Court Report -- August 18, 2013

by McDonnell Boehnen Hulbert & Berghoff LLP

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

Amgen Inc. et al. v. Teva Biopharmaceuticals USA, Inc. et al.
2:13-cv-04911; filed August 12, 2013 in the District Court of New Jersey

• Plaintiffs:  Amgen Inc.; Amgen Manufacturing, Limited
• Defendants:  Teva Biopharmaceuticals USA, Inc.; Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent No. 8,058,398 ("Modified G-CSF Polypeptide," issued November 15, 2011) based on Teva's manufacture, use, and intended sale of, and filing of a Biologics License Application for, its Lonquex® (lipegfilgrastim, used to to reduce the duration of severe neutropenia in cancer patients undergoing chemotherapy).  View the complaint here.

Novo Nordisk Inc. et al. v. Amneal Pharmaceuticals, LLC et al.
3:13-cv-04915; filed August 12, 2013 in the District Court of New Jersey

• Plaintiffs:  Novo Nordisk Inc.; Novo Nordisk Femcare AG
• Defendants:  Amneal Pharmaceuticals, LLC; Amneal Pharmaceuticals of New York, LLC

Infringement of U.S. Patent No. 7,018,992 ("Hormone Composition," issued March 28, 2006) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Novo Nordisk's Vagifem® (estradiol vaginal tablets, used to treat atrophic vaginitis due to menopause).  View the complaint here.

Astrazeneca AB et al. v. Wockhardt Ltd. et al.
3:13-cv-04854; filed August 12, 2013 in the District Court of New Jersey

• Plaintiffs:  Astrazeneca AB; Aktiebolaget Hassle; Astrazeneca LP; KBI Inc.; KBI-E Inc.
• Defendants:  Wockhardt Ltd.; Wockhardt USA LLC

Infringement of U.S. Patent Nos. 5,714,504 ("Compositions," issued February 3, 1988), 5,877,192 ("Method for the Treatment of Gastric Acid-Related Diseases and Production of Medication Using (-)Enantiomer of Omeprazole," issued March 2, 1999), and 6,875,872 ("Compounds," issued April 5, 2005), following a Paragraph IV certification as part of Wockhardt's filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease).  View the complaint here.

Depomed, Inc. v. Banner Pharmacaps Inc. et al.
1:13-cv-00653; filed August 9, 2013 in the Middle District of North Carolina

• Plaintiff:  Depomed, Inc.
• Defendants:  Banner Pharmacaps Inc.; Watson Laboratories, Inc.

Infringement of U.S. Patent Nos. 6,365,180 ("Oral Liquid Compositions," issued April 2, 2002), 7,662,858 ("Method of Treating Post-Surgical Acute Pain," issued February 16, 2010), 7,884,095 (same title, issued February 8, 2011), 7,939,518 (same title, issued May 10, 2011) and 8,110,606 (same title, issued February 7, 2012) following a Paragraph IV certification as part of Banner's filing of an ANDA to manufacture a generic version of Depomed's Zipsor® (diclofenac potassium, used for relief of mild to moderate acute pain).  View the complaint here.

Supernus Pharmaceuticals, Inc. v. Actavis Inc. et al.
2:13-cv-04740; filed August 7, 2013 in the District Court of New Jersey

• Plaintiff:  Supernus Pharmaceuticals, Inc.
• Defendants:  Actavis Inc.; Watson Laboratories, Inc. – Florida; Actavis Pharma, Inc.; Watson Laboratories, Inc.; Anda, Inc.

Infringement of U.S. Patent Nos. 7,722,898 ("Modified-Release Preparations Containing Oxcarbazepine and Derivatives Thereof,"  issued May 25, 2010) and 7,910,131 ("Method of Treating Seizures Using Modified Release Formulations of Oxcarbazepine," issued March 22, 2011) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Supernus'Oxtellar XR (oxcarbazepine extended-release tablets, used for adjunctive therapy in the treatment of partial seizures in adults and in children 6 to 17 years of age).  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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