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Volumn 34, Issue 2-3, 2008, Pages 107-124

Delivering drugs to the poor: Will the TRIPS amendment help?

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

EID: 58149111234     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: 10.1177/009885880803400202     Document Type: Conference Paper
Times cited : (24)

References (102)
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    • Concerning access, patents are not the issue but the overwhelming poverty of individuals, absence of state healthcare financing, lack of medical personnel, transport and distribution infrastructure plus supply chain charges which can make affordable originator or generic products unaffordable. In many countries, medicines are unaffordable from whatever source, price or patent status. Trevor Jones, Commentary, in PUBLIC HEALTH INNOVATION AND INTELLECTUAL PROPERTY RIGHTS: REPORT OF THE COMMISSION ON INTELLECTUAL PROPERTY RIGHTS, INNOVATION AND PUBLIC HEALTH 202 (World Health Organization ed., 2006), available at www.who.int/intellectualproperty/ documents/thereport/en/index.html.
    • "Concerning access, patents are not the issue but the overwhelming poverty of individuals, absence of state healthcare financing, lack of medical personnel, transport and distribution infrastructure plus supply chain charges which can make affordable originator or generic products unaffordable. In many countries, medicines are unaffordable from whatever source, price or patent status." Trevor Jones, Commentary, in PUBLIC HEALTH INNOVATION AND INTELLECTUAL PROPERTY RIGHTS: REPORT OF THE COMMISSION ON INTELLECTUAL PROPERTY RIGHTS, INNOVATION AND PUBLIC HEALTH 202 (World Health Organization ed., 2006), available at www.who.int/intellectualproperty/ documents/thereport/en/index.html.
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    • ERICH KAUFFR, THE ECONOMICS OF THE PATENT SYSTEM 6 (1989).
    • ERICH KAUFFR, THE ECONOMICS OF THE PATENT SYSTEM 6 (1989).
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    • Giulio Mandich, Patent Law of Venice (1450-1550), 30 J. PAT. OFF. SOC'Y 157, 176 (F.D. Prager trans., 1948) (quoting Sen. Terra reg. 7 p. 32).
    • Giulio Mandich, Patent Law of Venice (1450-1550), 30 J. PAT. OFF. SOC'Y 157, 176 (F.D. Prager trans., 1948) (quoting Sen. Terra reg. 7 p. 32).
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    • Id. at 177 (quoting Sen. Terra reg. 7 p. 32).
    • Id. at 177 (quoting Sen. Terra reg. 7 p. 32).
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    • 61449184007 scopus 로고    scopus 로고
    • Patent Systems as Regulatory Institutions, 54 INDIAN
    • Graham Dutfield, Patent Systems as Regulatory Institutions, 54 INDIAN ECON. J., 62, 65 (2006).
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    • Dutfield, G.1
  • 8
    • 61449150905 scopus 로고    scopus 로고
    • This point applies to those developing countries that have attained a reasonable capacity to adopt and benefit from such technologies. Countries with very limited capacity have far less to gain from free access to technologies. However, the relationship between technology transfer and levels of intellectual property protection is extremely complicated and generalizations should be made with extreme caution, if at all. See Keith E. Maskus, The Role of Intellectual Property Rights in Encouraging Foreign Direct Investment and Technology Transfer, 9 DUKE J. COMPARATTVE INT'L L. 109 1998
    • This point applies to those developing countries that have attained a reasonable capacity to adopt and benefit from such technologies. Countries with very limited capacity have far less to gain from free access to technologies. However, the relationship between technology transfer and levels of intellectual property protection is extremely complicated and generalizations should be made with extreme caution, if at all. See Keith E. Maskus, The Role of Intellectual Property Rights in Encouraging Foreign Direct Investment and Technology Transfer, 9 DUKE J. COMPARATTVE INT'L L. 109 (1998).
  • 9
    • 61449247633 scopus 로고    scopus 로고
    • European Community Patent Convention, 1989 O.J, L 401
    • European Community Patent Convention, 1989 O.J. (L 401).
  • 10
    • 61449244974 scopus 로고    scopus 로고
    • Patents Act, 1977, c. 37, 60(5) (Eng.).
    • Patents Act, 1977, c. 37, 60(5) (Eng.).
  • 11
    • 61449108495 scopus 로고    scopus 로고
    • Id
    • Id.
  • 12
    • 61449194642 scopus 로고    scopus 로고
    • See, e.g., Inhale Therapeutic Systems Inc. v. Quadrant Healthcare Plc, [2002] R.P.C. 21 (Eng. Pat. Ct.).
