生技製藥產業併購策略 / The biotechnology companies started with the development of genetic engineering and antibody production in the U.S. and until today U.S. is still the leader in this industry. In recent years, they are becoming particular interest to established pharmaceutical companies. This thesis will first introduce the characteristic of pharmaceutical industry and its current situations, Next to explain pharmaceutical company’s unique relationship with biotechnology by studying the merger and acquisition case of Roche and Genentech. With the results, we will have better understanding of the business challenge and strategy for the industry.

本研究主要是在探討台灣生技製藥產業中，廠商之技術知識特質與技術網路間之互動關係。其中技術知識特質是選取（1）技術知識生命週期（2）技術知識路徑相依度（3）技術知識複雜程度等三個變數來做探討。而技術網路包括了（1）內部技術網路（2）外部技術網路。內部技術網路是探討公司內部之專案管理及跨部門知識的流通，外部技術網路是探討公司與外界之學研單位、政府單位及廠商間互動關係。研究發現如下： ﹝一﹞ 技術知識生命週期會影響廠商主要的技術來源 ﹝二﹞ 技術知識路徑相依度高低會影響概念的生成與發展 ﹝三﹞ 技術知識路徑相依程度會影響進行知識創造團隊的類型 ﹝四﹞ 技術知識複雜程度會影響團隊組成的異質/ 多元化程度 ﹝五﹞ 在發展以基礎科學為基礎之產業，外部技術網路扮演著相當重要的角色 ﹝六﹞ 在探索新領域時，鼓勵實驗及容忍失敗的風氣是相當重要的 ﹝七﹞ 生技產業之研發投入時間長，領導者必須對此有較高的願景及承諾 ﹝八﹞ 生技領域的產品開發常是由新產品創業小組來進行 ﹝九﹞ 產品鬥士在發展生技產業時扮演了極重要的角色 ﹝十﹞ 台灣之生技產業必須“ 衡外情，量己力”，善用學研單位之智慧資本並以中小型投入的方式來進行開發

新藥開發是需要大量的資金投入，同時需要專業的技術實驗人才、以及具產業經驗的管理團隊，但是其所獲取的價值和領域也是相對較大的。生技製藥產業包括新藥、學名藥、中草藥、基因及蛋白質製劑、遠距醫療、預防醫學、醫療器材等。台灣在生技製藥已經投入許多資源，但是所獲得的成果並不如預期，主要原因除了缺乏像國際大廠的充足資金之外、且沒有完整的生技製藥產業鏈，更重要的是缺少了對生技製藥智慧財產管理的經驗、沒有國際行銷能力去取得市場。起因點則為台灣生技製藥公司仿照國際成功的生技製藥大廠模式，卻沒有自己的價值創造和創新模式，為了替台灣生技製藥廠商尋找新的利基和成功模式，本文分析了國內與國外的生技製藥公司，以尋找適合台灣的價值創造模式。 台灣生技製藥廠商主要缺乏的並非是技術，而是結合智慧財產的法律議題、並且發展出市場導向的生物技術研發模式。智慧財產相關議題在生技製藥產業更是最關鍵的因素，因為新藥研發動輒10年，而一般資金來源的銀行和創投都無法忍受所投資的公司必須要十年才可以獲利退出，因此透過不同臨床時期開發的新藥，其價值也會有顯著的不同，再透過技術移轉、授權和相關合約的簽訂，才能促使台灣中小型的生技製藥公司可以生存。本文要提出價值創造模型之前，必須要針對生技製藥產業的技術研發特性進行分析，接著必須透過智慧資本與財務會計的方式計算生技製藥產業無形資產的價值，最後透過個案中不同公司的營運策略，找出最適合現今生物製藥產業發展的模式。 生技產業需要相當多的資金去做新藥研發與市場行銷，這也是生技產業特殊的供應鏈上最重要的一環。因為，創投公司不只會投資金錢，它還會幫忙被投資公司尋找人才、市場、和策略發展。因此，本文第三個個案公司Burrill&Company為美國生技創投公司，最近幾年也可以看到它在大中華地區尋求投資機會。Apex International公司選對人才創造出優良品質的委託臨床試驗、和NexMed透過技術授權所產生平台技術，三家公司所創造的價值，去印證本文所提出的生技製藥產業價值創新模式的適用性。 論文研究結果顯示生技製藥產業最成功的關鍵因素至少有兩點，第一點就是核心能耐(Core Competence)的建立、第二點就是選擇對的人才。由本論文的價值創造模式中心出發，便是透過紮實的研究發展技能；建立優良的管理技巧以降低研發風險；透過創造新的技術和產品價值的核心能力建立，再選擇正確的人才組合，創造出外部的價值，最後達到整體價值創造的綜效。希望台灣不光只是擁有科技基本法與生技新藥產業發展條例等政策，而是可以透過本論文提出之價值創造模式，有效提升整體生技製藥產業的環境，以期產生更多成功的故事。 關鍵字：生技製藥、智慧財產、實體審查、無形資產鑑價、價值創造、技術移轉。 / Biopharmaceutical is driving force of the global healthcare economy transformation. In order for a biopharmaceutical company to gain value from a new drug during its clinical development, capital investment, professional talents, and management team with industrial experience are needed. Biopharmaceutical industry are included of new drugs, generic drugs, Chinese herbal medicine or traditional Chinese medicine, genetic and protein preparations, tele-medicine, preventive medicine, medical devices and so on. Taiwan has invested a lot of resources at biopharmaceutical fields but the results are not as expectation. The main reason is the lack of adequate funding from international big pharma, and the operation is no integrity of the value chain at biopharmaceutical industry. More importantly is the lack of management experience on Intellectual Property, and no marketing