㐃⥆௻⏬㸸ኚ໬ࡍࡿ࢖ࣀࣦ࢙࢖ࢩࣙࣥ࡜≉チไᗘࡢ࠶ࡾ᪉ ࡑࡢ㸰቟‫׎‬ƷඥƱ૎ሊƴƓƚǔᢡˡ‫܇‬ᚮૺƷཎᚩᢘ఍ࣱ 

Rochelle C. DREYFUSS๓⏣  ೺ ヂ ⡿ᅜ࡟࠾࠸࡚◊✲㛤Ⓨࡢ↔Ⅼࡣࠊデ᩿᪉ἲ࡟ࡘ࠸࡚ࡢ≉チࡢၥ㢟ࠊ≉࡟ᐙ᪘ⓗ᮲௳ࡢデ᩿࡟⏝࠸ࡽࢀࡿ㑇ఏ᝟ሗࢆྵࡴ≉チ࡟㞟ࡲࡗ࡚ࡁ࡚࠸ࡿࠋ᭱ࡶ㔜せ࡞ࡢࡣࠊࠕୖὶࠖࡢ◊✲࡬ࡢ≉チࡢືࡁ࡛࠶ࡿࠋ␗ㄽࡣ࠶ࡾࡘࡘ
ࡶ኱Ꮫࡀࡑࡢᩍဨࡢ◊✲ᡂᯝ࠿ࡽ⤒῭ⓗ౯್ࢆᘬࡁฟࡑ࠺࡜ࡍࡿヨࡳ࡟ᚋᢲࡋࡉࢀ࡚ࠊᇶ♏ᢏ⾡࡟≉チࢆ୚࠼ࡿ࡜࠸࠺⪃࠼ࡣࠊ≉チ஦௳ࡢୖッࢆᑓ㛛࡟ᑂ⌮ࡋ࡚≉チἲࢆᏳᐃࡉࡏࡿࡓࡵ࡟సࡽࢀࡓ⿢ุᡤ࡛࠶ࡿ⡿ᅜ㐃㑥ᕠᅇ༊᥍ッ⿢ุᡤ࡟ࡼࡗ࡚㸦ពእ࡞ࡇ࡜࡛ࡣ࡞࠸ࡀ㸧ዲពⓗ࡟㏄࠼ࡽPauline Newman Professor of Law, New York University School of Law.ᖺ  ᭶ࡢ㻹㻵㻼㻸㻯 ࡢ఍㆟ࡢᖿ஦࡛࠶ࡿ Nari Lee ࡜ Josef Drexl ࡟ᑐࡋ࡚ࡇࡢ㔜せ࡞ၥ㢟࡟ࡘ࠸࡚⚾ࡢぢゎࢆⓎ⾲ࡍࡿᶵ఍ࢆ୚࠼࡚ࡃࢀࡓࡇ࡜࡟ࡘ࠸࡚ࠊFilomen D’Agostino and
Max E. Greenberg Research Fund ࡟ᑐࡋ࡚ࡇࡢ◊✲ࢆ᥼ຓࡋ࡚ࡃࢀࡓࡇ࡜࡟ࡘ࠸࡚ࠊ
Jim Evans and Dianne Nicol ࡟ᑐࡋ࡚᭷┈࡞ࢥ࣓ࣥࢺࢆࡃࢀࡓࡇ࡜࡟ࡘ࠸࡚ࠊ㻺㼅㼁 ࡢᖺࡢࢡࣛࢫࡢ Jason Liu ࡟ᑐࡋ࡚◊✲ࢆᡭఏࡗ࡚ࡃࢀࡓࡇ࡜࡟ࡘ࠸࡚ឤㅰࡋࡓ
࠸ࠋ⚾ࡣࠊ㑇ఏᏛ࣭೺ᗣ࣭♫఍࡟㛵ࡍࡿ㛗ᐁࡢㅎၥጤဨ఍ࡢ࣓ࣥࣂ࣮࡛࠶ࡾࠊࡑࡢ
ࠕ㑇ఏᏊ≉チ࡜ࣛ࢖ࢭࣥࢫᐇົࠊཬࡧᝈ⪅ࡢ㑇ఏᏊ᳨ᰝ࡬ࡢ࢔ࢡࢭࢫ࡟ࡘ࠸࡚ࡑࢀ
ࡽࡀ୚࠼ࡿᙳ㡪࡟㛵ࡍࡿሗ࿌᭩ࠖ࡟ࡘ࠸࡚ᮏㄽᩥ࡛㆟ㄽࡋ࡚࠸ࡿࠋࡋ࠿ࡋ࡞ࡀࡽࠊ
ࡇࡇ࡛♧ࡍぢゎࡣࠊ⚾⮬㌟ࡢࡶࡢ࡛࠶ࡗ࡚ࠊጤဨ఍ࡢࡶࡢ࡛ࡣ࡞࠸ࠋᮏㄽᩥࡣࠊ
PHARMACEUTICAL INNOVATION, COMPETITION AND PATENT LAW 㸫A TRILATERAL PERSPECTIVE (Josef Drexl and Nari Lee, eds) ࡛බ⾲ணᐃ࡛࠶ࡿࠋ
⡿ᅜ࡛ࡣࠊࡇࡢࡼ࠺࡞άືࡢከࡃࡣ the Bayh Dole Act, 35 U.S.C. §§ 200-212 (2006)࡟౫ᣐࡋ࡚࠸ࡿࠋࡇࡢἲᚊࡣࠊ㐃㑥࠿ࡽ㈨㔠᥼ຓࢆཷࡅࡓⓎ᫂࡟ࡘ࠸࡚ࠊ኱Ꮫࡀ≉チᶒࢆಖᣢࡍࡿࡇ࡜ࢆㄆࡵ࡚࠸ࡿࠋ

▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO   㐃⥆௻⏬

⡿ᅜࡢἲ࡜ᨻ⟇࡟࠾ࡅࡿ㑇ఏᏊデ᩿ࡢ≉チ㐺᱁ᛶ 㻰㼞㼑㼥㼒㼡㼟㼟 ࢀࡓࠋ㐃㑥ᕠᅇ༊ࡢุỴࡢ⤖ᯝ࡜ࡋ࡚㸫≉࡟ State Street Bank & Trust Co. v.
᝟ሗࡢ඲యࢆศᯒ㸧࡞࡝ࡢᢏ⾡࡟ࡼࡾࠊ◊✲ࡀಁ㐍ࡉࢀࠊ་⪅ࡀࡑࢀࡒࢀ

Signature Financial Group, Inc. ࡟࠾ࡅࡿุ᩿࡟ࡼࡾ 㸫་⒪ࡢศ㔝࡛ࡶ≉チࡢᝈ⪅ࡢయ㉁࡟ྜࢃࡏࡓ἞⒪࡛࠶ࡿࠕಶู໬་⒪ࠖࢆ⾜࠺ࡇ࡜ࡀ࡛ࡁࡿࡼ

ࡀ⃭ቑࡋࡓࠋࡋࡓࡀࡗ࡚ࠊ௒ࡸࣄࢺࢤࣀ࣒ࢆᵓᡂࡍࡿ࡜࠸ࢃࢀࡿ㑇ఏᏊࡢ࠺࡟࡞ࡿࠋ

㸣ࢆ࢝ࣂ࣮ࡍࡿ≉チᶒࡀᏑᅾࡍࡿࡢ࡛࠶ࡿࠋ





ࡲࡉ࡟ࠊ
㸦㑇ఏᏊࡢࡼ࠺࡟㸧᝟ሗෆᐜࢆᣢࡘ≀ࡢ≉チࠊ㸦デ᩿᪉ἲࡢࡼ࠺

ࡶࡕࢁࢇࠊ◊✲࡜ၟᴗ໬ࢆಁ㐍ࡍࡿࡓࡵࡢ௙⤌ࡳ࡜ࡋ࡚≉チࢆ฼⏝ࡋࡓ࡟㸧᝟ሗࢆ฼⏝ࡍࡿ᪉ἲࡢ≉チ࡟ࡘ࠸࡚ࡢᠱᛕࡀࠊ⿢ุᡤཬࡧᨻ⟇ࡢሙࡢ࡜࠸࠺ඛ౛ࡣ㇏ᐩ࡟Ꮡᅾࡍࡿࠋࡋ࠿ࡋ࡞ࡀࡽࠊࡇࡢ㡿ᇦ࡟࠾ࡅࡿᶒ฼ࡣࠊ

཮᪉࡛⾲㠃໬ࡋࡓࡢ࡛࠶ࡿࠋLaboratory Corp. of America Holdings v. Me-⏕≀⛉Ꮫࡢᇶ♏࡜࡞ࡿ㐍Ṍࢆ࢝ࣂ࣮ࡋ࠺ࡿࡢ࡛ࠊ་⒪ࢆ኱㐍Ṍࡉࡏ་⸆◊tabolite Laboratories, Inc. ࡟࠾࠸࡚ࠊࡇࡢ஦௳ࡣデ᩿᪉ἲ࡟ᑐࡍࡿ≉チᶒ࡟✲ࢆኚᐜࡉࡏࡿ࡜࠸࠺ࢤࣀ࣒⛉Ꮫࡢ኱ࡁ࡞᭷ᮃᛶ࠿ࡽࠊ♫఍ࡀ༑ศ࡞฼┈ࡘ࠸࡚ࡢ஦௳࡛࠶ࡗࡓࡀ㸦ࡇࡢ஦௳࡛ࡣࠊ࠶ࡿ≉ᐃࡢ࢔࣑ࣀ㓟ࡢࣞ࣋ࣝࡢ

ࢆཷࡅࡽࢀ࡞ࡃࡋ࡚ࡋࡲ࠺ྍ⬟ᛶࡀ࠶ࡿࠋ㑇ఏᏊ࡟ࡘ࠸࡚ࡢ≉チཬࡧ㑇ఏࠊ᭱㧗⿢ࡢࢫࢸ࢕࣮
ୖ᪼ࡀࣅࢱ࣑ࣥ 㻮 ࡢḞᦆ࡜㛵㐃ࡀ࠶ࡿ࡜ࡉࢀ࡚࠸ࡓ㸧Ꮚ࡜㑇ఏⓗ᮲௳࡜ࡢ㛵㐃௜ࡅ࡟ࡘ࠸࡚ࡢ≉チࡣࠊデ᩿ࢧ࣮ࣅࢫ࡬ࡢ࢔ࢡࢭ

ࣈ࣭ࣥࣈࣛ࢖ุ࣮ࣖ஦ࡣࠊ෌ᑂ⌮ࡢ༷ୗ࡟཯ᑐࡋࠊࠕ᫬࡟ࠊ㐣ࡂࡓ≉チಖࢫࡢࢥࢫࢺࢆୖ᪼ࡉࡏࡓࡾࠊࡑࡢ௚࢔ࢡࢭࢫࡢ㞀ᐖ࡜࡞ࡗࡓࡾࡍࡿࡇ࡜ࡀ

ㆤࡣࠊࠗ⛉Ꮫཬࡧ᭷⏝࡞ᢏⱁࡢ㐍Ṍࢆಁ㐍ࡍࡿ࠘࡜࠸࠺ࡼࡾࠊࡴࡋࢁ㜼ᐖ࠶ࡿ ࠋࡇࢀࡽࡢ≉チ࡟ࡼࡾࠊࡼࡾຠ⋡ⓗ࡞デ᩿࣭◊✲ᢏ⾡ࡢ㛤Ⓨࡸᐇ᪋ࡋ࡚࠸ࡿࠖ࡜♧၀ࡋ࡚࠸ࡿࠋࡇࡢពぢࡣࠊ᫂ࡽ࠿࡟ࠊ㐃㑥ᕠᅇ༊࡟ᑐࡋ

ࢆ㜼ᐖࡍࡿࡇ࡜ࡀ࠶ࡿࠕ࢔ࣥࢳࢥࣔࣥࢬࠖࡶ⏕ࡌࡿ ࠋࡇࢀࡽࡢከ㔜᳨ᰝ࡚ࠊࡑࡢ᪉ἲࢡ࣮࣒ࣞ࡟ᑐࡍࡿ࢔ࣉ࣮ࣟࢳࢆࡼࡾ୍⯡ⓗ࡟⪃࠼┤ࡍࡼ࠺ಁ㸦኱㔞ࡢ㑇ఏᏊ୍ᘧࢆྠ᫬࡟ศᯒ࡛ࡁࡿ㸧ࠊ඲ࢤࣀ࣒㓄ิゎᯒ㸦ྛேࡢ㑇ఏࡋ࡚࠸ࡿࠋࡑࢀࡺ࠼ࠊIn re Bilski ࡟࠾࠸࡚᥍ッ⿢ุᡤࡣࠊ᪉ἲࢡ࣮࣒ࣞࡣࠊ



ࡑࢀࡀ༢࡟᝟ሗࢆ᧯సࡍࡿ௨ୖࡢࡇ࡜ࢆࡋ࡚࠸ࡿሙྜ࡟㝈ࡾࠊ≉チ㐺᱁࡛149 F.3d 1368 (Fed. Cir. 1998) ≉チ㐺᱁࡞୺㢟ࢆࢯࣇࢺ࢙࢘࢔࡜ࣅࢪࢿࢫ᪉ἲࡶ

࠶ࡿ࡜㏙࡭ࡓࡢ࡛࠶ࡿࠋ᥍ッ⿢ุᡤ࡟ࡼࢀࡤࠊ᪉ἲࢡ࣮࣒ࣞࡣࠊᶵᲔ࡜⤖࢝ࣂ࣮ࡍࡿࡼ࠺࡟ᣑᙇࡉࡏࡓ .୍⯡ⓗ࡟ࡣࠊRochelle Cooper Dreyfuss, In Search ofࡧ௜࠸࡚࠸ࡿ࠿ࠊ≀⌮ⓗ࡞ኚ᥮ࢆࡶࡓࡽࡍࡶࡢ࡛࡞ࡅࢀࡤ࡞ࡽ࡞࠸ࠋ᭱

Institutional Identity: The Federal Circuit Comes of Age, 23 BERKELEY TECH. L.J. 787(2008); Rochelle Cooper Dreyfuss, The Federal Circuit: A Continuing Experiment in Spe-

cialization, 54 CASE W. RES. L. REV. 769 (2004); Rochelle Cooper Dreyfuss, Specialized

Adjudication, 1990 BYU L. REV. 377; Rochelle Cooper Dreyfuss, The Federal Circuit: A

cine, NEJM.ORG, June 15, 2010, http://content.nejm.org/cgi/reprint/NEJMp1006304v1.pdf

ࡓ࡜࠼ࡤࠊMargaret A. Hamburg & Francis S. Collins, The Path to Personalized Medi-

Case Study in Specialized Courts, 64 N.Y.U. L. REV. 1 (1989) ࢆཧ↷ࠋ

ࢆཧ↷ࠋ



ࡓ࡜࠼ࡤࠊNat’l Research Council of the Nat’l Academies of Sci., A Patent System forthe 21st Century 59-64 (Nat’l Academies Press 2004) ࢆཧ↷ࠋ

Strategy Shape The Long-Run Supply Of Public Knowledge? Evidence From Human Ge-Cf. Heller & Eisenberg, supra note 6; Kenneth G. Huang & Fiona E. Murray, Does Patent

Kyle L. Jensen & Fiona E. Murray, Intellectual Property Landscape of the Human Ge-

netics, 52 ACAD. MGMT. J. 1193-1221 (2009), available at http://fmurray.scripts.mit.edu/

nome, 310 SCI. 239-40 (2005).

docs/Huang.Murray_AMJ_09.16.2008_FINAL.pdf; Fiona Murray & Scott Stern, Do For-ࡓ࡜࠼ࡤࠊAss’n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F.

mal Intellectual Property Rights Hinder the Free Flow of Scientific Knowledge: An Empir-

Supp. 2d 181, 203 (S.D.N.Y. 2010) 㻮㻾㻯㻭 㛵㐃ࡢங࢞ࣥࢆ࢝ࢼࢲࡢ࢜ࣥࢱ᳨࡛ࣜ࢜ᰝ

ical Test of the Anti-commons Hypothesis, 63 J. INDUS. BEHAV. & ORG. 648-87 (2007),

ࡍࡿ㈝⏝ࡣ㸦࢝ࢼࢲ࡛ࡣ 㻮㻾㻯㻭 ࡢ≉チࡀ࢚ࣥࣇ࢛࣮ࢫࡉࢀ࡚࠸࡞࠸ ࠊ⡿ᅜࡢ  ศavailable at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=755701.

ࡢ  ࡢ౯᱁࡛࠶ࡿ㸦⡿ᅜ࡛ࡣࡇࢀࡽࡢ≉チࡣ࢚ࣥࣇ࢛࣮ࢫࡉࢀ࡚࠸ࡿ㸧ࡇ࡜ࢆᣦ᦬

ࡋ࡚࠸ࡿ㸧ࢆཧ↷ࠋ

137-38 ┦㛵㛵ಀ࡟ᇶ࡙ࡃデ᩿᪉ἲࡣࠕ⮬↛⌧㇟࡛ࠖ࠶ࡿ࡜ุ᩿ࡋࡓ . Microsoft Corp.

Michael A. Heller & Rebecca S. Eisenberg, Can Patents Deter Innovation? The Anti-

v. AT&T Corp., 550 U.S. 437 (2007) ࢯࣇࢺ࢙࢘࢔≉チࡢᑕ⛬ࢆ㝈ᐃ ࡶཧ↷ࠋ

commons in Biomedical Research, 280 SCI. 698-701, 699-700 (1998) ཧ↷ࠋ548 U.S. 124, 126 (2006) ࣈࣛ࢖ุ࣮ࣖ஦ࠊ⿢㔞ୖッࡢᲠ༷࡟ᑐࡋ࡚཯ᑐ ; id. at

In re Bilski, 545 F.3d 943, 965 n.27 (Fed. Cir. 2008) (en banc) Metabolite ࢆᢎㄆ , ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO  ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO   㐃⥆௻⏬

⡿ᅜࡢἲ࡜ᨻ⟇࡟࠾ࡅࡿ㑇ఏᏊデ᩿ࡢ≉チ㐺᱁ᛶ 㻰㼞㼑㼥㼒㼡㼟㼟 㧗⿢ࡣࡢࡕ࡟ࠊࡇࡢᇶ‽࡟㐣ᗘ࡟㢗ࡿࡇ࡜ࢆᣄ⤯ࡋ࡚≉チ㐺᱁࡞୺㢟ࡢၥv. US PTO  >AMP@࡛ࠊࡲࡉ࡟㑇ఏᏊデ᩿࡟㛵ࡍࡿࡶࡢ࡛࠶ࡿࠋࡇࡢ⿢ุ

㢟࡟ࡘ࠸࡚ࡼࡾᰂ㌾࡞࢔ࣉ࣮ࣟࢳࢆ㑅ࢇࡔࡀࠊ᥍ッ⿢ุᡤࡣ State Street ࢆ஦௳࡛ࠊࣟࣂ࣮ࢺ࣭ࢫ࢖࣮ࢺุ஦ࡢุ᩿ࡋࡓ࡜ࡇࢁ࡟ࡼࢀࡤࠊMyriad᫂ࡽ࠿࡟ᣄ⤯ࡋࠊ⮬↛ἲ๎ࠊ≀⌮ⓗ⌧㇟ࠊཬࡧᢳ㇟ⓗ࢔࢖ࢹ࢔ࡣ≉チ࡛ࡁ

Genetics ♫࡟᤼௚ⓗ࡟ࣛ࢖ࢭࣥࢫࡉࢀ࡚࠸ࡓ࠶ࡿ≉ᐃࡢ㑇ఏᏊࡢኚ␗

࡞࠸ࡇ࡜ࢆ☜ㄆࡋࡓࡢ࡛࠶ࡿ ࠋ㸦ࠕ㻮㻾㻯㻭ࠖኚ␗࡜࠸ࢃࢀࡿ㸧࡜ங࢞ࣥࡢ㛵㐃௜ࡅ࡟ࡘ࠸࡚ࡢ≉チࡀ↓ຠ࡜ࡉࢀࡓࠋຍ࠼࡚ࠊMyriad ♫ࡀᣢࡗ࡚࠸ࡓ 㻮㻾㻯㻭㻝 ࡜ 㻮㻾㻯㻭㻞 㑇ఏᏊࡢ㓄ิṧᛕ࡞ࡀࡽࠊBilski ࡢ᭱㧗⿢ࡢุ᩿ࡣࠊከࡃࡢ␲ၥⅬࢆ࣮࢜ࣉࣥ࡞ࡲࡲ

