Will the Trans-Pacific Partnership Derail Biologics?


This article appeared in Pharmaceutical Compliance Monitor, December 4, 2015 and is reproduced with permission.

On October 5, 2015, trade ministers from the United States and 11 other Pacific Rim countries announced they reached a deal on the Trans-Pacific Partnership (TPP) trade agreement after five years of negotiations. The TPP, which was published on November 5, 2015, is the largest trade deal in history and aims to remove trade barriers and set common standards for goods ranging from dairy products to automobiles to drugs. U.S. biopharmaceutical companies should pay attention to Chapter 18 of the deal, which contains pharmaceutical-related intellectual property provisions.

Chapter 18 includes a provision relating to patent exclusivity for biologics, a type of drug prepared from living organisms which are gaining popularity for the treatment of various diseases including cancer, AIDS, rheumatoid arthritis, and diabetes. Biologics differ from small molecule drugs because they are structurally more complex, difficult to characterize and therefore, more difficult and expensive to make. It is estimated that biologics cost patients on average over 20 times more than non-biologic drugs.

If you have any questions about this article or would like to discuss this topic further, please contact the authors, Terry Mahn and Tasha Francis.