ability to access to the global technology supply and demand market. The key point is that they copy of the format of big pharma but lack the spirit of the creativity and innovation. I analyzed the three cases in the thesis and tried to find a niche and successful model for the value-adding on the Taiwan’s Biopharmaceutical industry. Taiwan does have the technology know-how, but most of the companies’ problems are the lack of market-oriented R&D model and the Intellectual Property issues. IP issues including management know-how related to biopharmaceutical industry are the most crucial factors. Most companies tends to spend ten years on developing a new drug. Most of the investment banking and venture capitals are hard to endure by the long-term exit mechanism. The value will be totally different if the investors can exit at various clinical stage of new drugs at various stages with the strategy of technology transfer and licensing agreement. Such business model can make Taiwan’s small and medium-sized biopharmaceutical companies easier to survive. To verify this value creation model, I analyzed the characteristics of the industrial research and development and calculate the value of intangible assets on the technology by the methodology of intellectual capital and financial accounting. Finally, I will identify the most suitable model by compared with the different business models in three representative cases. The biotech industry needs a lot of funding to do R&D and marketing of new drugs which is the most important on this special supply chain. Not only to invest money, venture capitalist should help the company to recruit the talent, target the market, plan and execute the strategy. Therefore, the third case is the U.S. venture capital firm called Burrill & Company. In recent years, it moved to the Great China region to seek the investment opportunities. Apex International recruit the right talents to the right position and create a great world class quality project on the clinical trial, and NexMed bring their value through the platform technology and technology licensing. All the cases are selected to examine the availability and suitability of the value creation model. At least two key successful factors for biopharmaceutical industry has been revealed by the research of the thesis study. The first one is the establishment of the core competence on the technology in their respective business, and the second one is the management know how in putting the right person on the correct position. Overall, the value creation model is build on a solid research and development skills, a great management know-how to reduce the risk, and the spirit of entrepreneurship to create the true innovative products or services. With all the core competences, we can integrate the team with multidisciplinary talents to expand the value with the outside resources, and give the synergy of the whole value-added model. Hope that with the recent enactment of the Basic Science and Technology law and New Pharmaceutical Development Act in Taiwan, more successful stories can be created by this value-added model discussed in this thesis.

