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

Kristina M Lybecker
Colorado College

DOI:https://doi.org/10.5912/jcb731

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.

Keywords:biologics ,data exclusivity protection ,Trans-Pacific Partnership Trade Agreement ,en ,