生技產業的發展以及育成中心的經營一直是受到矚目的議題，台灣在生技產業的發展上，已投入相當多的資源，至今明確且優異的成果卻甚為稀少。而台灣的生技廠商以中小企業為主，中小企業正是育成中心主要的輔導對象，因此生技型育成中心的經營成功與否，對於生技產業的發展將造成一定程度的影響。 透過文獻回顧的整理，本研究歸納出一般型育成中心之經營成功關鍵因素六項，分別為育成中心的經營者、各種網絡關係的建立、育成中心的企業化經營、進駐廠商的篩選與畢業過程、與大學保持密切的關係以及育成中心提供的服務內容。而藉由觀察國際上經營成功的生技型育成中心，發展出四項生技型育成中心之經營成功關鍵因素，分別為與醫院保持合作關係、配合園區的設立發展育成業務、具有多種技術平台的合作夥伴以及育成中心的國際化。綜合以上的分析，本研究以十項關鍵因素為基礎，透過個案訪談的方式，深入了解台灣生技型育成中心的現況，檢視以特定發展方向為主的育成中心，其發展狀況、營運方式以及成功之道，與一般育成中心的異同或特殊之處為何。 研究結果顯示，「技術」是台灣生技型育成中心在經營上最重要的關鍵，而與母組織互動越密切的育成中心成效亦較好。在一般型育成中心的六項經營關鍵成功因素上，各種網絡關係的建立 (例如對外部網絡的發展較不活絡、建立名聲)、企業化經營 (例如持續經營之資金與模式)、進駐廠商的篩選與畢業過程 (例如招商不易) 與育成中心提供的服務內容 (例如欠缺市場行銷與資金方面的能量) 等四項，對於育成中心的經營影響較大。在生技型育成中心的四個經營關鍵成功因素方面，與醫院保持合作關係為非必要之條件; 配合園區的設立發展育成業務與育成中心的國際化上，皆未有明確的規劃或明顯的表現; 對於具有多種技術平台的合作夥伴，目前在育成領域內並無實質的合作與整合效益出現，而以非正式的聯結關係為主，多數也認為轉變成正式的聯盟平台在執行上尚有許多困難待克服。 最後，本研究將生技型育成中心的發展程度，與該發展時期所需的關鍵成功因素做關聯，整體來說，台灣的生技型育成中心都還處於發展初期至中期。而參考國外發展歷程較久的生技型育成中心歸納得到的關鍵成功因素，對於台灣的生技型育成中心來說，是較遙遠的目標，就現階段而言，其經營成功因素大部分落在與一般型育成中心經營成功相同的關鍵上。 / Recent years, there were lots of attentions on the development of biotech industry and the operation of incubation center. Many resources have been invested in the biotech industry in Taiwan. However, superior or successful outcomes were rare. Moreover, most Taiwan biotech-related companies are small-medium enterprises which are the main coaching targets of incubation center. Therefore, the successful operation of incubation center would relate to and affect the development of biotech industry in Taiwan. Through reference review, six key success factors about general incubation center operation were identified as “the operator of incubation center”, “the establish of various relationship networks”, “operation by enterprise management”, “the selection of proper tenants and graduation exam for tenants”, “to keep close relationship with universities”, and “the incubation center’s service items”. In addition, by investigation of the successful foreign bio-incubation center, four key success factors which might influence the operation of bio-incubation center were concluded as “collaboration with hospitals”, “co-operation the development of bio-science parks and bio-incubation center”, “having partners with varieties of technologies”, and “the internationalization of incubation center”. Based on the ten factors above, this study would investigate the operation and development of bio-incubation center in Taiwan. In addition, the key success factors of general incubation centers would be compared with those of bio-incubation centers in order to give suggestions for success operation. According to the analysis, technology support is crucial and essential to the Taiwan bio-incubation center. In general, having better interaction with parent organization would result in better performance. Among the six key success factors of general incubation center, four of them influence the operation more deeply, which were “the establish of various relationship networks”, “operation by enterprise management”, “the selection of proper tenants and graduation exam for tenants”, “to keep close relationship with universities”, and “the incubation center’s service items”. For the four key success factors of bio-incubation center, “collaboration with hospitals” is not necessary; there were no obvious results or plan about the “co-operation the development of bio-science parks and bio-incubation center” and “the internationalization of incubation center”; “having partners with varieties of technologies” is focus on the informal collaboration. A formal technology platform based on alliance of incubation centers still faces many difficulties and most bio-incubation centers in Taiwan still considerate the possibility of this kind of collaborative platform. Finally, this study proposes a relation between bio-incubation center development stages and the key success factors. As a result, the developments of Taiwan bio-incubation centers are just in the beginning or middle stage. The four key success factors derived form foreign successful and well-developed bio-incubation centers might be a long-term goal to Taiwan bio-incubation centers.

