「歐盟生物科技專利指令」的可專利性之禁止範圍

The Prohibition on the Patentability of「Directive 98/44/EC on the Legal Protection of Biotechnological Inventions」

王服清(Fu-Ching Wang) ； 林忠亮(Chung-Liang Lin)

《真理財經法學》 1期 (2008/09) Pp. 20-57

摘要

「歐盟生物科技發明的法律保護之指令」（Richtlinie 98/44/EC des Europäischen Parlaments und des Rates vom 6. Juli 1998 über den rechtlichen Schutz biotechnologischer Erfindungen）簡稱為：「歐盟生物科技專利指令」（Biopatent-Richtlinie）。該指令是有關生物科技發明的智慧財產保護以及倫理議題，目前世界上重要有體系的詳細成文法，且為各個歐盟成員國樹立起內國之立法典範，我國專利法精神也大部源自於此。依據該指令之重要規定，列舉計有以下禁止授予專利的範圍：壹、第4條第1項：「1、植、動物的品種。2、培育植、動物的主要生物學方法」；貳、第5條第1項：「人體形成和發展的不同階段之身體以及人體的成分（包括基因序列或基因部分序列）之單純發現」；參、第6條第1項：「發明的產業開發使用違反公共秩序或善良風俗者。」；肆、第6條第2項：「1、複製人類的方法。2、人類生殖細胞發展過程的基因身份的變更之方法。3、使用人類的胚胎以為工業或產業之目的。4、動物基因身份的變更之方法，而此方法是無重要醫藥的用處而可能會導致人類或動物的痛苦。藉由上述指稱的方法所生產的動物，亦同」。本論文針對上述之可專利性禁止範圍逐一予以詳細探討，且提出吾人之建言，冀望有助於我國產、官、研、學術等機構對於決定生物科技是否授予其專利之理解與參考。

關鍵字

歐盟指令98/44/EC ； 生物科技發明 ； 可專利性 ； 禁止

並列摘要

「Directive 98/44/EC on the legal protection of biotechnological inventions」 (Richtlinie 98/44/EC des Europäischen Parlaments und des Rates vom 6. Juli 1998 über den rechtlichen Schutz biotechnologischer Erfindungen, Biopatent-Directive) is now the only statute of European Union protecting the intellectual property and legislating particularly and solely on ethical issue regarding to biotechnological inventions on earth; it builds the legislative model for the protection of the intellectual property on biotechnology. According to the Biopatent-Directive, the following shall not be patentable: first, Article 4.1: 「(a) plant and animal varieties; (b) essentially biological processes for the production of plants or animals」; second, Article 5.1: 「The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene」; third, Article 6.1: 「Inventions shall be considered unpatentable while their commercial exploitation would be contrary to ordre public or morality」; forth, Article 6.2: 「(a) processes for cloning human beings; (b) processes for modifying the germ line genetic identity of human beings; (c) uses of human embryos for industrial or commercial purposes; (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to men or animals, and also animals resulting from such processes」. By analyzing and studying the above unpatentability, we suggest some propositions in this paper. This paper feasibility studies not only to contribute to the understanding of it to our industry, government and research institution but also to provide the patentability of biotechnological inventions.

並列關鍵字

Directive 98/44/EC ； Biotechnological Inventions ； Patentability ； Prohibition