    • See, e.g., Inhale Therapeutic Systems Inc. v. Quadrant Healthcare Plc, [2002] R.P.C. 21 (Eng. Pat. Ct.).
  • 13
    • 61449083101 scopus 로고    scopus 로고
    • William R. Cornish, Experimental Use of Patented Inventions in European Community States, 29 INT'L REV. INDUS. PROP. & COPYRIGHT L. 735, 735-36 (1998).
    • William R. Cornish, Experimental Use of Patented Inventions in European Community States, 29 INT'L REV. INDUS. PROP. & COPYRIGHT L. 735, 735-36 (1998).
  • 15
    • 61449113351 scopus 로고    scopus 로고
    • For examples of how basic research carried out in universities, hospitals and government research agencies contributed to major biomedical revolutions, see GRAHAM DUTFIELD, INTELLECTUAL PROPERTY RIGHTS AND THE LIFE SCIENCE INDUSTRIES: A TWENTIEITH CENTURY HISTORY 2003, hereinafter DUTFIELD, LIFE SCIENCE
    • For examples of how basic research carried out in universities, hospitals and government research agencies contributed to major biomedical revolutions, see GRAHAM DUTFIELD, INTELLECTUAL PROPERTY RIGHTS AND THE LIFE SCIENCE INDUSTRIES: A TWENTIEITH CENTURY HISTORY (2003) [hereinafter DUTFIELD, LIFE SCIENCE].
  • 16
    • 61449117290 scopus 로고    scopus 로고
    • Madley, 307 F.3d at 1362,
    • Madley, 307 F.3d at 1362,
  • 17
    • 61449258747 scopus 로고    scopus 로고
    • Id
    • Id.
  • 18
    • 61449207581 scopus 로고    scopus 로고
    • Agreement on Trade-Related Aspects of Intellectual Property Rights, Annex 1C art. 8(1), Apr. 15, 1994, 33 I.L.M. 81, available at www.wto.org/english/docs_e/legal_e/27-trips.pdf (Marrakesh Agreement Establishing the World Trade Organization) [hereinafter the TRIPS Agreement].
    • Agreement on Trade-Related Aspects of Intellectual Property Rights, Annex 1C art. 8(1), Apr. 15, 1994, 33 I.L.M. 81, available at www.wto.org/english/docs_e/legal_e/27-trips.pdf (Marrakesh Agreement Establishing the World Trade Organization) [hereinafter the TRIPS Agreement].
  • 19
    • 61449209311 scopus 로고    scopus 로고
    • Panel Report, Canada - Patent Protection of Pharmaceutical Products WT/DS114/R, (Mar. 17, 2000).
    • Panel Report, Canada - Patent Protection of Pharmaceutical Products WT/DS114/R, (Mar. 17, 2000).
  • 21
    • 61449225956 scopus 로고    scopus 로고
    • DUTFIELD, LIFE SCIENCE, note 15, at
    • DUTFIELD, LIFE SCIENCE, supra note 15, at 56-60.
    • supra , pp. 56-60
  • 22
    • 61449085977 scopus 로고    scopus 로고
    • Paris Convention for the Protection of Industrial Property, Mar. 20, 1883, 21 U.S.T. 1583, 828 U.N.T.S. 305.
    • Paris Convention for the Protection of Industrial Property, Mar. 20, 1883, 21 U.S.T. 1583, 828 U.N.T.S. 305.
  • 23
    • 61449220430 scopus 로고    scopus 로고
    • Id. art. 5(4).
    • Id. art. 5(4).
  • 24
    • 61449171462 scopus 로고    scopus 로고
    • JEROME REICHMAN & CATHERINE HASENZAHL, UNITED NATIONS CONFERENCE ON TRADE AND DEVELOPMENT (UNCTAD) & INTERNATIONAL CENTRE FOR TRADE AND SUSTAINABLE DEVELOPMENT (ICTSD), UNCTAD-ICTSD PROJECT ON IPRS AND SUSTAINABLE DEVELOPMENT, ISSUE PAPER NO. 5: NON-VOLUNTARY LICENSING OF PATENTED INVENTIONS: HISTORICAL PERSPECTIVE, LEGAL FRAMEWORK UNDER TRIPS, AND AN OVERVIEW OF THE PRACTICE IN CANADA AND THE UNITED STATES OF AMERICA, at I (2003).
