Study on Patent Eligibility of Gene Invention in U.S. Patent Act

• Main Authors: Tien-Hsiang Wang, 汪天祥
• Other Authors: 林昱梅
• Format: Others
• Language: zh-TW
• Published: 2014
• Online Access: http://ndltd.ncl.edu.tw/handle/48080646237629247610

碩士 === 國立中興大學 === 法律學系碩士在職專班 === 102 === 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.