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...more
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...more
In a precedential decision issued on August 13, 2024, the U.S. Court of Appeals for the Federal Circuit held that a first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued,...more
On November 7, 2023, the Federal Trade Commission (FTC) sent notice letters1 to 10 brand drug manufacturers of drug-device combination products, including drugs delivered by asthma inhalers, epinephrine autoinjectors, and...more
Amgen Inc. et al. v. Sanofi et al., No. 22-157 (U.S. 2023) -
The U.S. Supreme Court, in a unanimous decision, has affirmed the Federal Circuit’s decision invalidating Amgen’s patent claims covering a genus of antibodies...more
The United States Patent and Trademark Office (USPTO) is implementing a COVID-19 Prioritized Examination Pilot Program for small and micro entities. The program is intended to help independent inventors and small businesses...more