生技新藥產業是指使用於人類及動植物用之新藥及高風險醫療器材之產業。而生技新藥產業與醫藥產業，在目的上均與人類及動植物用藥或醫療儀器相關；差異之處在於目前的生技醫藥產業相較於20餘年前的醫藥產業，多了生物技術的應用，產業結構由大型藥廠垂直整合演變為非營利組織、生物技術公司、大型藥廠分工的形態。總結來說，生物技術是生技新藥產業的重要組成要素，而生物技術的興起，則改變了過去醫藥產業產品與技術的組成，也改變了產業結構。
生物技術產業或醫藥產業是全球各國競相發展的產業類別，我國亦不例外；其中，美國無論於生物技術或醫藥產業的發展，均居於全球領先的地位，其成功必然有可以提供我們討論或學習之處。而在知識價值鏈的體系中，美國大學更扮演著提供創新以及產學合作的重要角色，對於全球生技新藥產業的進步有重要的貢獻。從而本研究以美國為標的，研究產業的發展歷程，並進一步以產業之觀點，探討大學產學合作的模式以及智慧財產管理，希望能供我國大學與產業實務發展的參考。
從美國生物技術與醫藥產業發展的歷史與經驗，本研究歸納出生物技術產業興起的因素，與1980年代發生的基礎科學上的突破性發展、拜杜法案的通過、專利法將生物技術的發明納入保護範圍，三項因素有關。另外，由大學所提供的創新，透過密切的產學合作、授權與技術移轉、企業間的策略聯盟等方式，於知識的價值鏈中流動並增加價值，而大學提供創新的人才，往往也是創業者和重要的經營者。
本研究認為，美國大學對生物技術發展具有重要性的貢獻，其中，大學內部創業與大學智慧財產的管理特別值得討論。在大學內部創業方面，美國大學不但鼓勵創業，並制定股權政策，允許新創公司以股權取代部分的授權報酬，給予新創公司實際的協助。透過限制大學持股比例與禁止大學擔任董事或參與董事投票活動之原則，則可兼顧大學避免利益衝突與公司專業經營的需求。
在大學智慧財產管理的部份，本研究認為加州大學系統的智慧財產管理方式，採用網路式的授權與技術移轉組織，將各校區共同的需求如政策、法務、資訊技術與通訊等活動統籌處理，而將需與發明人和企業密切交流的活動如授權與技術移轉的活動交由各校區的授權與技術移轉中心負責。透過此種統籌與分工管理的方式，能夠兼顧減少營運成本與增加授權效率的功能。
經由本研究節果，建議我國的大學可採用網路式的授權與技術移轉組織之概念，除各校之授權與技轉中心外，聯合設一統籌政策、法務、智慧財產資料庫之管理機構，並對大學持有公司股份、鼓勵創業、避免利益迴避等議題制定一致的政策，方能有效利用資源並發揮大學創新的價值。 / Biotech and new drug development industry are targeted toward the development of drugs for human, animal, or plant use. This also includes the high-risk industry in medical devices. Although the pharmaceutical industry shares common objectives, the biotech and new drug industry emphasizes on applications in biotechnology and its industrial structure is composed by non-profit organizations and biotech dedicated firms. While biotechnology forms the basis to the biotech and new drug industry, the improvement of biotechnology also changed the interaction between the pharmaceutical products and technologies as well as its industrial structure.
Biotechnology and pharmaceutical industry have received considerable attention around the world, including Taiwan. Since U.S. has been the leading country in the development of biotechnology and pharmaceutical industry, we can surely learn from its success. In particular, universities in the U.S. have played a crucial role in providing innovation and promoting university-industry cooperation and resulted in significant contributions to the progress of global biotech and new drug industry. Thus, this study will investigate the development of the industry within the U.S. by dissecting the various university-industry cooperation models and the management of intellectual property rights. Results from this study will hopefully shed some light on bridging our university with industry for further practice operation.
By examining the U.S. biotech and pharmaceutical industry, this study has concluded that breakthroughs in fundamental, the passage of Bayh-Dole Act, and the inclusion of biotechnology into patent law science in 1980s are responsible for the rise of biotechnology industry. In addition, active university-industry cooperation along with licensing, technology transfer, strategic alliance among enterprises and information flowing in the knowledge value chain added the value of the innovation provided by universities. In many cases, the university has not only provided innovation, but also a source for future leaders that would take on role of the founders or head of project management.
The U.S. universities have made significant contributions to the development of biotechnology by establishing entrepreneurship programs, intellectual property rights management, and often providing substantial assistance in business start-up. One type of assistance is rendered through regulating policies on equity that allows start-up companies to provide equity in place of part of license fee. In order to avoid a “conflict of interest”, universities should be limited of their possession of industry equity, which can prevents them from taking part in the company as the board director or members.
In terms of the management of intellectual property rights, the measures of management of the University of California system can help diminish operation cost and enhance licensing efficiency. University of California system resorts to Technology transfer in a distributed institutional network that feed the common needs from each campus such as patent policies, general counsel, and information technology and communications. A licensing and technology transfer center (OTT) on each campus will follow a system wide license and technology transfer process between the inventor and the enterprise.
In conclusion, it is recommended that our university could adopt the concept of network licensing and technology transfer. Through an overall arrangement, a management institute can be established to regulate the planning of policies, provide general counseling, and build a database of intellectual property rights aside from the existing licensing and technology center of each university. In the best interest of the developing biotech and new drug industry, universities should initiate policies with regard to equity holding limitation, encouragement of start-up business, and the avoidance in the “conflict of interest” so the industry may effectively utilize university resources and demonstrate its innovative values.
| Identifer | oai:union.ndltd.org:CHENGCHI/G0923610121 |
| Creators | 江雅鈴, Chiang, Ya Lin |
| Publisher | 國立政治大學 |
| Source Sets | National Chengchi University Libraries |
| Language | 中文 |
| Detected Language | English |
| Type | text |
| Rights | Copyright © nccu library on behalf of the copyright holders |
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