近年來全球醫藥市場競爭越來越激烈，歐美製藥產業面臨：1.暢銷藥品專利即將到期、2.新藥產品生命週期縮短、3. 研發支出與產出不成比例、4. 健保藥價之削減，過去傳統藥廠以垂直整合方式開發新藥的方式已無法負荷艱困的產業環境。因此，開發新藥方式已從過去垂直整合轉向產業分工的方式，減低風險，提升新藥開發成功機會。因此，吾人可以預測這些廠商必須借用大量的外部資源才能快速地推出新藥。 目前我國新藥開發處於萌芽期，廠商規模小且較無經驗，加上國內過去以學名藥為主，因此，開發新藥一直是國內廠商的一個夢，也是製藥產業獲利最高的一項產品。然而，過去的研究重點往往著重在製藥產業相關業者發展策略、關鍵成功因素、營運模式或生技公司之創新管理、智財管理等層面探討，對於新藥開發流程的實務歷程的研究較少著墨。故本研究針對我國新藥開發公司的「新藥開發流程」進行研究，試圖以開放式創新觀點，探討其新藥開發流程中，專案團隊的外部技術網路與內部專案管理的關係，期能對於「團隊間之開放式創新管理」方面，提供一些實務上與學理上的貢獻。 本研究方法採個案分析法，文獻探討部分包含新藥開發流程、開放式創新、外部技術網路、專案管理，導出本研究之觀念性架構，以此理論架構發展出個案訪談問題，在研究中實地訪談四家之我國新藥開發廠商，並從中分析我國新藥開發流程中外部技術網路與專案管理之關係，透過個案分析推論我國新藥開發流程內、外部合作的關鍵成功因素。 本研究發現，新藥開發流程中，各階段技術不同，新藥開發專案團隊須清楚地界定本身的研發能力，才能有效連結外部技術資源。同時，專案團隊要能有效連結外部技術資源，團隊成員須擔任技術中介人，以促進適當的技術流進、流出，達成開放式創新。因此，選擇適當的技術中介人是新藥開發成功的關鍵因素。

近年來中國大陸以其廣大的市場及較低的人力成本優勢，成為外資及台商競相投資的市場，台灣各產業莫不以進入中國市場為營運發展的重要目標。國內生技製藥產業在這一波投資中國熱中，也嘗試從生產、銷售、行銷、代工及研發等不同面向切入，以掌握商機及尋求企業的永續經營與成長。 本論文著眼於研究台商生技製藥公司在進入中國大陸市場時，所選擇的海外直接投資之進入模式分析。並以John H. Dunning對外投資之折衷理論為研究架構，從「所有權優勢」、「區位優勢」及「內部化優勢」等構面，來分析台灣生技醫藥公司的中國市場進入模式。藉由國內生技製藥公司的企業訪談及上市櫃公司公開資訊的分析，以及次級資料與公開報導的整理，以瞭解台商生技製藥公司在大陸的直接投資進入模式及影響投資決策的關鍵因素及公司優勢。 本研究共訪談國內四家生技製藥公司。研究發現，生技製藥台商在中國市場的進入模式選擇，主要可能受到區位優勢決定因素的影響，而決定因素則可分為市場導向、資源取得導向及風險評估等三項。本研究將有助於瞭解國內生技製藥業，在中國進行跨國經營與投資的決策考量，並裨益國際企業領域及國際策略管理的理論與實務發展。 / Over the past years, China has attracted much investment from Taiwan companies and foreign companies due to its advantages of board markets and low-cost labors. Companies in Taiwan also set “enter China market “as a goal in their business planning. Upon this wave of “Invest China fever” , the domestic Biotech & pharmaceutical companies have no doubt approached their business target by entering China market through different operations, that is, production, sales, marketing, out-sourcing, and research & development, etc to catch the opportunities and sustainable growth of business The objectives of the study were to analyze the entry mode of China market Taiwan biotech & pharmaceutical companies have conducted their foreign direct investment (FDI). Based on the theory of the eclectic paradigm of FDI initiated by John H. Dunning as a research framework, from the perspectives of Ownership advantages, Location advantages, and Internalization advantages, the analysis for the entry mode of FDI and the Key factors as well as company advantages to affect the decision were employed to examine both the primary data and secondary data. Primary data consisted of the interviews of domestic pharmaceutical companies and the data statistics from the Market Observation Post System (Taiwan stock market). Meanwhile, secondary data was collected from the news and the reports of the journals, magazines, and the websites. Four Biotech-pharmaceutical companies were interviewed in this study. The result shows that Location advantages may be the major factors for FDI in China of Taiwan companies. The factors consist of market -oriented, resources -oriented, and risk assessment factors. This study will contribute the strategic considerations for Taiwan international companies that operate foreign Biotechnology and Pharmaceutical business in China. This study also suggests the strategy for the international business and international management both in theory and the practice.