ࡢ඲㒊ཪࡣ୍㒊ࢆྵࡴ༢㞳 㻰㻺㻭㻌 ࡍ࡞ࢃࡕࠊኚ␗ࡀ㉳ࡇࡿ࡜ࠊங࢞ࣥࡢࣜ

࡟ࡋ࡚࠸ࡿࠋࡇࡢ஦௳ࡣࠊࣅࢪࢿࢫ᪉ἲ㸦ࣜࢫࢡ࣊ࢵࢪࡢ᪉ἲ㸧࡟㛵ࡍࡿࢫࢡࢆቑຍࡉࡏࡿࡇ࡜࡟࡞ࡿሷᇶ㓄ิࢆྵࡴ 㻰㻺㻭 ศᏊ ࡟ࡘ࠸࡚ࡢ≉チ

ࡶࡢ࡛ࠊデ᩿᪉ἲࡢ≉チ࡟࠾࠸࡚ࢡ࣮࣒ࣞࡉࢀ࡚࠸ࡿࡼ࠺࡞ࠊ⮬↛⛉Ꮫⓗࡶ↓ຠ࡜ࡉࢀࡓࡢ࡛࠶ࡿࠋ

㛵ಀࡢ≉チ㐺᱁ᛶࢆᢅ࠺ࡶࡢ࡛ࡣ࡞࠿ࡗࡓࠋࡲࡓࠊ༢㞳ࡋࡓ㑇ఏᏊࡢ≉チࡢࡼ࠺࡞ࠊ≀ࡢ≉チࢆᢅ࠺ࡶࡢ࡛ࡶ࡞࠿ࡗࡓࠋࡲࡉ࡟ࠊࢣࢿࢹ࢕ุ஦ࡀ௚

ᵝࠎ࡞⛉Ꮫᅋయࡶࠊࡇࡢၥ㢟࡟ࡘ࠸᳨࡚ウࡋ࡚࠸ࡿࠋᖺ࡟ࠊᅜ❧࢔ࡢ⿢ุᐁࡶཧຍࡋࡓከᩘពぢࡢ୰࡛≉࡟㏙࡭࡚࠸ࡿࡼ࠺࡟ࠊࠕ㧗ᗘ࡞デ᩿࢝ࢹ࣑࣮ࡢᅜ❧⛉Ꮫ◊✲ጤဨ఍ࡣࠊᅜ❧⾨⏕◊✲ᡤ >㻺㻵㻴@ ࡢせㄳ࡛ࠊ㑇ఏ་⒪ᢏ⾡ࠖࡢ≉チ㐺᱁ᛶ࡟ࡘ࠸࡚ࡣุ᩿ࡉࢀ࡞࠸ࡲࡲࡔࡗࡓࡢ࡛࠶ࡿࠋ

Ꮚཬࡧࢱࣥࣃࢡ㉁࡟ࡘ࠸࡚ࡢ≉チࡢ་⒪◊✲࡟ᑐࡍࡿᙳ㡪࡟ࡘ࠸࡚ࡢ◊ࡋ࠿ࡋ࡞ࡀࡽࠊ࠸ࡃࡘ࠿ࡢ஦௳ࡣᡭࡄࡍࡡࢆᘬ࠸࡚ᚅࡗ࡚࠸ࡓࠋ ࡘࡣ✲ࢆ᏶ᡂࡉࡏࡓࠋࡑࢀ࡟ࡼࡿ࡜ࠊ≉チ࡜ࡑࢀ࡟㛵㐃ࡍࡿάື㸦ヨᩱࡢඹ᭷

Prometheus Laboratories v. Mayo Collaborative Services ࡛ࠊMetabolite ࡛ၥࡀ࠺ࡲࡃ࠸ࡗ࡚࠸࡞࠸ࡇ࡜࡞࡝㸧࡟ࡼࡗ࡚ࠊ◊✲ࡀ㜼ᐖࡉࢀ࡚࠸ࡿࡇ࡜ࡀ

㢟࡟࡞ࡗࡓࡶࡢࡼࡾ࠸ࡃࡽ࠿」㞧࡞デ᩿᪉ἲ࡟㛵ࡍࡿࡶࡢ࡛࠶ࡿࠋ ࡘ┠ࢃ࠿ࡗࡓࡀࠊ࢔࢝ࢹ࣑࣮ࡢ່࿌ࡣ୺࡜ࡋ࡚ 㻺㻵㻴 ࡢࢧ࣏࣮ࢺ࡟ࡼࡾ࡞ࡉࢀࡓࡣࠊClassen Immunotherapies, Inc. v. Biogen IDEC  ࡛ࠊண㜵᥋✀ィ⏬ࡢᨵၿⓎ᫂࡟㝈ᐃࡉࢀ࡚࠸ࡓࠋ㑇ఏᏛ࣭೺ᗣ࣭♫఍࡟㛵ࡍࡿ㛗ᐁࡢㅎၥጤဨ఍

ࡢ᪉ἲ࡟ࡘ࠸࡚ࡢࡶࡢ࡛࠶ࡿࠋ ࡘࡵࡣࠊAssociation for Molecular Pathology

>㻿㻭㻯㻳㻴㻿@ ࡣࠊಖ೺⚟♴┬㛗ᐁ࡟ຓゝࢆ⾜࠺ᶵ㛵࡛࠶ࡿࡀࠊᝈ⪅ࡢ࢔ࢡࢭ

aff’d sub nom. Bilski v. Kappos, 130 S.Ct. 3218 (2010); id. at 1006 ࣓࢖ุ࣮ࣖ஦ࠊ཯ᑐ
ពぢMetabolite ࡟࠾ࡅࡿࣈࣛ࢖࣮ࣖ཯ᑐពぢࢆᘬ⏝ .

Bilski, 130 S.Ct. at 3225.≉࡟ࠊࣈࣛ࢖ุ࣮ࣖ஦ࡣࠊࢫ࣮࢝ࣜ࢔ุ஦ࡶཧຍࡋࡓಶูពぢ࡟࠾࠸࡚ࠊࠕ≉チ㐺᱁ᛶ࡟ࡘ࠸࡚ࠗ᭷⏝ࠊලయⓗࠊ࠿ࡘ᭷ᙧ࡞⤖ᯝ࠘࢔ࣉࣟ

ࢫၥ㢟࡟ࡘ࠸࡚ㄪᰝࢆ⾜ࡗࡓࠋ᰿ᣐ࡜ࡍ࡭ࡁ஦ᐇࢆࡼࡾヲ⣽࡟ぢࡿࡓࡵ࡟ࠊ
㻿㻭㻯㻳㻴㻿 ࡣ୍㐃ࡢࢣ࣮ࢫ◊✲ࢆጤクࡋࡓࠋ㻿㻭㻯㻳㻴6ࡣࠊࡇࢀࡽࡢ◊✲ࢆศᯒࡋࠊᩥ⊩ࢆ෌᳨ウࡋࠊᑓ㛛ᐙ࡜༠㆟ࡋࠊࣃࣈࣜࢵࢡ࣭ࢥ࣓ࣥࢺࢆồࡵࡓᚋࠊᖺ࡟ࠊᝈ⪅࡜◊✲⪅ࡢ཮᪉࡟デ᩿᪉ἲࡀࡼࡾ฼⏝ྍ⬟࡜࡞ࡿࡼ࣮ࢳࢆᑟධࡍࡿࡇ࡜ࡣࠊ㐃㑥ᕠᅇ༊ࡢ State Street ุỴ࡜⤖ࡧ௜ࡅࢀࡤࠊࠗᗄศࣂ࢝



ࡆࡓࡶࡢ࠿ࡽ᫂ࡽ࠿࡟୙᮲⌮࡞ࡶࡢ࡟ࡲ࡛ཬࡪ࠘≉チࢆ௜୚ࡍࡿࡇ࡜࡟຾ࡿࡇ࡜࡛



702 F. Supp. 2d 181 (S.D.N.Y. 2010).࠶ࡿࠋࠖ࡜ᣦ᦬ࡋ࡚࠸ࡿࠋId. at 3259 ࣈࣛ࢖࣮࣭ࣖࢫ࣮࢝ࣜ࢔ุ஦ࠊྠពពぢ  Bilski,NAT’L RESEARCH COUNCIL, REAPING THE BENEFITS OF GENOMIC AND PROTEOMIC

545 F.3d at 1004 ࣓࢖ุ࣮ࣖ஦ࠊ཯ᑐពぢ ࢆᘬ⏝ .

RESEARCH: INTELLECTUAL PROPERTY RIGHTS, INNOVATION, AND PUBLIC HEALTH (Nat’lBilski, 130 S.Ct. at 3227 㐃 㑥 ᕠ ᅇ ༊ ࡢ ࠕ ᶵ Ე ཪ ࡣ ኚ ᥮ ᇶ ‽ machine-or-

Academies Press 2006) >௨ୗREAPING THE BENEFITS ࡜࠸࠺@.

transformation testࠖࡣࠊデ᩿᪉ἲ࡟㛵ࡋ࡚୙☜ᐇᛶࢆ๰ࡾฟࡋࡓࡀࠊ᥍ッ⿢ุᡤࡣࠊ

㧗ᗘ࡞デ᩿᪉ἲࡶྵࡵ࡚ࠊ࠸࠿࡞ࡿ≉ᐃࡢⓎ᫂ࡢ≉チ㐺᱁ᛶ࡟ࡘ࠸࡚ࡶ㏙࡭࡚࠸࡞

cal Access to Genetic Testing in the United States, 12 GENETICS IN MED. S1-S211 (Supp.

࠿ࡗࡓࡇ࡜ࢆᣦ᦬ࡋ࡚࠸ࡿ .2010), available at http://journals.lww.com/geneticsinmedicine/toc/2010/04001; Robert

Cook-Deegan & Christopher Heaney, Gene Patents and Licensing: Case Studies Prepared581 F.3d 1336 (Fed. Cir. 2009), vacated and remanded _ U.S. _, 2010 WL 2571881 (U.S.

Patently Complicated: Case Studies on the Impact of Patenting and Licensing on Clini-

June 29, 2010)(No. 09-490).

for the Secretary's Advisory Committee on Genetics, Health, and Society, 12 GENETICS IN

304 Fed. Appx. 866 (Fed. Cir. 2008), vacated and remanded _ U.S. _, 2010 WL 2571877

MED. S1-S2 (Supp. 2010), available at http://journals.lww.com/geneticsinmedicine/Fulltext/(U.S. June 29, 2010)(No. 08-1509).

2010/04001/Gene_patents_and_licensing__Case_studies_ prepared. 1.aspx ࢆཧ↷ࠋ ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO  ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO   㐃⥆௻⏬

⡿ᅜࡢἲ࡜ᨻ⟇࡟࠾ࡅࡿ㑇ఏᏊデ᩿ࡢ≉チ㐺᱁ᛶ 㻰㼞㼑㼥㼒㼡㼟㼟 ࠺࡞ᨵၿࢆࡍࡿࡓࡵ࡟ࡣࠊ࠸ࡃࡘ࠿ࡢኚ໬ࢆ࡞ࡍ࡭ࡁࡇ࡜ࢆ່࿌ࡍࡿሗ࿌

࡟ᚑ࠸ࣉ࣮ࣝ࡟ཧຍࡍࡿࡔࢁ࠺࡜☜ಙࡍ࡭ࡁ⌮⏤ࡣ࡯࡜ࢇ࡝࡞࠸ࠋ

᭩ࢆฟࡋࡓ ࠋᮏㄽᩥࡢ⤖ㄽࡣࠊ࢔ࢡࢭࢫၥ㢟ࢆゎỴࡍࡿ᭱ࡶࡼ࠸᪉ἲࡣࠊデ᩿᪉ἲ㛵ᮏㄽᩥࡢ➨  㒊ࡣࠊ㑇ఏᏊ≉チࡀᥦ㉳ࡍࡿ≉᭷ࡢၥ㢟ࢆ᫂ࡽ࠿࡟ࡍࡿࡓ

㐃ࡢ◊✲ࡸᝈ⪅ࡢ་⒪࡟ᚑ஦ࡍࡿ⪅࡟ᑐࡋ࡚౵ᐖ㈐௵ࡢ᪂ࡋ࠸ᢠᘚࢆ๰

ࡵ࡟ࠊ㑇ఏᏊデ᩿ࡢಶேⓗཬࡧ♫఍ⓗ࡞㔜せᛶࢆㄝ᫂ࡋࠊࡑࡢᑗ᮶ⓗ࡞ᗈฟࡍࡿࡇ࡜ࡔࠊ࡜࠸࠺ࡇ࡜࡛࠶ࡿࠋ⤖ᒁࡢ࡜ࡇࢁࠊ㑇ఏ᝟ሗࡀ≉チไᗘ࡟ࡀࡾࢆド᫂ࡍࡿࡼ࠺࡞⡿ᅜࡢ㑇ఏᏊ≉チࡢᐇ౛ࢆᥦ౪ࡍࡿࠋ㻿㻭㻯㻳㻴㻿 ࡢሗᑐࡋ࡚ၥ㢟ࢆᥦ㉳ࡍࡿࡢࡣࠊ἞⒪࡜デ᩿࡜࠸࠺  ࡘࡢ኱ࡁࡃ␗࡞ࡿ་⒪ά

࿌᭩࡟౫ᣐࡋࠊ➨  㒊࡛ࡣࠊࡇࢀࡽࡢ≉チࡀᝈ⪅ࡢ་⒪࡟㈇ࡢᙳ㡪ࢆ୚࠼ື࡟࡜ࡗ࡚ࠊࡑࢀࡀࡁࢃࡵ࡚㔜せࡔ࠿ࡽ࡛࠶ࡿࠋⴭసᶒἲཬࡧၟᶆἲࡣࠊ

ࡿࡢࡳ࡞ࡽࡎࠊデ᩿᪉ἲࡢ㛤Ⓨࡸၟᴗ໬࡟ࡶ࡯࡜ࢇ࡝㛵ಀ࡞࠸ࡇ࡜ࢆ୺ᙇ

㛗ᖺࠊ▱㆑ၟရࡢࠕ஧㔜⏝㏵ᛶࠖ࡟ᑐฎࡋ࡚ࡁ࡚࠾ࡾࠊᥦ᱌ࡋࡓᢠᘚࡣࠊ

ࡍࡿࠋ➨  㒊࡛ࡣࠊ࢔ࢡࢭࢫࢆᨵၿࡍࡿࡓࡵࡢᵝࠎ࡞᪉ἲ࡟ࡘ࠸࡚㆟ㄽࡍࡇࢀࡽࡢไᗘ࡟࠾࠸࡚᥇⏝ࡉࢀ࡚ࡁࡓᡓ␎࡟ᚑ࠺ࡶࡢ࡛࠶ࡿࠋ
ࡿࠋࡑࡢ⤖ㄽࢆ࠸࠼ࡤࠊࡍ࡭࡚ࡢ㑇ఏᏊ㛵㐃Ⓨ᫂ࢆ≉チ㐺᱁࡞୺㢟࠿ࡽ㝖ࡃࡇ࡜ࡣࠊBilski ࡢୗ࡛ྍ⬟࡛ࡣ࠶ࡾAMP ࡟࠾࠸࡚ࢫ࢖࣮ࢺุ஦࡟ࡼࡾᐇ

➨㸯㒊 㑇ఏᏊデ᩿㸸ࡑࡢ᭷ᮃᛶ࡜≉チ㻌㝿࡟㐺⏝ࡉࢀࡣࡋࡓࡀࠊMetabolite ࡟࠾࠸࡚ࣈࣛ࢖ุ࣮ࣖ஦ࡀ♧၀ࡋࡓࡼ࠺࡟ࠊࡇࡢၥ㢟ࢆ࠺ࡲࡃฎ⌮ࡍࡿ࡟ࡣ࠶ࡲࡾ࡟ษࢀ࿡ࡢᝏ࠸㐨ල࡛࠶ࡿࠋ

㹟㸬᭷ᮃᛶ

୺㢟࠿ࡽ㝖ࡃ࡜࠸࠺᪉⟇ࡣࠊ༢⣧࡞㛵㐃௜ࡅ࡟ࡘ࠸࡚ࡢⓎ᫂࡟࡜ࡗ࡚ࡣጇ

࡝ࡢᢏ⾡࡟㛵ࡍࡿ≉チࡶࠊ≉チᶒ⪅࡟ಖㆤᢏ⾡ࢆᨭ㓄ࡋ࡚ࡑࡢ࢔ࢡࢭࢫ

ᙜ࡞᪉ἲ࠿ࡶࡋࢀ࡞࠸ࡀࠊࡍ࡭࡚ࡢ㑇ఏᏊ㛵㐃Ⓨ᫂࡟ࡘ࠸࡚ࡢ≉チࢆ㝖እ࡟➇த౯᱁௨ୖࡢ౯᱁ࢆㄢࡍࡇ࡜ࢆㄆࡵ࡚࠾ࡾࡑࡋ࡚ᐇ㝿ㄆࡵࡿࡼ࠺࡟

ࡋ࡚ࡋࡲ࠺࡜ࠊ」ྜⓗ࡞デ᩿᪉ἲ㸦≉チࡀ࠶ࡿ⛬ᗘࡣᚲせ࠿ࡶࡋࢀ࡞࠸㸧タィࡉࢀ࡚࠸ࡿⅬ࡟࠾࠸࡚ࠊ࠶ࡿ⛬ᗘࡣ࢔ࢡࢭࢫၥ㢟ࢆᥦ㉳ࡍࡿࡶࡢ࡛࠶

ࡸ἞⒪᪉ἲ㸦≉チࡀ୙ྍḞ࡛࠶ࡿ࡜⪃࠼ࡽࢀࡿ㸧࡟ࡘ࠸࡚ࡢ࢖ࣥࢭࣥࢸ࢕

ࡿࠋࡑࢀ࡟ࡶ࠿࠿ࢃࡽࡎࠊ㑇ఏᏊࡢศ㔝ࡣ≉࡟✺ฟࡋ࡚࠸ࡿࠋ㑇ఏⓗデ᩿ࣈࢆᾘ⁛ࡉࡏ࡚ࡋࡲ࠺ࠋࡉࡽ࡟ࠊ≉チࡢ௚ࡢせ௳ࢆᚤㄪᩚࡍࡿࡇ࡜ࡣࠊ㐃ࡢ㐍Ṍࡣࠊಶࠎࡢᝈ⪅ࡢ೺ᗣࡢᨵၿ࡟┦ᙜ࡞ྍ⬟ᛶࢆ⛎ࡵ࡚࠸ࡿࠋಶே࡟

㑥ᕠᅇ༊ࡀ᭱ึ࡟୺㢟ࡢ࢝ࢸࢦ࣮ࣜࢆᣑᙇࡋࡓ࡜ࡁ࡟♧၀ࡋ࡚࠸ࡓࡇ࡜

ࡘ࠸࡚ᚓࡽࢀࡿ᝟ሗࡣࠊ㔜せ࡛࠶ࡿ࡜࡜ࡶ࡟ࠊ♫఍࡟ᑐࡋ࡚ࢫࣆ࣮ࣝ࢜ࣂ

ࡶࡑࡢ୍౛ࡔࡀ ࠊㄽ⪅ࡀⓎぢࡋࡓၥ㢟ࢆᢅ࠺ࡢ࡟༑ศ࡟ᙉຊ࡞㐨ල࡛ࡣ࡞࠸ࠋࡲࡓࠊ࠶ࡿ⪅ࡣࠊ࢔ࢡࢭࢫࡢᠱᛕࢆゎỴࡍࡿ࡟ࡣࠊ࣋ࢫࢺࣉࣛࢡࢸ

࣮ຠᯝࢆᣢࡗ࡚࠸ࡿࡢ࡛࠶ࡿࠋ
࢕ࢫ࡟ࡘ࠸࡚ࡢ࢞࢖ࢻࣛ࢖ࣥࡸ≉チࣉ࣮ࣝ࡞࡝ࠊᵝࠎ࡞ไᗘࡢᩚഛࡀ᭷ຠ

᭱ࡶ᫂ⓑ࡞ࡢࡣࠊ㑇ఏ᝟ሗࡣࠊ་⒪ࢆᨵၿࡋࡑࢀ࡟ᚲせ࡞㈨※ࢆῶࡽࡍ࡛࠶ࡿ࡜♧၀ࡋ࡚࠸ࡿࡀࠊ㑇ఏᏊ≉チࡢᶒ฼⪅ࡀࡇࢀࡽࡢ࢞࢖ࢻࣛ࢖ࣥ

ࡇ࡜ࡀ࡛ࡁࡿ࡜࠸࠺ࡇ࡜࡛࠶ࡿࠋ࠶ࡿ ࡍ࡭࡚࡛ࡣ࡞࠸ ሙྜ࡟ࡣࠊ⮬ศ࡟

࠶ࡿ⑓Ẽ࡟࠿࠿ࡾࡸࡍࡃ࡞ࡿ㑇ఏⓗኚ␗ࡀ࠶ࡿࡇ࡜ࢆ▱ࡗࡓ⪅ࡣࠊࡑࢀ࡟

Sec’y’s Advisory Comm. on Genetics, Health, and Soc’y, Report on Gene Patents and

Licensing Practices and Their Impact on Patient Access to Genetic Tests, available at

ORATIVE LICENSING MODELS 383-463 (Geertrui Van Overwalle ed., Cambridge Univ. Press

http://oba.od.nih.gov/oba/SACGHS/SACGHS%20Patents%20Report%20Approved%202-5

2009)>௨ୗ LICENSING MODELS ࡜࠸࠺@; Geertrui Van Overwalle, Designing Models to-20010.pdf [௨ୗ Report on Gene Patents࡜࠸࠺]; see also Testing Time for Gene Patents,

Clear Patent Thickets in Genetics, in WORKING WITHIN THE BOUNDARIES OF INTELLEC-

464 NATURE 957 (2010) ጤဨ఍ࡢሗ࿌᭩ࢆࢧ࣏࣮ࢺࡋ࡚࠸ࡿ 

TUAL PROPERTY 305-23 (Rochelle Dreyfuss et al. eds., Oxford Univ. Press 2010)>௨ୗ



State Street Bank & Trust Co. v. Signature Financial Group, Inc., 149 F.3d 1368, 1375

Van Orwalle, Designing Models ࡜࠸࠺@; ORG. FOR ECON. CO-OPERATION & DEV., GUIDE-(Fed. Cir. 1998).

