再生醫療相關發明之專利適格性探討【本期企劃】 試閱
Patent Eligibility Issues in Regenerative Medicine Related Inventions
再生醫療相關發明，尤其是涉及人體胚胎幹細胞相關發明，其專利適格性判斷標準，各國規定不一。美國審查重點在於確認申請專利標的是否為自然產物本身，歐盟生物科技保護指令第6條第2項則明文排除「應用人類胚胎於產業或商業上利用」相關發明於專利保護客體之外，我國專利法亦定有發明定義與法定不予專利客體。本文比較美國、歐盟與我國法就再生醫療相關發明專利適格性判斷標準，提出觀察與研究心得。
The tests for determining patent eligibility of regenerative medicine related inventions, particularly research using human embryonic stem cells, differ across the nations. This article compares the patent eligibility standards adopted in the U.S., the E.U., and Taiwan and offers observations as a conclusion. The U.S. excludes natural products as patent-eligible subject matter. At the same time, the E.U. Biotechnology Directive stipulates that the uses of human embryos for industrial or commercial purposes are excluded from patent protection. Taiwan Patent Act also provides definitions of an invention and statutory subject matter bar.
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