新藥研發是台灣生技發展的重點產業。新藥研發一般具有高投資、高風險與研發期長的特性。因此，有些公司會透過多角化的策略來分散風險。不過，在有限的資源與人力下，發展多角化的產品通常是個極具挑戰的任務。因此，本研究針對新藥研發公司，就其採取多角化的動機與策略來加以探討。 此外，在知識經濟的時代，知識已成為企業最重要的資產，如何透過有效的知識管理以提昇組織知識的價值，則是企業所重視的關鍵性議題之一。新藥研發屬知識密集產業，知識管理對於公司相當重要。因此本研究亦從知識特性的觀點（路徑相依度、不確定程度與競爭衝擊程度）來探討其對知識管理的影響。 本研究在方法上採取多重個案研究的方式，透過深入個案訪談與次級資料收集，所得到的結論如下： 1. 台灣新藥研發公司選擇多角化策略的動機相當多元。 2. 台灣新藥研發公司多角化的動機與多角化目標領域之路徑相依度有關。 3. 台灣新藥研發公司多角化目標領域技術知識的路徑相依度與競爭衝擊程度會影響其技術知識吸收的方式。 4. 台灣新藥研發公司多角化目標領域技術知識的路徑相依度會影響其組織設計、分工與人員式知識擴散的對象。 5. 台灣新藥研發公司進行多角化產品研發時，其知識蓄積活動上傾向於採取「機械-整合式」的蓄積方式。 / New drug development industry is one of the key biotech development areas in Taiwan. The nature of new drug development involves high investment, high risk and long development time. As a result, some companies develop diversification as a strategy to reduce the risk. However, the scarcity of resource and manpower makes developing diversified products particularly challenging. This study would focus on why these companies choose diversification strategy and which strategies they develop. Knowledge management is very important for companies in research-intensive industry. This study would also explore how the companies practice knowledge management on its diversified projects. In addition, this study uses technological knowledge characteristics (path dependence, degree of uncertainty, and competitive position) to analyze the effect upon knowledge management process. In this study, multiple case study method to take the way through in-depth case interviews and secondary data collection, the conclusion is as follows: 1.The reasons why new drug development companies in Taiwan underwent diversification vary a lot. 2.Synergy motivation of new drug development companies in Taiwan will affect the path dependence of technological knowledge in target areas for diversification. 3.Path dependence and competitive intensity of technological knowledge in target areas for diversification will affect the way of technical knowledge acquired in Taiwan’s new drug development companies. 4.Path dependence of technological knowledge will affect the organizational design, the division of labor and object of personnel-type knowledge diffusion 5.New drug development companies in Taiwan tend to choose 「Mechanical-Integrated」mode of knowledge Storage when the diversification activities.

