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    題名: CRISPR-Cas9基因編輯技術專利之研究- 以BROAD v. UC-Berkley案為例
    The study of CRISPR-Cas9 gene editing technology patent- A case study of BROAD v. UC-Berkley
    作者: 張博淳
    Chang, Po-Chun
    貢獻者: 馮震宇
    Fong, Jerry G.
    張博淳
    Chang, Po-Chun
    關鍵詞: 基因編輯
    生物技術
    生技產業
    CRISPR-Cas9
    專利衝突
    專利聯盟
    商業模式
    Gene editing
    Biotechnology
    Biotech industry
    CRISPR-Cas9
    Interference proceeding
    Patent pool
    Business model
    日期: 2018
    上傳時間: 2018-08-29 15:56:29 (UTC+8)
    摘要: 隨著近代分子生物學及遺傳工程技術不斷發展，科學界已逐步將基因工程提升到基因編輯技術。基因編輯技術可標靶特定DNA序列，並對序列進行基因的剔除及加入，實現對目標基因進行編輯的目的。在現今三大主流基因編輯技術中，CRISPR-Cas9系統因製作簡單且精準度高，被認為是基因編輯技術中最具潛力的一種，因此學術界及產業界也積極發展相關技術及申請專利。
    本論文介紹基因編輯技術，整理CRISPR-Cas9發展之歷程，歸納此技術與其他技術之差異及優勢，以及最新的產業應用性及市場預測。CRISPR-Cas9專利兩大領頭羊為Jennifer Doudna領軍的UC-Berkley團隊及美國麻省理工學院張鋒領軍的BROAD研究所團隊。UC於2015年向USPTO提出專利衝突程序，主張BROAD專利與其專利有重複之處，並應予以撤銷。PTAB於2017年作出關鍵決定，認定二者專利並不存在衝突，因此張鋒團隊可保有其專利。本論文在美國專利適格性之最新判斷基準下，針對二者專利請求項進行專利適格性之分析，並討論PTAB對於此案新穎性及非顯而易見性之專利要件審理依據。
    PTAB的決定並不代表最終的結果，此案後續發展對於未來學術界乃至於生物技術產業界都有舉足輕重的影響。本論文建議未來應嚴謹審查生物技術專利請求項，免除因訴訟而引發之專利不確定性，延緩產業發展。在商業面上，本論文嘗試整合過去生物技術成功商業化案例關鍵要素及探討BROAD所創建之CRISPR專利聯盟授權模式，以作為此技術未來商業發展及技術推廣之方向。期待CRISPR-Cas9未來進入消費者市場後可提升人類生活品質並創造基因編輯技術之蓬勃發展。
    With the continuous development of modern molecular biology and genetic engineering technology, the scientific community has gradually upgraded genetic engineering to gene editing technology. Gene editing technology can target specific DNA sequences, and achieve the purpose of editing target gene by eliminating and adding genes to the sequence. Among the three current major gene editing technologies, CRISPR-Cas9 system is considered to be the most promising of genetic editing technology because of its simplicity and high precision. Therefore, academics and industry are actively developing related technologies and applying patents.
    This thesis introduces the development and advantages of CRISPR-Cas9 gene editing, as well as its latest industrial applicability and market forecast. The two leading organizations of CRISPR-Cas9 patent are UC-Berkley team led by Jennifer Doudna and BROAD Institute team led by Zhang Feng of the Massachusetts Institute of Technology. In 2015, UC filed an interference proceeding to USPTO, claiming that BROAD’s patent has interfered with UC’s patent and should be revoked. PTAB made a decision in 2017 and concluded that there is no interfernce-in-fact between two patents, so the Zhang Feng team can retain its patents. Under the latest judgment criteria of US patent eligibility, this paper analyzes the patent eligibility of the two patent claims and discusses the basis for PTAB`s patentability of the novelty and non-obviousness of the case.
    The decision of PTAB does not represent the final result. The subsequent development of this case will have a significant impact on the future academic community and even the biotechnology industry. This paper suggests that the biotechnology patent claims should be rigorously reviewed in the future, exempting patent uncertainty caused by litigation and delaying industrial development. On the commercial side, this paper attempts to integrate the key elements of the successful commercialization of biotechnology in the past and discuss the licensing model of CRISPR patent-pool created by BROAD for reference of future business development and technology promotion of this technology. With the future entry of CRISPR-Cas9 to the consumer market, hope it will enhance the quality of human life and create a flourishing development of genetic editing technology.
