By Sherri Oslick —

About
Court Report:  Each week we will report briefly on recently filed
biotech and pharma cases, and a few interesting cases will be selected
for periodic monitoring.

Pfizer Inc. et al. v. Kremers Urban LLC et al.
1:09-cv-00924; filed December 3, 2009 in the
District Court of Delaware

• Plaintiffs: 
Pfizer Inc.; Pfizer Ireland Pharmaceuticals; Warner-Lambert Co.;
Warner-Lambert Co. LLC
• Defendants: 
Kremers Urban LLC; KUDCO Ireland Ltd.

Infringement of U.S. Patent No. 5,969,156 ("Crystalline
[R- (R*,R*)]-2-(4 Fluorophenyl)-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 Kremers' 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 complaint here.

Takeda Pharmaceutical Co. Ltd. et al. v. Watson
Laboratories Inc. – Florida et al.
1:09-cv-00917; filed December 2, 2009 in the
District Court of Delaware

• Plaintiffs: 
Takeda Pharmaceutical Co. Ltd.; Takeda Pharmaceuticals North America
Inc.
• Defendant: 
Watson Laboratories Inc. – Florida; Watson Pharma Inc.; Watson
Pharmaceuticals Inc.

Infringement of U.S. Patent No. 6,034,239 ("Tricyclic
Compounds, Their Production and Use," issued March 7, 2000) following a
Paragraph IV certification as part of Watson's filing of an ANDA to manufacture
a generic version of Takeda's Rozerem® (ramelteon, used to treat
insomnia).  View the complaint here.

Cephalon Inc. et al. v. Teva Pharmaceuticals USA Inc. et al.
1:09-cv-00918; filed December 2, 2009 in the
District Court of Delaware

• Plaintiffs: 
Cephalon Inc.; Cephalon France
• Defendants: 
Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.

Infringement of U.S. Patent Nos. RE37,517 ("Acetamide
Derivative Having Defined Particle Size," issued January 15, 2002),
7,297,346 ("Pharmaceutical Fromulations of Modafinil," issued
November 20, 2007), and 7,132,570 ("Method for the Production of Crystalline
Forms of Optical Enantiomers of Modafinil," issued November 7, 2006)
following a Paragraph IV certification as part of Teva's filing of an ANDA to
manufacture a generic version of Cephalon's Nuvigil® (armodafinil, used to
improve wakefulness in patients with excessive sleepiness associated with
obstructive sleep apnea/hypopnea syndrome, narcolepsy, and shift work sleep
disorder).  View the complaint here.

Bristol-Myers Squibb Co. et al. v. Teva Pharmaceuticals USA
Inc.
1:09-cv-00919; filed December 2, 2009 in the
District Court of Delaware

• Plaintiffs: 
Bristol-Myers Squibb Co.; Novartis Corp.; Novartis Pharma AG
• Defendant: 
Teva Pharmaceuticals USA Inc.

Infringement of U.S. Patent Nos. 5,849,911 ("Antivirally
Active Heterocyclic Azahexane Derivatives," issued December 15, 1998) and
6,087,383 ("Bisulfate Salt of HIV Protease Inhibitor," issued July
11, 2000), both licensed to BMS, following a Paragraph IV certification as part
of Teva's filing of an ANDA to manufacture a generic version of BMS's Reyataz®
(atazanavir bisulfate, used to treat HIV infection).  View the complaint here.

Medicis Pharmaceutical Corp. v. Paddock Laboratories,
Inc.
2:09-cv-02498; filed December 1, 2009 in the
District Court of Arizona

Infringement of U.S. Patent No. 6,455,551 ("Use
of 1-Hydroxy-2-Pyridones For Treating Mucosa Diseases Which Are Difficult To
Treat," issued September 24, 2002) based on Paddock's manufacture and sale
of products, including ciclopirox shampoo for the topical treatment of
seborrheic dermatitis of the scalp.  View the complaint here.

Monsanto Co. et al. v. King
4:09-cv-01970; filed December 1, 2009 in the
Eastern District of Missouri

• Plaintiffs: 
Monsanto Co.; Monsanto Technology LLC
• Defendant: 
Billy King

Infringement of U.S. Patent Nos. 5,352,605 ("Chimeric
Genes for Transforming Plant Cells Using Viral Promoters," issued October
4, 1994) and RE39,247 ("Glyphosate-tolerant 5-enolpyruvylshikimate-3-phosphate
Synthases," issued August 22, 2006) based on defendant's use of soybean
seed produced from earlier planted Roundup Ready® soybean seed.  View the complaint here.

Teva Pharmaceuticals USA, Inc. v. Amgen Inc.
2:09-cv-05675; filed November 30, 2009 in the
Eastern District of Pennsylvania

Declaratory
judgment of non-infringement and invalidity of U.S. Patent Nos. 5,580,755 ("Human
Pluripotent Granulocyte Colony-Stimulating Factor," issued December 3,
1996) and 5,582,823 ("Methods of Treating Bacterial Inflammation and
Granulocytopoiesis by Administering Human Pluripotent Granulocyte
Colony-Stimulating Factor," issued December 10, 1996) in conjunction with
Teva's filing of a BLA seeking approval to market its NEUTROVAL product,
expected to compete with Amgen's Neupogen® product (filgrastim, used to treat
neutropenia).  View the complaint here.

Depomed, Inc. v. Lupin Pharmaceuticals, Inc. et al.
4:09-cv-05587; filed November 25, 2009 in the
Northern District of California

• Plaintiff: 
Depomed, Inc.
• Defendants:  Lupin Pharmaceuticals, Inc.; Lupin Ltd.

Infringement of U.S. Patent Nos. 6,723,340 ("Optimal
Polymer Mixtures for Gastric Retentive Tablets," issued April 20, 2004),
6,635,280 ("Extending the Duration of Drug Release Within the Stomach
During the Fed Mode," issued October 21, 2003), 6,488,962 ("Tablet
Shapes to Enhance Gastric Retention of Swellable Controlled-Release Oral Dosage
Forms, issued December 3, 2002), and 6,340,475 ("Extending the Duration of
Drug Release Within the Stomach During the Fed Mode," issued January 22,
2002) following a Paragraph IV certification as part of Lupin's filing of an
ANDA to manufacture a generic version of Depomed's Glumetza® (metformin
hydrochloride extended release tablets, used to improve glycemic control in
adults with type 2 diabetes mellitus).  View the complaint here.

Merck & Co., Inc. et al. v. Teva Parenteral Medicines, Inc.
et al.
2:09-cv-06026; filed November 25, 2009 in the
District Court of New Jersey

• Plaintiffs: 
Merck & Co., Inc.; Merck Sharp & Dohme Corp.
• Defendants: 
Teva Parenteral Medicines, Inc.; Teva Pharmaceuticals USA, Inc.; Teva
Pharmaceutical Industries, Ltd.

Infringement of U.S. Patent Nos. 5,378,804 ("Aza
Cyclohexapeptide Compounds," issued January 3, 1995), 5,514,650 (same
title, issued May 7, 1996), and 5,952,300 ("Antifungal Compositions,"
issued September 14, 1999) following a Paragraph IV certification as part of Teva's
filing of an ANDA to manufacture a generic version of Merck's Cancidas®
(caspofungin acetate, used to treat presumed fungal infections in febrile,
neutropenic patients, candidemia and certain Candida infections, esophageal candidiasis, and invasive aspergillosis
in patients who are refractory to or intolerant of other therapies).  View the complaint here.