Risk Regulation and Innovation: The Case of Rights-Encumbered Biomedical Data Silos

This Article discusses whether, and how, risk and social regulation can promote socially valuable innovation. The focus is on regulation as a force for creating a data infrastructure for future innovation. This Article briefly summarizes the history of overlapping and adjacent intellectual property rights in biomedical innovation. It then discusses the manner in which the Supreme Court’s reaction to such rights concentration may exacerbate legally-encumbered diagnostic data silos. It will go on to outlines the basic history of biopharmaceutical trial data silos as well as the core legal and policy arguments in favor of increasing access to the aggregated data held by risk regulators. It then discusses recent developments, including the stance taken by European risk regulators. Finally, it discusses lessons from the biopharmaceutical trial data experience and how some of these lessons may play out in current debates over diagnostic testing silos and overlapping rights