The Federal Circuit recently considered the scope of a permanent injunction that prohibited a drug manufacturer from conducting certain clinical and regulatory activities in Jazz Pharmaceuticals, Inc. v. Avadel CNS...more
6/6/2025
/ Appeals ,
Clinical Trials ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Injunctions ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Permanent Injunctions ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Safe Harbors
In October 2023, Teva Pharmaceuticals filed a patent infringement lawsuit against Amneal Pharmaceuticals alleging that their generic version of Teva’s ProAir® HFA inhaler infringed upon the asserted claims of U.S. Patent Nos....more
3/4/2025
/ Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Teva Pharmaceuticals
In February 2020, the U.S. Court of Appeals for the First Circuit found that Sanofi improperly listed U.S. Patent No. 8,556,864 (“the ’864 patent”)—which claims aspects of a drive mechanism of the Lantus® SoloSTAR® insulin...more