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

Idenix Pharmaceuticals LLC et al. v. Gilead Pharmasset LLC
1:15-cv-00416; filed May 21, 2015 in the District Court of Delaware

• Plaintiffs:  Idenix Pharmaceuticals LLC; Universita Degli Studi di Cagliari; Centre National de la Recherche Scientifique; Universite de Montpellier
• Defendant:  Gilead Pharmasset LLC

Review of the decision of the Patent Trial and Appeal Board awarding priority of invention to Gilead between U.S. Patent Application Serial No. 11/854,218 ("Modified Fluorinated Nucleoside Analogues," filed September 12, 2007), assigned to Gilead, and U.S. Patent No. 7,608,600 ("Modified 2' and 3'-Nucleoside Prodrugs for Treating Flaviviridae Infections," issued October 27, 2009), assigned to plaintiffs.  View the complaint here.

Sanofi et al. v. Lupin Atlantis Holdings SA et al.
1:15-cv-00415; filed May 21, 2015 in the District Court of Delaware

• Plaintiffs:  Sanofi; Sanofi-Aventis US LLC
• Defendants:  Lupin Atlantis Holdings SA; Lupin Ltd.; Lupin Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 8,318,800 ("Solid Pharmaceutical Compositions Containing Benzofuran Derivatives," issued November 27, 2012) and 8,410,167 ("Use of Dronedarone for the Preparation of a Medicament for Use in the Prevention of Cardiovascular Hospitalization or of Mortality," issued April 2, 2013) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Sanofi's Multaq® (dronedarone, used to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation).  View the complaint here.

Horizon Pharma Ireland Ltd. et al. v. IGI Laboratories, Inc.
1:15-cv-03508; filed May 21, 2015 in the District Court of New Jersey

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

Kowa Co., Ltd. et al. v. Lupin Ltd. et al.
1:15-cv-03935; filed May 21, 2015 in the Southern District of New York

• Plaintiffs:  Kowa Co., Ltd.; Kowa Pharmaceuticals America, Inc.; Nissan Chemical Industries, Ltd.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent No. 8,557,993 ("Crystalline Forms of Pitavastatin Calcium," issued October 15, 2013) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Kowa's Livalo® (pitavastatin, used as an adjunctive therapy to diet to reduce elevated total cholesterol, lowdensity lipoprotein cholesterol, apolipoprotein B, triglycerides, and to increase high-density lipoprotein cholesterol).  View the complaint here.

Merck & CIE et al. v. Lupin Ltd. et al.
1:15-cv-01472; filed May 21, 2015 in the District Court of Maryland

• Plaintiffs:  Merck & Cie; Bayer Pharma AG; Bayer HealthCare Pharmaceuticals Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Merck & Cie et al. v. Lupin Ltd. et al.
1:15-cv-00407; filed May 20, 2015 in the District Court of Delaware

• Plaintiffs:  Merck & Cie; Bayer Pharma AG; Bayer HealthCare Pharmaceuticals Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,441,168 ("Stable Crystalline Salts of 5-methyltetrahydrofolic Acid," issued August 27, 2002), licensed to Bayer, following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Bayer's Safyral® (drospirenone, 17α-ethinyl estradiol, and levomefolate calcium, used for oral contraception).  View the Delaware complaint here.

Eli Lilly and Company et al. v. HEC Pharm USA, Inc. et al.
1:15-cv-00792; filed May 20, 2014 in the Southern District of Indiana

• Plaintiffs:  Eli Lilly and Company; Daiichi Sankyo Co., Ltd.; Daiichi Sankyo, Inc.; Ube Industries, Ltd.
• Defendants:  HEC Pharm USA, INC.; HEC Pharm Co., Ltd.

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 HEC'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.

Gilead Sciences Inc. et al. v. AbbVie Inc.
1:15-cv-00399; filed May 19, 2015 in the District Court of Delaware

• Plaintiffs:  Gilead Sciences Inc.; Gilead Sciences Ireland Unlimited Co.
• Defendant:  AbbVie Inc.

Declaratory judgment of invalidity of U.S. Patent No. 9,034,832 ("Solid Compositions," issued May 19, 2015), allegedly covering Gilead's formulation and use of its Harvoni® product (Sofosbuvir and Sofosbuvir, used to treat Hepatitis C Virus).  View the complaint here.

Cephalon Inc. v. Apotex Inc. et al.
1:15-cv-00404; filed May 19, 2015 in the District Court of Delaware

• Plaintiff:  Cephalon Inc.
• Defendants:  Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent Nos. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013) and 8,436,190 ("Bendamustine Pharmaceutical Compositions," issued May 7, 2013), 8,609,863 (same title, issued December 17, 2013), and 8,791,270 (same title, issued July 29, 2014), 8,669,279 ("Solid Forms of Bendamustine Hydrochloride," issued March 11, 2014), 8,883,836 (same title, issued November 11, 2014), and 8,895,756 ("Bendamustine Pharmaceutical Compositions," issued November 25, 2014) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma).  View the complaint here.