Court Report - February 02, 2014

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

Eli Lilly and Company v. Glenmark Generics Inc., USA
1:14-cv-00104; filed January 23, 2013 in the Southern District of Indiana

Infringement of U.S. Patent No. 7,772,209 ("Novel Antifolate Combination Therapies," issued August 10, 2010) following a Paragraph IV certification as part of Glenmark's filing of an ANDA to manufacture a generic version of Lilly's Alimta® (pemetrexed for injection, used to treat malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer).  View the complaint here.

Eli Lilly and Company et al. v. Par Pharmaceutical Companies, Inc. et al.
1:14-cv-00109; filed January 23, 2013 in the Southern District of Indiana

• Plaintiffs:  Eli Lilly and Company; Daiichi Sankyo Co., Ltd.; Daiichi Sankyo, Inc.; UBE Industries, Ltd.
• Defendants:  Par Pharmaceutical Companies, Inc.; Par Pharmaceutical, Inc.

Infringement 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 Par's amendment of its 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.

AbbVie Inc. et al. v. Roxane Laboratories Inc.
2:14-cv-00085; filed January 23, 2014 in the Southern District of Ohio

• Plaintiffs:  AbbVie Inc.; AbbVie Deutschland GmbH & Co. KG
• Defendant:  Roxane Laboratories Inc.

Infringement of U.S. Patent No. 8,470,347 ("Self-Emulsifying Active Substance Formulation and Use of This Formulation," issued June 25, 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.

Millennium Pharmaceuticals Inc. v. Teva Pharmaceuticals USA Inc. et al.
1:14-cv-00093; filed January 22, 2014 in the District Court of Delaware

• Plaintiff:  Millennium Pharmaceuticals Inc.
• Defendants:  Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent Nos. 6,713,446 ("Formulation of Boronic Acid Compounds," issued March 30, 2004) and 6,958,319 (same title, issued October 25, 2005), licensed exclusively to Millennium, following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Millenium's Velcade® (bortezomib, used to treat multiple myeloma and mantle cell lymphoma).  View the complaint here.

Cadence Pharmaceuticals Inc. et al. v. Wockhardt Ltd. et al.
1:14-cv-00094; filed January 22, 2014 in the District Court of Delaware

• Plaintiffs:  Cadence Pharmaceuticals Inc.; SCR Pharmatop
• Defendants:  Wockhardt Ltd.; Wockhardt Bio AG; Wockhardt USA LLC

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 Wockhardt's filing of an ANDA 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 complaint here.

Lyne Laboratories, Inc. et al. v. Lupin Ltd. et al.
1:14-cv-10153; filed January 21, 2014 in the District Court of Massachusetts

• Plaintiffs:  Lyne Laboratories, Inc.; Fresenius USA Manufacturing, Inc.; Fresenius Medical Care Holdings, Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Lyne Laboratories, Inc. et al. v. Par Pharmaceutical, Inc. et al.
1:14-cv-10154; filed January 21, 2014 in the District Court of Massachusetts

• Plaintiffs:  Lyne Laboratories, Inc.; Fresenius USA Manufacturing, Inc.; Fresenius Medical Care Holdings, Inc.
• Defendants:  Par Pharmaceutical, Inc.; Par Pharmaceutical Companies, Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 8,591,938 ("Liquid Compositions of Calcium Acetate," issued November 26, 2013) and 8,592,480 (same title, issued November 26, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Fesenius' Phoslyra® (calcium acetate oral solution, used as a phosphate binder for the reduction of serum phosphorus in patients with end stage renal disease).  View the Lupin complaint here.

Takeda Pharmaceutical Co., Ltd. et al. v. Mylan Inc. et al.
3:14-cv-00314; filed January 21, 2014 in the Northern District of California

• Plaintiffs:  Takeda Pharmaceutical Co., Ltd.; Takeda Pharmaceuticals U.S.A., Inc.; Takeda Pharmaceuticals America, Inc.
• Defendants:  Mylan Inc.; Mylan Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. U.S. Patent No. 7,339,064 ("Benzimidazole Compound Crystal," issued March 4, 2008) in conjunction with Mylan's filing of an ANDA to manufacture a generic version of Takeda's Dexilant® (dexlansoprazole, used for the treatment of all grades of erosive esophagitis, maintaining healing of esophagitis, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease).  View the complaint here.

JRX Biotechnology, Inc. et al. v. Freedom Pharmaceuticals, Inc.
8:14-cv-00079; filed January 17, 2014 in the Central District of California

• Plaintiffs:  JRX Biotechnology, Inc.; Professional Compounding Centers of America, Inc.
• Defendant:  Freedom Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 7,201,919 ("Mixture for Transdermal Delivery of Low And High Molecular Weight Compounds," issued April 10, 2007), 7,220,427 (same title, issued May 22, 2007), 7,300,666 (same title, issued November 27, 2007), and 7,316,820 (issued January 8, 2008) based on Freedom's manufacture, sale, and offer for sale of its SiloMac Anhydrous Gel product.  View the complaint here.

 

Topics:  ANDA, Biotechnology, Life Sciences, Patent Infringement, Patent Litigation, Patents, Pharmaceutical

Published In: Civil Procedure Updates, Intellectual Property Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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