Patent Term Restoration and Non-Patent Exclusivity in the United States

Posted by D. Daniel Sokol

Margo A. Bagley, University of Virginia School of Law describes Patent Term Restoration and Non-Patent Exclusivity in the United States.

ABSTRACT: The United States provides companies engaged in drug discovery and marketing with a variety of statutory tools to maximize the exclusivity period for their products and delay generic competition in the marketplace. These tools include patent protection and patent term restoration, as well as marketing, data, pediatric testing, and orphan drug exclusivity. These tools are widely accepted and relied upon in the U.S. for most traditional drug product. However, the use of these tools to maintain pharmaceutical development incentives is in constant tension with their negative impact on drug cost and availability. This chapter surveys the various U.S. drug exclusivity maximizing tools, how they differ, and how they can be used, singly or in combination, to extend the marketing advantage of innovator pharmaceutical company products. It also outlines the exclusivity regime for large molecule drugs, known as biologics, and touches on some of the areas of controversy associated with innovator firm efforts to extend the lifecycles of successful pharmaceutical products.