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研究生: 劉承慶
Liu, Cheng-ching
論文名稱: 生物科技智慧財產權歸屬之研究 -以人體組織所衍生之權利為中心-
指導教授: 蔡維音
Tsai, Wei-In
學位類別: 碩士
Master
系所名稱: 社會科學院 - 法律學系
Department of Law
論文出版年: 2004
畢業學年度: 92
語文別: 中文
論文頁數: 156
中文關鍵詞: 人體組織生物材料權利歸屬智慧財產權生物科技
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  • 隨著生物科技研發的能量日益擴大,對於生物材料的需求也更加殷切,這也包括了對於人體組織的需求在內。本文所要探討的核心問題,乃是在生技研發價值鍊中的人體組織供應者與利用者,對於將人體組織投入生技研發所獲致的成果,究竟有何法律上的基礎以請求參與分配;同時,我們又可以考慮以哪些法律所規定,或是由何種契約形式,來決定分配這些研發成果的機制。

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    論文摘要 I 謝 詞 II 簡 目 III 詳 目 V 壹、緒論 1 一、研究動機 1 二、名詞定義與研究範圍 7 三、研究步驟與論文架構 13 貳、問題之提出 15 一、人體組織衍生權利之形成及其歸屬認定之原則 15 二、可能獲得權利分配之權利主體 18 參、我國現行法令架構下之人體組織利用概況 28 一、人體組織之利用方式及相關法令 28 二、我國現有之人體組織服務機構 33 三、我國現況之檢討 38 肆、美國實務上對人體組織相關財產權之處理 45 一、人體組織是否有財產權 45 二、以契約規範人體組織之移轉 56 三、小結 64 伍、人體組織、衍生權利及權利主體 67 一、人體組織所構成之權利性質 67 二、人體組織之利用所衍生智慧財產權 74 三、人體組織及其衍生權利所歸屬之權利主體 80 陸、由法律與契約角度分析權利歸屬 92 一、由法律角度分析權利歸屬 92 二、由契約角度分析參與分配之法律基礎 108 柒、結論 116 參考資料 121 附錄一、統一生物移轉材料合約(Uniform Biological Material Transfer Agreement)之主合約(master agreement) 129 附錄二、美國細胞培養暨儲存中心(ATCC)之材料移轉合約(Material Transfer Agreement, issued on 2003/9/8) 136 附錄三、凱斯西儲大學(Case Western Reserve University)之制式生物材料移轉合約(Biological Material Transfer Agreement) 142 附錄四、商業性網站1000ventures所提供之制式MTA 149 附錄五、中央研究院生物材料移轉合約 154

    一、中文部分
    ◆ 專書
    王澤鑑,《民法總則》,自刊 (2000/10)
    王澤鑑,《民法物權通則˙所有權》,自刊 (1996/10)
    陳文吟,《專利法專論》,五南 (1996/10)
    陳文吟,《我國專利制度之研究》,五南 (1995)
    陳智超,《專利法理論與實務》,五南 (2002/11)
    陳逸南,《化學品、醫藥品及生物科技之法律保護》,自刊 (1993)
    黃丁全,《醫事法》,月旦 (1995/11)
    蔡明誠,《發明專利法研究》,自刊 (1998/8)
    劉承愚、賴文智,《技術授權契約入門》,智勝 (2000/10)
    謝在全,《民法物權論(上冊)(下冊)》,自刊 (1994/6)
    Boyce Rensberger, Life Itself- Exploring the Realm of the Living Cell (1996),中譯本涂可欣譯,《一粒細胞見世界》,天下 (1998/11)
    Lori Andrews & Dorothy Nelkin, Body Bazaar- The Market for Human Tissue in the Biotechnology Age (2001),中譯本廖月娟譯,《出賣愛因斯坦-人體組織販賣市場》,時報 (2001/9)
    ◆ 學位論文
    王凱玲,《生物技術發明之專利保護》,八十八年台灣大學法律學研究所碩士論文 (1999/6)
    李凡嶢,《人類胚胎幹細胞研究及醫療應用之法律建制》,九十年台北大學法律學研究所碩士論文 (2001/6)
    周一成,《生物技術專利相關法律問題之研究》,九十年東吳大學法律學研究所碩士論文 (2001/6)
    高培恆,《生物醫學人體試驗之國際法規範》,九十年東吳大學法律學研究所碩士論文 (2001/7)
    陳仲嶙,《從新生兒篩檢探討隱私權的法之規制》,九十二年台灣大學法律學研究所碩士論文 (2003/7)
    廖文孜,《生物遺傳資源之智慧財產權保護》,九十年台灣大學法律學研究所碩士論文 (2001/6)
    賴文智,《智慧財產權與民法的互動-以專利授權契約為主》,八十九年台灣大學法律學研究所碩士論文 (2000/6)
    ◆ 期刊論文
    朱世霓,〈歐盟關於生技產業研發成果保護之法制趨勢〉,科技法律透析第十三卷第十二期,頁29 (2001/12)
    李素華,〈德國胚胎幹細胞法(草案)介紹與淺析〉,科技法律透析第十四卷第七期,頁22 (2002/7)
    李震山,〈胚胎基因工程之法律意涵-以生命全保障為例〉,台大法學論叢第三十一卷第三期,頁1 (2002/5)
    林衛理、鄭惠蓉,〈生物科技公司無形資產價值評估〉,萬國法律第一二三期,頁55 (2002/6)。
    孫文玲,〈美國生技研發基本規範及新近爭議之初步研析〉,科技法律透析第十三卷第九期,頁25 (2001/9)
    孫文玲,〈談美國生技專利法制及新近WARF胚胎幹細胞相關專利授權〉,智慧財產權第三十一期,頁47 (2001/12)
    陳文吟,〈由胚胎幹細胞研究探討美國專立法上「道德」實用性因應生物科技的必要性〉,台北大學法學論叢第四十九期,頁179 (2001/12)
    陳文吟,〈從美國申請人體基因組序列專利探討我國專利制度對生物科技發展的因應之道〉,中正法學集刊第一期,頁111 (1998/7)
    陳英鈐,〈人類胚胎幹細胞研究的管制〉,資策會科技法律中心,生物醫藥科技領域之法律規範座談會-從胚胎幹細胞研究之爭議談起會議資料 (2002/5)
