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研究生:江雅鈴
研究生(外文):Chiang, Ya Lin
論文名稱:從生技新藥產業觀點探討大學之智慧財產管理
論文名稱(外文):The intellectual property management of university in biotech and new drug development industry
指導教授:劉江彬劉江彬引用關係陳桂恆
學位類別:碩士
校院名稱:國立政治大學
系所名稱:智慧財產研究所
學門:商業及管理學門
學類:其他商業及管理學類
論文種類:學術論文
論文出版年:2008
畢業學年度:97
語文別:中文
論文頁數:130
中文關鍵詞:生物技術新藥產學合作智慧財產管理
外文關鍵詞:biotechnologynew druguniversity-industry cooperationintellectual property management
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生技新藥產業是指使用於人類及動植物用之新藥及高風險醫療器材之產業。而生技新藥產業與醫藥產業,在目的上均與人類及動植物用藥或醫療儀器相關;差異之處在於目前的生技醫藥產業相較於20餘年前的醫藥產業,多了生物技術的應用,產業結構由大型藥廠垂直整合演變為非營利組織、生物技術公司、大型藥廠分工的形態。總結來說,生物技術是生技新藥產業的重要組成要素,而生物技術的興起,則改變了過去醫藥產業產品與技術的組成,也改變了產業結構。
生物技術產業或醫藥產業是全球各國競相發展的產業類別,我國亦不例外;其中,美國無論於生物技術或醫藥產業的發展,均居於全球領先的地位,其成功必然有可以提供我們討論或學習之處。而在知識價值鏈的體系中,美國大學更扮演著提供創新以及產學合作的重要角色,對於全球生技新藥產業的進步有重要的貢獻。從而本研究以美國為標的,研究產業的發展歷程,並進一步以產業之觀點,探討大學產學合作的模式以及智慧財產管理,希望能供我國大學與產業實務發展的參考。
從美國生物技術與醫藥產業發展的歷史與經驗,本研究歸納出生物技術產業興起的因素,與1980年代發生的基礎科學上的突破性發展、拜杜法案的通過、專利法將生物技術的發明納入保護範圍,三項因素有關。另外,由大學所提供的創新,透過密切的產學合作、授權與技術移轉、企業間的策略聯盟等方式,於知識的價值鏈中流動並增加價值,而大學提供創新的人才,往往也是創業者和重要的經營者。
本研究認為,美國大學對生物技術發展具有重要性的貢獻,其中,大學內部創業與大學智慧財產的管理特別值得討論。在大學內部創業方面,美國大學不但鼓勵創業,並制定股權政策,允許新創公司以股權取代部分的授權報酬,給予新創公司實際的協助。透過限制大學持股比例與禁止大學擔任董事或參與董事投票活動之原則,則可兼顧大學避免利益衝突與公司專業經營的需求。
在大學智慧財產管理的部份,本研究認為加州大學系統的智慧財產管理方式,採用網路式的授權與技術移轉組織,將各校區共同的需求如政策、法務、資訊技術與通訊等活動統籌處理,而將需與發明人和企業密切交流的活動如授權與技術移轉的活動交由各校區的授權與技術移轉中心負責。透過此種統籌與分工管理的方式,能夠兼顧減少營運成本與增加授權效率的功能。
經由本研究節果,建議我國的大學可採用網路式的授權與技術移轉組織之概念,除各校之授權與技轉中心外,聯合設一統籌政策、法務、智慧財產資料庫之管理機構,並對大學持有公司股份、鼓勵創業、避免利益迴避等議題制定一致的政策,方能有效利用資源並發揮大學創新的價值。
Biotech and new drug development industry are targeted toward the development of drugs for human, animal, or plant use. This also includes the high-risk industry in medical devices. Although the pharmaceutical industry shares common objectives, the biotech and new drug industry emphasizes on applications in biotechnology and its industrial structure is composed by non-profit organizations and biotech dedicated firms. While biotechnology forms the basis to the biotech and new drug industry, the improvement of biotechnology also changed the interaction between the pharmaceutical products and technologies as well as its industrial structure.
