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KMID : 0986720160240020141
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Korean Journal of Medicine and Law
2016 Volume.24 No. 2 p.141 ~ p.166
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Patentability on Human Genome Researches(I) : Gene Segment, Genetic Diagnosis, and Somatic Gene Therapy
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Kim So-Yoon
Kim Su-Min
Kim Han-Nah
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Abstract
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This article aims to examine international trend related patentability of human genome researches focusing on gene segment, genetic diagnosis, and somatic gene therapy, and then review the research results. Recently in biotechnology area the patentability of gene segment arouse controversy. Previously patentability of gene segment was rightly acknowledged but with the development of biotechnology, leading by U.S., the gene segment turned out unpatentable, and it affects internationally. To examine this tendency more in-depth, first of all this article introduce the recent research trend of gene segment, genetic diagnosis, and somatic gene therapy. Then researchers investigate each country’s trend of patent system in human genome researches and review the result of analysis. Consequently, each country has slightly different standards in patentability on human gaenome researches. First, the patentability of gene segment’s meaning will be faded by affected the development of biotechnology and sharing international gene database, so our system’s improvement is needed. Second, in case of genetic diagnosis, in U.S., the medical practice is patentable so as to genetic diagnosis, but most countries accept the patentability of genetic diagnosis in the point of in vitro medical devices or non-medical practices, and it is same as in our patent system. Third, every research subject countries classify somatic gene therapy as medicine, therefore it is patentable like existing medicine.
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KEYWORD
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gene segment, genetic diagnosis, and somatic gene therapy, patentability, human genome research
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