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  • i

    OECD

    2006 2 OECD

    NIH

    NIH NIH

    EC 1998

    2006 5 2007 3

    2007 5 2007

  • ii

    OECD(Organisation for Economic

    Co-operation and Development )

    EU(European Union;

    OECDEU

    ii

  • iii

    iiiiv

    TRIPS 30

    30

    69 1

    60 5 (b) 11 (b)

    613 5(b) 28 (1)(b)

    2007 6 22 9 (1)b

  • iv

    2005 4 28 28 (1)(b)

    (on)

    (with)

    2007 6 22

    9 (1)

    1984 FDA

    2005

  • v

    NIHNational Institutes of HealthNIH

    1999

    NIH

    OECD 2002 2006 2

    OECD

    OECD

    OECD

    2006 5 23

  • vi

    2007 3 1

    OECD

    OECD

    PIPLA 2007 10 SC4SM

  • vii

    iPS

    1980

    1988 1980

    20

    21

    Myriad

    OECD 2003

    OECD

    OECD

    OECD

  • viii

    OECD OECD

    OECD

  • ( OECD)

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    EU(European Union; .......................... 38

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    61

    75

    113

    123

    165

  • - 1 -

    .

    OECD

    1 2006 2 OECD

    NIH

    NIH 2

    EC 1998

    3 2006 5 2007

    3

    4

    1 http://www.oecd.org/dataoecd/39/38/36198812.pdf2 http://ott.od.nih.gov/NewPages/64FR72090.pdf3 http://www8.cao.go.jp/cstp/output/iken060523_2.pdf4 http://www8.cao.go.jp/cstp/output/iken070301.pdf

  • - 2 -

    2007 5 20075

    5 http://www.kantei.go.jp/jp/singi/titeki2/kettei/070531keikaku.pdf

  • - 3 -

    OECD TRIPS

    2.1

    OECD(Organisation for Economic Co-operation and

    Development)

    TRIPS Agreement on Trade-Related Aspects of

  • - 4 -

    Intellectual Property Rights;

    EU(European Union;

    2.1

    2.1

    Prof.Joshua D. Sarnoff Wahington College of LawAmerican Univ.

    Prof.Jeremy Phillips IP Consultant of OlswangEditor of Oxford Journal of Intellectual Property Law & Practice

    Dr. Prinz zu Waldeck und Pyrmont Program Director, Munich Intellectual Property Law CenterMember of the Research Staff, Max Planck Institute for Intellectual Property, Competition and Tax Law

    Mr. Alain Gallochat Former Adviser to the governmentConsultant

    Dr. Lucas Bu"hler Swiss Federal Institute of Intellectual Property

    Prof. Dr. Geertrui Van Overwalle Katholieke Universiteit Leuven

    Ms. Christina Sampogna Administrator Biotechnology Division

  • - 5 -

    OECD

    2.1

  • - 6 -

    2.1 2.2

    2.2 2.1

    2.2

    Item Object Description( analysis includes evaluation )

    1 Settled law suites and its regalanalysis

    * Settled law suites * Analysis of law suites including judgment,process of argument, its effect on the followinglaw suites, movement of the government,research activity etc.

    * Theoretical analysis

    * Summary of information in academic paperand journals etc

    2 Law suites pending in court andincidents and troubles

    * Unsettled law suites Analysis of law suites, incidents and troublesincluding the forecast of judgment, process ofargument, its effect on the following law suites,movement of the government, research activityetc.

    * Unsettled troubles andincidents ( outside court )

    * Summary of information in academic paperand journals etc

    3 The trend of law and regulation * The trend of discussion andactivities amonggovernmental, political,bureaucratic, business, andacademic circles and generalpublic

    * Analysis

    * Summary of information in academic journalsetc

    4 4. The discussion upon law andregulation,and its social back ground

    * The discussion upon law andregulation, and its social background among governmental,political, bureaucratic,business, and academiccircles

    * Analysis

    * The discussion upon law andregulation, and its social background and of general public

    * Summary of information listed in right columns

  • - 7 -

    5 Altering process and background ofthe altering law (ex. Belgium)

    * The history of of altering,including political and socialprocess

    * Analysis

    * The action and reaction ofpolitical circle

    * The action and reaction ofacademia

    * The action and reaction ofbusiness circle

    * The social background ofaltering law

    * Summary of information in publication

    6 The process and background tostart, the process to alter the law(ex. UK, Swiss)

    * The history of of altering,including political and socialprocess

    * Analysis

    * The action and reaction ofpolitical, academic andbusiness people

    * The social background ofaltering law

    * Summary of information in academic journalsetc

    7 The guideline to protect and useresearch tool patents

    * Guidelines of government andprivate sector

    * Analysis

    * Summary of information in report fromgovernment, business and academic sector.