LINES FOR LICENSING OF GENETIC INVENTIONS (2006)>௨ୗ OECD GUIDELINES ࡜࠸࠺@,

available at http://www.oecd.org/dataoecd/39/38/36198812.pdf ࡶཧ↷ࠋ

Geertrui Van Overwalle, Of Thickets, Blocks and Gaps, in GENE PATENTS AND COLLAB- ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO  ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO   㐃⥆௻⏬

⡿ᅜࡢἲ࡜ᨻ⟇࡟࠾ࡅࡿ㑇ఏᏊデ᩿ࡢ≉チ㐺᱁ᛶ 㻰㼞㼑㼥㼒㼡㼟㼟 ᑐࡋ࡚ண㜵ⓗ⾜ືࢆྲྀࡿࡇ࡜ࡀ࡛ࡁࡿࠋࡲࡓ࠶ࡿሙྜ࡟ࡣࠊಶேࡀྲྀࡿ࡭

ᅾ࡛ࡣࠊ㑇ఏᏛࡣ⸆ࡢ௦ㅰࡸ཯ᛂᛶ࡟㛵ಀࡍࡿ࡜⌮ゎࡉࢀ࡚࠾ࡾࠊ་⪅ࡁ⾜Ⅽࡣᛮ࠸ษࡗࡓࡶࡢ࡛࠶ࡿࠋࡓ࡜࠼ࡤࠊAMP ࡢ஦௳࡛ၥ㢟࡟࡞ࡗࡓࡣ㑇ఏ᝟ሗࢆ⏝࠸࡚ࠊ᭱ࡶຠᯝⓗ࡜ᛮࢃࢀࡿ἞⒪ἲࠊᑡ࡞ࡃ࡜ࡶ᭱ࡶ๪స

㻮㻾㻯㻭 ኚ␗ࡣࠊங࢞ࣥࡀⓎ⑕ࡍࡿࣜࢫࢡࢆ⏕ᾭ࡟࠾࠸࡚㸣ቑຍࡋࠊ༸ᕢ

⏝ࡢᑡ࡞࠸࡜ᛮࢃࢀࡿ἞⒪ἲࢆ㑅ᢥࡍࡿࡇ࡜ࡀ࡛ࡁࡿࠋ

࢞ࣥࡢⓎ⑕ࡢࣜࢫࢡࢆ㹼㸣ቑຍࡍࡿࡶࡢ࡛࠶ࡿࠋࡇࡢኚ␗ࢆᣢࡗࡓዪ

ᛶࡣࠊࡋࡤࡋࡤࠊண㜵ⓗ࡟ஙᡣษ㝖ᡭ⾡ཪࡣᏊᐑษ㝖ᡭ⾡ࢆ⾜࠺ࠋ௚ࡢ

ᐦ᥋࡟㛵㐃ࡍࡿࡶࡢ࡟ࠊ་⸆ࡢ㛤Ⓨ㐣⛬࡟࠾ࡅࡿ㑇ఏ᝟ሗࡢ౑⏝ࡀ࠶ሙྜ࡟ࡣࠊண㜵᪉ἲࡣࡼࡾ✜ࡸ࠿࡛࠶ࡿࠋࡓ࡜࠼ࡤࠊ㑇ఏⓗ࡟⤖⭠࢞ࣥࡢࡿࠋヨ⾜㘒ㄗ࡟㢗ࡿ௦ࢃࡾ࡟ࠊ⛉Ꮫ⪅ࡓࡕࡣ௒ࡸࠊ㑇ఏᏊ࡜ࡑࢀࡀⓎ⌧ࣜࢫࢡࡢቑຍࡀỴᐃࡉࢀ࡚࠸ࡿሙྜ࡟࠾࠸࡚ࡣࠊ⤖⭠㙾࡟ࡼࡿࢫࢡ࣮ࣜࢽ

ࡍࡿ㸦య࡟⏕⏘ࡉࡏࡿ㸧ࢱࣥࣃࢡ㉁ࡢᵓ㐀࡟ࡘ࠸࡚ࡢ᝟ሗࢆ౑ࡗ࡚ࠊ◊✲ࣥࢢࡢ㢖ᗘࢆୖࡆࡿࡇ࡜ࡀ᥎ዡࡉࢀࡿ ࠋᚰ⮚⑓ࡢࣜࢫࢡࡀ㧗ࡃ࡞ࡗ࡚࠸

࡜ࢫࢡ࣮ࣜࢽࣥࢢࡢ┠ᶆࢆỴᐃࡋ࡚࠸ࡿࠋ⮫ᗋヨ㦂࡟⏝࠸ࡿ⸆ࡢೃ⿵ࡀ

ࡿྍ⬟ᛶ࡟Ẽ௜࠸ࡓࡽࠊࡼࡾ㐠ືࡋ↮ⲡࢆῶࡽࡍẼࢆ㉳ࡇࡍ࠿ࡶࡋࢀ࡞࠸ࠋ

ぢࡘ࠿ࡗࡓࡽࠊ◊✲⪅ࡓࡕࡣࡑࡢヨ㦂ࡍࡿ≀㉁࠿ࡽࠊᐖࢆ୚࠼ࡿ㸦ཪࡣࠊ୍⯡ⓗ࡟ࠊ⑓Ẽࢆ㑊ࡅࡿࡇ࡜࡛ࠊ་⒪⾜Ⅽࡢࡓࡵ࡟♫఍ࡀ㈇ᢸࡍ࡭ࡁ㈝⏝฼┈ࢆ୚࠼࡞࠸㸧ྍ⬟ᛶࡢ㧗࠸ᑐ㇟ࢆ㝖እࡍࡿࡇ࡜ࡀ࡛ࡁࡿࠋ⾜ᨻࡢᢎㄆࢆῶࡽࡍࡇ࡜ࡀ࡛ࡁࡿࡢ࡛࠶ࡿ ࠋࡀᚓࡽࢀࡿ࠿ࡣࠊᏳ඲ᛶ࡜᭷ຠᛶࢆ♧ࡍࡇ࡜ࡀ࡛ࡁࡿ࠿࡟౫Ꮡࡍࡿࡢ࡛ࠊ

ࡇࡢ⸆ࡢ㛤Ⓨ࡟ᑐࡍࡿ⸆⌮㑇ఏᏛⓗ࢔ࣉ࣮ࣟࢳ࡟ࡼࡗ࡚ࠊ᪂ࡋ࠸⸆ࡀᕷሙ

㑇ఏᏊデ᩿ࡣ἞⒪ἲࡢ㑅ᢥ⫥ࢆὙ⦎ࡍࡿࡢ࡟ࡶ౑࠺ࡇ࡜ࡀ࡛ࡁࡿࠋࡑࢀ
ࡺ࠼ࠊ⑓ᅉㄽ࡟ࡼࡾࠊ⑓Ẽࡢ㐍⾜ࡢண

ࡸᵝࠎ࡞ᢚṆ᪉ἲࡢ㐺ྜᛶࢆỴᐃࡍࡿࡇ࡜ࡀ࡛ࡁࡿࠋኻ⫈ࡀࡑࡢ୍౛࡛࠶ࡿࠋ⫈ぬ㞀ᐖࡢཎᅉ࡜࡞ࡿ㑇ఏⓗ࡟ࡶࡓࡽࡉࢀࡿ࡟㐪࠸࡞࠸ࡋࠊከࡃࡢேࠎ࡟࡜ࡗ࡚ࡣᏳ඲ཪࡣ᭷ຠ࡛ࡣ࡞
࠸ࡀ≉ᐃࡢ㑇ఏᏊࣉࣟࣇ࢓࢖ࣝࢆᣢࡗࡓᝈ⪅࡟ࡣ㐺⏝࡛ࡁࡿ⸆ࡀ᚟άࡍ
ࡿࡇ࡜ࡉ࠼࠶ࡿ࠿ࡶࡋࢀ࡞࠸ࠋ
᮲௳ࡣ࠸ࡃࡘ࠿Ꮡᅾࡍࡿࠋᝈ⪅ࡢ≉ᐃࡢኚ␗ࢆ▱ࢀࡤࠊ་⪅ࡣ㞀ᐖࡀ࡝ࡢ
ࡼ࠺࡟Ⓨ⏕ࡋࠊࡑࢀࡀࡶࡓࡽࡍᅔ㞴ࡀ࡝ࡢࡼ࠺࡞ࡶࡢ࠿ࢆண ࡍࡿࡇ࡜ࡀ

ࡑࡢ௚࡟㑇ఏ᝟ሗࢆ౑࠼ࡿࡢࡣࠊᐙ᪘ィ⏬࡛࠶ࡿࠋࡓ࡜࠼ࡤࠊࢸ࢖㸻ࢧ࡛ࡁࡿࠋຍ࠼࡚ࠊ≉ᐃࡢኚ␗࡟ࡼࡾࠊᝈ⪅ࡀ⿵⫈ჾࢆ⏝࠸ࡓࡾ⼗∵⛣᳜ࢆࢵࢡࢫ⑓ࡣࠊ࢔ࢩࣗࢣࢼࢪ࣒࡜࠸࠺ࣘࢲࣖேࡢ㞟ᅋ㸦୰ḢཪࡣᮾḢ࡟㉳※ࡋࡓࡾࡋ࡚ᝈ⪅ࡀᨵၿࡍࡿ࠿ྰ࠿ࢆỴᐃ࡛ࡁࡿࡇ࡜ࡶ࠶ࡿࠋࡉࡽ࡟ࠊ⌧



(Supp. 2010).



AMP, 702 F. Supp. 2d, at 203.

ࡓ࡜࠼ࡤࠊGuy de Backer et al., European Guidelines on Ccardiovascular Disease(2003).

Richard Weinshilboum, Inheritance and Drug Response, 348 NEW ENG. J. MED. 529-37

Prevention in Clinical Practice, 24 EUR. HEART J. 1601-10, 1605 ⾜ືⓗ࡞ࣜࢫࢡせᅉࠊࡓ࡜࠼ࡤႚ↮ࡸᗙࡗ࡚ࡤ࠿ࡾࡢ⏕άࢆ㏦ࡿࡇ࡜ࠊࢆῶࡽࡍࡇ࡜ࡀࠊᚰ⮚⑓ࡢ㧗࠸ࣜ

1235-36 (2010) ཧ↷ࠋࢫࢡࢆᢪ࠼࡚࠸ࡿ⪅࡟࡜ࡗ࡚ᚲせ࡛࠶ࡿࡇ࡜ࢆᣦ᦬ ࢆཧ↷ࠋ

27

ࡓ࡜࠼ࡤ Theresa M. Marteau & Caryn Lerman, Genetic Risk and Behavioral Change,

techresources/Human_Genome/medicine/pharma.shtml (last visited June 27, 2010); see322 BRITISH MED. J. 1056-59 (2001) ࢆཧ↷ࠋ

also Arti K. Rai, The Information Revolution Reaches Pharmaceuticals: Balancing Innova-

tion Incentives, Cost, and Access in the Post-Genomics Era, 2001 U. ILL. L. REV. 173-209☜࠿࡟ࠊ㑇ఏ᝟ሗࡀ་⒪ࢆᨵၿࡋࡑࡢ㈝⏝ࢆῶࡽࡍ࠿࡝࠺࠿ࡣࠊ⤒㦂ⓗ࡟ࡋ࠿ࢃࡓ࡜࠼ࡤࠊRichard P. Lifton, Individual Genomes on the Horizon, 362 NEW ENG. J. MED.
Human Genome Project, Pharmacogenomics, available at http://www.ornl.gov/sci/࠿ࡽ࡞࠸ࠋ᪂ࡋ࠸᳨ᰝἲࡸண㜵ἲࡣ㧗౯࡛ࠊ⑓Ẽ࡟ᙉ࠸࡜デ᩿ࡉࢀࡓேࠎࡢഃ࡟ࣜ

ཧ↷ࠋࢫࢡࡢ࠶ࡿ⾜ືࢆㄏⓎࡍࡿࡇ࡜ࡶ࠶ࡿࠋKelly E. Ormand et al., Challenges in theClinical Application of Whole-Genome Sequencing, 375 THE LANCET 1749-51 (2010) ཧ↷ࠋ

nlm.nih.gov/About/primer/pharm.html; Mark Henderson, Gene Test Could Prevent Ineffec-

Subhashini Chandrasekharan & Melissa Fiffer, Impact of Gene Patents and Licensing

tive Use of Taxol in Breast Cancer, THE TIMES, March 1, 2010, available at http://www.

Practices on Access to Genetic Testing for Hearing Loss, 12 GENETICS IN MED. S171-S193

timesonline.co.uk/tol/life_and_style/health/article7044486.eceཧ↷ࠋࡓ࡜࠼ࡤࠊNat’l Ctr. for Biological Info., A Science Primer, available at http://www.ncbi.

 ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO  ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO   㐃⥆௻⏬

⡿ᅜࡢἲ࡜ᨻ⟇࡟࠾ࡅࡿ㑇ఏᏊデ᩿ࡢ≉チ㐺᱁ᛶ 㻰㼞㼑㼥㼒㼡㼟㼟 ࢆᣢࡘࣘࢲࣖே㸧୍࡛⯡࡟ぢࡽࢀࡿ⚄⤒࡟㛵ࡍࡿ㑇ఏ⑓࡛࠶ࡿࠋࡇࡢ⑓Ẽศ㔝࡟ࡼࡾࠊ⑓Ẽࡢ㐍⾜ࡸࡑࡢ἞⒪ἲࡢⓎぢࢆ⌮ゎࡍࡿ᪂ࡋ࠸ྍ⬟ᛶࡀ㛤ࡣ⮴Ṛⓗ࡛἞⒪ἲࡀ࡞࠸ࡓࡵࠊඹྠయ࡟ࡼࡗ࡚ࡣⱝ࠸኱ேࢆ᳨ᰝࡋࠊࡑࡢ

࠿ࢀࡓࠋࡓ࡜࠼ࡤࠊ࢞ࣥࡢ἞⒪ࡣࠊ⭘⒆Ꮫ⪅ࡢศᏊ࡛ࣞ࣋ࣝࡢ⑓Ẽࡢ⌮⤖ᯝࢆ㓄അ⪅ࡢ㑅ᢥ࡟฼⏝ࡋ࡚࠸ࡿ ࠋࡑࡇࡲ࡛ࡋ࡞ࡃ࡚ࡶࠊฟ⏕๓᳨ᰝゎࡀ㐍ࢇ࡛࠸ࡿࡇ࡜࡟ࡼࡗ࡚ࠊࡍ࡛࡟ᜠᜨࢆཷࡅ࡚࠸ࡿࠋ

ࢆ฼⏝ࡋ࡚ࠊ㔜⠜࡞㞀ᐖࢆᣢࡗࡓᏊ౪ࡀ⏕ࡲࢀࡿࡢࢆ㜵࠸ࡔࡾࠊ๓ࡶࡗ࡚

㑇ఏ⑓࡟ࡼࡗ࡚ᐙ᪘࡟࠿࠿ࡿ≉ู࡞㈇ᢸ࡟ࡘ࠸࡚‽ഛࡋࡓࡾࡍࡿࡇ࡜ࡀ㹠㸬≉チ࡛ࡁࡿࠋࡓ࡜࠼ࡤࠊࢧ࣭ࣛ࣌࢖ࣜࣥࡣࠊ࢟ࣜࢫࢺᩍཎ⌮୺⩏⪅࡛࠶ࡾ ࡇࢀࡽࡢ฼┈ࡀࡍ࡭࡚ᐇ⌧࡛ࡁࡿ࡟ࡣࠊ㑇ఏᏊ࡟ࢥ࣮ࢻࡉࢀ࡚࠸ࡿ᝟ሗ

ᖺࡢ㑅ᣲ࡟࠾࠸࡚๪኱⤫㡿ೃ⿵࡛ࠊ୰⤯࡟཯ᑐࡋ࡚࠸ࡓࠋࡑࢀ࡟ࡶ࠿࠿ࢃ

࡟࢔ࢡࢭࢫࡍࡿࡇ࡜ࡀྍ⬟࡞ࡇ࡜ࡀᚲ㡲ࡢ᮲௳࡛࠶ࡿࠋඛ࡟ᣦ᦬ࡋࡓࡼ࠺

ࡽࡎࠊᙼዪࡣᮎࡢᏊ౪ࡀࢲ࢘ࣥ⑕࠿࡝࠺࠿ࢆ▱ࡿࡓࡵ࡟ࠊ㑇ఏᏊ᳨ᰝࢆ౑

࡟ࠊࣄࢺࢤࣀ࣒ࡢ࠾࠾ࡼࡑ㸣࡟ࡣ≉チࡀ࠶ࡿࠋࡇࢀࡽࡢ≉チࡢࢡ࣮ࣞ⏝ࡋࡓࡢ࡛࠶ࡿࠋ

࣒ࡢᑕ⛬ࢆỴࡵࡿࡢࡣࠊᗄศ㞴ࡋ࠸ࠋㄽ⪅ࡢ୰࡟ࡣࠊከࡃࡢ≀ࡢ≉チࡣࡁࢃࡵ࡚⊃࠸࡜ಙࡌࡿ⪅ࡀ࠸ࡿ୍᪉࡛ࠊ⿢ุᡤࡀ࠶ࡿ≉ᐃࡢࢡ࣮࣒ࣞࢆ࡝
㑇ఏᏊ◊✲ࡣࠊ᳨ᰝࡢᢏ⾡ࡀᨵၿࡉࢀ᳨࡚ᰝࡢ㈝⏝ࡀᏳࡃ࡞ࢀࡤࠊࡶࡗ

