Court Report - August 2014 #4

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.

Aptalis Pharmatech Inc. et al. v. Apotex Inc. et al.
1:14-cv-01038; filed August 11, 2014 in the District Court of Delaware

• Plaintiffs:  Aptalis Pharmatech Inc.; Ivax International GmbH
• Defendants:  Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent Nos. 7,790,199 ("Modified Release Dosage Forms of Skeletal Muscle Relaxants," issued September 7, 2010) and 7,829,121 (same title, issued November 9, 2010), licensed to Ivax, following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Cephalon's Amrix® (cyclobenzaprine hydrochloride, used for relief of muscle spasm associated with acute, painful musculoskeletal conditions).  View the complaint here.

Pfizer Inc. et al. v. Intellipharmaceutics International Inc. et al.
1:14-cv-06373; filed August 11, 2014 in the Southern District of New York

• Plaintiffs:  Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.; PF Prism C.V.
• Defendants:  Intellipharmaceutics International Inc.; Intellipharmaceutics Corp.; Intellipharmaceutics Ltd.

Pfizer Inc. et al. v. Intellipharmaceutics International Inc. et al.
1:14-cv-01028; filed August 8, 2014 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; Wyeth LLC; Wyeth Pharmaceuticals Inc.; PF Prism C.V.
• Defendants:  Intellipharmaceutics International Inc.; Intellipharmaceutics Corp.; Intellipharmaceutics Ltd.

The complaints in these cases are substantially identical.  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 Intellipharmaceutics' filing of an ANDA to manufacture a generic version of Pfizer's Pristiq® (desvenlafaxine, used to treat depression).  View the Delaware complaint here.

Senju Pharmaceutical Co., Ltd. et al. v. Metrics, Inc. et al.
4:14-cv-00141; filed August 8, 2014 in the Eastern District of North Carolina

• Plaintiffs:  Senju Pharmaceutical Co., Ltd.; Bausch & Lomb, Inc.; Bausch & Lomb Pharma Holdings Corp.
• Defendants:  Metrics, Inc.; Coastal Pharmaceuticals, Inc.; Mayne Pharma Group Ltd.; Mayne Pharma (USA), Inc.

Senju Pharmaceutical Co., Ltd. et al. v. Metrics, Inc. et al.
1:14-cv-04964; filed August 7, 2014 in the District Court of New Jersey

• Plaintiffs:  Senju Pharmaceutical Co., Ltd.; Bausch & Lomb, Inc.; Bausch & Lomb Pharma Holdings Corp.
• Defendants:  Metrics, Inc.; Coastal Pharmaceuticals, Inc.; Mayne Pharma Group Ltd.; Mayne Pharma (USA), Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 8,129,431 ("Aqueous Liquid Preparation Containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid," issued March 6, 2012), 8,669,290 (same title, issued March 1, 2014), and 8,754,131 (same title, issued June 17, 2014) following a Paragraph IV certification as part of Metrics' filing of an ANDA to manufacture a generic version of B&L's Prolensa® (bromfenac ophthalmic solution, used to treat postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery).  View the New Jersey complaint here.

Merck Sharp & Dohme Corp. v. Fresenius Kabi USA LLC
1:14-cv-01018; filed August 7, 2014 in the District Court of Delaware

Merck Sharp & Dohme Corp. v. Fresenius Kabi USA, LLC
2:14-cv-04989; filed August 7, 2014 in the District Court of New Jersey

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,514,650 ("Aza Cyclohexapeptide Compounds," issued May 7, 1996) and 5,952,300 ("Antifungal Compositions," issued September 14, 1999) following a Paragraph IV certification as part of Fesenius' filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Merck's Cancidas® (caspofungin acetate, used to treat presumed fungal infections in febrile, neutropenic patients, candidemia and certain Candida infections, esophageal candidiasis, and invasive aspergillosis in patients who are refractory to or intolerant of other therapies).  View the New Jersey complaint here.

Prometheus Laboratories Inc. v. Par Pharmaceutical Companies Inc. et al.
1:14-cv-01017; filed August 6, 2014 in the District Court of Delaware

• Plaintiff:  Prometheus Laboratories Inc.
• Defendants:  Par Pharmaceutical Companies Inc.; Par Pharmaceutical Inc.

Infringement of U.S. Patent No. 6,284,770 ("Medicaments for the Treatment of Non-Constipated Female Irritable Bowel Syndrome," issued September 4, 2001) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Prometheus' Lotronex® (alosetron hydrochloride, used to treat women with severe diarrhea-predominant irritable bowel syndrome).  View the complaint here.

Esoterix Genetic Laboratories, LLC v. Qiagen N.V. et al.
1:14-cv-13228; filed August 5, 2014 in the District Court of Massachusetts

• Plaintiff:  Esoterix Genetic Laboratories, LLC
• Defendants:  Qiagen N.V.; Qiagen GmbH; Qiagen North American Holdings, Ltd.; Qiagen Manchester, Ltd.; Qiagen, Inc.

Infringement of U.S. Patent No. 7,294,468 ("Method to Determine Responsiveness of Cancer to Epidermal Growth Factor Receptor Targeting Treatments," issued November 13, 2007) based on Qiagen's offer for sale and sale of test kits allegedly falling outside the scope of an existing licensing agreement.  Also, various claims sounding in state law.  View the complaint here.

Hospira Inc. et al. v. Ben Venue Laboratories Inc. et al.
1:14-cv-01008; filed August 1, 2014 in the District Court of Delaware

• Plaintiffs:  Hospira Inc.; Orion Corp.
• Defendants:  Ben Venue Laboratories Inc.; Hikma Pharmaceuticals PLC; West-Ward Pharmaceuticals Corp.

Infringement of U.S. Patent No. 6,716,867 ("Use of Dexmedetomidine for ICU Sedation," issued April 6, 2004) following a Paragraph IV certification as part of Ben Venue's filing of an ANDA to manufacture a generic version of Hospira's Precedex® (dexmedetomidine hydrochloride injection, used for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting).  View the complaint here.

Mallinckrodt LLC et al. v. Zydus Pharmaceuticals (USA) Inc.
1:14-cv-04901; filed August 1, 2014 in the District Court of New Jersey

• Plaintiffs:  Mallinckrodt LLC; Mallinckrodt Inc.; Nuvo Research Inc.
• Defendant:  Zydus Pharmaceuticals (USA) Inc.

Infringement of U.S. Patent Nos. 8,217,078 ("Treatment of Pain with Topical Diclofenac," issued July 10, 2012), 8,546,450 (same title, issued October 1, 2013), 8,618,164 (same title, issued December 31, 2013), and 8,741,956 (same title, issued June 3, 2014) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Mallinckrodt's Pennsaid® (diclofenac sodium topical solution, used for the treatment of signs and symptoms of osteoarthritis of the knee(s)).  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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