    • JEROME REICHMAN & CATHERINE HASENZAHL, UNITED NATIONS CONFERENCE ON TRADE AND DEVELOPMENT (UNCTAD) & INTERNATIONAL CENTRE FOR TRADE AND SUSTAINABLE DEVELOPMENT (ICTSD), UNCTAD-ICTSD PROJECT ON IPRS AND SUSTAINABLE DEVELOPMENT, ISSUE PAPER NO. 5: NON-VOLUNTARY LICENSING OF PATENTED INVENTIONS: HISTORICAL PERSPECTIVE, LEGAL FRAMEWORK UNDER TRIPS, AND AN OVERVIEW OF THE PRACTICE IN CANADA AND THE UNITED STATES OF AMERICA, at I (2003).
  • 25
    • 61449244973 scopus 로고    scopus 로고
    • Id. at 12
    • Id. at 12.
  • 26
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    • Id. at 4
    • Id. at 4.
  • 27
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    • Id. at 19
    • Id. at 19.
  • 28
    • 61449093182 scopus 로고    scopus 로고
    • Id
    • Id.
  • 29
    • 61449196165 scopus 로고    scopus 로고
    • Id. at 19-20
    • Id. at 19-20.
  • 30
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    • Lifestyle Medicines, 321
    • David Gilbert, Tom Walley, & Bill New, Lifestyle Medicines, 321 BRIT. MED. J. 1341, 1341-44 (2000)
    • (2000) BRIT. MED. J , vol.1341 , pp. 1341-1344
    • Gilbert, D.1    Walley, T.2    New, B.3
  • 31
    • 34347236489 scopus 로고    scopus 로고
    • Are Pharmas Addicted to Lifestyle Drugs?
    • June 15, at
    • Arlene Weintraub, Are Pharmas Addicted to Lifestyle Drugs?, BUSINESSWEEK June 15, 2007, at 40-41.
    • (2007) BUSINESSWEEK , pp. 40-41
    • Weintraub, A.1
  • 32
    • 61449237709 scopus 로고    scopus 로고
    • MÉDICINS SANS FRONTIÈRES (MSF) AND DRUGS FOR NEGLECTED DISEASES (DND) WORKING GROUP, FATAL IMBALANCE: THE CRISIS IN RESEARCH AND DEVELOPMENT FOR DRUGS FOR NEGLECTED DISEASES 10 (MSF and DND Working Group, 2001).
    • MÉDICINS SANS FRONTIÈRES (MSF) AND DRUGS FOR NEGLECTED DISEASES (DND) WORKING GROUP, FATAL IMBALANCE: THE CRISIS IN RESEARCH AND DEVELOPMENT FOR DRUGS FOR NEGLECTED DISEASES 10 (MSF and DND Working Group, 2001).
  • 33
    • 61449205550 scopus 로고    scopus 로고
    • James Orbinski, Health, Equity, and Trade: A Failure in Global Governance, in THE ROLE OF THE WORLD TRADE ORGANIZATION IN GLOBAL GOVERNANCE 223,230-31 (Gary P. Sampson ed., 2001).
    • James Orbinski, Health, Equity, and Trade: A Failure in Global Governance, in THE ROLE OF THE WORLD TRADE ORGANIZATION IN GLOBAL GOVERNANCE 223,230-31 (Gary P. Sampson ed., 2001).
  • 34
    • 61449194641 scopus 로고    scopus 로고
    • WORLD HEALTH ORGANIZATION (WHO), INVESTING IN HEALTH RESEARCH AND DEVELOPMENT: REPORT OF THE AD HOC COMMITTEE ON HEALTH RESEARCH RELATING TO FUTURE INTERVENTION OPTIONS 102 (WHO, 1996).
    • WORLD HEALTH ORGANIZATION (WHO), INVESTING IN HEALTH RESEARCH AND DEVELOPMENT: REPORT OF THE AD HOC COMMITTEE ON HEALTH RESEARCH RELATING TO FUTURE INTERVENTION OPTIONS 102 (WHO, 1996).
  • 35
    • 61449136301 scopus 로고    scopus 로고
    • For two critical perspectives on this issue and the industry more generally, see MARCIA ANGELL, THE TRUTH ABOUT THE DRUG COMPANIES: HOW THEY DECEIVE US AND WHAT TO DO ABOUT IT (2004)
    • For two critical perspectives on this issue and the industry more generally, see MARCIA ANGELL, THE TRUTH ABOUT THE DRUG COMPANIES: HOW THEY DECEIVE US AND WHAT TO DO ABOUT IT (2004)
  • 36
    • 84887360252 scopus 로고    scopus 로고
    • MERRILL GOOZNER, THE $800 MILLION PILL: THE TRUTH BEHIND THE COST OF NEW DRUGS (2004).
    • MERRILL GOOZNER, THE $800 MILLION PILL: THE TRUTH BEHIND THE COST OF NEW DRUGS (2004).
