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) | 2002 | en_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) | G0088651040 | en_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) | 88651040 | zh_TW |
dc.description (描述) | 91 | zh_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.language.iso | en_US | - |
dc.source.uri (資料來源) | http://thesis.lib.nccu.edu.tw/record/#G0088651040 | en_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) | thesis | en |
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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 |
dc.relation.reference (參考文獻) | 1. Ackiron, Evan, The Human Genome Initiative and The Impact of Genetic Testing and Screening Technologies: Note and Comment: Patents For Critical Pharmaceuticals: The AZT Case, 17 Am. J. L. and Med. 145 (1991). | zh_TW |
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 |
dc.relation.reference (參考文獻) | 9. Blaese, R. Michael, Challenges of Genetic Disease: Gene Addition or Gene Repair, 17 (Supp.) Nature Biotech. 8 (1999). | zh_TW |
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 |
dc.relation.reference (參考文獻) | 15. Capen, Karen & Kothari, Anita, Lawsuits Over Laser Patents Raise Serious Issues For Physicians, Patients, 157 CMAJ 737 (1997). | zh_TW |
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 |
dc.relation.reference (參考文獻) | 19. Dastgheib-Vinarov, Sara, A Higher Nonobviousness Standard for Gene Patents: Protecting Biomedical Research from the Big Chill, 4 Marq. Intell. Prop. L. Rev. 143 (2000). | zh_TW |
dc.relation.reference (參考文獻) | 20. Doll, John J., The Patenting of DNA, 280 Science 689 (1998). | zh_TW |
dc.relation.reference (參考文獻) | 21. Eisenberg, R., Re-Examining The Role of Patents In Appropriating The Value of DNA Sequences, 49 Emory Law J. 783 (2000). | zh_TW |
dc.relation.reference (參考文獻) | 22. Eisenberg, Rebacca S., Patent Swords and Shields, 299 Science 1018 (2003). | zh_TW |
dc.relation.reference (參考文獻) | 23. Friedmann, Theodore, Principles for Human Gene Therapy Studies, 287 Science 2163 (2000). | zh_TW |
dc.relation.reference (參考文獻) | 24. Garris, Joel J., The Case for Patenting Medical Procedures, 22 Am. J. L. and Med. 85 (1996). | zh_TW |
dc.relation.reference (參考文獻) | 25. Gavaghan, Helen, NIH Wins Patent on Basic Technique Covering All Ex Vivo Gene Therap, 374 Nature 393 (1995). | zh_TW |
dc.relation.reference (參考文獻) | 26. Gocyk-Farber, Beata, Patenting Medical Procedures: A Search For a Compromise Between Ethics and Economics, 18 Cardozo L. Rev. 1527 (1997). | zh_TW |
dc.relation.reference (參考文獻) | 27. Golden, John M., Biotechnology, Technology Policy, and Patentability: Natural Products and Invention In The American System, 50 Emory L.J. 101 (2001). | zh_TW |
dc.relation.reference (參考文獻) | 28. Ho, Cynthia M., Patents, Patients, and Public Policy: An Incomplete Intersection at 35 U.S.C. §287(c), 33 U.C. Davis L. Rev. 601 (2000). | zh_TW |
dc.relation.reference (參考文獻) | 29. Ho, Cynthia M., Who Deserves the Patent Pot of Gold?: An Inquiry into the Proper Inventorship of Patient-Based Discoveries, 2002 Hous. J. Health L. & Pol`y 107 (2002). | zh_TW |
dc.relation.reference (參考文獻) | 30. Holman, Molly A. & Munzer, Stephen R., Intellectual Property Rights In Genes and Gene Fragments: A Registration Solution for Expressed Sequence Tags, 85 Iowa L. Rev. 735 (2000). | zh_TW |
dc.relation.reference (參考文獻) | 31. Jager, Charles F. De, The Development of Regulatory Standards for Gene Therapy In The European Union, 18 Fordham Int`l L.J. 1303 (1995). | zh_TW |
dc.relation.reference (參考文獻) | 32. Jenks, Susan, NIH Wins Broad Patent on Human Gene Therapy, 87 J Natl Cancer Inst 569 (1995). | zh_TW |
dc.relation.reference (參考文獻) | 33. Katopis, Chris J., Patients v. Patents: Policy Implications of Recent Patent Legislation, 71 St. John`s L. Rev. 329 (1997). | zh_TW |
dc.relation.reference (參考文獻) | 34. Knowles, Sherry M. & Adams, Stephanie D., Who Owns My DNA?: The National and International Intellectual Property Laws on Human Embryonic Tissue and Cloning, 32 Cumb. L. Rev. 475 (2001). | zh_TW |
