Court Report - December 2014 #2

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

Eli Lilly and Company v. Sandoz Inc.
1:14-cv-02008; filed December 5, 2014 in the Southern District of Indiana

Infringement of U.S. Patent No. 7,772,209 ("Novel Antifolate Combination Therapies," issued August 10, 2010) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Lilly's Alimta® (pemetrexed for injection, used to treat malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer).  View the complaint here.

Fresenius Medical Care Holdings, Inc. v. Lotus Pharmaceutical Co., Ltd. et al.
1:14-cv-14345; filed December 5, 2014 in the District Court of Massachusetts

• Plaintiff:  Fresenius Medical Care Holdings, Inc.
• Defendants:  Lotus Pharmaceutical Co., Ltd.; Alvogen Pine Brook, Inc.

Fresenius Medical Care Holdings, Inc. v. Lotus Pharmaceutical Co., Ltd et al.
2:14-cv-07612; filed December 5, 2014 in the District Court of New Jersey

• Plaintiff:  Fresenius Medical Care Holdings, Inc.
• Defendants:  Lotus Pharmaceutical Co., Ltd; Alvogen Pine Brook, Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,576,665 ("Encapsulated Calcium Acetate Caplet and a Method for Inhibiting Gastrointestinal Phosphorous Absorption," issued June 10, 2003) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Fresenius' PhosLo® GelCaps (calcium acetate, used to treat renal failure).  View the D. Mass. complaint here.

Allergan Inc. et al. v. Wilshire Pharmaceuticals Inc.
1:14-cv-01461; filed December 4, 2014 in the District Court of Delaware

• Plaintiffs:  Allergan Inc.; Vistakon Pharmaceuticals LLC
• Defendant:  Wilshire Pharmaceuticals Inc.

Infringement of U.S. Patent No. 8,664,215 ("Ocular Allergy Treatments with Alcaftadine," issued March 4, 2014), licensed to Allergan, following a Paragraph IV certification as part of Wilshire's filing of an ANDA to manufacture a generic version of Allergan's Lastacaft® (alcaftadine ophthalmic solution 0.25%, used for the prevention of itching associated with allergic conjunctivitis).  View the complaint here.

Novartis Pharmaceuticals Corp. v. Amneal Pharmaceuticals, LLC et al.
2:14-cv-07557; filed December 3, 2014 in the District Court of New Jersey

• Plaintiff:  Novartis Pharmaceuticals Corp.
• Defendants:  Amneal Pharmaceuticals, LLC; Amneal-Agila, LLC; Mylan Inc.; Mylan Institutional Inc.

Novartis Pharmaceuticals Corp. v. Sagent Pharmaceuticals, Inc.
2:14-cv-07556; filed December 3, 2014 in the District Court of New Jersey

Novartis Pharmaceuticals Corp. v. Par Sterile Products, LLC et al.
2:14-cv-07558; filed December 3, 2014 in the District Court of New Jersey

• Plaintiff:  Novartis Pharmaceuticals Corp.
• Defendants:  Par Sterile Products, LLC; Par Pharmaceutical Companies, Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 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 defendants' filing of an ANDA to manufacture a generic version of Novartis' Zometa® (zoledronic acid, used for the prevention of skeletal-related complications associated with cancer).  View the Amneal 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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