    陳英鈐,〈人類幹細胞研究的法議題〉,政大法學評論第六十七期,頁1 (2001/9)
    黃三榮,〈ES細胞、EG細胞vs.法律〉,萬國法律第一二○期,頁63 (2001/12)
    黃三榮,〈臍帶血之法律面觀察〉,萬國法律第一二一期,頁59 (2002/2)
    黃三榮,〈再生醫療與法律〉,萬國法律第一二四期,頁37 (2002/8)
    曾淑瑜,〈從日本之生命倫理法-「規範基因技術法」之訂定為相關問題之初探〉,法令月刊第五十二卷第八期,頁3 (2001/8)
    楊君仁,〈德國生物科技應用倫理研究簡介〉,應用倫理研究通訊第十四期,頁28 (2000/4)
    蔡維音,〈「擬似權利主體」之法律意涵-重新建構人類基因之法律定位〉,成大法學第二期,頁41 (2001/12)
    鄧曉芳,〈從告知後同意程序評析「研究用人體檢體採集與使用注意事項」〉,科技法律透析第十四卷第五期,頁20 (2002/5)
    鄧曉芳,〈簡介日本生技法制倫理規範趨勢-兼評析我國相關生技法規概況(上)〉,科技法律透析第十四卷第八期,頁46 (2002/8)
    鄧曉芳,〈簡介日本生技法制倫理規範趨勢-兼評析我國相關生技法規概況(下)〉,科技法律透析第十四卷第九期,頁29 (2002/9)
    蘇永欽,〈論動產加工的物權及債權效果(上)〉,政大法學評論第二十七期,頁1 (1983/6)
    二、英文部分
    ◆ 專書
    George J. Annas & Sherman Elias et al., Gene Mapping - Using Law and Ethics as Guides, Oxford University Press (1992)
    Gerhold K. Becker & James P. Buchanan, Changing Nature’s Course: The Ethical Challenge of Biotechnology, Hong Kong University Press (1996)
    Klara Goldbach et. al., Protection of Biotechnological Matter Under European and German Law, Munich: VCH (1997)
    Tom L. Beauchamp & James F. Childress, Principles of Biomedical Ethics, Oxford University Press (2001)
    ◆ 期刊論文
    Amy S. Pignatella, Property Rights in Human Biological Materials: Studies in Species Reproduction and Biomedical Technology, 17 Arizona Journal of International and Comparative Law 449 (2000)
    Anne Marie Murphy, The Biomaterials Access Assurance Act of 1998 and Supplier Liability: Who You Gonna Sue? 25 Delaware Journal of Corporate Law 715 (2000)
    Anne Nichols Hill, One Man’s Trash is Another Man’s Pleasure, Bioprospecting: Protecting the Rights and Interests of Human Donors of Genetic Material, 5 Journal of Health Care Law & Policy 259 (2002)
    Anne T. Corrigan, A Paper Tiger: Lawsuits Against Doctors for Non-Disclosure of Economic Interests in Patients' Cells, Tissues and Organs, 42 Case Western Reserve University 565 (1992)
    Arti K. Rai and Rebecca S. Eisenberg, Bayh-Dole Reform and the Progress of Biomedicine, 66 Law and Contemporary Problems 289 (2003)
    Barbara Indech, The International Harmonization of Human Tissue Regulation: Regulatory Control Over Human Tissue Use and Tissue Banking in Select Countries and the Current State of International Harmonization Efforts, 55 Food and Drug Law Journal 343 (2000)
    Charlotte H. Harrison, Neither Moore nor the Market: Alternative Models for Compensating Contributors of Human Tissue, 28 American Journal of Law & Medicine 77 (2002)
    Christian Williams, Combating the Problems of Human Rights Abuses and Inadequate Organ Supply Through Presumed Donative Consent, 26 Case Western Reserve Journal of International Law 315 (1994)
    Christopher Cates, Property in Human Tissues: History, Society and Possible Implementations, 4 Appeal Review of Current Law and Law Reform 32 (1998)
