Case Name: Spectrum Pharms., Inc. v. Sandoz, Inc., 2015-1407, 2015 U.S. App. LEXIS 17313 (Fed. Cir. Oct. 2, 2015) (Circuit Judges Lourie, Wallach, and Hughes presiding; Opinion by Lourie, J.) (Appeal from D. Nev., Navarro,...more
Case Name: Prometheus Labs., Inc. v. Roxane Labs., Inc., 2014-1634, -1635, 2015 U.S. App. LEXIS 19556 (Fed. Cir. Nov. 10, 2015) (Circuit Judges Dyk, Taranto, and Hughes presiding; Opinion by Dyk, J.) (Appeal from D.N.J.,...more
Case Name: Endo Pharms. Inc. v. Amneal Pharms. LLC, Civ. Nos. 12 Civ. 8115 (TPG), 12 Civ. 8060 (TPG), 12 Civ. 8317 (TPG), 12 Civ. 8985 (TPG), 13 Civ. 435 (TPG), 13 Civ. 436 (TPG), 13 Civ. 3288 (TPG), 13 Civ. 4343 (TPG), 13...more
11/4/2015
/ Abbreviated New Drug Application (ANDA) ,
Endo Pharmaceuticals ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Merck Sharp & Dohme Corp. v. Sandoz Inc., Civ. No. 3:12-cv-03289-PGS-LHG, 2015 U.S. Dist. LEXIS 113710 (D.N.J. Aug. 27, 2015) (Sheridan, J.) -
Drug Product and Patent(s)-in-Suit: Emend® (fosaprepitant...more
10/29/2015
/ Abbreviated New Drug Application (ANDA) ,
Cancer ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Merck ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Sandoz
Case Name: Allergan, Inc., v. Sandoz Inc., Civ. No. 2014-1275, 2015 U.S. App. LEXIS 13616 (Fed. Cir. Aug. 4, 2015) (Circuit Judges Lourie, Linn, and Hughes presiding; Opinion by Lourie, J.) (Appeal from E.D. Tex., Schneider,...more
10/21/2015
/ Abbreviated New Drug Application (ANDA) ,
Allergan Inc ,
Allergan v Sandoz ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Sandoz
Case Name: Shire LLC v. Amneal Pharms. LLC, 2014-1736, -1737, -1738, -1739, -1740, -1741, 2015 U.S. App. LEXIS 16908 (Fed. Cir. Sept. 24, 2015) (Circuit Judges Moore, Mayer, and Linn presiding; Opinion by Linn, J.) (Appeal...more
Case Name: Purdue Pharma L.P. v. Amneal Pharms., LLC, Civ. Nos. 04-Md-1603 (SHS); 13-cv-3372 (SHS), 2015 U.S. Dist. LEXIS 45967 (S.D.N.Y. Apr. 8, 2015) (Stein, J.) -
Drug Product and Patent(s)-in-Suit: OxyContin®...more
8/17/2015
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
OxyContin ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
WIPO
Case Name: GlaxoSmithKline LLC. v. Glenmark Generics Inc., USA, Civ. Nos. 14-877-LPS-CJB; 14-878-LPS-CJB, 2015 U.S. Dist. LEXIS 52525 (D. Del. Apr. 22, 2015) (Burke, J.) -
Drug Product and Patent(s)-in-Suit: Coreg®...more
8/12/2015
/ Abbreviated New Drug Application (ANDA) ,
Federal Rule 12(b)(6) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
GlaxoSmithKline ,
Hatch-Waxman ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Otsuka Pharmaceutical Co., Ltd. v. Burwell, Civ. No. GJH-15-852, 2015 U.S. Dist. LEXIS 68230 (D. Md., May 27, 2015) (Hazel, J.) -
Drug Product and Patent(s)-in-Suit: Abilify® (aripiprazole); N/A -
Nature...more
8/10/2015
/ Abbreviated New Drug Application (ANDA) ,
Bipolar Disorder ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Restraining Orders ,
SNDAs ,
TRO
Case Name: Amarin Pharms. Ireland Ltd v. FDA, Case No. 14-cv-00324 (RDM), 2015 U.S. Dist. LEXIS 68723 (D.D.C. May 28, 2015) (Moss, J.) -
Drug Product and Patent(s)-in-Suit: Vascepa® Capsules (icosapent ethyl); N/A...more
8/7/2015
/ Abbreviated New Drug Application (ANDA) ,
Amarin ,
Chevron Deference ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Braintree Labs., Inc. v. Novel Labs., Inc., Case No. 3:11-cv-01341-PGS-LHG, 2015 U.S. Dist. LEXIS 70993 (D.N.J. June 2, 2015) (Sheridan, J.) -
Drug Product and Patent(s)-in-Suit: Suprep® Bowel Prep Kit (sodium...more
8/6/2015
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Summary Judgment
