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: Indivior Inc. v. Dr. Reddy’s Labs. S.A., No. 2018-2167, 2018 U.S. App. LEXIS 32776 (Fed. Cir. Nov. 20, 2018) (Circuit Judges Newman, Lourie, and Stoll; Opinion by Stoll, J.) (Appeal from D.N.J., McNulty, J.)....more
2/8/2019
/ Dr. Reddy’s Labs. ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
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
Case Name: Novartis AG v. Ezra Ventures LLC, Fed. Cir. No. 2017-2284, 2018 U.S App. LEXIS 34459 (Fed. Cir. Dec. 7, 2018) (Circuit Judges Moore, Chen, and Hughes presiding; Opinion by Chen, J.) (Appeal from D. Del., Stark,...more
2/6/2019
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Novartis ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Novartis Pharms. Corp v. Breckenridge Pharm. Inc., No. 2017-2173, 2018 U.S. App. LEXIS 34462 (Fed. Cir. Dec. 7, 2018) (Circuit Judges Prost, Wallach, and Chen; Opinion by Chen, J.) (Appeal from D. Del., Andrews,...more
2/5/2019
/ Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Novartis ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Uruguay Round Agreements Act (URAA)
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: Bayer Intellectual Prop. GmbH v. Aurobindo Pharma Ltd., No. 15-902, 2018 U.S. Dist. LEXIS 116931 (D. Del. July 13, 2018) (Stengel, C.J.)....more
11/5/2018
/ Abbreviated New Drug Application (ANDA) ,
Bayer ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art
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: Pernix Ir. Pain DAC v. Alvogen Malta Operations, Ltd., No. 16-139, 2018 U.S. Dist. LEXIS 144226 (D. Del. Aug. 24, 2018) (Bryson, J.)....more
11/1/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Galderma Labs., L.P. v. Amneal Pharmaceuticals LLC, No. 16-207-LPS, 2018 U.S. Dist. LEXIS 151037 (D. Del. Aug. 27, 2018) (Stark, C.J.)....more
10/31/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art
Case Name: Purdue Pharma L.P. v. Collegium Pharm., Inc., No. 15-cv-13099, 2018 U.S. Dist. LEXIS 167895 (D. Mass. Sept. 28, 2018) (Saylor, J.)....more
Case Name: Endo Pharms. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374, 2018 U.S. App. LEXIS 19265 (Fed. Cir. July 13, 2018) (Circuit Judges Moore, Linn, and Chen presiding; Opinion by Chen, J.) (Appeal from D. Del., Robinson,...more
10/29/2018
/ Abbreviated New Drug Application (ANDA) ,
Endo Pharmaceuticals ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art
Case Name: Supernus Pharms., Inc. v. TWi Pharms., Inc., Fed. Cir. No. 2017-2513, 2018 U.S. App. LEXIS 25271 (Fed. Cir. Sept. 6, 2018)....more
10/26/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Orexo AB v. Actavis Elizabeth LLC, Fed. Cir. No. 2017-1333, 2018 U.S. App. LEXIS 25531 (Fed. Cir. Sept. 10, 2018) (Circuit Judges Newman, Hughes, and Stoll presiding; Opinion by Newman, J.) (Appeal from D. Del.,...more
10/25/2018
/ Actavis Inc. ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Opioid ,
Pain Management ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Acorda Therapeutics, Inc. v. Roxane Labs., Inc., Fed. Cir. Nos. 2017-2078, -2134, 2018 U.S. App. LEXIS 25536 (Fed. Cir. Sept. 10, 2018) (Circuit Judges Newman, Dyk, and Taranto presiding; Opinion by Taranto, J.;...more
10/24/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Roxane Laboratories
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: Pernix Ir. Pain DAC v. Alvogen Malta Operations, Ltd., Civ. No. 16-139-WCB, 2018 U.S. Dist. LEXIS 81419 (D. Del. May 15, 2018) (Bryson, C.J.)....more
8/1/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Summary Judgment
Case Name: Shire Orphan Therapies LLC v. Fresenius Kabi USA, LLC, Civ. No. 15-1102-GMS, 2018 U.S. Dist. LEXIS 93911 (D. Del. June 5, 2018) (Sleet, J.)....more
7/31/2018
/ Fresenius ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Shire Orphan Therapies LLC
Case Name: Eli Lilly & Co. v. Hospira, Inc., Civ. No. 12-3460-TWP-MPB, 2018 U.S. Dist. LEXIS 100550 (S.D. Ind. June 15, 2018) (Pratt, J.)....more
7/30/2018
/ Eli Lilly ,
Generic Drugs ,
Hatch-Waxman ,
Hospira ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Eli Lilly & Co. v. Dr. Reddy’s Labs., Ltd., Civ. No. 16-0308-TWP-MPB, 2018 U.S. Dist. LEXIS 104653 (S.D. Ind. June 22, 2018) (Pratt, J.).
Drug Product and Patent(s)-in-Suit: Alimta® (pemetrexed disodium); U.S....more
7/27/2018
/ Dr. Reddy’s Labs. ,
Eli Lilly ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
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