About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Novartis AG et al. v. Ezra Ventures LLC
1:15-cv-00150; filed February 11, 2015 in the District Court of Delaware
• Plaintiffs: Novartis AG; Novartis Pharmaceuticals Corp.; Mitsubishi Tanabe Pharma Corp.; Mitsui Sugar Co. Ltd.
• Defendant: Ezra Ventures LLC
Novartis AG et al. v. HEC Pharm Group et al.
1:15-cv-00151; filed February 11, 2015 in the District Court of Delaware
• Plaintiffs: Novartis AG; Novartis Pharmaceuticals Corp.; Mitsubishi Tanabe Pharma Corp.; Mitsui Sugar Co. Ltd.
• Defendant: HEC Pharm Group; HEC Pharm Co. Ltd.; HEC Pharm USA Inc.
The complaints in these cases are substantially identical. 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 defendants' 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 Ezra complaint here.
Roxane Laboratories, Inc. v. Lupin Ltd. et al.
2:15-cv-01095 filed February 10, 2015 in the District Court of New Jersey
• Plaintiff: Roxane Laboratories, Inc.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals, Inc.
Infringement of U.S. Patent No. 8,563,032 ("Formulation and Manufacturing Process for Calcium Acetate Capsules," issued October 22, 2013) based on defendants' anticipated manufacture and sale of a generic calcium acetate capsule, having filed an ANDA to manufacture a generic version of Fresenius' PhosLo® Gelcaps (calcium acetate, used for the reduction of serum phosphorous in patients with end stage renal disease). View the complaint here.
Novartis Pharmaceuticals Corp. v. BPI Labs, LLC
8:15-cv-00272; filed February 9, 2015 in the Middle District of Florida
Novartis Pharmaceuticals Corp. v. BPI Labs LLC
2:15-cv-00950; filed February 5, 2015 in the District Court of New Jersey
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 8,324,189 ("Use of Zolendronate for the Manufacture of a Medicament for the Treatment of Bone Metabolism Diseases," issued December 4, 2012) following a Paragraph IV certification as part of BPI's filing of an ANDA to manufacture a generic version of Novartis' Zometa® (zoledronic acid, used for the prevention of skeletal-related complications associated with cancer). View the New Jersey complaint here.
Jazz Pharmaceuticals, Inc. et al. v. Amneal Pharmaceuticals, LLC
2:15-cv-01043; filed February 6, 2015 in the District Court of New Jersey
• Plaintiffs: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Ltd.
• Defendant: Amneal Pharmaceuticals, LLC
Infringement of U.S. Patent Nos. 8,731,963 ("Sensitive Drug Distribution System and Method," issued May 20, 2014), 8,772,306 ("Method of Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters," issued July 8, 2014), and 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 Amneal's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy). View the complaint here.
AstraZeneca AB et al. v. Perrigo Co. PLC et al.
3:15-cv-01057; filed February 4, 2015 in the District Court of New Jersey
• Plaintiffs: AstraZeneca AB; Aktiebolaget Hassle; AstraZeneca LP; Zeneca Inc.
• Defendants: Perrigo Co. PLC; Perrigo Co.; L. Perrigo Co.; Paddock Laboratories, LLC
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 Perrigo'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.
