IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
On December 20th, 2024, the Court of Appeals for the Federal Circuit issued an important decision in Teva Branded Pharmaceutical Products R&D v. Amneal Pharmaceuticals that impacts Orange Book (OB) listings for patents...more
Exeltis USA, Inc. and other parties (Exeltis) recently prevailed against Lupin Ltd. and Lupin Pharmaceuticals, Inc. (Lupin) in a patent infringement suit brought in the District of Delaware. After a three-day bench trial, the...more
CloudofChange, LLC v. NCR Corp., Appeal No. 2023-1111 (Fed. Cir. Dec. 18, 2024) In our Case of the Week, the Federal Circuit addressed the question of divided infringement in the context of system claims. In its...more
On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. ...more
Forty years ago, Congress passed the Hatch-Waxman Act, which streamlined the generic drug approval process and revamped how patent infringement claims would be litigated against those prospective generic drug applicants. At...more
Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed release portions infringed on a...more
In Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc., the US District Court for the District of Delaware decided an open question regarding pre-filing investigation and attorney fees under Title 35 of the US Code, Section...more
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more
As the FTC continues to crack down on pharmaceutical manufacturers’ allegedly improper listing of patents in the FDA Orange Book, counsel for Teva and Amneal presented oral arguments in the Court of Appeals for the Federal...more
Case Name: Pacira Pharms., Inc. v. eVenus Pharms. Labs., Inc., Civ. No. 21-19829, 2024 WL 3812188 (D.N.J. Aug. 9, 2024) (Arleo, J.)....more
Case Name: Novartis Pharms. Corp. v. MSN Pharms. Inc., Civ. No. 20-MD-2930-RGA, 2024 WL 3756787 (D. Del. Aug. 12, 2024)....more
Case Name: Novartis Pharms. Corp. v. Hetero USA Inc., Civ. No. 20-md-2930-RGA, 2024 WL 3757086 (D. Del. Aug. 12, 2024)....more
Case Name: Novartis Pharms. Corp. v. Becerra, No. 24-CV-02234 (DLF), 2024 WL 3823270 (D.D.C. Aug. 13, 2024) (Friedrich, J.)....more
Case Name: Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S., Civ. No. 24-4404 (SRC), 2024 WL 3966314 (D.N.J. Aug. 28, 2024) (Chesler, J.)....more
Case Name: Exeltis USA, Inc. v. Lupin Ltd., Civ. No. 22-434-RGA, 2024 WL 4040470 (D. Del. Sept. 4, 2024) (Andrews, J.)....more
Case Name: Purdue Pharma L.P v. Accord Healthcare Inc., Civ. No. 22-913-WCB, 2024 WL 4120717 (D. Del. Sept 9, 2024) (Bryson, J.) Drug Product and Patent(s)-in-Suit: OxyContin® (oxycodone HCl); U.S. Patent No. 11,304,908 (“the...more
Case Name: Astellas Pharma, Inc. v. Sandoz Inc., Nos. 2023-2032, 2023-2063, 2023-2089, 2024 WL 4219374 (Fed. Cir. Sept. 18, 2024) (Circuit Judges Lourie, Prost, and Reyna presiding; Opinion by Lourie, J.) (Appeal from D....more
In Allergan USA, Inc. et al., v. MSN Laboratories Private Ltd., et al., the United States Court of Appeals for the Federal Circuit issued a precedential decision relating to obviousness-type double patenting (“ODP”) and...more
This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more
This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more
Case Name: Pharmacyclics LLC v. Alvogen Pine Brook LLC, Civ. No. 19-434-CFC, 2024 WL 1885677 (D. Del. Apr. 30, 2024) (Connolly, J.) - Drug Product and Patent(s)-in-Suit: Imbruvica® (ibrutinib); U.S. Patents Nos. 8,008,309...more
Case Name: Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC, Civ. No. 23-20964 (SRC), 2024 WL 2923018 (D.N.J. June 10, 2024) (Chesler, J.)....more