Court Report - January 2015

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

Sanofi-Aventis U.S. LLC et al. v. Breckenridge Pharmaceutical, Inc.
9:15-cv-80056; filed January 15, 2015 in the Southern District of Florida

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
• Defendant:  Breckenridge Pharmaceutical, Inc.

Sanofi-Aventis U.S. LLC et al. v. Apotex Corp. et al.
3:15-cv-00287; filed January 14, 2015 in the District Court of New Jersey

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
• Defendants:  Apotex Corp.; Apotex Inc.

Sanofi-Aventis U.S. LLC et al. v. Breckenridge Pharmaceutical, Inc.
3:15-cv-00289; filed January 14, 2015 in the District Court of New Jersey

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
• Defendant:  Breckenridge Pharmaceutical, Inc.

Sanofi-Aventis U.S. LLC et al. v. Onco Therapies Ltd.
3:15-cv-00290; filed January 14, 2015 in the District Court of New Jersey

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
• Defendant:  Onco Therapies Ltd.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,847,170 ("Taxoids, Their Preparation and Pharmaceutical Compositions Containing Them" issued December 8, 1998) and 7,241,907 ("Acetone Solvate of Dimethoxy Docetaxel and its Process of Preparation" issued July 10, 2007) following a Paragraph IV certification as part of defendants' filing of an ANDA 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 Apotex complaint here.

Millennium Pharmaceuticals Inc. v. Hetero Labs Ltd. et al.
1:15-cv-00039; filed January 14, 2015 in the District Court of Delaware

• Plaintiff:  Millennium Pharmaceuticals Inc.
• Defendants:  Hetero Labs Ltd.; Hetero USA Inc.

Millennium Pharmaceuticals Inc. v. Onco Therapies Ltd., et al.
1:15-cv-00040; filed January 14, 2015 in the District Court of Delaware

• Plaintiff:  Millennium Pharmaceuticals Inc.
• Defendants:  Onco Therapies Ltd.; Agila Specialties Inc.

The complaints in these cases are substantially identical.  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 defendants' filing of an ANDA to manufacture a generic version of Millenium's Velcade® (bortezomib, used to treat multiple myeloma).  View the Hetero complaint here.

Horizon Pharma Ireland Ltd. et al. v. Paddock Laboratories LLC et al.
1:15-cv-00043; filed January 14, 2015 in the District Court of Delaware

• Plaintiffs:  Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA Inc.
• Defendants:  Paddock Laboratories LLC; Perrigo Co.

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 Paddock'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.

C T E Global, Inc. v. Novozymes A/S et al.
1:15-cv-00181; filed January 9, 2015 in the Northern District of Illinois

• Plaintiff:  C T E Global, Inc.
• Defendants:  Novozymes A/S; Novozymes North America, Inc.

Declaratory judgment of invalidity and noninfringement of U.S. Patent Nos. 6,255,084 ("Thermostable Glucoamylase," issued July 3, 2001) and 7,060,468 (same title, issued June 13, 2006) based on CTE's manufacture and sale of certain glucoamylase enzyme products.  View the complaint here.

Pfizer Inc. et al. v. Mylan Inc. et al.
1:15-cv-00004; filed January 9, 2014 in the Northern District of West Virginia

• Plaintiffs:  Pfizer Inc.; Wyeth LLC; Pfizer Pharmaceuticals LLC; PF Prism C.V.; Pfizer Manufacturing Holdings LLC
• Defendants:  Mylan Inc.; Agila Specialties Private Ltd.; Mylan Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 7,879,828 ("Tigecycline Compositions and Methods of Preparation," issued February 1, 2011) and 8,372,995 ("Crystalline Solid Forms of Trigecycline and Methods of Preparing Same," issued February 12, 2013), licensed to Pfizer, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Pfizer's Tygacil® (tigecycline injectible, used for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia).  View the complaint here.

Jazz Pharmaceuticals, Inc. v. Ranbaxy Laboratories Ltd. et al.
2:15-cv-00187; filed January 9, 2015 in the District Court of New Jersey

• Plaintiff:  Jazz Pharmaceuticals, Inc.
• Defendants:  Ranbaxy Laboratories Ltd.; Ranbaxy Inc.

Jazz Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc.
2:15-cv-00173; filed January 8, 2015 in the District Court of New Jersey

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,859,619 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued October 14, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy).  View the Par complaint here.

Salix Pharmaceuticals Inc. et al. v. Novel Laboratories Inc.
1:15-cv-00027; filed January 8, 2015 in the District Court of Delaware

• Plaintiffs:  Salix Pharmaceuticals Inc.; Dr. Falk Pharma GmbH
• Defendant:  Novel Laboratories Inc.

Infringement of U.S. Patent No. 8,865,688 ("Compositions and Methods For Treatment of Bowel Diseases With Granulated Mesalamine," issued October 21, 2014) following a paragraph IV certification as part of Novel's amendment of its ANDA to manufacture a generic version of Salix's Apriso® (mesalamine, used for the maintenance of remission of ulcerative colitis in adults).  View the complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Hetero Drugs Limited et al.
1:15-cv-00161; filed January 8, 2015 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Hetero Drugs Limited; Hetero Labs Limited; Hetero USA, Inc.

Infringement of U.S. Patent Nos. 8,580,796 ("Low Hygroscopic Aripiprazole Drug Substance and Processes for the Preparation Thereof," issued November 12, 2013), 8,642,760 (same title, issued February 4, 2014), and 8,759,350 ("Carbostyril Derivatives and Serotonin Reuptake Inhibitors for Treatment of Mood Disorders," issued June 24, 2014) following a Paragraph IV certification as part of Hetero's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  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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