Court Report - May 2015

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

Horizon Pharma Ireland Ltd. et al. v. Lupin Ltd. et al.
1:15-cv-03051; filed April 30, 2015 in the District Court of New Jersey

• Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Limited; Horizon Pharma USA, Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

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 Lupin'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.

Apotex Inc v. Daiichi Sankyo, Inc. et al.
1:15-cv-03695; filed April 27, 2015 in the Northern District of Illinois

• Plaintiff:  Apotex Inc
• Defendants:  Daiichi Sankyo, Inc.; Daiichi Sankyo Co., Ltd.

Declaratory judgment of non-infringement of U.S. Patent No. 6,878,703 ("Pharmaceutical Composition," issued April 12, 2005) in conjunction with Aptoex's filing of an ANDA to manufacture a generic version of Daiichi's Benicar® HCT (olmesartan medoxomil/ hydrochlorothiazide, used to treat hypertension).  View the complaint here.

Eli Lilly and Co. et al. v. Lupin Ltd. et al.
1:15-cv-00673; filed April 27, 2015 in the Southern District of Indiana

• Plaintiffs:  Eli Lilly and Co.; Daiichi Sankyo Co., Ltd.; Daiichi Sankyo, Inc.; Ube Industries, Ltd.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of certain of U.S. Patent Nos. 8,404,703 ("Medicinal Compositions Containing Aspirin," issued March 26, 2013) and 8,569,325 ("Method of Treatment with Coadministration of Aspirin and Prasugrel," issued October 29, 2013) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Lilly's Effient® (prasugrel hydrochloride, to be used in combination with aspirin for the reduction of thrombotic cardiovascular events in certain patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention).  View the complaint here.

Noven Pharmaceuticals, Inc. et al. v. Mylan Technologies, Inc. et al.
1:15-cv-00069; filed April 24, 2015 in the Northern District of West Virginia

• Plaintiffs:  Noven Pharmaceuticals, Inc.; Hisamitsu Pharmaceutical Co., Inc.
• Defendants:  Mylan Technologies, Inc.; Mylan Pharmaceuticals, Inc.; Mylan Inc.

Noven Pharmaceuticals Inc. et al. v. Mylan Technologies Inc. et al.
1:15-cv-00328; filed April 23, 2015 in the District Court of Delaware

• Plaintiffs:  Noven Pharmaceuticals Inc.; Hisamitsu Pharmaceutical Co. Inc.
• Defendants:  Mylan Technologies Inc.; Mylan Pharmaceuticals Inc.; Mylan Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,841,716 ("Patch," issued January 11, 2005) and 8,231,906 ("Transdermal Estrogen Device and Delivery," issued July 31, 2012) following a Paragraph IV certification as part of Mylan's 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 Delaware 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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