生技產業的發展以及育成中心的經營一直是受到矚目的議題，台灣在生技產業的發展上，已投入相當多的資源，至今明確且優異的成果卻甚為稀少。育成中心在培育中小企業的類型中生技業一直是培育的重點之一，而生技產業涵蓋範圍極廣，從生物農業、動物疫苗、一直到醫藥、幹細胞療法等都屬於生技的範疇，且生技產業的法規限制高，那麼一家育成中心的資源與能力是否可以滿足不同類型產業的生技廠商？本文想要探討的是以育成中心的資源是否可以兼顧所有生技類型廠商的需求？並就藉由個案描述育成中心對進駐廠商的價值。 透過文獻回顧的整理，本研究歸納出一般型育成中心之經營成功關鍵因素六項。以台大創新育成中心與生技類進駐廠商為個案，介紹台大育成體系的架構與校方關係，再分別挑選飼料添加，技術服務，與傳統中草藥三個不同產業的進駐廠商，描述三個個案自其企業進駐育成中心發展至今，經營過程中所遭遇的狀況，與育成中心所提供的協助、資源。分析育成中心對廠商所提供的服務所產生的價值為何。 研究結果發現，同樣的育成中心服務，呈現於不同產業的進駐廠商，會有極大的差異，而不同的進駐廠商需要的育成中心所提供的服務要項也不盡相同，而台大育成中心內最有價值的部分來自於母組織台灣大學的學術資源，藉由豐沛、完整的各院所資源，台大創新育成中心才有可能滿足各個不同產業別的生技產業，但仍偏向技術上的升級與開發，對於資金融通、產品行銷等服務仍較無法滿足進駐廠商的需求。 關鍵字: 「生物技術」、「育成中心」、「關鍵成功因素」 / The development of the biotechnology industry and the management of the innovation incubation centers (IICs) have been topics that receive great attention. Taiwan has invested many resources in the development of the biotechnology industry. However, there has been no clear and outstanding result so far. Among all types of small business, IICs have been focusing on incubating biotechnology related industry. The biotechnology related industry broadly covers many fields such as bio-agriculture, animal vaccines, drugs and stem cell treatment. In addition, the regulation in biotechnology related industry is very strict. This article would like to discuss whether it is possible to use the resources of IICs to meet the need of all biotechnology companies in different fields. With the case study, this article would also describe the value of IICs to biotechnology companies which engage NTUIIC services. Through organizing the published articles, this study concludes that the key factors of managing successful regular-sized IICs are the six items listed below. Take National Taiwan University Innovation Incubation Center (NTUIIC) and the biotechnology companies that engage its services for example, he study introduced the structure of the incubation system in National Taiwan University (NTU) and the relationship between NTUIIC and NTU, and focused respectively on three fields: feeding, skill service and traditional Chinese herbal medicine. This article describes three cases from the time these three biotechnology companies engaged NTUIIC services until now, the challenges these companies faced in management process, and the supports and resources provided by NTUIIC, to analyze the value of the services provided by NTUIIC to these companies. The study results show that same IICs services provided to biotechnology companies in different fields will have enormously different impact; and different biotechnology companies need different services from IICs. The most valuable asset of NTUIIC is its