Kējì Fǎxué Pínglùn (Jun 2006)
人類胚胎幹細胞專利與胚胎保護 ― 一部 98/44/EC 指令各自表述 Human Embryonic Stem Cell Patent and Protection of Embryos Controversies Surrounding Directive 98/44/EC
Abstract
許多專家相信，從早期胚胎取得的幹細胞最具彈性，可能導致生物醫學革命，甚至治療許多現今無可救藥的疾病。然而從胚胎取得幹細胞，可能摧毀胚胎。關於胚胎法律與道德地位的爭議，也深深影響著予胚胎幹細胞相關發明的可專利性。歐洲專利公約本即規定，發明之公開或商業利用違反公序良俗者，不與專利。被整合進歐洲專利公約的歐洲生物科技指令更例示，複製人類的方法、改變人類生殖系基因同一性的方法以及為產業或商業目的使用人類胚胎不與發明專利。歐洲專利局與審查與異議部門迄今採取相當嚴格態度，禁止一切與胚胎幹細胞相關的產品與方法專利，德國、英國與瑞士 則在不同程度上容許之。 本文認為，TRIPS 第27 條第2 項規定，生物科技的發明原則上亦具 有可專利性，因此公序良俗條款及其例示規定應從嚴解釋，相關爭議包括EGE 第16 號意見，應由此加以批判性地檢視。 Many experts believe that human embryonic stem cells may lead to medical revolution and treat a lot of hitherto incurable diseases. Since embryos may be destroyed in this process, the controversies over the legal and ethical status of human embryos are extended to, weather inventions involving human embryonic stem cells are patentable. Article 53 (a) EPC excludes the patentability of inventions the publication or exploitation of which would be contrary to “ordre public” or morality. Directive 98/44/EC, integrated into the EPC implementing regulations, illustrates the following examples as not patentable: the processes for cloning human beings; processes for modifying the germ line genetic identity of human beings and uses of human embryos for industrial or commercial purposes. The Examining and Opposition Divisions of EPO exclude from patentability all inventions involving human embryonic stem cells. Since the principal patentability of biotechnological inventions is enshrined in Article 27(2) TRIPS, this essay starts from the strict interpretation of morality clause and its illustrating examples, and critically evaluates the controversies including the EGE opinion No. 16.
