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) recently issued a Notice of Proposed Rulemaking seeking to revise its rules on amendment practice under the America Invents Act (AIA). Specifically, the USPTO is proposing...more
3/8/2024
/ America Invents Act ,
Comment Period ,
Inter Partes Review (IPR) Proceeding ,
Motion to Amend ,
NPRM ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Proposed Rules ,
USPTO ,
USPTO Pilot Program
An August 2023 decision from the Federal Circuit Court of Appeals highlighted potential new fragilities in the patent portfolios of many industry giants, especially those in the pharmaceutical industry....more
1/9/2024
/ Amicus Briefs ,
Congressional Intent ,
Intellectual Property Protection ,
IP Litigation ,
Life Sciences ,
Obviousness ,
Obviousness-Type Double Patenting (ODP) ,
Patent Litigation ,
Patent Portfolios ,
Patents ,
Petition For Rehearing ,
Pharmaceutical Industry ,
Pharmaceutical Patents