academic resources. With abundant and complete resources each department in NTU has, NTUIIC can therefore satisfy the needs from biotechnology companies in many different fields. However, the service NTUIIC can provide is more related to the upgrades and development in the technology itself, not the financial or marketing services. Keywords: Biotechnology, Innovation Incubation Centers, Key Factors

由美國的高科技生物技術事業發展過程來看，創業投資公司提供了高科技公司成長所需的資金，造就了黃金矽谷，對於美國持續繁榮功不可沒，此成功經驗如今已廣泛地為世界各國所效法。台灣的產業結構以中小企業為主，新創公司不易取得銀行融資，而對持有技術、市場、但對缺錢、缺管理經驗之新興事業主而言，創投公司提供了最佳之資金與管理上之協助；並在政府的大力推動參與與租稅減免的獎勵下，創業投資事業也在台灣蓬勃發展。 本研究即針對國內投資生技公司之創投公司（含工業銀行）之專業投資經理人為對象，進行訪談，希望達成以下目的： 一、探討國內創業投資公司投資生物技術公司之發展情形與動態。 二、探討國內創投公司之公司特質和經營團隊對投資生物技術公司之投資行為影響。 經實證結果，將重要結論摘錄如下： 1.各家創投公司，股東結構與經營團隊組成或有不同，也因此形成各自獨特的利基，但對投資生技公司行為之影響，歸納如下： 股東結構會影響投資網路的建構，投資案取得方式，投資標的選擇；主要經理人經歷會影響投資案階段之評估重點、網路建構、涉入管理方式和程度；經營團隊組成會影響對案件評估方式，團隊人數會影響涉入管理方式。可以看出股東結構，主要經理人經歷與經營團隊三項對生技事業投資行為的影響較大。 2.創投公司主要提供生技公司之附加價值計有：技術移轉與諮詢，理財顧問，投資顧問業務，資源整合共同承擔風險，提供產品之未來市場趨勢，行銷通路，協助股票上市上櫃準備，找企業合作夥伴，購併機會，資源整合，策略規劃，市場開發，策略聯盟，產銷規劃，進度管理，稽核制度，財務，人事管理資金，生技商品化之經驗，財務規劃等方面。 3.投資後介入管理被投資生技公司之程度：派專業經理人介入日常營運，參加董事會影響公司政策方向，提供被投資公司策略方面的諮詢；提供資金募集的便利及通路與知名度之擴展方便性。 4.我國創投公司在生技投資案出脫上：一般以公開上市（櫃）為主出脫股票，或考慮到被購併或合併，亦有持有被投資公司股權以共創雙贏為主要目的。 5.各創投公司皆表示的評估則會因生技案投資階段或產業別的差異而予以不同權重，大體上在生技公司投資上均相當重視技術平台，尤其是否有專利，與技術團隊之背景及CEO之人格特質。

生技產業為典型的高附加價值、知識導向型產業。由政策面來看，生技產業是我國兩兆雙星計畫中所勾畫出的新興產業之一；近年來，國際間生技產業發展迅速，帶領生技產業走向多元化的發展。然而，我國在這股趨勢洪流中，整體生技產業的發展上並不蓬勃。本研究針對國內從事生物技術研發的重要的研究機構，對於該研究機構在生物技術的智慧財產權保護與技術移轉機制上進行探討，其目的不在於比較各研究機構獲得了多少件專利，技術移轉了多少件項目，而是著重於我國生技產業發展的過程中，產、官、學、研之間的互動及分工關係上的探討。 本研究中的每個研究機構在組織定位、發展歷程、技術類型、組織文化等皆不盡相同，但在我國生技產業發展上皆扮演重要且關鍵角色。希望能藉由個案研究比較分析出各單位在運作機制上的相似處與不同處，更加釐清各研究機構在整個國家創新體系及產業發展的角色與位置。研究目的包括：1. 瞭解研究機構在智慧財產權保護和技術移轉上的運作機制。 2. 探討推動國內生物技術產業發展過程中，研究機構與產業界間連結互動有的關鍵因素。 3. 在研究機構的策略發展和遇到的困難，對於機構內部組織上與政府生技產業政策的推動上給予適當建議。 本研究以研究機構技術移轉單位的『運作流程』、『產研連結』、『技轉策略與個案』三個主要構面來探討我國研究機構在生物技術移轉上的機制。研究方式採用個案研究法以及質化研究法，深度訪談中央研究院、國家衛生研究院、工業技術研究院與生物技術開發中心，四間研究機構的技轉單位主管與技轉專員，獲得以下結論： 1. 技轉單位需要得到機構高層的支持，同時很多重要的技轉案會採跨單位的專案形式為之，整個技轉過程需要跨領域的團隊合作。 2. 在技轉單位內部的運作上，近年開始有將專利業務與技術推廣業務分開之改變，這樣的改變效果短時間還不是很明顯。 3. 專利申請維護的預算也普遍成為技轉單位當下遇到的問題之一。研究機構著重於專利品質，以更貼近產業與市場需求，進而強化技術移轉之成效。 4. 國內在技術移轉後的相互回饋機制略顯不足，仍須再建立更細緻的互動機制來強化後續的技術商品化。 5. 現階段國內生技產業發展不蓬勃，也沒有成功的個案公司，廠商普遍經營困難。研究機構在生物技術移轉會給予比較大的彈性，讓技術繼續開發下去為原則。 6. 技術移轉是相當複雜與專業性高的領域，與市場互動至關密切。而政府在政策上應放在著眼於公平交易與經濟發展方面。現今經濟部已經廢除研發成果『專屬授權』限制的相關規定。然而，在研發成果『境外實施』上的政策法令，仍有許多爭議有待政府重視與鬆綁法令。

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.

本論文研究主題係針對生物技術專利的要件的探討外，更探討跨學科領域的結合所形成的專利制度，如何透過實務的見解來具體化專利的要件，本文希望嘗試透過探討法律層面的專利取得要件及專利審查基準的認定外，更進一步希望透過法院實務的見解，來具體化專利要件之內涵，架構其中一段完整生物技術專利要件之評估，除作為本論文探討的具體內容。