近年來在相關產業與政府的努力及人才培育之下，我國許多生技研究已有初步的規模且可說是居於亞洲領先地位。然而，這些技術在商品化應用的階段卻一直沒有重大突破與發展，難以將研發成果的實質效益挹注到產業中。研發成果商品化的過程中，必須兼備技術面、法律面、財務面、管理面的考量，面面俱到才能將初萌的技術逐步發展為成熟的商品，進而在市場上獲取實質利潤，再將獲得的資源挹注於研發活動，形成良性循環。 研發成果商品化的策略視產業特性而截然不同，在「生技醫療產業」中，因其具有「受衛生主管機關高度管制」、「商業化認證需時」、「行銷國際化」的特性，在法規面的複雜度較高，且為專案成功與否的關鍵因素之一，進行商品化評估時必須熟悉相關醫藥法規，才能著手為專案發展做正確的規畫 ，極度仰賴「跨領域」、「高度技術」與「熟稔特殊商業技巧」的人才。依各國藥物法規的不同，商品化的開發時程也受此影響，生技製藥產業之技術及研發成果必須將為達到法規規範的要求而必須投入的時間、資金、人力等各項資源納入總體可行性評估之考量依據。。因法規具有地域性，本研究無法齊備全球各國，將以美國及台灣為研究主體，台灣的法規深受世界公認醫藥法規先進的美國影響，熟知美國的法規可以預估台灣法規機構的思路；且美國藥品市場佔全世界最大規模，此外，美國也極有可能成為潛在合作廠商之所在地，因此本研究將比較美國與台灣之醫藥法規，並評估在技術研發的過程中，衛生主管機關之要求對於技術商品化過程中所產生的影響。 明確、具科學性、可預期性的法規環境能降低製藥產業於研發過程中的不確定性，提高廠商投入的意願。衛生醫療政策及藥政管理政策直接影響到醫藥法規的訂立，政府制定的法規將引導產業發展的方向，對於藥品市場有極重要的影響。一個好的政策應該能夠與國家的總體背景相匹配，法規要求應與國家發展程度及國家內需市場成比例。台灣生技製藥產業目前的困境之一，就是國內廠商在開發新藥時，為了符合台灣衛生主管機關訂定的高標準法規必須投入更多的成本，但台灣卻沒有足夠的內需市場得以支撐，造成擁有豐厚資源的國外廠商可以將符合世界（十大先進國）高標準的藥品進入台灣市場，但國內廠商卻無法立足。為解決此困境，台灣廠商一定要設法將業務範圍擴大到外需市場，以獲取足以支持藥物發展所需的資金成本。因此，了解國內、外之藥物相關法規，做出能符合各國法規要求的產品，為踏出國際外銷市場的第一步；此外，各國的智財法以及與商業相關的法律，還有其之間的互相關聯，都是技術商品化是否能夠成功至為重要的關鍵因素。本文擬就藥物法規面為討論之主軸，其間輔以智財、商業相關構面，對生技製藥產業之技術商品化之過程做一探討。在本研究所選的個案—核子醫學藥物，是眾多創新產品的一種，如果能把握技術、智財、法規、法律、國際商業運作，很有可能為台灣的藥業打開另一片天。 / In recent years, we have already developed some achievements in biotech researches in Taiwan and are in a leading position in Asia under the efforts of government and industries. However, these technologies still are slowly developed to the commercialized phase. Thus, the achievement of these researches does not benefit industry substantially. In the process of commercialization of biotech research, we have to consider all the aspects, including technology and regulation, intellectual property, finance and management. With a well-rounded development plan, technologies in the bud will gradually develop to a mature commodity, and earn fiscal profit in the market. The profit will consequently contribute to research activity. A virtuous circle will be formed. The strategies of commercialization differ considerably among industries. Regarding biopharmaceutical industry which has the properties of highly regulated by competent authorities, time consuming, heavy capital, and global marketing, the regulation assessment is not only complicate but also critical to project implementation. The required documents according by regional authorities will be a decisive factor to consider the development plan including the estimated timetable, needed resources. Due to the regulation system in US affected a lot legislation for laws in Taiwan , America and Taiwan will be the prior topics in this research. A well-developed legal framework and protection of intellectual property rights is the prerequisite for building an ideal environment where the biotechnology and pharmaceutical industries can flourish. In order to improve the environment for these industries, in recent years the government has approved the amendment and execution of related laws and regulations. Amendments have been made to related tax benefit and incentive measures of investment. Other amendments have been made which have allowed R&D results to be more easily transferred to academia and industry. Looking into the future, under the joint cooperation of industry, academia and research institutes, and with the government’s policy to fully promote the sector, it is believed that Taiwan will have well developed in the near future.