Biotechnology and pharmaceutical industry have received considerable attention around the world, including Taiwan. Since U.S. has been the leading country in the development of biotechnology and pharmaceutical industry, we can surely learn from its success. In particular, universities in the U.S. have played a crucial role in providing innovation and promoting university-industry cooperation and resulted in significant contributions to the progress of global biotech and new drug industry. Thus, this study will investigate the development of the industry within the U.S. by dissecting the various university-industry cooperation models and the management of intellectual property rights. Results from this study will hopefully shed some light on bridging our university with industry for further practice operation.
By examining the U.S. biotech and pharmaceutical industry, this study has concluded that breakthroughs in fundamental, the passage of Bayh-Dole Act, and the inclusion of biotechnology into patent law science in 1980s are responsible for the rise of biotechnology industry. In addition, active university-industry cooperation along with licensing, technology transfer, strategic alliance among enterprises and information flowing in the knowledge value chain added the value of the innovation provided by universities. In many cases, the university has not only provided innovation, but also a source for future leaders that would take on role of the founders or head of project management.
The U.S. universities have made significant contributions to the development of biotechnology by establishing entrepreneurship programs, intellectual property rights management, and often providing substantial assistance in business start-up. One type of assistance is rendered through regulating policies on equity that allows start-up companies to provide equity in place of part of license fee. In order to avoid a “conflict of interest”, universities should be limited of their possession of industry equity, which can prevents them from taking part in the company as the board director or members.
In terms of the management of intellectual property rights, the measures of management of the University of California system can help diminish operation cost and enhance licensing efficiency. University of California system resorts to Technology transfer in a distributed institutional network that feed the common needs from each campus such as patent policies, general counsel, and information technology and communications. A licensing and technology transfer center (OTT) on each campus will follow a system wide license and technology transfer process between the inventor and the enterprise.
In conclusion, it is recommended that our university could adopt the concept of network licensing and technology transfer. Through an overall arrangement, a management institute can be established to regulate the planning of policies, provide general counseling, and build a database of intellectual property rights aside from the existing licensing and technology center of each university. In the best interest of the developing biotech and new drug industry, universities should initiate policies with regard to equity holding limitation, encouragement of start-up business, and the avoidance in the “conflict of interest” so the industry may effectively utilize university resources and demonstrate its innovative values.
第一章 緒論
第一節 研究動機與目的…………………………………………1
第二節 研究範圍…………………………………………………3
第三節 章節安排…………………………………………………7
第二章 文獻探討
第一節 生物技術產業之範疇與產業特性……………… …… 8
第二節 醫藥產業簡介……………………………………………10
第三節 生物技術對醫藥產業的影響……………………………14
第四節 政策與專利法對生技新藥產業的影響……… … ……25
