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3.12.25
FDA Can Keep Tirzepatide off the Drug Shortage List, Judge Says
On March 5, 2025, the U.S. District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction to prevent the U.S. Food and Drug Administration (FDA) from removing tirzepatide products (Mounjaro and Zepbound; Eli Lilly and Company) from the FDA’s drug shortage list.1 This denial keeps in place the FDA’s declaratory order determining that the shortage of diabetes and weight-loss tirzepatide products has been resolved and phases out compounded tirzepatide, which Wilson Sonsini reported about here.
Client Highlights
2.03.25
Wilson Sonsini Successfully Represents Impossible Foods in First-of-Its-Kind FoodTech Patent Suit
Wilson Sonsini served as lead counsel for Impossible Foods in a patent infringement litigation alleging infringement of seven Impossible Foods patents covering manufacturing processes, ingredients, and finished products relating to plant-based food containing heme and Impossible’s innovative transgenic yeast used to manufacture that heme. Our team successfully represented Impossible Foods in defense of six inter partes review petitions before the Patent Trial and Appeal Board in 2022 and 2023. Wilson Sonsini defeated the defendant’s motion to dismiss and motion to stay the District Court litigation. The matter was closely watched as the first patent infringement case in the burgeoning foodtech industry. With trial approaching, the parties resolved the matter and released a joint statement that said: “This resolution affirms Impossible Foods’ category leadership and the strength of its product portfolio related to heme.”
Alerts
1.02.25
FDA Announced Removal of Tirzepatide from the Drug Shortage List
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a declaratory order determining that the shortage of diabetes and weight-loss tirzepatide injection products (Mounjaro and Zepbound; Eli Lilly and Company) has been resolved. The declaratory order revokes and replaces the agency’s October 2, 2024, decision on the same subject after a court remanded the decision to the agency for reevaluation.1