Hatch-Waxman Patents

News & Analysis as of

Helsinn Healthcare S.A. v. Hospira, Inc.

Case Name: Helsinn Healthcare S.A. v. Hospira, Inc., Civil No. 15-2077 (MLC), 2016 U.S. Dist. LEXIS 45826 (D.N.J. Apr. 5, 2016) (Cooper, J.) - Drug Product and Patents-in-Suit: Aloxi® (palonosetron); U.S. Patents Nos....more

Otsuka Phama. Co., Ltd. v. Zydus Pharms. USA, Inc., et al.

Case Name: Otsuka Phama. Co., Ltd. v. Zydus Pharms. USA, Inc., et al., Civil Action Nos. 14-3168 (JBS/KMW), 2016 U.S. Dist. LEXIS 48689 (D.N.J. Apr. 12, 2016) (Simandle, C.J.) - Drug Product and Patent(s)-in-Suit:...more

Allergan, Inc. v. Teva Pharmaceuticals USA, Inc.

Case Name: Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., Civ. No. 15-cv-1455 (WCB), 2016 U.S. Dist. LEXIS 51851 (E.D. Tex. Apr. 19, 2016) (Bryson, J.) - Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine...more

Pfizer Inc. v. Sandoz Inc

Case Name: Pfizer Inc. v. Sandoz Inc., C.A. No. 13-1110-GMS, 2016 U.S. Dist. LEXIS 52762 (D. Del. Apr. 20, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Toviaz® (fesoterodine fumarate); U.S. Patents Nos....more

Bayer Pharma AG v. Watson Labs., Inc

Case Name: Bayer Pharma AG v. Watson Labs., Inc., Civ. No. 12-cv-517 (GMS), 2016 U.S. Dist. LEXIS 55752 (D. Del. Apr. 27, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Staxyn® (vardenafil hydrochloride...more

Endo Pharm. Inc. v. Amneal Pharms. LLC

Case Name: Endo Pharm. Inc. v. Amneal Pharms. LLC, Civil 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 Civ. 8597...more

Bayer Pharma AG v. Watson Labs., Inc.

Case Name: Bayer Pharma AG v. Watson Labs., Inc., Civ. No. 12-cv-517 (GMS), 2016 U.S. Dist. LEXIS 57888 (D. Del. May 2, 2016) (Sleet, J.) - Drug Product and U.S. Patent(s)-in-Suit: Staxyn® and Levitra® (vardenafil...more

Genzyme Corp. v. Dr. Reddy’s Labs., Ltd.

Case Name: Genzyme Corp. v. Dr. Reddy’s Labs., Ltd., C.A. No. 13-1506-(GMS), 2016 U.S. Dist. LEXIS 62056 (D. Del. May 11, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Mozobil® (plerixafor solution); U.S. Pat....more

Takeda Pharms. U.S.A., Inc. v. West-ward Pharm. Corp.

Case Name: Takeda Pharms. U.S.A., Inc. v. West-ward Pharm. Corp., Civ. No. 14-1268-SLR, 2016 U.S. Dist. LEXIS 65317 (D. Del. May 18, 2016) (Robinson, J.) - Drug Product and Patent(s)-in-Suit: Colcrys® (colchicine); U.S....more

Ferring B.V. v. Actavis, Inc.

Case Name: Ferring B.V. v. Actavis, Inc., Civil No. 15-4222 (SRC)(CLW), 2016 U.S. Dist. LEXIS 69328 (D.N.J. May 26, 2016) (Chesler, J.) - Drug Product and Patents-in-Suit: Lysteda® (tranexamic acid); U.S. Patent No....more

Reckitt Benckiser Pharms, Inc. v. Watson Labs., Inc.

Case Name: Reckitt Benckiser Pharms, Inc. v. Watson Labs., Inc., Civil No. 13-1674-RGA, 2016 U.S. Dist. LEXIS 72391 (D. Del. June 3, 2016) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Suboxone® (buprenorphine HCl...more

In Re Bendamustine Consolidated Cases

Case Name: In Re Bendamustine Consolidated Cases, No. 13-2046-GMS, 2016 U.S. Dist. LEXIS 75624 (D. Del. June 10, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Treanda® (bendamustine HCl); U.S. Patents Nos....more

Merck & Cie v. Watson Labs., Inc.

