Case Name: Bausch Health Ireland Ltd. v. Mylan Labs. Ltd., No. 21-10403 (SRC) (JSA), 2022 WL 683084 (D.N.J. Mar. 8, 2022) (Chesler, J.) Drug Product and Patent(s)-in-Suit: Trulance® (plecanatide); U.S. Patents Nos. 7,041,786...more
Symbicort® (budesonide and formoterol fumarate dihydrate) - Case Name: AstraZeneca AB v. Mylan Pharms. Inc., No. 1:18CV193, 2021 WL 798856 (N.D.W.V. Mar. 2, 2021) (Keeley, J.) - Drug Product and Patent(s)-in-Suit: Symbicort®...more
Jublia® (efinaconazole) -
Case Name: Valeant Pharm. N. Am. LLC v. Mylan Pharm. Inc.,978 F.3d 1374 (Fed. Cir. Nov. 5, 2020)(Circuit Judges Newman, O’Malley, and Taranto presiding; Opinion by O’Malley, J.) (Appeal from D.N.J.,...more
2/8/2021
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Valeant
Colcrys®/colchicine -
Case Name: Takeda Pharms. U.S.A., Inc. v. Mylan Pharms. Inc., No. 2020-1407, -1417 (Fed. Cir. July 31, 2020) (Circuit Judges Prost, Newman, and Hughes presiding; Opinion by Prost, C.J.; Dissent by...more
11/4/2020
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Takeda Pharmaceuticals
BECAUSE THE PRIOR ART TAUGHT OVERLAPPING PH RANGES AND STRUCTURALLY SIMILAR COMPOUNDS AS THOSE CLAIMED IN THE PATENT-IN-SUIT, THE FEDERAL CIRCUIT REVERSED SUMMARY JUDGMENT OF NON-OBVIOUSNESS.
Case Name: Valeant Pharms...more
8/21/2020
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Mylan Pharmaceuticals ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art ,
Valeant
THE COURT GRANTED DEFENDANT’S MOTION TO ENFORCE ITS SETTLEMENT AGREEMENT, FINDING THAT THE AGREEMENT WAS NOT ANTICOMPETITIVE AND IN VIOLATION OF ANTITRUST LAW.
Case Name: Somaxon Pharma, Inc. v. Actavis Elizabeth LLC, No....more
8/20/2020
/ Actavis Inc. ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Settlement Agreements
AMENDING CLAIMS AND ADDING INVENTOR TO CLAIM NEW ASPECT OF INVENTION, WITHOUT AMENDING SPECIFICATION, RESULTS IN JUDGMENT OF INVALIDITY FOR LACK OF WRITTEN DESCRIPTION.
Case Name: Biogen Int’l GmbH v. Mylan Pharms. Inc.,...more
8/13/2020
/ Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Takeda Pharms. U.S.A., Inc. v. Mylan Pharms., Inc., No. 19-2216-RGA, 2020 U.S. Dist. LEXIS 12753 (D. Del. Jan. 27, 2020) (Andrews, J.)....more
5/21/2020
/ Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Takeda Pharmaceuticals
BECAUSE DELAWARE WAS AN IMPROPER VENUE FOR DEFENDANT MYLAN, AND DEFENDANT 3M DEMONSTRATED THAT VARIOUS FACTORS WEIGHED IN FAVOR OF A TRANSFER, THE CASE WAS TRANSFERRED TO THE NORTHERN DISTRICT OF WEST VIRGINIA.
Case...more
2/13/2020
/ 3M Company ,
Abbreviated New Drug Application (ANDA) ,
AstraZeneca ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mootness ,
Motion to Dismiss ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
BECAUSE PLAINTIFFS FAILED TO SHOW SPECIFICALLY HOW DEFENDANTS COMMITTED ANY ACT OF INFRINGEMENT IN NEW JERSEY—PARTICULARLY BY FILING AN ANDA IN WEST VIRGINIA WITH THE FDA IN MARYLAND—OR THAT ANY FUTURE, INTENDED ACTS WERE A...more
12/2/2019
/ Abbreviated New Drug Application (ANDA) ,
Declaratory Judgments ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Valeant ,
Venue
Case Name: Salix Pharms., Inc. v. Mylan Pharms Inc., No. 2017-2312, 2017 U.S. App. LEXIS 2312 (Fed. Cir. Feb. 8, 2019) (Circuit Judges Lourie, O’Malley, and Reyna presiding; Opinion by O’Malley, J.) (Appeal from N.D.W.V,...more
5/16/2019
/ Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Valeant Pharms. Int’l v. Mylan Pharms., Civ. No. 15-8180 (SRC), 2018 U.S. Dist. LEXIS 73069 (D.N.J. May 1, 2018) (Chesler, J.)....more
8/2/2018
/ Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Valeant
Case Name: Celgene Corp. v. Hetero Labs Ltd., 17-3387 (ES) (MAH), 2018 U.S. Dist. LEXIS 34025 (D.N.J. Mar. 2, 2018) (Salas, J.)....more
5/2/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Venue
Case Name: Indivior Inc. v. Mylan Techs. Inc., 15-cv-1016-RGA, 15-cv-0477-RGA, 2018 U.S. Dist. LEXIS 47151 (D. Del. Mar. 22, 2018) (Andrews, J.)....more
4/27/2018
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Otsuka Pharm. Co. v. Mylan Inc., Civ. No. 14-4508 (JBS-KMW), 2017 U.S. Dist. LEXIS 184160 (D.N.J. Nov. 7, 2017) (Simandle, J.)....more
2/12/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
Otsuka Pharmaceutical ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Pfizer Inc. v. Mylan Pharms. Inc., No. 15-79-GMS, 2017 U.S. Dist. LEXIS 125634 (D. Del. Aug. 9 2017) (Sleet, J.).
