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 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
On June 28, 2024, the United States Patent and Trademark Office (“USPTO”) requested the public’s views on the current state of the common law experimental use exception to patent infringement and whether legislative action...more
9/18/2024
/ Experimental Use Exception ,
Germany ,
Hungary ,
Italy ,
Netherlands ,
Patent Act ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Comment ,
Spain ,
Sweden ,
UK ,
USPTO
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
Previously, it was recommended that regulatory attorneys consult patent attorneys when preparing labels covering branded pharmaceuticals. In so doing, the label would closely reflect limitations in the asserted patent claims...more
For every new drug application, the Hatch-Waxman Act requires pharmaceutical companies to identify each patent that claims the drug, its formulation, or a method of using it....more
Ensnarement is a potent, albeit rarely used, defense to allegations of infringement under the doctrine of equivalents. It is based on the principle that the allowable range of equivalents to a patent claim cannot encompass or...more
In Genentech, Inc. v. Eli Lilly and Co., 18-cv-1518 JLS (JLB) (S.D. Cal.), the California district court denied Lilly’s motion to dismiss for improper venue under the patent venue statute, 28 U.S.C. § 1400(b). Opinion, Sept....more
Some commentators have suggested that since Hatch-Waxman actions share certain similarities with declaratory judgment (“DJ”) actions to prevent future infringement, venue in such actions should be governed by the general...more
In a March 31, 2019 opinion in Belcher Pharmaceuticals LLC v. International Mediation Systems, Limited, Judge Stark of the Delaware District Court held that complaints in Hatch-Waxman actions can satisfy the requirements...more
Can a party that did not submit an abbreviated biologics license application or an abbreviated new drug application, but will market the biosimilar or generic product after U.S. Food and Drug Administration approval, be sued...more
4/15/2019
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
BPCIA ,
Federal Rule 12(b)(6) ,
Food and Drug Administration (FDA) ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Popular
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
Originally posted in Law360, July 25, 2016.
In Amgen Inc. v. Apotex Inc., the Federal Circuit addressed the 180-day notice provision of the Biologics Price Competition and Innovation Act of 2009 where the parties had...more