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
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
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
A. Introduction - A prodrug is a medication or compound that after administration is metabolized (i.e., converted in the body) into a pharmacologically active drug (e,g., a metabolite). Often, the prodrug has no function...more
As more biosimilars continue to be approved across the world, it is helpful to compare the applicable regimes across major jurisdictions. We have collaborated with Brian Coggio of Fish & Richardson, and Mary Foord-Weston and...more
12/2/2019
/ Biologics ,
Biosimilars ,
BPCIA ,
Canada ,
Data Protection ,
Drug Approvals ,
EU ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Health Canada ,
Orphan Drugs ,
Patent Term Adjustment ,
Patent Term Extensions ,
Patented Medicines ,
Patents ,
PMNOC Regulations ,
Supplemental Protection Certificates ,
United States
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