As part of the Hatch-Waxman Act, given the lack of information on the allegedly infringing product, courts have found that patentees can satisfy the pleading requirements of Twombly/Iqbal without having access to the accused...more
10/31/2023
/ Abbreviated New Drug Application (ANDA) ,
Federal Rules of Civil Procedure ,
Hatch-Waxman ,
Novartis ,
Orange Book ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pleading Standards ,
Popular ,
Twombly/Iqbal Pleading Standard
The Federal Circuit will consider the relevance of an alleged infringer’s intent in a safe harbor analysis in the appeal of Edwards Lifesciences Corp. v. Meril Life Scis. Pvt.1 The District Court granted summary judgment that...more
4/3/2023
/ Clinical Trials ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Imports ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Patent Infringement ,
Pharmaceutical Patents ,
Safe Harbors
Prescription drug prices have long been a source of frustration for the American public and the subject of intense political debates about the best way to lower them without stifling innovation. One of the most significant...more
Are patented products that are not themselves subject to FDA approval, but used to develop products that are subject to FDA approval, protected under the Hatch-Waxman safe harbor? While courts have reached different...more