Intellectual Property Protection for Biologics: Why the Trans-Pacific Partnership (TPP) Trade Agreement Fails to Deliver

Authors

  • Kristina M Lybecker Colorado College

DOI:

https://doi.org/10.5912/jcb731

Keywords:

biologics, data exclusivity protection, Trans-Pacific Partnership Trade Agreement

Abstract

Biopharmaceutical research and development is overwhelmingly focused in the U.S. becasue here it is incentivized and encouraged through a robust intellectual property rights protection environment.  Across the board, the United States provides the most comprehensive, effective intellectual property rights protections for biopharmaceuticals.  As a result, the industry locates here, researches here, and thrives here.  With an acknowledgement of the importance of intellectual property rights as well as the wider benefits of biopharmaceutical research and development, it's tremendously disappointing that the recently negotiated Trans-Pacific Partnership (TPP) Trade Agreement fails to deliver sufficient IP protections for biologics.  This article explores the importance of a rigorous intellectual property environemtn for the biopharmaceutical industry through an examination of the importance of data exclusivity provisions.  Such protection is critical as the number, complexity and cost of clinical trials increases.  Technology inevitably evolves faster than the legal architecture that surrounds it.  As technology evolves, making the development of new biologic vaccines and therapies possible, society's commitment to incentivize innovation and protect it must be enshrined in the intellectual property protections of agreements such as the TPP.

Author Biography

  • Kristina M Lybecker, Colorado College

    Kristina M. Lybecker is an associate professor of economics at the Colorado College. Her research analyzes the difficulties of strengthening intellectual property rights protection in developing countries, specifically in the context of the pharmaceutical and environmental technology industries. Her research also addresses alternatives to the existing patent system, the balance between pharmaceutical patent protection and access to essential medicines, and the markets for jointly produced goods such as blood and blood products.   She has also worked with US FDA, Reconnaissance International, PhRMA, the National Peace Foundation, the OECD, the Fraser Institute, and the World Bank, on issues of innovation, international trade, and corruption.

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Published

2016-05-05

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