࠺ゎ㔘ࡍࡿ࠿ࢆ☜ᐇ࡟▱ࡿࡇ࡜ࡣ୙ྍ⬟࡛࠶ࡿࠋ≀ࡢ≉チࡢ୍㒊ࡣࠊࡑ࡜᭷ᮃ࡞ࡶࡢ࡟࡞ࡿࠋࡼࡾ኱ࡁࡃከᵝ࡞㞟ᅋ࠿ࡽࡢࢹ࣮ࢱࡀ࠶ࢀࡤࠊኚ␗

ࡋ࡚デ᩿᪉ἲࡢ≉チࡢከࡃࡣࠊࡁࢃࡵ࡚ᗈ࠸ࡼ࠺࡟ᛮ࠼ࡿࠋ౛࡜ࡋ࡚ࠊ

࡜⑓Ẽ࡜ࡢ㛵㐃௜ࡅ࠶ࡿ࠸ࡣ㑇ఏⓗ㈨㉁࡜⸆๣࡬ࡢ཯ᛂᛶ࡜ࡢ㛵㐃௜ࡅ⡿ᅜ≉チྕ࡟ࡘ࠸࡚⪃࠼࡚ࡳࡼ࠺ࠋࡇࢀࡣ≀ࡢ≉チ࡛࠶ࡾࠊࢡ

ࢆࡼࡾከࡃ㸫ࡑࡋ࡚ࡼࡾ」㞧࡞㛵㐃௜ࡅࢆ㸫Ⓨぢࡋド᫂ࡍࡿࡇ࡜ࡀ࡛ࡁ

࣮࣒ࣞࡢ୍㒊ࢆ♧ࡍ࡜௨ୗࡢ㏻ࡾ࡛࠶ࡿࠋ

ࡿࡼ࠺࡟࡞ࡿࠋྠᵝ࡟ࠊ௚ࡢᛂ⏝ࡶ࠶ࡿࠋࡓ࡜࠼ࡤࠊ࢘࢖ࣝࢫ࡟㛵ࡍࡿ㑇ఏ᝟ሗ࡟ࡼࡾࠊ་⒪⏺ࡣࠊࣃࣥࢹ࣑ࢵࢡࢆ⌮ゎࡋࠊ㏣㊧ࡋࠊᑐฎࡋࠊண   㻮㻾㻯㻭㻞 ࣏ࣜ࣌ࣉࢳࢻࢆࢥ࣮ࢻࡍࡿ༢㞳 㻰㻺㻭 ศᏊ࡛࠶ࡗ࡚ࠊヱ 㻰㻺㻭 ศᏊࡀ 㻿㻱㻽㻌㻵㻰㻌㻺㻻㻦㻞 ࡟♧ࡋࡓ࢔࣑ࣀ㓟㓄ิࢆࢥ࣮ࢻࡍࡿ᰾㓟㓄ิ࠿ࡽᡂࡿࠊ༢㞳㜵ࡍࡿࡇ࡜ࡀ࡛ࡁࡿࡼ࠺࡟࡞ࡾ࠺ࡿ ࠋ᳜≀ࡸື≀ࡢ㑇ఏᏛ࡟ࡘ࠸࡚ࡢ᝟

㻰㻺㻭㻌ศᏊࠋ

ሗ࡟ࡼࡾࠊ㣗ࡢᏳ඲ᛶࡀᨵၿ࡛ࡁࡿࠋ࢚ࣆࢪ࢙ࢿࢸ࢕ࢡࢫ࡜࠸࠺᪂ࡋ࠸







PHG FOUNDATION, TAY SACHS DISEASE CARRIER SCREENING IN THE ASHKENAZI JEW-୍⯡ⓗ࡟ࡣࠊDAVID ALLIS ET AL., EPIGENETICS (Cold Spring Harbor Lab. Press 2007)

ISH POPULATION 1 (2009), available at www.phgfoundation.org/file/4591/ ཧ↷ࠋ

ཧ↷ࠋ





Sarah Palin, Sarah Palin: My Life With Trig, Our Down Syndrome Child; Excerpt From

Eleftherios P. Diamandis, Next-Generation Sequencing: A New Revolution in Molecular

New Book, LIFENEWS.COM, http://www.lifenews.com/state4591.html ཧ↷ࠋ

Diagnostics?, 55 CLINICAL CHEMISTRY 2088-92, 2091 (2009).

Cf. Nicholas Wade, A Decade Later, Human Gene Map Yields Few New Cures, N.Y.



Jensen & Murray, supra note 4, at 239.

TIMES, June 13, 2010, at A1, available at http://www.nytimes.com/2010/06/13/health/ࡓ࡜࠼ࡤࠊLICENSING MODELS, supra note 19, at 387 ୍㒊ࠊḢᕞ≉チࡢศᯒ࡟౫ᣐ

research/13genome.html ⌧ᅾࡢࢹ࣮ࢱࡣࠊࡲࡔ㔜せ࡞἞⒪ἲࡢ㑅ᢥ⫥ࢆ⏕ࢇ࡛࠸࡞ࡋ࡚࠸ࡿ ; Christopher M. Holman, The Impact of Human Gene Patents on Innovation࠸ࡇ࡜ࢆᣦ᦬ࡋ࡚࠸ࡿ .

and Access: A Survey of Human Gene Patent Litigation, 76 UMKC L. REV. 295-361 (2007)

U.S. Dept. of Agriculture, Agricultural Research Service, ARS National Research Pro-ཧ↷ࠋgrams in Genomics and Genetics for Food Security, available at http://www.ars.usda.gov/

is/AR/archive/may10/research0510.htm (last visited June 27, 2010). 

More Predictable?, 9 LEWIS & CLARK L. REV. 231-47 (2005) ཧ↷ࠋ

U.S. Dept. of Agriculture, Agricultural Research Service, ARS National Research Pro-ࡓ࡜࠼ࡤࠊKimberly A. Moore, Markman, Eight Years Later: Is Claim Construction≉チࡢࢡ࣮࣒ࣞసᡂࡣࠊᑐヰⓗ࡞㐣⛬࡛࠶ࡿࠋึᮇࡢࢡ࣮࣒ࣞࡣ⊃ࡃゎ㔘ࡉࢀࡿ

grams in Genomics and Genetics for Food Security, available at http://www.ars.usda.gov/

࠿ࡶࡋࢀ࡞࠸ࡀࠊゎ㔘ⓗ࡞࢔ࣉ࣮ࣟࢳ࡛ࠊ≉チᘚㆤኈࡣࡶࡗ࡜ᗈࡃ㉳᱌ࡍࡿ᪉ἲࢆ

is/AR/archive/may10/research0510.htm (last visited June 27, 2010).ぬ࠼ࡿࠋ

 ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO  ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO   㐃⥆௻⏬

   ㄳồ㡯  グ㍕ࡢ 㻰㻺㻭㻌ศᏊࡢᑡ࡞ࡃ࡜ࡶࡢ㞄᥋ࢾࢡࣞ࢜ࢳࢻࢆྵࡴࠊ༢㞳 㻰㻺㻭㻌ศᏊࠋ   㻿㻱㻽㻌 㻵㻰㻌 㻺㻻㻦㻞 ࡟♧ࡉࢀࡓ 㻮㻾㻯㻭㻞㻌࣏ࣜ࣌ࣉࢳࢻࡢኚ␗యࢆࢥ࣮ࢻࡍࡿ༢㞳㻰㻺㻭㻌ศᏊ࡛࠶ࡗ࡚ࠊヱ 㻮㻾㻯㻭㻞 ࣏ࣜ࣌ࣉࢳࢻࡢኚ␗యࡣ࢞ࣥ࡟ᑐࡍࡿឤཷᛶ
ࢆకࡗ࡚࠸ࡿࠊ༢㞳 㻰㻺㻭㻌ศᏊࠋ⡿ᅜࡢἲ࡜ᨻ⟇࡟࠾ࡅࡿ㑇ఏᏊデ᩿ࡢ≉チ㐺᱁ᛶ 㻰㼞㼑㼥㼒㼡㼟㼟 ࠸࠿࡞ࡿ༢㞳ࡶせࡋ࡞࠸᳨ᰝ᪉ἲࡀ㛤Ⓨࡉࢀࡓ࡜ࡋ࡚ࡶࠊࡇࡢ≉チࡢ౵ᐖ࡜࡞ࡿࡢ࡛࠶ࡿࠋࡇࢀࡣせࡍࡿ࡟ࠊMetabolite ࡟࠾࠸࡚ࣈࣛ࢖ุ࣮ࣖ஦ࡀ
␲ၥࢆᢞࡆ࠿ࡅࡓࠊ㛵㐃௜ࡅ⮬యࢆࢡ࣮࣒ࣞࡍࡿ⾜Ⅽ࡜➼ࡋ࠸࡜ศᯒ࡛ࡁ
ࡿࠋࡲࡓࠊࡇࡢࡼ࠺࡞ࢡ࣮࣒ࣞࡣ⡆༢࡟㎽ᅇⓎ᫂ࡍࡿࡇ࡜ࡀ࡛ࡁ࡞࠸ࠋ≉   ㄳồ㡯  グ㍕ࡢ 㻰㻺㻭㻌ศᏊࡢᑡ࡞ࡃ࡜ࡶࡢ㞄᥋ࢾࢡࣞ࢜ࢳࢻࢆྵࡴࠊ༢㞳 㻰㻺㻭㻌ศᏊ

ࡇࡢ≉チࡣࠊ≉ᐃࡉࢀࡓ 㻰㻺㻭㻌㓄ิࢆ༢㞳ࡍࢀࡤࡍ࡭࡚౵ᐖ࡜࡞ࡿࠋ༢㞳ࡣ㑇ఏᏊኚ␗ࢆྠᐃࡍࡿࡓࡵ࡟ᚲ㡲࡞ࡇ࡜ࡀከ࠸ࡢ࡛ࠊ᫂ࡽ࠿࡟ࡇࡢ≉チ࡟ࡼࡗ࡚ࠊᝈ⪅ࡀ 㻮㻾㻯㻭㻌㛵㐃ࡢங࢞ࣥ࡟ᙅ࠸࠿࡝࠺࠿ࢆỴࡵࡿࡢ࡟ᚲせ࡞᝟ሗࢆࠊデ᩿⪅ࡀධᡭࡍࡿࡇ࡜ࡀࡁࢃࡵ࡚ᅔ㞴࡟࡞ࡿࠋ
デ᩿᪉ἲࡢࢡ࣮࣒ࣞ࡟ࡣࠊࡉࡽ࡟ᗈ࠸ࡶࡢࡶ࠶ࡿࠋࡓ࡜࠼ࡤࠊ≉チྕࡣࠊ᪉ἲࡢ≉チ࡛࠶ࡾࠊࢡ࣮࣒ࣞࡣ௨ୗࡢ㏻ࡾ࡛࠶ࡿࠋ   ࢞ࣥ࡟࡞ࡾࡸࡍ࠸య㉁ࢆỴᐃࡍࡿ᪉ἲ࡛࠶ࡗ࡚ࠊࣄࢺࡢ㌟యヨᩱࢆ᳨ᰝࡋࠊ
㼔㻹㻿㻴㻞 ࡜ࡋ࡚ྠᐃࡉࢀ࡚࠸ࡿ㑇ఏᏊ࡟ኚ␗ࡀᏑᅾࡍࡿࡇ࡜͐࢞ࣥ࡟࡞ࡾࡸ
ࡍ࠸య㉁࡛࠶ࡿࡇ࡜ࡢᚩೃ࡛࠶ࡿࡑࡢࡼ࠺࡞ኚ␗ࡀᏑᅾࡍࡿࡇ࡜͐ࢆ☜ㄆチⓎ᫂ࡢ኱༙࡛ࡣ㎽ᅇⓎ᫂ࡀྍ⬟࡛࠶ࡾࠊࣛ࢖ࣂࣝࡀ㠀౵ᐖ࡞௦᭰ရࢆ
ぢࡘࡅࡿྍ⬟ᛶࡀ࠶ࡿࡇ࡜࡟ࡼࡗ࡚ࠊ㏻ᖖࠊ≉チᶒ⪅ࡣࣛ࢖ࢭࣥࢫࡋࡓࡾ
ᕷሙ࡬༑ศ࡞౪⤥ࢆࡋࡓࡾࡍࡿࡼ࠺ಁࡉࢀࡿࠋ㎽ᅇⓎ᫂ࡢ⬣ጾࡣࠊࡑ࠺࡛
࡞ࡅࢀࡤ≉チᶒ⪅ࡀసࡾฟࡋࡓ࠿ࡶࡋࢀ࡞࠸㸦࢔ࢡࢭࢫࡢ㈝⏝࡜᮲௳࡟ࡘ
࠸࡚ࡢ㸧㟂せࡢୖ㝈࡜ࡋ࡚ࡶാࡃࠋࡋ࠿ࡋࠊ⛉Ꮫⓗ࡞ၥ㢟࡜ࡋ࡚ࠊࡇࡢ
ࡼ࠺࡞ࢡ࣮࣒ࣞࡣ⏕≀Ꮫ࡟࡜ࡗ࡚ே㉁ࢆྲྀࡽࢀࡓࡇ࡜࡟࡞ࡿ࡜࠸࠺Ⅼ࡛␗࡞ࡿࡢ࡛࠶ࡿࠋ␗࡞ࡿᩘከࡃࡢኚ␗ࡀ⑓Ẽࡢཎᅉ࡜࡞ࡿࡀࠊࡋ࠿ࡋࠊࡑ
ࢀࡺ࠼࡟ࠊ࠶ࡿ≉ᐃࡢ⑓Ẽ࡟࡞ࡾࡸࡍ࠸ഴྥࡀ࠶ࡿࡇ࡜ࢆ༑ศ࡟デ᩿ࡍࡿ࡟ࡣࠊ඾ᆺⓗ࡟ࡣࠊࡑࡢ⑓Ẽࡢཎᅉ࡜࡞ࡾ࠺ࡿࡶࡢࡍ࡭࡚ࢆ⥙⨶ⓗ࡟ศᯒࡍࡿࡇ࡜ࡀᚲせ࡛࠶ࡿࠋ࠶ࡿኚ␗ࡢྠᐃࢆ௚ࡢኚ␗࡟௦࠼ࡿࡇ࡜ࡣ୙ྍ⬟࡛࠶ࡿࠋྠᵝ࡟ࠊ⑓Ẽࢆ◊✲ࡍࡿ⛉Ꮫ⪅ࡣࠊ◊✲ࡢᑐ㇟࡛ࡣ࡞࠸ᆺࡢ⑓Ẽ࡟࠿࠿ࡗ࡚࠸ࡿᝈ⪅ࢆ◊✲ᑐ㇟࠿ࡽእࡑ࠺࡜ࡍࡿ࡜ࡁ࡛ࡉ࠼ࠊ⑓Ẽࡢཎᅉࡢྍ⬟ᛶࡢ࠶ࡿࡶࡢࢆࡍ࡭࡚ㄪ࡭࡞ࡅࢀࡤ࡞ࡽ࡞࠸ࠋ
ࡍࡿࡇ࡜࠿ࡽᡂࡿࠊ᪉ἲࠋ   ヨᩱࡀ 㻰㻺㻭㻌࡛࠶ࡿࠊㄳồ㡯  グ㍕ࡢ᪉ἲࠋ

ࡇࡢ≉チࡣࠊ≉ᐃࡢኚ␗࡜࢞ࣥࢆ⤖ࡧ௜ࡅࡓࡇ࡜࡟ᑐࡍࡿࡶࡢ࡛࠶ࡿࠋኚ

☜࠿࡟ࠊఱே࠿ࡢㄽ⪅ࡀᣦ᦬ࡋ࡚࠸ࡿࡼ࠺࡟ࠊ≉チᶒ⪅ࡀチㅙࢆಖ␃ࡋ

ࡓ࡜࠼ࡤࠊGert Matthijs & Gert-Jan B. Van Ommen, Gene Patents: From Discovery toInvention: A Geneticist’s View, in LICENSING MODELS, supra note 19, at 311-30; Isabeele␗ࢆ᳨▱ࡍࡿ࠸࠿࡞ࡿ᪉ἲࡶࠊࡑࡢ㛵㐃௜ࡅ࡟౫ᣐࡍࡿ㝈ࡾࠊࡇࡢ≉チࡢ

Huys et al., Legal Uncertainty in the Area of Genetic Diagnostic Testing, 27 NATURE BIO-

౵ᐖ࡜࡞ࡿ࡜ᛮࢃࢀࡿࠋࡋࡓࡀࡗ࡚ࠊඛ࡯࡝ࡢ౛࡛ࡣ༢㞳ࡀᚲせࡔࡗࡓࡀࠊTECHNOLOGY 903-09 (2009) ཧ↷ࠋ



J. ECON. 907, 913 (1981) ࡇࡢ◊✲ࡀᑐ㇟࡟ࡋࡓ≉チ〇ရࡢ㸣ࡣࠊ࠾ࡼࡑ  ᖺ௨ෆ

Chromosome 13-Linked Breast Cancer Susceptibility Gene, U.S. Patent No. 5,837,492

Edwin Mansfield et al., Imitation Costs and Patents: An Empirical Study, 91(issued Nov. 17, 1998).

࡟㎽ᅇⓎ᫂ࡉࢀ࡚࠸ࡿ ཧ↷㹿㑇ఏᏊࢆᵓᡂࡍࡿ 㻰㻺㻭 ࡢ᰾㓟㓄ิࡣࠊୖグࡢグ㍕࠿ࡽࡣ┬␎ࡋ࡚࠸ࡿࡀࠊ≉チ୍⯡ⓗ࡟ࡣࠊNancy Gallini, Deterrence by Market Sharing: A Strategic Incentive forࢆぢࢀࡤぢࡘࡅࡿࡇ࡜ࡀ࡛ࡁࡿࠋ

Licensing, 74 AM. ECON. REV. 931 (1984); Dana W. Hayter, When a License Is Worse Than

Linked Breast and Ovarian Cancer Susceptibility Gene, U.S. Patent No. 5,693,473 (is-a Refusal: A Comparative Competitive Effects Standard to Judge Restrictions in Intellectual

sued Dec. 2, 1997).

