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.