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題名 基因治療之發明專利保護
作者 陳明群
貢獻者 蔡明誠
陳明群
關鍵詞 基因治療
專利
診斷方法
治療方法
基因
日期 2002
上傳時間 24-Apr-2010 15:35:45 (UTC+8)
摘要 基因治療係利用正常基因或治療基因移轉至標的細胞，使其修飾缺陷基因或表現正常蛋白質，或是以特定核酸序列干擾缺陷基因之表現，以回復細胞正常功能之一種治療方法。該治療方法配合人類基因組之解碼，將是未來治療遺傳性疾病或是癌症等疾病最重要之發展趨勢。
基因治療技術門檻高，所需投入之資金與人力相當龐大，為促進該技術之研發創新，實需專利制度之保障。然而關於基因治療技術過程相關之診斷或治療方法，因為存在著倫理上之爭議，為大多數國家不予專利之標的。因此本文係從基因檢測、基因藥物以至於基因移轉之治療方法，探討目前相關專利法制之規定及其爭議，以為我國專利法制修法之參考。
基因藥物關於基因或DNA成分之可專利性，先前爭議不斷，然目前國際之規定已趨一致，凡是經過人工努力，經過技術過程所純化而分離之DNA產物，只要符合專利保護要件者，均可獲予專利。DNA是否予以專利之法制爭議，雖然暫時告一段落，但是關於倫理之爭議卻仍方興未艾，而與基因治療相關之診斷或治療方法專利也因為醫護政策之倫理考量，引起不少之譴責與衝擊。在醫護政策予專利制度相互衝擊下，適度權衡二者，將是立法者未來一重要任務。病人受治療權益之維護以及專利制度促進研發投資之經濟效益必須同時兼顧，雖我國目前不予其專利，僅給予體外基因治療獲予專利之機會，但在醫療趨勢與科學研究之發展之下，未來不妨參酌美國立法例，或許將治療方式予以類型化後，適度開放治療方法之專利，但同時限制專利權對醫療人員在醫療院所實施之效力，以維護病人權益以及國家政策之最大效益。
參考文獻 一、中文部分（依作者姓氏筆畫排列）
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描述 碩士
國立政治大學
法律學系碩士班學士後法學組
88651040
91
資料來源 http://thesis.lib.nccu.edu.tw/record/#G0088651040
資料類型 thesis
dc.contributor.advisor 蔡明誠zh_TW
dc.contributor.author (Authors) 陳明群zh_TW
dc.creator (作者) 陳明群zh_TW
dc.date (日期) 2002en_US
dc.date.accessioned 24-Apr-2010 15:35:45 (UTC+8)-
dc.date.available 24-Apr-2010 15:35:45 (UTC+8)-
dc.date.issued (上傳時間) 24-Apr-2010 15:35:45 (UTC+8)-
dc.identifier (Other Identifiers) G0088651040en_US
dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/38965-
dc.description (描述) 碩士zh_TW
dc.description (描述) 國立政治大學zh_TW
dc.description (描述) 法律學系碩士班學士後法學組zh_TW
dc.description (描述) 88651040zh_TW
dc.description (描述) 91zh_TW
dc.description.abstract (摘要) 基因治療係利用正常基因或治療基因移轉至標的細胞，使其修飾缺陷基因或表現正常蛋白質，或是以特定核酸序列干擾缺陷基因之表現，以回復細胞正常功能之一種治療方法。該治療方法配合人類基因組之解碼，將是未來治療遺傳性疾病或是癌症等疾病最重要之發展趨勢。
基因治療技術門檻高，所需投入之資金與人力相當龐大，為促進該技術之研發創新，實需專利制度之保障。然而關於基因治療技術過程相關之診斷或治療方法，因為存在著倫理上之爭議，為大多數國家不予專利之標的。因此本文係從基因檢測、基因藥物以至於基因移轉之治療方法，探討目前相關專利法制之規定及其爭議，以為我國專利法制修法之參考。
基因藥物關於基因或DNA成分之可專利性，先前爭議不斷，然目前國際之規定已趨一致，凡是經過人工努力，經過技術過程所純化而分離之DNA產物，只要符合專利保護要件者，均可獲予專利。DNA是否予以專利之法制爭議，雖然暫時告一段落，但是關於倫理之爭議卻仍方興未艾，而與基因治療相關之診斷或治療方法專利也因為醫護政策之倫理考量，引起不少之譴責與衝擊。在醫護政策予專利制度相互衝擊下，適度權衡二者，將是立法者未來一重要任務。病人受治療權益之維護以及專利制度促進研發投資之經濟效益必須同時兼顧，雖我國目前不予其專利，僅給予體外基因治療獲予專利之機會，但在醫療趨勢與科學研究之發展之下，未來不妨參酌美國立法例，或許將治療方式予以類型化後，適度開放治療方法之專利，但同時限制專利權對醫療人員在醫療院所實施之效力，以維護病人權益以及國家政策之最大效益。		zh_TW
dc.description.tableofcontents 第一章 前言 1
第一節 研究動機與目的 1
第二節 研究方法與範圍 4
第二章 基因治療之技術背景 6
第一節 基因治療之意義 6
第二節 基因治療技術 7
第一項 基因疾病之診斷 8
第二項 修補基因之載體設計 8
第三項 基因移轉方法 9
第四項 標的細胞之選擇 13
第五項 治療基因之作用與表現 14
第三節 基因治療研究發展現況 16
第四節 基因治療技術所衍生之專利保護爭議 20
第三章 基因治療之發明專利保護 23
第一節 發明專利保護要件 23
第一項 可予專利之標的 23
第二項 產業利用性 29
第三項 新穎性 35
第四項 進步性 40
第二節 重組基因技術之發明專利保護 45
第一項 DNA與基因 45
第二項 載體與重組基因 72
第三項 化學物質與基因藥物 76
第四章 基因治療中診療方法之專利保護 80
第一節 診療方法之專利性 80
第一項 基因檢測 80
第二項 基因治療方法 81
第二節 診療方法是否應為得予專利之標的 82
第一項 診療方法可專利性之發展 83
第二項 醫療方法可專利性之論戰 85
第三項 小結 93
第三節 醫療方法專利權能之限制 94
第四節 基因治療專利保護之比較法分析 102
第一項 TRIPS之規定 102
第二項 歐洲之規定 104
第三項 我國之規定 105
第五章 基因治療發明專利之權利範圍 116
第一節 基因治療之權利內容與範圍 116
第一項 基因治療專利保護態樣 116
第二項 專利請求範圍之主張 119
第二節 基因治療專利之權利實施 120
第一項 基因治療專利之專利權範圍 120
第二項 基因治療專利實施之限制 126
第六章 結論與建議 136
參考文獻 143		zh_TW
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dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0088651040en_US
dc.subject (關鍵詞) 基因治療zh_TW
dc.subject (關鍵詞) 專利zh_TW