Property Licenses, 11 BERKELEY TECH. L.J. 281, 284 (1996) ཧ↷ࠋ ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO  ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO   㐃⥆௻⏬

⡿ᅜࡢἲ࡜ᨻ⟇࡟࠾ࡅࡿ㑇ఏᏊデ᩿ࡢ≉チ㐺᱁ᛶ 㻰㼞㼑㼥㼒㼡㼟㼟 ࡚࠸ࡿ࡜ࡁ࡟௦᭰ⓗ࡟฼⏝࡛ࡁࡿ᪉ἲࡣᏑᅾࡍࡿࠋࡇࢀࡽࡢ᪉ἲ࡟ࡣࠊኚ

➨㸰㒊 ≉チ㸸㈝⏝࡜౽┈㻌␗࡟㏆᥋ࡍࡿ㓄ิࡢ᳨ᰝࡸࠊኚ␗࡟㛵㐃ࡍࡿᮦᩱࡢࢫࢡ࣮ࣜࢽࣥࢢࡶྵࡲ

ࢀࡿࠋࡋ࠿ࡋ࡞ࡀࡽࠊࡇࢀࡽࡢ௦᭰ᡭẁࡀ࡝ࡢࡼ࠺࡞≧ἣ࡛ࡶ౑࠺ࡇ࡜

⛉Ꮫ⪅ࡓࡕࡀࢤࣀ࣒ゎᯒࢆጞࡵࡓ▐㛫࠿ࡽࠊㄽ⪅ࡣࠊ≉チࡀ◊✲࡟෭Ỉࡀ࡛ࡁࡿ࡜࠿ࠊ≉チ࡛ࢡ࣮࣒ࣞࡉࢀࡓኚ␗ࢆᝈ⪅ࡀᣢࡗ࡚࠸ࡿ࠿ࢆỴᐃࡍࢆᾎࡧࡏࠊᝈ⪅ࡢ἞⒪ࢆ㜼ᐖࡍࡿྍ⬟ᛶࢆᚰ㓄ࡋ࡚ࡁࡓࠋࡋ࠿ࡋ࡞ࡀࡽࠊ

ࡿࡢ࡜ྠࡌࡃࡽ࠸ṇ☜࡛࠶ࡿ࡞࡝࡜୺ᙇࡍࡿ⪅ࡣ࠸࡞࠸ ࠋᐇ㝿ࠊࡇࡢࡼࡇࢀࡽࡢ≉チࡢ᭱⤊ⓗ࡞ຠᯝࡣホ౯ࡍࡿࡇ࡜ࡀ㞴ࡋ࠸ࠋࡶࡋ᭱⤊ⓗ࡟ࡣࠊ࠺࡞௦᭰ᡭẁࡢ➨୍ẁ㝵࡛⏝࠸ࡽࢀࡿᡭἲ࡛࠶ࡿ㐃㙐୙ᖹ⾮ࡢ⌧㇟ࡣㄗ≉チࡀ㛵㐃௜ࡅࡢ◊✲࡜㌿᥮ࡢ◊✲㸦㑇ఏᏊ࡜೺ᗣ≧ែ࡜ࡢ㛵㐃௜ࡅࢆⓎᕪ⋡ࢆᐃ⩏ࡋ࡚࠾ࡾࠊ௦᭰ᡭẁࡀၥ㢟ࡢ㑇ఏᏊࢆ┤᥋ศᯒࡍࡿࡇ࡜࡟ࡃࡽ

ぢࡋࠊࡑࡢാࡁࢆ᭷ຠ࡞స⏝࡟㌿᥮ࡍࡿ㸧ࢆዡບࡋᨭ࠼ࡿࡢ࡟ᚲせ࡛࠶ࡿ࡭࡚ᚲ↛ⓗ࡟ឤᗘࡀప࠸ࡇ࡜ࢆ♧ࡋ࡚࠸ࡿ ࠋ᫂ࡽ࠿࡟ࠊஙᡣษ㝖ᡭ⾡ࢆ࡞ࡽࡤࠊ≉チᶒ࡟ࡼࡾ୍᫬ⓗ࡟ㄢࡉࢀࡿไ㝈ࡼࡾࡑࡢ౽┈ࡢ᪉ࡀ຾ࡿࡇ࡜

ཷࡅࡿྍ⬟ᛶ࡟┤㠃ࡋࡓᝈ⪅ࡣࠊ୙ṇ☜ࡔ࡜ࢃ࠿ࡗ࡚࠸ࡿ᳨ᰝ࡟ࡣ୙ᛌឤ

࡟࡞ࡿࠋ㔜せ࡞ࡢࡣࠊᢏ⾡ࡀ≉チࡉࢀࡿ࡜࠸࠺ࡇ࡜⮬యࡣࠊ୰❧ⓗ࡛࠶ࡿࢆ♧ࡍ࡛࠶ࢁ࠺ࠋἲⓗ࡞ၥ㢟࡜ࡋ࡚ࠊࡇࡢ㡿ᇦ࡟࠾ࡅࡿ≉チࡢ୰࡟ࡣࠊ⊃࡜࠸࠺ࡇ࡜࡛࠶ࡿࠋᝈ⪅࡜◊✲⪅ࡢ཮᪉࡟࡜ࡗ࡚ࡇࢀࡽࡢᢏ⾡ࡀᐇ㝿࡟฼࠸ࢡ࣮࣒ࣞࢆ᭩࠸࡚ࠊ㎽ᅇⓎ᫂ࢆྍ⬟࡟ࡍࡿࡇ࡜ࡀ࡛ࡁࡿࡶࡢࡶ࠶ࡿ࠿ࡶ

⏝ྍ⬟࠿࡝࠺࠿࡟ᙳ㡪ࢆ୚࠼ࡿࡢࡣࠊࣛ࢖ࢭࣥࢫ࡜࢚ࣥࣇ࢛࣮ࢫ࣓ࣥࢺ࡟

ࡋࢀ࡞࠸ࠋࡋ࠿ࡋ࡞ࡀࡽࠊ኱㒊ศࡢデ᩿᪉ἲࡢ≉チࢆྵࡵ࡚ࠊ௚ࡢ≉チ㛵ࡍࡿ⾜ື࡞ࡢ࡛࠶ࡿࠋ

ࡣࠊᗈ࠸ࡓࡵ㎽ᅇࡢᶵ఍ࢆ๰ࡿࡇ࡜ࡣ࡛ࡁ࡞࠸ࡢ࡛࠶ࡿࠋ

㻿㻭㻯㻳㻴㻿 ࡣࠊࡉࡽ࡟◊✲ࢆ㐍ࡵࡿࡓࡵ࡟ࠊࢹ࣮ࣗࢡ኱Ꮫࢤࣀ࣒⛉Ꮫ࣭ᨻ⟇◊✲ᡤࠊࢤࣀ࣒೔⌮࣭ἲ࣭ᨻ⟇ࢭࣥࢱ࣮㛗࡛࠶ࡿࠊࣟࣂ࣮ࢺ࣭ࢡࢵࢡࢹ
ࠕኳ↛ࡢᐇ㦂ࠖ࢕࣮࢞ࣥ࡟ࠊ୍㐃ࡢࢣ࣮ࢫ◊✲ࢆᣦ᥹ࡍࡿࡼ࠺࡟ጤクࡋࡓࠋ

ࢆసࡿࡓࡵࠊࢡࢵࢡࢹ࢕࣮࢞ࣥ࡜ࡑࡢྠ൉ࡓࡕࡣࠊ㑇ఏᛶࡢ␗ᖖ࡜㑇ఏᏊࡓ࡜࠼ࡤࠊMyriad Defendant’s Memorandum in Reply to Plaintiff’s Opposition to᳨ᰝࢆ฼⏝࡛ࡁࡿ୍⩌ࡢ␗ᖖࢆྵࡴࠊಶࡢ⮫ᗋ≧ែࢆ㑅ᢥࡋࡓࠋࡑࢀ

Myriad Defendant’s Motion for Summary Judgment, Ass’n for Molecular Pathology v. U.S.

ࡽࡢ≧ែ࡟ࡣࠊ≉チࢆక࠺ࡶࡢ࡜కࢃ࡞࠸ࡶࡢࠊࡑࡢ≉チࡀᗈࡃࣛ࢖ࢭࣥ

Patent & Trademark Office, 2010 WL 1048411 (S.D.N.Y. March 29, 2010) (No. 09 Civ.
4515) 㺀⛉Ꮫ⪅ࡓࡕࡣࠊ㑇ఏᛶࡢங࢞ࣥཬࡧ༸ᕢ࢞ࣥࢆྠᐃࡍࡿ௦⌮࣐࣮࣮࢝࡜ࡋ

ࢫࡉࢀ࡚࠸ࡿࡶࡢ࡜ࡑ࠺࡛࡞࠸ࡶࡢࠊ㞟ᅋ࡟㧗࠸⨯ᝈ⋡ࢆ♧ࡍࡶࡢ࡜ᑠ

࡚฼⏝ྍ⬟࡞͐㑇ఏᏊࡢ≉ᚩࢆྠᐃࡍࡿࡇ࡜࡟ᡂຌࡋࡓ㹿㺁 ཧ↷ࠋ୍⯡ⓗ࡟ࡣࠊ

Talysia Howell, Genetic Screening, http://www.ndsu.edu/pubweb/~mcclean/plsc431/

students99/howell.htm (last visited June 27, 2010) 㻰㻺㻭 ࡜ࢱࣥࣃࢡ㉁ࡢࢫࢡ࣮ࣜࢽࣥ

Convergence of Law, Economic Interests, and Ethics, 67 BROOK. L. REV. 233-48 (2001) ཧࡓ࡜࠼ࡤࠊDaniel J. Kevles & Ari Berkowitz, The Gene Patenting Controversy: Aࢢ࡟ࡘ࠸࡚㆟ㄽࡋ࡚࠸ࡿ ཧ↷ࠋ

↷ࠋ





ࡓ࡜࠼ࡤࠊAlessandra Colaianni et al., Impact of Gene Patents and Licensing Practices

on Access to Genetic Testing and Carrier Screening for Tay-Sachs and Canavan Disease,୍⯡ⓗ࡟ࡣࠊJames P. Evans, Putting Patients Before Patents, 2 GENETICS IN MED.

S3-S4 (Supp. 2010), available at http://journals.lww.com/geneticsinmedicine/Fulltext/

12 GENETICS IN MED. S5-S14, S7 (Supp. 2010) ࢸ࢖㸻ࢧࢵࢡࢫ⑓࡜࢝ࢼࣂࣥ⑓ࢆ᳨ᰝ

2010/04001/Putting_patients_before_patents.2.aspxཧ↷ࠋReport on Gene Patents, supraࡍࡿ㓝⣲ࢫࢡ࣮ࣜࢽࣥࢢࡣ↓ຊ࡛࠶ࡿ࡜㆟ㄽࡋ࡚࠸ࡿ ཧ↷ࠋnote 17, at line 330.ࡑࡢ≧ែ࡜ࡣࠊ  ங࢞ࣥ༸ᕢ࢞ࣥࠊ  ⤖⭠࢞ࣥࠊ  ኻ⫈ࠊRobert L. Nussbaum et. al, THOMPSON & THOMPSON’S GENETICS IN MEDICINE 213-16 ᄞ⬊ᛶ⧄⥔⑕ 㻯㻲 ࠊ  ࢔ࣝࢶࣁ࢖࣐࣮⑓࡬ࡢ㑇ఏⓗ࡞ឤཷᛶࠊ  㑇ఏᛶ࣊ࣔ(Saunders/Elsevier Press 2007) ཧ↷ࠋࢡ࣐ࣟࢺ࣮ࢩࢫ 㻴㻴 ࠊ  ⬨㧊ᑠ⬻ኚᛶ⑕ 㻿㻯㻭 ࠊ  㻽㼀 ᘏ㛗⑕ೃ⩌ 㻸㻽㼀㻿 ࠊ ࡓ࡜࠼ࡤࠊChristopher M. Holman, Learning from Litigation: What Can Lawsuits Teach࢝ࢼࣂࣥ⑓ࠊ  ࢸ࢖㸻ࢧࢵࢡࢫ⑓ࠋࢣ࣮ࢫ◊✲ࡣ࢜ࣥࣛ࢖࡛ࣥධᡭྍ⬟࡛࠶ࡿࠋUs About the Role of Gene Patents in Research and Innovation?, 18 WTR KAN. J.L. & PUB.

Supra note17 ཧ↷ࠋ

POL’Y 215 (2009) ཧ↷ࠋ ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO  Report on Gene Patents, supra note 17, at lines 345-46, 352-72.

▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO   㐃⥆௻⏬

⡿ᅜࡢἲ࡜ᨻ⟇࡟࠾ࡅࡿ㑇ఏᏊデ᩿ࡢ≉チ㐺᱁ᛶ 㻰㼞㼑㼥㼒㼡㼟㼟 ࡉ࡞ࢢ࣮ࣝࣉ࡟ࡋ࠿ឤᰁࡋ࡞࠸ࡶࡢࡀ࠶ࡿࠋྛࢣ࣮ࢫ࡛ࡣࠊ㛵㐃௜ࡅࡣࡇࡢࡼ࠺࡞ࢣ࣮ࢫ࡟࠾ࡅࡿᖐ⤖ࡣࠊᝈ⪅ࡢ฼┈࡟┿ࡗྥ࠿ࡽ཯ࡍࡿࡶࡢ

ᑡ࡞ࡃ࡜ࡶᖺ๓࠿ࡽ㸫་⒪⏺ࡢ୰࡛デ᩿᪉ἲࡢ౑⏝ࡀࡼࡃ☜❧ࡉࢀ࡚࡛࠶ࡿࠋ ࡘࡢ࠶ࡾ࠺ࡿഃ㠃ࡣࠊᨭᡶ࠸࡟㛵ࡍࡿࡶࡢ࡛࠶ࡿࠋAMP ࡛⿢ุᝈ⪅࡬ࡢᙳ㡪ࡀド᫂ࡉࢀࡿࡢ࡟༑ศ࡞᫬㛫㸫▱ࡽࢀ࡚ࡁࡓࡶࡢ࡛࠶ࡿࠋ

ᡤࡀᣦ᦬ࡋࡓࡼ࠺࡟ࠊ㻮㻾㻯㻭 ᳨ᰝࡢ㈝⏝ࡣࠊMyriad ࡀࡑࡢ≉チࢆ࢚ࣥࣇ࢛

ㄪᰝ࡛ࡣࠊᵝࠎ࡞≉チᡓ␎࡜ࣛ࢖ࢭࣥࢫᡓ␎ࡢୗ࡛ࡢ⤒㦂ࢆẚ㍑ࡍࡿࡇ࡜࣮ࢫࡋ࡚࠸ࡿ⡿ᅜࡢ᪉ࡀࠊࡑࡢ≉チࡀ࢚ࣥࣇ࢛࣮ࢫࡉࢀ࡚࠸࡞࠸࢝ࢼࢲࡼ

࡟ࡼࡗ࡚ࠊ≉チࡀࠊ㑇ఏᏊデ᩿ࡢⓎᒎཬࡧᝈ⪅ࡸ་ᖌࡀࡑࢀࢆ࡝ࢀࡃࡽ࠸

ࡾࡶ㧗࠸ࠋࡋ࠿ࡋࠊ㑇ఏᏊ᳨ᰝ࡟ㄢࡉࢀ࡚࠸ࡿ౯᱁࡟ࡘ࠸࡚ẚ㍑◊✲ࢆ฼⏝ྍ⬟࡞ࡢ࠿࡟ᑐࡋ࡚࡝ࡢࡼ࠺࡞ᙳ㡪ࢆ୚࠼ࡿ࠿ࢆ≉ᐃࡋ࡚ࠊᐃ㔞ⓗ࡟⾜࠺ࡇ࡜ࡣᅔ㞴࡛࠶ࡾࠊ࡜࠸࠺ࡢࡶࠊ◊✲ᐊ࡛ࡢฎ⨨࡟࠿࠿ࡿ㈝⏝ࡣࠊศホ౯ࡍࡿࡇ࡜ࢆ┠ᣦࡋ࡚࠸ࡿࠋ

ᯒࡍࡿኚ␗࡟ࡼࡗ࡚ᵝࠎ࡛࠶ࡿ࠿ࡽ࡛࠶ࡿࠋࡉࡽ࡟ࠊ་⒪ࡢ㈝⏝ࡣࠊ㏻ᖖ

ࡣ⡿ᅜᨻᗓ࡟ࡼࡗ࡚ᐃࡵࡽࢀ࡚࠸ࡿࡢ࡛ࡶつไࡉࢀ࡚࠸ࡿࡢ࡛ࡶ࡞࠸ࡢ

㹟㸬㈝⏝࡛ࠊᥦ౪⪅ࡣ㸫බⓗ࡞ᥦ౪⪅ࡸ◊✲⪅ࡶྵࡵ࡚㸫⮬ࡽ஦ᴗࡢ㈨㔠ㄪ㐩ࢆࡋ ࢣ࣮ࢫ◊✲ࡢ㸫ᩥ⊩ㄪᰝࠊ࢖ࣥࢱࣅ࣮ࣗࠊ㻿㻭㻯㻳㻴㻿 ࡢཷࡅྲྀࡗࡓࣃࣈࣜ

࡞ࡅࢀࡤ࡞ࡽࡎࠊ᳨ᰝࡢ⤒㊰ୖ⏕ࡌ࡚ࡃࡿࡶࡢࡍ࡭࡚࡟ㄢ㔠ࡍࡿഴྥࡀ࠶

ࢵࢡ࣭ࢥ࣓ࣥࢺ࠿ࡽࡢ᝟ሗ࡛⿵ࡗ࡚㸫♧ࡍ࡜ࡇࢁ࡟ࡼࢀࡤࠊ≉チ௜୚ࡢ♫ࡿࠋ⡿ᅜ࡛ࡣࠊࡑࢀࡣಖ㝤఍♫ࡀఱࢆᨭᡶࡗ࡚ࡃࢀࡿ࠿࡟ࡼࡗ࡚Ỵࡲࡿࡢ఍ⓗ㈝⏝ࡣࠊㄽ⪅ࡀᜍࢀࡿࡼ࠺࡟㧗࠸ࡶࡢ࡛࠶ࡿྍ⬟ᛶࡀ࠶ࡿࠋᗈࡃࣛ࢖

࡛ࠊ⌧ᅾ฼⏝ྍ⬟࡞ࢹ࣮ࢱ࠿ࡽࠊ≉チᡓ␎ཪࡣࣛ࢖ࢭࣥࢫᡓ␎ࡀ౯᱁࡟ᙳ

ࢭࣥࢫࡉࢀ࡚࠸ࡿ≉チࡶ࠶ࢀࡤࠊ࢚ࣥࣇ࢛࣮ࢫࡉࢀ࡚࠸࡞࠸≉チࡶ࠶ࡿࠋ㡪ࢆ୚࠼࡚࠸ࡿ࡜⤖ㄽ௜ࡅࡿࡇ࡜ࡣ୙ྍ⬟࡛࠶ࡿࠋᐇ㝿ࠊ㻿㻭㻯㻳㻴㻿 ࡢሗࡋ࠿ࡋࠊᶒ฼ࢆ㈙࠸༨ࡵ࡚ᕷሙ࠿ࡽ➇த⪅ࢆ᤼㝖ࡍࡿ⊂༨ⓗ࡞ࣛ࢖ࢭࣥࢩ

࿌᭩㸦ཬࡧࡑࢀࡀ㒊ศⓗ࡟౫ᣐࡋࡓࢣ࣮ࢫ◊✲㸧ࡣࠊ㻮㻾㻯㻭㻝㻛㻞 ᳨ᰝࡢሙ࣮ࡸ≉チᶒ⪅ࡶᏑᅾࡍࡿ㸫ࡍ࡞ࢃࡕࠊᙼࡽࡣࠊデ᩿࡟ᚲせ࡞᝟ሗࡢ㓄ิゎྜࠊ≉チࡢࣉ࣑ࣞ࢔࣒ࡣࢃࡎ࠿ࡋ࠿࡞࠸ࡇ࡜ࢆぢฟࡋ࡚࠸ࡿࠋ

ᯒࡢ၏୍ࡢᥦ౪⪅࡜ࡋ࡚ࡢ⮬ࡽࡢᆅ఩ࢆ☜❧ࡉࡏ࡚࠸ࡿࡢ࡛࠶ࡿࠋ




Id. at lines 336-46.

Id. at lines 352.

◊✲ࡣࡍ࡭࡚ᰝㄞࢆཷࡅ࡚࠾ࡾࠊ㛵ಀ⪅ ≉チᶒ⪅ࢆྵࡴ ࡣࠊ⤖ᯝࢆぢ࡚஦ᐇࡢㄗࡾࢆゞṇࡍࡿࡇ࡜ࡀチࡉࢀ࡚࠸ࡿࠋid. at lines 346-50.ࡉࡽ࡟ࠊ㻿㻭㻯㻳㻴㻿 ࡣሗ࿌᭩ࡢⲡ᱌࡟ᑐࡋࠊእ㒊࠿ࡽࡢࢥ࣓ࣥࢺࢆ᠓ㄳࡋ࡚࠸ࡿࠋId. at lines 374-76.

ࡋ࠿ࡋ࡞ࡀࡽࠊᨭᡶ࠸ࡢႆဃ ࡣูၥ㢟࡛࠶ࡿࠋࡍ࡭࡚ࡢಖ㝤఍♫ࡀࡍ࡭࡚ࡢᥦ౪⪅࡜ၟ኎ࢆࡋ࡚࠸ࡿࢃࡅ࡛ࡣ࡞࠸ࠋᥦ౪⪅ࡀ  ேࡋ࠿࠸࡞࠸ሙྜ
࡟ࡣࠊࡑࡢᥦ౪⪅ࢆྲྀࡾᢅࡗ࡚࠸࡞࠸఍♫࠿ࡽಖ㝤ࢆཷࡅ࡚࠸ࡿᝈ⪅ࡣࠊ㐠ࡀᝏ࠿ࡗࡓ࡜࠸࠺ࡇ࡜࡟࡞ࡿࠋࡇࡢࡼ࠺࡞ᝈ⪅ࡣ࡝ࡇ࡟⾜ࡗ࡚ࡶ᳨ᰝࢆ
ཷࡅࡿࡇ࡜ࡀ࡛ࡁ࡞࠸ ࠋࡑࡢ௦ࢃࡾ࡟ࠊᥦ౪⪅ࡀᥦ౪ࡋ࡚ࡃࢀࡿࠕዡᏛ

Report on Gene Patents, supra note 17, at lines 1294-1302 ཧ↷ࠋ௨ୗࡶཧ↷ࠊMisha㔠ࠖ࡟ሙྜ࡟ࡼࡗ࡚ࡣ㢗ࡗ࡚ࠊ⮬⭡ࢆษࡗ࡚ᨭᡶࢃ࡞ࡅࢀࡤ࡞ࡽ࡞࠸ࠋ㈋Angrish et al., Impact of Gene Patents and Licensing Practices on Access to Genetic Test-ࡋ࠸ᝈ⪅࡟࡜ࡗ࡚ࡣࠊ၏୍ࡢᥦ౪⪅ࡢపࢥࢫࢺ࡞᳨ᰝࣉࣟࢢ࣒ࣛࡀࠊ౑࠺



ing for Long QT Syndrome, 12 GENETICS IN MEDICINE S111-S151, S111-S112 (Supp.
2010) ᖺࡲ࡛ࡣ 㻽㼀 ᘏ㛗⑕ೃ⩌ࡢ⮫ᗋデ᩿࡟㛵ࡍࡿ 㻵㻼 ࡣࠊPgxHealth ࡟ࡼࡗ࡚

⊂༨ⓗ࡟౪⤥ࡉࢀ࡚࠾ࡾࠊྠ♫ࡣ᳨ᰝἲࡢࢧࣈࣛ࢖ࢭࣥࢫࢆࡋ࡞࠿ࡗࡓࡇ࡜ࢆᣦ᦬

Athena Diagnostics ࡟ࡼࡗ࡚࡯ࡰ⊂༨ⓗ࡟౪⤥ࡉࢀ࡚࠾ࡾࠊྠ♫ࡣᙜヱ᳨ᰝࢆᥦ౪ࡋ

ࡋ࡚࠸ࡿ ; Robert Cook-Deegan, Impact of Gene Patents and Licensing Practices onࡼ࠺࡜ࡋࡓ௚ࡢ◊✲ᡤ࡟㆙࿌᭩ࢆ㏦ࡗ࡚࠸ࡓࡇ࡜ࢆᣦ᦬ࡋ࡚࠸ࡿ .

