Please use this identifier to cite or link to this item: http://hdl.handle.net/11455/93301
標題: Study on Patent Eligibility of Gene Invention in U.S. Patent Act
論基因發明在美國專利法上專利標的適格性
作者: 汪天祥
Tien-Hsiang Wang
關鍵字: 基因發明;基因專利;專利標的;專利適格性;美國專利法;gene patent;patentable subject matter;patent eligibility
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摘要: 
自1980美國最高法院判決遺傳工程生物可被專利後,三十年來,基因同樣地被推定是適格專利標的。最近美國最高法院Myriad案判決推翻已建立的生技專利實務,使得生物體內DNA分子序列成為不適格專利標的。
美國最高法院表示:「國會打算讓美國專利法第101條專利標的包括所有凡太陽底下由人類製造的任何事物」,但法院在此條文下,已強加一些法官適用法律的限制,在各個判決中已說明下列事項是不可專利標的:自然法則或科學原則、抽象概念、自然現象或過程和自然產物。法院為了分析方便,時常將所有美國專利法第101條的標的混合一起分析,這是錯誤的,因美國專利法第101條含有兩種形式的原則,具有完全不同的性質。將基因發明分成物之組成和遺傳訊息,能完成更明智分析,物之組成適用自然產物排除之明確界線規則,遺傳訊息是自然法則,需要劃定專利範圍的標準。
本文基於對美國專利法第101條之「新且有用」要件之解釋,建議發明應用檢測方法分析專利標的範圍。

In 1980, the U.S. Supreme Court ruled that engineered organisms could be patented. For 30 years, genes have likewise been presumed to be eligible for patents. Recent Myriad case suggest that the Court may reverse established practice in biotechnology patents, by making DNA molecules whose sequences are found in living organisms ineligible to be patented.
The Supreme Court pronounced that 'Congress intended statutory patentable subject matter to include anything under the sun that is made by man,' but courts have imposed several judge-made restrictions under the rubric of this section. Various decisions have stated that the following are not patentable subject matter: Laws of nature or scientific principles, Abstract ideas, Natural phenomena or processes, and Natural products. Frequently, courts lump together all subject matters of §101 for purposes of analysis. This is a mistake because §101 contain two types of subject matters that differ radically in their qualitative attributes. Once gene inventions have been separated into composition of matter and genetic information, a more intelligent analysis can be made. Composition of matter applies the exclusion of natural products from patentability that are bright-line rules. Genetic information is laws of nature function as standards that delineate patent scope.
This Article proposes the inventive application test for patentable subject matter based on an invigoration of the language 'new and useful' in 35 U.S.C. §101.
URI: http://hdl.handle.net/11455/93301
Rights: 同意授權瀏覽/列印電子全文服務,2014-08-31起公開。
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