPAA 50 7 2
9 MFDS
246
KPAA 247
178
KFTC 3
2 1 19 1 23 1
248 MFDS
249
1
2
KPAA
15
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246 2015 3 13 50 8 1 2
247 2015 3 13 50 10 1
248 2015 3 13 50 10 2 1-4
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68
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254 2015 3 13 50 12
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69
2.
20 20
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30
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255 1992 8 12 17 1709 5
255 CANADA GOVERNMENT, Text of the North American Free Trade Agreement (NAFTA),
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70
256
1993
nominalcompulsory license
257 55.24The
Governor in Council258
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Notice of Compliance PMNOC
Abbreviated New Drug Submission ANDS
Health Canada
Notice of Compliance NOC
259
256 Article 1709.5: Each Party shall provide that:
(a) where the subject matter of a patent is a product, the patent shall confer on the patent owner the
right to prevent other persons from making, using or selling the subject matter of the patent, without
the patent owner's consent; and
(b) where the subject matter of a patent is a process, the patent shall confer on the patent owner the
right to prevent other persons from using that process and from using, selling, or importing at least
the product obtained directly by that process, without the patent owner's consent; CANADA
GOVERNMENT, supra note 255.
257 Jeong, Seung Joo, supra note 212, at 14.
258 180 35
259 Suzanne Marie Porter, Canadas Patented Medicines(Notice of Compliance)Regulation:
Removing Inefficiencies to Encourage Generic Competition (2011), at 17-18, A thesis for the
degree of Master of Laws of Toronto University, available at
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71
19981999 2006
260
PMNOC
patent registernotice of allegation45 24
automatic stay
New Drug Submission NDS
patent list
261
262medicinal
ingredientformulationdosage formindication
263
264saltsesters
enantiomerssolvates
265
https://tspace.library.utoronto.ca/bitstream/1807/31388/1/Porter_Suzanne_M_201111_LLM_thesis
.pdf.
260 174 94
261 PM(NOC) Regulations4 (1),(5).
262 Porter, supra note 259, at 16.
263 PM(NOC) Regulations4 (2).
264 PM(NOC) Regulations4 (3).
265 Health Canada, Guidance Document: Patented Medicines (Notice of Compliance)Regulations
(2012), Page 8, 10 180 30
18 12 2006 12 6
-
72
NDS 12
3
4
5
266 3 NDS
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30
PMNOC267
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268
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270
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268 PM(NOC) Regulations3 (2) 180 35
269 PM(NOC) Regulations3 (8).
270 Health Canada, Guidance Document: Patented Medicines (Notice of Compliance)
Regulations (2012), Page15 180 31
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73
ANDS
NOC
1statementPMNOC
4 (4) (d)23
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PMNOC
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275
45 24
45
271 PM(NOC) Regulations5 (1).
272 Jeong, Seung Joo, supra note 212, at 17-18.
273 PM(NOC) Regulations5 (4).
274 PM(NOC) Regulations5 (3) 180 34
275 PM(NOC) Regulations5 (1)(b) 174 96
-
74
PMNOC
276
ANDA
judicial review
application
parallel patent actions
NOC
277
PMNOC
24
278,279
280
281
276 174 98
277 98 Jeong, Seung Joo, supra note 212, at 18.
278 PM(NOC) Regulations7.
279 Jeong, Seung Joo, supra note 212, at 18.
280 174 99
281 PM(NOC) Regulations6 (2).
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75
282
24 283
284
24 PM
NOC 8 PMNOC
285
286
287
PMNOC
288
289290
282 PM(NOC) Regulations6 (5).
283 PM(NOC) Regulations7 (5).
284 PM(NOC) Regulations7 (4) 180 34-35
285 PM(NOC) Regulations8 (1).
286 PM(NOC) Regulations8 (2).
287 180 37
288 PM(NOC) Regulations8 (3).
289 PM(NOC) Regulations8 (5).
290 PM(NOC) Regulations8 (6) 180 35-36
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76
PMNOC
PMNOC
NOC
291parallel
proceeding
292
293
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Naproxen PMNOC
291 Porter, supra note 259, at 26.
292 E. Iacobucci, Innovation for a Better Tomorrow: A Critique, at 20 (2011), available at:
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0Tomorrow%20-%20A%20Critique_FINAL.pdf, last visited: Jul. 19, 2016 Porter,
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293 Porter, supra note 259, at 27-28.
294 Hoffmann-LaRoche Ltd. v. Apotex Inc., File No. T-1898-93, April 30, 1999.
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77
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Apotex NOC
295
296
PMNOC
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297
295 E. Hore, A Comparison of United States and Canadian Laws as They Affect Generic
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LaRoche Ltd. v. Apotex Inc., File No. T-1898-93, April 30, 1999.) Porter, supra note 259,
at 28.
