Court Report

By Sherri Oslick --

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

Pfizer Inc. et al. v. Alembic Ltd. et al.
1:11-cv-01213; filed December 7, 2011 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; Warner-Lambert Co. LLC; C P Pharmaceuticals International CV; Northwestern University
• Defendants:  Alembic Ltd.; Alembic Pharmaceuticals Ltd.

Infringement of U.S. Patent No. 6,197,819 ("Gamma Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001) following a Paragraph IV certification as part of Alembic's filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia).  View the complaint here.

Abbott Laboratories et al. v. Sun Pharmaceutical Industries Ltd. et al.
1:11-cv-01190; filed December 2, 2011 in the District Court of Delaware

• Plaintiffs:  Abbott Laboratories; Abbott Respiratory LLC
• Defendants:  Sun Pharmaceutical Industries Ltd.; Sun Pharma Global FZE

Infringement of U.S. Patent Nos. 6,129,930 ("Methods and Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia at Night," issued October 10, 2000), 6,406,715 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Urinary Metabolite Profiles," issued June 18, 2002), 6,676,967 ("Methods for Reducing Flushing in Individuals Being Treated with Nicotinic Acid for Hyperlipidemia," issued January 13, 2004), 6,746,691 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Biopharmaceutical Characteristics," issued June 8, 2004), 6,818,229 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia," issued November 16, 2004), and 7,011,848 ("Hydrophobic Component Free Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued March 14, 2006) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Abbott's Niaspan® (niacin extended-release tablets, used to treat hypercholesterolemia).  View the complaint here.

Alkermes Pharma Ireland Ltd. et al. v. Wockhardt, Ltd. et al.
2:11-cv-07047; filed December 2, 2011 in the District Court of New Jersey

• Plaintiffs:  Alkermes Pharma Ireland Ltd.; Fournier Laboratories Ireland Ltd.
• Defendants:  Wockhardt, Ltd.; Wockhardt USA, LLC

Infringement of U.S. Patent Nos. 7,276,249 ("Nanoparticulate Fibrate Formulations," issued October 2, 2007) and 7,320,802 ("Methods of Treatment Using Nanoparticulate Fenofibrate Compositions," issued January 22, 2008), all licensed to Abbott, following a Paragraph IV certification as part of Wockhardt's filing of an ANDA to manufacture a generic version of Abbott's Tricor® (fenofibrate, used in the treatment of increased triglyceride levels).  View the complaint here.

Abbott Laboratories et al. v. Wockhardt, Ltd. et al.
2:11-cv-07046; filed December 2, 2011 in the District Court of New Jersey

• Plaintiffs:  Abbott Laboratories; Laboratories Fournier S.A.
• Defendants:  Wockhardt, Ltd.; Wockhardt USA, LLC

Infringement of U.S. Patent Nos. 6,277,405 ("Fenofibrate Pharmaceutical Composition Having High Bioavailability and Method for Preparing It," issued August 21, 2001), 7,037,529 (same title, issued May 2, 2006), and 7,041,319 ("Fenofibrate Pharmaceutical Composition Having High Bioavailabilty," issued May 9, 2006) following a Paragraph IV certification as part of Wockhardt's filing of an ANDA to manufacture a generic version of Abbott's Tricor® (fenofibrate, used in the treatment of increased triglyceride levels).  View the complaint here.

Celgene Corp. et al. v. Teva Pharmaceuticals USA, Inc.
2:11-cv-07064; filed December 2, 2011 in the District Court of New Jersey

• Plaintiffs:  Celgene Corp.; Novartis Pharmaceuticals Corp.; Novartis Pharma AG
• Defendants:  Teva Pharmaceuticals USA, Inc.

Infringement of U.S. Patent Nos. 5,908,850 ("Method of Treating Attention Deficit Disorders with d-Threo Methylphenidate," issued June 1, 1999), 6,355,656 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 12, 2002, with a reexamination certificate issued March 27, 2007), 6,528,530 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 4, 2003), 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998), 6,635,284 (same title, issued October 21, 2003), and 7,431,944 ("Delivery of Multiple Doses of Medications," issued October 7, 2008) all licensed exclusively to Novartis in certain fields of use, following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Novartis' Focalin XR® (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Alkermes Pharma Ireland Ltd. v. Teva Pharmaceuticals USA Inc.
1:11-cv-01186; filed December 1, 2011 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,228,398 ("Multiparticulate Modified Release Composition," issued May 8, 2001) and 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Novartis' Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Senju Pharmaceutical Co. Ltd. et al. v. Apotex Inc. et al.
1:11-cv-01171; filed November 28, 2011 in the District Court of Delaware

• Plaintiffs:  Senju Pharmaceutical Co. Ltd.; Kyorin Pharmaceutical Co. Ltd.; Allergan Inc.
• Defendants:  Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent No. 6,333,045 ("Aqueous Liquid Pharmaceutical Composition Comprised of Gatifloxacin," issued December 25, 2001), licensed to Allergan, in relation to Apotex's ANDA to manufacture a generic version of Allergan's Zymaxid® (gatifloxacin ophthalmic solution, used to treat bacterial conjunctivitis).  View the complaint here.

Warner Chilcott Co., LLC et al. v. Teva Pharmaceuticals USA, Inc. et al.
2:11-cv-06936; filed November 22, 2011 in the District Court of New Jersey

• Plaintiffs:  Warner Chilcott Co., LLC; Warner Chilcott(US), LLC
• Defendants:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent Nos. 7,645,459 ("Dosage Forms of Bisphosphonates," issued January 12, 2010) and 7,645,460 ("Dosage Forms of Risedronate" issued January 12, 2010) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Warner Chilcott's Atelvia^TM (risedronate sodium delayed-release, used to treat osteoporosis in women after menopause).  View the complaint here.