By Sherri Oslick --
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Cornerstone
Therapeutics Inc. et al. v. Exela Pharma Sciences LLC et al.
1:13-cv-01275;
filed July 24, 2013 in the District Court of Delaware
• Plaintiffs:
Cornerstone Therapeutics Inc.; Cornerstone Biopharma Inc.; EKR Therapeutics LLC
• Defendants:
Exela Pharma Sciences LLC; Exela Pharmsci Inc.; Exela Holdings Inc.
Infringement of U.S. Patent Nos. 7,612,102 ("Pre-mixed, Ready-to-Use Pharmaceutical Compositions," issued November 3, 2009) and 7,659,291 ("Methods of Treatment with Pre-Mixed, Ready-to-Use Pharmaceutical Compositions," issued February 9, 2010) following a Paragraph IV certification as part of Exela's filing of a supplemental NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of EKR's Cardene® I.V. Premixed Injection (nicardipine hydrochloride premixed injection for intravenous administration, used for the short-term treatment of hypertension when oral therapy is not feasible or not desirable). View the complaint here.
Merck &
Cie et al. v. Watson Laboratories, Inc. et al.
2:13-cv-01309;
filed July 24, 2013 in the District Court of Nevada
• Plaintiffs:
Merck & Cie; Bayer Pharma AG; Bayer Healthcare Pharmaceuticals, Inc.
• Defendants:
Watson Laboratories, Inc.; Actavis, Inc.
Merck &
Cie et al. v. Watson Laboratories Inc. et al.
1:13-cv-01272;
filed July 23, 2013 in the District Court of Delaware
• Plaintiffs:
Merck & Cie; Bayer Pharma AG; Bayer HealthCare Pharmaceuticals Inc.
• Defendants:
Watson Laboratories Inc.; Actavis 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) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Merck's Beyaz® (drospirenone, 17α-ethinyl estradiol, and levomefolate calcium, used for oral contraception). View the Delaware complaint here.
AbbVie Inc. v.
Roxane Laboratories, Inc.
2:13-cv-00708;
filed July 18, 2013 in the Southern District of Ohio
Infringement of U.S. Patent Nos. 8,268,349 ("Solid Pharmaceutical Dosage Form," issued September 18, 2012) and 8,399,015 (same title, issued March 19, 2013) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of AbbVie's Norvir® (ritonavir, used to treat human immunodeficiency virus (HIV) infection). View the complaint here.
Cumberland
Pharmaceuticals Inc. v. Akorn Inc.
1:13-cv-01232;
filed July 12, 2013 in the District Court of Delaware
Infringement of U.S. Patent No. 8,148,356 ("Acetylcysteine Composition and Uses Therefor," issued April 3, 2012) following a Paragraph IV certification as part of Akorn's filing of an ANDA to manufacture a generic version of Cumberland's Acetadote® (N-acetylcysteine injection, used to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen). View the complaint here.
Alcon
Pharmaceuticals Ltd et al. v. Lupin Ltd. et al.
1:13-cv-01230;
filed July 12, 2013 in the District Court of Delaware
• Plaintiff:
Alcon Pharmaceuticals Ltd; Alcon Research Ltd.
• Defendants:
Lupin Ltd.; Lupin Pharmaceuticals Inc.
Infringement of U.S. Patent No. 8,450,311 ("Pharmaceutical Compositions Containing a Fluoroquinolone Antibiotic Drug," issued May 28, 2013) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Alcon's Moxeza® (moxifloxacin hydrochloride, used to treat bacterial conjunctivitis). View the complaint here.
Everett
Laboratories, Inc. v. Acella Pharmaceuticals, LLC
1:13-cv-04294;
filed July 12, 2013 in the District Court of New Jersey
Infringement of U.S. Patent No. 6,863,904 ("Compositions and Methods for Prophylactic and Therapeutic Supplementation of Nutrition in Subjects," issued March 8, 2005) based on Acella's manufacture and sale of its Choice-Tabs, an alleged copy of Everett's Strovite® One (prescription-only nutritional supplement). View the complaint here.
Aptalis
Pharma US Inc. et al. v. Sandoz Inc.
3:13-cv-04290;
filed July 12, 2013 in the District Court of New Jersey
• Plaintiffs:
Aptalis Pharma US Inc.; Aptalis Pharma Canada Inc.
• Defendant:
Sandoz Inc.
Infringement of U.S. Patent Nos. 8,217,083 ("Mesalamine Suppository," issued July 10, 2012) and 8,436,051 (same title, issued May 7, 2013) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Aptalis' Canasa® (mesalamine rectal suppository product, used to treat active ulcerative proctitis). View the complaint here.
Pegasus
Laboratories, Inc. v. Weatherford Compounding Pharmacy
2:13-cv-02333;
filed July 10, 2013 in the District Court of Kansas
Pegasus
Laboratories, Inc. v. Diamondback Drugs, LLC
2:13-cv-02334;
filed July 10, 2013 in the District Court of Kansas
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 5,747,476 ("Treatment of Equine Protozoal Myeloencephalitis" issued May 5, 1998), 6,255,308 (same title, issued July 3, 2001), and 6,448,252 (same title, issued September 10, 2002), licensed to Pegasus, based on defendants' compounding and sale of a sulfadiazine and pyrimethamine producted used for the treatment of horses with EPM, similar to Pegasus' ReBalance® product. View the Weatherford complaint here.
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