知識經濟時代的來臨，代表知識早已經取代勞力、土地、資本，成為最重要的生產要素，而知識創造的具體果實就是智慧財產，此項無形資產占企業財產的重要性已遠超過有形資產。個人、企業和國家唯有專注在智慧財產的創造、保護、管理和運用上，方可成為知識經濟下的大贏家。 近年來，隨著人類科學知識與生活智慧的增長與演進，與人類日常生活和生命安全息息相關的生物醫學技術日益突破且其重要性與日俱增，國際間生技產業發展迅速，並帶領生技產業走向多元化的發展；除此之外，生技產業也是台灣兩兆雙星計畫中所追求的新興產業之一。然而，台灣在這股趨勢洪流中，整體生技產業的發展上並不蓬勃。歸根究柢，生技產業乃為典型的高附加價值、知識導向型產業，智慧財產的重要性不言可喻並且更加突顯。智慧財產如同其他企業資產一樣，需要善加管理與運用才能發揮其價值，若企業擁有大量之智慧財產，但對該智慧財產欠缺有效之管理運用，亦無法為公司創造任何價值。因此，如何為智慧財產尋求正確的運用管道，應是智慧財產所有人最為關心的議題。由於生物技術產業十分重視技術的掌握與應用，故本論文研究將焦點放在與技術知識保護有關的「專利授權與技術移轉」上，並特別針對屬於智慧財產行銷管理層面的策略進行探討。 《時代》雜誌年度風雲人物華裔科學家何大一曾說過要用人才賭生技，其需要的是什麼樣的人才?又該如何賭?本論文研究希望能提出相對應之見解，藉由個案研究方法分析找出台灣生技企業在「專利授權與技術移轉」上的策略思考邏輯，並更加釐清智慧財產行銷管理對產業發展影響的角色與位置。 由於台灣生物技術公司目前本身先天條件不佳且資源不足，無法透過商品化與產業化之智慧財產實施方式來創造最大利益，因此透過智慧財產交換方式乃是其最佳模式，而考量相關環境條件後，其中又以「專利授權與技術移轉」為最具經濟效益且最可能成功之智慧財產商業模式與型態，因此本論文研究便針對此方面進行深入探討，以提供產業後續發展之參考借鏡。 本論文研究目的包括：1.探討推動台灣生物技術產業公司發展過程中，考量「專利授權與技術移轉」的重要因素。2.瞭解台灣生物技術產業公司目前在「專利授權與技術移轉」方面的運作機制。3.介紹台灣生物技術產業公司之指標性個案，分析其智慧財產行銷策略，歸納其關鍵成功因素，以茲其他業者參考。4.了解智慧財產行銷策略的核心結構，提出智慧財產行銷策略規劃上的建議。5.綜合研究結果，提出對台灣生物技術產業公司「專利授權與技術移轉」策略之建議，並分析該產業之潛在問題與可能限制。 本論文研究提出理論強調台灣生物技術產業公司必須考量智慧財產行銷的六大要素(6P)，以『主導產業鏈』、『控制價值鏈』、『分配供應鏈』等三鏈為目標，因而決定採取「專利授權與技術移轉」之正確的智慧財產商業模式後，站在目標被授權人的立場思考，透過「策略九說」來作檢驗，以找出最適合的智慧財產行銷之執行策略，並在執行時確實考量組織行銷之特性。 本論文研究方式採用個案研究法以及質化研究法，獲得以下結論： 1. 「專利授權與技術移轉」必須著重於專利品質，以更貼近產業與市場需求，進而強化技術移轉之成效。 2. 「專利授權與技術移轉」是屬於相當複雜且專業性高的領域，與市場互動至關密切。 3. 任何產業的任何公司當其智慧財產行銷策略之方向目標正確，且手段方法合理，則成功便是可以預期的。 4. 一旦擬定正確的智慧財產行銷策略，則後續的執行力，便成為是否成功之唯一重點。 / The coming of Knowledge-based Economy Era indicates the fact that knowledge had taken the place of labor, land and capital to become the most important production factor. The results of knowledge creation are Intellectual Property (IP). The Intangible Assets are much more important than Tangible Assets for industries in nowadays. It becomes crucial for individuals, industries, and countries to achieve success in the Knowledge-based Economy Era to concentrate on the creation, protection, management and application of intellectual property. In the recent years, because of the developments of scientific knowledge and life wisdom, the progress and importance of the biomedical technology which closely related to human life and safety advances rapidly. Besides, the biotechnology industry is also one of the booming industries of Taiwan “Two Millions, Two Stars” projects. However, the Taiwan Biotechnology Industry does not follow the trend well. The biotechnology industry is a typical high value added and knowledge oriented industry, and the importance of IP is much more distinct. Same as other corporation’s property, intellectual property needs to be managed and put to use well to manifest its value. If a corporation owns a lot of IP without