Court Report

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

Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories Inc.
1:14-cv-01508; filed December 23, 2014 in the District Court of Delaware

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
• Defendant:  Roxane Laboratories Inc.

Infringement of U.S. Patent Nos. 5,665,772 (“O-alkylated Rapamycin Derivatives and Their Use, Particularly as Immunosuppressants,” issued September 9, 1997), 7,297,703 (“Macrolides,” issued November 20, 2007), and 7,741,338 (same title, issued June 22, 2010) following a Paragraph IV certification as part of Roxane’s filing of an ANDA to manufacture a generic version of Novartis’ Afinitor® (everolimus, used for the treatment of: postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole; adults with progressive neuroendocrine tumors of pancreatic origin that are unresectable, locally advanced or metastatic; adults with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib; adults with renal angiomyolipoma and tuberous sclerosis complex, not requiring immediate surgery; and pediatric and adult patients with tuberous sclerosis complex who have subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected).  View the complaint here.

Eisai Co. Ltd. et al. v. Roxane Laboratories Inc.
1:14-cv-01511; filed December 23, 2014 in the District Court of Delaware

• Plaintiffs:  Eisai Co. Ltd.; Eisai Inc.; Novartis Pharma AG
• Defendant:  Roxane Laboratories Inc.

Infringement of U.S. Patent Nos. 6,740,669 (“Crystal Modification of 1-(2,6-Difluorobenzyl)-1H-1,2,3-Triazole-4-Carboxamide and its Use as Antiepileptic,” issued May 25, 2004) and 7,750,028 (“Crystal Modifications of 1-(2,6-Difluorobenzyl)-1H-1,2,3-Triazole-4-Carboxamide,” issued July 6, 2010) following a Paragraph IV certification as part of Roxane’s filing of an ANDA to manufacture a generic version of Eisai’s Banzel® (rufinamide oral suspension, used for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in children 4 years and older and adults).  View the complaint here.

iCeutica Pty Ltd. et al. v. Lupin Ltd. et al.
1:14-cv-01515; filed December 23, 2014 in the District Court of Delaware

• Plaintiffs:  iCeutica Pty Ltd.; Iroko Pharmaceuticals LLC
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

Infringement of U.S. Patent No. 8,679,544 (“Formulation of Diclofenac,” issued March 25, 2014) following a Paragraph IV certification as part of Lupin’s filing of an ANDA to manufacture a generic version of Iroko’s Zorvolex® (diclofenac, used for the management of mild to moderate acute pain and osteoarthritis pain).  View the complaint here.

Cadence Pharmaceuticals, Inc. et al. v. Agila Specialties Private Ltd., Inc. et al.
1:14-cv-08000; filed December 23, 2014 in the District Court of New Jersey

• Plaintiffs:  Cadence Pharmaceuticals, Inc.; SCR Pharmatop; Mallinckrodt IP
• Defendants:  Agila Specialties Private Ltd., Inc.; Agila Specialties Inc.

Cadence Pharmaceuticals Inc. et al. v. Agila Specialties Private Ltd. Inc. et al
1:14-cv-01499; filed December 19, 2014 in the District Court of Delaware

• Plaintiffs:  Cadence Pharmaceuticals Inc.; SCR Pharmatop; Mallinckrodt IP
• Defendants:  Agila Specialties Private Ltd. Inc.; Agila Specialties Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,028,222 (“Stable Liquid Paracetamol Compositions, and Method for Preparing the Same,” issued February 22, 2000) and 6,992,218 (“Method for Obtaining Aqueous Formulations of Oxidation-Sensitive Active Principles,” issued January 31, 2006), both licensed to Cadence, following a Paragraph IV certification as part of Agila’s filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Cadence’s Ofirmev® (acetaminophen injection, used for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fevers).  View the Delaware complaint here.

Forest Laboratories LLC et al. v. Breckenridge Pharmaceutical Inc.
1:14-cv-01504; filed December 22, 2014 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories LLC; Forest Laboratories Holdings Ltd.
• Defendant:  Breckenridge Pharmaceutical Inc.

Infringement of U.S. Patent Nos. 5,763,476 (“Sublingual or Buccal Pharmaceutical Composition,” issued June 9, 1998), 7,741,358 (“Crystal Form of Asenapine Maleate,” issued June 22, 2010), and 8,022,228 (same title, issued to September 20, 2011) following a Paragraph IV certification as part of Breckenridge’s filing of an ANDA to manufacture a generic version of Forest’s Saphris® (asenapine maleate, sublingual, used to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder).  View the complaint here.

