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 BlueAllele Corp. v. Intellia Therapeutics, Inc., 2024 U.S. Dist. Lexis 222094 (D. Del. Dec. 9, 2024)1, the District of Delaware addressed several issues relevant to the safe harbor defense in Hatch-Waxman litigation. ...more
1/16/2025
/ Biotechnology ,
Burden of Proof ,
Defense Strategies ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Research Tools ,
Safe Harbors
We have been monitoring the dispute between Edwards Lifesciences Corp. (“Edwards”) and Meril Life Sciences Pvt., Ltd. (“Meril”) before and after the initial Federal Circuit decision.
The dispute focused on whether Meril’s...more
The Federal Circuit considered the relevance of an alleged infringer’s intent in a safe harbor analysis in Edwards Lifesciences Corp. v. Meril Life Scis. Pvt. The District Court had previously granted summary judgment that...more
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
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
Are research tools protected from patent infringement under the Hatch-Waxman safe harbor, section 271(e)(1)? While different courts have reached different conclusions on this question, one recent district court decision...more
This somewhat arcane question took on significant, real-world consequences when Judge Andrews of the Delaware District Court denied Hospira’s JMOL to overturn a jury’s $70 million award to Amgen for Hospira’s manufacture and...more