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National Chung Hsing University Institutional Repository - NCHUIR > 法政學院 > 法律學系 > 依資料類型分類 > 碩博士論文 >  人類胚胎幹細胞相關發明之專利分析與法制比較

Please use this identifier to cite or link to this item: http://nchuir.lib.nchu.edu.tw/handle/309270000/104715

標題: 人類胚胎幹細胞相關發明之專利分析與法制比較
Patent Analysis and Legal Comparative on Human Embryonic Stem Cell Related Invention
作者: 陳致浤
Chen, Chih-Hung
Contributors: 陳省三;王服清
許舜喨
中興大學
關鍵字: 人類胚胎幹細胞;幹細胞專利;專利檢索;專利分析;專利保護範圍;研究管制規範
human embryonic stem cel;stem cell patent;patent search;patent analysis;patent protection scope;research regulation
日期: 2010
Issue Date: 2012-09-04 13:55:54 (UTC+8)
Publisher: 科技法律研究所
摘要: 人類胚胎幹細胞研究之發展,近年來已經引起許多法律方面之關注,其中有關人類胚胎幹細胞研究與專利法間之議題有其特殊的重要性,本研究嘗試從人類胚胎幹細胞研究與專利保護之間的法律政策進行探討。
首先利用幹細胞專利檢索和分析探討目前幹細胞研究之趨勢,並且瞭解各國幹細胞研究與發展狀況,進一步比較並歸納先進國家對於人類胚胎幹細胞研究之立法模式與規範特色。研究結果顯示,幹細胞專利件數從2001年開始大量成長,2004年進入技術成熟期,而幹細胞技術最重要的應用領域在於醫療用醫藥配製品、幹細胞培養、保存以及培養基的相關試劑等領域。基於幹細胞專利的檢索和分析結果,本研究進一步比較美國、歐盟、英國、德國、日本和南韓之幹細胞研究規範與專利保護範圍,發現除了美國對於人類胚胎幹細胞研究管制規範和專利範圍採取寬鬆態度之外,其他國家均採取嚴謹的規範態度。相較之下,我國目前對於人類胚胎幹細胞研究的法律規範可以說是付之闕如。並且在幹細胞專利保護方面,本次對於生物相關發明審查基準之修正,仍有與專利法之立法目的衝突、片面立法以及與本次修法目的顯有矛盾等缺失,相較其他國家之專利審查基準,對於幹細胞新興技術的說明也顯得不足。
據此,本研究建議我國應優先建制人類胚胎幹細胞研究管制規範,並以法律明訂違法使用人類胚胎之情況或不予專利之人類胚胎幹細胞發明態樣,另一方面配合幹細胞技術的應用趨勢,對於幹細胞相關的細胞療法、基因療法以及幹細胞特性檢測等潛在發展領域進行相關規範之增修,並且針對幹細胞產業設立研究基金、擬定獎勵研究或優惠投資方案,以達到促進幹細胞產業發展之政策目的。
The research for the development of human embryonic stem cells has triggered many legal issues recently. Therefore, the issues about human embryonic stem cell research and patent law are of special importance. This research tried to discuss such issues from the perspective of legal policy on human embryonic stem cell research and patent protection.
Firstly, a comprehensive stem cell patent search and analysis was carried out to identify the trend and current status of stem cell research. Furthermore, comparison of the regulations of human embryonic stem cell research and patent protection of leading countries were made to examine the characteristics of them. The results showed that the number of stem cell patents grew significantly in 2001 and reached technical maturity in 2004. The most important areas of stem cell applications fell into medicinal preparations, stem cell preparations and culture media. Based on our results of stem cell patent search and analysis, this research compared the stem cell research regulations and patent protection scopes among the United States, European Community, the United Kingdom, Germany, Japan and the South Korea. We discovered that all the countries took a strict legal construction except the United States. Compared with them, the legal regulation on human embryonic stem cell research in Taiwan is almost nonexistent. In addition, the amendment of examination guideline of biotechnology inventions in Taiwan has problems such as in conflict with the principle of patent law and insufficient explanation of new technology of stem cell research.
Because of this situation, we suggested that the construction of human embryonic stem cell research regulations in Taiwan should be of first priority and illegal use of human embryo or unpatentable types of human embryonic stem cell inventions should be regulated by law. Moreover, following the trend of stem cell technology, the regulation of cell therapy, gene therapy and analysis or diagnostic technologies related to stem cells should be amended to support stem cell research and research foundation, research awards or preference of business investment should be established to improve development of stem cell industry in Taiwan.
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