Transparency policies and the increased technological ability to gather and process large amounts of data has created new possibilities and innovation dynamics to be seized and new legal and ethical issues to be addressed in the biomedical area, where particularly overlapping legal claims are a central issue. Patent claims, intellectual property rights and sui generis rights for data collections, trade secrets, regulatory data protection and the protection of personal data forms a complex legal framework applying to the data supposed to fuel big data driven biomedical advances.
Two of the central issues in this landscape of rights and regulation are the problem of data aggregation and of data transparency. This presentation will focus on the role of Clinical research 2.0 in driving the development of personalized medicine as well as Orphan drugs and the legal issues arising in this context related to data protection (GDPR) as well as IPR.