Case Name: Merck & Cie v. Watson Labs., Inc., 2015-2063, -2064, 2016 U.S. App. LEXIS 8782 (Fed. Cir. May 13, 2016) (Circuit Judges Dyk, Mayer, and Hughes presiding; Opinion by Mayer, J.) (Appeal from D. Del., Andrews, J.)...more

Intendis GMBH et al. v. Glenmark Pharms. Inc., USA

Case Name: Intendis GMBH et al. v. Glenmark Pharms. Inc., USA, 822 F.3d 1355 (Fed. Cir. May 16, 2016) (Circuit Judges Prost, Moore, and Taranto presiding; Opinion by Moore, J.) (Appeal from D. Del., Robinson, J.) - Drug...more

Spectrum Pharms., Inc. v. Burwell

Case Name: Spectrum Pharms., Inc. v. Burwell, No. 15-5166, 2016 U.S. App. LEXIS 10095 (D.C. Cir. June 3, 2016) (Circuit Judges Griffith, Cavanaugh, and Wilkins presiding; Opinion by Griffith) (Appeal from D.D.C., Lamberth,...more

Federal Circuit Rules on Biosimilar Notice Requirement

Biosimilar Applicants Must Provide Notice of Commercial Launch: What You Need To Know - Case Background - In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who...more

Recent Court Cases Interpreting “Reverse Payments” Post-Actavis

Patent settlement agreements were traditionally deemed outside the purview of antitrust scrutiny unless the patent holder’s conduct fell outside the legitimate scope of the patent’s exclusionary power. This all changed when...more

Supernus Pharms., Inc. v. Actavis Inc.

Case Name: Supernus Pharms., Inc. v. Actavis Inc., Civil Nos. 13-4740 (RMB/JS), 14-1981 (RMB/JS), 2016 U.S. Dist. LEXIS 14111 (D.N.J. Feb 5, 2016) (Bumb, J.)... Drug Product and Patent(s)-in-Suit: Oxtellar XR®...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 (MLC), 2016 U.S. Dist. LEXIS 27477 (D.N.J. Mar. 3, 2016) (Cooper, J.)... Drug Product and Patent(s)-in-Suit: Aloxi® (palonosetron); U.S....more

Braintree Labs. Inc. v. Breckenridge Pharm., Inc.

Case Name: Braintree Labs. Inc. v. Breckenridge Pharm., Inc., C.A. No 12-cv-6851 (AJN), 2016 U.S. Dist. LEXIS 33336 (S.D.N.Y. Mar. 15, 2016) (Nathan, J.)... Drug Product and Patent(s)-in-Suit: Suprep® (sodium sulfate /...more

Shire Development, LLC v. Watson Pharms., Inc.

Case Name: Shire Development, LLC v. Watson Pharms., Inc., Civ. No. 12-60862-CIV-MIDDLEBROOKS/BRANNON, 2016 U.S. Dist. LEXIS 40360 (S.D. Fla. Mar. 25, 2016) (Middlebrooks, J.)... Drug Product and Patent(s)-in-Suit:...more

Purdue Pharma L.P. v. Epic Pharma, LLC

Case Name: Purdue Pharma L.P. v. Epic Pharma, LLC, 811 F.3d 1345 (Fed. Cir. Feb. 1, 2016) (Circuit Judges Prost, Reyna, and Stark [sitting by designation] presiding; Opinion by Prost, C.J.) (Appeal from S.D.N.Y., Stein,...more

Warner Chilcott Co., LLC v. Teva Pharms. USA, Inc.

Case Name: Warner Chilcott Co., LLC v. Teva Pharms. USA, Inc., 2015-1588, 2016 U.S. App. LEXIS 4945 (Fed. Cir. March 18, 2016) (Circuit Judges Lourie, Dyk, and Hughes presiding; Opinion by Lourie, J.) (Appeal from D.N.J.,...more

Acorda Therapeutics Inc. v. Mylan Pharms. Inc.

Case Name: Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 2015-1456, 2015-1460, 2016 U.S. App. LEXIS 4942 (Fed. Cir. Mar. 18, 2016) (Circuit Judges Newman, O’Malley, and Taranto presiding; Opinion by Taranto, J.; Concurring...more

March 2016 Life Sciences Litigation Update

Federal Circuit Affirms Broad Personal Jurisdiction Over ANDA Filers. On March 18, 2016, in the first decision of its kind since the U.S. Supreme Court decided Daimler AG v. Bauman, 134 S. Ct. 746 (2014), the Federal...more

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