effective management and application, none value or benefit will be produced for the corporation from the IP. Therefore, for the IP owner, how to find out the correct application ways of IP will be the most important concern. Since technology familiarity and application is a highly emphasized issue for biotechnology industry, this study will focus on the technology knowledge protection concerning “Patent Licensing and Technology Transferring,” especially on the IP Marketing Management Strategy. David Ho, a Chinese American scientist and the Man of the year 1996 of “Time” magazine, once said that “we have to bet on biotechnology with talents”. The question is what talents are needed, and how to bet? This study aims to provide some corresponding thoughts and find out the strategy of “Patent Licensing and Technology Transferring” for Taiwan biotechnology corporation through case study. Furthermore, the study will manifest how IP Marketing Management will influence industry development. Due to the immature company structure and small business size of Taiwan biotechnology corporations, these corporations are unable to create the best profit through IP commercialization or industrization. Thus, the best model for them will be through IP Exchange and the “Patent Licensing and Technology Transferring” will be the most effective and feasible IP Business Model given the conditions of Taiwan biotechnology industry. This thesis will concentrate on this aspect and provide advices for industrial developments. The purposes of this study include: a. the important factors and the significnace of “Patent Licensing and Technology Transferring” in the promotion of Taiwan biotechnology corporation development; b. the current mechanism of “Patent Licensing and Technology Transferring” of Taiwan biotechnology corporation; c. a case study of Taiwan biotechnology corporation, including the IP Marketing Strategy analysis and the key successful factors as reference for other corporations; d. the core structure of IP Marketing Strategy and IP Marketing Strategy planning; and e. strategy suggestions for “Patent Licensing and Technology Transferring” and the potential problem analysis of the industry to Taiwan biotechnology corporation. This study proposes that the Taiwan biotechnology corporation must put the 6P factors of IP Marketing into consideration and target to dominate Industry Chain, to control Value Chain, and to allocate Supply Chain. They should also take the correct IP Business Model of “Patent Licensing and Technology Transferring”, and then think in the position of the targeted licensee through the examination of “9 