Court Report -- August 11, 2013

by McDonnell Boehnen Hulbert & Berghoff LLP

Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Exela Pharma Sciences, LLC v. EKR Therapeutics, LLC et al.
5:13-cv-00111; filed August 8, 2013 in the Western District of North Carolina

• Plaintiff:  Exela Pharma Sciences, LLC
• Defendants:  EKR Therapeutics, LLC; Cornerstone Therapeutics Inc.; Cornerstone BioPharma, Inc.

Declaratory judgment of non-infringement and invalidity of U.S. Patent No. 7,659,290 ("Methods of Preparing Pre-Mixed, Ready-to-Use Pharmaceutical Compositions," issued February 9, 2010) based on Exela's filing of a supplemental NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of EKR's Cardene® I.V. Premixed Injection (nicardipine hydrochloride premixed injection for intravenous administration, used for the short-term treatment of hypertension when oral therapy is not feasible or not desirable).  View the complaint here.

Pfizer Inc. et al. v. Wockhardt Bio AG et al.
1:13-cv-01387; filed August 2, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; UCB Pharma GmbH
• Defendants:  Wockhardt Bio AG; Wockhardt USA LLC

Infringement of U.S. Patent Nos. 6,858,650 ("Stable Salts of Novel Derivatives of 3,3-Diphenylpropylamines," issued February 22, 2005), 7,384,980 ("Derivatives of 3,3-Diphenylpropylamines," issued June 10, 2008), 7,855,230 (same title, issued December 21, 2010), 7,985,772 (same title, issued July 26, 2011), and 8,338,478 (same title, issued December 25, 2012) following a Paragraph IV certification as part of Wockhardt's filing of an ANDA to manufacture a generic version of Pfizer's Toviaz® (fesoterodine fumarate, used to treat the symptoms of overactive bladder).  View the complaint here.

Novartis Pharmaceuticals Corp. v. Hospira, Inc.
2:13-cv-04669; filed August 2, 2013 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 7,932,241 ("Pharmaceutical Products Comprising Bisphosphonates," issued April 26, 2011) and 8,324,189 ("Use of Zolendronate for the Manufacture of a Medicament for the Treatment of Bone Metabolism Diseases," issued December 4, 2012) following a Paragraph IV certification as part of Hospira's filing of an ANDA and an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act)  to manufacture a generic versions of Novartis' Zometa® (zoledronic acid, used for the prevention of skeletal-related complications associated with cancer).  View the complaint here.

Repros Therapeutics Inc. v. Fisch
4:13-cv-02266; filed August 2, 2013 in the Southern District of Texas

Declaratory judgment of ownership and inventorship for U.S. Patent Nos. 7,173,064 ("Methods and Compositions with Trans-Clomiphene for Treating Wasting and Lipodystrophy," issued February 6, 2007), 7,368,480 ("Methods and Compositions with Trans-Clomiphene), 7,737,185 (same title, issued June 15, 2010) and 7,759,360 ("Methods and Materials for the Treatment of Testosterone Deficiency in Men," issued July 20, 2010), relating to Repros' pipeline drug Androxal®(trans-isomer of clomiphene citrate, to be used for the treatment of male secondary hypogonadism).  View the complaint here.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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