Case Name: Astellas US LLC v. Hospira, Inc., No. 2022-1878, 2022 WL 17998229 (Fed. Cir. Dec. 30, 2022) (Circuit Judges Dyk, Reyna, and Cunningham presiding; Opinion by Dyk, J.) (Appeal from D. Del., Connolly, J.)...more
Case Name: Sanofi-Aventis U.S. LLC v. Apotex Corp., C.A. No. 20-cv-804-RGA, 2022 WL 2643532 (D. Del. July 8, 2022) (Hall, J.) Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patents Nos. 8,927,592 (“the ’592...more
12/9/2022
/ Abbreviated New Drug Application (ANDA) ,
Apotex ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Healthcare ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Sanofi-Aventis
Case Name: Bausch Health Ireland, Ltd. v. Padagis Israel Pharms., Ltd., Civ. No. 20-5426 (SRC), 2022 WL 1606961 (D.N.J. May 20, 2022) (Chesler, J.) Drug Product and Patent(s)-in-Suit: Duobrii® (halobetasol propionate /...more
Case Name: Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 2021-1070, 2022 WL 2204163 (Fed. Cir. June 21, 2022) (Circuit Judges Moore, Linn, and Hughes presiding; Opinion by Moore, J.; Dissenting Opinion by Linn, J.)...more
Case Name: Amarin Pharm., Inc. v. Hikma Pharms. USA Inc., No. 20-1630-RGA-JLH, 2022 WL 605734 (D. Del. Jan. 4. 2022) (Andrews, J.) Drug Product and Patent(s)-in-Suit: Vascepa® (icosapent ethyl); U.S. Patents Nos. 8,642,077...more
Case Name: Azurity Pharms., Inc. v. Alkem Labs., Ltd., No. 20-cv-1094, 2022 WL 605746 (D. Del. Jan. 31, 2022) (Goldberg, J.) Drug Product and Patent(s)-in-Suit: Firvanq® (vancomycin HCl); U.S. Patents Nos. 10,493,028 (“the...more
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
Case Name: Genentech, Inc. v. Sandoz, Inc., Civ. No. 19-78-RGA (D. Del. Mar. 22, 2022) (Andrews, J.) Drug Product and Patent(s)-in-Suit: Esbriet® (pirfenidone); U.S. Patent Nos. 7,566,729 (“the ’729 patent”), 7,635,707...more
Case Name: Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 2021-1070, 2022 WL 16759 (Fed. Cir. Jan. 3, 2022) (Circuit Judges Moore, Linn, and O’Malley presiding; Opinion by O’Malley, J.; Dissenting Opinion by Moore,...more
Case Name: Adapt Pharma Operations Ltd. v. Teva Pharms. USA, Inc., Case No. 2020-2106, 25 F.4th 1354 (Fed. Cir. Feb. 10, 2022) (Circuit Judges Newman, Prost, and Stoll presiding; Opinion by Stoll, J.; Dissenting Opinion by...more
Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 25 F.4th 949 (Fed. Cir. 2022) (Circuit Judges Moore, Newman, Dyk, Prost, O’Malley, Reyna, Taranto, Chen, Hughes, and Stoll presiding; Moore, Newman, O’Malley, Taranto,...more
Case Name: H. Lundbeck A/S v. Lupin Ltd., Civ. No. 18-88-LPS (D. Del. Oct. 5, 2021) (Stark, J.) - Drug Product and Patent(s)-in-Suit: Trintellix® (vortioxetine hydrobromide); U.S. Patents Nos. 7,144,884 (“the ’884 patent”),...more
Case Name: AstraZeneca AB v. Zydus Pharms. (USA) Inc., C.A. No. 18-664-RGA, 2021 WL 4819905 (D. Del. Oct. 15, 2021) (Andrews, J.) Drug Product and Patent(s)-in-Suit: Farxiga® (dapagliflozin); U.S. Patent No. 6,515,117 (“the...more
Case Name: Melinta Therapeutics, LLC v. Nexus Pharms., Inc., C.A. No. 2:21-cv-11198 (BRM) (AME), 2021 WL 5150157 (D.N.J Nov. 5, 2021) (Martinotti, J.) - Drug Product and Patent(s)-in-Suit: Minocin® (minocycline HCl); U.S....more
