By Sherri Oslick

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

Astellas US LLC et al. v. Nycomed U.S. Inc.
1:10-cv-08274; filed November 2, 2010 in the Southern District of New York

• Plaintiffs:  Astellas US LLC; Astellas Pharma Inc.
• Defendant:  Nycomed U.S. Inc.

Astellas US LLC et al. v. Nycomed U.S. Inc.
2:10-cv-05599; filed October 27, 2010 in the District Court of New Jersey

• Plaintiffs:  Astellas US LLC; Astellas Pharma Inc.
• Defendant:  Nycomed U.S. Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 5,665,727 ("Use of 11,28-dioxa-4-azatricyclo[22.3.1.04,9 ]octacos-18-ene Derivatives and Pharmaceutical Compositions Containing Them," issued September 9, 1997) and 5,385,907 ("Ointments Containing FK-506 or Derivatives Thereof," issued January 31, 1995) following a Paragraph IV certification as part of Nycomed's filing of an ANDA to manufacture a generic version of Astellas' Protopic® (tacrolimus ointment, used to treat moderate to severe eczema).  View the New York complaint here.


Daiichi Sankyo Co., Ltd. v. Kappos

1:10-cv-01862; filed November 1, 2010 in the District Court of the District of Columbia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,335,765 ("Nucleoside and Oligonucleotide Analogues," issued February 26, 2008).  View the complaint here.


Daiichi Sankyo Inc. et al. v. Lupin Ltd. et al.

1:10-cv-00935; filed November 2, 2010 in the District Court of Delaware

• Plaintiffs:  Daiichi Sankyo Inc.; Genzyme Corp.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 5,607,669 ("Amine Polymer Sequestrant and Method of Cholesterol Depletion," issued March 4, 1997) and 5,693,675 ("Alkylated Amine Polymers," issued December 2, 1997) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of plaintiffs' Welchol® (colesevelam hydrochloride, used to treat primary hyperlipidemia and type 2 diabetes mellitus).  View the complaint here.


Eli Lilly and Company v. Teva Parenteral Medicines, Inc. et al.

1:10-cv-01376; filed October 29, 2010 in the Southern District of Indiana

• Plaintiff:  Eli Lilly and Company
• Defendants:  Teva Parenteral Medicines, Inc.; APP Pharmaceuticals, LLC; Pliva Hrvatska D.O.O.; Teva Pharmaceuticals USA Inc.; Barr Laboratories, Inc.

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 defendants' 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.


Fresenius Medical Care Holdings, Inc. v. Lupin Ltd. et al.

1:10-cv-11856; filed October 29, 2010 in the District Court of Massachusetts

• Plaintiff:  Fresenius Medical Care Holdings, Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

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 Lupin's filing of an ANDA to manufacture a generic version of Fresenius' PhosLo® GelCaps (calcium acetate, used to treat renal failure).  View the complaint here.


Pfizer Inc., et al. v. Actavis Inc. et al.

1:10-cv-08197; October 29, 2010 in the Southern District of New York

• Plaintiffs:  Pfizer Inc.; Pfizer Ltd.; Pfizer Ireland Pharmaceuticals
• Defendants:  Actavis Inc.; Actavis Pharma Manufacturing Pvt. Ltd. LLC; Amneal Pharmaceuticals LLC; Apotex Inc.; Apotex Corp.; Mylan Inc.; Mylan Pharmaceuticals Inc.

Infringement of U.S. Patent No. 6,469,012 ("Pyrazolopyrimidinones for the Treatment of Impotence," issued October 22, 2002) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Pfizer's Viagra® (sildenafil citrate, used to treat erectile dysfunction).  View the complaint here.


Hoffman-La Roche Inc. v. Dr. Reddys Laboratories, Ltd. et al.

2:10-cv-05623; filed October 27, 2010 in the District Court of New Jersey

• Plaintiff:  Hoffman-La Roche Inc.
• Defendants:  Dr. Reddys Laboratories, Ltd.; Dr. Reddy's Laboratories, Inc.

Infringement of U.S. Patent No. 7,718,634 ("Method of Treatment Using Bisphosphonic Acid," issued May 18, 2010) following a Paragraph IV certification as part of an amendment to Dr. Reddy's ANDA to manufacture a generic version of Roche's Boniva® (ibandronate sodium, used to treat post-menopausal osteoporosis).  View the complaint here.

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