  • 37
    • 61449139555 scopus 로고    scopus 로고
    • As James Le Fanu puts it: [t]he pharmaceutical industry has also had no alternative, in the absence of new and lucky drug discoveries, other than to keep hammering away. This takes several forms of which the most obvious is the 'better mousetrap, new and more costly variants of drugs already available. These may well be 'better' in the sense of being easier to take and having fewer side-effects, but they are no more effective therapeutically, Alternatively, when there is no effective remedy for a disease the drug companies have adopted the 'useless mousetrap' on the grounds that patients and relatives want to be doing 'something, Thus new drugs for Alzheimer's and multiple sclerosis are increasingly widely prescribed even though their efficacy is scarcely detectable. JAMES LE FANU, THE RISE AND FALL OF MODERN MEDICINE 396 1999
    • As James Le Fanu puts it: [t]he pharmaceutical industry has also had no alternative, in the absence of new and lucky drug discoveries, other than to keep hammering away. This takes several forms of which the most obvious is the 'better mousetrap' - new and more costly variants of drugs already available. These may well be 'better' in the sense of being easier to take and having fewer side-effects, but they are no more effective therapeutically, Alternatively, when there is no effective remedy for a disease the drug companies have adopted the 'useless mousetrap' on the grounds that patients and relatives want to be doing 'something'. Thus new drugs for Alzheimer's and multiple sclerosis are increasingly widely prescribed even though their efficacy is scarcely detectable. JAMES LE FANU, THE RISE AND FALL OF MODERN MEDICINE 396 (1999).
  • 38
    • 33646231981 scopus 로고    scopus 로고
    • The Fight Against Disease Mongering: Generating Knowledge for Action, PLoS
    • Apr, at
    • Ray Moynihan & David Henry, The Fight Against Disease Mongering: Generating Knowledge for Action, PLoS MEDICINE, Apr. 2006, at 425
    • (2006) MEDICINE , pp. 425
    • Moynihan, R.1    Henry, D.2
  • 39
    • 61449154238 scopus 로고    scopus 로고
    • see also RAY MOYNIHAN & ALAN CASSELS, SELLING SICKNESS: HOW THE WORLD'S BIGGEST PHARMACEUTICAL COMPANIES ARE TURNING US ALL INTO PATIENTS (2005); LYNNE PAYER, DISEASE-MONGERS: HOW DOCTORS, DRUG COMPANIES, AND INSURERS ARE MAKING You FEEL SICK (1992).
    • see also RAY MOYNIHAN & ALAN CASSELS, SELLING SICKNESS: HOW THE WORLD'S BIGGEST PHARMACEUTICAL COMPANIES ARE TURNING US ALL INTO PATIENTS (2005); LYNNE PAYER, DISEASE-MONGERS: HOW DOCTORS, DRUG COMPANIES, AND INSURERS ARE MAKING You FEEL SICK (1992).
  • 40
    • 61449154179 scopus 로고    scopus 로고
    • See DUTFIELD, LIFE SCIENCE, note 15, at
    • See DUTFIELD, LIFE SCIENCE, supra note 15, at 25-26.
    • supra , pp. 25-26
  • 41
    • 61449118223 scopus 로고    scopus 로고
    • SUSAN K. SELL, PRIVATE POWER, PUBLIC LAW: THE GLOBALIZATION OF INTELLECTUAL PROPERTY RIGHTS 55-56 (2003).
    • SUSAN K. SELL, PRIVATE POWER, PUBLIC LAW: THE GLOBALIZATION OF INTELLECTUAL PROPERTY RIGHTS 55-56 (2003).
  • 42
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    • See the TRIPS Agreement, supra note 18
    • See the TRIPS Agreement, supra note 18.
  • 43
    • 61449220428 scopus 로고    scopus 로고
    • Id. art. 27.1
    • Id. art. 27.1.
  • 44
    • 61449121492 scopus 로고    scopus 로고
    • Id
    • Id.
  • 45
    • 61449109489 scopus 로고    scopus 로고
    • MICHAEL J. TREBILCOCK & ROBERT HOWSE, THE REGULATION OF INTERNATIONAL TRADE 430 (3d. ed. 2005).
    • MICHAEL J. TREBILCOCK & ROBERT HOWSE, THE REGULATION OF INTERNATIONAL TRADE 430 (3d. ed. 2005).
