Court Report - Part III

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

Eli Lilly and Company et al. v. Apotex Corp. et al.
1:14-cv-00586; filed April 16, 2014 in the Southern District of Indiana

• Plaintiffs: Eli Lilly and Company; Daiichi Sankyo Co., Ltd.; Daiichi Sankyo, Inc.; Ube Industries, Ltd.
• Defendants: Apotex Corp.; Apotex Inc.

Infringement of certain 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 Apotex’s filing of an 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.

The Medicines Company v. Aurobindo Pharma Ltd. et al.
3:14-cv-02367; filed April 11, 2014 in the District Court of New Jersey

• Plaintiff:  The Medicines Company
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA, Inc.

Infringement of U.S. Patent Nos. 7,582,727 ("Pharmaceutical Formulations of Bivalirudin and Process of Making the Same," issued September 1, 2009) and 7,598,343 (same title, issued October 6, 2009) following a Paragraph IV certification as part of Aurobindo’s filing of an ANDA to manufacture a generic version of The Medicines Company's Angiomax® (bivalirudin, used as an anticoagulant in patients with unstable angina undergoing percutaneous translurninal coronary angioplasty).  View the complaint here.

Glenmark Generics Ltd. et al. v. Sanofi-Aventis U.S. LLC et al.
2:14-cv-02374; filed April 11, 2014 in the District Court of New Jersey

• Plaintiffs:  Glenmark Generics Ltd.; Glenmark Generics Inc., USA
• Defendants:  Sanofi-Aventis U.S. LLC; Ferring B.V.

Declaratory judgment of non-infringement and invalidity of U.S. Patent No. 7,022,340 (“Pharmaceutical Composition as Solid Dosage Form and Method for Manufacturing Thereof,” issued April 4, 2006) in conjunction with Glenmark’s Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of Sanofi-Aventis’ DDAVP® Tablets (desmopressin acetate, used as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region).  View the complaint here.

Novartis Pharmaceuticals Corp. et al. v. Dr. Reddys Laboratories, Ltd. et al.
2:14-cv-02329; filed April 10, 2014 in the District Court of New Jersey

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
• Defendants:  Dr. Reddys Laboratories, Ltd.; Dr. Reddys Laboratories, Inc.

Infringement of U.S. Patent No. RE43,932 ("Crystal Modification of a N-phenyl-2-pyrimidineamine Derivative, Processes for Its Manufacture and Its Use," issued January 15, 2013) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Novartis' Gleevec® (imatinib mesylate, used for various indications, including treatment of myeloid leukemia).  View the complaint here.

Kowa Company, Ltd. et al. v. Aurobindo Pharma Ltd. et al.
3:14-cv-02290; filed April 10, 2014 in the District Court of New Jersey

• Plaintiffs: Kowa Company, Ltd.; Kowa Pharmaceuticals America, Inc.; Nissan Chemical Industries, Ltd.
• Defendants: Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

Kowa Company, Ltd. et al. v. Aurobindo Pharma Limited et al.
1:14-cv-02497; filed April 9, 2014 in the Southern District of New York

• Plaintiffs:  Kowa Co.; Kowa Pharmaceuticals America, Inc.; Nissan Chemical Industries, Ltd.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,856,336 ("Quinoline Type Mevalonolactones," issued January 5, 1999) and 8,557,993 ("Crystalline Forms of Pitavastatin Calcium," issued October 15, 2013) following a Paragraph IV certification as part of Aurobindo’s filing of an ANDA to manufacture a generic version of Kowa’s Livalo® (pitavastatin, used as an adjunctive therapy to diet to reduce elevated total cholesterol, lowdensity lipoprotein cholesterol, apolipoprotein B, triglycerides, and to increase high-density lipoprotein cholesterol).  View the SDNY complaint here.

St. Jude Children's Research Hospital, Inc. v. Amgen Inc.
2:14-cv-02254; filed April 8, 2014 in the Western District of Tennessee

Infringement of U.S. Patent Nos. 5,529,925 (“Nucleic Acid Sequences and Fusion Proteins Present in Human T(2;5) Lymphoma,” issued June 25, 1996), 5,770,421 (“Human ALK Protein Tyrosine Kinase,” issued June 23, 1998), and 6,696,548 (“Antibodies for Recognition of ALK Protein Tyrosine/Kinase Receptor,” issued February 24, 2004) based on Amgen’s activities to research, develop, and evaluate small molecule tyrosine kinase inhibitors, including making or using ALK nucleic acids, proteins, polypeptides, and/or antibodies in a manner allegedly infringing the patents-in-suit.  View the complaint here.

 

Topics:  Biotechnology, 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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