IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., Appeal No. 2023-1977 (Fed. Cir. Apr. 8, 2025) In our Case of the Week, the Federal Circuit affirmed that defendant Alkem’s proposed generic antibiotic did not...more
On January 3, in Novartis Pharmaceuticals Corporation v. Accord Healthcare, Inc., the Federal Circuit found written description support for a negative claim limitation, even though the negative claim limitation did not have...more
Stipulating to infringement after a contrary claim construction is a conventional stratagem for a losing party to have a final judgment that can be challenged before the Federal Circuit. The risk of course, is that if the...more
PATENT CASE OF THE WEEK - Amgen Inc. v. Amneal Pharmaceuticals LLC, et al., Appeal Nos. 2018-2414, et al. (Fed. Cir. Jan. 7, 2020) - In this appeal from Markman and summary judgment opinions by the district court in a...more
The Federal Circuit recently reversed a lower court’s ruling of validity under the § 112 written description requirement effectively opening the door for a number of generic drug manufacturers to enter the market with a...more
01 Communique Laboratory, Inc. v. Citrix Online, LLC (No. 2017-1869, 4/26/18) (Newman, Mayer, Stoll) - Mayer J. Affirming plaintiff's motion for a new trial motion. The defendant did not improperly assert a “practicing...more
Fractured Federal Circuit Holds Patent Owner Does Not Bear Burden of Persuasion in IPR Motions to Amend - In Aqua Products, Inc. v. Matal, Appeal No. 2015-1177, the Federal Circuit, sitting en banc, held that a patent...more
The Hatch-Waxman Litigation and Life Sciences practice groups at Robins, Kaplan, Miller & Ciresi L.L.P. are pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the...more