Data Exclusivity for Biologic Drugs: The TPP's Potential Poison Pill?

Abstract

On October 5, 2015, after many years of secretive negotiations, the US government with 11 other countries across the Asia Pacific and Latin America reached an agreement on the largest free-trade deal in history, the Trans-Pacific Partnership (TPP). Addressing everything from wildlife conservation and tax reductions for agriculture, to the free flow of information on the Internet and intellectual-property rights for movies and pharmaceutical drugs, this far-reaching agreement has the potential to impact up to one-third of world trade. One of the most contentious parts of the agreement involves intellectual property rights of pharma companies to data exclusivity for biologics, a hot and promising type of pharmaceutical derived from living organisms.