Case Name: Spectrum Pharms., Inc. v. Burwell, Civ. No. 15-631 (RCL), 2015 U.S. Dist. LEXIS 73218 (D.D.C. May 27, 2015) (Lamberth, J.) -
Drug Product and Patent(s)-in-Suit: Fusilev® (levoleucovorin); N/A -
Nature of...more
8/5/2015
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Orphan Drugs ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Sandoz ,
Spectrum
Case Name: Veloxis Pharmaceuticals, Inc. v. FDA, Civ. No. 14-2126 (RBW), 2015 U.S. Dist. LEXIS 77559 (D.D.C. June 12, 2015) (Walton, J.) -
Drug Product and Patent(s)-in-Suit: Astagraf XL® (tacrolimus); N/A...more
Case Name: Takeda Pharms. U.S.A., Inc. v. West-Ward Pharm. Corp., 785 F.3d 625 (Fed. Cir. May 6, 2015) (Circuit Judges Newman, Dyk, and Hughes presiding; Opinion by Dyk, J.; Dissent by Newman, J.) (Appeal from D. Del.,...more
Case Name: AstraZeneca LP v. Breath Ltd., 2015-1335, 2015 U.S. App. LEXIS 7525 (Fed. Cir. May 7, 2015) -
Drug Product and Patent(s)-in-Suit: Pulmicort Respules® (budesonide inhalation suspension); U.S. Patent No....more
Case Name: Classen Immunotherapies, Inc. v. Elan Pharms., Inc., 786 F.3d 892 (Fed. Cir. May 13, 2015) (Circuit Judges Prost and Lourie, and District Judge Gilstrap presiding; Opinion by Lourie, J.) (Appeal from D. Md.,...more
7/28/2015
/ Abbreviated New Drug Application (ANDA) ,
Classen Immunotherapies ,
Elan Pharmaceuticals ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs
Case Name: Acorda Therapeutics, Inc. v. Mylan Pharms. Inc., Nos. 14-935-LPS, 2015 U.S. Dist. LEXIS 4056 (D. Del. Jan. 14, 2015) (Stark, C.J.).
Drug Product and Patent(s)-in-Suit: Ampyra® (dalfampridine); U.S. Pats. Nos....more
Case Name: AstraZeneca LP v. Breath Ltd., Civ. No. 08-1512 (RMB/AMD), 2015 U.S. Dist. LEXIS 17687 (D.N.J. Feb. 13, 2015) (Bumb, J.).
Drug Product and Patent(s)-in-Suit: Pulmicort Respules® (budesonide inhalation...more
Case Name: Ranbaxy Labs., Ltd. v. Burwell, 14-cv-1923 BAH, 2015 U.S. Dist. LEXIS 29459 (D.D.C. Mar. 11, 2015) (Howell, J.).
Drug Products and Patents-in-Suit: Nexium® (esomeprazole) and Valcyte® (valganciclovir);...more
Case Name: Apotex Inc. v. Daiichi Sankyo, Inc., 2014-1282, -1291 2015 U.S. App. LEXIS 5134 (Fed. Cir. Mar. 31, 2015) (Circuit Judges Taranto, Mayer, and Clevenger presiding; Opinion by Taranto, J.) (Appeal from N.D. Ill.,...more
Case Name: Civ. No. 3:14-cv-422-HEH, 2014 U.S. Dist. LEXIS 146528 (E.D. Va. Oct. 14, 2014) (Hudson, J.) (Where patent holder disclaims patent and asks FDA to delist, but patent remains in Orange Book, declaratory judgment...more
Case Name: Allergan, Inc. v. Actavis, Inc., Nos. 14-cv-638, 14-cv-188, 2014 U.S. Dist. LEXIS 176551 (E.D. Tex. Dec. 23, 2014) (Gilstrap, J.) (Only an ANDA “received” by the FDA can form the basis for a patent infringement...more
Case Name: Warner Chilcott Co, LLC v. Teva Pharms. USA, Inc., Nos. 2014-1439, 2014-1441, 2014-1444, 2014-1445, 2014-1446, 2014 U.S. App. LEXIS 21946 (Fed. Cir. Nov. 18, 2014) (Circuit Judges Lourie, Reyna and Taranto...more
Case Name: Sandoz Inc. v. Amgen Inc., No. 2014-1693, 2014 U.S. App. LEXIS 22903 (Fed. Cir. Dec. 5, 2014) (Circuit Judges Dyk, Taranto, and Chen presiding; Opinion by Taranto, J.) (appeal from N.D. Cal, Chesney, J.) (A...more
2/16/2015
/ Amgen ,
Biosimilars ,
Declaratory Judgments ,
Food and Drug Administration (FDA) ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen
Nature of the Case and Issue(s) Presented: Precedex is commonly used as a sedative. Specifically, the FDA has approved Precedex for two uses: (i) sedation of initially intubated and mechanically ventilated patients during...more