在各大藥廠明星藥品專利到期、新藥開發數量銳減的當下，全球首例植物新藥MediGene Veregen™ 的核准上市為製藥產業帶來新的希望，雖然製藥價值鏈與商品化模式已為人所熟知，但針對植物新藥特殊性所架構之商品化模式還是一個全新的議題，為了架構一個適合台灣中小型藥廠的植物新藥開發模式，本研究嘗試以技術層面為根基，從法規面、產品面與產業面深入探討MediGene Veregen™ 關鍵的成功因素，從中獲取值得台灣藥廠參考的經驗，同時考量台灣植物新藥開發的大環境限制因素，包括法規與健保，給予台灣藥廠一些植物新藥商品化策略建議。 本研究之架構以實務觀點出發，首先整理參考文獻以探討植物新藥包含的範圍與藥品開發流程，幫助藥廠了解植物新藥商品化需要具備的條件與資訊；接著針對台灣與美國在植物新藥方面審查上市之法規、流程與審核成果進行研究，結果顯示目前台灣有兩種植物新藥審查系統「中藥新藥」與「植物抽取新藥」，對廠商而言並不如美國單一系統來得便利；再者藉由探討植物新藥的價值鏈結構、法規結構、產品結構與產業結構，試圖架構植物新藥商品化模式；接下來以兩家新藥開發廠商為例進行實際個案研究，一家為成功推出植物新藥商品的德國藥廠MediGene AG，一家為台灣藥廠中天生技/合一生技，主要藉由分析MediGene Veregen™ 商品化過程的關鍵成功因素，比較中天生技/合一生技WH-1商品化模式的異同，探討是否有足以借鏡與改進之處。最後，歸納整理上述的研究做出結論，並且對於台灣藥廠提出策略建議，希望能對於台灣新藥開發公司有實質上的幫助。 / While the star drug patents of each big pharmaceutical company are expired one after another and the quantity of their newly developed drugs sharply declines in these years, MediGene Veregen™, the first botanical new drug in the world, enters the market and therefore brings a new hope for the pharmaceutical industry. Although the value chain and the commercialization model of pharmaceutical industry have been known and researched a lot, the specific construction of commercialization model for botanical drugs is still a brand new subject. In older to construct the model that is suitable for Taiwanese middle and small pharmaceutical companies for the process from development to commercialization of botanical new drugs, this research, based on the technical analysis, attempts to discuss the key success factors of MediGene Veregen™ through analyzing the aspects of the laws, regulations, industry and product itself. With the case study about the environmental limited factors of new drug development in Taiwan, including the laws and regulations as well as the health insurance, this research tries to offer Taiwan pharmaceutical companies some strategic suggestions for the development and commercialization of botanical new drugs. The structure of this research is based on the practical viewpoints. First, we reorganize the reference in order to define the scope of botanical new drugs and the processes of drug development. It can help pharmaceutical companies understand the conditions and information needed for botanical new drug commercialization. Then, our studies focus on the laws and regulations in Taiwan and the United States, as well as the application processes and approvals for botanical new drugs. The results show that there are two evaluation systems in Taiwan for botanical new drug applications. For those pharmaceutical companies, the dual system is not as convenient as the sole evaluation system in the States. Furthermore; based on the discussion on the structure of the value chain, laws, regulations, product and industry, this paper makes an attempt to construct a better commercialization model of botanical new drugs. Next, two pharmaceutical companies are chosen as case study in this paper. One is a German pharmaceutical company, MediGene AG, which launched the first botanical new drug. The other is a Taiwan pharmaceutical company, MicroBio Co., Ltd/Oneness Bio-Tech Co., Ltd. By analyzing the key success factors in the commercialization process of MediGene Veregen™ and comparing its commercialization model with MicroBio Co., Ltd/Oneness Bio-Tech Co. WH-1, we try to get any valuable idea and insight. Finally, our conclusion and strategic suggestions may have solid help for Taiwan botanical new drug pharmaceutical companies.

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。

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.

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)

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.