Theories of Strategy” to find out the most suitable IP Marketing strategy. They should also take the characteristics of “Organizational Marketing” into consideration in practice. This study comes to the conclusions below with case study and qualitative methods: a. The quality of patents is always important in “Patent Licensing and Technology Transferring” to meet the industry and market demand and thus to reinforce the technology transferring achievement. b. “Patent Licensing and Technology Transferring” is complicated, highly professional and closely related to the market. c. The success of any corporation of any industry lies on a correct IP Marketing Strategy and a legitimate method. d. Once the correct IP Marketing Strategy is settled, the only key factor to success will be how to enforce the strategy.

University of Macau / Institute of Chinese Medical Sciences

生物科技產業，是一個被預期將於未來使人類在醫學、製藥、材料、糧食乃至於能源、生態等各方面所面臨的問題，獲得重大突破的產業；也是被公認為二十一世紀最具發展潛力的重點產業！世界上各個先進國家莫不競相投入大量資源，積極進行生技產業的培植與發展。研究單位與大專院校，一向被稱為所謂的「知識引擎」。照理說，在良好的智財管理之下，理當成為智慧財產生產之重鎮，並經由技術轉移實際地應用在產業界，協助提昇企業的競爭力，進而強化國家整體的經濟能量。 本研究藉由各方相關之文獻、著作加以分析，先從美國與我國在科技或技術移轉相關法規的介紹，再整理生物技術與生技製藥產業的特性，和我國目前的現況與問題，最後由商品化角度歸納出技術移轉在各階段的組成要素，再參考美國麻省理工學院技術移轉中心實例。與國內產學成功之案例-「寶齡富錦PBF1681專案」及「陽明大學新藥中心」對照，從中比較出國內學校與產業之間的交流，哪一環節出了問題？在探討我國大學生技製藥產學合作機制上，本研究採用的架構主要是從國內外大學負責產學合作單位的「運作流程」開始瞭解在智慧財產權、技術推廣、技術移轉過程與移轉後的回饋監控機制等。 交相比較之後，建議國內大學之技術移轉中心需擬定明瞭易懂之政策 設計簡單易填之表格、重視商品化流程、經驗豐富之授權人才引進、設置「成功故事」區，來激勵想要新創公司之人。另外，也對國內生技製藥產業建議，台灣的切入點以植物藥為迅速且花費少、成功機會高，這是值得投入之領域。而產業之結構也應有所調整，台灣藥廠規模小，無法與國外大廠競爭開發新藥。開發新藥需投入大量時間及金錢，故國外藥廠之產業結構為垂直整合，亦即是將上市前所有試驗及上市後行銷一手包辦。國內藥廠需仿照科技業一般，將整個產業作水平分工，將核心能力保留，其餘皆可外包。這樣不但節省時間，也可減少對不熟悉領域之摸索，由仿製之學名藥廠，走向新藥開發，進而與國外大廠相互抗衡。 / The universities are long taken as the “knowledge engine” for industries. Through a well-designed cooperation or licensing system, that is, the academic-industry liaison, those intellectual property produced from academic researches should be applied in the industry and industrial competency can thus be improved. However, the academic-industry liaison concerning biotechnology and drug in Taiwan is deficient. This thesis compares the cases of “Panion & BF Biotech Inc. PBF1681 Project,” “Research Center for Drug Discovery in National Yang-Ming University” in Taiwan with the Technology Licensing Office (TLO) of MIT in the U.S. Through the comparison, it can be found that techonology transfer office of universities in Taiwan needs to design a more friendly procedesure for licensee applicants and focuses on technology commercialization. Moreover, the pharmaceutical industry needs to invest more in herbal drug development. The industry itself needs corporate reengineering. The structure of the industry should be a horizontal division instead of the vertical integration. They should focus on their core competency and strengthen the mutual cooperation between companies to form a network of efficient production divisions. Key word: academic-industry liaison, biotechnology, drug discovery, pharmaceutical, Technology Licensing Office (TLO)

