有鑑於生物科技成為科技趨勢，以及其創造出的龐大價值，近年來台灣也開始大力推動生技產業的發展。產業是企業的組合，企業的成長與否正是驅動產業生態變化的主要原因。本研究主要探討台灣生技藥物研發公司的創業過程，希望透過研究成果對台灣生技公司的發展有所貢獻。 　　本研究的研究架構以Timmons Model做為主軸，以機會、資源、團隊做為主要的研究構面，先對個案公司進行靜態的研究構面探討，然後分析其發展的動態平衡過程。 / Because biotechnology sets a trend and creates great value, Taiwan government tries to develop his own biotechnology industry. However, an industry will bloom if most of companies related to the industry are operated well. The objective of this study is to observe and analyze the entrepreneurial process of biomedical R&D companies in Taiwan. 　　The research bases on Timmons Model that was developed by Timmons for analyzing an entrepreneurial process of a company and consists of three driving forces, opportunity, resource, and team. Every entrepreneurial process of companies in the thesis is observed first according to the three driving forces. Then it is analyzed by using the idea of constant balancing.

University of Macau / Institute of Chinese Medical Sciences

生物科技之專利對於生物科技產業之重要性更是不可言喻。由於生物科技發展之特性，例如：高度不確定性、研究週期長、投資成本高等因素，許多發明人在申請生物科技專利時，都試圖擬定較廣泛的申請專利範圍。「延展性申請專利範圍」（reach-through claims）為基於目前專利說明書揭露之內容來涵蓋所有「未來」可能衍生之產物；或是某特定化合物尚未被確認前，試圖藉由一個上游基礎研究「先驅型發明」之申請專利範圍擴大延展至下游後續發明之商業產品，這非但會箝制技術後續之發展，更可對已存在之先前技術主張侵權，影響範圍極廣。從2004年University of Rochester v. G.D. Searle案 和2010年Ariad v. Eli Lilly案 ，美國聯邦巡迴上訴法院皆認為「延展性申請專利範圍」無效，歸因於專利內容未清楚揭露而不符合美國專利法第112條第1段中所規定的「可據以實施性」和「書面說明要件」。2013年德國聯邦最高法院對同是屬於「延展性申請專利範圍」之Probiodrug案與前述兩件美國相關判例有分歧之見解和判決。有鑑於此，本文以比較法觀點分析國外相關判例及實踐標準，全面性針對生物科技領域「延展性申請專利範圍」問題進行探討，嘗試建立一最適的法律模式，並期許未來可作為我國對其相關法制與解決方案之參考依據。

