About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Shire LLC v. Par Pharmaceutical, Inc. et al.
1:15-cv-01454; filed February 25, 2015 in the District Court of Massachusetts
• Plaintiff: Shire LLC
• Defendants: Par Pharmaceutical, Inc.; Par Pharmaceutical Companies, Inc.
Infringement of U.S. Patent Nos. RE42,096 ("Oral Pulsed Dose Drug Delivery System," issued February 1, 2011) and RE41,148 (same title, issued February 23, 2010) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Shire's Adderall XR® (a combination of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate, used to treat attention deficit hyperactivity disorder). View the complaint here.
Cephalon Inc. v. Sandoz Inc. et al.
1:15-cv-00178; filed February 23, 2015 in the District Court of Delaware
• Plaintiff: Cephalon Inc.
• Defendants: Sandoz Inc.; Accord Healthcare Inc.; Intas Pharmaceuticals Ltd.; InnoPharma Inc.; Agila Specialties Inc.; Onco Therapies Limited; Glenmark Pharmaceuticals Ltd.; Glenmark Generics S.A.; USA Eurohealth International SARL; West-Ward Pharmaceutical Corp.; Glenmark Generics Ltd.; Glenmark Generics Inc USA
Cephalon Inc. v. Dr Reddy's Laboratories Ltd et al.
1:15-cv-00179; filed February 23, 2015 in the District Court of Delaware
• Plaintiff: Cephalon Inc.
• Defendants: Dr Reddy's Laboratories Ltd; Dr Reddy's Laboratories Inc.; Emcure Pharmaceuticals Ltd.; Emcure Pharmaceuticals USA Inc.; Pharmascience Inc.; Hospira Inc.; Breckenridge Pharmaceutical Inc.; Natco Pharma Ltd.; Hetero Labs Ltd.; Hetero USA Inc.; Sun Pharmaceutical Industries Ltd.; Actavis LLC; Sagent Pharmaceuticals Inc.; Wockhardt Bio AG; Wockhardt Ltd.; Wockhardt USA LLC; Sun Pharma Global FZE
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 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 defendants' 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 Sandoz complaint here.
Ferring Pharmaceuticals Inc. et al. v. Par Pharmaceutical Inc.
1:15-cv-00173; filed February 20, 2015 in the District Court of Delaware
• Plaintiffs: Ferring Pharmaceuticals Inc.; Ferring International Center SA
• Defendant: Par Pharmaceutical Inc.
Infringement of U.S. Patent Nos. 8,450,338 ("Granular Compositions of Sodium Picosulfate and Potassium Bicarbonate and Uses Thereof," issued May 28, 2013) and 8,481,083 ("Granular Compositions of Magnesium Oxide and Citric Acid and Uses Thereof," issued July 9, 2013) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Ferring's Prepopik® (sodium picosulfate, magnesium oxide and citric acid, used for the cleansing of the colon as a preparation for colonoscopy in adults). View the complaint here.
Fresenius Medical Care Holdings, Inc v. Novel Laboratories, Inc.
1:15-cv-10472; filed February 20, 2015 in the District Court of Massachusetts
Fresenius Medical Care Holdings, Inc. v. Novel Laboratories, Inc.
3:15-cv-01361; filed February 20, 2015 in the District Court of New Jersey
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 6,576,665 ("Encapsulated Calcium Acetate Caplet and a Method for Inhibiting Gastrointestinal Phosphorous Absorption," issued June 10, 2003) following a Paragraph IV certification as part of Novel's filing of an ANDA to manufacture a generic version of Fresenius' PhosLo® GelCaps (calcium acetate, used to treat renal failure) and infringement of U.S. Patent No. 6,875,445 ("Encapsulated Calcium Acetate Caplet and a Method for Inhibiting Gastrointestinal Phosphorous Absorption," issued April 5, 2005) based on Novel's anticipated manufacture and sale of its generic PhosLo®. View the D. Mass. complaint here.
Jazz Pharmaceuticals, Inc. et al. v. Roxane Laboratories, Inc.
2:15-cv-01360; filed February 20, 2015 in the District Court of New Jersey
• Plaintiffs: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Ltd.
• Defendant: Roxane Laboratories, Inc.
Infringement of U.S. Patent Nos. 8,461,203 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued June 11, 2013), 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 Roxane's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy). View the complaint here.
Cosmo Technologies Ltd. et al. v. Actavis Laboratories FL, Inc.
2:15-cv-01312; filed February 19, 2015 in the District Court of New Jersey
• Plaintiffs: Cosmo Technologies Ltd.; Santarus, Inc.
• Defendant: Actavis Laboratories FL, Inc.
Infringement of U.S. Patent Nos. 7,410,651 ("Controlled Release and Taste Masking Oral Pharmaceutical Composition," issued August 12, 2008), 7,431,943 (same title, issued October 7, 2008), 8,293,273 (same title, issued October 23, 2012), 8,784,888 (same title, issued July 22, 2014), 8,895,064 (same title, issued November 25, 2014), and RE43,799 (same title, issued November 13, 2012) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Santarus' Uceris® (budesonide, used to treat mildly to moderately active ulcerative colitis). View the complaint here.
