論基因專利實務發展及其評析

A Study ＆ Review on the Development of Genetic Patents

基因，是否得為可專利之標的？此為生物技術領域發展下，無可避免的重要議題之一。本文將該議題分四部分討論，綜觀性地探討基因技術發展下專利法制實務的對應與評析。首先回顧歷年與基因可專利性相關之歐盟規定、指令及美國實務判決，觀察歷年對於基因可專利性主流觀點之演變。繼而研析基因的可專利性與生技產業於經濟面上之互動，以及基因在被予以專利時所面臨的挑戰。第三，從基因技術專利化引發之倫理爭議出發，以法律經濟之角度，將基因專利區分成資訊與物質面，探討基因被授予專利時應考量的因素，並評論「人類共同遺產」概念導入基因技術保護之可行性，最後回顧並檢討我國現行專利制度之不足，以期未來建構生物技術產業相關制度時，有更通盤之考量。

Should gene be patentable? Such a question is one of the most im-portant issues in the biotechnology area. This article contemplates the patentability of gene generally by four-part discussions. In this article, we first review the European rules and its Directives and U.S. court de-cisions to construct the previous development in the main stream opin-ion about whether gene is patentable. And then we introduce the rela-tionship between the patentability of gene and its economic impacts on bioindustries. Also, the confronting problems when gene were patenta-ble are elaborated. Furthermore we analyze the patentability of gene by its informative aspect and its material aspect through the law and eco-nomics, specifying the factors that should be considered. Moreover, its ethical issues are discussed. Finally, we review the current domestic pa-tent law, expecting there will be more comprehensive concerns when designing the biotechnology-related patent system in future.