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.
Sepracor Inc. et al. v. Barr Pharmaceuticals, Inc. et al.
5:08-cv-00362; filed July 30, 2008 in the Eastern District of North Carolina
Infringement of U.S. Patent No. 5,698,558 ("Methods for Treating Allergic Disorders Using Optically Pure (-)Cetirizine," issued December 16, 1997), licensed to UCB, following a Paragraph IV certification as part of Barr's filing of an ANDA to manufacture a generic version of UCB's XYZAL® (levocetirizine dihydrochloride, used to treat seasonal and perennial allergic rhinitis). View the complaint here.
Astrazeneca Pharmaceuticals LP et al. v. Handa Pharmaceuticals, LLC et al.
3:08-cv-03773; filed July 28, 2008 in the District Court of New Jersey
Infringement of U.S. Patent Nos. 4,879,288 ("Novel Dibenzothiazepine Antipsychotic," issued November 7, 1989) and 5,948,437 ("Pharmaceutical Compositions Using Thiazepine," issued September 7, 1999) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of AstraZeneca's Seroquel® XR (quetiapine fumarate, used to treat schizophrenia and bipolar disorder). View the complaint here.
Endo Pharmaceuticals Inc. et al. v. Impax Laboratories Inc.
1:08-cv-00463; filed July 25, 2008 in the District Court of Delaware
Infringement of U.S. Patent Nos. 5,662,933 ("Controlled Release Formulation (Albuterol)," issued September 2, 1997) and 5,958,456 (same title, issued September 28, 1999) following a Paragraph IV certification as part of Impax's amendment of their ANDA (adding additional dosage forms) to manufacture a generic version of Endo's Opana® ER (oxymorphone hydrochloride, used to treat moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time). View the complaint here. [NB: Endo previously asserted these patents against Impax in January, as we reported here.]
Brigham and Women's Hospital Inc. et al. v. Teva Pharmaceuticals USA Inc. et al.
1:08-cv-00464; filed July 25, 2008 in the District Court of Delaware
Infringement of U.S. Patent Nos. 6,211,244 ("Calcium Receptor-Active Compounds, issued April 3, 2001), 6,313,146 (same title, issued November 6, 2001), 6,011,068 (same title, issued January 4, 2000), and 6,031,003 (same title, issued February 29, 2000), licensed to Amgen, following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Amgen's Sensipar® (cinacalcet hydrochloride, used to treat secondary hyperparathyroidism in patients on dialysis, and hypercalcemia in patients with parathyroid carcinoma). View the complaint here.
Novartis Corporation et al. v. Teva Parenteral Medicines Inc. et al.
1:08-cv-00459; filed July 24, 2008 in the District Court of Delaware
Declaratory judgment that Teva's Paragraph IV notices were improper, null, void, and without legal effect, that the Court therefore has no subject matter jurisdiction over the claims surrounding the patents at issue, that Teva's notices did not trigger the 45-day period for filing an infringement action under the Hatch-Waxman Act, and that Teva must serve new Paragraph IV notice upon Novartis if and when the FDA accepts Teva's ANDAs. Also, infringement of U.S. Patent No. 4,939,130 ("Substituted Alkanediphosphonic Acids and Pharmaceutical Use," issued July 3, 1990) following Paragraph IV certifications as part of Teva's filing of two ANDAs to manufacture generic versions of Novartis' Zometa® (zoledronic acid injection, used to treat patients with multiple myeloma and patients with documented bone metastases from solid tumors). View the complaint here.
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