    參考文獻: 一、中文參考資料
    (一)期刊
    1.尹守信，淺析美國專利法上之新穎性要件，智慧財產權月刊，第78期，頁52-70，2005年6月。
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    4.徐弘光，台灣專利聯盟（Patent Pool）的可行性探討－－以國際產業標準的營運模式為例，政大智慧財產評論，5卷1期，頁65-100，2007年4月。
    (二)書籍
    1.馮震宇，智慧財產權發展趨勢與重要問題研究，2版，2011年1月。
    2.楊智傑，美國專利法與重要判決，2015年10月。
    二、英文參考資料
    (一) Cases
    1.The BROAD Institute, Inc. et al. v. the Regents of the University of California, Patent Interference No. 106,048 (PTAB 2017).
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    (二)書籍
    1.Feldman, Maryann, et al., (2007). Lessons from the Commercialization of the Cohen-Boyer Patents: The Stanford University Licensing Program, Handbook of best practices.
    2.O`Hamilton, Joan (1988). A biotech hit and a bold way to profit from it. Business Week.
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    (三)期刊論文
    1.Baringaga Marcia, Biotech nightmare: does Cetus own PCR? 251 Science 739 (1991).
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    14.Fisken, Jane & Rutherford, Jan, Business models and investment trends in the biotechnology industry in Europe, 8 J. of Comm. Biotechnology 191, 192 (2002).
    15.Fore, Joe et al., The effects of business practices, licensing, and intellectual property on development and dissemination of the polymerase chain reaction: case study, 1 J. Biomed. Discov. Collab. 1 (2006).
    16.Gantz, Valentino M. et al., Highly Efficient Cas9-Mediated Gene Drive for Population Modification of the Malaria Vector Mosquito Anopheles Stephensi, 112 Proc. Natl. Acad. Sci. U S A 6736 (2015).
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    20.Jinek, Martin et al, A Programmable Dual-Rna-Guided DNA Endonuclease in Adaptive Bacterial Immunity, 337 Science 816 (2012).
    21.Kaminski, Rafal et al., Excision of Hiv-1 DNA by Gene Editing: A Proof-of-Concept in Vivo Study, 23 Gene Ther. 690 (2016).
    22.Ku, Deborah (2017). The Patentability of the Crispr-Cas9 Genome Editing Tool, 16 Chi. -Kent J. Intell. Prop. 408.
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    三、網際網路
    1.BROAD Institute, Information about licensing CRISPR genome editing systems, available at https://www.broadinstitute.org/partnerships/office-strategic-alliances-and-partnering/information-about-licensing-crispr-genome-edi (last visited:Jul/10/2018).
    2.ERS Genomics, CRISPR Therapeutics, Intellia Therapeutics, Caribou Biosciences and ERS Genomics announce appellate brief seeking reversal of U.S. Patent Board Decision on CRISPR/Cas9 gene editing, available at http://www.ersgenomics.com/2017-11-22%20UCB%20Brief%20(Public).pdf (last visited: Jan/15/2018).
    3.Forbes, How Much Is a CRISPR Patent License Worth? available at https://www.forbes.com/sites/jacobsherkow/2017/02/21/how-much-is-a-crispr-patent-license-worth/#3e573ae66b77 (last visited: Feb/23/2018).
    4.Global Market Insights Inc., Gene Editing Market size was valued at over USD 2.17 billion in 2015 and will grow at over 14% CAGR from 2016 to 2024, available at https://www.gminsights.com/industry-analysis/gene-editing-market (last visited: Feb/23/2018).
    5.Harvard University, CRISPR: A game-changing genetic engineering technique, available at http://sitn.hms.harvard.edu/flash/2014/crispr-a-game-changing-genetic-engineering-technique/ (last visited:Nov/10/2017).
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    描述: 碩士
    國立政治大學
    法學院碩士在職專班
    103961030
    資料來源: http://thesis.lib.nccu.edu.tw/record/#G0103961030
    資料類型: thesis
    DOI: 10.6814/THE.NCCU.LLME.014.2018.F10
    顯示於類別:[法學院碩士在職專班] 學位論文

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