    8 The status quo of using theguideline

    * Working mechanism inacademic and businessresearch.

    * Analysis

    * The opinion of academic andbusiness circle

    * Summary of information in academic journalsetc

    9 Other information( technologicalfield, bibliographic item, price tolicense etc )

    * Major items not includedabove items

    * Analysis

    * Summary of information in academic journalsetc

    10 OECD guideline * Working mechanism of theguideline

    * Analysis

    Status quo of using * Summary of information in academic journalsetc

    11 NIH guideline * Working mechanism of theguideline

    * Analysis

    * Status quo of using * Summary of information in academic journalsetc

  • - 8 -

    2.1

    69 1

    2004 11

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    2006 5 23

    2007 3 1

    OECD NIH

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    2006.5.23

    http://www8.cao.go.jp/cstp/output/iken060523_2.pdf

    1.(2)

    2.(1)

    3.

  • - 11 -

    2007.3.1

    http://www8.cao.go.jp/cstp/output/iken070301.pdf

    1.

  • - 12 -

    2.

    3.

    4.

  • - 13 -

    5.

  • - 14 -

    2004.11

    http://www.jpo.go.jp/shiryou/toushin/shingikai/pdf/strategy_wg_prob/00.pdf

    691

    69

    2

    691

    691

  • - 15 -

    691

    691

    69 1

    TRIPS

  • - 16 -

    OECD

    30 OECD 2006

    OECD (GUIDELINES FOR THE LICENSING OF GENETIC

    INVENTIONS)

    OECD

    OECD

    6

    7

    OECD

    TRIPS

    6 OECD JBA 1.http://www.jba.or.jp/top/top%20data/oecdguideline060323.pdf

    7 7.

  • - 17 -

    TRIPS Agreement on Trade-Related Aspects of Intellectual

    Property Rights; 30

    31

    30

    31

    (

    )

    (a)

    (b)

    (c)

    (d)

    (e)

    (f)

    (g)

  • - 18 -

    (h)

    (i)

    (

    )

    (j)

    (

    )

    (k)

    (b)

    (f)

    (l) ((i)(iii) 1

    )(

    2 )

    (i) 2 1

    (ii) 1 2

    (iii) 1 2

  • - 19 -

    OECD

    GUIDELINES FOR THE LICENSING OF GENETIC INVENTIONS

    2006.2

    OECD

  • - 20 -

    http://www.oecd.org/dataoecd/39/38/36198812.pdfJBA

    http://www.jba.or.jp/top/top%20data/oecdguideline060323.pdf

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    TRIPS

    TRIPS

    1998

    TRIPS Agreement on Trade-Related Aspects of

    Intellectual Property Rights;

    30

    Article 30 Exceptions to Rights Conferred

    Members may provide limited exceptions to the exclusive rights conferred by

    a patent, provided that such exceptions do not unreasonably conflict with a normal

    exploitation of the patent and do not unreasonably prejudice the legitimate

    interests of the patent owner, taking account of the legitimate interests of third

    parties.

    http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm

    http://www.jpo.go.jp/shiryou/s_sonota/fips/trips/ta/mokuji.htm

    12 773 1997

    TRIPS

    12 773 1997

    31

    (

  • - 22 -

    )

    (a)

    (b)

    (c)

    (d)

    (e)

    (f)

    (g)

    (h)

    (i)

    ()

    (j)

    ()

    (k)

    (b)(f)

    (l) ((i)(iii) 1 )

    ( 2

    )

    (i) 2 1

    (ii) 1 2

  • - 23 -

    (iii) 1 2

    Article 31 Other Use Without Authorization of the Right Holder

    Where the law of a Member allows for other use of the subject matter of a patent

    without the authorization of the right holder, including use by the government

    or third parties authorized by the government, the following provisions shall

    be respected:

    (a) authorization of such use shall be considered on its individual merits;

    (b) such use may only be permitted if, prior to such use, the proposed user has

    made efforts to obtain authorization from the right holder on reasonable

    commercial terms and conditions and that such efforts have not been successful

    within a reasonable period of time. This requirement may be waived by a Member

    in the case of a national emergency or other circumstances of extreme urgency

    or in cases of public non-commercial use. In situations of national emergency

    or other circumstances of extreme urgency, the right holder shall,

    nevertheless, be notified as soon as reasonably practicable. In the case of

    public non-commercial use, where the government or contractor, without making

    a patent search, knows or has demonstrable grounds to know that a valid patent

    is or will be used by or for the government, the right holder shall be informed

    promptly;