Access to Genetic Testing for Inherited Susceptibility to Cancer: Comparing Breast andSee supra note 5.

Ovarian Cancers with Colon Cancers, 12 GENETICS IN MEDICINE S15-S38, S20 (Supp.

㻭㻹㻼㻌࡟࠾ࡅࡿ࢝ࢼࢲ࡜ࡢẚ㍑࡟ࡣၥ㢟ࡀ࠶ࡿ࠿ࡶࡋࢀ࡞࠸ࠋ࡜࠸࠺ࡢࡣࠊ⡿ᅜ࡜2010) Myriad ࡀ⡿ᅜ࡟࠾࠸࡚ 㻮㻾㻯㻭㻝 ࡜ 㻮㻾㻯㻭㻞 ࡢ඲㛗㓄ิ᳨ᰝࡢ၏୍ࡢᥦ౪⪅࡛࢝ࢼࢲࡢ་⒪㈝⤥௜ไᗘࡣ␗࡞ࡿ࠿ࡽ࡛࠶ࡿࠋCanada Health Act, R.S.C., ch. C-6, sec.

࠶ࡗࡓࡇ࡜ࢆᣦ᦬ࡋ࡚࠸ࡿ ; Katie Skeehan, Impact of Gene Patents and Licensing

7 (1985) ་⒪࡟ᑐࡍࡿไᐃἲୖࡢᶒ฼ࢆ๰ฟࡋ࡚࠸ࡿ ཧ↷ࠋ.

Practices on Access to Genetic Testing for Alzheimer Disease, 12 GENETICS IN MEDICINEReport on Gene Patents, supra note 17, at lines 1198-1292 ཧ↷ࠋ

S71-S82, S73-S74 (Supp. 2010) ⡿ᅜ࡟࠾ࡅࡿ࢔ࣝࢶࣁ࢖࣐࣮⑓ࡢ㑇ఏᏊ᳨ᰝࡣࠊ



Id. at lines 1629-49 ཧ↷ࠋ ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO  ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO   㐃⥆௻⏬

⡿ᅜࡢἲ࡜ᨻ⟇࡟࠾ࡅࡿ㑇ఏᏊデ᩿ࡢ≉チ㐺᱁ᛶ 㻰㼞㼑㼥㼒㼡㼟㼟 ࡟ࡣ⚗Ṇⓗ࡟㧗࠸㸫࡜࡜ࡶ࡟㔜Ⲵ࡜࡞ࡿ㸫ࡓࡵࠊࡇࢀࡣ≉࡟ၥ㢟࡛࠶ࡿࠋ

ࡍࡿ་⪅ࡣࠊ௚࡛᝟ሗࢆࢳ࢙ࢵࢡࡋ࡚ࡶࡽ࠺ࡇ࡜ࡀ࡛ࡁ࡞࠸ࠋࡲࡓࠊࢭ

☜࠿࡟ࠊ㈋ࡋ࠸ᝈ⪅ࡢ୰࡟ࡣᨻᗓࡀᚋ᥼ࡍࡿࣉࣟࢢ࣒ࣛ㸦Medicaid ཪࡣ࢝ࣥࢻ࢜ࣆࢽ࢜ࣥࡀ࡯ࡋ࠸ᝈ⪅ࡶࠊஙᡣࡸ༸ᕢࡢ㝖ཤࡢࡼ࠺࡞㔜኱࡞⾜ືࡢ

Medicare㸧࡟ࡼࡗ࡚ಖ㝤ࢆཷࡅ࡚࠸ࡿ⪅ࡶ࠸ࡿࠋࡋ࠿ࡋࠊ၏୍ࡢᥦ౪⪅ࡣࠊሙྜ࡛ࡶࠊࡑࡢ๓࡟  ࡘពぢࢆᡭ࡟ධࢀࡿࡢࡀࡸࡗ࡜࡛࠶ࡿࠋࡉࡽ࡟ࠊ◊✲ࡇࢀࡽࡢࣉࣟࢢ࣒ࣛ࡜ዎ⣙ࢆ⤖ࢇ࡛࠸࡞࠸ࡇ࡜ࡶࡋࡤࡋࡤ࡛࠶ࡿࠋ

ࡸࡑࡢ㛵㐃ᩥ⊩ࡀ♧၀ࡍࡿࡢࡣࠊ၏୍ࡢᥦ౪⪅ࡀᥦ౪ࡍࡿ᳨ᰝࡣࠊ㔜኱࡞Ḟ㝗ࢆᣢࡗ࡚࠸ࡿࡇ࡜࡛࠶ࡿࠋࡇࢀࡽᥦ౪⪅ࡣࠊᚲࡎࡋࡶ࣐࢖ࢼ࣮࡞ኚ✀࡟㑇ఏᏊ≉チࡢᶒ฼⪅ࡣࠊ᳨ᰝࡢ᮲௳࡟ࡘ࠸࡚ࡶᨭ㓄ࢆཬࡰࡑ࠺࡜ࡋ࡚࠸

ࡘ࠸࡚ࡢ᳨ᰝࢆ⾜ࡗ࡚࠸࡞࠸ࡋࠊᖖ࡟ࡑࡢࣉࣟࢺࢥࣝ࡟᭱᪂ࡢ⛉Ꮫࢆ㏿ࡿࠋ᳨ᰝࡣ୰⤯࡜㛵㐃ࡍࡿࡢ࡛ࠊฟ⏕๓᳨ᰝ࡟ࡘ࠸࡚⡿ᅜ࡛ࡣ㆟ㄽࡀࡓࡸ࠿࡟ᑟධࡍࡿࢃࡅ࡛ࡶ࡞࠸ࠋࡓ࡜࠼ࡤࠊMyriad ࡣ 㻮㻾㻯㻭 デ᩿ࡢ၏୍ࡢ

࠼࡞࠸ࠋ≉チᶒ⪅ࡢ୰࡟ࡣ㸦ࡓ࡜࠼ࠊࡍ࡛࡟ぢ࡚ࡁࡓࡼ࠺࡟ࠊ୰⤯┠ⓗ࡟ᥦ౪⪅࡛ࠊ㻮㻾㻯㻭㻝㻛㻞 㑇ఏᏊࡢ㓄ิࡔࡅࢆỴࡵࡿࡇ࡜࡟ࡼࡾ஦ᴗࢆጞࡵࡓ

཯ᑐࡍࡿィ⏬࡟ࡶ౑⏝ࡍࡿࡇ࡜ࡀ࡛ࡁࡿ࡜ࡋ࡚ࡶ㸧ࡇࢀࡽࡢ᳨ᰝࢆᥦ౪ࡍ

ࡀࠊ࠶ࡿ᝟ሗ࡟ࡼࡿ࡜ࠊ㻮㻾㻯㻭㻝㻛㻞 ࡢḞኻࡸ෌ᵓᡂ㸦ᬑ㏻ࡢ㓄ิゎᯒ࡛ࡣࡿࡇ࡜ࢆᮃࡲ࡞࠸⪅ࡶ࠸ࡿ ࠋ୰࡟ࡣࠊ౑࠸ࡑ࠺࡞ேཱྀࡀ༑ศ኱ࡁࡃၟᴗ୍⯡࡟ࡣぢ㐣ࡈࡉࢀ࡚ࡋࡲ࠺ኚ␗ࡢ୍✀㸧ࢆ᳨ฟ࡛ࡁࡿ᪂ࡋ࠸ᢏ⾡ࡢ᥇⏝ⓗ࡟㨩ຊⓗ࡞࡜ࡁ࡟㝈ࡗ࡚ࠊ᳨ᰝ᪉ἲࢆ㛤Ⓨࡍࡿ⪅ࡶ࠸ࡿࠋࡓ࡜࠼ࡤࠊ࢝

ࡀ㐜࠿ࡗࡓࠋMyriad ࡣḟ➨࡟ࡑࡢ௙⤌ࡳࢆኚ࠼ࡓࡀࠊࡑࢀࡣ་Ꮫ⏺࠿ࡽࢼࣂࣥ༠఍ࡣࠊ࢝ࢼࣂࣥ⑓ࡢ㑇ఏᏊ᳨ᰝࡢ㛤Ⓨࡢ᥼ຓࢆࡍࡿᅋయࡔࡀࠊ≉ࡢ┦ᙜ࡞ᅽຊࢆཷࡅࡓᚋ࡛࠶ࡿࠋ

チᶒ⪅࡟᳨ᰝࢆ฼⏝ྍ⬟࡟ࡍࡿࡼ࠺ㄝᚓࡍࡿࡓࡵ࡟ࠊッゴࢆᥦ㉳ࡋࡓࠋ

≉チࡣࡲࡓࠊ◊✲࡟ྰᐃⓗ࡞ᙳ㡪ࢆ୚࠼ࡿࡇ࡜ࡶ࠶ࡿࠋMadey v. Dukeࡶ࠺୍ࡘࡢᠱᛕࡣ㉁࡛࠶ࡿࠋ᳨ᰝࡢಙ㢗ᛶ☜ㄆࡢࡓࡵࡢࠕ㕲๎ࠖࡣࠊྠ
ࡌヨᩱࢆ࠸ࡃࡘ࠿ࡢ◊✲ᐊ࡟㏦ࡗ࡚ࠊࡍ࡭࡚ྠ➼ࡢ⤖ᯝࡀ㏉ࡗ࡚ࡃࡿ࠿ࢆ

University௨᮶ࠊ⡿ᅜἲ࡟࠾ࡅࡿ౵ᐖ㈐௵࡟ᑐࡍࡿ◊✲ࡢᢠᘚࡢᏑᅾ࡟ᑐ


ぢࡿࡇ࡜࡛࠶ࡿࠋ ேࡋ࠿ᥦ౪⪅ࡀ࠸࡞࠸࡜ࡁࡣࠊࡇࢀࡣ୙ྍ⬟࡛࠶ࡿ ࠋId. at lines 1684-86.

ྠᵝ࡟ࠊ࠶ࡿ≉ᐃࡢ⤖ᯝࡀᝈ⪅ࡢᐙ᪘Ṕࡸ⮫ᗋᡤぢ࡜ᩚྜࡋ࡞࠸Ⅼࢆᚰ㓄

Id. at lines 1653-56.

Robert Cook-Deegan et al., Impact of Gene Patents and Licensing Practices on Access
to Genetic Testing for Inherent Susceptibility to Cancer: Comparing Breast and Ovarianࡓ࡜࠼ࡤࠊ㻹㼑㼐㼕㼏㼍㼕㼐 ࡢᝈ⪅ࡣࠊ࢔ࢸࢼࡢ㈨㔠᥼ຓࣉࣟࢢ࣒ࣛࢆ㏻ࡌ࡚㸣ࡲ࡛ࡢCancers and Colon Cancers, 12 GENETICS IN MED. S15-S38, S29 (Supp. 2010); Erik Stok-๭ᘬࢆせㄳࡍࡿࡇ࡜ࡀ࡛ࡁࡿࠋࡋ࠿ࡋࠊࠕᨭฟࠊ㈨㔠᥼ຓࣉࣟࢢ࣒ࣛࡢ⏦㎸᭩ࠊ

stad, Genetic Screen Misses Mutations in Women at High Risk of Breast Cancer, 311 SCI.

㻹㼑㼐㼕㼏㼍㼕㼐 㐺᱁࡛࠶ࡿࡇ࡜ࡢド᫂ࠊ⣡⛯ド᫂᭩࡜┤㏆ࣧ᭶㛫ࡢࡍ࡭࡚ࡢ་⒪㈝ࡢ㡿1847 (2006) ࡶཧ↷ࠋ཰᭩ࢆῧ௜ࡋࡓୡᖏ཰ධࡢド᫂ࠖࢆᥦฟࡋ࡞ࡅࢀࡤ࡞ࡽ࡞࠸ࠋReport on Gene Patents,supra note 17, at lines 1618-22.⮫ᗋ་ࡓࡕࡢほᐹ࡟ࡼࢀࡤࠊ࢔ࢸࢼࣉࣟࢢ࣒ࣛ࡬ࡢཧ

ilies at High Risk of Breast Cancer, 295 J. AM. MED. ASS’N 1379-88, 1386 ங࢞ࣥࡢ㧗࠸

Tom Walsh et al., Spectrum of Mutations in BRCA1, BRCA2, CHEK2, and TP53 in Fam-ຍ⋡ࡣప࠸ࠋId. at lines 1623-27.

ࣜࢫࢡࢆᢪ࠼ࡿᐙ⣔ࡢேࡢ࠺ࡕ㸣ࡀࠊࠕ࢞ࣥ࡟࠿࠿ࡾࡸࡍࡃ࡞ࡿࢤࣀ࣒ࡢḞኻཪReport on Gene Patents, supra note 17, at lines 1609-15.

ࡣ෌ᵓᡂࠖࢆ᭷ࡋ࡚࠸ࡿ࡟ࡶ࠿࠿ࢃࡽࡎࠊ㻮㻾㻯㻭㻝 ࡜ 㻮㻾㻯㻭㻞 ࡢၟᴗⓗ᳨ᰝ࡛㝜ᛶࡢ

Id. at lines 1662-70.᳨ᰝ⤖ᯝࢆཷࡅྲྀࡗ࡚࠸ࡿࡇ࡜ࢆぢฟࡋ࡚࠸ࡿ .௨ୗࡶཧ↷ࠊRobert Cook-DeeganId. at lines 1665; see also Angrish, supra note 56, at S124-125; Ashton Powell et al.,

et al., supra note 69, at S28; Richard Li-dar Wang, Biomedical Upstream Patenting and

Sipnocerebellar Ataxia: Patient and health Professional Perspectives on Whether and How

Scientific Research: The Case for Compulsory Licenses Bearing Reach-Through Royalties,

Patents Affect Access to Clinical Genetic Testing, 12 GENETICS IN MEDICINE S83-S110,

10 YALE J.L. & TECH. 251, 296 (2008), Eliot Marshall, Lawsuit Challenges Legal Basis for

S88 (Supp. 2010).

Patenting Human Genes, 324 SCI. 1000-01 (May 22, 2009).Colaianni, supra note 47, at S7-S8. ୍⯡ⓗ࡟ Walsh et al., supra note 70 ࢆཧ↷ࠋReport on Gene Patents, supra note 17, at lines 1651-53.

307 F.3d 1351 (Fed. Cir. 2002). ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO  ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO   㐃⥆௻⏬

⡿ᅜࡢἲ࡜ᨻ⟇࡟࠾ࡅࡿ㑇ఏᏊデ᩿ࡢ≉チ㐺᱁ᛶ 㻰㼞㼑㼥㼒㼡㼟㼟 ࡋ࡚␲࠸ࡀᣢࡓࢀ࡚࠸ࡿࠋࡋ࠿ࡋࠊࡓ࡜࠼㠀ၟᴗⓗ࡞Ꮫ⾡◊✲ࡢ౛እࡀᘬ

࡚࠸࡞࠸ኚ␗ࡢࠊຠᯝࢆゎ㔘ࡍࡿ⬟ຊࡀ࠶ࡿࡇ࡜ࢆྵࡵ࡚ࠊ⮬ࡽࡢࢧ࣮ࣅ

ࡁ⥆ࡁᏑᅾࡍࡿࡇ࡜ࢆ๓ᥦ࡟ࡍࡿ࡜ࡋ࡚ࡶࠊࡑࢀࢆデ᩿ࡢศ㔝࡟࡝࠺㐺⏝ࢫࢆᐉఏࡍࡿࡇ࡜ࡀ࡛ࡁࡿࠋࡇࡢࡼ࠺࡟ࡋ࡚ࠊᙼࡽࡣࠊ
㸦ᑡ࡞ࡃ࡜ࡶ୍᫬ⓗࡍࡿࡢ࠿ࡣ」㞧࡛࠶ࡿࠋデ᩿◊✲ࡢ኱༙ࡣ⮫ᗋ࡛࠶ࡿࠋ◊✲⪅ࡣᐇ㝿ࡢ࡟ࡣ㸧≉チࡢᮇ㛫‶஢ᚋࡲ࡛ࠊ᤼௚ᛶࡢ᭷ຠᮇ㛫ࢆᘏࡤࡍࡇ࡜ࡀ࡛ࡁࡿࠋ

㸦ከࡃࡣᩱ㔠ࢆᨭᡶࡗ࡚࠸ࡿ㸧ᝈ⪅ࡢデ⒪࠿ࡽ᝟ሗࢆᚓ࡚࠸ࡿࡢ࡛ࠊ≉チࡋ࠿ࡋ࡞ࡀࡽࠊࡑ࠺ࡍࡿࡇ࡜࡟ࡼࡗ࡚ࠊᙼࡽࡣ་⒪⏺ࡸᝈ⪅࠿ࡽࠊ㐺ษ࡟ᶒ⪅ࡣ◊✲⪅ࡀ≉チⓎ᫂ࢆၟᴗ┠ⓗ࡟౑⏝ࡋ࡚࠸ࡿ࡜୺ᙇࡍࡿࡇ࡜ࡀ࡛

㑇ఏᏊ᳨ᰝࢆゎ㔘ࡍࡿ⬟ຊ࡜࠸࠺୙ྍḞ࡞㈨※ࢆዣࡗ࡚࠸ࡿࡢ࡛࠶ࡿࠋࡲ

ࡁࡿࠋᐇ㝿࡟ࠊ࢖࢙࣮ࣝ኱Ꮫࡢ◊✲⪅ࡀ Myriad ࠿ࡽ୰Ṇࢆồࡵࡿ᭩㠃ࢆࡉ࡟ࠊࡑࡢ⮫ᗋ౑⏝ࡀ๓㐍ࡍࡿࡓࡵ࡟᭱ࡶ῝้࡞ㄢ㢟ࡣࠊࡑࡢࡼ࠺࡞」㞧

ཷࡅྲྀࡗ࡚࠾ࡾࠊ࡝ࡇࡢᏛ⾡◊✲⪅ࡶࡑ࠺࡞ࡢ࡛࠶ࡿࠋ

࡞᳨ᰝࡢゎ㔘࡞ࡢ࡛࠶ࡿࠋࡇࡢࡼ࠺࡞᝟ሗࡢ⮬⏤࡞ὶࢀࢆไ㝈ࡍࡿ࡜ࠊࢤ



ࣀ࣒་⒪ࡢᑗ᮶࡟῝้࡞ᡴᧁࢆ୚࠼ࡿࠋຍ࠼࡚ࠊ≉チᶒ⪅ࡢᗈ⠊࡞ࣛ࢖ࢭࡇࡢᖐ⤖ࡣ࠸ࡃࡘ࠿ࡢⅬ࡛᭷ᐖ࡛࠶ࡿࠋ➇தࡀ࡞࠸࡜ࠊ၏୍ࡢᥦ౪⪅ࡣࣥࢫᣄ⤯࡟ࡼࡗ࡚ࠊྠࡌ⑓Ẽࡢ௚ࡢ⑓ᅉ࡟ࡘ࠸࡚ࡢ◊✲ࡀ㜼ᐖࡉࢀ࠺ࡿࠋ

