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    Title: 生技製藥產業併購之專利權盡職調查－美國與台灣之發明人適格與專利權歸屬議題
    A Study on Patent Due Diligence during Mergers and Acquisitions in Biopharmaceutical Industry - The Inventorship and Ownership Issues in U.S. and Taiwan
    Authors: 許宏銘
    Hsu, Hung-Ming
    Contributors: 陳桂恒
    Chan, Kwei-Hang
    許宏銘
    Hsu, Hung-Ming
    Keywords: 專利權
    盡職調查
    生技製藥
    發明人適格
    專利權歸屬
    Patent
    Due diligence
    Biopharmaceutical
    Inventorship
    Ownership
    Date: 2018
    Issue Date: 2019-01-04 17:17:20 (UTC+8)
    Abstract: 生技製藥產業為高知識高技術密集的產業，核心技術是一家生技製藥公司的重要資產，其商業活動與專利權的運用息息相關。隨著生技製藥產業的發展，生技製藥公司的併購交易數量與規模亦顯著增加，生技製藥公司藉由併購交易得以快速提升其市場競爭力。對於核心技術的專利權進行盡職調查，當然是生技製藥公司併購活動中重要且必要的程序。
    不論是內部自行研發或與外部機構共同研發產生的專利權，其專利發明人與權利歸屬都是基本且重要的議題。因此對專利權進行盡職調查時，確認專利發明人是否適格以及專利權的歸屬，攸關於日後實施專利權的自由度與營運風險。
    本研究實際調查台灣生技製藥公司發明人的情形，發現其專利發明人為高階經理人（比如公司董事長或總經理）的比例超過32%，較美國公司僅0.02%的比例明顯高出許多；以及透過美國法院的判決，探討專利發明人適格與專利權歸屬發生錯誤時將導致的嚴重結果。因此在專利權的盡職調查時，應確認專利發明人適格與專利權的歸屬是否正確且無瑕疵，同時提出下列四點建議：（1）確實做好專利權歸屬的盡職調查；（2）發明人與專利權歸屬契約的重要；（3）有關專利權歸屬文件的管理要確實；以及（4）儘早採取補救的措施，以供未來台灣生技製藥公司在併購交易時的參考。
    The biopharmaceutical industry is a high-knowledge and high-tech intensive industry. The core technology is an important asset of a biopharmaceutical company. The business of a biopharmaceutical company is closely related to the its patents. With the development of the biopharmaceutical industry, the number and scale of M&A by biopharmaceutical companies have also increased significantly. Biopharmaceutical companies have leveraged their competitiveness through M&A transactions. Patent due diligence on the core technologies is actually an important and necessary process during the biopharmaceutical companies’ M&A.
    Whether a biopharmaceutical company’s patent is developed by R&D internally or corperated with external institutions, the inventorship and ownership are fundamental and important issues. Therefore, when conducting the patent due diligence, confirmation of the inventorship and ownership of the patent is important and related to the freedom and risk of operation in the future.
    This study investigates the inventorship of biopharmaceutical companies in Taiwan and finds that the ratio which the company’s excutive managers, such as Chairman of the board or General Manager, as inventors is higher than 32%. That is significantly higher than the ratio of only 0.02% in US companies. Serious consequences from the inventorship ineligibility or ownership error of the patent are also discussed through the US court judgments. Therefore, in the patent due diligence, it should be confirmed whether the inventorship and ownership of a patent are correct and flawless. At the same time, the following four suggestions are proposed: (1) do the patent due diligence solidly; (2) the contracts relating to a patent’s inventorship and ownership are important; (3) management of the documents relating to a patent’s inventorship and ownership should be solid; and (4) take remedies as soon as possible. Hope it may provide references for biopharmaceutical companies in Taiwan when conducting M&A transactions in the future.
    Reference: 專書
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    05. 謝銘洋. 智慧財產權法. 七版 ed. 台北市: 元照, 2016.
    期刊論文
    01. Adda, C. Gogoris, and J. Clarke Patricia. "Patent Due Diligence in Biotechnology Transactions." Nature Biotechnology 19, no. 2 (2001): 175.
    02. Hantos, Susanne. "Helping Others Acquire, License or Invest in Patents with Confidence – a Guide for Patent Searchers to Patent Due Diligence." World Patent Information 32, no. 3 (2010): 188-97.
    03. Konski, Antoinette F., and Linda X. Wu. "Inventorship and Authorship." Cold Spring Harbor Perspectives in Medicine 5, no. 11 (2015): a020859.
    04. Richman, Barak D., Will Mitchell, Elena Vidal, and Kevin Schulman. "Pharmaceutical M&Amp;a Activity: Effects on Prices, Innovation, and Competition.". Loyola University of Chicago Law Journal 48, no. 3 (2017): 787-819.
    05. Sheldon, Jeffrey G. "Intellectual Property Due Diligence in Acquisitions and Mergers." The Licensing Journal 24, no. 8 (2004): 9-15.
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    07. 王世晞. "製藥產業之演進、現況、與趨勢." 國立臺灣大學, 2004.
    08. 王立達, and 陳師敏. "專利間接侵權之制度規範：我國判決實證研究與法制建議." 科技法學評論 11, no. 2 (2014): 41-86.
    09. 王偉霖. "我國學術機構技術移轉機制實施成效與法律制度之檢討." 科技法學評論 4, no. 2 (2007): 59-96.
