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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, 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
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
Antibody-drug conjugates (ADCs) are typically composed of a monoclonal antibody attached to a cytotoxic drug via a chemical linker. The antibody is able to identify biomarkers on and attach to cancer cells, allowing targeted...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
The Federal Circuit once again had an opportunity to opine on the extent of behavior by a generic drugmaker who opts to accept a "section viii carve-out" in its FDA approval (resulting in a so-called "skinny label) on...more
Case Name: Janssen Pharms., Inc. v. Tolmar, Inc., Civ. No. 21-1784-WCB, 2024 WL 2972832 (D. Del. June 13, 2024) (Bryson, J.) - Drug Product and Patent(s)-in-Suit: Invega Sustenna® (paliperidone palmitate); U.S. Patent No....more
Case Name: Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 2022-1258, 2022-1307, 2024 WL 1355733 (Fed. Cir. Apr. 1, 2024) (Circuit Judges Dyk, Prost, and Hughes presiding; Opinion by Prost, J.) (Appeal from D.N.J.,...more
Case Name: Salix Pharms., Ltd. v. Norwich Pharms. Inc., No. 2022-2153, 2023-1952, 2024 WL 1561195 (Fed. Cir. Apr. 11, 2024) (Circuit Judges Lourie, Chen, and Cunningham presiding; Opinion by Lourie, J.; Dissenting-in-part...more
Case Name: Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. 2023-1169, 2024 WL 3152087 (Fed. Cir. June 25, 2024) (Circuit Judges Moore, Lourie, and Albright presiding; Opinion by Lourie, J.) (Appeal from D. Del., Andrews,...more
The Situation: The Hatch-Waxman Act allows generic drug manufacturers to "carve out" a brand's patented indications from their proposed labeling. Generic manufacturers often rely on these so-called "skinny labels" to try to...more
Amarin Pharma, Inc., et al. v. Hikma Pharmaceuticals USA Inc., et al., No. 2023-1169 (Fed. Cir. (D. Del.) June 25, 2024). Opinion by Lourie, joined by Moore and Albright (sitting by designation). Amarin markets and sells...more
Case Name: Novartis Pharms. Corp. v. Mylan Pharms. Inc., Civ. No. 19-cv-201, 2024 WL 384929 (N.D.W.V. Jan. 31, 2024) (Kleeh, J.) - Drug Product and Patent(s)-in-Suit: Entresto® (sacubitril/valsartan); U.S. Patents Nos....more
Case Name: Endo Par Innovation Co. v. BPI Labs, LLC, C.A. No. 8:23-cv-1953-WFJ-TGW, 2024 WL 730478 (M.D. Fla. Feb. 22, 2024) (Jung, J.) - Drug Product and Patent(s)-in-Suit: Adrenalin® (epinephrine); U.S. Patents Nos....more
Case Name: Genentech, Inc. v. Sandoz, Inc., Civ No. 23-4085 (JXN)(LDW), 2024 WL 939692 (D.N.J. Mar. 5, 2024) (Wettre, M.J.) - Drug Product and Patent(s)-in-Suit: Esbriet® (pirfenidone); U.S. Patent No. 10,118,637 (“the ’637...more
The Federal Circuit handed down an opinion last week that invalidated several asserted claims and found infringement under 35 U.S.C. § 271(e)(2) of the claims, while refusing to modify its judgment on infringement after...more
Case Name: Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd., Civ. No. 22-4248 (SRC), 2023 WL 7131809 (D.N.J. Oct. 30, 2023) (Chesler, J.) - Drug Product and Patent(s)-in-Suit: Arazlo® (tazarotene); U.S. Patent Nos....more
Case Name: Norwich Pharms., Inc. v. Becerra, Civ. No. 23-1611 (RDM), 2023 WL 7174558 (D.D.C. Nov. 1, 2023) (Moss, J.) - Drug Product and Patent(s)-in-Suit: Xifaxan® (rifaximin); U.S. Patents Nos. 7,612,199 (“the ’199...more
Case Name: Eisai R&D Mgmt. Co., Ltd. v. Dr Reddy’s Labs., Inc., No. 22-CV-5950, 2023 WL 7331272 (D.N.J. Nov. 7, 2023) (Chesler, J.) - Drug Product and Patent(s)-in-Suit: Halaven® (eribulin mesylate); U.S. Patents Nos....more
Case Name: Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc., No. 18-CV-03632 (RMB/LDW), 2023 WL 9017081 (D.N.J. Dec. 29, 2023) (Bumb, J.) - Drug Product and Patent(s)-in-Suit: Korlym® (mifepristone); U.S. Patents Nos....more
Case Name: Actelion Pharms. Ltd. v. Mylan Pharms. Inc., No. 2022-1889, 2023 WL 7289417 (Fed. Cir. Nov. 6, 2023) (Circuit Judges Reyna, Stoll, and Stark presiding; Opinion by Stoll, J.) (Appeal from N.D.W.V., Bailey, J.) - ...more
Case Name: H. Lundbeck A/S v. Lupin Ltd., 87 F.4th 1361, 2023 WL 8462010 (Fed. Cir. Dec. 7, 2023) (Circuit Judges Dyk, Prost, and Hughes presiding; Opinion by Dyk, J.) - Drug Product and Patent(s)-in-Suit: Trintellix®...more
Case Name: Novartis Pharms. Corp. v. Mylan Pharms. Inc., Civ. No. 19-cv-201, 2023 WL 4375445 (N.D.W.V. July 6, 2023) (Kleeh, J.) - Drug Product and Patent(s)-in-Suit: Entresto® (sacubitril / valsartan); U.S. Patents Nos....more