dc.relation.reference (參考文獻) | 35. Koopman, Jerzy, The Patentability of Transgenic Animals In The United States of America and The European Union: A Proposal For Harmonfization, 13 Fordham Intell. Prop. Media & Ent. L.J. 103 (2002). | zh_TW |
dc.relation.reference (參考文獻) | 36. Lafferty, William B., Statutory and Ethical Barriers In The Patenting of Medical and Surgical Procedures, 29 J. Marshall L. Rev. 891 (1996). | zh_TW |
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 |
dc.relation.reference (參考文獻) | 42. Malinowski, Michael J. & O`Rourke, Maureen A., A False Start? The Impact of Federal Policy on The Genotechnology Industry, 13 Yale J. on Reg. 163 (1996). | zh_TW |
dc.relation.reference (參考文獻) | 43. Marchant, Robert, From The Test Tube to The Table, 2 EMBO Reports 354 (2001). | zh_TW |
dc.relation.reference (參考文獻) | 44. Marden, Emily & Nelkin, Dorothy, Displaced Agendas: Current Regulatory Strategies for Germline Gene Therapy, 45 MoGill L. J.461 (2000). | zh_TW |
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 |
dc.relation.reference (參考文獻) | 47. Meier, Bradley J., The New Patent Infringement Liability Exception For Medical Procedures, 23 J. Legis. 265 (1997). | zh_TW |
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 |
dc.relation.reference (參考文獻) | 50. Miller, Geoffrey P., Cultural-Legal Analysis, 9 Va. J. Soc. Pol`y & L. 497 (2002). | zh_TW |
dc.relation.reference (參考文獻) | 51. Nichols, Steven L., Hippocrates, The Patent-Holder: The Unenforceability 0f Medical Procedure Patents, 5 Geo. Mason L. Rev. 227 (1997). | zh_TW |
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 |
dc.relation.reference (參考文獻) | 53. Olsen, Byron V., The Biotechnology Balancing Act: Patents for Gene Fragments, and Licensing The "Useful Arts", 7 Alb. L.J. Sci. & Tech. 295 (1997). | zh_TW |
dc.relation.reference (參考文獻) | 54. Owens, Susan R. & Breithaupt, Holger , From Genomes to Cures—A Long Way to Go, 3(1) EMBO Reports 11 (2002). | zh_TW |
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 |
dc.relation.reference (參考文獻) | 60. Robertson, Debra, Gene Pill Patents a Surprise For Gene Therapy, 19 Nature Biotech. 604 (2001). | zh_TW |
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 |
dc.relation.reference (參考文獻) | 63. Salynn, Boyles et al., Genetic Therapy, Inc. Wins Broad Patent for Human Gene Therapies, Gene Therapy Weekly 13 (April 17, 1995). | zh_TW |
dc.relation.reference (參考文獻) | 64. Sturges, Melissa L., Who Should Hold Property Rights to the Human Genome? An Application of the Common Heritage of Humankind, 13 Am. U. Int`l L. Rev. 219 (1997). | zh_TW |
dc.relation.reference (參考文獻) | 65. Taylor, Jeffrey A., Medical Process Patents and Patient Privacy Rights, 14 J. Marshall J. Computer & Info. L. 131 (1995). | zh_TW |
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 |
dc.relation.reference (參考文獻) | 67. Tyers, Mike & Mann, Matthias, From Genomics to Proteomics, 422 Nature 193 (2003). | zh_TW |
dc.relation.reference (參考文獻) | 68. Upadhye, Shashank, To Use or Not to Use: Reforming Patent Infringement, the Public Use Bar, and the Experimental Use Doctrine as Applied to Clinical Testing of Pharmaceutical and Medical Device Inventions, 4 Minn. Intell. Prop. Rev. 1 (2002). | zh_TW |
dc.relation.reference (參考文獻) | 69. Upadhye, Shashank, Understanding Patent Infringement Under 35 U.S.C. §271(e)-The Collisions Between Patent, Medical Device, and Drug Law, 17 Santa Clara Computer & High Tech. L.J. 1 (2000). | zh_TW |
dc.relation.reference (參考文獻) | 70. Verma, Inder M. et al., Gene Therapy- Promises, Problems and Prospects, 389 Nature 239 (1997). | zh_TW |
dc.relation.reference (參考文獻) | 71. Walsh, John P. et al., Working Through the Patent Problem, 299 Science 102 (2003). | zh_TW |
dc.relation.reference (參考文獻) | 72. Whitaker, Damon J., The Patentability of Embryonic Stem Cell Research Results, 13 J. Law. & Pub. Pol`y 361 (2002). | zh_TW |
dc.relation.reference (參考文獻) | 73. Willgoos, Christine, FDA Regulation: An Answer to The Questions of Human Cloning and Germline Gene Therapy, 27 Am. J. L. and Med. 101 (2001). | zh_TW |
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dc.relation.reference (參考文獻) | (三)官方出版品 | zh_TW |
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