Court Report - May 2015 #2

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

Galderma Laboratories LP et al. v. Glenmark Generics Inc USA
3:15-cv-01416; filed May 6, 2015 in the Northern District of Texas

• Plaintiffs:  Galderma Laboratories LP; Galderma SA; Galderma Research & Development SNC
• Defendant:  Glenmark Generics Inc USA; Glenmark Generics Ltd.

Infringement of U.S. Patent Nos. 8,071,644 ("Combinations of Adapalene and Benzoyl Peroxide for Treating Acne Lesions," issued December 6, 2011), 8,080,537 (same title, issued December 26, 2011), 8,129,362 ("Combination/Association of Adapalene and Benzoyl Peroxide for Treating Acne Lesions," issued March 6, 2012), 8,445,543 ("Combinations of Adapalene and Benzoyl Peroxide for Treating Acne Lesions," issued May 21, 2013), and 8,809,305 ("Administration of Adapalene and Benzoyl Peroxide for the Long-Term Treatment of Acne Vulgaris," issued August 19, 2014) following a Paragraph IV certification as part of Glenmark's filing of an ANDA to manufacture a generic version of Galderma's Epiduo® Gel (adapalene and benzoyl peroxide, used to treat acne vulgaris).  View the complaint here.

Vanda Pharmaceuticals Inc. v. Inventia Healthcare PVT Ltd.
1:15-cv-00362; filed May 5, 2015 in the District Court of Delaware

Infringement of U.S. Patent No. 8,586,610 ("Methods for the Administration of Iloperidone," issued November 19, 2013) in conjunction with Inventia's filing of an ANDA to manufacture a generic version of Vanda's Fanapt® (iloperidone, used for the acute treatment of adults with schizophrenia).  View the complaint here.

Apotex Inc. et al. v. Lupin Ltd. et al.
1:15-cv-00357; filed May 4, 2015 in the District Court of Delaware

• Plaintiffs:  Apotex Inc.; Apotex Technologies Inc.; SmithKline Beecham (Cork) Ltd.; SmithKline Beecham Ltd.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Apotex Inc. et al. v. Lupin Ltd. et al.
2:15-cv-00599; filed May 1, 2015 in the Eastern District of Texas

• Plaintiffs:  Apotex Inc.; Apotex Technologies, Inc.; SmithKline Beecham (Cork) Ltd.; SmithKline Beecham Ltd. f/k/a Smithkline Beecham PLC
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 7,229,640 ("Paroxetine Controlled Release Compositions," issued June 12, 2007) following a paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of plaintiffs' Paxil CR® (paroxetine hydrochloride controlled release tablets, used to treat depression).  View the E.D. TX complaint here.

Sanofi-Aventis U.S. LLC et al. v. Actavis LLC et al.
3:15-cv-03107; filed May 1, 2015 in the District Court of New Jersey

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
• Defendants:  Actavis LLC; Actavis Elizabeth LLC

Infringement of U.S. Patent No. 8,927,592 ("Antitumoral Use Of Cabazitaxel," issued January 6, 2015) following a Paragraph IV certification as part of Actavis' filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Sanofi's Jevtana® (cabazitaxel injection, used in combination with prednisone for the treatment of patients with hormonerefractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen).  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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