Drug Product and Patent(s)-in-Suit: Toviaz® (fesoterodine fumarate extended-release tablets);...more
11/16/2017
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Bristol-Myers Squibb Co. v. Mylan Pharms., Inc., Civ. No. 17-379-LPS, 2017 U.S. Dist. LEXIS 146372 (D. Del. Sept. 11, 2017) (Stark, J.)...
Drug Product and U.S. Patent: Eliquis® (apixaban); U.S. Patents Nos....more
11/6/2017
/ Abbreviated New Drug Application (ANDA) ,
Bristol-Myers Squibb ,
FRCP 12(b)(3) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
State of Incorporation
Case Name: The Medicines Co. v. Mylan Inc., Civ. No. 11-cv-1285, 2017 U.S. Dist. LEXIS 99898 (N.D. Ill. June 28, 2017) (St. Eve, J.)....more
8/8/2017
/ Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: The Medicines Co. v. Mylan, Inc., No. 2015-1113, -1151, -1181 (Fed. Cir. Apr. 6, 2017) (Circuit Judges Dyk, Wallach, and Hughes presiding; Opinion by Dyk, J.) (appeal from N.D. Ill., St. Eve, J.)....more
8/4/2017
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Mylan Institutional LLC v. Aurobindo Pharma Ltd., 2017-1645, 2017 U.S. App. LEXIS 8792 (Fed. Cir. May 19, 2017) (Circuit Judges Lourie, Moore, and Reyna presiding; Opinion by Lourie, J.) (appeal from E.D. Tex.,...more
8/1/2017
/ Aurobindo Pharmaceuticals ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Shire Development, LLC v. Mylan Pharms., Inc., No: 12-1190-T-36AEP, 2017 U.S. Dist. LEXIS 11441 (M.D. Fla. Jan. 27, 2017) (Honeywell, J.).
Drug Product and Patent(s)-in-Suit: Lialda® (mesalamine); U.S. Patent...more
5/23/2017
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Purdue Pharma L.P., v. Mylan Pharms. Inc., 15-1155-RGA-SRF, 2017 U.S. Dist. LEXIS 28460 (D. Del. Mar. 1, 2017) (Fallon, M.J.).
Drug Product and Patent(s)-in-Suit: OxyContin® (oxycodone hydrochloride); U.S....more
5/10/2017
/ Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
OxyContin ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Cumberland Pharms. Inc. v. Mylan Institutional LLC, Nos. 2016-1155, -1259, 846 F.3d 1213 (Fed. Cir. Jan. 26, 2017) (Circuit Judges Moore, Taranto, and Reyna presiding; Opinion by Taranto, J.) (appeal from N.D....more
5/2/2017
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Mylan Institutional LLC v. Aurobindo Phama Ltd, 2:16-cv-00491-RWS-RSP, 2016 U.S. Dist. LEXIS 180551 (E.D. Tex. Nov. 21, 2016) (Payne, MJ).
Drug Product and Patents-in-Suit: isosulfan blue; U.S. Patents Nos....more
1/31/2017
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Forest Labs. Holdings Ltd. v. Mylan Inc., No. 13–1602–SLR (Consolidated), 2016 U.S. Dist. LEXIS 89268 (D. Del. July 11, 2016) (Robinson, J.) -
Drug Product and Patent(s)-in-Suit: Savella® (milnacipran...more
11/22/2016
/ Abbreviated New Drug Application (ANDA) ,
Forest Laboratories ,
Generic Drugs ,
Hatch-Waxman ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs