Court Report - November 2015 #4

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

Vivus, Inc. v. Actavis Laboratories FL, Inc.
2:15-cv-06256; filed August 17, 2015 in the District Court of New Jersey

• Plaintiff:  Vivus, Inc.
• Defendant:  Actavis Laboratories FL, Inc.; Actavis, Inc.; Allergan PLC

Infringement of U.S. Patent Nos. 9,011,905 ("Low Dose Topiramate/Phentermine Composition and Methods of Use Thereof," issued April 21, 2015) and 9,011,906 ("Escalating Dosing Regimen for Effecting Weight Loss and Treating Obesity" issued April 21, 2015) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Vivus' Qsymia® (phentermine and topiramate extended-release capsules, used as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management).  View the complaint here.

Noven Therapeutics, LLC v. Actavis Laboratories FL, Inc. et al.
2:15-cv-06225; filed August 14, 2015 in the District Court of New Jersey

• Plaintiff:  Noven Therapeutics, LLC
• Defendant:  Actavis Laboratories FL, Inc.; Actavis Pharma, Inc.; Andrx Corp; Actavis, Inc.

Infringement of U.S. Patent No. 8,946,251 ("Method of Treating Thermoregulatory Dysfunction with Paroxetine," issued February 3, 2015) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Noven's Brisdelle® (paroxetine mesylate, used for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause).  View the complaint here.

Millennium Pharmaceuticals Inc. v. Pharmascience Inc. et al.
1:15-cv-00702; filed August 13, 2015 in the District Court of Delaware

• Plaintiff:  Millennium Pharmaceuticals Inc.
• Defendants:  Pharmascience Inc.; Pharmascience Laboratories Inc.

Infringement of U.S. Patent Nos. 6,713,446 ("Formulation of Boronic Acid Compounds," issued March 30, 2004) and 6,958,319 (same title, issued October 25, 2005), licensed exclusively to Millennium, following a Paragraph IV certification as part of Pharmascience's filing of an ANDA to manufacture a generic version of Millenium's Velcade® (bortezomib, used to treat multiple myeloma).  View the complaint here.

Hospira Inc. v. Amneal Pharmaceuticals LLC
1:15-cv-00697; filed August 11, 2015 in the District Court of Delaware

Infringement of U.S. Patent Nos. 8,242,158 ("Dexmedetomidine Premix Formulation," issued August 14, 2012), 8,338,470 (same title, issued December 25, 2012), 8,455,527 ("Methods of Treatment Using a Dexmedetomidine Premix Formulation," issued June 4, 2013), and 8,648,106 ("Dexmedetomidine Premix Formulation," issued February 11, 2014) following a Paragraph IV certification as part of Amneal'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.

Par Pharmaceutical, Inc. et al. v. TWi Pharmaceuticals, Inc. et al.
1:15-cv-00698; filed August 11, 2015 in the District Court of Delaware

• Plaintiffs:  Par Pharmaceutical, Inc.; Alkermes Pharma Ireland Ltd.
• Defendants:  TWi Pharmaceuticals, Inc.; TWi Pharmaceuticals USA, Inc.

Infringement of U.S. Patent No. 9,101,540 ("Nonoparticulate Megestrol Formulations," issued August 11, 2015) and 9,101,549 (same title, issued August 11, 2015) in conjunction with defendants' filing of an ANDA to manufacture a generic version of Par's Megace ES® (megestrol acetate, used for the treatment of appetite loss, severe malnutrition, or unexplained, significant weight loss in AIDS patients).  View the complaint here.

Boehringer Ingelheim Pharmaceuticals, Inc. et al. V. Intas Pharmaceuticals, Ltd., et al.
1:15-cv-00664; filed August 11, 2015 in the Middle District of North Carolina

• Plaintiffs:  Boehringer Ingelheim Pharmaceuticals, Inc.; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim Corp.
• Defendants:  Intas Pharmaceuticals, Ltd.; Accord Healthcare, Inc.

Infringement of U.S. Patent Nos. 8,673,927 ("Uses of DPP-IV Inhibitors," issued March 18, 2014) and 8,846,695 ("Treatment For Diabetes In Patients With Inadequate Glycemic Control Despite Metformin Therapy Comprising A DPP-IV Inhibitor," issued September 30, 2014) following a Paragraph IV certification as part of Intas' filing of an ANDA to manufacture a generic version of Boehringer's Jentadueto® (linagliptin and metformin hydrochloride, used an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate) products.  View the complaint here.  [NB: The complaint was later voluntarily dismissed.]

Horizon Pharma Ireland Ltd. et al. v. Actavis Laboratories UT, Inc. et al.
1:15-cv-06131; filed August 11, 2015 in the District Court of New Jersey

• Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
• Defendants:  Actavis Laboratories UT, Inc.; Actavis, Inc.; Allergan PLC

Horizon Pharma Ireland Ltd. et al. v. Amneal Pharmaceuticals LLC
1:15-cv-06132; filed August 11, 2015 in the District Court of New Jersey

• Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
• Defendant:  Amneal Pharmaceuticals LLC

Horizon Pharma Ireland Ltd. et al. v. IGI Laboratories, Inc.
1:15-cv-06134; filed August 11, 2015 in the District Court of New Jersey

• Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
• Defendant:  IGI Laboratories, Inc.

Horizon Pharma Ireland Ltd. et al. v.Taro Pharmaceuticals USA, Inc. et al.
1:15-cv-06135; filed August 11, 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 Pharmaceuticals Industries, Ltd.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 9,101,591 ("Diclofenac Topical Formulation," issued August 11, 2015) in conjunction with defendants' 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 Actavis complaint here.

Eli Lilly and Company v. Emcure Pharmaceuticals Ltd. et al.
1:15-cv-01244; filed August 7, 2015 in the Southern District of Indiana

• Plaintiff:  Eli Lilly and Company
• Defendants:  Emcure Pharmaceuticals Ltd.; Heritage Pharma Labs Inc.; Heritage Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 7,772,209 ("Novel Antifolate Combination Therapies," issued August 10, 2010) following a Paragraph IV certification as part of Emcure's filing of an ANDA to manufacture a generic version of Lilly's Alimta® (pemetrexed for injection, used to treat malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer).  View the complaint here.

AstraZeneca AB et al. v. Lupin Ltd. et al.
3:15-cv-06092; filed August 7, 2015 in the District Court of New Jersey

• Plaintiffs:  AstraZeneca AB; Aktiebolaget Hassle; AstraZeneca LP; Zeneca Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 6,369,085 ("Form of S-omeprazole," issued April 9, 2002) and 7,411,070 (same title, issued August 12, 2008) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium 24HR®  (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease).  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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