15 Feb2016
Data Exclusivity, Medications, and the Trans-Pacific Partnership
The Trans-Pacific Partnership (TPP) is a recently ratified and controversial free trade agreement between 12 Pacific Rim countries: Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, United States, and Vietnam. One of the more controversial provisions of the TPP concerns the data-exclusivity term for biologics, which effectively enforces a monopoly for that medication by preventing a competitive manufacturer from leveraging the owner’s data about treatment efficacy during the exclusivity term. This exclusivity term runs concurrently with any patent protection and can extend beyond the expiration of applicable patents.
What Are Biologics?
