The enormous opportunities of Big Dara and the gradual shift to more “personalized”, “open” and “transparent” innovation models highlight the importance of an effective governance and use of human biological material and the associated data stored in biobanks. Intellectual Property Rights (IPRs) come into play when research needs to be translated into safe and efficient ”real world”- applications. Previous studies mainly focused on the potential negative impacts and risks of IPRs in the context of biobanking. Only a few projects highlighted the opportunities and potential benefits of user-generated solutions and a proper governance of high quality, well defined IPRs in biobanking. While the choice of how to address and interact with IPRs might vary much between different types of biobanks, it is clear that an appropriate balance in the user modalities of IPRs appears particularly important in “open innovation” scenarios and translational medicine.
Against this background my presentation will start out by (1) briefly describing the most important IPRs that might be relevant for biological material and – most importantly – data during the distinct phases of the life of a biobank. This will serve as the basis for (2) a discussion on how to reconcile IPRs and openness in biobanking in order to (3) sketch out various options for stimulating the sharing of HBM, data and research results. Special emphasis will be laid on analyzing and comparing new case law developments from the US and Europe and their effect on the availability of IPRs directed to technologies involving “Big Data” settings, such as in the area of diagnostics and personalized medicine. Besides describing the differences in EU and US law with regard to relevant IPRs, such as patents, trade secrets, copyrights and data based protection, my contribution will also highlight how IPRs might function as data aggregators