Court Report - March 2016

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

Merck & Cie et al. v. Lupin Ltd. et al.
1:15-cv-00899; filed October 8, 2015 in the District Court of Delaware

• Plaintiffs:  Merck & Cie; Bayer Pharma AG; Bayer HealthCare Pharmaceuticals Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 6,441,168 ("Stable Crystalline Salts of 5-methyltetrahydrofolic Acid," issued August 27, 2002) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Merck's Beyaz® (drospirenone, 17α-ethinyl estradiol, and levomefolate calcium, used for oral contraception).  View the complaint here.

Salix Pharmaceuticals, Inc. et al. v. Taro Pharmaceuticals U.S.A., Inc. et al.
1:15-cv-00900; filed October 8, 2015 in the District Court of Delaware

• Plaintiffs:  Salix Pharmaceuticals, Inc.; Norgine B.V.
• Defendants:  Taro Pharmaceuticals U.S.A., Inc.; Taro Pharmaceutical Industries Ltd.

Infringement of U.S. Patent Nos. 7,169,381 ("Colon Cleansing Compositions and Methods," issued January 30, 2007) and 7,658,914 ("Colon Cleansing Compositions," issued February 9, 2010) following a paragraph IV certification as part of Taro's filing of an ANDA to manufacture a generic version of Salix's MoviPrep® (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid oral solution, used for cleansing of the colon as a preparation for colonoscopy).  View the complaint here.

Helsinn Healthcare S.A. et al. v. Fresenius Kabi USA, LLC et al.
3:15-cv-07378; filed October 8, 2015 in the District Court of New Jersey

• Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendants:  Fresenius Kabi USA, LLC; Exela Pharma Sciences, LLC; Exela Holdings, Inc.; Exela Pharmsci, Inc.

Infringement of U.S. Patent Nos. 7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 24, 2011), 8,518,981 ("Liquid Pharmaceutical Formulations of Palonosetron," issued August 27, 2013), 8,598,218 (same title, issued December 3, 2013), 9,066,980 (same title, issued June 30, 2015), and 9,125,905 (same title, issued September 8, 2015) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting).  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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