dc.subject (關鍵詞) 診斷方法zh_TW
dc.subject (關鍵詞) 治療方法zh_TW
dc.subject (關鍵詞) 基因zh_TW
dc.title (題名) 基因治療之發明專利保護zh_TW
dc.type (資料類型) thesisen
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dc.relation.reference (參考文獻) （三）學位論文zh_TW
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dc.relation.reference (參考文獻) 2. 李文琦，基因可專利性之研究：以美國專利制度為中心，東吳大學法律研究所碩士論文，民國九十年六月。zh_TW
dc.relation.reference (參考文獻) 3. 周一成，生物技術專利相關法律問題之研究，東吳大學法律研究所碩士論文，民國九十一年六月。zh_TW
dc.relation.reference (參考文獻) 4. 林志六，人體基因治療規範機制之研究，台灣大學法律研究所碩士論文，民國八十九年七月。zh_TW
dc.relation.reference (參考文獻) 5. 林倩如，重組DNA技術可專利性之研究，東吳大學法律研究所碩士論文，民國八十四年六月。zh_TW
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dc.relation.reference (參考文獻) 7. 劉慧德，美國CAFC基因工程專利訴訟案例分析，交通大學科技管理學程碩士班碩士論文，民國八十九年六月。zh_TW
dc.relation.reference (參考文獻) （四）官方出版品zh_TW
dc.relation.reference (參考文獻) 1. 經濟部，2002生物技術產業年鑑，民國九十一年。zh_TW
dc.relation.reference (參考文獻) 2. 經濟部工業局，2002生物產業白皮書，民國九十一年。zh_TW
dc.relation.reference (參考文獻) 3. 經濟部智慧財產局，專利侵害鑑定基準，< http://www.tipo.gov.tw/patent/ patent_law/patent_law_4.asp> （last updated Sep. 4, 2001）。zh_TW
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dc.relation.reference (參考文獻) 二、英文部分（依作者姓氏字母順序排列）zh_TW
dc.relation.reference (參考文獻) （一）書籍zh_TW
dc.relation.reference (參考文獻) 1. Borem, Aluizio et al., Understanding Biotechnology (2003)。zh_TW
dc.relation.reference (參考文獻) 2. Boylan, Michael & Brown, Kevin E., Genetic Engineering- Science and Ethics on The New Frontier (2002).zh_TW
dc.relation.reference (參考文獻) 3. Ducor, Philippe G., Patenting The Recombinant Products of Biotechnology (1998).zh_TW
dc.relation.reference (參考文獻) 4. Elias, Stephen, Patent It Yourself (4th ed. 1995).zh_TW
dc.relation.reference (參考文獻) 5. Hoscheit, Dale H. & Hemmendinger, Lisa M., Biotechnology and The Federal Circuit- 2000 Cumulative Supplement (2000).zh_TW
dc.relation.reference (參考文獻) 6. Jackson, Knight H., Patent Strategy- For Researchers and Research Managers (1996).zh_TW
dc.relation.reference (參考文獻) 7. Kamstra, Gerald et al., Patents on Biotechnological Inventions: The E.C. Directive (2002).zh_TW
dc.relation.reference (參考文獻) 8. Lannis, Veikko et al., Genes and Morality (1999).zh_TW
dc.relation.reference (參考文獻) 9. Lechter, Michael A. et al., Successful Patents and Patenting for Engineers and Scientists (1995).zh_TW
dc.relation.reference (參考文獻) 10. Palmer, Walters, Ethics of Human Gene Therapy (1997).zh_TW
dc.relation.reference (參考文獻) 11. Peterson, Gale R., Understanding Biotechnology Law (1993).zh_TW
dc.relation.reference (參考文獻) 12. Sterckx, Sigrid, Biotechnology, Patents and Morality (2000).zh_TW
dc.relation.reference (參考文獻) 13. Towse, Ruth & Holzhauer, Rudi, The Economics of Intellectual Property (2002).zh_TW
dc.relation.reference (參考文獻) 14. Watson, James D. & Gilman, Michael, Recombinant DNA (2d ed. 1992).zh_TW
dc.relation.reference (參考文獻) （二）期刊論文zh_TW
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dc.relation.reference (參考文獻) 2. Alten, Brett G., Left To One`s Devices: Congress Limits Patents on Medical Procedures, 8 Fordham Intell. Prop. Media & Ent. L.J. 837 (1998).zh_TW
dc.relation.reference (參考文獻) 3. Anderson, Scott D., A Right Without A Remedy: The Unenforceable Medical Procedure Patent, 3 Marq. Intell. Prop. L. Rev. 117 (1999).zh_TW
