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

Sucampo AG et al. v. Dr. Reddy's Laboratories, Inc. et al.
3:14-cv-07114; filed November 12, 2014 in the District Court of New Jersey

• Plaintiffs:  Sucampo AG; Sucampo Pharmaceuticals, Inc.; R-Tech Ueno, Ltd.; Takeda Pharmaceutical Co. Ltd.; Takeda Pharmaceuticals USA, Inc.; Takeda Pharmaceuticals America, Inc.
• Defendants:  Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories Ltd.

Infringement of U.S. Patent Nos. 6,414,016 ("Anti-Constipation Composition," issued July 2, 2002), 7,795,312 ("Method for Treating Abdominal Discomfort," issued September 14, 2010), 8,071,613 ("Anti-Constipation Composition," issued December 6, 2011), 8,097,653 ("Dosage Unit Comprising a Prostaglandin Analog for Treating Constipation," issued January 17, 2012), 8,389,542 (same title, issued March 5, 2013), 8,026,393 ("Soft-Gelatin Capsule Formulation," issued September 27, 2011), and 8,338,639 (same title, issued December 25, 2012) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Amitiza® (lubiprostone, used to treat Chronic Idiopathic Constipation in adults and  to treat Irritable Bowel Syndrome with Constipation in women 18 years of age and older).  View the complaint here.

Baxter Healthcare Corp. et al. v. Agila Specialties Private Ltd. et al.
2:14-cv-07094; filed November 12, 2014 in the District Court of New Jersey

• Plaintiffs:  Baxter Healthcare Corp.; Baxter International Inc.; Baxter Healthcare S.A.
• Defendants:  Agila Specialty Inc.; Agila Specialties Inc.; Mylan Inc.; Mylan Pharmaceuticals Inc.; Mylan Institutional Inc.; Mylan Institutional LLC; Agila Specialties Private Ltd.

Infringement of U.S. Patent Nos. 6,310,094 ("Ready-to-Use Esmolol Solution," issued October 30, 2001) and 6,528,540 ("Esmolol Formulation," issued March 4, 2003) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Baxter's Brevibloc® (esmolol hydrochloride, used for the rapid control of the heart rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of the heart rate with a short-acting agent is desirable).  View the complaint here.

Amgen Inc. v. Sanofi et al.
1:14-cv-01393; filed November 11, 2014 in the District Court of Delaware

• Plaintiff:  Amgen Inc.
• Defendants:  Sanofi; Sanofi-Aventis U.S. LLC; Aventisub LLC; Regeneron Pharmaceuticals Inc.

Infringement of U.S. Patent No. 8,883,983 ("Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9)," issued November 11, 2014) based on defendants' current and/or imminent manufacture, use, sale, offer to sell, and/or importation into the U.S. of alirocumab, an anti-PCSK9 antibody (used to treat dyslipidemia and other cholesterol disorders).  View the complaint here.

Genovis AB et al. v. Promega Corp.
1:14-cv-01391; filed November 10, 2014 in the District Court of Delaware

• Plaintiffs:  Genovis AB; Hansa Medical AB
• Defendant:  Promega Corp.

Infringement of U.S. Patent No. 7,666,582 ("IDES, An IgG-Degrading Enzyme of Streptococcus Pyogenes," issued February 23, 2010), licensed to Genovis, based on Promega's manufacture, use, sale, or offer of sale of its IdeS Protease.  View the complaint here.

Biomune Co. v. Merial Ltd. et al.
2:14-cv-02567; filed November 10, 2014 in the District Court of Kansas

• Plaintiff:  Biomune Co.
• Defendants:  Merial Ltd.; Merial LLC

Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 6,660,272 ("Porcine Circoviruses, Vaccines, and Diagnostic Reagents," issued October 17, 2006) and 7,122,192 (same title, issued December 9, 2003) based on Biomune's manufacture and sale of its Porcine Circovirus Vaccine, Type-2, Killed Virus-Mycoplasma Hyopneumonia Bacterin.  View the complaint here.

Shire Development LLC et al. v. Natco Pharma Ltd.
2:14-cv-07053 filed November 10, 2014 in the District Court of New Jersey

• Plaintiffs:  Shire Development LLC; Shire Canada Inc.; Shire International Licensing B.V.
• Defendant:  Natco Pharma Ltd.

Infringement of U.S. Patent Nos. 5,968,976 ("Pharmaceutical Composition Containing Selected Lanthanum Carbonate Hydrates," issued October 19, 1999), 7,381,428 ("Stabilized Lanthanum Carbonate Compositions," issued June 3, 2008), and 7,465,465 ("Pharmaceutical Formulation Comprising Lanthanum Compounds," issued December 16, 2008) following a Paragraph IV certification as part of Natco's filing of an ANDA to manufacture a generic version of Shire's Fosrenol® (lanthanum carbonate chewable tablets, used for the reduction of serum phosphate in patients with end stage renal disease).  View the complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Actavis Elizabeth LLC et al.
1:14-cv-07106; filed November 10, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co., Ltd.
• Defendants:  Actavis Elizabeth LLC; Actavis, Inc.; Actavis PLC

Infringement of U.S. Patent Nos. 8,580,796 ("Low Hygroscopic Aripiprazole Drug Substance and Process 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 Actavis' 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.

Pfizer Inc. et al. v. Tiger Pharmaceuticals, LLC
1:14-cv-08958; filed November 10, 2014 in the Southern District of New York

• Plaintiffs:  Pfizer Inc.; Pfizer Ltd.; Pfizer Ireland Pharmaceuticals
• Defendant:  Tiger Pharmaceuticals, LLC

Pfizer Inc. et al. v. Tiger Pharmaceuticals, LLC
1:14-cv-01501; filed November 10, 2014 in the Eastern District of Virginia

• Plaintiffs:  Pfizer Inc.; Pfizer Ltd.; Pfizer Ireland Pharmaceuticals
• Defendant:  Tiger Pharmaceuticals, LLC

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,124,363 ("Dofetilide Polymorphs," issued September 26, 2000) following a Paragraph IV certification as part of Tiger's filing of an ANDA to manufacture a generic version of Pfizer's Tikosyn® (dofetilide, used for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm and for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm).  View the New York complaint here.