生物醫藥產業對人類健康福祉影響甚鉅，同時也屬於技術、資本密集、開發期長、風險偏高的產業，在新藥開發的歷程中，臨床試驗是開發中藥品自「試驗階段」邁向「市場階段」的絕對關鍵過程，其重要性不言而喻。對藥廠而言，臨床試驗若能有效率地被執行，一方面可縮短試驗時間減少花費；另一方面則是搶得先機佔據市場，及早實現獲利。因應臨床試驗重要且繁複需求的臨床試驗服務公司（Contract Research Organization, CRO）便應蘊而生。 CRO產業在美國的發展已逾40年，在奠基於過去的競爭基礎之外，其CRO產業已朝向「便利性」與「客製化」等利基市場佈局，以滿足新的顧客價值主張，並創新商業模式，追求新的成長機會。本研究在介紹美國CRO之產業市場營運模式之外，也以個案分析方式，自國內CRO公司與藥廠/生技公司的互動、合作，探討CRO的營運模式是否符合客戶需求，並嘗試以<白地策略>書中四個核心市場要素：顧客價值主張、利潤公式、關鍵流程與關鍵資源，思索CRO公司應如何經營市場白地。希望借鏡國外CRO公司的演進，反饋予國內CRO產業的未來發展及策略調整參考。 / Bio-pharmaceutical industry on human health well-being highly influential, but also a industry of technical, capital intensive, long development periods, and high risk. Among the course of drug development, clinical trials are absolute the key to the process, and advance the development process from the pilot phase to the market phase. For pharmaceutical companies, if the clinical trial can be executed efficiently, they can shorten the test time and spending; seize the market in advance, and reap profits as soon as possible. In response to the important and complex clinical trial requirements, the Contract Research Organization (CRO) prospers and takes advantage of a favorable situation. The evolvement of the CRO industry in US is more than 40 years. In the foundation base in the past, the CRO industry has been towards convenience and customization and other niche market distribution, to meet new customer value propositions, innovative business models and pursue new growth opportunities. In this thesis, the author not only introduces the CRO’s business models in US, but also explores the CRO’s business models in Taiwan by way of case studies. Through the interaction and cooperation between domestic pharmaceutical companies and CROs, the author wants to find out if the business models of CROs are in line with customer needs. The author also wants to quest if the CROs can learn how to manage and operate a white space which the CROs hope to seize by way of the book Seizing the White Space lists four fundamental building blocks including customer value proposition, profit formula, key resources, and key processes that make a company business model works. The domestic CROs can adjust their strategy and business model for fitting customer’s value proposition.