Standardization, IPRs and Open Innovation in Synthetic Biology

Abstract

Innovation finds itself embedded in an expanding milieu of openness these days, which is closely connected to the increase in knowledge flows across traditional boundaries of scientific disciplines, geography, languages, businesses, institutions, markets, professions and subjects. The general concept of openness assumes many forms and variations depending on the context. The idea of openness has also found its way to the emerging technological area of synthetic biology (SB). SB applies the principles of engineering – abstraction, decoupling and standardization – to the study of biology. This includes the design and construction of new biological parts, devices and systems, and the re-design of existing natural biological systems. Due to recent advances in nanotechnology, automated strain engineering, protein modification, DNA synthesis, and related technical standards, these activities rapidly boost both the sophistication and scope of genetically encoded functions. This enhances the development of complex integrated biological systems that can be customized to optimize various industrial, medical, or agricultural applications. Spurred by the great promises of SB, public and private investments in SB have increased dramatically. Meanwhile, the inherent dangers of this technology, as well as the numerous scientific, socio-economic, ethical, regulatory, and legal challenges posed by SB, remain a multifaceted conundrum. One of the many different legal issues concerns the questions of how to best enhance the scientific advances of SB and how to best stimulate and govern its translational exploitation towards useful applications.

Keywords: standardization, open innovation, synthetic biology, intellectual property rights