人類胚胎幹細胞研究之法律管制及發明之專利保護

Abstract

「幹細胞」為具有自我更新並分化為其他種類細胞或組織的能力，在新藥開發、重大疾病治療及未來再生醫療發展上扮演舉足輕重的角色。在幹細胞中最具倫理爭議者則屬胚胎幹細胞，原因在於要取得胚胎幹細胞必須對胚胎進行破壞。然而胚胎幹細胞技術的發展為世界必然趨勢，如何對人類胚胎幹細胞研究進行有效管制，且不致對技術發展產生阻遏效應，正考驗各國及我國政府的政策與智慧。 本論文先由人類胚胎幹細胞研究之合法性出發，在參酌國外之立法例及對當前我國相關法規範之檢討後，探究利用胚胎進行研究及提供胚胎法律保護之正當性，並提出對人類胚胎幹細胞研究是否予以法律管制及如何管制之法制建議。其次，在確定人類胚胎幹細胞研究的合法前提下，進行其可專利性的探討，即討論牽涉人類胚胎使用之人類胚胎幹細胞研究的發明，在通過可專利性要件的審核下，是否應予專利保護。若僅因該技術建立涉及對胚胎的破壞，有違公序良俗規定而不予專利保護，此限制規定之正當性亦為本文關心的議題之一。本研究進一步討論在授予人類胚胎幹細胞研究發明專利保護同時，對於尚在發展與建立初期之人類胚胎幹細胞研究，應如何藉由既有之專利產權規則防止專利範圍的過度擴張，而避免對後續創新技術發展產生阻礙。最後，如何避免反共用悲劇發生及促進人類胚胎幹細胞研究資源共享，則為本文對人類胚胎幹細胞研究發明專利實施時著重的課題。

“Stem cell“ is referred to possess the capacity to self-renew and to differentiate into mature cells of different body tissues, playing very important roles on new drug discovery, incurable disease treatment and development of regenerative medicine in the future. The most ethics dispute of stem cells belongs to embryonic stem cells, the reason lies in obtaining embryonic stem cells has to destroy the embryos. However, the development of embryonic stem cell technology is an inexorable trend in the world nowadays. How to manage effectively and not to produce the obstruct effects in human embryonic stem cell research are testing the policy and intelligence of the governments of various countries and our country. The present thesis was set out by the legitimacy of human embryonic stem cell research firstly. After deliberating the foreign legislation and reviewing the present relevant laws of our country, the validity of utilizing embryos to carry on researches and offering embryos legal protection was explored. Moreover, the issues of whether to enact a law to regulate human embryonic stem cell research or not and to propose the legislative suggestions about the research were addressed. Secondly, patentability issue of the results related to human embryonic stem cell research was discussed under confirming the legal prerequisite of human embryonic stem cell research. Whether the invention of embryonic stem cell research concerning the utilization of human embryos can be granted a patent protection after passing through the verification of patentability was discussed, too. If a patent protection of embryonic stem cell technology is denied only because the establishment of embryonic stem cell technology involves destruction of embryos that is to violate the “ordre public” or morality. The validity of such restriction is one of the issues that this study cared about. Following, the present thesis discussed the issues of when the patent protection of human embryonic stem cell research can be authorized, how to prevent the excessive expansion of the patent extent with the patent property rule that has already set up and to avoid hindering the continuing development of innovative technology concerning human embryonic stem cell research which is on the initial stage of developing and establishing. Finally, how to avoid occurrence of tragedy of the anticommons and promote the resource-sharing of human embryonic stem cell research while implementing the patent right of human embryonic stem cell is another topic of this thesis focused on.