Court Report -- June 17, 2013

by McDonnell Boehnen Hulbert & Berghoff LLP
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Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Fresenius Kabi USA, LLC v. Watson Laboratories Inc. et al.
1:13-cv-01015; filed June 6, 2013 in the District Court of Delaware

• Plaintiff:  Fresenius Kabi USA, LLC
• Defendants:  Watson Laboratories Inc.; Actavis Inc.

Infringement of U.S. Patent Nos. 5,714,520 ("Propofol Compostion [sic] Containing Edetate," issued February 3, 1998), 5,731,355 ("Pharmaceutical Compositions of Propofol and Edetate," issued March 24, 1998), 5,731,356 ("Pharmaceutical Compositions of Propofol and Edetate," issued March 24, 1998) and 5,908,869 ("Propofol Composition Containing Edetate," issued June 1, 1999) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Fresenius' Diprivan® (propofol injectable emulsion, used for the induction and maintenance of general anesthesia and sedation in certain patient populations).  View the complaint here.

Everett Laboratories, Inc. v. Acella Pharmaceuticals, LLC
2:13-cv-03529; filed June 6, 2013 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 6,814,983 ("Compositions and Methods for Nutrition Supplementation," issued November 9, 2004) and 7,390,509 (same title, issued June 24, 2008) based on Acella's manufacture and sale of its PNV - OB with DHA product, an alleged copy of Everett's Vitafol®-OB+DHA (prescription prenatal nutritional supplement).  View the complaint here.

AbbVie Inc. et al. v. Dr. Reddy's Laboratories Ltd. et al.
1:13-cv-01012; filed June 5, 2013 in the District Court of Delaware

• Plaintiffs:  AbbVie Inc.; Wisconsin Alumni Research Foundation
• Defendants:  Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.

Infringement of U.S. Patent Nos. 6,136,799 ("Cosolvent Formulations," issued October 24, 2000), 6,361,758 (same title, issued March 26, 2002), and 5,597,815 ("Prevention of Hyperphosphatemia in Kidney Disorder Patients," issued January 28, 1997) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of AbbVie's Zemplar® (paricalcitol, used to treat secondary hyperparathyroidism in patients with kidney failure).  View the complaint here.

Everett Laboratories, Inc. v. Acella Pharmaceuticals, LLC
1:13-cv-03487; filed June 5, 2013 in the District Court of New Jersey

Infringement of U.S. Patent No. 8,197,855 ("Compositions and Methods for Nutrition Supplementation," issued June 12, 2012) based on Acella's manufacture and sale of its Choice-OB+DHA product, an alleged copy of Everett's Select-OB®+DHA (prescription prenatal nutritional supplement).  View the complaint here.

Merck & Cie et al. v. Watson Laboratories Inc. et al.
1:13-cv-00978; filed June 4, 2013 in the District Court of Delaware

• Plaintiffs:  Merck & Cie; Bayer Pharma AG; Bayer HealthCare Pharmaceuticals Inc.
• Defendants:  Watson Laboratories Inc.; Actavis Inc.

Merck & Cie et al. v. Watson Laboratories, Inc. et al.
2:13-cv-00990; filed June 4, 2013 in the District Court of Nevada

• Plaintiffs:  Merck & Cie; Bayer Pharma AG; Bayer Healthcare Pharmaceuticals Inc.
• Defendants:  Watson Laboratories, Inc.; Actavis, Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,441,168 ("Stable Crystalline Salts of 5-methyltetrahydrofolic Acid," issued August 27, 2002), licensed to Bayer, following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Bayer's Safyral® (drospirenone, 17a-ethinyl estradiol, and levomefolate calcium, used for oral contraception).  View the Delaware complaint here.

Pfizer Inc. et al. v. Dr. Reddy's Laboratories, Ltd. et al.
1:13-cv-00989; filed June 4, 2013 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.; PF Prism CV
• Defendants:  Dr. Reddy's Laboratories, Ltd.; Dr. Reddy's Laboratories, Inc.

Infringement of U.S. Patent Nos. 6,673,838 ("Succinate Salt of O-Desmethyl-Venlafaxine," issued January 6, 2004) and 8,269,040 ("Derivatives of Venlafaxine and Methods of Preparing and Using the Same," issued September 18, 2012) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Pfizer's Pristiq® (desvenlafaxine, used to treat depression).  View the complaint here.

Everett Laboratories, Inc. v. Acella Pharmaceuticals, LLC
2:13-cv-03470; filed June 4, 2013 in the District Court of New Jersey

Infringement of U.S. Patent No. 8,183,227 ("Compositions, Kits and Methods for Nutrition Supplementation," issued May 22, 2012) based on Acella's manufacture and sale of its PNV-First product, an alleged copy of Everett's Vitafol®-One (prescription prenatal nutritional supplement).  View the complaint here.

Vertex Pharmaceuticals Inc. v. Rea
1:13-cv-00653; filed May 31, 2013 in the Eastern District of Virginia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 8,324,242 ("Viscous Budesonide for the Treatment of Inflammatory Diseases of the Gastrointestinal Tract," issued December 4, 2012).  View the complaint here.

Avanir Pharmaceuticals Inc. et al. v. Sandoz Inc.
1:13-cv-00961; filed May 30, 2013 in the District Court of Delaware

• Plaintiffs:  Avanir Pharmaceuticals Inc.; Avanir Holding Co.; Center for Neurologic Study
• Defendant:  Sandoz Inc.

Infringement of U.S. Patent Nos. 7,659,282 ("Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorder," issued February 9, 2010), 8,227,484 (same title, issued July 24, 2012), and RE38,115 ("Dextromethorphan and an Oxidase Inhibitor for Treating Intractable Conditions," issued May 6, 2003) in conjunction with Sandoz's purchase of an ANDA filed by Watson Pharmaceuticals, Inc., which included a Paragraph IV certification relating to Avanir's Nuedexta® (dextromethorphan hydrobromide/quinidine sulfate, used to treat pseudobulbar affect).  View the complaint here.

Regents of the University of California v. Rea
1:13-cv-00647; filed May 30, 2013 in the Eastern District of Virginia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 8,324,192 ("Viscous Budesonide for the Treatment of Inflammatory Diseases of the Gastrointestinal Tract," issued December 4, 2012).  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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