Court Report - October 2015 #2

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

Mylan Pharma Acquisition Ltd. et al. v Fresenius Kabi USA, LLC
1:15-cv-06700; filed July 30, 2015 in the Northern District of Illinois

• Plaintiffs:  Mylan Pharma Acquisition Ltd.; Mylan Teoranta; Mylan Institutional LLC
• Defendant:  Fresenius Kabi USA, LLC

Infringement of U.S. Patent No. 5,866,591 ("Stable Formulations of Remifentanil," issued February 2, 1999) following a Paragraph IV certification as part of Fesenius' filing of an ANDA to manufacture a generic version of Mylan's Ultiva® (remifentanil hydrochloride for injection, used as an analgesic agent during the induction and maintenance of general anesthesia for inpatient and outpatient procedures, as an analgesic for continuation into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner, and in a postoperative anesthesia care unit or intensive care setting as an analgesic component of monitored anesthesia care in adult patients).  View the complaint here.

Janssen Pharmaceutica N.V. et al. v. FERA Pharmaceuticals, LLC
1:15-cv-05997; filed July 30, 2015 in the Southern District of New York

• Plaintiffs:  Janssen Pharmaceutica N.V.; Janssen Pharamceuticals, Inc.; Janssen Research & Development, LLC
• Defendant:  FERA Pharmaceuticals, LLC

Infringement of U.S. Patent No. 6,407,079 ("Pharmaceutical Compositions Containing Drugs Which Are Instable or Sparingly Soluble in Water and Methods for Their Preparation," issued June 18, 2002) following a Paragraph IV certification as part of FERA's filing of an ANDA to manufacture a generic version of Janssen's Sporanox® (itraconazole, used for the treatment of certain fungal infections).  View the complaint here.

Sanofi-Aventis U.S. LLC et al. v. Genentech, Inc. et al.
2:15-cv-05685; filed July 27, 2015 in the Central District of California

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Regeneron Pharmaceuticals, Inc.
• Defendants:  Genentech, Inc.; City of Hope

Declaratory judgment of invalidity and noninfringement of U.S. Patent No. 7,923,221 ("Methods of Making Antibody Heavy and Light Chains Having Specificity for a Desired Antigen," issued April 12, 2011) in conjunction with Sanofi-Aventis' manufacture and sale of its Praluent® product (alirocumab, usedfor the treatment of adult patients with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-cholesterol).  View the complaint here.

Alcon Pharmaceuticals Ltd. et al. v. Dr. Reddys Laboratories, Inc. et al.
3:15-cv-05756; filed July 24, 2015 in the District Court of New Jersey

• Plaintiffs:  Alcon Pharmaceuticals Ltd.; Alcon Laboratories, Inc.; Alcon Research, Ltd.
• Defendants:  Dr. Reddys Laboratories, Inc.; Dr. Reddys Laboratories, Ltd.

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 Dr. Reddy'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.

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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