    Christopher Scott Pennisi, More on Moore: A Novel Strategy for Compensating the Human Sources of Patentable Cell-Line Inventions Based on Existing Law, Fordham Intellectual Property, 11 Media & Entertainment Law Journal 747 (2001)
    Curtis E. Harris & Stephen P. Alcorn, To Solve a Deadly Shortage: Economic Incentives for Human Organ Donation, 16 Issues in Law & Medicine 213 (2001)
    Cynthia M. Ho, Patents, Patients, and Public Policy: An Incomplete Intersection at 35 U.S.C. 287(c), 33 U.C. Davis Law Review 601 (2000)
    Danielle M. Wagner, Property Rights in the Human Body: The Commercialization of Organ Transplantation and Biotechnology, 33 Duquesne Law Review 931 (1995)
    Donna M. Sheinbach, Examining Disputes Over Ownership Rights to Frozon Embryos: Will Prior Consent Documents Survive if Challenged by State Law and/or Constitutional Principles? 48 Catholic University Law Review 989 (1999)
    Dorothy Nelkin and Lori B. Andrews, Symposium on Legal Disputes Over Body Tissue: Introduction: The Body, Economic Power and Social Control, 75 Chicago-Kent Law Review 3 (1999)
    Gloria J. Banks, Legal & Ethical Safeguards: Protection of Society's Most Vulnerable Participants in a Commercialized Organ Transplantation System, 21 American Journal of Law & Medicine 45, (1995)
    Gregory S. Crespi, Overcoming the Legal Obstacles to the Creation of a Futures Market in Bodily Organs, 55 Ohio State Law Journal 1 (1994)
    Henry L. Hipkens, The Failed Search for the Perfect Analogy: More Reflections on the Unusual Case of John Moore, 80 Kentucky Law Journal 337 (1992)
    Henry T. Greely, Breaking the Stalemate: A Prospective Regulatory Framework for Unforseen Research uses of Human Tissue Samples and Health Information, 34 Wake Forest Law Review 737 (1999)
    Jay A. Soled, The Sale of Donors' Eggs: A Case Study of Why Congress Must Modify the Capital Asset Definition, 32 U.C. Davis Law Review 919, (1999)
    Jennifer Long Collins, Hecht v. Superior Court: Recognizing a Property Right in Reproductive Material, 33 University of Louisville Journal of Family Law 661 (1995)
    Joshua A. Kalkstein, Speech: Moore v. Regents of the University of California Revisited, edited transcript of remarks delivered to the Yale Law and Technology Society on February 1, 2000, 3 Yale Journal of Law & Technology 4 (2000)
    Julia D. Mahoney, The Market for Human Tissue, 86 Virginia Law Review 163 (2000)
    June Carbone, Back to the Future: Intellectual Property and the Rediscovery of Property Rights - And Wrongs, 46 Saint Louis University Law Journal 629 (2002)
    Keith Sealing, Teaching Fundamental Learning Techniques With Moore v. Regents of the University of California, 46 Saint Louis University Law Journal 755 (2002)
    Kevin H. Smith, Security Interests in Human Materials, 28 Hofstra Law Review 127 (1999)
