Court Report - March 2015 #5

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

Purdue Pharma L.P. et al. v. Collegium Pharmaceutical, Inc.
1:15-cv-11294; filed March 26, 2015 in the District Court of Massachusetts

• Plaintiffs:  Purdue Pharma L.P.; P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies
• Defendant:  Collegium Pharmaceutical, Inc.

Purdue Pharma LP et al. v. Collegium Pharmaceutical Inc.
1:15-cv-00260; filed March 24, 2015 in the District Court of Delaware

• Plaintiffs:  Purdue Pharma LP; P.F. Laboratories Inc.; Purdue Pharmaceuticals LP; Rhodes Technologies
• Defendant:  Collegium Pharmaceutical Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), and 7,683,072 (same title, issued March 23, 2010) following a Paragraph IV certification as part of Collegium's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture its Extampza ER product (oxycodone myristate), comparable to Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).   Also, infringement of U.S. Patent No. 8,652,497 ("Pharmaceutical Formulation Containing Irritant," issued February 18, 2014) based on Collegium's filing of its Extampza ER NDA.  View the Delaware complaint here.

Helsinn Healthcare S.A. et al. v. Hospira Inc.
1:15-cv-00264; filed March 25, 2015 in the District Court of Delaware

• Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendant:  Hospira, Inc.

Helsinn Healthcare S.A. et al. v. Par Pharmaceutical Companies Inc. et al.
1:15-cv-00265; filed March 25, 2015 in the District Court of Delaware

• Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendants:  Par Pharmaceutical Companies Inc.; Par Pharmaceutical Inc.

Helsinn Healthcare S.A. et al. v. Hospira, Inc.
3:15-cv-02077; filed March 23, 2015 in the District Court of New Jersey

• Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendant:  Hospira, Inc.

Helsinn Healthcare S.A. et al. v. Par Pharmaceutical Companies, Inc. et al.
3:15-cv-02078; filed March 23, 2015 in the District Court of New Jersey

• Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendants:  Par Pharmaceutical Companies, Inc.; Par Pharmaceutical, Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 24, 2011), 7,947,725 (same title, issued May 24, 2011), 7,960,424 (same title, issued June 14, 2011), 8,598,219 (same title, issued December 3, 2013), and 8,729,094 (same title, issued May 20, 2014) 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 Hospira New Jersey complaint here.

Merck Sharp & Dohme Corp. v. Amneal Pharmaceuticals LLC
1:15-cv-00250; filed March 20, 2015 in the District Court of Delaware

Infringement of U.S. Patent No. 6,127,353 ("Mometasone Furoate Monohydrate, Process for Making Same and Pharmaceutical Compositions," issued October 3, 2000) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Merck's Nasonex® (mometasone furoate monohydrate metered nasal spray, used to treat diseases of the upper airways, including allergic and nonallergic rhinitis).  View the complaint here.

Noven Pharmaceuticals Inc. v. Actavis Laboratories UT Inc.
1:15-cv-00249; filed March 20, 2015 in the District Court of Delaware

Infringement of U.S. Patent No. 8,231,906 ("Transdermal Estrogen Device and Delivery," issued July 31, 2012) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Noven's Minivelle® (estradiol transdermal system, used for the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis).  View the complaint here.

Boehringer Ingelheim Pharma GmbH & Co. KG et al. v. Breckenridge Pharmaceutical, Inc.
9:15-cv-80377; filed March 20, 2015 in the Southern District of Florida

• Plaintiffs:  Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim International GMBH; Boehringer Ingelheim Pharmaceuticals, Inc.
• Defendant:  Breckenridge Pharmaceutical, Inc.

Infringement of U.S. Patent No. 6,087,380 ("Disubstituted Bicyclic Heterocycles, the Preparations and the Use Thereof as Pharmaceutical Compositions," issued July 11, 2000) following a Paragraph IV certification as part of Breckenridge's filing of an ANDA to manufacture a generic version of Boehringer's Pradaxa® (dabigatran etexilate mesylate, used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation).  View the complaint here.

Horizon Pharma Ireland Ltd. et al. v. Taro Pharmaceuticals USA, Inc. et al.
1:15-cv-02046; filed March 13, 2015 in the District Court of New Jersey

• Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
• Defendants:  Taro Pharmaceuticals USA, Inc.; Taro Pharmaceutical Industries, Ltd.

Infringement of U.S. Patent Nos. 8,217,078 ("Treatment of Pain with Topical Diclofenac," issued July 10, 2012), 8,252,838 ("Diclofenac Topical Formulation," issued August 28, 2012), 8,546,450 ("Treatment of Pain with Topical Diclofenac," issued October 1, 2013), 8,563,613 ("Diclofenac Topical Formulation," issued October 22, 2013), 8,618,164 ("Treatment of Pain with Topical Diclofenac," issued December 31, 2013), and 8,871,809 ("Diclofenac Topical Formulation," issued October 28, 2014) following a Paragraph IV certification as part of Taro's filing of an ANDA to manufacture a generic version of Horizon'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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