296 Porter, supra note 259, at 30.
297 P. Grootendorst, and A. Hollis, The Canada-European Union Comprehensive Economic &
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298 PM
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300
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301 PMNOC 8
298 Porter, supra note 259, at 30-31.
299 Id. at 31-32.
300 174 99
301 99
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79
302
303
PMNOC
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12 PMNOC304
PMNOC
305 PMNOC
ANDS
43 306 PMNOC
24
302 R.A. Bouchard et al., Structure-Function Analysis of Global Pharmaceutical Linkage Regulations,
12 MINN. J.L. SCI. & TECH. 391, 407, n47 (2011) Porter, supra note 259, at 37.
303 Porter, supra note 259, at 36-37.
304 Bouchard et al., supra note 302, at 399 Porter, supra note 259, at 37.
305 Porter, supra note 259, at 37.
306 Id. at 38.
-
80
307
3.
20
45
45 PMNOC
30 24
180
FTCDOJ
308
307 Id. at 36-38.
308 (Canadian Competition Bureau) 2014 9 23
John Pecman (Canadian
Commissioner of Competition), Remarks at the Global Antitrust Institute Conference: Global
Antitrust Challenges for the Pharmaceutical Industry (2014),
http://www.competitionbureau.gc.ca/eic/site/cb-bc.nsf/eng/03817.html, last visited on Jul. 20,
2016 174 98
-
81
Trade and Investment Framework
Agreement, TIFATrans-
Pacific Strategic Economic Partnership AgreementTPP
2014
2016 8 4
48 3
48 3 2 1
-
82
48 4 1 48 3
2
48 4
48 7
48 5
48 3
-
83
48 6
1
48 6 2
48 4 2
48 6
82 2
48 4 1 1
48 6 1
48 3 1 48 5
48 6
48 7
48 7 1
-
84
48 3
2
48 7 2 3
1
48 8
48 7
48 22
48 9
48 9
48
9
48 10
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85
48 9 1 2
48
11 48 9 3
48 11
48 9 3
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48 12 1 48 9 4
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1 2
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89
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48 18
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48
3 48 4
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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
-
97
-
98
-
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
334 Danzon, supra note 330, at 6.
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.
343 Guha, Andrew M. Lacy, Sally Woodhouse, supra note 339, at 7.
-
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.
345 Danzon, supra note 330, at 15.
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
352 Danzon, supra note 330, at 15.
353 Id. at 15-16.
-
112
PBM
354
355
10-30%
80-90%356
357
PBM
net price
358
354 Guha, Andrew M. Lacy, Sally Woodhouse, supra note 339, at 7.
355 Danzon, supra note 330, at 10.
356 Id. at 16.
357 Guha, Andrew M. Lacy, Sally Woodhouse, supra note 339, at 7.
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
359 Danzon, supra note 330, at 16.
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
366 Vaishnav, supra note 361 , at 591.
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.
382 Morse, supra note 362 at 649-650.
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.
391 Morse, supra note 362 at 648-649.
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
394 Morse, supra note 362 at 645.
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
402 Morse, supra note 362 at 663.
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.
405 Vaishnav, supra note 361 , at 595.
-
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).
409 Morse, supra note 362 at 661.
-
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
414 Vaishnav, supra note 361 , at 601.
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).
417 Morse, supra note 362 at 661.
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.
420 Vaishnav, supra note 361 , at 603.
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.
423 Vaishnav, supra note 361 , at 602-604.
424 Barr Lab., Inc. v. Abbott Lab., 978 F.2d 98 (3d Cir. 1992).
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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.
429 Vaishnav, supra note 361 , at 607-608.
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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.
434 Vaishnav, supra note 361 , at 606.
-
133
435
PBM
436
437
PBM P&T
P&T
distributionconsumption438
435 FEDERAL TRADE COMMISSION, supra note 427, at 8.
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.
437 Morse, supra note 362 at 662.
438 Vaishnav, supra note 361 , at 610-612.
-
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.
442 Vaishnav, supra note 361 , at 614.
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).
445 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).
446 Fed. Trade Comm'n v. Lundbeck, Inc., NOS. 08-6379 (JNE/JJG), 08-6381 (JNE/JJG), 2010 WL
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).
448 Vaishnav, supra note 361 , at 615.
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).
450 Vaishnav, supra note 361 , at 615.
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
452 Vaishnav, supra note 361 , at 615.
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
456 FEDERAL TRADE COMMISSION, supra note 427, at 81.
457 Vaishnav, supra note 361 , at 623-624.
458 supra note 401, at 404.
459 Id. at 380-381.
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139
460