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Regulatory IP

Essentials of Lifecycle Management

Intellectual property (IP) rights are among the most vital economic assets for any research or corporate organization. Traditionally, IP has focused on patents, trademarks, copyrights, and trade secrets. These IP protections convey exclusive rights and advantages that provide incentives for investments needed for research and development.

For pharmaceutical and biotechnology products, these traditional rights are enhanced by significant regulatory rights that provide data and market exclusivity and other market advantages. This guide describes these regulatory advantages as regulatory intellectual property or Regulatory IP.

This guide provides a description of the life cycle management tools that can be used to develop a regulatory intellectual property (Regulatory IP) strategy for pharmaceutical and biotechnology products. The lifecycle management tools covered in this guide will help enhance value for biopharmaceutical investors, developers, and manufacturers and strengthen the incentives for continued medical progress.

Regulatory IP by Gregory Glover, MD JD
Purchase your hard or digital copy:

What’s in the book?

  • Hatch-Waxman
    Exclusivity
  • Biologics and
    Biosimilars
  • BCPIA: Beyond
    Hatch-Waxman
  • Patent & Regulatory
    Exclusivity Analysis
  • Personalized
    Medicine
  • Strategic
    Regulatory Issues

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Market Exclusivity Insights & Strategies
to Enhance Return on Investment

  • 1

    Coordinated intellectual
    property protections

  • 2

    Pharmaceutical and biological
    product market exclusivity

  • 3

    Expedited regulatory
    review programs

  • 4

    Specialized
    innovation incentives