癌症基因治療相關發明專利之研究

A Study on Patent of Cancer Gene Therapy

何叔孋(Su-Li Her)

指導教授 ： 謝銘洋

國立臺灣大學/法律學院/法律學研究所/碩士(2009年)

https://doi.org/10.6342/NTU.2009.10408

摘要

基因治療在現代醫療領域中扮演重要的角色，藉由基因篩檢、基因檢驗與治療等生物技術，大大填補了傳統醫療方法裡不足的部分。尤其是癌症基因治療，為病患及家屬帶來無限的希望。然而開放的法律規範可以鼓勵國內基因科技的研究並提升該國經濟發展，但也可能衍生許多問題。
本論文介紹基因治療科技的現階段技術狀況、癌症基因治療方法，分析我國關於癌症基因治療的進展和現況，再探討我國對於基因治療議題的立法動向，進而提出檢討與修正建議。全文架構分為七個章節：
第一章為前言，旨在敘述引發本文撰寫動機的問題意識，對於論文所涵蓋內容作一概要說明。
第二章在於釐清基因治療之概念，並介紹基因治療之發展歷程、方法以及介紹基因治療載體，同時對於基因治療未來發展趨勢作一闡述。
第三章旨在介紹癌症基因治療之發展，討論我國癌症基因治療之臨床現況、探討藥物基因體學；第四章探討基因治療之專利法規範，對於基因技術專利保護爭議加以討論，並提出我國可參考之方向。
第五章探討癌症基因診療方法專利保護，分別就診斷方法以及載體加以討論；第六章對於基因治療專利權限制，學者提出之看法予以分析說明；第七章則闡述我國在癌症基因治療方面可能在國際上占有之優勢，期能作為我國未來制定或修正基因治療相關規範之參考。

關鍵字

基因 ； 基因治療 ； 癌症 ； 癌症基因治療 ； 藥物基因體學 ； 授權 ； 免責

並列摘要

Gene Therapy plays an important role in the modern medical treatment field. Through the utilizing genetic testing and Gene Therapy, the deficiencies of traditional medical treatment could be made up. Furthermore, Cancer Gene Therapy brings unlimited hope to the patients and their family. However an open-minded regulation can encourage related research achievement and domestic economy; as well as the same regulation could be abused and lead to many other issues.
The fundamental research base is built on scientific research development and the method of Cancer Gene Therapy and I intend to analyze the current regulation status of our country in the subject of Cancer Gene Therapy, and to explore the legal direction in our county for the Gene Therapy subject. Last but not least, I will raise the argument of the appropriateness of the issue above. This thesis is consisted of seven chapters as follows:
Chapter one is the preface, it describes the incentives and brief outlines the scope of this thesis and realms of the research for following chapters.
Chapter two is to illustrate the conception of Gene Therapy and to introduce the history, the methods and the vectors for Gene Therapy. In addition, this part focuses on introduction of the tendency for Gene Therapy.
Chapter three is to introduce the development of Cancer Gene Therapy, its clinical actualities and to confer the issue of Pharmacogenomics. Chapter four is to emphasize the laws and regulations of Gene Therapy and to analyze the contention of gene technical patents, afterward demonstrate the suggestions for our country.
Chapter five is to discuss the diagnosis methods for Cancer Gene Therapy, the discussions will refer to the diagnosis methods and the vectors of Cancer Gene Therapy. Chapter six is to illustrate and analyze the restrictions for Gene Therapy patents and concerned opinions from the scholars. And the chapter seven is to expound the advantageous position in Cancer Gene Therapy that we may have .As stated in the thesis, we expect the suggestions and ideas are able to be adopted as reference for the establishment or modification of Gene Therapy regulation frameworks in the future.

並列關鍵字

gene ； gene therapy ； cancer ； cancer gene therapy ； Pharmacogenomics ； licensing ； exemption

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