Pharmaceutical Innovation, Competition and Patent Law
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Pharmaceutical Innovation, Competition and Patent Law

A Trilateral Perspective

Edited by Josef Drexl and Nari Lee

Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care.
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Chapter 4: Patent term restoration and non-patent exclusivity in the US

A Trilateral Perspective

Margo A. Bagley


The US 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, patent term restoration, and marketing, data, pediatric testing, and orphan drug exclusivity. These tools are widely accepted and relied upon in the US for most traditional drug products. In 2006, patent term restoration and exclusivity accounted for approximately 39 percent of the total sales revenue of +$100 billion for the 40 top-selling drug products. However, the use of these tools to maintain pharmaceutical development incentives is in constant tension with their negative impact on drug cost and availability. Moreover, efforts to export some of these tools to other countries have generated resistance and controversy. In addition, the issue of how much exclusivity should be provided for large molecule drugs, known as biologics, is quite contentious in the US and remains unresolved at the time of writing this chapter. This chapter surveys the various US 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 will also touch on some of the areas of controversy associated with innovator firm efforts to extend the lifecycles of successful pharmaceutical products. Currently, a firm seeking to sell a pharmaceutical product in the US must file one of three types of applications with the US Food and Drug Administration (FDA) to obtain marketing approval.

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