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.

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.

本研究透過個案研究，運用資料包絡分析法(DEA)的評估方式，分析製藥業在不同生命週期及通路上資源分配之行銷策略與銷售績效之關聯性。研究結果發現： 一、不同生命週期「成長期」、「成熟期」及「衰退期」產品，其整體銷售技術效率、純銷售技術效率與銷售規模效率之差異，均達統計上之顯著水準。「成長期」產品效率值最差、「成熟期」產品效率值次之、「衰退期」產品效率值最佳。 二、不同生命週期產品在主要銷售通路醫學中心、醫院、診所與藥房的銷售比重不同。「成長期」與「成熟期」產品的主要銷售通路均在醫學中心，而「衰退期」產品的主要銷售通路在藥房。其銷售績效差異在醫學中心與藥房通路，衰退期產品與成熟期、或成長期產品比較，均達到統計上之顯著差異水準，但在醫院與診所通路的銷售績效，三類產品族群的差異就不明顯。 三、個案藥廠對其主要銷售的藥品，雖然都有非常明確的個別產品銷售策略與目標，但差額變數分析結果顯示，仍有部份產品在資源分配及運用上，可以加以改善以提高銷售績效。 / This research is conducted using Data Envelope Analysis (DEA) assessment method to analyze the particular pharmaceutical company on the association between marketing strategy and sales performance with different life-cycle products and sales channels. The results are as follows: 1.Sales performance appears significant differences among different life-cycle products with respect to the overall technical efficiency、pure technical efficiency and scale efficiency. The results revealed that products in「Growth Stage」had the worst efficiency performances, 「Maturity Stage」products placed the second, and「Decline Stage」products were the best. 2.Sales weight differs from different life-cycle products in the major sales channels of medical centers, hospitals, general practitioners and drug stores. The main sales channel of「Growth Stage」and「Maturity Stage」products are in medical centers；while「Decline Stage」products are in drug stores. Statistics showed that the sales performance differed substantially when the three different life-cycle products were distributed to sell in medical centers and drug stores; however, the results were not as evident in hospitals and general practitioners channels. 3.Although the case pharmaceutical company has very clear sales strategies and goals for its individual products, the analytical results showed some changes could be made to improve sales performance.

本論文之研究動機乃基於個人在醫藥相關領域多年的工作經驗，了解台灣製藥業現正處於內需小、廠商多、競爭愈來愈激烈且相互分食之市場環境，加上在現行醫療健保體制及政府相關政策(如cGMP制度)的影響下，尚需面對台灣未來加入WTO可能之衝擊，台灣製藥廠商如何依公司資源優勢尋求聯盟，以提升競爭力，使得企業能夠永續經營，是本研究之動機所在。基於上述之研究動機，本研究以台灣製藥業者為對象，探討下列的問題：(1)聯盟動機與聯盟型態之關係；(2)組織特性與聯盟型態、聯盟管理之關係；(3)聯盟型態與聯盟管理、聯盟績效之關係；(4)聯盟管理與聯盟績效之關係。本研究欲達成之目的有：(1)解析出台灣製藥業所採行之策略聯盟方式，及其如何經由不同之聯盟，以提升企業競爭力；(2)藉由本研究之發現，提供產業內的其他業者於日後進行策略聯盟時之參考。 本論文之研究架構，係由個人之實務經驗，加上參考相關之文獻推導而成，並依架構中各變數之關係設計出問卷，以問卷與訪談併用之方式，鎖定台灣製藥業四家知名企業為訪談對象，推展出四大類命題：聯盟動機、組織特性、聯盟型態及聯盟管理。 經由第五章之個案分析發現，台灣製藥廠商之聯盟方式主要以研究發展聯盟、生產聯盟及共同行銷聯盟為主；在策略聯盟中以降低風險及資源互補為主要動機；另在分析過程中亦發現，學理所稱聯盟管理為影響聯盟績效之重要因素，此點對台灣製藥業而言亦得出相同結果。研究中同時發現，台灣製藥廠商雖已逐漸重視國際化課題，然國際化發展策略及整體規畫仍嫌不足。 在研究過程中，已儘量追求結構之完整，逐步撰寫、推導對台灣製藥業現行策略聯盟之分析，惟仍不免有許多主客觀因素，形成本研究之限制。在後續研究上，建議後續研究者可針對本土規模相當之大型製藥公司間如何進行合作、研擬製藥業相互專業分工或轉型之道、或分析國際化的最佳步驟與途徑等，為台灣製藥業找出值得發展的新契機。