dc.relation.reference (參考文獻) 4. Anderson, W. French, Gene Therapy, 273 Sci. Am. 124 (1995).zh_TW
dc.relation.reference (參考文獻) 5. Andrews, Lori B., Genes and Patent Policy: Rethinking Intellectual Property Rights, 3 Nature Rev. Genetics 803 (2002).zh_TW
dc.relation.reference (參考文獻) 6. Andrews, Lori B., The Gene Patent Dilemma: Balancing Commercial Incentives With Health Needs, 2002 Hous. J. Health L. & Pol`y 65 (2002).zh_TW
dc.relation.reference (參考文獻) 7. Avedissian, Grace K., Global Implications of a Potential U.S. Policy Shift Toward Compulsory Licensing of Medical Inventions in a New Era of "Super-Terrorism", 18 Am. U. Int`l L. Rev. 237 (2002)。zh_TW
dc.relation.reference (參考文獻) 8. Beh, Hazel Glenn, The Role of Institutional Review Boards In Protecting Human Subjects: Are We Really Ready to Fix A Broken System? 26 Law & Psychol. Rev. 1, (2002).zh_TW
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dc.relation.reference (參考文獻) 10. Broadhurst, Tom, Biotechnology Patent Developments In Europe: An Overview, 20 Nature Biotech. 309 (2002).zh_TW
dc.relation.reference (參考文獻) 11. Brower, Vicki, Gene therapy revisited, 2 EMBO Reports 1064 (2001).zh_TW
dc.relation.reference (參考文獻) 12. Brown, Barry, Human Cloning and Genetic Engineering: The Case for Proceeding Cautiously, 65 Alb. L. Rev. 649 (2002).zh_TW
dc.relation.reference (參考文獻) 13. Burk, Dan L., Patenting Transgenic Human Embryos: A Nonuse Cost Perspective, 30 Hous. L. Rev. 1597 (1993).zh_TW
dc.relation.reference (參考文獻) 14. Campbell, Paula et al., Gene Therapy: Legal, Financial and Ethical Issues, 4 B.U. J. Sci. & Tech. L. 3 (1997).zh_TW
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dc.relation.reference (參考文獻) 16. Chambers, Jasemine, Patent Eligibility of Biotechnological Inventions In The United States, Europe, and Japan: How Much Patent Policy Is Public Policy, 34 Geo. Wash. Int`l L. Rev. 223 (2002).zh_TW
dc.relation.reference (參考文獻) 17. Correa, Carlos M., Proceedings of The 2002 Conference Access to Medicines In The Developing World: International Facilitation or Hindrance?: Panel # 2: TRIPS and Access to Medicines: Internationalization of The Patent System and New Technologies, 20 Wis. Int`l L.J. 523 (2002).zh_TW
dc.relation.reference (參考文獻) 18. Cregan, Judith A., Symposium: Biotechnology and The Law: Light, Fast, and Flexible: A New Approach To Regulation of Human Gene Therapy, 32 McGeorge L. Rev. 261 (2000).zh_TW
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dc.relation.reference (參考文獻) 22. Eisenberg, Rebacca S., Patent Swords and Shields, 299 Science 1018 (2003).zh_TW
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dc.relation.reference (參考文獻) 37. Langer, Robert, Drug Delivery: Drugs on Target, 293 Science 58 (2001).zh_TW
dc.relation.reference (參考文獻) 38. Larson, Edward J., Human Gene Therapy and The Law: An Introduction to The Literature, 39 Emory L.J. 855 (1990).zh_TW
dc.relation.reference (參考文獻) 39. Leibovitz, John S., Inventing A Nonexclusive Patent System, 111 Yale L.J. 2251 (2002).zh_TW
