Court Report - February 2016 #3

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

Actavis Laboratories UT, Inc. v. Par Pharmaceutical, Inc.
1:15-cv-00886; filed October 2, 2015 in the District Court of Delaware

Infringement of U.S. Patent Nos. 7,029,694 ("Compositions and Methods for Transdermal Oxybutynin Therapy," April 18, 2006), 7,179,483 (same title, issued February 20, 2007), 8,241,662 ("Unoccluded Topical Oxybutynin Gel Composition and Methods for Transdermal Oxybutynin Therapy," issued August 14, 2012), and 8,920,392 ("Method for Treating Overactive Bladders and a Device for Storage and Administration of Topical Oxybutynin Compositions," issued December 30, 2014) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Actavis' Gelnique® (oxybutynin chloride 10% gel, used in the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency).  View the complaint here.

AbbVie Inc. et al. v. Hetero USA Inc. et al.
1:15-cv-00889; filed October 2, 2015 in the District Court of Delaware

• Plaintiffs:  AbbVie Inc.; Abbvie Deutschland GmbH & Co. KG
• Defendants:  Hetero USA Inc.; Hetero Labs Ltd.; Hetero Labs Limited Unit-III

Infringement of U.S. Patent Nos. 6,037,157 ("Method for Improving Pharmacokinetics," issued March 14, 2000), 6,703,403 (same title, issued March 9, 2004), 7,148,359 ("Polymorph of a Pharmaceutical," issued December 12, 2006), 7,364,752 ("Solid Dispersion Pharmaceutical Formulations," issued April 29, 2008), 8,025,899 ("Solid Pharmaceutical Dosage Form," issued September 27, 2011), 8,268,349 (same title, issued September 18, 2012), 8,399,015 (same title, issued March 19, 2013), 8,309,613 (same title, issued November 13, 2012), 8,377,952 ("Solid Pharmaceutical Dosage Formulation," issued February 19, 2013), 8,470,347 ("Self-emulsifying Active Substance Formulation and Use of this Formulation," issued June 25, 2013), and 8,691,878 ("Solid Pharmaceutical Dosage Form," issued April 8, 2014) following a Paragraph IV certification as part of Hetero's filing of an ANDA to manufacture a generic version of AbbVie's Kaletra® (lopinavir and ritonavir, used to treat HIV infections).  View the complaint here.

Amgen Inc. et al. v. Apotex Inc. et al.
0:15-cv-62081; filed October 2, 2015 in the Southern District of Florida

• Plaintiffs:  Amgen Inc.; Amgen Manufacturing Ltd.
• Defendants:  Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent Nos. 8,952,138 ("Refolding Proteins Using a Chemically Controlled Redox State," issued February 10, 2015) and 6,162,427 ("Combination of G-CSF With a Chemotherapeutic Agent for Stem Cell Mobilization," issued December 19, 2000) based on Apotex's filing of a BLA to market a biosimilar version of Amgen's Neupogen® (filgrastim, used to treat side effects of certain forms of chemotherapy).  View the complaint here.

Altergon SA et al. v. Actavis Laboratories UT, Inc.
1:15-cv-00883; filed October 1, 2015 in the District Court of Delaware

• Plaintiffs:  Altergon SA; IBSA Institut Biochimique SA; Teikoku Seiyaku Co., Ltd.
• Defendant:  Actavis Laboratories UT, Inc.

Infringement of U.S. Patent No. 5,607,690 ("External Anti-Inflammatory and Analgesic Plaster Preparation," issued March 4, 1997) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Altergon's Flector® (diclofenac epolamine patch, used for the topical treatment of acute pain due to minor strains, sprains, and contusions).  View the complaint here.

Alcon Pharmaceuticals Ltd. et al. v. Par Pharmaceutical, Inc.
3:15-cv-07240; filed October 1, 2015 in the District Court of New Jersey

• Plaintiffs:  Alcon Pharmaceuticals Ltd.; Alcon Laboratories, Inc.; Alcon Research, Ltd.
• Defendant:  Par Pharmaceutical, Inc.

Infringement of U.S. Patent Nos. 6,284,804 ("Topical Suspension Formulations Containing Ciprofloxacin and Dexamethasone," issued September 4, 2001) and 6,359,016 (same title, issued March 19, 2002) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Alcon's Ciprodex® (0.3% ciprofloxacin and 0.1% dexamethasone sterile otic suspension).  View the complaint here.

Actelion Pharmaceuticals Ltd. v. Lee
1:15-cv-01266; filed October 1, 2015 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. 8,518,912 ("Phosphonic Acid Derivates and Their Use as P2Y12 Receptor Antagonists," issued August 27,2013).  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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