  • 46
    • 61449260594 scopus 로고    scopus 로고
    • This is particularly well evidenced by the annual Special 301 Reports of the Office of the United States Trade Representative. 301 Reports dating back to 2002 are available on the website of the Office of the U.S. Trade Representative at
    • This is particularly well evidenced by the annual Special 301 Reports of the Office of the United States Trade Representative. 301 Reports dating back to 2002 are available on the website of the Office of the U.S. Trade Representative at www.ustr.gov/Document_Library/ Reports_Publications/Section_Index.html.
  • 47
    • 61449223302 scopus 로고    scopus 로고
    • See generally OFFICE OF THE U.S. TRADE REPRESENTATIVE, 2007 SPECIAL 301 REPORT (2007), available at www.ustr.gov/assets/ Document_Library/Reports_Publications/2007/2007_Special_301_Review/ asset_upload_file230_11122.pdf.
    • See generally OFFICE OF THE U.S. TRADE REPRESENTATIVE, 2007 SPECIAL 301 REPORT (2007), available at www.ustr.gov/assets/ Document_Library/Reports_Publications/2007/2007_Special_301_Review/ asset_upload_file230_11122.pdf.
  • 48
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    • See DUNCAN MATTHEWS, GLOBALISING INTELLECTUAL PROPERTY RIGHTS: THE TRIPS AGREEMENT 18-19 (2002)
    • See DUNCAN MATTHEWS, GLOBALISING INTELLECTUAL PROPERTY RIGHTS: THE TRIPS AGREEMENT 18-19 (2002)
  • 49
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    • SELL, supra note 38, at 48-49
    • SELL, supra note 38, at 48-49
  • 50
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    • Global Property Rights in Information: The Story of TRIPS at the GATT
    • June
    • Peter Drahos, Global Property Rights in Information: The Story of TRIPS at the GATT, PROMETHEUS, June 1995, 6-7.
    • (1995) PROMETHEUS , pp. 6-7
    • Drahos, P.1
  • 51
    • 61449237708 scopus 로고    scopus 로고
    • Graham Dutfield, To Copy is to Steal': TRIPS, (Unfree Trade Agreements & the New Intellectual Property Fundamentalism, 1 J. INFO. L. & TECH. (SPECIAL ISSUE) 1 (2006), www2.warwick.ac.uk/fac/soc/law/elj/jilt/2006_I/dutfield/dutfield.pdf.
    • Graham Dutfield, "To Copy is to Steal': TRIPS, (Unfree Trade Agreements & the New Intellectual Property Fundamentalism, 1 J. INFO. L. & TECH. (SPECIAL ISSUE) 1 (2006), www2.warwick.ac.uk/fac/soc/law/elj/jilt/2006_I/dutfield/dutfield.pdf.
  • 52
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    • The basis for such an argument is Article 12 of the International Covenant on Economic, Social and Cultural Rights: The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for: (a) the provision for the reduction of the stillbirth-rate and of infant mortality and for the healthy development of the child; (b) the improvement of all aspects of environmental and industrial hygiene; (c) the prevention, treatment and control of epidemic, endemic, occupational and other diseases; (d) the creation of conditions which would assure to all medical service and medical attention in the event of sickness. International Covenant on Economic, Social, and Cultural Rights, Dec. 16,1966,993 U.N.T.S. 4,8.
    • The basis for such an argument is Article 12 of the International Covenant on Economic, Social and Cultural Rights: The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for: (a) the provision for the reduction of the stillbirth-rate and of infant mortality and for the healthy development of the child; (b) the improvement of all aspects of environmental and industrial hygiene; (c) the prevention, treatment and control of epidemic, endemic, occupational and other diseases; (d) the creation of conditions which would assure to all medical service and medical attention in the event of sickness. International Covenant on Economic, Social, and Cultural Rights, Dec. 16,1966,993 U.N.T.S. 4,8.
  • 53
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    • Bayer Agrees to Charge Government a Lower Price for Anthrax Medicine
    • Oct. 25, at
    • Keith Bradsher, Bayer Agrees to Charge Government a Lower Price for Anthrax Medicine, N.Y. TIMES, Oct. 25, 2001 at B8.
    • (2001) N.Y. TIMES
    • Bradsher, K.1
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    • Id
    • Id.
  • 55
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    • Carlos M. Correa, Protecting Test Data for Pharmaceutical and Agrochemical Products under Free Trade Agreements, in NEGOTIATING HEALTH: INTELLECTUAL PROPERTY AND ACCESS TO MEDICINES 81, 91 (Pedro Roffe, Geoff Tansey & David Vivas-Eugui eds. 2006) [hereinafter Correa, Protecting Test Data for Pharmaceutical and Agrochemical Products].
