Court Report -- December 15, 2013

by McDonnell Boehnen Hulbert & Berghoff LLP

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

Pfizer Inc. et al. v. Hetero USA Inc. et al.
1:13-cv-02021; filed December 11, 2013 in the District Court of Delaware

• Plaintiffs: Pfizer Inc.; UCB Pharma GmbH
• Defendants: Hetero USA Inc.; Hetero Labs Ltd.

Pfizer Inc. et al. v. Apotex Inc.
1:13-cv-02022; filed December 11, 2013 in the District Court of Delaware

• Plaintiffs: Pfizer Inc.; UCB Pharma GmbH
• Defendant: Apotex Inc.

The complaints in these cases are substantially identical.  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 defendants’ 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 Delaware Hetero complaint here.

MUSC Foundation for Research Development et al. v. AstraZeneca Pharmaceuticals LP
2:13-cv-03438; filed December 9, 2013 in the District of South Carolina

• Plaintiffs:  MUSC Foundation for Research Development; Charleston Medical Therapeutics Inc.
• Defendant:  AstraZeneca Pharmaceuticals LP

Infringement of U.S. Patent No. 8,507,219 (“Use of Statins to Inhibit Inflammation and Vascular Disease,” issued August 13, 2013) based on AstraZeneca’s manufacture and sale of its Crestor® product (rosuvastatin calcium, used to treat high cholesterol). View the complaint here.

Reckitt Benckiser Pharmaceuticals Inc. et al. v. Alvogen Pine Brook Inc. et al.
1:13-cv-02003; filed December 6, 2013 in the District Court of Delaware

• Plaintiffs:  Reckitt Benckiser Pharmaceuticals Inc.; RB Pharmaceuticals Limited; MonoSol Rx LLC
• Defendants:  Alvogen Pine Brook Inc.; Alvogen Group Inc.

Infringement of U.S. Patent Nos. 8,475,832 ("Sublingual and Buccal Film Compositions," issued July 2, 2013) and 8,017,150 ("Polyethylene Oxide-Based Films and Drug Delivery Systems Made Therefrom," issued on September 13, 2011) following a Paragraph IV certification as part of Alvogen’s filing of an ANDA to manufacture a generic version of Reckitt Benckiser's Suboxone® (buprenorphine hydrochloride and naloxone hydrochloride sublingual film, used for the maintenance treatment of opioid dependence).  View the complaint here.

Teva Pharmaceuticals USA Inc. et al. v. Forest Laboratories Inc.
1:13-cv-02002; filed December 5, 2013 in the District Court of Delaware

• Plaintiffs:  Teva Pharmaceuticals USA Inc.; Mayne Pharma International Pty Ltd.
• Defendant:  Forest Laboratories Inc.

Infringement of U.S. Patent No. 6,194,000 (“Analgesic Immediate and Controlled Release Pharmaceutical Composition,” issued February 27, 2001) based on Forest’s manufacture and sale of its Namenda XR® (memantine hydrochloride, used for the treatment of moderate to severe dementia of the Alzheimer's type).  View the complaint here.

Endo Pharmaceuticals Inc. v. Ranbaxy Laboratories Ltd. et al.
1:13-cv-08597; filed December 3, 2013 in the Southern District of New York

• Plaintiff:  Endo Pharmaceuticals Inc.
• Defendants:  Ranbaxy Laboratories Ltd.; Ranbaxy Inc.; Ranbaxy Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 7,851,482 ("Method for Making Analgesics," issued December 14, 2010), 8,309,122 ("Oxymorphone Controlled Release Formulations," issued November 13, 2012), and 8,329,216 (same title, issued December 11, 2012) following a Paragraph IV certification as part of Ranbaxy’s filing of an ANDA to manufacture a generic version of Endo's Opana® ER CRF (oxymorphone hydrochloride, crush-resistant formulation, used to treat moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time).  View the complaint here.

Biogen Idec MA Inc. v. Japanese Foundation for Cancer Research et al.
1:13-cv-01489; filed December 3, 2013 in the Eastern District of Virginia

• Plaintiff:  Biogen Idec MA Inc.
• Defendants:  Japanese Foundation for Cancer Research; Kyowa Hakko Kirin Co., Ltd.; Toray Industries, Inc.; Bayer Pharma AG

Review of the decision of the Patent Trial and Appeal Board awarding priority of invention to the Japanese Foundation for Cancer Research in the interference between U.S. Patent Application No. 08/253,843 ("DNA Sequences, Recombinant DNA Molecules and Processes for Producing Human Fibroblast Interferon-like Polypeptides," filed June 3, 1994), assigned to Biogen Idec and U.S. Patent Application No. 08/463,757 (filed June 5, 1995), assigned to Japanese Foundation for Cancer Research.  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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