⮬ࡽ◊✲ࢆ⾜࠺࢖ࣥࢭࣥࢸ࢕ࣈࡀ࡞࠸㸫ࡍ࡞ࢃࡕࠊࡍ࡛࡟⮬ศࡓࡕࡀ⾜ࡗࡓ࡜࠼ࡤࠊ◊✲⪅ࡣࠊㄪ࡭࡚࠸ࡿヨᩱࡢ㑇ఏᏊࣉࣟࣇ࢓࢖ࣝࢆ▱ࡿᚲせࡀ࡚࠸ࡿ◊✲ࢆ࢔ࢵࣉࢢ࣮ࣞࢻࡍࡿ࢖ࣥࢭࣥࢸ࢕ࣈࡀ࡞࠸ࡢ࡛࠶ࡿࠋḞኻ࠶ࡿࡓࡵࠊ㻮㻾㻯㻭 㠀㛵㐃ங࢞ࣥ࡟ࡘ࠸࡚ࡢ◊✲࡛ࡉ࠼ࠊ㻮㻾㻯㻭 ᳨ᰝ࠿ࡽጞ

෌ᵓᡂ᳨ฟࡢၥ㢟࡟㛵㐃ࡋ࡚ぢࡽࢀࡿࡼ࠺࡟ࠊ◊✲⪅࡜⮫ᗋ་ࡣࡑࢀࡺ࠼

ࡵࡿࡇ࡜ࡶࡋࡤࡋࡤ࡛࠶ࡿࠋ

࡟デ᩿⬟ຊࢆ᏶ᡂࡉࡏࡿࡢ࡟㔜せ࡞ᙺ๭ࢆᯝࡓࡋ࡚࠸ࡿࠋ㏫࡟࠸࠼ࡤࠊ၏

୍ࡢᥦ౪⪅ࡣࠊ᪂ࡋ࠸ኚ␗࡜㛵㐃௜ࡅࢆྠᐃࡍࡿࡇ࡜ࡀྍ⬟࡛࠶ࡿ࡟ࡶ࠿
ᑗ᮶ⓗ࡟ࡣࠊࡇࢀࡽࡢ≉チࡢᙳ㡪ࡣࡉࡽ࡟ၥ㢟࡜࡞ࡾ࠺ࡿࠋ๓࡟ᣦ᦬ࡋ

࠿ࢃࡽࡎࠊ⮬ࡽࡢⓎぢࢆᢪ࠼㎸ࢇ࡛࠸ࡿ࠿ࡶࡋࢀ࡞࠸ ࠋ⤖ᒁࠊ᪂ࡋ࠸ኚ

ࡓࡼ࠺࡟ࠊ᪂ࡋ࠸᳨ᰝᢏ⾡ࡢ඙ࡋࡀぢ࠼ጞࡵ࡚࠸ࡿࠋከ㔜᳨ᰝ࡟ࡘ࠸࡚࠸

␗ࡣࠊⓎ᫂ᛶࡀ࡞࠸ࡓࡵ≉チಖㆤ࡟್ࡋ࡞࠸࠿ࡶࡋࢀ࡞࠸ࠋࡶࡋࠊࡑࡢ

࠼ࡤࠊ࠶ࡿ≉ᐃࡢ⑓Ẽࡢ᪤▱ࡢ㑇ఏⓗཎᅉࡢࡍ࡭࡚ࢆࠊྠ᫬࡟᥈⣴ࡍࡿࡇ௦ࢃࡾࠊᥦ౪⪅ࡀࠊ᝟ሗࢆ⛎ᐦ࡟ࡋࡓࡽࠊࣛ࢖ࣂࣝࡀ࡯࡜ࢇ࡝᝟ሗࢆᣢࡗ


࡜ࡀ࡛ࡁࡿࠋࡋ࠿ࡋࠊ၏୍ࡢᥦ౪⪅ࡣࠊᚲࡎࡋࡶ᭱ࡶຠ⋡ⓗ࡞᪉ἲㄽࢆ㛤࠸࠺ࡲ࡛ࡶ࡞ࡃࠊ௚ࡢ㡿ᇦ࡛ࡣ◊✲࡜ᛂ⏝ࡢ㛫࡟ࡣ᫂☜࡞⥺ᘬࡁࡀᏑᅾࡋࠊࡇࢀ

ࡣデ᩿ࡢሙ㠃࡟≉᭷࡞ᠱᛕ࡛࠶ࡿࠋ୍⯡࡟ Katherine J. Strandburg, What Does the
Public Get? Experimental Use and the Patent Bargain, 2004 WIS. L. REV. 81 ࢆཧ↷ࠋ

Declaration of Ellen T. Matloff in the AMP case, at ¶ 7 available at http://www.aclu.org/

files/pdfs/freespeech/brca_Matloff_declaration_20090826.pdf ཧ↷ࠋࡓ࡜࠼ࡤࠊReport on Gene Patents, supra note 17, at lines 788-89, 1240-41, 1266-67,

1540-41 ཧ↷ࠋMarshall, supra note 70, at 1001; Daniel J. Kevles, Genes, Railroads andⓎࡋ࡞࠸ࡋࠊᙼࡽࡀ௚⪅࡟ࡑ࠺ࡍࡿࡢࢆチࡍ࡜ಙࡌࡿ࡭ࡁ⌮⏤ࡶ࡯࡜ࢇ࡝
࡞࠸ࠋ඲ࢤࣀ࣒㓄ิゎᯒ࡟ࡼࡗ࡚ࠊ་⪅ࡣಶู໬་⒪ࢆ⾜࠸ྛᝈ⪅࡟≉᭷࡞ឤཷᛶ࡟἞⒪ࢆྜࢃࡏࡿࡇ࡜ࡀ࡛ࡁࡿࡼ࠺࡟࡞ࡿ࠿ࡶࡋࢀ࡞࠸㸫ࡋ࠿ࡋࠊࡑࢀࡣࡑࡢࡼ࠺࡞ᢏ⾡ࡀ฼⏝ྍ⬟࡞ሙྜ࡟㝈ࡽࢀࡿࠋ≉チࡢ⸭࡜ࡑࡢ⤖ᯝ࡜ࡋ࡚ࡢㄪᩚၥ㢟࡟ࡼࡗ࡚ࠊࡇࡢࡼ࠺࡞᳨ᰝࡢ౯᱁ࡣ⚗Ṇⓗ࡞ࡶࡢ࡜࡞ࡾ࠼ࠊཧຍᣄ⤯࡟ࡼࡗ࡚ࠊࡇࡢࡼ࠺࡞࢔ࣉ࣮ࣟࢳࡣ୙ྍ⬟࡜࡞ࡿ࠿

Regulation: Intellectual Property and the Public Interest, in WORDLY SCIENCE: INSTRU-MENTS, PRACTICES, AND THE LAW (Mario Biagioli & Jessica Riskins eds., forthcoming◊✲ᐊ㛫ࡢ➇த࡟ࡼࡾࠊࡇࡢඃ఩ᛶࡣ㏿ࡸ࠿࡟ᾘ⁛ࡋ࡚࠸ࡃࠋၥ㢟ࡣࠊᝈ⪅ࡸࡑࡢ2010)㸦᭱⤊ⓗ࡟ࡣࠊ㻹㼥㼞㼕㼍㼐 ࡣ 㻺㻵㻴 ࡜ዎ⣙஺΅ࢆࡋ࡚ࠊ◊✲ࡢ㐣⛬࡛⾜ࢃࢀࡿ᳨ᰝ

་ᖌࡀࠊࡑࢀࡀᾘ⁛ࡍࡿࡇ࡜ࢆಙࡌࡿ࠿࡝࠺࠿࡛࠶ࡿࠋ

࡬ࡢㄢ㔠ࢆ࠾࠾ࡼࡑ༙ศ࡟ῶࡽࡋࡓࡇ࡜ࢆᣦ᦬ࡋ࡚࠸ࡿ ࡶཧ↷ࠋὀ࡛ᣦ᦬ࡋࡓࡼ࠺࡟ࠊ≉チࡀ࡞࠸࡜ࡁ㸦ཪࡣ≉チᮇ㛫ࡀ‶஢ࡋࡓᚋ㸧ࡣࠊ

Ashton Powell et al., Spinocerebellar Ataxia: Patient and Health Professional Perspec-

See Julia Carbone et al., DNA patents and Diagnostics: Not a Pretty Picture, NATURE

tives on Whether and How Patents Affect Access to Clinical Genetic Testing, 12 GENETICS

BIOTECHNOLOGY (forthcoming, 2010) ᖺ௨㝆ࠊ㻹㼥㼞㼕㼍㼐 ࡣබඹࡢࢹ࣮ࢱ࣮࣋ࢫ࡬IN MED. S83-S110, S90 (Supp. 2010); see also Chandrasekharan & Fiffer, supra note 24, atࡢ㈉⊩ࢆ୰Ṇࡋ࡚࠸ࡿ .

S180-S181 ≉チᶒ⪅࠿ࡽࣛ࢖ࢭࣥࢫࢆᚓ࡞࠸࡛⤌⧊ࡀ⾜ࡗࡓࠊ࣐࢖ࢡࣟ࢔ࣞ࢖࡟

ᇶ࡙ࡃኻ⫈ࡢデ᳨᩿ᰝࡢ◊✲࡟ࡘ࠸࡚㆟ㄽࡋ࡚࠸ࡿ .

Cf. In re Kubin, 561 F.3d 1351 (Fed Cir 2009) 㑇ఏᏊ≉チࡢࢣ࣮ࢫ࡟ࠊ㧗࠸Ⓨ᫂ᛶࡢᇶ‽ࢆ㐺⏝ࡋ࡚࠸ࡿ . ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO  ࡓ࡜࠼ࡤࠊHamburg & Collins, supra note 7 ࢆཧ↷ࠋ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO   㐃⥆௻⏬

⡿ᅜࡢἲ࡜ᨻ⟇࡟࠾ࡅࡿ㑇ఏᏊデ᩿ࡢ≉チ㐺᱁ᛶ 㻰㼞㼑㼥㼒㼡㼟㼟 ࡶࡋࢀ࡞࠸ࠋ

ࡶ᳨ᰝࢆ฼⏝ྍ⬟࡟ࡍࡿࡇ࡜ࡀ࡛ࡁࡿࠋࡇࢀࡽࡢ◊✲ᐊ࡟࠾࠸࡚ࠊ⮫ᗋ་ࡣࠊᚓࡽࢀࡓ᝟ሗࢆ⑓Ẽ࡜἞⒪ࡢ㑅ᢥ⫥ࢆࡼࡾࡼࡃ⌮ゎࡍࡿࡢ࡟฼⏝ࡋ࡚၏୍ࡢᥦ౪⪅࡟ࡼࡗ࡚ᨭ㓄ࡉࢀ࡚࠸ࡿ㑇ఏᏊ᳨ᰝࡢ฼⏝ྍ⬟ᛶ࡜ࠊ≉チ࠸ࡿࠋࡇࡢࡼ࠺࡞་⪅ࡣᏛ✲ⓗ࡞つ⠊ࢆࡑࡢືᶵ࡜ࡋ࡚࠸ࡿࡢ࡛ࠊࡑࡢⓎࡉࢀ࡚࠸࡞࠸࠿㠀᤼௚ⓗ࡟ࣛ࢖ࢭࣥࢫࡉࢀ࡚࠸ࡿ㑇ఏᏊ᳨ᰝࡢ฼⏝ྍ⬟ぢࡣබ⾲ࢆ㏻ࡌ࡚㛤♧ࡉࢀ࡚࠸ࡃࠋࡋࡓࡀࡗ࡚ࠊࡓࡗࡓ୍ேࡢᥦ౪⪅ࡋᛶ࡜ࢆ༢⣧࡟ẚ㍑ࡍࢀࡤࠊᮏᙜࡢ࡜ࡇࢁࡀぢ࠼࡚ࡃࡿࠋࡓ࡜࠼ࡤࠊᄞ⬊ᛶ࠿ゎ㔘࡛ࡁ࡞࠸ࠕ⛎ᐦࡢࠖ㻯㻲 ࡢኚ␗ࡀᏑᅾࡍࡿ࡜࠸࠺ᠱᛕࡣ࡯࡜ࢇ࡝࡞

⧄⥔⑕ 㻯㻲 ࡣࠊẚ㍑ⓗ୍⯡ⓗ࡞㑇ఏᛶࡢ⫵ࡢ⑓Ẽ࡛࠶ࡿࡀࠊ㛵㐃ࡍࡿ≉࠸ࠋࢃࡎ࠿ࡋ࠿㞟ᅋ୰࡟⌧ࢀ࡞࠸ࡓࡵၟᴗⓗ࡟㔜せ࡟ࡣ࡞ࡽ࡞࠸ኚ␗ࡔࡗ

チࡀከࡃᏑᅾࡍࡿࠋࡋ࠿ࡋࠊᇶ♏ࢆ࡞ࡍ㐍Ṍࡢከࡃࡣࠊࢺࣟࣥࢺᑠඣ⑓㝔ࡓ࡜ࡋ࡚ࡶࡑࢀ࡜㛵ಀ࡞ࡃࠊ◊✲ࡋࡓ࠸࡜࠸࠺ዲወᚰ࡟ࡼࡾ◊✲ᐊࡣデ᩿ࡢᚎ❧அ࡜ࠊᨻᗓᚋ᥼ࡢࣄࢺࢤࣀ࣒ィ⏬ࢆ⋡࠸࡚⌧ᅾࡣ 㻺㻵㻴 ࡢᡤ㛗࡛࠶ࡿࢧ࣮ࣅࢫࢆ฼⏝ྍ⬟࡟ࡍࡿࠋࣁࣥࢳࣥࢺࣥ⑓ࡢሙྜࡀࡑࢀࢆࡼࡃ♧ࡋ࡚࠸ࣇࣛࣥࢩࢫ࣭ࢥࣜࣥࢬ࡜࡟ࡼࡗ࡚࡞ࡉࢀࡓࠋᙼࡽࡣࠊ≉チࡢࢤࣀ࣒⛉Ꮫࡿࠋࡇࢀࡣࡁࢃࡵ࡚⛥࡞⑓Ẽ࡛࠶ࡿ࡟ࡶ࠿࠿ࢃࡽࡎࠊ㠀᤼௚ⓗ࡞ࣛ࢖ࢭࣥ

࡟ᑐࡍࡿᙳ㡪࡟ࡘ࠸࡚ᠱᛕࡋ࡚࠾ࡾࠊࡑࢀࡺ࠼ࠊ㻯㻲 ࡢ≉チࢆ㠀᤼௚ⓗ࡟ࢫ࡟ࡼࡗ࡚௨ୖࡶࡢ⚾ⓗ࡞㠀Ⴀ฼ࡢ◊✲ᐊ࡟ࡼࡿ᳨ᰝࡀ☜࠿࡟฼⏝ྍࣛ࢖ࢭࣥࢫࡍ࡭ࡁ࡜୺ᙇࡋࡓ ࠋ⤖ᯝ࡜ࡋ࡚ࠊ㻯㻲 ࡢ᳨ᰝࡣࠊ⌧ᅾࡢ࢔࣓

⬟࡟࡞ࡗ࡚࠸ࡿࠋ

ࣜ࢝ࡢ◊✲ᐊ࡛฼⏝ྍ⬟࡛࠶ࡿࠋࡇࢀࡽࡢ◊✲ᐊࡣࠊ㉁࣭ࢧ࣮ࣅࢫ࣭ᢏ⾡㠉᪂࡟࠾࠸࡚➇தࢆࡋ࡚࠸ࡿ ࠋࡇࢀࡽࡢ᪋タࡢከࡃࡣᏛ⾡ⓗ࡞ᶵ㛵ࡢ୰㹠㸬౽┈࡟࠶ࡾࠊࡑࢀࡽᏛ⾡ᶵ㛵ࡣࠊࡑ࠺࡛࡞ࡅࢀࡤᨭᡶ࠸⬟ຊࡀ࡞࠿ࡗࡓᝈ⪅࡟ ≉チࡀ୙฼┈࡞ᖐ⤖ࢆ⏕ࡴ࡜ࡋ࡚ࡶࠊ≉チࡀ◊✲㛤Ⓨࢆዡບࡋ㈨㔠ㄪ㐩

ࡍࡿࡢ࡟ᚲせࡔ࡜ࡍࢀࡤࠊ≉チไᗘࡣチᐜࡉࢀࡿ࡛࠶ࢁ࠺ࠋ≉チࡢᙳ㡪࡟Report on Gene Patents, supra note 17, at lines 1898-1942, 1990-2051.☜࠿࡟ 㻿㻭㻯㻙ࡘ࠸࡚ࡣࠊ୍⯡ⓗ࡞ၥ㢟࡜ࡋ࡚ࡣ኱ࡁ࡞㆟ㄽࡢᑐ㇟࡛࠶ࡿࠋࡋ࠿ࡋࠊ໬㻳㻴㻿 ࡣࠊ㑇ఏᏊࡸ㐃㛵ࡀ≉チࡉࢀ࡚࠸ࡿ࡜ࡁ࡟ࡣ᫬࡟デ᩿᝟ሗࡀᢪ࠼㎸ࡲࢀࡿࡇ࡜

Ꮫศ㔝ཬࡧ་⸆ศ㔝࡛ࡢ≉チࡢ㔜せᛶ࡟ࡘ࠸࡚ࡣ㆟ㄽࡣ࡯࡜ࢇ࡝࡞࠸ࠋㄪ

ࡀ࠶ࡿ࡜ࠊ㠀බᘧ࡟⪺࠸࡚࠸ࡿࠋࡓ࡜࠼ࡤࠊ23andme, Navigenics, and Knowme ࡢࡼᰝ࡟ࡼࢀࡤࠊ௻ᴗࡸ࣋ࣥࢳ࣮ࣕ࢟ࣕࣆࢱࣝࡣ≉チࡢ᤼௚ᛶ࡟࠿࡞ࡾ౫Ꮡࡋ

࠺࡞఍♫ࡣࠊ㻿㻺㻼㻿㸦୍ሷᇶከᆺ㸫せࡍࡿ࡟ࠊ㑇ఏᏊヨᩱࡢࢃࡎ࠿࡞ኚ␗㸧୍ᘧࡢ᳨ᰝࢆ⾜ࡗ࡚࠸ࡿࠋࡑࢀࡽࡢ఍♫ࡀ≉チ㑇ఏᏊ࡟㛵ಀࡍࡿ୍ሷᇶከᆺࢆぢࡘࡅࡿ࡜ࠊ
ᝈ⪅࡟チㅙࢆᚓ࡚࠸ࡿ◊✲ᐊ᳨࡛ᰝࢆཷࡅࡿࡼ࠺࡟່ࡵࡿࡢࡳ࡛࠶ࡿࠋⓎぢࡉࢀࡓၥ㢟ࢆ≉ᐃࡋࡼ࠺࡜ࡣࡋ࡞࠸ࠋࡓ࡜࠼ࡤࠊChandrasekharan & Fiffer, supra note 24, at࡚࠸ࡿࡇ࡜ࡀᖖࠎ᫂ࡽ࠿࡟ࡉࢀ࡚࠸ࡿࠋ≉࡟ࠊࣅ࣭ࣝࢡࣜࣥࢺࣥ኱⤫㡿 ᙜ᫬ ࡜ࢺࢽ࣮࣭ࣈࣞ࢔㤳┦ ᙜ᫬ ࡀࢤࣀ࣒⛉Ꮫࡢ㡿ᇦ࡟࠾ࡅࡿ≉チࡢ฼⏝ྍ⬟ᛶ࡟ࡘ࠸࡚␲ၥࢆᢞࡆ࠿ࡅࡿኌ᫂ࢆฟࡋࡓ࡜ࡁࡣࠊࣂ࢖࢜ࢸࢡࣀࣟࢪ

S182 ཧ↷ࠋఱࣃ࣮ࢭࣥࢺࡢᝈ⪅ࡀࡑࡢ່ࡵ࡟ᚑࡗ࡚࠸ࡿࡢ࠿ࢆỴࡵࡿࡇ࡜ࡣ୙ྍ⬟࡛࠶ࡿࠋࡓ࡜࠼ࡤࠊAMP, 702 F. Supp. 2d, at 187 ୍ேࡢཎ࿌ࡀࠊ◊✲୺㢟࡟ࡘ࠸࡚

㻮㻾㻯㻭㻝㻛㻞 ᳨ᰝࡢ⤖ᯝࢆ㛤♧࡛ࡁ࡞࠸ࡇ࡜ࢆᣦ᦬ࡋ࡚࠸ࡿ ཧ↷ࠋ≉チ࡟ࡼࡗ࡚⬣࠿ࡉࢀ࡚࠸ࡿูࡢࢱ࢖ࣉࡢ◊✲࡟ࡘ࠸࡚ࡣࠊThomas Goetz, Sergey Brin’s Search for a

Research, 97 YALE L.J. 177-231, 181- 84 (1987) ⛉Ꮫ⏺ࡣබ⾲ࢆ㔜せどࡋ࡚࠸ࡿ࡜㆟

Parkinson’s Cure, WIRED, June 22, 2010, available at http://www.wired.com/magazineㄽࡋ࡚࠸ࡿ ཧ↷ࠋ/2010/06/ff_sergeys_search/ ࢹ࣮ࢱⓎ᥀ᢏ⾡࡟ࡘ࠸࡚グ㏙ࡋ࡚࠸ࡿ ࢆཧ↷ࠋReport on Gene Patents, supra note 17, lines 3005-3006.