Case Name: Association for Accessible Medicines v. Bonta, Civ. No. 2:20-cv-01708-TLN-DB, 2021 WL 5853431 (E.D. Ca. Dec. 9, 2021) (Nunley, J.) - Drug Product and Patent(s)-in-Suit: N/A - Nature of Case and Issue(s) Presented:...more
2/1/2022
/ BPCIA ,
Dormant Commerce Clause ,
Due Process ,
Generic Drugs ,
Hatch-Waxman ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Standing
Case Name: Biogen Int’l GMBH v. Mylan Pharms. Inc., 18 F.4th 1333 (Fed. Cir. 2021) (Circuit Judges O’Malley, Reyna, and Hughes presiding; Opinion by Reyna; Dissent by O’Malley) (Appeal from N.D.W.V., Keeley, J.)...more
Case Name: AstraZeneca AB v. Mylan Pharms., Inc., No. 2021-1729, 2021 WL 5816742 (Fed. Cir. Dec. 8, 2021) (Circuit Judges Taranto, Hughes, and Stoll presiding; Opinion by Stoll, J.; Opinion dissenting in part by Taranto, J.)...more
Case Name: Auxilium Pharms., Inc. v. FCB I LLC, Civ. No. 20-16456, 2021 WL 2802537 (D.N.J. July 6, 2021) (Vazquez, J.) - Drug Product and Patent(s)-in-Suit: Testim® (testosterone gel); U.S. Patents Nos. 7,320,968 (“the ’968...more
11/18/2021
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Life Sciences ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art
Case Name: Takeda Pharma Co. v. Zydus Pharma Inc., No. 18-1994, 2021 WL 3144897 (D.N.J. July 26, 2021) (Wolfson, J.) - Drug Product and Patent(s)-in-Suit: Prevacid® SoluTab™ (lansoprazole delayed-release orally-disintegrating...more
11/16/2021
/ Abbreviated New Drug Application (ANDA) ,
Counterclaims ,
Hatch-Waxman ,
Monopolization ,
Noerr-Pennington Doctrine ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
Case Name: Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. CV 20-1630-RGA-JLH, 2021 WL 3396199 (D. Del. Aug. 3, 2021) (Hall, J.) - Drug Product and Patent(s)-in-Suit: Vascepa® (icosapent ethyl); U.S. Patents Nos. 9,700,537...more
11/15/2021
/ Abbreviated New Drug Application (ANDA) ,
Amarin ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Pharmacyclics LLC v. Alvogen Pine Brook LLC, No. 19-0434, 2021 WL 3680317 (D. Del. Aug. 19, 2021) (Connolly, J.) Drug Product and Patent(s)-in-Suit: Imbruvica® (ibrutinib); U.S. Patents Nos. 8,008,309 (“the ’309...more
Case Name: Par Pharmaceutical Inc. v. Eagle Pharmaceuticals Inc., No. 18-0823-CFC-JLH, 2021 WL 3886418 (D. Del. Aug. 31, 2021) (Connolly, J.) -
Drug Product and Patent(s)-in-Suit: Vasostrict® (vasopressin); U.S. Patents...more
11/11/2021
/ Abbreviated New Drug Application (ANDA) ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preponderance of the Evidence
Case Name: Sun Pharma Global FZE v. Lupin Ltd., Civ No. 18-2213 (FLW), 2021 WL 4473411 (D.N.J. Sept. 30, 2021) (Wolfson, J.) - Drug Product and Patent(s)-in-Suit: Bromsite® (bromfenac ophthalmic solution); U.S. Patent No....more
Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., Nos. 2018-1976, 2018-2023, 2001 WL 3412496 (Fed. Cir. Aug. 5, 2021) (Circuit Judges Moore, Newman, and Prost presiding; Opinion per curiam) (Appeal from D. Del.,...more
Case Name: Belcher Pharms., LLC v. Hospira, Inc., Nos. 2020-1799, 2021 WL 3889810 (Fed. Cir. Sept. 1, 2021) (Circuit Judges Reyna, Taranto, and Stoll presiding; Opinion by Reyna, J.) (Appeal from D. Del., Stark, J.) - Drug...more