In 2024, the Hatch-Waxman Act continued to play a critical role in the U.S. pharmaceutical landscape, driving the dynamics between brand-name drugmakers and generics. This landmark legislation, enacted to encourage innovation...more
1/16/2025
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Life Sciences ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
USPTO
On October 18, 2024, the Federal Circuit issued a precedential decision in UTTO Inc. v. Metrotech Corp., No. 2023-145 (Fed. Cir. Oct. 18, 2024), addressing, in relevant part, the propriety of claim construction at the Rule 12...more
The United States Patent and Trademark Office (USPTO) released a Notice on the Federal Register (“the Notice”) today requesting public commentary and input on the current state of the experimental use exception. The USPTO is...more
7/2/2024
/ Agricultural Sector ,
Biden Administration ,
Defense Strategies ,
Disclosure Requirements ,
Executive Orders ,
Experimental Use Exception ,
Federal Register ,
Food and Drug Administration (FDA) ,
Genetic Materials ,
Genetic Testing ,
Patent Applications ,
Patent Infringement ,
Patents ,
Public Comment ,
Safe Harbors ,
TRIPS Agreement ,
USPTO