୍⯡ⓗ࡟ࡣ JAMES BESSEN & MICHAEL J. MEURER, PATENT FAILURE: HOW JUDGES,U.S. Dept of Health & Human Servs., The NIH Director (June 2, 2010), available atRebecca S. Eisenberg, Proprietary Rights and the Norms of Science in Biotechnology

http://www.nih.gov/about/director/index.htm.

BUREAUCRATS, AND LAWYERS PUT INNOVATION AT RISK (Princeton Univ. Press 2008) ≉チࡣࠊ⥲య࡜ࡋ࡚ࡣࠊ࢖ࣀ࣮࣋ࢩࣙࣥ࡟୙฼┈࡞ᙳ㡪ࢆ୚࠼࡚࠸ࡿ࡜୺ᙇࡋ࡚࠸ࡿ ;Subhashini Chandrasekharan et al., Impact of Gene Patents and Licensing on Access to

Genetic Testing for Cystic Fibrosis, 12 GENETICS IN MEDICINE S194-S211, S196 (Supp.

FRITZ MACHLUP, AN ECONOMIC REVIEW OF THE PATENT SYSTEM (1958) ≉チࡀࡼ࠸࠿2010).ᝏ࠸࠿ࢆỴࡵࡿࡇ࡜ࡣ୙ྍ⬟࡛࠶ࡿ࡜୺ᙇࡋ࡚࠸ࡿ ࢆཧ↷ࠋ

Id. at S197; Report on Gene Patents, supra note 17, at lines 1358-67.

 ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO  ࡓ࡜࠼ࡤࠊBESSEN & MEURER, supra note 87, at 89ཧ↷ࠋ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO   㐃⥆௻⏬

⡿ᅜࡢἲ࡜ᨻ⟇࡟࠾ࡅࡿ㑇ఏᏊデ᩿ࡢ≉チ㐺᱁ᛶ 㻰㼞㼑㼥㼒㼡㼟㼟 ࣮௻ᴗࡢᰴ౯ࡀ┤ࡕ࡟ᛴⴠࡋࡓࠋ

࠸ࡿࠋࡲࡓࠊ㈨㔠ࢆᚓࡿࡢ࡟ࡶ≉チࡣᚲせ࡛ࡣ࡞࠸ࠋデ᩿࡟ࡣ࠾㔠ࡢ࠿࠿ࡿつไୖࡢせ௳ࡀㄢࡉࢀ࡚࠸࡞࠸ࡢ࡛ࠊ┦㛵㛵ಀࡢ◊✲ࡢ㈨㔠ㄪ㐩ࡸࡋ࠿ࡋ࡞ࡀࡽࠊ἞⒪᪉ἲ࡜デ᩿᪉ἲ࡜ࢆ༊ูࡍࡿࡇ࡜ࡀ㔜せ࡛࠶ࡿࠋ୧

Ⓨぢࢆデ᩿᪉ἲ࡟㌿᥮ࡉࡏࡿࡇ࡜࡟ࠊ࠾㔠ࡣ࠿࠿ࡽ࡞࠸ࠋ㻿㻭㻯㻳㻴㻿 ࡢሗ᪉ࡢࢣ࣮ࢫ࡟࠾࠸࡚㐍Ṍࢆࢥࣆ࣮ࡍࡿࡇ࡜ࡣ⡆༢࡛࠶ࡾࠊࡑࡢࡓࡵ࡟᤼௚

࿌᭩࡟ࡼࢀࡤࠊ㈝⏝ࡣ㸢ࢆ㉸࠼࡞࠸ࠋࢧ࣮ࣅࢫ࡟ᑐࡍࡿᨭᡶ࠸ࠊᶒࡀᚲせ࡟࡞ࡿ࡜࠸࠺ぢ㎸ࡳࡣ㧗ࡃ࡞ࡿࠋၥ㢟ࡣࠊࡑࢀࡀఱࡢࡓࡵ࡟ᚲせᝈ⪅ࡢᨭ᥼ᅋయ࠿ࡽࡢ⩏᥼㔠ࠊཪࡣᨻᗓ࠿ࡽࡢ஺௜㔠࡟ࡼࡗ࡚ᨭ࠼ࡽࢀ࡚

࡜ࡉࢀࡿ࠿࡛࠶ࡿࠋ ࡘࡢྍ⬟ᛶࡣᢞ㈨ࢆಁࡍࡓࡵ࡛࠶ࡿࠋࡋ࠿ࡋࠊデ᩿࠸ࡿࠋ㔜せ࡞ࡇ࡜࡟ࠊࢣ࣮ࢫ◊✲ࡢ♧ࡍ࡜ࡇࢁ࡟ࡼࢀࡤࠊ᤼௚ⓗ࡞ᶒ฼᪉ἲ㸫≉࡟㑇ఏᏊ࡜㌟యⓗ≧ែ࡜ࡢ┤᥋ⓗ࡞㛵㐃௜ࡅ㸫ࢆ㛤Ⓨࡍࡿ㈝⏝⪅ࡀ࠸ࡿ࡜ࡁ࡛ࡶࠊ࡯࡜ࢇ࡝᳨ᰝ᪉ἲࡣᶒ฼⪅ࡀࡑࡢࡼ࠺࡞≧ἣ࡟࡞ࡿ๓

ࡣࠊ᪂ࡋ࠸໬Ꮫ≀㉁ࢆⓎぢࡍࡿࡇ࡜ࡸࠊᕷሙ࡟἞⒪᪉ἲࢆᣢࡗ࡚࠸ࡃࡲ࡛

࡟฼⏝ྍ⬟࡟࡞ࡗ࡚࠸ࡿࠋᐇࡢ࡜ࡇࢁࠊ≉チࡣ୺࡟ᕷሙ࠿ࡽ➇த⪅ࢆ᤼㝖࡟ᚲせ࡜ࡉࢀࡿ◊✲ࠊ㛤Ⓨࠊ⮫ᗋ࡜࠸࠺㐨➽ࢆࡓ࡝ࡗ࡚࠸ࡇ࠺࡜ࡍࡿࡇ࡜

ࡍࡿࡓࡵ࡟౑ࢃࢀ࡚࠾ࡾࠊᕷሙࢆసࡿࡓࡵ࡟ࡣ౑ࢃࢀ࡚࠸࡞࠸ࠋࡢ㈝⏝࡜ࡣࠊࡲࡗࡓࡃࡶࡗ࡚␗࡞ࡿࡶࡢ࡛࠶ࡿࠋ἞⒪᪉ἲࡢሙྜࠊ㈝⏝ࡣ┦ᙜ࡞ࡶࡢ࡛࠶ࡿࠋࡍ࡞ࢃࡕࠊ⮫ᗋヨ㦂ࡣ㧗౯࡛࠶ࡾࠊ⤖ᒁࡶࡢ࡟࡞ࡽ࡞

ࡶࡕࢁࢇࠊ≉チ௜୚ࡢຠᯝࡣࠊⓎ᫂ẁ㝵ࡼࡾᚋࡢẁ㝵࡟ཬࡪࡇ࡜ࡶ࠶ࡿࠋ

࠸๭ྜࡣ࡜࡚ࡶ㧗ࡃࠊࣜࢫࢡࡣⳘ኱࡛࠶ࡿࠋࡋࡓࡀࡗ࡚ࠊ㛤Ⓨ⪅ࡣ኱ࡁࡋࡓࡀࡗ࡚ࠊࡶ࠺୍ࡘࡢၥ㢟ࡣࠊ≉チࡀⓎ᫂ࡢ㛤♧ࡸᬑཬࡢࡓࡵ࡟ᚲせ࡜࡞ሗൾࡀᚓࡽࢀࡿྍ⬟ᛶ㸫ཬࡧࠊࡑࢀࡺ࠼࡟ࣇ࣮ࣜࣛ࢖ࢲ࣮࠿ࡽࡢಖㆤ㸫ࢆᚲせ࡜ࡋ࡚࠸ࡿࠋࡋ࠿ࡋࠊデ᩿᪉ἲࢆ㛤Ⓨࡍࡿ㈝⏝ࡣపࡃࠊ㻿㻭㻯㻳㻴㻿 ࡢ
Katherine J. Strandburg, Curiosity-Driven Research and University Technology Transfer,ࢣ࣮ࢫ◊✲ࡀ♧၀ࡍࡿࡼ࠺࡟ࠊ≉チࡣ◊✲ࢆᨭ࠼ࡿࡢ࡟ᚲせ࡜ࡉࢀ࡞࠸ࡢ

in 16 ADVANCES IN THE STUDY OF ENTREPRENEURSHIP, INNOVATION AND ECONOMIC࡛࠶ࡿࠋGROWTH, UNIVERSITY ENTREPRENEURSHIP AND TECHNOLOGY TRANSFER: PROCESS, DE-

SIGN, AND INTELLECTUAL PROPERTY 93 (Gary D. Libecap ed., JAI Press 2005).☜࠿࡟ࠊ㻿㻭㻯㻳㻴㻿 ࡣ≉チࡀᢞ㈨ࢆ࿧ࡧ㎸ࡴࡢࡔ࡜୺ᙇࡍࡿ௻ᴗ࠿ࡽࡢ⪺ࡁྲྀࡾࢆ⾜ࡗ࡚࠸ࡿ ࠋࡋ࠿ࡋࠊ≉チ࡟ࡼࡾ࢖ࣥࢭࣥࢸ࢕ࣈࢆ୚࠼ࡽࢀࡓ
ᢞ㈨ࡀᚲせࡔࡗࡓ࡜⤖ㄽ௜ࡅࡿࡇ࡜ࡣ୙ྍ⬟࡛࠶ࡿࠋඛ࡟♧၀ࡋࡓࡼ࠺࡟ࠊ
◊✲⪅࡜⮫ᗋ་ࡣኚ␗ࢆྠᐃࡋࠊ㐃ᦠࢆ࡞ࡋ࡚࠸ࡿࠋᙼࡽࡢືᶵࡣࠊ≉チ౫Ꮡⓗ࡛ࡣ࡞࠸ࠋࡴࡋࢁࠊዲወᚰࡸᝈ⪅ࢆᩆ࠸ࡓ࠸࡜࠸࠺ᮃࡳ࡟⏤᮶ࡋ࡚Report on Gene Patents ࡶㄆ㆑ࡋ࡚࠸ࡿࡼ࠺࡟ࠊࡇࢀࡣኚ໬ࡍࡿ࠿ࡶࡋࢀ࡞࠸ࠋ

Report on Gene Patents, supra note 17, at lines 3440-3442; Andrew Pollack, F.D.A. Faults
Companies on Unapproved Genetic Tests, N.Y. TIMES, June 12, 2010, at B2 ཧ↷ࠋࡉࡽ࡟ࠊ
ᕞ࡟ࡼࡗ࡚ࡣࠊデ᩿ࢧ࣮ࣅࢫࡢ౪⤥ࢆไ㝈ࡋ࡚࠸ࡿ࡜ࡇࢁࡶ࠶ࡿࠋPeter M. Kazon,
Regulatory Issues Facing Genetic Tests, 3 J. HEALTH & LIFE SCI. 111-49, 130-31 (2010) ཧ↷ࠋࡑ࠺ࡔ࡜ࡋ࡚ࡶࠊ≧ἣࡣ἞⒪࡜ࡣ␗࡞ࡗ࡚࠸ࡿࠋ༢࡟デ᩿᪉ἲࡢࡓࡵ࡟ヨᩱࢆ᥇ྲྀࡍࡿࡇ࡜࡟㛵㐃ࡍࡿ㌟యⓗ࡞೺ᗣ࡬ࡢࣜࢫࢡࡣ࡞࠸ࠋࡋࡓࡀࡗ࡚ࠊつไࢡࣜ࢔
ࡓ࡜࠼ࡤࠊRicki Lewis, Clinton, Blair Stoke Debate on Gene Data, 14 THESCIEN-ࡢၥ㢟ࡣࠊ࠶ࡃࡲ࡛᭷ຠᛶ࡟㛵ࡍࡿࡶࡢ࡛࠶ࡗ࡚ᝈ⪅ࡢᏳ඲ᛶ࡟ࡘ࠸࡚࡛ࡣ࡞࠸ࠋ
ࡋࡓࡀࡗ࡚ࠊⓎ᫂ࡀつไࢆࢡࣜ࢔࡛ࡁ࡞࠸࡜࠸࠺ࣜࢫࢡࡣࠊ┦ᙜ࡟ᑠࡉ࠸ࡶࡢ࡜࡞

TIST.COM 1 (2000), http://www.the-scientist.com/article/display/11786/ཧ↷ࠋࡿഴྥࡀ࠶ࡿࠋ

ࡓ࡜࠼ࡤࠊHelen M. Berman & Rochelle C. Dreyfuss, Reflections on the Science andReport on Gene Patents, supra note 17, at lines 1325-29.

Law of Structural Biology, Genomics, and Drug Development, 53 UCLA L. REV. 871-908,



Report on Gene Patents, supra note 17, at lines 1327-29.

883-88 (2006) ཧ↷ࠋࡓ࡜࠼ࡤࠊWalsh et al., supra note 70 ㈨㔠ㄪ㐩ࡣࠊᅜ❧⾨⏕◊✲ᡤࠊḢᕞ⛉Ꮫᢏ

F.M. SCHERER, THE INNOVATION LOTTERY, EXPANDING THE BOUNDARIES OF INTEL-⾡༠ຊᶵᵓࡢࣉࣟࢢ࣒ࣛࠊࢳ࢙ࢥඹ࿴ᅜࡢᩥ㒊┬ࠊࢳ࢙ࢥඹ࿴ᅜࡢಖ೺┬ࠊங࢞ࣥ

3-21 (Rochelle Dreyfuss et al. eds., Oxford Univ. Press 2001) >௨ୗ

◊✲ᇶ㔠࠿ࡽࡢ஺௜㔠࡟ࡼࡗ࡚࠸ࡿ ; Report on Gene Patents, supra note 17, lines

LECTUAL PROPERTYEXPANDING THE BOUNDARIES ࡜࠸࠺@.

987-1004 㐃㑥࡜ᨭ᥼ᅋయ࠿ࡽࡢ㈨㔠᥼ຓ࡟ࡘ࠸࡚㆟ㄽࡋ࡚࠸ࡿ .Report on Gene Patents, supra note 17, at lines 879-937.

 ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO  Report on Gene Patents, supra note 17, at lines 1192-1323.

▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO   㐃⥆௻⏬

ࡉࢀ࡚࠸ࡿࡢ࡛ࡣ࡞࠸࠿࡜࠸࠺ࡇ࡜࡛࠶ࡿࠋࡇࡇ࡛ࡶࠊࡑࡢ⟅࠼ࡣྰ࡛࠶
ࡿࠋ၏୍ࡢࢧ࣮ࣅࢫᥦ౪⪅ࡣ⤖ᯝࢆ㞃ࡍ࢖ࣥࢭࣥࢸ࢕ࣈࡀ࠶ࡿ࠿ࡶࡋࢀ࡞
࠸ࡀࠊᏛ⾡ⓗ◊✲⪅ࡣࡑࢀࢆබ⾲ࡍࡿᙉ࠸࢖ࣥࢭࣥࢸ࢕ࣈࢆᣢࡗ࡚࠸ࡿࠋ
ࡋ࠿ࡶࠊኚ␗ࡢⓎぢ࡟➇தࡀ࠶ࡿ࡜ࡁ࡟ࡣࠊ➨୍Ⓨぢ⪅࡟࡞ࡾࡓ࠸࡜࠸࠺
㢪࠸࡟ࡼࡗ࡚ࠊ◊✲⪅ࡣྍ⬟࡞㝈ࡾබ⾲ࡋࡼ࠺࡜ࡍࡿࠋ㑇ఏᏊデ᩿ࡢ୰࡟ࡣࣜࣂ࣮ࢫ࢚ࣥࢪࢽ࢔ࣜࣥࢢࡀྍ⬟࡞ࡶࡢࡶ࠶ࡿࡋࠊᕞཪࡣ㐃㑥ᨻᗓࡢබ㛤ࢆせồࡍࡿつไୗ࡟᭹ࡋ࡚࠸ࡿࡶࡢࡶ࠶ࡿࠋ

Ⓨ᫂ࡢᬑཬ࡟㛵ࡋ࡚ࡣࠊᶒ฼⪅ࡢ୰࡟ࡣ 㻿㻭㻯㻳㻴㻿 ࡟ᑐࡋࠊ᤼௚ᶒࡀ࡞
ࡅࢀࡤ᳨ᰝࡢ฼Ⅼ࡟ࡘ࠸࡚་⪅࡜ᝈ⪅࡟ᑐࡋ࡚ᩍ⫱ࡍࡿ࢖ࣥࢭࣥࢸ࢕ࣈ
ࡀ࡞࠿ࡗࡓ࡛࠶ࢁ࠺ࡇ࡜ࢆ♧၀ࡍࡿ⪅ࡶ࠸ࡿࠋࡋ࠿ࡋࠊࡇࡢᩥ⬦࡛ࡣࠕᩍ⫱ࠖࡣᐉఏ࡜ྠ㢮࡛࠶ࡿࠋࡇࢀࡣࠊᡭ๓࿡ჯ࡛࠶ࡗ࡚୙ṇ☜࡛࠶ࡿࠋᐇ㝿ࠊ㻿㻭㻯㻳㻴㻿 ࡣࠊ་⒪ᥦ౪⪅ࡢ㑇ఏᏛ࡟ᑐࡍࡿ⌮ゎࢆᨵၿࡍࡿูࡢ᪉ἲࡢⓎぢ࡟⢭ຊⓗ࡟ྲྀࡾ⤌ࢇ࡛࠾ࡾࠊᾘ㈝⪅࡬ࡢ┤᥋ࡢᐉఏࢆつไࡍࡿࡼ࠺࡟ᨻᗓ
࡟ാࡁ࠿ࡅ࡚࠸ࡿࠋ᭱ᚋ࡟ࠊ㻿㻭㻯㻳㻴㻿 ࡀಖ㝤࡟㛵ࡋ࡚ぢฟࡋࡓၥ㢟ࡣࡍ࡭࡚ࠊ၏୍ࡘࡢ࡜ࡇࢁ࠿ࡽ౪⤥ࡉࢀ࡚࠸ࡿデ᩿᪉ἲ࡟㛵ࡍࡿࡶࡢ࡛࠶ࡾࠊ
ᗈࡃ฼⏝ྍ⬟࡞デ᩿᪉ἲ࡟㛵ࡍࡿࡶࡢࡣ࡞࠿ࡗࡓࠋ



ROBERT K. MERTON, THE SOCIOLOGY OF SCIENCE (Univ. of Chicago Press 1973).



Report on Gene Patents, supra note 17, at lines 462-66, 1066-85.



Id. at lines 1378-85.



Id. at lines 1381-91.ࡓ࡜࠼ࡤࠊDraft Report of SACGHS, Genetics Education andTraining of Health Care Professionals, Public Health Providers and Consumers (2010),
available at http://oba.od.nih.gov/oba/SACGHS/SACGHS%20Draft%20Genetics%20
Education%20and%20Training%20Report.pdf ཧ↷ࠋhttp://oba.od.nih.gov/SACGHS/
sacghs_focus_marketing.html ᾘ㈝⪅࡬ࡢ┤᥋ࡢᐉఏ࡟㛵ࡍࡿ 㻿㻭㻯㻳㻴㻿 ࡢດຊࢆิ
ᣲࡋ࡚࠸ࡿ ࡶཧ↷ࠋ ▱ⓗ㈈⏘ἲᨻ⟇Ꮫ◊✲ 9RO  