二十一世紀是知識經濟的時代，傳統製造業所看重的有形資本已不足以維持企業優勢，無形的智慧資本在新型態的企業競爭中所扮演的角色日顯重要。各行各業都有無形資產，種類性質因產業而異，傳統製造業重視營業秘密、商譽，高科技產業的專利則是公司競爭力的核心，而屬於知識高度密集產業的生技產業更需要重視智慧資本的管理。生技產業的結構複雜，價值鏈長、分工專業、產品開發期漫長，在產品成功上市之前的開發時期中，公司資產多屬於無形的智慧資本，無法從傳統的財務報表觀察其真正的企業價值。相較於其他產業，生技公司更必須訴求於正確的無形資產管理方式，方能成功兌現其智慧資本。 本研究先藉由文獻回顧統整台灣生技產業的相關現況、過去相關智慧資本管理研究以及研發管理等議題，歸納出一般性共識與管理原則。接著依循這些重點，訪談三家台灣生技公司的經理人，包括台灣微脂體、中裕新藥與因華生技，深入了解台灣產業經營實務與現況，探討其智慧資本中的人力、組織與關係資本在個案公司內的蓄積方式，從研發管理模式、組織制度設計與智財管理等面向進行綜合比較。 本研究認為研發能量與知識管理在組織制度中的蓄積，是台灣業界經營管理上常見的盲點，台灣生技新藥業者多重視新技術的研發，普遍對智慧資本其他面向的重視程度不高，但對生技產業而言，扣除資金與技術後，公司的長期競爭力往往都是在組織發展的過程中累積而來的，忽視知識管理與組織制度的養成，對於企業長久發展有關鍵性的負面影響。研究中的個案最終都必須往累積組織資本的方向邁進，若不針對組織資本的蓄積設計恰當的管理方法，為研發人才設計合適的制度與生涯發展管道，將研發團隊的知識能量內化為企業自有資產，只期望以短期的數據績效取得資金支持，忽視智慧資本的管理與培養，並非生技產業長久經營之道。建議生技公司除了聘僱專業經理人處理資金與股東的關係外，也要重視研發長與策略長在組織中的地位，大膽給予權利，調整組織的運作模式，設計出能累積公司能量的專案管理流程，才是生技公司創造競爭力之本。 / In the era of knowledge-based economy, the tangible assets highly-valued by traditional manufacturing industry is no more enough solely to maintain industrial competency. Intangible intellectual assets become more and more important in modern commercial competitions. The intangible assets exist and vary according to different industries. Traditional manufacturing industry looks highly upon trade secrets and brand reputation while patent is the core competency to high-tech companies. Biotech industry belongs to a high knowledge-intensive business and should emphasize more on the management of intellectual assets. Biotech industry is characterized of a complicated system, a long value chain, specialized divisions of labor, and a prolonged timeline of product development. The company assets before the successful commercialization of a product are usually intangible intellectual property and a biotech company during this period cannot be accurately evaluated from traditional financial reports. Hence, compared to other business, biotech companies should resort more actively to appropriate intangible intellectual asset management to achieve a successful redemption of its intellectual assets. This thesis will firstly through the literature study depict the current condition of Taiwan biotech industry and important issues on intellectual asset management and R&D management, inducing several principles of management. Further, the study proceeds with the principles induced to examine three new ventures in Taiwan, Taiwan Liposome Company (TLO), TaiMed Biologics, and InnoPharmax. The discussion will elaborate the practice of intellectual asset management of biotech industry in Taiwan, analyzing and comparing the accumulation of human capital, organizational capital, and relationship capital in the three cases. The study proposes that Taiwan biotech companies usually neglect the accumulation and management of R&D capacity and knowledge in the enterprise organization system. The companies in question invest their resources mostly on the development of new technology and less on other intellectual assets. However, in the long run, the competency of a biotech company accumulates while the organization develops, other than the financial capital and technology. The depreciation of knowledge management and organization system will cause fatal influences on the company. The cases in the thesis must eventually develop their own organizational capital. Biotech companies need to devise appropriate management for organizational capital and preferable career paths for researchers and engineers, to internalize the knowledge capacity of the research team into the company assets. It is not beneficial to a biotech company in the long run to expect financial supports with short-termed achievements, instead of the management and cultivation of intellectual assets. It is advised that other than hiring professional manager for investor relations, the biotech company should pay more attention to the function of CRO and CSO in the organization and sufficiently authorize them into full play. It should also focus on the operation of the organization, adjusting and devising program management to accumulate knowledge capacity, to firmly establish the core competency in a biotech company.

