Categories & Search

TPP Biologics Exclusivity Period Maintains The Status Quo

After half a decade of negotiations, the Trans-Pacific Partnership seems to do little more than maintain the status quo for biologics.  A leaked draft of the agreement appears to require member states to provide between five and eight years of exclusivity for new biologics. But almost all TPP signatories provide that duration under current law, and some governments have already said that the pact will not require them to change their laws. The United States will be able to maintain its current twelve years of protection. Additionally, the agreement appears to provide only market exclusivity, which prevents biosimilars from being sold, and not data exclusivity, which prevents biosimilar makers from using innovators’ regulatory data. Because the TPP largely reflects existing exclusivity periods for biologics, many view it as a missed opportunity for incentivizing global investment in new biologics.

To read more, please see Irena Royzman’s and Nathan Monroe-Yavneh’s recent article in Law360.