Court Report - May 28, 2012

[author: Sherri Oslick]

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

Cumberland Pharmaceuticals Inc. v. InnoPharma Inc.
1:12-cv-00618; filed May 17, 2012 in the District Court of Delaware

Cumberland Pharmaceuticals Inc. v. Paddock Laboratories LLC et al.
1:12-cv-00619; filed May 17, 2012 in the District Court of Delaware

• Plaintiff:  Cumberland Pharmaceuticals Inc.
• Defendants:  Paddock Laboratories LLC; Perrigo Co.

Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC et al.
1:12-cv-03846; filed May 17, 2012 in the Northern District of Illinois

• Plaintiff:  Cumberland Pharmaceuticals Inc.
• Defendants:  Mylan Institutional LLC; Mylan Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,148,356 ("Acetylcysteine Composition and Uses Therefor," issued April 3, 2012) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Cumberland's Acetadote® (N-acetylcysteine  injection, used to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen).  View the InnoPharma complaint here.

Allergan, Inc. v. Hi-Tech Pharmacal Co., Inc.
1:12-cv-00492; filed May 16, 2012 in the Middle District of North Carolina

Infringement of U.S. Patent No. 8,101,161 ("Method of Enhanced Hair Growth," issued  January 24, 2012) following a Paragraph IV certification as part of Hi-Tech'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.

Warner Chilcott Co., LLC v. Watson Laboratories, Inc. et al.
3:12-cv-02928; filed May 16, 2012 in the District Court of New Jersey

• Plaintiff:  Warner Chilcott Co., LLC
• Defendants:  Watson Laboratories, Inc.; Watson Pharma, Inc.; Watson Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 5,552,394 ("Low Dose Oral Contraceptives with Less Breakthrough Bleeding and Sustained Efficacy," issued September 3, 1996) and 7,704,984 ("Extended Estrogen Dosing Contraceptive Regimen" issued April 27, 2010) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Warner Chilcott's Lo Loestrin® Fe (norethindrone acetate and ethinyl estradiol tablets, and ethinyl estradiol and ferrous fumarate tablets, used for oral contraception).  View the complaint here.

Novartis Pharmaceuticals Corp. v. Lupin Ltd. et al.
1:12-cv-00595; filed May 14, 2012 in the District Court of Delaware

• Plaintiff:  Novartis Pharmaceuticals Corp.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

Novartis Pharmaceuticals Corporation v. Torrent Pharmaceuticals Ltd. et al.
1:12-cv-00596; filed May 14, 2012 in the District Court of Delaware

• Plaintiff:  Novartis Pharmaceuticals Corp.
• Defendants:  Torrent Pharmaceuticals Ltd.; Torrent Pharma Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 6,294,197 ("Solid Oral Dosage Forms of Valsartan," issued September 25, 2001) and 8,101,599 ("Pharmaceutical Composition Containing Anti-Hypertensive Agents," issued January 24, 2012) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Novartis's Exforge HCT® (amlodipine, valsartan, and hydrochlorothiazide, used to treat hypertension).  View the Lupin complaint here.

Helsinn Healthcare S.A. et al. v. Dr. Reddy's Laboratories, Ltd. et al.
3:12-cv-02867; filed May 11, 2012 in the District Court of New Jersey

• Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendants:  Dr. Reddy's Laboratories, Ltd.; Dr. Reddy's Laboratories, Inc.

Infringement of U.S. Patent No. 7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 24, 2011) following a Paragraph IV certification as part of Dr. Reddy's filing of an NDA (under  § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses  of moderately emetogenic chemotherapy, and acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy).  View the complaint here.