策略的目的是在特定的競爭環境中，憑藉企業的特質條件為它創造競爭地位或發展的方向，也就是創造具競爭性的差異優勢，使企業得以順利發展和持續成長。在競爭的環境中，組織能耐常會隨著時間經過而演化；演化的方式會隨著技術本身的特性、外部市場競爭強弱、與內部的組織與管理特性的差異，而有所不同。除此之外，體制環境會影響整個產業內的創新速率，因而對廠商的能耐演化造成影響。但是在環境急速變動的情況下，組織能耐要完全由內部產生不但不可能，而且其速度亦嫌過於緩慢，再加上現代企業的專業分工網絡，企業必須與客戶、供應商、甚至競爭同業合作，以獲得相關的資訊與技術；在企業的發展歷程中，如何有效提升內部經營管理及促進組織之間的知識交流與能耐移轉，便成為組織管理的重要課題。 本研究以一家台灣本土醫藥公司，在台灣生技製藥產業的架構下，創業、轉型、成長的發展歷程，仔細描述影響企業發展的關鍵因素 ─ 企業策略轉變、環境變動、能耐演化，以及企業內部管理提升，彼此之間如何相互配適，並塑造出企業的獨特發展路徑；茲藉由個案公司過去的回顧，描繪其成長的軌跡，作為其未來發展路徑的參考。 / Under the favorable government policy support and a well-established regulatory environment, there are more and more new start-up companies established in Taiwan biotechnology and pharmaceutical industry in the past dacade. However, most of the new emerging companies are still facing very difficult situation. New drug discovery is one kind of long-term time-consuming and heavily cash-investment-needed business. Besides, Taiwan is a small market in the world. The market potential can not afford to develop a R&D based local pharmaceutical company. However, biotechnology and pharmaceutical industry is a very diversified and versatile industry. Under such circumstances, how does a biotech and pharmaceutical company make use of the limited resources and scarce capital assets to identify the niche market, create a new business model, develop the corporate competence, and construct the internal operation to strengthen the core business and secure a sustainable growth in the industry? Besides, due to the evolution of the modern tools including genomic science, bioinformatics, high-through-put screening machine, and gene therapy, the speed of new drug discovery becomes much faster and much more efficient, but the product life cycle also becomes much shorter. How does a local company play in such a highly competitive, technically professional, and dramatically changed environment? This study tracks the growth path of a local pharmaceutical company to show how the key factors, which are, environmental uncertainty, the development of core competence in the firm, and the choice of a successful strategy by top management and the organization, can be manipulated in the entrepreneurial firm that grows rapidly and formalizes its structure and internal operation. The growth path of the company in the past years could be interpretated as the mutual interactions (dynamic fit) of those key factors. Evenmore, the interaction consequences influence the strategic intent to confront the changing environment, and facilitate the practice of the law and the establishment of a government policy. Besides, in order to improve the whole healthcare system in certain medical care, the company develops a new operation model to run the specific business. Traditionally, most pharmaceutical companies are pursuing market-oriented product management, instead of sales-oriented business management. Nowadays, most multi-national firms are actively involved in disease management to expand the market share of certain disease. However, how to integrate the healthcare system and strengthen individual disease management under the specific healthcare system has become a new operation model of a pharmaceutical company to a specific market segment. The company has to work together and closely with the stakeholders, such as health authorities, medical societies, patient associations, healthcare personnel, and the patients themselves to improve the whole healthcare system and even the policy of the law, regulatory, social, and welfare system in the specific medical care, as well.

