Generic Drugs

News & Analysis as of

Ranbaxy and AstraZeneca Prevail in Nexium® Pay-For-Delay Case

On November 21, 2016, the U.S. Court of Appeals for the First Circuit upheld a 2014 jury verdict for AstraZeneca (AZ) and Ranbaxy regarding a 2012 payment of $700 million from AstraZeneca for Ranbaxy to abandon its challenge...more

White Collar Crime Law Enforcement in a Trump Justice Department - 8 Predictions

After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...more

Competition News November 2016

Gun jumping in France: penalty imposed by the French Competition Authority on early partial completion of two mergers prior to their authorization - By a decision not yet published, issued on November 8, 2016 by the...more

Boehringer Ingelheim Pharma GMBH & Co. KG v. FDA

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

Forest Labs. Holdings Ltd. v. Mylan Inc.

Case Name: Forest Labs. Holdings Ltd. v. Mylan Inc., No. 13–1602–SLR (Consolidated), 2016 U.S. Dist. LEXIS 89268 (D. Del. July 11, 2016) (Robinson, J.) - Drug Product and Patent(s)-in-Suit: Savella® (milnacipran...more

Bayer Pharma AG v. Watson Labs., Inc.

Case Name: Bayer Pharma AG v. Watson Labs., Inc., Case No. 12-1726-LPS, 2016 U.S. Dist. LEXIS 96267 (D. Del. July 18, 2016) - Drug Product and Patent(s)-in-Suit: Natazia® (estradiol valerate / dienogest); U.S. Patent No....more

Basics of the BPCIA

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.

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

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

Tyco Healthcare Group LP v. Mutual Pharm. Co., Inc.

Case Name: Tyco Healthcare Group LP v. Mutual Pharm. Co., Inc., Civ. No. 07-cv-1299 (SRC)(CLW), 2016 U.S. Dist. LEXIS 95789 (D.N.J. July 22, 2016) (Chesler, J.) - Drug Product and Patent(s)-in-Suit: Restoril®...more

Torrent Pharmaceuticals Ltd. et al v. Daiichi Sankyo Co., Ltd., et al

Case Name: Torrent Pharmaceuticals Ltd. et al v. Daiichi Sankyo Co., Ltd., et al, Civ. No. 16-C-2988, 2016 U.S. Dist. LEXIS 96448 (N.D. Ill. July 25, 2016) (Pallmeyer, J.) - Drug Product and Patent(s)-in-Suit: Benicar®...more

Supreme Court Will Not Review Pay-For-Delay Case over GSK’s Lamictal

On November 7, 2016, the U.S. Supreme Court declined to review an appeal from a Third Circuit decision finding that a settlement between GlaxoSmithKline (GSK) and Teva Pharmaceutical Industries Ltd. (Teva) involving the...more

UCB, Inc. v. Accord Healthcare, Inc.

Case Name: UCB, Inc. v. Accord Healthcare, Inc., Civ. No. 13-1206-LPS (Consolidated), 2016 U.S. Dist. LEXIS 109362 (D. Del. Aug. 12, 2016) (Stark, J.) - Drug Product and Patent(s)-in-Suit: Vimpat® (lacosamide); U.S....more

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

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.

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.

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

Two reverse-payment appeals to watch

It has been over three years since the Supreme Court’s Actavis decision. Since then, numerous putative class actions alleging harm to competition as a result of “reverse-payment” settlements have flooded the courts. The...more

Merck Sharp & Dohme B.V. v. Warner Chilcott Co., LLC

Case Name: Merck Sharp & Dohme B.V. v. Warner Chilcott Co., LLC, Civ. No. 13-2088-GMS, 2016 U.S. Dist. LEXIS 114419 (D. Del. Aug 26, 2016) (Sleet, J.) - Drug Product and Patent(s)-in-Suit: NuvaRing® (etonogestrel /...more

Sanofi v. Glenmark Pharms. Inc.

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

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

NYSBA’s REMS and Other Drug Distribution Restrictions Program Provided an Excellent and Informative Discussion

On November 3, 2016, the New York State Bar Association’s Sections, Food, Drug and Cosmetic Law and Antitrust Law, held a program in New York City: “REMS and Other Drug Distribution Restrictions: When Does a Brand Company...more

Your Daily Dose of Financial News

Wells Fargo is well past the rain, the pouring, and even the flooding. So why not possible liability for its RMBS practices? As part of an SEC disclosure, the bank acknowledge that it’s “in discussion” with the RMBS Working...more

Fresenius Kabi USA, LLC v. Fera Pharms., LLC

Case Name: Fresenius Kabi USA, LLC v. Fera Pharms., LLC, No. 15-cv-3654 (KM)(MAH), 2016 U.S. Dist. LEXIS 128126 (D.N.J. Sept. 20, 2016) (McNulty, J.) - Drug Product and Patent(s)-in-Suit: Levothyroxine Sodium for...more

3rd Circuit Weighs In On Product-Hopping

On Sept. 28, 2016, in Mylan Pharmaceuticals Inc. v. Warner Chilcott Public Limited Co. (Doryx), the Third Circuit affirmed the lower court’s grant of summary judgment rejecting antitrust claims brought against Warner Chilcott...more

Novartis AG v. Ezra Ventures, LLC

Case Name: Novartis AG v. Ezra Ventures, LLC, Civ. No. 15-0150-LPS, 2016 U.S. Dist. LEXIS 129502 (D. Del. Sept. 22, 2016) (Stark, J.) - Drug Product and Patent(s)-in-Suit: Gilenya® (fingolimod); U.S. Patent No. 5,604,229...more

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