Court Report - April 2015

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

Gilead Sciences Inc. et al. v. Watson Laboratories Inc. et al.
1:15-cv-00289; filed April 1, 2015 in the District Court of Delaware

• Plaintiffs:  Gilead Sciences Inc.; Royalty Pharma Collection Trust
• Defendants:  Watson Laboratories Inc.; Actavis Inc.; Actavis plc

Infringement of U.S. Patent No. RE42,462 ("Carboxylic Acid Derivatives, Their Preparation and Use," issued June 14, 2011) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Gilead's Letairis® (ambrisentan, used to treat pulmonary arterial hypertension).  View the complaint here.

Forest Laboratories LLC et al. v. InvaGen Pharmaceuticals Inc.
1:15-cv-00277; filed March 27, 2015 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories LLC; Forest Laboratories Holdings Ltd.; Merck KGaA; Merck Patent Gesellschaft mit beschrankter Haftung
• Defendant:  InvaGen Pharmaceuticals Inc.

Forest Laboratories LLC et al. v. Accord Healthcare Inc.

1:15-cv-00272; filed March 27, 2015 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories LLC; Forest Laboratories Holdings Ltd.; Merck KGaA; Merck Patent Gesellschaft mit beschrankter Haftung
• Defendant:  Accord Healthcare Inc.

Forest Laboratories LLC et al. v. Alembic Pharmaceuticals Ltd. et al.
1:15-cv-00273; filed March 27, 2015 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories LLC; Forest Laboratories Holdings Ltd.; Merck KGaA; Merck Patent Gesellschaft mit beschrankter Haftung
• Defendants:  Alembic Pharmaceuticals Ltd.; Alembic Global Holding SA; Alembic Pharmaceuticals Inc.

Forest Laboratories LLC et al. v. Apotex Inc. et al.
1:15-cv-00274; filed March 27, 2015 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories LLC; Forest Laboratories Holdings Ltd.; Merck KGaA; Merck Patent Gesellschaft mit beschrankter Haftung
• Defendants:  Apotex Inc.; Apotex Corp.

Forest Laboratories LLC et al. v. Teva Pharmaceuticals USA Inc.
1:15-cv-00275; filed March 27, 2015 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories LLC; Forest Laboratories Holdings Ltd.; Merck KGaA; Merck Patent Gesellschaft mit beschrankter Haftung
• Defendant:  Teva Pharmaceuticals USA Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 7,834,020 ("Polymorphic forms of 1-'4-(5-Cyanoindol-3-YL)Butyl-4-(2-Carbamoylbenzofuran-5-YL) Piperazine Hydrochloride," issued November 16, 2010), 8,193,195 (same title, issued June 5, 2012), 8,236,804 (same title, issued August 7, 2012), and 8,673,921 (same title, issued March 18, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Forest's Viibryd® (vilazodone hydrochloride, used for the treatment of major depressive disorder in adults).  View the Accord complaint here.

Enzo Life Sciences Inc. v. Hologic Inc.
1:15-cv-00271; filed March 27, 2015 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,992,180 ("Oligo- Or Polynucleotides Comprising Phosphate-Moiety Labeled Nucleotides," issued January 31, 2006) and 7,064,197 ("System, Array and Non-Porous Solid Support Comprising Fixed or Immobilized Nucleic Acids," issued June 20, 2006) based on Hologic's manufacture, use, and sale of nucleic acid assay products.  View the complaint here.

IPXpharma LLC v. Millennium Pharmaceuticals Inc.
1:15-cv-00276; filed March 27, 2015 in the District Court of Delaware

Infringement of U.S. Patent No. 6,171,786 ("Methods for Preventing Multidrug Resistance in Cancer Cells," issued January 9, 2001) based on Millennium's manufacture and sale of its Velcade® product (bortezomib, used to treat multiple myeloma).  View the complaint here.

McNeil-PPC, Inc. et al. v. Watson Laboratories, Inc.
2:15-cv-02197; filed March 27, 2015 in the District Court of New Jersey

• Plaintiffs:  McNeil-PPC, Inc.; Stiefel Research Australia Pty. Ltd.
• Defendant:  Watson Laboratories, Inc.

Infringement of U.S. Patent No. 6,946,120 ("Pharmaceutical Composition," issued September 20, 2005) following a Paragraph IV certification as part of Watons' filing of an ANDA to manufacture a generic version of McNeil's Rogaine® (minoxidil topical aerosol foam, used to treat androgenic alopecia of the vertex of the scalp).  View the complaint here.

Novo Nordisk Inc. v. Baxter Healthcare Corp. et al.
3:15-cv-02157; filed March 26, 2015 in the District Court of New Jersey

• Plaintiff:  Novo Nordisk Inc.
• Defendants:  Baxter Healthcare Corp.; Baxter Innovations GmbH; Baxter Aktiengesellschaft

Declaratory judgment of non-infringement and invalidity of U.S. Patent No. 6,100,061 ("Recombinant Cell Clone Having Increased Stability in Serum and Protein-Free Medium and a Method of Recovering the Stable Cell Clone and the Production of Recombinant Proteins by Using a Stable Cell Clone," issued August 8, 2000), 6,475,725 ("Recombinant Cell Clones Having Increased Stability and Methods of Making and Using the Same," issued November 5, 2002), 6,936,441 (same title, issued August 30, 2005), 7,094,574 (same title, issued August 22, 2006), 8,080,414 (same title, issued December 20, 2011), 8,084,251 (same title, issued December 27, 2011), 8,084,252 (same title, issued December 27, 2011), and 8,329,465 (same title, issued December 11, 2012) based on Novo Nordisk's imminent manufacture and sale of its Novoeight® product (turoctocog alfa, used to treat adults and patients with hemophilia), a competitive product to Baxter's Advate® product (Antihemophilic Factor [Recombinant], used to treat adults and patients with hemophilia).  View the complaint here.

Reckitt Benckiser LLC v. Amneal Pharmaceuticals LLC
2:15-cv-02155; filed March 26, 2015 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 6,372,252 ("Guaifenesin Sustained Release Formulation and Tablets," issued April 16, 2002), 6,955,821 ("Sustained Release Formulations of Guaifenesin and Additional Drug Ingredients," issued October 18, 2005), and 7,838,032 ("Sustained Release of Guaifenesin," issued November 23, 2010 following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of plaintiff's Mucinex® (guaifenesin, used to treat chest congestion).  View the complaint here.

Reckitt Benckiser LLC v. Perrigo Co. et al.
2:15-cv-02155; filed March 26, 2015 in the District Court of New Jersey

• Plaintiff:  Reckitt Benckiser LLC
• Defendants:  Perrigo Co.; Perrigo Research and Development Co.

Infringement of U.S. Patent Nos. 6,372,252 ("Guaifenesin Sustained Release Formulation and Tablets," issued April 16, 2002), 6,955,821 ("Sustained Release Formulations of Guaifenesin and Additional Drug Ingredients," issued October 18, 2005), and 7,838,032 ("Sustained Release of Guaifenesin," issued November 23, 2010 following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of plaintiff's Mucinex® DM (guaifenesin/dextromethorphan, used to treat chest congestion).  View the complaint here.

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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