Practice Area



TPP Biologics Exclusivity Period Maintains The Status Quo

October 27, 2015

Earlier this month, a final agreement was reached on the Trans-Pacific Partnership that could provide for as little as five years of nonpatent exclusivity for new biologics. In recent months, it was reported that the biologics exclusivity period remained one of the thorniest issues facing the TPP in its last rounds of wrangling. The final agreement is not yet officially available and thus its exact contours are not yet clear. The leaked text of the agreement, however, appears to represent a complicated compromise, allowing countries to choose between an eight-year exclusivity period and a five-year period that may also provide additional protections.

To continue reading Irena Royzman and Nathan Monroe-Yavneh's article from Law360 please click here.