    (c) the scope and duration of such use shall be limited to the purpose for which

    it was authorized, and in the case of semi-conductor technology shall only

    be for public non-commercial use or to remedy a practice determined after

    judicial or administrative process to be anti-competitive;

    (d) such use shall be non-exclusive;

    (e) such use shall be non-assignable, except with that part of the enterprise

    or goodwill which enjoys such use;

    (f) any such use shall be authorized predominantly for the supply of the domestic

    market of the Member authorizing such use;

    (g) authorization for such use shall be liable, subject to adequate protection

    of the legitimate interests of the persons so authorized, to be terminated

    if and when the circumstances which led to it cease to exist and are unlikely

    to recur. The competent authority shall have the authority to review, upon

    motivated request, the continued existence of these circumstances;

    (h) the right holder shall be paid adequate remuneration in the circumstances

    of each case, taking into account the economic value of the authorization;

    (i) the legal validity of any decision relating to the authorization of such

    use shall be subject to judicial review or other independent review by a

    distinct higher authority in that Member;

  • - 24 -

    (j) any decision relating to the remuneration provided in respect of such use

    shall be subject to judicial review or other independent review by a distinct

    higher authority in that Member;

    (k) Members are not obliged to apply the conditions set forth in

    subparagraphs (b) and (f) where such use is permitted to remedy a practice

    determined after judicial or administrative process to be anti-competitive.

    The need to correct anti-competitive practices may be taken into account in

    determining the amount of remuneration in such cases. Competent authorities

    shall have the authority to refuse termination of authorization if and when

    the conditions which led to such authorization are likely to recur;

    (l) where such use is authorized to permit the exploitation of a patent (the

    second patent) which cannot be exploited without infringing another patent

    (the first patent), the following additional conditions shall apply:

    (i) the invention claimed in the second patent shall involve an important

    technical advance of considerable economic significance in relation to the

    invention claimed in the first patent;

    (ii) the owner of the first patent shall be entitled to a cross-licence on

    reasonable terms to use the invention claimed in the second patent; and

    (iii) the use authorized in respect of the first patent shall be non-assignable

    except with the assignment of the second patent.

    http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm

    http://www.jpo.go.jp/shiryou/s_sonota/fips/trips/ta/mokuji.htm

  • - 25 -

    Sarnoff 8 Holman 9 Recent

    Developments in the United States Regarding the Law and Practical

    Application of Patents on Research Tool Inventions

    Madey v. Duke University

    2002 CAFC Merck, KGaA

    v. Integra LifeSciences I Ltd.

    2005

    2000

    CAFC 2002 Madey

    CAFC

    Merck

    CAFC

    8 Joshua D. Sarnoff, Practitioner-in-Residence & Assistant Director, Glushko-Samuelson Intellectual Property Law Clinic, Washington College of Law, American University

    9 Christopher M. Holman, Associate Professor of Law, University of Missouri, Kansas City School

  • - 26 -

    10

    (experimental use)

    (regulatory approval exception)

    CAFC

    CAFC

    (forbearance)

    10 I. Executive Summary

  • - 27 -

    11

    11 VIII Conclusions

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    1

    (experimental use exception)

    (regulatory approval exception)

    (practice)

    (potential patent liability)

    CAFC

    DNA PCR

    ProfSarnoff, ProfHolman

    Recent Development in the United States

    Regarding the Law and Practical Application of

    Patents on Research Tool Inventions

  • - 29 -

    1 Integra LifeSciences I Ltd. V. Merck KGaA, 331 F.3d 860, 872

    n.4(Fed.Cir.2003)

    2 polymerase chain reaction

    19 Story

    Whittemore v. Cutter

    1813 Story

    3 29F.Cas.1120(C.C.D.Mass.1813)(No.17,600)

    (making without use)

    Whittemore

    Whittmore

    ( Philosophical )

    Sawin v. Guild

    Sawin v. Guild Story

    4 21 F.Cas.554(C.C.D.Mass.1813)(No.12,391)

  • - 30 -

    1852 1950

    Ruth v. Stearns-Roger

    Manufacturing Co.

    1950

    1952 271(a)

    Section271

    (a)

    1984 CAFC Roche Products Inc. v. Bolar Pharmaceuticals Co.

    FDA

    FDA

    5 Section271(e)(1)

    Section271

    (e)(1) ((

    1913 3 4

    ) DNA RNA

    )

    CAFC

    1984 271 CAFC

    271(e)(1)2000 Embrex Inc. v.

    Service Engine...

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