Digital sequence information–legal questions for patent, copyright, trade secret protection and sharing of genomic sequencing data

Abstract

Advances in sciences–both in molecular biology and information technology–have enabled new understandings of genetic resources and biological processes which lead to an ongoing fundamental paradigm shift. The phenomenon of big data resulting from genomic sequencing has emerged as a consequence of next generation sequencing technologies that generate large data sets in biotechnological research. Technical progress in such big data generation and management has opened previously unprecedented possibilities for research, the development of new products and leads to a vast amount of data being generated at an unprecedented speed, ranging from the extraction of information to data analysis and interpretation. While there will always remain a reliance on genetic materials, one may observe a trend that research and development activities using genetic materials are increasingly supplemented or substituted by computerized research activities based on digital sequence information (DSI). These developments lead to a revolutionary transformation in the use of genetic resources (GR), which is currently undergoing radical changes and may be considered as a “fourth industrial revolution”. It results not only in exponential growth of generated genetic data, which may lead to innovation and new products and services, but also poses a range of new regulatory and legal questions due to its specific characteristics. The rise of big data raises specific legal challenges in terms of data ownership and intellectual property, data stewardship and governance, as well as technology transfer and licensing. One example is the question on how to regulate access and benefit-sharing for plant genetic resources and regulatory approvals for gene-edited plants as a result of new genomic technologies, which illustrates the use of DSI as an essential tool for research and development along with the requirements to exchange such information. Existing exchange mechanisms include, for instance, open-access databases and DSI platforms. Their data access and exchange policies would presumably be intended to maintain consistency with the objectives, policies and regulations of the Access and Benefit-Sharing system (ABS system). A large number of these questions are currently subject to discussions on an international, regional, as well as on a national level. This paper shall shed light on some of these questions to reflect the current and ongoing discussion on the issue and focus on the protection of DSI and address the question of the application of ABS systems to DSI.