dc.relation.reference (參考文獻) 40. Looze, Marie Angele de & Ramani, Shyama V., Biotechnology Patent Applications In Europe, 17(1) Nature Biotechnol. 83 (1999).zh_TW
dc.relation.reference (參考文獻) 41. Magill, Gerard, The Ethics Weave In Human Genomics, Embryonic Stem Cell Research, and Therapeutic Cloning- Promoting and Protecting Society`s Interests, 65 Alb. L. Rev. 701 (2002)。zh_TW
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dc.relation.reference (參考文獻) 43. Marchant, Robert, From The Test Tube to The Table, 2 EMBO Reports 354 (2001).zh_TW
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dc.relation.reference (參考文獻) 45. Marshall, Eliot, Gene Therapy on Trial, 288 Science 951 (2000).zh_TW
dc.relation.reference (參考文獻) 46. Marshall, Eliot, Gene Therapy’s Growing Pains, 269 Science 1050 (1995).zh_TW
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dc.relation.reference (參考文獻) 48. Merz, Jon F. et al., Diagnostic Testing Fails the Test, 415 Nature 577 (2002).zh_TW
dc.relation.reference (參考文獻) 49. Michael, Waldholz, Genetic Therapy Wins Patent for Use of Gene Treatment, 225(56) Wall Street Journal B6- Eastern Edition (1995).zh_TW
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dc.relation.reference (參考文獻) 52. Nichols, Steven L., The Unenforceability of Medical Procedure Patents, 5 Geo. Mason L. Rev. 227 (1997).zh_TW
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dc.relation.reference (參考文獻) 55. Parkman, Robertson, Symposium on Biomedical Technology and Health Care: Social and Conceptual Transformations: Technical Article: Gene Therapy In The 1990s, 65 S. Cal. L. Rev. 411 (1991).zh_TW
dc.relation.reference (參考文獻) 56. Portman, Robert M., Legislative Restriction on Medical and Surgical Procedure Patents Removes Impediment to Medical Progress, 4 U. Balt. Intell. Prop. J. 91 (1996).zh_TW
dc.relation.reference (參考文獻) 57. Powell, Daniel J., Using The False Claims Act As A Basis for Institutional Review Board Liability, 69 U. Chi. L. Rev. 1399 (2002).zh_TW
dc.relation.reference (參考文獻) 58. Rabin, Linda Judge, Issues Surrounding The Patenting of Medical Procedures, 13 Computer & High Tech. L.J. 181 (1997).zh_TW
dc.relation.reference (參考文獻) 59. Rainsbury, Joseph M., Biotechnology on The RAC- FDA/NIH Regulation of Human Gene Therapy, 55 Food Drug L.J. 575 (2000).zh_TW
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dc.relation.reference (參考文獻) 61. Rowe, Paul M., Broad Patent on Gene Therapy, 345 (8953) Lancet 852 (1995).zh_TW
dc.relation.reference (參考文獻) 62. Rowe, Paul M., US Senate Probes Gene-Therapy Trials, 355 (9203) Lancet 560 (2000).zh_TW
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dc.relation.reference (參考文獻) 66. Thomas, John R., The Future of Patent Law: Liberty and Property In The Patent Law, 39 Hous. L. Rev. 569 (2002).zh_TW
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dc.relation.reference (參考文獻) （三）官方出版品zh_TW
dc.relation.reference (參考文獻) 1. European Patent Office, Convention on the Grant of European Patents (European Patent Convention) (11th ed. July, 2002), < http://www.european-patent-office.org/legal/epc/e /ma1.html#CVN > (last visited June 5, 2003).zh_TW
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