Court Report

By Sherri Oslick --

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

Sandoz Inc. v. Novo Nordisk, Inc. et al.
2:11-cv-13594; filed August 17, 2011 in the Eastern District of Michigan

• Plaintiff:  Sandoz Inc.
• Defendants:  Novo Nordisk, Inc.; Novo Nordisk A/S

Declaratory judgment of invalidity, unenforceability, and non-infringement of U.S. Patent No. 6,677,358 ("NIDDM Regimen," issued January 13, 2004) in conjunction with Sandoz's Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of Novo Nordisk's Prandin® (repaglimide, used to treat non-insulin dependent diabetes mellitus in combination with metformin).  View the complaint here.

Allergan, Inc. et al. v. Hi-Tech Pharmacal Co., Inc.
1:11-cv-00650; filed August 17, 2011 in the Middle District of North Carolina

• Plaintiffs:  Allergan, Inc.; Duke University
• Defendant:  Hi-Tech Pharmacal Co., Inc.

Infringement of U.S. Patent Nos. 7,351,404 ("Method of Enhanced Hair Growth," issued April 1, 2008), 7,388,029 ("Compositions and Methods for Treating Hair Loss Using Non-Naturally Occurring Prostaglandins," issued June 17, 2008), and 6,403,649 (""Non-Acidic Cyclopentane Heptanoic Acid,2-Cycloalkyl Or Arylalkyl Derivatives As Therapeutic Agents, issued June 11, 2002) following a Paragraph IV certification as part of Sandoz's filing of an ANDA to manufacture a generic version of Allergan's Latisse® (bimatoprost topical solution/drops, 0.03%, used to treat inadequate or not enough eye lashes).  View the complaint here.

Endo Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc. et al.
1:11-cv-00717; filed August 16, 2011 in the District Court of Delaware

• Plaintiff:  Endo Pharmaceuticals Inc.
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.; Matrix Laboratories Ltd.; Matrix Laboratories Inc.

Infringement of U.S. Patent Nos. 5,464,864 ("Use of Tetrahydrocarbazole Derivatives As 5HT₁ Receptor Agonists," issued November 7, 1995), 5,637,611 ("Medicaments," issued June 10, 1997), and 5,827,871 ("Medicaments 1,2,3,4,-Tetrahydrocarbazoles and 5-HT1 Agonist Use Thereof," issued October 27, 1998), assigned to Endo, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Endo's Frova® (frovatriptan succinate, used to treat migrane attacks with our without aura).  View the complaint here.

Pfizer Inc. et al. v. MSP Singapore Co. LLC
1:11-cv-00713; filed August 15, 2011 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; Pfizer Ireland Pharmaceuticals; Warner-Lambert Co.; Warner-Lambert Company LLC
• Defendant:  MSP Singapore Co. LLC

Pfizer, Inc. et al. v. Macleods Pharmaceuticals LTD
1:11-cv-05662; filed August 15, 2011 in the Southern District of New York

• Plaintiffs:  Pfizer Inc.; Pfizer Ireland Pharmaceuticals; Warner-Lambert Co.; Warner-Lambert Company LLC
• Defendant:  Macleods Pharmaceuticals LTD

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 5,969,156 ("Crystalline [R- (R*,R*)]-2-(4-Dfluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)- 3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin)," issued October 19, 1999) following a Paragraph IV certification as part of MSP's filing of an ANDA to manufacture a generic version of Pfizer's Lipitor® (atorvastatin calcium, used to treat high cholesterol and heart disease).  View the MSP complaint here.

Abbott Laboratories et al. v. Teva Pharmaceuticals USA Inc. et al.
1:11-cv-00712; filed August 12, 2011 in the District Court of Delaware

• Plaintiffs:  Abbott Laboratories; Abbott Respiratory LLC
• Defendants:  Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

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), 7,011,848 ("Hydrophobic Component Free Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued March 14, 2006), 6,818,229 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia," issued November 16, 2004), 6,080,428 ("Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued June 27, 2000), and 6,469,035 ("Methods of Pretreating Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by Nicotinic Acid," issued October 22, 2002) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Abbott's Simcor® (niacin extended release / simvastatin tablets, used to treat hypercholesterolemia).  View the complaint here.