Public Biological Databases and the Sui Generis Database Right

IIC https://doi.org/10.1007/s40319-023-01373-0 ARTICLE Public Biological Databases and the Sui Generis Database Right Alexander Bernier . Christian Busse . Tania Bubela Accepted: 31 July 2023  The Author(s) 2023 Abstract The sui generis database right is an intellectual property right created in the European Union to stimulate investment in the curation of databases. Since its inception, communities engaged in research and development efforts have questioned its potential to incentivise database production, and posit that it stifles productive downstream uses of existing datasets. European courts have restricted the right’s ambit through a restrictive interpretation of the circumstances in which it applies, which we argue, enables downstream use of biological databases. Nonetheless, residual ambiguities about potential infringement of the right exist. The prospect of unintentional infringement can frustrate downstream innovation. These ambiguities are compounded because the criteria that determine whether or not the right applies are reliant on information that is not available to the prospective downstream users of public datasets. Repealing the sui generis database right is recommended. Legislatures are advised to refrain from the implementation of broad novel intellectual property rights in the future, without first adopting safeguards that The authors wish to thank Daniel Emerling, Susanna Marquez, Jamie Scott, and Jacob S. Sherkow for their significant substantive contributions to the development of the manuscript. Alexander Bernier further wishes to thank Marc Bourreau, Zichuan Li and Emmanuel Raynaud for their thoughtful comments and input on the substance, structure, and overall articulation of an earlier draft of this manuscript. A. Bernier (&) Ph.D. student; Faculty of Law, University of Toronto, Toronto, Canada e-mail: C. Busse Ph.D.; Team Leader, German Cancer Research Center, Heidelberg, Germany e-mail: T. Bubela Ph.D.; Professor and Dean, Faculty of Health Sciences, Simon Fraser University, Burnaby, Canada e-mail: 123 A. Bernier et al. mitigate the potential for such rights to frustrate the reuse of available intangibles to the detriment of pro-social innovation. Keywords Innovation policy
Open science
Public biological databases
Sui generis database right 1 Introduction Public databases have become a backbone of modern data-driven biological research. Especially in the European Union (EU), it is expected that large-scale research data infrastructure projects such as the European Open Science Cloud (EOSC) will expand existing databases over the coming decade and bring novel databases into existence. However, several long-running curated repositories for biological reference data (legacy databases) have failed to respond to the needs of their scientific communities and do not provide up-to-date services, for example, programmatic access via application programming interfaces (APIs), fine-grained and transparent data versioning and the use of persistent identifiers (PIDs). Replication, derivation and recreation of such legacy databases may address these gaps, but such activities may be hampered by the sui generis database right, a form of intellectual property rights (IPRs), enshrined in the EU’s Database Directive. Public biological databases are sometimes subject to central creation and central management. For example, a research institution or consortium develops or brings together related datasets for the purposes of future analysis or future use.1 In other instances, a central institution or a research consortium operates a platform on which external contributors can integrate their own datasets for the purpose of making such data available for downstream use.2 Operators of the central platforms are often responsible only for hosting the provided datasets. Other times, operators also provide value-added services to data contributors. Value-added services include curating the data to improve its technical interoperability with other available datasets or creating enriched datasets from the original input data via data analysis, data aggregation, or data visualisation tools.3 Alternatively, some public biological databases are decentralised, with a formal or informal arrangement of research institutions or citizen scientists each contributing data, cloud computing, or cloud storage resources, and analysis tools for common purposes without appointing a central data custodian.4 Here, we discuss the implications of the EU Database Directive on the establishment by research communities of biological data resources, including both databases and value-added services. Our legal analysis raises a number of policy considerations relevant to the functioning of public biological databases. For our purposes, public biological databases refer to collections of biological data, or 1 O’Doherty et al. (2021). 2 Poupon et al. (2017). See also Malsagova et al. (2020). 3 Bui et al. (2017). See also Olk and West (2020); Maccari et al. (2020). 4 Saez-Rodriguez et al. (2016); Ahsanuddin et al. (2016), p. 29; Greshake et al. (2014). 123 Public Biological Databases and the Sui Generis Database Right secondary outputs derived from such data, that are made available to the public using an open access, registered access, or controlled access mechanism.5 In Sect. 2, we discuss the relationship between the public policy justifications for the creation of intellectual property rights. In Sect. 3, we discuss the law, jurisprudence, and doctrine establishing the ambit and scope of application of the EU sui generis database right. In Sect. 4, we consider the potential for the sui generis database right to find application to public biological databases. We also consider the potential for downstream services that enable data discovery, and analysis to infringe the sui generis database right. Section 5 details public policy reforms that may better align the database right with contemporary approaches to open science and reduce the transaction costs inherent in negotiating downstream rights in IPR-encumbered data. In Sect. 6, we address the potential repeal of the sui generis database right. Section 7 outlines generalisable conclusions directed to the broader effort to establish EU information policy. 2 Intellectual Property Rights versus Open Science 2.1 Justifications For and Against Intellectual Property Rights The design of IPRs attempts to find balance between two conflicting imperatives, first, to provide creators of intangible goods with protection from reuse of their goods absent suitable compensation and/or authorisation, and second, to enable the secondary use of existing intangible goods, especially for those that are necessary economic inputs into other productive activities.6 In balancing these interests, IPRs are limited in scope and duration. Upon the expiration of IPRs, the protected intangibles and associated rights of use return to the publ (...truncated)