Practice Area Articles

IP Academy: FDA Final Rule

December 13, 2020

By Paul Hastings Professional

IP Academy: FDA’s Final Rule Implementing the M.M.A. and the Potential Impact on Hatch-Waxman Patent Litigation

This presentation provides an overview of the FDA’s October 6, 2016 Final Rule implementing Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) with a focus on how the Final Rule may affect strategies for Hatch-Waxman patent litigation and settlement.