IPRs in Biobanking: Risks and Opportunities for Translational Research

Rapid technological advances, bio-pharmaceutical innovation gaps and the gradual shift to more “open” and “transparent” innovation models highlight the importance of an effective governance and use of biobanks. This raises important legal questions such as how to deal with intellectual property rights (IPRs) that may arise out of the collection and use of samples and data in biomedical research. Against this background, our article aims to (1) provide the biobank community with an introduction and a general overview of the most relevant IPRs in biobanking; (2) give IP lawyers a basic understanding of the biobank setting and various forms of biobanks; (3) analyse the risks and opportunities associated with IPRs in biobanking; and (4) investigate proposals for an more effective use of IPRs in translational research and innovation. To achieve these objectives, we identify and describe in in the first section the types of IPRs that we consider as most relevant in the various phases of a biobank’s “life-cycle”. The second section specifies challenges in finding an appropriate balance between open and closed collaboration models. Considering these challenges, the third section analyses and discusses potential strategies and options to stimulate the exchange of human biological samples, data and research results. It also looks into the question of how to address, govern and manage IPRs directed to biobank material and data. This ultimately allows us to draw conclusions in the final section.status: publishe