學術研究機構向來是科技創新的主要動力來源，許多與人類生活息息相關的發明多半來自於學術研究機構此一孕育創新的搖籃。此外，一個國家的學術研究能量往往也反映了該國的技術能力與競爭力，因此世界各國無不投注大量資源於大專院校及研究機構，期望除了學術產出之外，亦能將原始的創新概念透過研發活動轉化為智慧財產，並進一步將其商業化，滿足市場需求，實現知識之最大價值。 我國之學術研究能量並不落於美、歐、日等主要技術領先國之後，從我國政府投注於學術研發活動之經費、歷年發表於SCI、EI等期刊論文以及取得美國專利之數量等科技發展成果指標便可說明此點，然我國於1999年通過與美國拜杜法案意義相當之科技基本法至今已滿九年，各學研機構之專利申請量雖有成長之勢，然而2007年實際之智慧財產權收益卻僅佔研發總投入費用的0.87%；2005年全國技術貿易額收支比僅達0.23，與美、日、英等國相較，實可謂差強人意，顯見我國在研發成果商業化上已面臨一定瓶頸。 在知識大爆炸方興未艾的二十一世紀，可以預見的是將有越來越多的研發成果持續產出，學研機構花費於取得並維護智慧財產之費用亦將持續提高，如何在產出的眾多研發成果及專利中，篩選出真正有商業化潛力之標的，以將有限的人力、時間、資金等資源投注於其上並轉化為實質的經濟效益，將是學研機構進行研發成果商業化時的重要課題；此外，在學研機構法人化之潮流下，若未來大學等學研單位須自行負擔大部份資金之籌措時，此一評估機制將更顯重要。另，在資訊高度不對稱的情況下，技術需求方難以辨認技術供給方之技術是否為適合之交易標的，因此若能建立一套商業化可行性評估機制，亦能使雙方間之資訊交流更為順暢，促進技術之移轉與商業化。 因此，本研究嘗試提出一研發成果商業化可行性評估機制，以供學研機構進行內部評估，使國內「悶住」的研發能量得以透過有效的評估機制而活化。又，由於不同科技領域所適用之商業化可行性評估方式將有所差異，而生物科技領域為二十一世紀科技發展中之重要領域，且列為政府政策下的重點發展產業之一，加以作者本身之相關學經歷背景，是以本研究選擇生物科技領域研發成果為討論之重點。 本研究分別從5W的角度來探討研發成果商業化可行性之評估機制，分別是進行商業化可行性評估之目的(Why)、進行商業化可行性評估之時點(When)、商業化可行性評估之執行者(Who)、評估所需資訊之取得(How)以及進行商業化可行性評估時所需考量之因素(What)，最後建立一研發成果商業化可行性評估機制，作為本研究之核心概念以及後續個案探討之依據。 此外，本研究針對研發成果商業化可行性評估之各項構面進行介紹，並提出學研機構於進行評估時在各構面應考量之重要項目與問題。依所建立之評估機制與架構流程，將評估構面分為技術、智慧財產、市場、法規與財務五大構面，並以技術與智慧財產構面為探討之重點。 由於本研究之研究對象為學術研究機構，且以生物科技領域為重心，故由大專院校、基礎研究機構及應用研究機構中各挑選一具代表性之單位作為個案研究對象，分別為國立陽明大學、中央研究院以及財團法人工業技術研究院，透過與各機構之研發成果管理專責單位進行訪談，深入了解其運作機制與現況，以期綜覽各類型學研機構之研發成果商業化可行性評估機制，並得出研究發現及建議。 根據個案研究之發現，本研究對於國內學研機構之整體建議，主要包括：研發成果商業化可行性評估機制應依機構之目的、性質、智財管理現況加以擬定；研發成果商業化可行性評估之構面應配合研發成果之性質及開發階段而設定，並以技術構面為基礎，智財構面為樞紐連結市場與法規構面之評估，最後以財務構面進行統合；而學研機構若欲採外部審查方式執行評估工作，須考量可能之缺失；此外，研發成果商業化可行性之評估應由具備跨領域能力之團隊加以執行，並應使具備產業經驗與市場背景之人員有一定程度之涉入；再者，生物科技領域研發成果因其本質上之特殊性，故於進行商業化可行性評估時，有諸多因素需加以考量；最後，政府可主動協助建立專業之機構或團隊，提供學研機構進行研發成果商業化可行性評估甚至後續之技術行銷服務，以有效符合規模經濟、範疇經濟與專業、客觀之考量。 / Academic and research institutes are the origins of technology innovation. Many of the significant inventions were devised in these cradles of innovation. Academic and research power can often indicates the technology capability and competency of a nation. Every government invests vast resources to universities and research institutes in order not only to make academic publication but also to realize the maximum value of the knowledge through converting the innovative ideas into intellectual properties (IP) and further commercializing the R&D achievements to meet the market needs. The academic researches in Taiwan can compete with the technological leading countries such as the U.S, Japan, and E.U. countries, in terms of some science and technology indicators like R & D expenditure, SCI / EI publications, and the number of U.S. patent granted. Nevertheless, the actual revenue generated by IP in 2007 was only account for 0.87% of the total R&D input and the coverage ratio of technology balance of payments was only 0.23 in 2005. The fact indicates that there were some barriers on the path of R&D commercialization in Taiwan. In the 21st century of knowledge explosion, it is predictable that more and more R&D achievements will be generated from academic institutes and the expenses devoted to the acquisition and protection of IP will keep rising. Therefore, it will become a critical issue in academic institutes to sieve out the targets of the higher commercial potential from numerous R&D results and patents so as to concentrate the time, human and financial resources on those targets for its further commercialization. Moreover, under the highly asymmetrical information situation during the technology trading, technology buyers have difficulty in identifying whether the technology is a suitable trading target or not. A well-established feasibility evaluation mechanism will also stimulate the interflow of information and promote the technology transfer and commercialization. Accordingly, this thesis will try to establish a feasibility evaluation mechanism (FEM) for commercialization of R&D achievements in academic institutes in order to activate the stuffy R&D energy in Taiwan. Biotechnology is one of the most important fields of technology in the 21st century and thus be the main concern of the discussion of this thesis. This thesis will investigate the feasibility evaluation mechanism for commercialization of R&D achievements on a “5W” basis, including the purposes of evaluation (why), the time of evaluation (when), the executives of evaluation (who), the information needed in the evaluation process (how), and the factors that should be taken into consideration in the evaluation process (what). Accordingly, a feasibility evaluation mechanism for commercialization of R&D achievements will be established as the central concept of this study and as the ground of follow-up case analysis. In addition, each aspects of feasibility evaluation as well as the significant issues and questions of each aspect will be illustrated in this study. According to the feasibility evaluation mechanism and framework established in this study, there are five main evaluation aspects including the technical aspect, intellectual property aspect, market aspect, legal aspect, and financial aspect. The main subjects of this study were the academic institutes in biotechnology field in Taiwan, the National Yang-Ming University, the Academia Sinica, and the Industrial Technology Research Institute (ITRI). These institutes are chosen as the subjects of case study standing respectively for the higher education institute, basic research institute, and the applied research institute. By way of interviewing the personnel of R&D achievements and IPR management department in the institutes in question, the feasibility evaluation mechanism implemented by different types of academic institutes was investigated to delineate the key findings, followed up with some practical advices. The overall advices proposed by this study for the academic institutes in Taiwan were summarized as follows: (1) The feasibility evaluation mechanism for commercialization of R&D achievements should be devised in accordance with the purpose, the nature, and the IP management status of each institute. (2) The feasibility evaluation should be set to match up the development stage of the R&D achievements and take the technical aspect as the groundwork, IP aspect as the pivot connecting to the market and legal aspect, and the financial aspect as an integrated result. (3) Evaluation executed by external parties may be of some defects that should be taken into consideration. (4) The feasibility evaluation for R&D commercialization should be executed by multi-disciplinary team and the industry-experienced or market personnel should as well participate in the evaluation process. (5) Due to the characteristics of biotechnology, many special factors should be involved in the evaluation process. (6) The government may actively assist in setting up a professional organization or team to provide feasibility evaluation and even the further technology marketing services to meet the consideration of economies of scale/ scope, specialty, and objectivity.

University of Macau / Institute of Chinese Medical Sciences