    • Carlos M. Correa, Protecting Test Data for Pharmaceutical and Agrochemical Products under Free Trade Agreements, in NEGOTIATING HEALTH: INTELLECTUAL PROPERTY AND ACCESS TO MEDICINES 81, 91 (Pedro Roffe, Geoff Tansey & David Vivas-Eugui eds. 2006) [hereinafter Correa, Protecting Test Data for Pharmaceutical and Agrochemical Products].
  • 56
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    • See MATTHEWS, supra note 44, at 115
    • See MATTHEWS, supra note 44, at 115.
  • 57
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    • Id
    • Id.
  • 58
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    • See id. According to a key World Bank publication of the time, while it may be a heavy dose of regulation, South Africa's law is probably consistent with TRIPS. THE WORLD BANK, GLOBAL ECONOMIC PROSPECTS AND THE DEVELOPING COUNTRIES 2002: MAKING TRADE WORK FOR THE WORLD'S POOR 138 (The World Bank, 2001).
    • See id. According to a key World Bank publication of the time, "while it may be a heavy dose of regulation, South Africa's law is probably consistent with TRIPS." THE WORLD BANK, GLOBAL ECONOMIC PROSPECTS AND THE DEVELOPING COUNTRIES 2002: MAKING TRADE WORK FOR THE WORLD'S POOR 138 (The World Bank, 2001).
  • 59
    • 61449127744 scopus 로고    scopus 로고
    • But having made this point, drug companies can be very creative and aggressive in using legal means to prevent generic producers from entering the market even when the patents protecting the drug have expired. See DUTFIELD, LIFE SCIENCE, supra note 15, at 109-11.
    • But having made this point, drug companies can be very creative and aggressive in using legal means to prevent generic producers from entering the market even when the patents protecting the drug have expired. See DUTFIELD, LIFE SCIENCE, supra note 15, at 109-11.
  • 60
    • 61449164303 scopus 로고    scopus 로고
    • Drug Price Competition and Patent Term Restoration (Hatch-Waxman) Act of 1984, Pub. L. No. 98-417, § 101(13)(ii, 98 Stat. 1585, 1586 1984, codified as amended at 21 U.S.C. § 355
    • Drug Price Competition and Patent Term Restoration (Hatch-Waxman) Act of 1984, Pub. L. No. 98-417, § 101(13)(ii), 98 Stat. 1585, 1586 (1984) (codified as amended at 21 U.S.C. § 355).
  • 61
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    • Id
    • Id.
  • 62
    • 61449203249 scopus 로고    scopus 로고
    • Council Directive 2004/27, art. 10, 2004 O.J. (L 136) 34 (EC).
    • Council Directive 2004/27, art. 10, 2004 O.J. (L 136) 34 (EC).
  • 63
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    • Id
    • Id.
  • 65
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    • Meir Perez Pugatch, Intellectual Property, Data Exclusivity, Innovation and Market Access. in NEGOTIATING HEALTH: INTELLECTUAL PROPERTY AND ACCESS TO MEDICINES, supra note 49, at 97, 101-10.
    • Meir Perez Pugatch, Intellectual Property, Data Exclusivity, Innovation and Market Access. in NEGOTIATING HEALTH: INTELLECTUAL PROPERTY AND ACCESS TO MEDICINES, supra note 49, at 97, 101-10.
  • 66
    • 61449190102 scopus 로고    scopus 로고
    • TRIPS Agreement, note 18, art. 39.3
    • TRIPS Agreement, supra note 18, art. 39.3.
    • supra
  • 67
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    • Id
    • Id.
  • 68
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    • Id
    • Id.
  • 69
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    • Id. art. 39.1
    • Id. art. 39.1.
  • 70
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    • UNCTAD-ICTSD, PROJECT ON IPRS AND SUSTAINABLE DEVELOPMENT: RESOURCE BOOK ON TRIPS AND DEVELOPMENT 531 (2005).
    • UNCTAD-ICTSD, PROJECT ON IPRS AND SUSTAINABLE DEVELOPMENT: RESOURCE BOOK ON TRIPS AND DEVELOPMENT 531 (2005).
  • 71
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    • Id
    • Id.
  • 72
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    • United States-Chile Free Trade Agreement, U.S.-Chile, art. 17.10.1, Jan. 1, 2004, available at www.ustr.gov/assets/Trade_Agreements/ Bilateral/Chile_FTA/Final_Texts/asset_upload_fileq12_4011.pdf [hereinafter U.S.-Chile FTA].
    • United States-Chile Free Trade Agreement, U.S.-Chile, art. 17.10.1, Jan. 1, 2004, available at www.ustr.gov/assets/Trade_Agreements/ Bilateral/Chile_FTA/Final_Texts/asset_upload_fileq12_4011.pdf [hereinafter U.S.-Chile FTA].
