News & Analysis as of

Generic Drugs The United States Food and Drug Administration Patents

In re copaxone consolidated cases

by Robins Kaplan LLP on

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

Par Pharm., Inc. v. Luitpold Pharms., Inc.

by Robins Kaplan LLP on

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

Apotex Inc. v. Alcon Research, Ltd.

by Robins Kaplan LLP on

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

Reckitt Benckiser LLC v. Aurobindo Pharma Ltd.

by Robins Kaplan LLP on

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

Novartis Pharms. Corp. v. Breckenridge Pharm., Inc.

by Robins Kaplan LLP on

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

Eli Lilly and Co. v. Teva Parenteral Medicines, Inc.

by Robins Kaplan LLP on

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

Cumberland Pharms. Inc. v. Mylan Institutional LLC

by Robins Kaplan LLP on

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

Novartis v. Noven: The PTAB is not Bound by Prior Decisions of District Courts

Novartis, together with LTS Lohmann Therapie-Systeme, owns a pair of patents covering rivastigmine transdermal patches. These patches are useful for treating Alzheimer’s disease. Noven Pharmaceuticals filed an abbreviated new...more

Wrong Inventor Defense Fails in Pharmaceutical Litigation

by McDermott Will & Emery on

Addressing derivation and obviousness issues, the US Court of Appeals for the Federal Circuit affirmed the district court’s denial of a generic drug manufacturer’s attempt to invalidate a patent based on the theory that the...more

Second Circuit Declares That, to Survive Motions to Dismiss, Antitrust Allegations Require Factual Support for All “Necessary...

Last Wednesday, the Second Circuit Court of Appeals partially vacated the judgment of the district court in In re Actos End-Payor Antitrust Litigation. In doing so, the Second Circuit allowed only plaintiffs’ claims that...more

Endo Pharms. Inc. v. Amneal Pharms. LLC

by Robins Kaplan LLP on

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

Mylan Institutional LLC v. Aurobindo Phama Ltd

by Robins Kaplan LLP on

Case Name: Mylan Institutional LLC v. Aurobindo Phama Ltd, 2:16-cv-00491-RWS-RSP, 2016 U.S. Dist. LEXIS 180551 (E.D. Tex. Nov. 21, 2016) (Payne, MJ). Drug Product and Patents-in-Suit: isosulfan blue; U.S. Patents Nos....more

Bayer Pharma AG v. Watson Labs., Inc.

by Robins Kaplan LLP on

Case Name: Bayer Pharma AG v. Watson Labs., Inc., 12-1726-LPS, 2016 U.S. Dist. LEXIS 179103 (D. Del. Dec. 28, 2016) (Stark, J.). Drug Product and Patent(s)-in-Suit: Natazia® (estradiol valerate/estradiol...more

Endo Pharms. Inc. v. Actavis Labs. UT, Inc.

by Robins Kaplan LLP on

Case Name: Endo Pharms. Inc. v. Actavis Labs. UT, Inc., 2016-1146, 2016 U.S. App. LEXIS 18490 (Fed. Cir. Oct. 14, 2016) (Circuit Judges Moore, Taranto, and Hughes presiding; Opinion by Taranto, J.) (Appeal from E.D. Tex.,...more

Speculation of ANDA Product Launch Before FDA Approval Does Not Warrant Permanent Injunction

by Locke Lord LLP on

On December 28, 2016, Judge Stark of the District of Delaware, despite having previously found infringement, held that plaintiffs Bayer Pharma AG, Bayer Intellectual Property GmbH, and Bayer HealthCare Pharmaceuticals Inc....more

Boehringer Ingelheim Pharma GMBH & Co. KG v. FDA

by Robins Kaplan LLP on

Case Name: Boehringer Ingelheim Pharma GMBH & Co. KG v. FDA, Civ. No. 15-656 (CKK), 2016 U.S. Dist. LEXIS 86952 (D.D.C. July 6, 2016) (Kollar-Kotelly, J.) - Drug Product and Patent(s)-in-Suit: Pradaxa® (dabigatran...more

GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.

by Robins Kaplan LLP on

Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., Civ. No. 14-878-LPS-CJB, 2016 U.S. Dist. LEXIS 94438 (D. Del. July 20, 2016) (Burke, M.J.) - Drug Product and Patent(s)-in-Suit: Coreg® (carvedilol); U.S....more

Super Moon Harkens Low Tide for Hatch-Waxman Patent Disputes

by Michael Volkov on

This week, the U.S. Supreme Court denied a petition for writ of certiorari in a case that will give pharmaceutical companies pause when considering whether to settle patent challenges under Hatch-Waxman. The Supreme Court’s...more

Horizon Pharma Ireland Ltd. v. Actavis Labs., UT, Inc.

by Robins Kaplan LLP on

Case Name: Horizon Pharma Ireland Ltd. v. Actavis Labs., UT, Inc., Civ. No. 14-7992 (NLH/AMD), 2016 U.S. Dist. LEXIS 109068 (D.N.J. Aug. 17, 2016) (Hillman, J.) - Drug Product and Patent(s)-in-Suit: Pennsaid® (diclofenac...more

Eli Lilly & Co. v. Perrigo Co.

by Robins Kaplan LLP on

Case Name: Eli Lilly & Co. v. Perrigo Co., Case No. 1:13-cv-00851-SEB-DKL (S.D. Ind. Aug. 22, 2016) - Drug Product and Patent(s)-in-Suit: Axiron® (testosterone metered transdermal solution); U.S. Patents Nos. 8,071,075...more

Vanda Pharm. Inc. v. Roxane Labs., Inc.

by Robins Kaplan LLP on

Case Name: Vanda Pharm. Inc. v. Roxane Labs., Inc., Civ. No. 14-757-GMS (Consolidated), 2016 U.S. Dist. LEXIS 113521 (D. Del. Aug. 25, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: Fanapt® (iloperidone); U.S....more

Sanofi v. Glenmark Pharms. Inc.

by Robins Kaplan LLP on

Case Name: Sanofi v. Glenmark Pharms. Inc., Civ. No. 14-264-RGA (Consolidated), 2016 U.S. Dist. LEXIS 116950 (D. Del. August 31, 2016) (Andrews, J.) - Drug Product and Patent(s)-in-Suit: Multaq® (dronedarone); U.S....more

Ferring Pharms., Inc. v. Burwell

by Robins Kaplan LLP on

Case Name: Ferring Pharms., Inc. v. Burwell, Case No. 15-0802 (RC), 2016 U.S. Dist. LEXIS 121826 (D.D.C. Sept. 9, 2016) - Drug Product and Patent(s)-in-Suit: Prepopik® (sodium picosulfate, magnesium oxide, anhydrous...more

Hatch-Waxman Venue Update: Will SCOTUS Limit Where Brands Can Sue Generics?

by Robins Kaplan LLP on

Generic and branded pharma companies alike are waiting with baited breath to see if the U.S. Supreme Court will take up the issue of personal jurisdiction in Hatch-Waxman patent cases this term. After a broad ruling from the...more

Classen Immunotherapies, Inc. v. Elan Pharms., Inc.

by Robins Kaplan LLP on

Case Name: Classen Immunotherapies, Inc. v. Elan Pharms., Inc., Case No. RDB-04-3521, 2016 U.S. Dist. LEXIS 131964 (D. Md. Sept. 27, 2016) - Drug Product and Patent(s)-in-Suit: Skelaxin® (metaxalone); U.S. Patent No. 6,...more

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