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Browsing by Author "Bützow, Alexander"

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  • Bützow, Alexander (2017)
    The work in question seeks to set a relatively novel form of biotechnology, synthetic biology, in the frame of European intellectual property law, with an additional focus on patent law. The primary questions that the thesis seeks to address are 1) is synthetic biology structurally incompatible with existing forms of patent law, and 2) if some incompatibility is evident, what measures are best suited to ameliorate it. Methodologically, the thesis is heavily oriented towards a combination of legal dogmatics for descriptive sections and a classical law & economics approach for the normative sections. The specific form of synthetic biology discussed in the thesis is the so-called biopart-approach (also known as biobricks), which seeks to standardize DNA and other cellular material into modular units, which can subsequently be constructed into devices and systems, implemented in a minimal genome chassis, resulting in a synthetically constructed organism. Such organisms may exhibit properties which are more commonly associated with e.g. computers. The fundamental difference between synthetic biology and other forms of genetic engineering is the introduction of true engineering principles, mathematical modelling, standardization, quality characterization, and modular construction. The research community involved in synthetic biology exhibits two distinct forms of IP practices: the IP frame is a continuation of pre-existing practises in biotechnology, in which innovations are typically appropriated through patenting. The A2K frame seeks to limit the role of IP concerns in the development of synthetic biology, somewhat analogous to how the computer operating systems market is divided into proprietary actors and open source advocates. It is taken as a matter of course that the A2K frame will not exhibit major issues in innovation being hindered from within their own group. However, the same cannot be said in regards to the IP frame. The bioparts, devices, systems and chassis, along with all of their requisite enabling technologies, biotechnological standards, and research tools are patentable subject-matter as defined in the Biotechnology Directive and EPC. One section of the thesis is devoted to exploring the implications of both EU and EPO jurisprudence on the patenting of synthetic biology. The main focus of the latter part of the work concentrates on the fact that many of the aforementioned elements of the bioparts approach are complementary goods. This raises a problem when they are granted in a disaggregated manner, as licensees must conduct a series of non-coordinated negotiations with multiple patent holders to obtain the upstream patents needed for the development of downstream commercial applications. This fragmentation of exclusionary rights is called an anticommons. Furthermore, patent claims may not be entirely independent, with the production of a seemingly discrete technology requiring the licensing of multiple overlapping input patents. This configuration is called a patent thicket. Given the international nature of synthetic biology research, and the ever increasing strain on patent offices and its concomitant effect on patent quality, it is possible that synthetic biology will exhibit both phenomena. Despite the difference in origin, these phenomena result in a similar series of market failure, namely a) royalty stacking, b) patent hold-up, and c) suboptimal transaction costs in the form of high bargaining costs and search costs. These problems exacerbate each other, and they tend to exhibit a somewhat monotonic relationship with increased patenting. Both anticommons and patent thickets are well-known and studied in relation to e.g. the ICT and semiconductor industries. The last section of the thesis explores various options to resolve both the anticommons and patent thicket. The options are divided into market solutions, such as cross-licensing, patent pooling and patent clearinghouses, as well as patent policy tools, such as patent quality management, public institution participation in the IP market and the role of courts as potential arbiters of innovation and utility. An underlying theme in the work is the presumed advent of the unitary patent system, as well as its accompanying Unified Patent Court, and their effects on the incentive structures of actors within the IP frame.