Intellectual Property Management of Academic-Industrial Collaboration in Biotech-Pharmaceutical Industry

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