인간배아 관련 연구 결과물의 특허성에 관한 연구

StudyonthePatentabilityof HumanStem CellRelated R&D Resultant

책임연구원 : 충 남 대 학 교 정 차 호
공동연구원 : 한국생명공학연구원 유 권
공동연구원 : 충 남 대 학 교 신 유 철
공동연구원 : ㈜ 시 온 텍 강 경 석

목 차
연구결과요약
제1장 인간배아 줄기세포 관련 기술동향 ··········································································· 1
1.1 줄기세포의 개요 ·········································································································· 1
1.1-1 줄기세포 정의 및 특성 ················································································· 1
1.1-2 줄기세포 연구 배경 ······················································································· 6
1.2 배아 줄기세포 연구동향 ···························································································· 9
1.2-1 배아 줄기세포 정의 및 특성 ······································································· 9
1.2-2 배아 줄기세포 연구 배경 ··········································································· 13
1.2-3 배아 줄기세포 확립기술 ············································································· 16
1.2-4 배아 줄기세포 활용기술 ············································································· 21
1.3 줄기세포 시장동향 ···································································································· 24
1.4 줄기세포 연구의 향후 과제 ···················································································· 29
1.4-1 기술적 과제 ··································································································· 29
1.4-2 산업화 전략 ··································································································· 30
제2장 인간배아 줄기세포 관련 특허출원 동향 ······························································· 32
2.1 기술계통도 ·················································································································· 32
2.2 선행조합식 ·················································································································· 33
2.3 특허출원 동향분석 ···································································································· 35
2.3-1 출원연도 분석 ······························································································· 35
2.3-2 출원국가 분석 ······························································································· 36
2.3-3 출원인 분석 ··································································································· 37
2.3-4 기술별 분석 ··································································································· 39
2.4 기술발전도 ·················································································································· 42
2.4-1 생산기술 ········································································································· 42
2.4-2 분화기술 ········································································································· 43
2.4-3 유지기술 ········································································································· 45
2.5 요지리스트 ·················································································································· 46
2.5-1 한국특허 ········································································································· 46
2.5-2 미국특허 ········································································································· 47
2.5-3 유럽연합특허 ································································································· 49
2.5-4 일본특허 ········································································································· 50
2.6 핵심특허 인용관계분석 ···························································································· 51
제3장 인간배아 줄기세포연구에 관한 설문조사 ····························································· 57
3.1 설문배경 ······················································································································ 57
3.1-1 설문목적 ········································································································· 57
3.1-2 조사항목 ········································································································· 57
3.1-3 조사방법 ········································································································· 58
3.1-4 표본특성 ········································································································· 58
3.1-5 타 설문조사결과 ··························································································· 60
3.2 설문조사분석 ·············································································································· 62
3.3 설문조사내용 ·············································································································· 76
제4장 인간배아 줄기세포 관련 주요국가 특허사례연구 ··············································· 80
4.1 유럽연합 ······················································································································ 80
4.1-1 서설 ················································································································· 80
4.1-2 인간배아 연구결과물의 특허가능성 ························································· 81
가. 관련법규 ·································································································· 81
나. 특허의 종류 ···························································································· 83
다. 인간배아관련 연구결과물의 특허청구 대상 ···································· 83
라. 배아줄기세포관련 특허청구 내역 ······················································ 84
마. 줄기세포관련 물질특허의 가능성 ······················································ 85
바. 줄기세포관련 방법특허의 가능성 ······················································ 87
사. 줄기세포관련 특허의 일반요건 ·························································· 88
4.2 일본 ······························································································································ 92
4.2-1 생명윤리문제에 관한 논의 ········································································· 92
4.2-1-1 생명윤리에 관한 논의의 경위 ·················································· 92
4.2-1-2 인간클론기술관련 논의 ······························································ 93
4.2-1-3 인간배아줄기세포관련 논의 ······················································ 95
4.2-1-4 인간게놈연구관련 논의 ······························································ 97
4.2-2 인간클론기술관련 논의 ·································································· 99
4.2-2-1 클론기술 규제법 ·········································································· 99
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4.2-2-2 인간에 관한 클론기술등의 규제에 관한
법률 시행규칙 ··········································································· 100
4.2-3 인간배아줄기세포와 관련된 논의 ··························································· 101
4.2-3-1 인간배아줄기세포의 수립 및 사용의 장점 및 문제점 ····· 101
4.2-3-2 인간배아줄기세포의 연구에 관한 과학기술회의의 견해 · 102
4.2-3-3 인간배아줄기세포의 수립 및 사용에 관한 지침 ··············· 103
4.2-3-4 지침 시행 후 각 연구기관의 대응 ······································· 105
4.2-3-5 인간배아 취급에 관한 종합과학기술회의의 견해 ············· 106
4.2-3-6 종합과학기술회의의 견해에 대한 변호사회의 의견 ········· 108
4.2-4 인간배아를 포함한 첨단의료기술과 특허심사기준 ····························· 109
4.2-4-1 지적재산전략 대강 ··································································· 109
4.2-4-2 첨단의료기술의 특허화에 대한 논의의 경의 ····················· 110
4.2-4-3 특허심사기준의 개정 ······························································· 113
4.2-4-4 의료관련 행위의 특허보호의 의상에 대한
지적재산전략본부의 견해 ······················································· 117
4.2-4-5 지적재산전략본부의 견해에 대한 각 계의 의견 ··············· 119
4.2-4-6 인간세포관련 심사사례분석 ··················································· 122
4.2-5 인간배아관련 특허성 기준에 관한 예측 ··············································· 125
4.2-5-1 의료특허 인정의 실의 ····························································· 125
4.2-5-2 첨단의료의 가능성 ··································································· 125
4.2-5-3 의료방법특허의 문제점에 대한 판단 ··································· 125
4.2-5-4 판례 및 심사기준의 변경 ······················································· 125
4.2-5-5 소결 ····························································································· 126
4.3 인간배아관련 연구에 관한 미국법제 ································································· 127
4.3-1 연구지원에 관한 제도 ··············································································· 127
4.3-2 특허성 판단기준 ························································································· 129
4.4 인간배아관련 연구에 관한 한국법제 ·································································· 133
4.4-1 서론 ··············································································································· 133
4.4-2 기존의 법제 ································································································· 133
4.4-3 생명윤리 및 안전에 관한 법률 ······························································· 134
4.4-4 생명윤리법의 문제점 ················································································· 139
4.4-5 생명윤리법에 대한 논쟁 ··········································································· 140
4.4-6 생명윤리법의 시행에 따른 실례 ····························································· 140
제5장 인간배아 줄기세포 특허보호 필요성, 윤리성 및 가능성 ······························· 142
5.1 인간배아 줄기세포 연구결과물의 특허보호 필요성 ································ 142
5.2 인간배아 줄기세포 연구결과물의 특허보호 윤리성 ································ 147
5.3 인간배아 줄기세포 연구결과물의 특허보호 가능성 ································ 150
제6장 의료방법발명의 특허보호 타당성 검토 ······························································· 155
6.1 검토배경 ············································································································· 155
6.2 현황 ····················································································································· 155
6.3 특허제도의 개관 ······························································································· 156
6.4 의료방법발명 관련 각국 법제 ······································································· 160
6.5 의료방법발명에 대한 특허보호의 타당성 검토 ········································· 164
6.6 입법론 ················································································································· 169
6.7 소결 ····················································································································· 172
제7장 결론 ····························································································································· 175
7.1 사안별 결론 ······································································································· 175
7.2 종합적 결론 ·······································································································

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