    Marc O. Williams, The Regulation of Human Tissue in the United States: A Regulatory and Legislative Analysis, 52 Food and Drug Law Journal 409 (1997)
    Melissa M. Perry, Fragmented Bodies, Legal Privilege, and Commodification in Science and Medicine, 51 Maine Law Review 169 (1999)
    Michael Orlando, Moore Revisited: State-Sponsored Biotechnological Research and the Takings Clause, 23 Whittier Law Review 437 (2001)
    Michele Goodwin, Rethinking Legislative Consent Law? 5 DePaul Journal of Health Care Law 257 (2002)
    Radhika Rao, Property, Privacy, and the Human Body, 80 Boston University Law Review 359 (2000)
    Remigius N. Nwabueze, Biotechnology and the New Property Regime in Human Bodies and Body Parts, 24 Loyola of Los Angeles International & Comparative Law Review 19 (2002)
    Richard Gold, Owning Our Bodies: An Examination of Property Law and Biotechnology, 32 San Diego Law Review 1167 (1995)
    Robert Heidt, Maintaining Incentives for Bioprospecting: The Occasional Need for a Right to Lie, 13 Berkeley Technology Law Journal 667 (1998)
    Roderick T. Chen, Organ Allocation and the States: Can the States Restrict Broader Organ Sharing? 49 Duke Law Journal 261 (1999)
    Russell Scott, Human Organs and Tissues for Therapy - A Review of Demand and Supply, 9 Journal of Contemporary Health Law & Policy 139 (1993)
    Samrat Ganguly, Organ and Tissue Transplantation in the European Union: Management of Difficulties and Health Risks Linked to Donors, 3 Columbia Journal of European Law 519 (1997)
    Symposium: At the Crossroads of Law & Technology: Third Annual Conference: Plaintiff's Opposition Reply to Defendant Dolly's Motion for Summary Judgment, 35 Loyola of Los Angeles Law Review 1051 (2002)
    William Boulier, Sperm, Spleens, and Other Valuables: The need to Recognize Property Rights in Human Body Parts, 23 Hofstra Law Review 693 (1995)
    三、重要參考網站
    中央研究院
    網址:http://www.sinica.edu.tw/
    中華血液基金會
    網址:http://www.blood.org.tw
    司法院法學檢索資料庫
    網址:http://nwjirs.judicial.gov.tw/Index.htm
    世界智慧財產權組織(World Intellectual Property Organization, WIPO)
    網址:http://www.wipo.org
    行政院衛生署
    網址:http://www.doh.gov.tw/
    和信治癌中心醫院腫瘤庫
    網址:http://www.kfsyscc.org/prof/prf04.html
    美國專利商標局(United States Patent and Trademark Office, USPTO)
    網址:http://www.uspto.gov/
    美國細胞培養暨儲存中心(American Type Culture Collection, ATCC)
    網址:http://www.atcc.org/
    美國國家衛生院(National Institute of Health, NIH)
    網址:http://www.nih.gov/
    美國凱斯西儲大學研究與技轉中心(Case Western Reserve University (CWRU) Research Administration and Technology Transfer)
    網址:http://ora.ra.cwru.edu/
    美國農業部(United States Department of Agriculture, USDA)
    網址:http://www.usda.gov/
    華文生技網
    網址:http://www.bioweb.com.tw/
    國家衛生研究院細胞庫
    網址:http://www.nhri.org.tw/cellbank
    資訊工業策進會科技法律中心
    網址:http://stlc.iii.org.tw/

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