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    题名: 基因治療之發明專利保護
    作者: 陳明群
    贡献者: 蔡明誠
    陳明群
    关键词: 基因治療
    專利
    診斷方法
    治療方法
    基因
    日期: 2002
    上传时间: 2010-04-24 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)
    (一)書籍
    1. 吳書榆譯,知識的戰爭,聯經出版社,民國九十年十一月。
    2. 李茂堂著,專利法實務,健行文化出版社,民國八十六年二月。
    3. 杜寶□編,基因治療的原理與應用,九州出版社,民國九十年三月。
    4. 曹國維譯,生物科技大未來,麥格羅希爾,民國九十一年八月。
    5. 陳哲宏等著,專利法解讀,元照出版社,民國九十一年。
    6. 陳逸南著,化學品、醫藥品及生物技術之保護,作者發行,民國七十九年十二月。
    7. 馮震宇著,了解智慧財產權,永然文化出版社,民國八十七年四月。
    8. 黃文儀著,申請專利範圍的解釋與專利侵害判斷,三民書局,民國八十三年二月。
    9. 黃文儀著,專利實務,作者發行,民國八十八年三月。
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    13. 劉尚志編,二○○○全國科技法律研討會論文集,國立交通大學,民國八十九年十一月。
    14. 劉尚志編,二○○一 全國科技法律研討會論文集,國立交通大學,民國九十年十一月。
    15. 劉尚志編,二○○二 全國科技法律研討會論文集,國立交通大學,民國九十一年十一月。
    16. 蔡明誠著,發明專利法研究,作者發行,民國八十六年四月。
    17. 謝銘洋著,智慧財產權之制度與實務,作者發行,民國八十四年五月。
    18. 謝銘洋著,智慧財產權之基礎理論,作者發行,民國九十年六月三版。
    (二)期刊論文
    1. 何建志,法務部「複製人相關問題研討」會議評論,生物科技與法律研究通訊,第一期,民國八十八年一月,頁5-6。
    2. 李幸懋,「生物技術相關專利實務 (1), DNA 片段 (ESTs) 專利實務與範例分析」,智慧財產權,第十四期,民國八十九年二月,頁25-33。
    3. 李茂生,遺傳因子、理性與法律,生物科技與法律研究通訊,第九期,民國九○年一月,頁42-46。
    4. 李瑞全,人體基因組計畫之倫理、法律和社會意涵,應用倫理研究通訊,第六期,民國八十七年四月,頁9。
    5. 周志宏,複製人與生物科技之法律規範,月旦法學,第三十五期,民國八十七年四月,頁46-69。
    6. 林子儀,基因資訊與隱私權保障,「基因科技之法律管制體系與社會衝擊研究研討會論文」,民國八十九年三月。
    7. 徐偉群,各國基因治療法律管制介紹,生物科技與法律研究通訊,第四期,民國八十八年十月,頁8-19。
    8. 袁國芳,「基因專利之探討」,菌種保存刊及研究簡訊,第三十六卷,民國八十七年十二月,頁1-6。
    9. 陳文吟,由35 U.S.C.§287(c)之訂定探討人體治療方法之可專利性,智慧財產權,創刊號,民國八十八年一月,頁47-62。
    10. 陳文吟,從美國核准動物專利之影響評估動物專利之利與弊,台大法學論叢,第二十六卷第四期,民國八十六年,頁173-231。
    11. 陳文吟,探討因應醫藥品專利之合理措施,國立中正大學法學集刊,第八期,民國九十一年七月,頁67-112。
    12. 陳文吟,探討修改「進步性」專利要件以因應生物科技發展的必要性--以美國法為主,華岡法粹,第二十七期,民國八十八年十二月,頁271-299。
    13. 程明修,遺傳基因工程之公法規制,全國律師,第二卷第三期,民國八十七年三月,頁27-39。
    14. 黃三榮,基因諮詢、基因檢查與基因診斷實務所涉法律問題,,生物科技與法律研究通訊,第十二期,民國九十年十月,頁25-38。
    15. 黃三榮,論基因治療所涉法律問題,生物醫學報導,第九期,民國九十年九月,頁16-26。
    16. 楊雅雯,複製人類的倫理爭辯與法律管制模式研究,生物科技與法律研究通訊,第七期,民國八十九年七月,頁22-36。
    17. 劉江彬、孫遠釗、耿筠,「美國法院對生物科技發展之專利醫療用產品之非顯著性的見解」,智慧財產權,第二十三期,民國八十九年十一月,頁12-26。
    18. 劉江彬、孫遠釗、耿筠,「美國法院對醫療用生物科技產品專利之可實施性的見解」,智慧財產權,第二十六期,民國九十年二月,頁3-21。
    19. 蔡季廷,基因工程與學術自由之保障,法律學刊,第二十六期,民國八十七年六月,頁99-131。
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    22. 蔡明誠,基因技術與發明專利,生物科技與法律研究通訊,第十一期,民國九十年七月,頁19-42。
    23. 蔡明誠,歐洲發明專利之特色與取得,智慧財產權管理,第十期,民國八十五年七月,頁46-49。
    24. 蔡明誠,談生物科技與法律互動、分工與整合之研究規劃與推動,生物科技與法律研究通訊,第九期,民國九十年一月,頁59-64。
    25. 蔡明誠,談制定基因技術法的意義,生物產業,第十二期第一卷,民國九十年三月,頁45-49。
    26. 蔡達智,基因資訊之隱私權保護,憲政時代,第二十三卷第二期,民國八十七年四月,頁81-95。
    27. 蔡維音,人體基因實驗所涉之法益侵害,生物科技與法律研究通訊,第九期,民國九十年一月,頁28-31。
    28. 鍾方樺,美國生物倫理諮詢委員會複製人報告之摘要,生物科技與法律研究通訊,第一期,民國八十八年一月,頁17-42。
    29. 顏厥安,生物科技之倫理、法律與社會意涵問題簡介,生物科技與法律研究通訊,第二期,民國八十八年四月,頁5-10。
    (三)學位論文
    1. 王凱玲,生物技術發明之專利保護,臺灣大學法律研究所碩士論文,民國八十八年六月。
    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。
    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。
    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。
    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。
    6. 許瑞青,生物技術專利與侵害分析,東吳大學法律研究所碩士論文,民國八十七年七月。
    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。
    (四)官方出版品
    1. 經濟部,2002生物技術產業年鑑,民國九十一年。
    2. 經濟部工業局,2002生物產業白皮書,民國九十一年。
    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)。
    4. 經濟部智慧財產局,專利審查基準彙編, < http://www.tipo.gov.tw/ patent/ patent_ law/patent_law_3.asp> (last updated Mar. 11, 2003)。
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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
    数据类型: thesis
    显示于类别:[法律學系] 學位論文

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