生物信息產業之法律與策略問題分析 —個案研究與對台灣之啟示

Abstract

美國歐巴馬總統在2015年發表精準醫學起始宣告 (the Precision Medicine Initiative)，以促進人類健康及疾病治療。美國此份精準醫學宣告已經加速生化醫學的研究，提供醫師更新的工具丶知識及治療方法; 精準醫學其實就是生物信息科技的應用之一。生物信息產業已經成為當紅且有前途值得投入研發及資金的領域。有人預估生物信息產業的產值在2020年會高達130億美元。 本篇碩士論文先簡短描述生物信息產業的現況，特別就生物資料庫(biobank)丶電腦科技幫助解讀及演譯巨量生物資料丶資訊技術在生物科技的應用及基因檢測產業。本論文接續探討生物信息產業衍生出的法律議題，例如基因是否可取得專利及人類基因資料儲存於生物資料庫或在接受基因檢測之後衍生出的隱私權問題。 最後，本論文藉由研究二家美國生物信息的上市公司Illumina 及Sequenom，試圖擷取生物信息公司成功經營的秘笈，俾便對臺灣的生物信息公司有所助益!

President Obama of the USA in 2015 announced the Precision Medicine Initiative to improve human beings’ health and treat disease. The USA Precision Medicine Initiative, which is part of bioinformatics industry, accelerates biomedical discoveries and provides medical doctors with new tools, knowledge and therapies to select much better treatments. Bioinformatics industry has becoming one of the booming and promising new fields for further research, development and investment. And the bioinformatics market is estimated to have revenue at around US$ 13 billion in 2020. This master thesis will highlight the current bioinformatics market situation briefly, in particular for biobanks, dry lab technologies, the application of information technology in biotechnology, and the genetic testing industry. This master thesis will also tackle the related legal issues of patentability for gene patents and the privacy concerns while storing patients’ genetic information at biobanks or receiving genetic testing. Lastly, by means of case studies of two publicly traded bioinformatics companies - Illumina and Sequenom in the USA, this thesis tries to glean some information and factors, and implication for Taiwanese bioinformatics companies so as to come up with better plans for their bioinformatics business.