第五節 小結……………………………………………….… 28
第三章 生技新藥產業之研發與智慧財產議題
第一節 智慧財產類別……………………………………………31
第二節 生技新藥產業的研發投入………………………………38
第三節 生技新藥產業的價值創造………………………………45
第四節 生技新藥產業的合作模式………………………………48
第五節 智慧財產議題……………………………………………61
第四章 產學合作與智慧財產管理
第一節 產學合作的定義與重要性………………………. ……63
第二節 合作研發模式……………………………… ……… …67
第三節 合約與權利金結構………………………………… … 71
第四節 權利保留條款………………………………………… 76
第五節 研究工具的專利與授權…………………………………79
第五章 個案研究-加州大學之產學合作與智慧財產管理
第一節 加州大學簡介……………………………………………85
第二節 技術移轉機構的組織與分工……………………………87
第三節 智慧財產權的歸屬與管理………………………………95
第四節 產學合作績效………………………………………… 112
第六章 結論與建議
第一節 結論…………………………………………………… 118
第二節 建議…………………………………………………… 121
參考文獻……………………………………………..……………125


圖目錄

【圖2-1】生物技術的跨領域特質- 以生物製藥為例
【圖2-2】製藥產業的產業結構
【圖2-3】新藥開發程序
【圖2-4】美國醫療產業的價值鏈
【圖2-5】1970-2002年,美國藥物研發之趨勢
【圖3-1】全球健康領域之研發支出
【圖3-2】生技新藥公司的合作模式
【圖3-3】1997年至2006年授權交易趨勢
【圖3-4】發展階段與交易價值
【圖4-1】新成立公司之模式
【圖4-2】已成立公司之模式
【圖4-3】物質移轉合約模式
【圖5-1】加州大學系統技術移轉辦公室組織圖
【圖5-2】UCSD校區TechTIPS組織圖
壹、中文部份
01.「2002年生技產業白皮書」,經濟部工業局出版,2003年。
02.吳豐祥,「產學合作創新與其相關政策之探討」,科技發展政策報導,2000。
03.李秋緯,「我國產學合作的影響因素之實證研究」,政治大學科技管理研究所,碩士論文,2003年。
04.巫文玲,朱兆文,「台灣製藥產業」(1998/1999),生物技術開發中心,1999年。
05.胡舜文,「以『哈佛鼠』為核心論基因轉殖動物之可專利性及其產業利用」,國立清華大學科技法律研究所,碩士論文,2005年。
06.陳則銘,「企業併購之相關智慧財產管理策略與法律規畫研究-以併購美國高科技公司時之專利查核評估探微」,政治大學智慧財產研究所,碩士論文,2004年。
07.陳文吟,「由美國專利實務探討專利侵害之實驗免責」,台北大學法學論叢,64期,2007年。
08.法蘭秀斯.西蒙,飛利浦.柯特勒著,李振昌譯,「打造全球生技品牌」,天下遠見,2005年。
09.張可盈,印永翔,「高科技產業『策略聯盟』之探討-生物技術產業之實證應用」,經濟研究 (Taipei Economic Inquiry),40:1,2004年。
10.劉江彬,黃俊英,「智慧財產管理總論」,華泰書局,2004年。
11.劉錦龍(1983),「國內企業與學術研究機構合作模式之研究」,崇徳工業發展基金會,1983年。

貳、英文部份
一、書籍
01.National Research Council , Case Studies, Intellectual Property Rights and Research Tools in Molecular Biology , National Academy Press, 1997. [available at:http://books.nap.edu/readingroom/books/property/]
02.Lawton R. Burns, The Business of Healthcare Innovation, Cambridge University Press, 2005.
03.MIHR and PIPRA, Intellectual Property Management in Health and Agricultural Innovation︰A Handbook of Best Practice, MIHR︰Oxford, U.K., and PIPRA: Davis, U.S.A., 2007.
04.Michael J. Malinowski, Biotechnology:Law, Business, and Regulation, ASPEN Law & Business, A Division of Aspen Publishers, Inc., 2001.
05.Stuart J. Pocok, Clinical Trials – A Practical Approach, John Wiley & Sons Ltd, 1983.

二、期刊文章
01.Alan B. Bennett and Michael Carriere , “Technology Transfer at the University of California”, In Intellectual Property Management in Health and Agriculture Innovation:A Handbook of Best Practices, 2007.
02.Alan B. Bennett,“Reservation of Rights for Humanitarian Uses”, In Intellectual Property Management in Health and Agriculture Innovation:A Handbook of Best Practices , 2007.
03.Amanda L. Brewster, Audrey R. Chapman, Stephen A. Hansen, “Facilitating Humanitarian Access to Pharmaceutical and Agricultural Innovation”, Innovation Strategy Today, 1(3):pp. 203~216, 2003.
04.Carrie Conway, “The Pros and Cons of Pharmaceutical Patents”, Regional Review, Federal Reserve Bank of Boston, pp.10~p.18, 2003.
05.Christopher P. Adams and Van V. Brantner, “Estimating the Costs of New Drug Development: Is it Really $802m? ”, Federal Trade Commission, 2004.
06.Edwin Mansfield, “Patents and Innovation: An Empirical Study”, Management Science, pp. 173~181, 1986.
07.Iain Cockburn, “The Changing Structure of Pharmaceutical Industry”, Health Affairs, vol. 23, No. 1, pp. 10~22, 2004.
08.Iain Cockburn and R.M. Henderson, “Absorptive Capacity, Coauthoring Behavior, and the Organization of Research in Drug Discovery,” Journal of Industrial Economics, no. 2, pp. 157~182, 1998.
09.John P. Walsh, Ashish Arora, and Wesley M. Cohen, “Research Tool Patenting and Licensing and Biomedical Innovation”, Patents in the Knowledge-Based Economy. Washington, DC, p285-340, 2003.