  • 73
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    • Id
    • Id.
  • 74
    • 61449261315 scopus 로고    scopus 로고
    • Central America-Dominican Republican Free Trade Agreement, art. 15.10.1, May 28, 2004, available at www.ustr.gov/assets/Trade_Agreements/ Regional/CAFTA/CAFTA_DR_Final_Texts/asset_upload_file934_3935.pdf [hereinafter DR-CAFTA].
    • Central America-Dominican Republican Free Trade Agreement, art. 15.10.1, May 28, 2004, available at www.ustr.gov/assets/Trade_Agreements/ Regional/CAFTA/CAFTA_DR_Final_Texts/asset_upload_file934_3935.pdf [hereinafter DR-CAFTA].
  • 75
    • 61449262311 scopus 로고    scopus 로고
    • Id
    • Id.
  • 76
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    • Id
    • Id.
  • 77
    • 61449165238 scopus 로고    scopus 로고
    • For more detailed explanations of the data protection-related problems with US-DR-CAFTA and other FTAs, see Correa, Protecting Test Data for Pharmaceutical and Agrochemical Products, supra note 49
    • For more detailed explanations of the data protection-related problems with US-DR-CAFTA and other FTAs, see Correa, Protecting Test Data for Pharmaceutical and Agrochemical Products, supra note 49
  • 78
    • 61449233542 scopus 로고    scopus 로고
    • Frederick Abbott, The Doha Declaration on the TRIPS Agreement and Public Health and the Contradictory Trend in Bilateral and Regional Free Trade Agreement, (Quaker United Nations Office, Occasional Paper No. 14, 2004), available at www.quno.org/geneva/pdf/economic/ Occassional/TRIPS-Public-Health-FTAs.pdf.
    • Frederick Abbott, The Doha Declaration on the TRIPS Agreement and Public Health and the Contradictory Trend in Bilateral and Regional Free Trade Agreement, (Quaker United Nations Office, Occasional Paper No. 14, 2004), available at www.quno.org/geneva/pdf/economic/ Occassional/TRIPS-Public-Health-FTAs.pdf.
  • 79
    • 61449253347 scopus 로고    scopus 로고
    • Exceptions to
    • Patent Rights in Developing Countries, Issues Paper 17, UNCTAD-ICTSD Project on IPRs and Sustainable Development 2006
    • Christopher Garrison, Exceptions to Patent Rights in Developing Countries, Issues Paper 17, UNCTAD-ICTSD Project on IPRs and Sustainable Development (2006).
    • Garrison, C.1
  • 80
    • 61449144847 scopus 로고    scopus 로고
    • TRIPS Agreement, note 18, art. 31b
    • TRIPS Agreement, supra note 18, art. 31(b)
    • supra
  • 81
    • 61449133556 scopus 로고    scopus 로고
    • Curiously this clause is rarely discussed in debates on access to medicines. The reason may be that many developing countries have deficient competition regulations
    • Curiously this clause is rarely discussed in debates on access to medicines. The reason may be that many developing countries have deficient competition regulations.
  • 82
    • 61449198890 scopus 로고    scopus 로고
    • F.M. Scherer & Jayashree Watal, The Economics of TRIPS Option for Access to Medicines, in THE ECONOMICS OF ESSENTIAL MEDICINES 32, 37-38 (B. Granville ed. 2002).
    • F.M. Scherer & Jayashree Watal, The Economics of TRIPS Option for Access to Medicines, in THE ECONOMICS OF ESSENTIAL MEDICINES 32, 37-38 (B. Granville ed. 2002).
  • 83
    • 61449199818 scopus 로고    scopus 로고
    • World Trade Organization, Ministerial Declaration of 14 November 2001, WT/MIN(01)/DEC/1, 41 I.L.M. 746, (2002) available at www.wto.org/ english/thewto_e/minist_e/mino1_e/mindecl_trips_e.pdf [hereinafter the Doha Declaration]. In November 2005, the TRIPS Council extended the deadline for LDCs to fully implementing TRIPS by a further seven and a half years to 1 July 2013. Press Release, World Trade Organization, Poorest Countries Given More Time to Apply Intellectual Property Rules (Nov. 29, 2005), available at www.wto.org/English/news_e/pres05_e/ pr424_e.htm.