Fresenius Kabi USA LLC v. Claris Lifesciences Ltd. et al.
1:14-cv-01498; filed December 19, 2014 in the District Court of Delaware

• Plaintiff:  Fresenius Kabi USA LLC
• Defendants:  Claris Lifesciences Ltd.; Claris Lifesciences Inc.

Fresenius Kabi USA, LLC v. Claris Lifesciences Ltd. et al.
1:14-cv-07953; filed December 19, 2014 in the District Court of New Jersey

• Plaintiff:  Fresenius Kabi USA, LLC
• Defendants:  Claris Lifesciences Ltd.; Claris Lifesciences Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,476,010 (“Propofol Formulations with Non-Reactive Container Closures,” issued July 2, 2013) following a Paragraph IV certification as part of Claris’ filing of an ANDA to manufacture a generic version of Fresenius’ Diprivan® (propofol injectable emulsion, used for the induction and maintenance of general anesthesia and sedation in certain patient populations).  View the Delaware complaint here.

Sanofi-Aventis US LLC et al. v. Fresenius Kabi USA LLC
1:14-cv-01496; filed December 18, 2014 in the District Court of Delaware

• Plaintiffs:  Sanofi-Aventis US LLC; Aventis Pharma SA; Sanofi
• Defendant:  Fresenius Kabi USA LLC

Sanofi-Aventis U.S. LLC et al. v. Fresenius Kabi USA, LLC
3:14-cv-07869; filed December 17, 2014 in the District Court of New Jersey

• Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
• Defendant:  Fresenius Kabi USA, LLC

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 Fesenius’ filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) 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 New Jersey complaint here.

Novartis AG et al. v. Actavis, Inc. et al.
2:14-cv-07849; filed December 17, 2014 in the District Court of New Jersey

• Plaintiffs:  Novartis AG; Novartis Pharmaceuticals Corp.; Mitsubishi Tanabe Pharma Corp.; Mitsui Sugar Co., Ltd.
• Defendants:  Actavis, Inc.; Actavis Elizabeth LLC

Infringement of U.S. Patent No. 5,604,229 (“2-Amino-1,3-Propanediol Compound and Immunosuppressant,” issued February 18, 1997) following a Paragraph IV certification as part of Actavis’ filing of an ANDA to manufacture a generic version of Novartis’ Gilenya® (fingolimod hydrochloride, used to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability in patients with relapsing forms of multiple sclerosis).  View the complaint here.

AstraZeneca AB et al. v. Actavis Laboratories FL, Inc. et al.
3:14-cv-07870; filed December 17, 2014 in the District Court of Delaware

• Plaintiffs:  AstraZeneca AB; Aktiebolaget Hassle; AstraZeneca LP; Zeneca Inc.
• Defendants:  Actavis Laboratories FL, Inc.; Actavis Pharma, Inc.

Infringement of U.S. Patent Nos. 5,714,504 (“Compositions,” issued February 3, 1988), 6,369,085 (“Form of S-omeprazole,” issued April 9, 2002), 7,411,070 (same title, issued August 12, 2008), and 8,466,175 (same title, issued June 18, 2013) following a Paragraph IV certification as part of Actavis’ filing of an ANDA to manufacture a generic version of AstraZeneca’s Nexium® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease).  View the complaint here.

Jazz Pharmaceuticals, Inc. et al v. Watson Laboratories, Inc.
2:14-cv-07757; filed December 11, 2014 in the District Court of New Jersey

• Plaintiffs:  Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Ltd.
• Defendant:  Watson Laboratories, Inc.

Infringement of U.S. Patent Nos. 6,472,431 (“Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy,” issued October 29, 2002), 6,780,889 (same title, issued August 24, 2004), 7,262,219 (same title, issued August 28, 2007), 7,851,506 (same title, issued December 14, 2010 (“Sensitive Drug Distribution System and Method” issued February 22, 2011), 8,263,650 (“Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy,”  issued September 11, 2012), 8,324,275 (same title,  issued December 4, 2012), 8,461,203 (“Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy,” issued June 11, 2013), 7,668,730 (“Sensitive Drug Distribution System and Method,” issued February 23, 2010), 7,765,106 (same title, issued July 27, 2010), 7,765,107 (same title, issued July 27, 2010), 7,895,059 (same title, issued February 22, 2011), 8,457,988 (same title, issued June 4, 0213), 8,589,182 (same title, issued November 19, 2013), 8,731,963 (same title, issued May 20, 2014), and  8,772,306 (“Method of Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters,” issued July 8, 2014) following a Paragraph IV certification as part of Watson’s filing of an ANDA to manufacture a generic version of Jazz’s Xyrem® (sodium oxybate, used to treat narcolepsy).  View the complaint here.