Regulatory Competitive Shelters in the Area of Personalized Medicine

Much has been written about the ramifications of recent Supreme Court decision in the area of patent subject matter eligibility on innovation in the area of personalized medicine. Yet, regulatory competitive shelters (RCSs) have remained largely unexplored as a mechanism for incentivizing innovation in that area, possibly in lieu of patents. Similarly, in a recent report and related guidance documents, the Food and Drug Administration (FDA) made clear its commitment to streamlining regulation in the area of personalized medicine. These documents, however, also do not address the RCSs available to personalized medicine technologies. This Article seeks to explore the existing landscape of RCSs that are currently available to personalized medicine technologies and highlight further ways in which RCSs may provide incentives for innovation in such technologies