[author: Sherri Oslick]

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

Takeda Pharmaceutical Co. et al. v. Lupin Ltd. et al.
3:12-cv-07333; filed November 29, 2012 in the District Court of New Jersey

• Plaintiffs:  Takeda Pharmaceutical Co.; Takeda Pharmaceuticals U.S.A., Inc; Takeda Pharmaceuticals LLC; Takeda Pharmaceuticals America, Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 6,328,994 ("Orally Disintegrable Tablets," issued December 11, 2001), 7,431,942 ("Orally Disintegrable Tablets," issued October 7, 2008), 7,399,485 ("Rapidly Disintegrable Solid Preparation," issued July 15, 2008), and 7,875,292 ("Orally Disintegrable Tablets," issued January 25, 2011) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of plaintiffs' Prevacid® SoluTab (lansoprazole delayed release orally disintegrating tablets, used to treat ulcers, gastroesophageal reflux disease, erosive esophagitis, and pathological hypersecretory conditions, including Zollinger-Ellison syndrome).  View the complaint here.

Bayer Pharma AG et al. v. Lupin Ltd. et al.
1:12-cv-01592; filed November 28, 2012 in the District Court of Delaware

• Plaintiffs:  Bayer Pharma AG; Bayer Intellectual Property GmbH; Bayer HealthCare Pharmaceuticals Inc.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

Infringement of U.S. Patent No. 8,071,577 ("Multi-phase Contraceptive Preparation Based On a Natural Estrogen," issued December 6, 2011) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Bayer's Natazia® (estradiol valerate and estradiol valerate/dienogest, used as oral contraception).  View the complaint here.

Biopharm Gesellschaft Zur Biotechnologischen Entwicklung Von Pharmaka MBH v. Kappos
1:12-cv-01355; filed November 26, 2012 in the Eastern District of Virginia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 8,188,226 ("High Activity Growth Factor Mutants," issued May 29, 2012).  View the complaint here.

Noven Pharmaceuticals, Inc. v. Kappos
1:12-cv-01354; filed November 26, 2012 in the Eastern District of Virginia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 8,187,628 ("High Activity Growth Factor Mutants," issued May 29, 2012).  View the complaint here.

Glycobiosciences, Inc. v. Innocutis Holdings, LLC et al.
1:12-cv-01901; filed November 25, 2012 in the District Court of the District of Columbia

• Plaintiff:  Glycobiosciences, Inc.
• Defendants:  Innocutis Holdings, LLC.; Dara Biosciences, Inc.

Infringement of U.S. Patent Nos. 6,120,804 ("Topical Drug Preparations," issued September 19, 2000) and 6,723,345 (same title, issued April 20, 2004) based on defendants' manufacture, use, offer for sale, and sale of their Bionect® product (hyaluronic acid sodium salt, 0.2%, used to manage signs and symptoms associated with irritations of the skin).  View the complaint here.

Merck Sharp & Dohme Corp. et al. v. Kappos
1:12-cv-01344; filed November 23, 2012 in the Eastern District of Virginia

• Plaintiffs:  Merck Sharp & Dohme Corp.; Scynexis, Inc.
• Defendant:  David J. Kappos

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 8,188,085 ("Antifungal Agents," issued May 29, 2012).  View the complaint here.

Vertex Pharmaceuticals Inc. v. Kappos
1:12-cv-01343; filed November 21, 2012 in the Eastern District of Virginia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 8,188,281 ("Azaindoles Useful as Inhibitors of JAK and Other Protein Kinases," issued May 29, 2012).  View the complaint here.