有鑑於我國長期以來皆為技術引入國，為強調自主創新，產學合作受到了相當程度的重視，而生技製藥產業的價值鏈長、高風險、高研發成本、高知識內涵等特性，使得產學合作成為生技製藥產業中相當重要的機制。又由於上述的產業特性，使得生技製藥公司在產品上市前，所有的研發投入，皆以「無形資產」的形式，儲存在階段性的開發成果之中，因此，智慧財產的保護與管理，對生技製藥公司而言，確實有很高的重要性，智慧財產若經過妥善的經營與管理，能有效成為企業的競爭優勢來源。 本研究即以生技製藥產業之產學合作為前提，針對智財管理與企業策略因子，以產業方的觀點，探討「產學合作－智財管理－企業營運模式」三者之間的關連性，並從智財管理的四大內涵－「創造、保護、管理、運用」作為分析之構面，釐清重要議題與關鍵因素，以作為日後雙方架構合作與管理模式之依據，達到知己知彼，互信合作，創造雙贏的綜效。 本研究以個案訪談方式，訪談台灣微脂體、台灣東洋、世基生醫三間國內生技製藥公司，並根據訪談結果之分析與彙總比較，得到研究發現並提出建議如下： 1. 生技智財策略與其營運模式有關，受到獲利方式影響而採取不同的智財策略。 2. 生技產學合作成果，「權利歸屬」之模式多元化，與該成果距離商品化之成功率有關；此外，「先專利、後發表」的慣例已普遍採用，無保密與公開之衝突。 3. 智財專責部門的設立與人數配置，應隨企業的成長而增置，人才網羅應以生技背景之跨領域專業人才為主，且需經過商管課程之訓練，方能對產業發展與競爭脈動有所掌握。 4. 產學合作成果運用，與企業核心能力與互補性資產掌控度有關，國內廠商而言，「對外授權」仍然必要；運用訴訟的方式與否，與「智財策略」有關聯，並受成本因素之影響。 5. 產業方應主動積極參與產學合作，由於學界缺乏商品化之經驗，技轉辦公室現階段亦無法充份發揮功能，因此，由產業方積極參與產學合作，能以產業方敏銳的商業嗅覺協助學界補捉具有潛力的研究，發揮引導之功能，使前瞻研究能進入應用階段，而實際造福人群，同時帶動產業的活絡發展。 / Regarding that Taiwan is always in the position of “technology transfer licensee”, to emphasize the goal of innovation, academic-industrial collaboration has becoming an important issue. Especially with regards to the features of bio-pharmaceutical value chain, such as compartmentalization, high risk, high return, highly knowledge-based, the investment input is thus transformed into the form of “intangible assets”before the product actually launched. Therefore, the protection and management of intellectual property is critical to bio-pharmaceutical companies. If IP is properly managed and utilized, it could become a source of competitive advantage. This thesis is based on the study of bio-pharmaceutical academic-industrial collaborations, from an industrial perspective, focusing on IP management and strategy. Four components of IP management－development, protection, management, and exploitation, is set as major constructs of this thesis. The primary goal of this study is to find important issues and key factors toward a successful collaboration. This thesis studied three bio-pharmaceutical companies, Taiwan Liposome Company, TTY Biopharm, and Pharmigene. According to results of interviews and analytical comparison, this thesis concludes some findings and suggestions as follow: 1. The IP strategy of a bio-pharmaceutical company is related to its business model. Different profitable models should apply different IP strategies. 2. The way which academia and industry allocate the IP right and interest is diversed, according to the risk and commercialization successful rate of the collaboration. Also, “patent goes first, publication goes after”is a common route. Therefore there is no collision between secrecy and openness. 3. The establishment and expansion of in-house IP department should go in accordance with the growing of company. It is necessary for an accountable one to be bio-tech educated and further received MBA training, in order to be competent to business competition and strategic planning. 4. The exploitation of collaboration is in relation to company’s core competence and complementary assets. For Taiwan bio-pharm companies, the“licensing out”model is necessary. With regards to litigation, the attitude toward litigation is related to its IP strategy and cost of litigation. 5. The industrial part in such collaboration should take an active attitude, because the academic part lacks commercialization experience. It would be helpful for industry to guide and help capturing valuable study in academia, therefore makes radical innovation an usful one.