Please see Chart below for more information....more
5/22/2019
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Adverio Pharma Gmbh v. Alembic Pharms. Ltd., C.A. No. 18-73-LPS, 2019 U.S. Dist. LEXIS 23021 (D. Del. Feb. 13, 2019) (Stark, J.)....more
5/21/2019
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Teva Pharms. U.S.A., Inc. v. Azar, C.A. No. 18-2394 (RDM), 2019 U.S. Dist. LEXIS 30346 (D.D.C. Feb 26, 2019) (Moss, J.)....more
5/20/2019
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Teva Pharmaceuticals
Case Name: Grünenthal GmbH v. Alkem Labs. Ltd., 2017-1153, 2017-2048, 2017-2049, 2017-2050, 2019 U.S. App. LEXIS 9187 (Fed. Cir. Mar. 28, 2019) (Circuit Judges Reyna, Taranto, and Chen presiding; Opinion by Reyna) (Appeal...more
5/13/2019
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., No. 17-1229, 139 S. Ct. 628 (Jan. 22, 2019) (Thomas, J. delivered the opinion for a unanimous Court), on cert. from the Federal Circuit, 855 F.3d 1356. ...more
5/9/2019
/ America Invents Act ,
Food and Drug Administration (FDA) ,
Form 8-K ,
Generic Drugs ,
Hatch-Waxman ,
Helsinn Healthcare SA v Teva Pharmaceuticals USA Inc ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Teva Pharmaceuticals
Please see Chart below for more information....more
2/25/2019
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
License Agreements ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Bristol-Myers Squibb Co. v. Aurobindo Pharma USA Inc., C.A. No. 17-374-LPS (Consolidated), 2018 U.S. Dist. LEXIS 179154 (D. Del. Oct. 18, 2018) (Stark, J.)....more
2/21/2019
/ Abbreviated New Drug Application (ANDA) ,
Bristol-Myers Squibb ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
TC Heartland LLC v Kraft Foods
Case Name: BTG Int’l v. Amneal Pharms. LLC, No. 15-cv-5909, 2018 U.S. Dist. LEXIS 183854 (D.N.J. Oct. 25, 2018) (McNulty, J.)....more
2/20/2019
/ Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Impax Labs. V. Zydus Pharms. USA, Inc., C.A. No. 17-13476, 2018 U.S. Dist. LEXIS 202879 (D.N.J. Nov. 29, 2018) (Chesler, J.)....more
2/15/2019
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Takeda Pharms., U.S.A., Inc. v. West-Ward Pharm. Corp., C.A. No. 14-1268-RGA-SRF, 2018 U.S. Dist. LEXIS 209127 (D. Del. Dec. 12, 2018) (Andrews, J.)....more
2/14/2019
/ Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Takeda Pharmaceuticals
Case Name: Hospira, Inc. v. Fresenius Kabi USA, LLC, Civ. Nos. 16 C 651, 17 C 7903, 2018 U.S. Dist. LEXIS 212916 (N.D. Ill. Dec. 17, 2018) (Pallmeyer, J.)....more
2/13/2019
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Fresenius ,
Generic Drugs ,
Hatch-Waxman ,
Hospira ,
Intellectual Property Protection ,
Nonobvious ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Teva Pharms. USA, Inc. v. Sandoz Inc. (In re Copaxone Consol. Cases), 906 F.3d 1013, Fed. Cir. No. 2017-1575, 2018 U.S. App. LEXIS 28751 (Fed. Cir. Oct. 12, 2018) (Circuit Judges Reyna, Bryson, and Stoll; Opinion...more
2/11/2019
/ Abbreviated New Drug Application (ANDA) ,
Clinical Trials ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs
Case Name: Tris Pharma Inc. v. Actavis Labs. Fl, Inc., Fed. Cir. Nos. 2017-2557, -2559, -2560, 2018 U.S. App. LEXIS 32774 (Fed. Cir. Nov. 20, 2018) (Circuit Judges Newman, O’Malley, and Chen presiding; Opinion by Chen, J.)...more
2/7/2019
/ Abbreviated New Drug Application (ANDA) ,
Actavis Inc. ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art
Please see Chart below for more information.
...more
Please see Chart below for more information....more
Case Name: Indivior Inc. v. Dr. Reddy’s Labs. S.A., No. 17-7111, 2018 U.S. Dist. LEXIS 116974 (D.N.J. July 13, 2018) (McNulty, J.)....more
11/6/2018
/ Abbreviated New Drug Application (ANDA) ,
Dr. Reddy’s Labs. ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Amgen Inc. v. Amneal Pharms. LLC, Civ. No. 16-0853 (MSG), 2018 U.S. Dist. LEXIS 125631 (D. Del. July 27, 2018) (Goldberg, J.)....more
11/2/2018
/ Abbreviated New Drug Application (ANDA) ,
Amgen ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. Apr. 13, 2018) (Circuit Judges Prost, Lourie, and Hughes presiding; Opinion by Lourie, J.; Dissent by Prost, C.J.) (Appeal from D. Del.,...more
7/26/2018
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Sumitomo Dainippon Pharma Co. v. Emcure Pharms. Ltd., Fed. Cir. Nos. 2017-1798, 2017-1799, 2017-1800 (Fed. Cir. Apr. 16, 2018) (Circuit Judges Moore, Mayer, and Stoll presiding; Opinion by Stoll, J.) (Appeals from...more
7/25/2018
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Impax Labs., Inc. v. Actavis Labs. FL, Inc., Civ. No. 15-6934, 2018 U.S. Dist. LEXIS 38623 (D.N.J. Mar. 8, 2018) (Chesler, J.)....more
5/1/2018
/ Abbreviated New Drug Application (ANDA) ,
Actavis Inc. ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Shire LLC v. Abhai, LLC, Nos. 15-13909-WGY (D. Mass. Mar. 22, 2018) (Young, J.).
Drug Product and Patent(s)-in-Suit: Adderall® XR (dextroamphetamine sulfate / dextroamphetamine saccharate / amphetamine aspartate...more
4/30/2018
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
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: The Medicines Co. v. Hospira, Inc., 2014-1469, 2014-1504 (Fed. Cir. Feb. 6, 2018) (Circuit Judges Dyk, Wallach, and Hughes presiding; Opinion by Hughes, J.) (Appeal from D. Del., Andrews, J.)....more
4/24/2018
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Hospira ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC, 881 F.3d 1376 (Fed. Cir. 2018) (Circuit Judges Taranto, Clevenger, and Stoll presiding; Opinion by Stoll, J.) (Appeal from D. Del., Robinson, J.)....more
4/23/2018
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Merck ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Sanofi v. Lupin Atl. Holdings S.A., Civ. No. 15-415-RGA (consol.), 2017 U.S. Dist. LEXIS 174931 (D. Del. Oct. 23, 2017) (Andrews, J.)....more
2/14/2018
/ Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Sanofi