    • World Trade Organization, Ministerial Declaration of 14 November 2001, WT/MIN(01)/DEC/1, 41 I.L.M. 746, (2002) available at www.wto.org/ english/thewto_e/minist_e/mino1_e/mindecl_trips_e.pdf [hereinafter the Doha Declaration]. In November 2005, the TRIPS Council extended the deadline for LDCs to fully implementing TRIPS by a further seven and a half years to 1 July 2013. Press Release, World Trade Organization, Poorest Countries Given More Time to Apply Intellectual Property Rules (Nov. 29, 2005), available at www.wto.org/English/news_e/pres05_e/ pr424_e.htm.
  • 84
    • 61449126305 scopus 로고    scopus 로고
    • Doha Declaration, supra note 74, 5(b).
    • Doha Declaration, supra note 74, 5(b).
  • 85
    • 61449203250 scopus 로고    scopus 로고
    • Id. 5c
    • Id. 5(c).
  • 86
    • 61449206552 scopus 로고    scopus 로고
    • Id. 5d
    • Id. 5(d).
  • 87
    • 61449089914 scopus 로고    scopus 로고
    • This is known as international exhaustion. It may be contrasted with national exhaustion according to which rights are exhausted only in the case of first sale in that country. With national exhaustion regimes, parallel importation is not permitted. FREDRICK M. ABBOTT, PARALLEL IMPORTATION: ECONOMIC AND SOCIAL WELFARE DIMENSIONS 5 2007
    • This is known as "international exhaustion." It may be contrasted with "national exhaustion" according to which rights are exhausted only in the case of first sale in that country. With national exhaustion regimes, parallel importation is not permitted. FREDRICK M. ABBOTT, PARALLEL IMPORTATION: ECONOMIC AND SOCIAL WELFARE DIMENSIONS 5 (2007), www.iisd.org/pdf/2007/ parallel_importation.pdf
  • 88
    • 61449231045 scopus 로고    scopus 로고
    • See TRIPS Agreement, note 18, art. 28
    • See TRIPS Agreement, supra note 18, art. 28,
    • supra
  • 90
    • 61449156786 scopus 로고    scopus 로고
    • Id. 1b
    • Id. 1(b).
  • 91
    • 61449089915 scopus 로고    scopus 로고
    • Id. 2
    • Id. 2.
  • 92
    • 61449250061 scopus 로고    scopus 로고
    • Id. 2a
    • Id. 2(a).
  • 93
    • 61449137239 scopus 로고    scopus 로고
    • Id. 2b
    • Id. 2(b).
  • 95
    • 61449107044 scopus 로고    scopus 로고
    • Id. at n. 3
    • Id. at n. 3.
  • 96
    • 61449134524 scopus 로고    scopus 로고
    • Id. 6i
    • Id. 6(i).
  • 97
    • 66849108619 scopus 로고    scopus 로고
    • Decision by General Council for TRIPS, Dec. 6, 2005, available at
    • Decision by General Council for TRIPS, Amendment of the TRIPS Agreement, WT/L/641 (Dec. 6, 2005), available at www.wto.org/ english/tratop_e/trips_e/wtl641_e.htm
    • Amendment of the TRIPS Agreement, WT/L/641
  • 98
    • 61449250062 scopus 로고    scopus 로고
    • As of 20 Feb. 2008
    • As of 20 Feb. 2008.
  • 99
    • 61449208358 scopus 로고    scopus 로고
    • Communication from Rwanda's Government Centre for the Treatment & Research on AIDS (TRAC), Notification under Paragraph 2(a) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, IP/N/9/ RWA/1 (July 19, 2007), available at docsonline.wto.org/ DDFDocuments/t/IP/N/9RWA1.doc.
    • Communication from Rwanda's Government Centre for the Treatment & Research on AIDS (TRAC), Notification under Paragraph 2(a) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, IP/N/9/ RWA/1 (July 19, 2007), available at docsonline.wto.org/ DDFDocuments/t/IP/N/9RWA1.doc.
  • 100
    • 61449231096 scopus 로고    scopus 로고
    • Id
    • Id.
  • 101
    • 61449197152 scopus 로고    scopus 로고
    • See Rwanda and Canada: Leading the Implementation of the August 2003 Decision for Import/Export of Pharmaceuticals Produced Under Compulsory License, INTELL. PROP. Q, UPDATE, Third Quarter 2007, at 5, available at www.ciel.org/Publications/IP_Update_3QO7.pdf.
    • See Rwanda and Canada: Leading the Implementation of the August 2003 Decision for Import/Export of Pharmaceuticals Produced Under Compulsory License, INTELL. PROP. Q, UPDATE, Third Quarter 2007, at 5, available at www.ciel.org/Publications/IP_Update_3QO7.pdf.
  • 102
    • 61449245930 scopus 로고    scopus 로고
    • See id. at 5-7.
    • See id. at 5-7.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.