Generic Drugs ANDA

News & Analysis as of

Court Report - February 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Astellas Pharma Inc. et al. v. Apotex Inc. et al. 1:15-cv-00857; filed September 22, 2015 in the District Court of...more

Court Report - January 2016 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Purdue Pharma L.P. et al. v. Amneal Pharmaceuticals LLC 1:15-cv-00831; filed September 17, 2015 in the District Court of...more

Otsuka Pharm. Co., Ltd. v. Zydus Pharms. USA,

Case Name: Otsuka Pharm. Co., Ltd. v. Zydus Pharms. USA, C.A. Nos. 14-3168 (JBS/KMW),14-4671 (JBS/KMW),14-5878 (JBS/KMW),14-6398 (JBS/KMW),14-7252 (JBS/KMW), 2015 U.S. Dist. LEXIS 138853 (D.N.J. Oct. 13, 2015) (Simandle,...more

Helsinn Healthcare S.A. v. Dr. Reddy’s Labs., Ltd.

Case Name: Helsinn Healthcare S.A. v. Dr. Reddy’s Labs., Ltd., Civ. No. 11-3962, 2015 U.S. Dist. LEXIS 167048 (D.N.J. Nov. 13, 2015) (Cooper, J.)... Drug Product and Patent(s)-in-Suit: Aloxi® (palonosetron); U.S. Patents...more

Spectrum Pharms., Inc. v. Sandoz, Inc.

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

Prometheus Labs., Inc. v. Roxane Labs., Inc.

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

Court Report - January 2016 #3

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Merck Sharp & Dohme B.V. v. Teva Pharmaceuticals USA Inc. 1:15-cv-00806; filed September 11, 2015 in the District Court...more

Court Report - January 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Sage Labs Inc. v. Transposagen Biopharmaceuticals Inc. 1:15-cv-00791; filed September 9, 2015 in the District Court of...more

A Stay of Litigation Pending IPR Does Not Provide a Basis For Extending 30-Stay of FDA ANDA Approval

On December 11, 2015, the United States District Court for the Southern District of Indiana granted a motion to stay a Hatch-Waxman litigation pending the outcome of inter partes reviews (IPRs) on two of the patents-in-suit...more

Court Report - January 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Spectrum Pharmaceuticals, Inc. et al. v. Amneal Pharmaceuticals LLC - 2:15-cv-01697; filed September 3, 2015 in the...more

Court Report - December 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Warner Chilcott (US), LLC et al. v. Teva Pharmaceuticals USA, Inc. et al. - 1:15-cv-00761; filed August 31, 2015 in...more

Washington Healthcare Update

This Week: Congress raced to exit for the holidays and passed a $1.5 trillion omnibus spending bill and $680 billion tax-extenders package on Friday. The omnibus funds the government through September 2016. President Obama...more

Court Report - December 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Merck Sharp & Dohme Corp. et al. v. Med-Pharmex, Inc. 3:15-cv-01905; filed August 28, 2015 in the Southern District of...more

Court Report - November 2015 #6

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Forest Laboratories LLC et al. v. Amneal Pharmaceuticals LLC et al. 1:15-cv-00756; filed August 27, 2015 in the District...more

Momenta Pharma., Inc. v. Teva Pharma. USA Inc.

In Momenta Pharma., Inc. v. Teva Pharma. USA Inc., Nos. 2014-1274, -1277, -1276, and -1278 (Fed. Cir. Nov. 10, 2015) (“Momenta II”), the Federal Circuit found that, pursuant to 35 U.S.C. § 271(g), “made” is limited to steps...more

Court Report - November 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Vivus, Inc. v. Actavis Laboratories FL, Inc. 2:15-cv-06256; filed August 17, 2015 in the District Court of New...more

Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc.

Case Name: Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc., Civ. No. 14-874-SLR-SRF, 2015 U.S. Dist. LEXIS 85279 (D. Del. July 1, 2015) (Fallon, M.J.) - Drug Product and Patent(s)-in-Suit: Nasonex® (mometasone...more

Intendis GMBH. v. Glenmark Pharms. Ltd.

Case Name: Intendis GMBH. v. Glenmark Pharms. Ltd., 13-421 (SLR), 2015 U.S. Dist. LEXIS 97403 (D. Del. July 27, 2015) (Robinson, J.) - Drug Product and Patent(s)-in-Suit: Finacea® Gel, 15% (azelaic acid gel); U.S. Pat....more

Court Report - November 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Purdue Pharma L.P. et al. v. Actavis Laboratories FL, Inc. 1:15-cv-00686; filed August 5, 2015 in the District Court of...more

Novartis Pharm. Corp. v. Zydus Noveltech Inc.

Case Name: Novartis Pharm. Corp. v. Zydus Noveltech Inc., Civ. No. 14-cv-1104-RGA, 2015 U.S. Dist. LEXIS 103708 (D. Del. Aug. 7, 2015) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Exelon® (rivastigmine); U.S....more

Endo Pharms. Inc. v. Amneal Pharms. LLC

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

Supplier to ANDA Filer Is Not Liable for Induced Infringement Until After ANDA Approval - Shire LLC v. Amneal Pharms., LLC

Addressing the scope of the safe harbor provision of § 271(e)(1), the U.S. Court of Appeals for the Federal Circuit reversed the district court, holding that supplying an active pharmaceutical ingredient (API) to the filer of...more

Eli Lilly & Co. v. Nang Kuang Pharm.Co., Ltd.

Case Name: Eli Lilly & Co. v. Nang Kuang Pharm.Co., Ltd., 1:14-cv-1647-TWP-DKL, 2015 U.S. Dist. LEXIS 11510 (S.D. Ind. Aug. 24, 2015) - Drug Product and Patent-in-Suit: Alimta® (pemetrexed disodium); U.S. Patents Nos....more

ANDA Update - October 2015

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Merck Sharp & Dohme Corp. v. Sandoz Inc.

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

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