    10. 王靖傑. "企業策略與國家文化對跨國購併之影響 : 以鴻海購併夏普為例." 國立政治大學, 2016.
    11. 王碩汶. "專利稽核之研究." 世新大學, 2008.
    12. 江雅鈴. "從生技新藥產業觀點探討大學之智慧財產管理." 國立政治大學, 2008.
    13. 吳東哲. "藥品的核准前專利爭端解決程序－ 美國專利連結為借鏡." 碩士論文--國立政治大學法律科際整合研究所104., 2016.
    14. 呂明美. "企業策略性併購之法律分析及個案研究." 國立臺灣科技大學, 2012.
    15. 宋皇志. "專利交易之交易風險及其控管策略." 科技管理學刊 20, no. 4 (2015): 1-27.
    16. 侯旻伸. "企業併購中法律盡職調查之目的及其範圍." 國立臺北大學, 2014.
    17. 洪子秋. "生技製藥產業之技術商品化研究--由法規政策面分析." 國立政治大學, 2010.
    18. 范文昇. "論美國專利法及拜杜法案對生技產業發展之影響―兼論我國專利法及科學技術基本法." 東吳大學, 2006.
    19. 康琦. "論大學之科技研發成果與智慧財產權之運用—以專利管理為核心之探討." 國立東華大學, 2006.
    20. 郭靜芬. "從國際生技製藥業併購趨勢看台灣生技公司被併購價值." 國立臺灣大學, 2017.
    21. 陳則銘. "企業併購之相關智慧財產管理策略與法律規劃研究－以併購美國高科技公司時之專利查核評估探微." 國立政治大學, 2004.
    22. 陳斌. "美國專利法第271條(G)項「方法專利侵權」之研究." 國立交通大學, 2004.
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    25. 楊智傑. "反省美國拜杜法的理論與經驗." 科技法學評論 6, no. 1 (2009): 207-40.
    26. 葉雲卿. "學研機構專利權共有型態與專利權歸屬之研究." 智慧財產評論 15, no. 1 (2018): 1-68.
    27. 劉振泰, 蔡岳勳. "從美國專利改革法案看美國專利法新穎性要件之變革." 智慧財產評論 13, no. 1 (2015): 119-65.
    28. 蔡佳臻. "企業併購中智慧財產權相關問題之研究─以專利與品牌為中心." 世新大學, 2010.
    29. 蔣瑞琴. "美國專利侵權訴訟之證據能力與舉證責任." 國立交通大學, 2005.
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    產業研究報告
    01. EvaluatePharma, "World Preview 2017, Outlook to 2022" (2017, Jun).
    02. Igeahub, "TOP 10 Pharmaceutical Companies 2018" (2018).
    03. J.P.Morgan, "2018 Global M&A Outlook" (2018).
    04. QuintilesIMS Institute, "Outlook for Global Medicines through 2021" (2016).
    05. The Pharmaceutical Research and Manufacturers of America, "Biopharmaceutical research industry profile 2016" (2017).
    06. 中華民國經濟部工業局, "2017生技產業白皮書" (2017).
    07. 中華民國經濟部工業局, "2018生技產業白皮書" (2018).

    法院判決
    01. 131 S. Ct. 2188 (2011).
    02. 303 F.R.D. 254 (W.D.Pa. 2014).
    03. 443 F. Supp. 2d 570 (S.D.N.Y. 2006).
    04. 447 US 303 (1980).
    05. 487 F. Supp. 2d 1099, 1117-19 (N.D. Cal., 2007).
    06. 583 F.3d 832, 841-842(Fed. Cir., 2009).
    07. 838 F.3d 1283 (Fed. Cir. 2016)
    08. 智慧財產法院98年度民專更（ㄧ）字第1號民事判決。
    09. 智慧財產法院101年度民專訴字第100號。
    10. 最高法院104年度台上字第2077號民事裁定。
    網路資料
    01. Drug Behemoth Novartis Simultaneously Announces Three Huge Deals. 來源：http://www.businessinsider.com/r-novartis-exchanges-assets-with-glaxosmithkline-2014-22, (最後瀏覽日：2018.11.25.)
    02. FDA, "Approved Risk Evaluation and Mitigation Strategies (REMS)" 來源: https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm （最後瀏覽日:2018.11.25）
    03. FDA, "Developing Products for Rare Diseases & Conditions”, 來源: https://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/default.htm （最後瀏覽日: 2018.11.25）
    04. Gilead bets $11 billion on hepatitis in Pharmasset deal. 來源：https://www.reuters.com/article/us-gilead-pharmasset-idUSTRE7AK0XU20111121, (最後瀏覽日：2018.11.25.)
    05. Pfizer, Allergan scrap $160 billion deal after U.S. tax rule change. 來源：https://www.reuters.com/article/us-allergan-m-a-pfizer-idUSKCN0X3188, (最後瀏覽日：2018.11.25.)
    06. 林孝樺, "專利懸崖對藥廠R&D的影響", (2015). 來源：http://www.phycos.com.tw/articles/162, (最後瀏覽日：2018.11.25).
    Description: 碩士
    國立政治大學
    科技管理與智慧財產研究所
    105364209
    Source URI: http://thesis.lib.nccu.edu.tw/record/#G0105364209
    Data Type: thesis
    DOI: 10.6814/THE.NCCU.TIIPM.033.2018.F08
    Appears in Collections:[Graduate Institute of TIPM] Theses

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