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: Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 855 F.3d 1356, 2017 U.S. App. LEXIS 7650 (Fed. Cir. May 1, 2017) (Circuit Judges Dyk, Mayer, and O’Malley presiding; Opinion by Dyk, J.) (appeal from D.N.J.,...more
8/3/2017
/ Abbreviated New Drug Application (ANDA) ,
America Invents Act ,
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: Braintree Labs., Inc. v. Breckenridge Pharm., Inc., No. 2016-1731 (Fed. Cir. May 5, 2017) (Circuit Judges Newman, Moore, and Wallach presiding; Opinion by Moore, J.) (appeal from S.D.N.Y., Nathan, J.)....more
8/2/2017
/ 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: 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: Allergan, Inc. v. Teva Pharms. USA, Inc., 15-1455-WCB, 2017 U.S. Dist. LEXIS 4545 (E.D. Tex. Jan. 12, 2017) (Bryson, J.).
Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine ophthalmic solution); U.S....more
5/25/2017
/ Abbreviated New Drug Application (ANDA) ,
Allergan Inc ,
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: Sanofi v. Lupin Atlantis Holdings SA, Civ. No. 15-415-RGA, 2017 U.S. Dist. LEXIS 10653 (D. Del. Jan. 26, 2017) (Andrews, J.).
Drug Product and U.S. Patent: Multaq® (dronedarone tablets); U.S. Patent No....more
5/24/2017
/ 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 ,
Sanofi
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: Merck Sharp & Dohme Corp. v. Amneal Pharms. LLC, Civ. No. 15-250-SLR, 2017 U.S. Dist. LEXIS 12165 (D. Del. Jan. 30, 2017) (Robinson, J.).
Drug Product and U.S. Patent: Nasonex® (mometasone furoate nasal...more
5/22/2017
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Merck ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: In re copaxone consolidated cases, No. 14-1171-GMS (consolidated) 2017 U.S. Dist. LEXIS 12168 (D. Del. Jan. 30, 2017) (Sleet, J.).
Drug Product and Patent(s)-in-Suit: Copaxone® (prefilled syringes of...more
5/19/2017
/ 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: Par Pharm., Inc. v. Luitpold Pharms., Inc., No. 16-2290 (WHW)(CLW), 2017 U.S. Dist. LEXIS 15050 (D.N.J. Feb. 1, 2017) (Walls, J.).
Drug Product and Patent(s)-in-Suit: Adrenalin® (epinephrine); U.S. Patents...more
5/18/2017
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Par Pharmaceutical ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: AstraZeneca AB v. Aurobindo Pharma Ltd., 14-664-GMS, 2017 U.S. Dist. LEXIS 14647 (D. Del. Feb. 2, 2017) (Sleet, J.).
Drug Product and Patent(s)-in-Suit: Onglyza® (saxagliptin) and Kombiglyze™ XR (saxaglibtin...more
5/17/2017
/ Abbreviated New Drug Application (ANDA) ,
AstraZeneca ,
Aurobindo Pharmaceuticals ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Endo Pharma. Solutions Inc. v. Custopharm, Inc., 14-1422-SLR, 2017 U.S. Dist. LEXIS 19035 (D. Del. Feb. 10, 2017) (Robinson, J.).
Drug Product and Patent(s)-in-Suit: Aveed® (testosterone undecanoate); U.S....more
5/16/2017
/ 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
Case Name: Helsinn Healthcare S.A. v. Dr. Reddy's Labs., Ltd., No. 12-2867 (MLC) (DEA), 2017 U.S. Dist. LEXIS 21477 (D.N.J. Feb. 14, 2017) (Cooper, J.).
Drug Product and Patent(s)-in-Suit: Aloxi® (palonosetron); U.S....more
5/15/2017
/ 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: Recro Gainesville LLC v. Actavis Labs. FL, Inc., Civ. No. 14-1118-GMS, 2017 U.S. Dist. LEXIS 24428 (D. Del. Feb. 22, 2017) (Sleet, J.).
Drug Product and U.S. Patent: Zohydro® ER (hydrocodone bitartrate...more
5/12/2017
/ Abbreviated New Drug Application (ANDA) ,
Actavis Inc. ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Apotex Inc. v. Alcon Research, Ltd., No. 16-3145-WTL-MJD, 2017 U.S. Dist. LEXIS 27016 (S.D. Ind. Feb. 27, 2017) (Lawrence, J.).
Drug Product and Patent(s)-in-Suit: Pataday® (olopatadine); U.S. Patents Nos....more
5/11/2017
/ Abbreviated New Drug Application (ANDA) ,
Apotex ,
Article III ,
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 ,
Standing
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: Reckitt Benckiser LLC v. Aurobindo Pharma Ltd., Civ. No. 14-1203-LPS, 2017 U.S. Dist. LEXIS 31985 (D. Del. Mar. 6, 2017) (Stark, J.).
Drug Product and Patent(s)-in-Suit: Mucinex® DM (dextromethorphan...more
5/9/2017
/ Abbreviated New Drug Application (ANDA) ,
Aurobindo Pharmaceuticals ,
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: Novartis Pharms. Corp. v. Breckenridge Pharm., Inc., Civ. Nos. 14-1043-RGA, 14-1196-RGA, 14-1289-RGA, 2017 U.S. Dist. LEXIS 46595 (D. Del. Mar. 28, 2017) (Andrews, J.)....more
5/8/2017
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Novartis ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Impax Labs., Inc. v. Lannett Holdings Inc., Nos. 14-0984, -999 (RGA), 2017 U.S. Dist. LEXIS 47244 (D. Del. Mar. 29, 2017) (Andrews, J.)....more
Case Name: Acorda Therapeutics Inc. v. Roxane Labs., Inc., 14-882-LPS, 2016 U.S. Dist. LEXIS 48479 (D. Del. Mar. 31, 2017) (Stark, J.)....more
5/4/2017
/ 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 ,
Roxane Laboratories
Case Name: Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., No. 2015-2067, 2017 U.S. App. LEXIS 555 (Fed. Cir. Jan. 12, 2017) (Circuit Judges Prost, Newman, and Dyk presiding; Opinion by Prost, C.J.) (Appeal from S.D....more
5/3/2017
/ Abbreviated New Drug Application (ANDA) ,
Eli Lilly ,
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: 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: Shire Development, LLC v. Watson Pharms., Inc., No. 2016-1785, 848 F.3d 981 (Fed. Cir. Feb. 10, 2017) (Circuit Judges Prost, Taranto, and Hughes presiding; Opinion by Hughes, J.) (appeal from S.D. Fla.,...more
5/1/2017
/ 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 ,
Shire Development v Watson ,
Watson Pharmaceuticals
Case Name: Allergan, Inc. v. Sandoz, Inc., Nos. 2016-1085, -1160, 2017 U.S. App. LEXIS 4733 (Fed. Cir. Mar. 17, 2017) (Circuit Judges Reyna, Wallach, and Chen presiding; Opinion by Wallach, J.) (Appeal from M.D.N.C., Eagles,...more
4/28/2017
/ Allergan v Sandoz ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
USPTO
Case Name: Endo Pharms. Inc. v. Amneal Pharms. LLC, Civ Nos. 14-1382-RGA, 14-1389-RGA, 2016 U.S. Dist. LEXIS 140112 (D. Del. Oct. 7, 2016) (Andrews, J.).
Drug Product and Patent(s)-in-Suit: Opana® ER (oxymorphone...more
2/6/2017
/ Abbreviated New Drug Application (ANDA) ,
Endo Pharmaceuticals ,
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