| Summary: | 碩士 === 東吳大學 === 法律學系 === 94 === The biotechnology industry has been called the emerging industry of the 21st Century, and is a classic knowledge economy industry. With the development of technology, biotechnology has revealed potential for diverse application, including in medicine, agriculture, food, environmental protection, energy, and industry – all of which allow development of biotechnology application. At the same time, in comparison to traditional industries, biotechnology has the advantages of low- pollution and energy-efficiency, so it is also called the green industry. From this, it can be known that development of the biotechnology industry not only beneficial for the elevation of citizen health and safety, but also has proactive and positive implications for the long-term development of the national economy, thus this is a key direction for development for many countries. In Taiwan Executive Yuan’s “Challenge 2008 National Development Plan” and the Two Trillion Twin Stars Industries Development Plan, biotechnology was also expressly listed as a key point of development for the nation. However, the successful development of an industry is not only based on private efforts; whether an overall atmosphere conducive to the industry can be created in national regulations and government policies is exceedingly important.
Globally, the United States is now the most successful country at developing the biotechnology industry. Whether it is the aspect of techniques, finances, regulation, or policy, it has points from which is worth learning. Because biotechnology emphasizes the control and application of techniques, this paper focuses on patent law, in relation to knowledge protection, and the Bayh-Dole Act of 1980 responsible for transferring research results under government subsidy. This paper not only introduces the legislative developments and trends of related regulations, but through using empirical data from related literature, also discusses the role of such regulations in the development of American biotechnology industry and reactions of industry, government, academia, and researchers. Additionally, in terms of the patent issue, this thesis analyzes and introduces the problems of genetics, stem cells, transgenic animal patents, and biotechnology patent securitization. In terms of technology transfer, this thesis uses actual cases to explain the operational conditions of intervention rights (march-in rights). The influences on academic ethics and research caused by the Bayh-Dole Act, which changed the interaction between industry and academia, are also addressed. Additionally, this thesis also makes comparisons between Taiwanese and American patent systems in terms of biotechnology development and protection, as well as the regulation of the Basic Law of Science and Technology on government- funded research and development results transferred to private industries, to understand whether there are still shortcomings of domestic regulations. At the same time, practical experience is borrowed from America, which is used propose possible developments for the future.
In summary, this thesis sees a great degree of influence in patent protection in the process of biotechnology industrial development. For parts with which Taiwan has a great degree of research and development capabilities but are unprotected by patents, such as transgenic animals and plants, these should be opened after supplementing regulation has been established. Additionally, for the existing biological invention evaluation standards, there should be a more concrete determination rubric for the essential items of examination, so that the industry has a basis to follow. In the system for transfers of results in government-funded research and development, program executive agencies should be offered the option to retain research and development achievements. In terms of government intervention, it should definitively clarify not only the elements that trigger rights. Additionally, the nationalizing requirement in intervention should be eliminated. Furthermore, this thesis also suggests to related authorities that monitoring and control mechanisms should be realized, so that the Basic Law of Science and Technology can truly promote development of national technological industries.
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