10.Jonathan de Ridder, “Data Exclusivity: Further Protection for Pharmaceuticals”, Find Law, 2003.
11.Joseph A. DiMasi, Ronald W. Hansen, and Henry G. Grabowski. “The Price of Innovation: New Estimates of Drug /Development Costs”, Journal of Health Economics, pp.151~185. 2003.
12.Joseph A. DiMasi and Henry G. Grabowski, “The Cost of Biopharmaceutical R&D︰Is Biotech Different? ”, Managerial and Decision Economics, pp. 469~479 , 2007.
13.L. Zucker, M. Darby, and M. Brewer,“Intellectual Human Capital and the Birth of U.S. Biotechnology Enterprises”, American Economic Review, pp. 290~306, 1998.
14.Lita Nelsen, “Massachusetts Institute of Technology”. Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996
15.Lynne G. Zucker, Michael R. Darby, and Jeff S. Armstrong, “Commercializing Knowledge: University Science, Knowledge Capture, and Firm Performance in Biotechnology”, Management Science, pp. 138~153, 2002.
16.M.A. Heller and R.S. Eisenberg, “Can Patents Deter Innovation? The Anticommons in Biomedical Research”, Science, pp. 698~701, 1998.
17.Mark G Edwards, Fiona Murray & Robert Yu, “Value Creation and Sharing Among Universities, Biotechnology and Pharma”, Nature Biotechnology, pp.618~624, 2003.
18.Mark Kessel & Frederick Frank, “A better prescription for drug-development financing”, Nature Biotechnology, p859-866, 2007.
19.Michael Dickson and Jean Paul Gagnon, “Key Factors in the Rising Cost of New Drug Discovery and Development”, Nature Reviews, pp. 417~428, 2004.
20.Philip Cook, Dan Kaufmann, Chen Levin, and Rob Wilson, “The Biosciences Knowledge Value Chain and Comparative Incubation Models”, Journal of Technology Transfer, pp.115~129, 2006.
21.Raju Adhikaryi, “Patents, Royalty Stacking, and Management”, World Pharmaceutical Frontiers, 2005.
22.Rebecca S. Eisenberg and Richard R. Nelson, “Public vs. Proprietary Science: A Fruitful Tension?,” Daedalus, 2002.
23.Riku Lähteenmäki & Stacy Lawrence,“Public Biotech 2006 – the Numbers”, Nature Biotechnology, pp. 729~737, 2007.
24.R.S. Eisenberg, “Property Rights and the Norms of Science in Biotechnology Research” , Yale Law Journal, pp. 177~223, 1998.
25.Stacy Lawrence, “Tech transfer revs up”, Nature Biotechnology, pp. 13, 2006.
26.Wesley M. Cohen, Richard R. Nelson, and John P. Walsh, “Protecting Their Intellectual Assets: Appropriability Conditions and Why U.S. Manufacturing Firms Patent (or Not) ”, NBER Working Paper 7552, Cambridge, National Bureau of Economic Research, 2000.

三、研究機構報告
01. Andrés de Francisco and Stephen Matlin, Monitoring Financial Flows for Health Research 2006, Global forum for Health Research.
02.FY 2008 Budget in Brief, U.S. Department of Health and Human Services, Washington, DC: FDA, 2007.
03.NIH Funding Falls in 2008 Budget,American Association for the Advancement of Science.
04.Pharmaceutical Industry Profile 2007, Pharmaceutical Research and Manufacturers of America.
05.Pharmaceutical Industry Profile 2008, Pharmaceutical Research and Manufacturers of America.
06.Report of the National Institutes of Health Working Group of Research Tools, National Institutes of Health, 1998.
07.Technology Transfer Annual Report, University of California, 2000~2006.
08.The Pharmaceutical Industry in Figures, European Federation of Psychologist’s Associations, 2003 Update.
09.The Office of Technology Transfer, University of California.
10.UC Technology Transfer Policies & Guidance,
11.U.S. Licensing Activity Survey:FY 2006, The Association of University Technology Managers.
12.United States Patent and Trademark Office, News, Press Release .
13.Wendy H. Schacht, Patent Reform:Issues in Biomedical and Software Industries, Congressional Research Services Report RL33367, 2006.
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