Court Report

About Court Report: Each week http://www.patentdocs.org/ report briefly on recently filed biotech and pharma cases, and they select few interesting cases for periodic monitoring.

Procter & Gamble Co. et al. v. Sun Pharma Global, Inc.2:09-cv-10342; filed January 29, 2009 in the Eastern District of Michigan (Risedronate)

Monsanto Co. et al. v. Manhart4:09-cv-00172; filed January 29, 2009 in the Eastern District of Missouri

Eli Lilly & Co. v. Invagen Pharmaceuticals, Inc.1:09-cv-00087; filed January 28, 2009 in the Southern District of Indiana (Raloxifene)

Caraco Pharmaceutical Laboratories, Ltd. v. Forest Laboratories, Inc. et al.2:09-cv-10274; filed January 26, 2009 in the Eastern District of Michigan (Escitalopram Oxalate)

Aventis Pharmaceuticals Inc. et al. v. Sun Pharma Global Inc. et al.1:09-cv-00481; filed January 26, 2009 in the Northern District of Illinois
Aventis Pharmaceuticals Inc. et al. v. Sun Pharma Global Inc. et al.2:09-cv-00325; filed January 23, 2009 in the District Court of New Jersey (fexofenadine/pseudoephedrine)

Baxter Healthcare Corp. et al. v. Minrad Inc.1:09-cv-00054; filed January 23, 2009 in the District Court of Delaware

The detailed complaints and other details can be read here.

Galderma Wins FDA Approval for Vectical Ointment, a Novel Topical Therapy for Mild-to-Moderate Plaque Psoriasis

February 3, 2009 – Galderma Laboratories, L.P. today announced that the U.S. FDA has approved Vectical (calcitriol) Ointment 3mcg/g, a unique vitamin D3 product for the treatment of mild-to-moderate plaque psoriasis in adults.

The details can be read here.

Acorda Therapeutics Submits NDA for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis

Feb 2, 2009 - Acorda Therapeutics, Inc. today announced the submission of a New Drug Application to the U.S. FDA on January 30, 2009 for Fampridine-SR, a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS).

The details can be read here.

EpiCept Receives Permission to File Ceplene NDA

Feb 2, 2009 - EpiCept Corporation announced today that the U.S. FDA indicated that the Company has the necessary pivotal data to file a New Drug Application for Ceplene (histamine dihydrochloride) in conjunction with interleukin-2 (IL-2) as a remission maintenance treatment of acute myeloid leukemia (AML).

The details can be read here.

Takeda: FDA-Approved GERD Treatment

January 30, 2009 – Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. FDA approved KAPIDEX (dexlansoprazole) delayed release capsules for the once-daily, oral treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD), the healing of erosive esophagitis and the maintenance of healed EE. KAPIDEX (30 mg and 60 mg) is the first proton pump inhibitor with a Dual Delayed Release (DDR) formulation designed to provide two separate releases of medication.

The details can be read here.

Watson Acknowledges Federal Trade Commission Action Regarding AndroGel Patent Settlement

Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that the U.S. Federal Trade Commission (FTC) and the State of California have filed a lawsuit in the United States District Court for the Central District of California alleging that the Company's 2006 patent lawsuit settlement with Solvay Pharmaceuticals Inc. related to AndroGel(R) 1% (testosterone gel) CIII is unlawful.

The details can be read here.

Orexo, NovaMed Pharma sign Abstral licensing agreement

Orexo and the Chinese pharmaceutical company NovaMed Pharmaceuticals have signed an exclusive licensing and distribution agreement that grants NovaMed rights to seek approval for Abstral, Orexo's product for treatment of breakthrough cancer pain, in the People's Republic of China, and if granted, to market and sell the product in that market.

The details can be read here.

ZymoGenetics secures worldwide rights to IL-21 from Novo Nordisk

ZymoGenetics, Inc. announced the acquisition of ex-North American rights to Interleukin 21 (IL-21) from Novo Nordisk A/S, resulting in ZymoGenetics owning worldwide rights to IL-21. Novo Nordisk previously announced that they had reached a corporate decision to exit the oncology therapeutic area, resulting in the suspension of all ongoing oncology programmes.

The details can be read here.

GlaxoSmithKline and Genmab Submit Arzerra (Ofatumumab) Application to FDA for the Treatment of Advanced Stage Blood Cancer

January 30, 2009 -- GlaxoSmithKline and Genmab A/S announced today the submission of a Biologics License Application to the U.S. FDA for Arzerra (ofatumumab) to treat patients whose chronic lymphocytic leukemia (CLL) is resistant (refractory) to previous therapies.
The details can be read here.

Santarus Submits New Drug Application for Zegerid Tablet Product

Jan 30, 2009 - Santarus, Inc., a specialty pharmaceutical company, today announced that it has submitted a New Drug Application to the U.S. FDA for a new tablet formulation to add to its ZEGERID family of branded prescription pharmaceutical products.

The details can be read here.

DA Sends Abbott Letter Regarding Depakote ER/Depakote Continuum Care Pharmacy Formulary Flashcard

Jan. 30, 2009--The FDA posted on its web site yesterday a letter sent to Abbott Laboratories about its review of a Depakote ER/Depakote Continuum Care Pharmacy Formulary Flashcard (744-160303) (Flashcard) for Depakote (divalproex sodium delayed-release) Tablets and Depakote ER (divalproex sodium extended-release) Tablets.

The details can be read here.

Biotec Pharmacon ASA (NO) - Favourable ruling for Biotec Pharmacon in U.S patent case

Jan. 30, 2009-A decision by the U.S district court judge in Minnesota on January 28 largely rules in Biotec Pharmacon's favour in the patent infringement suit brought by Biopolymer Engineering, Inc. d/b/a Biothera against Biotec Pharmacon ASA and its U.S. affiliate, Immunocorp. The decision eliminates from further litigation all of Biothera's claims under 12 of the 14 U.S. patents at issue in the case.

The details can be read here.

Mylan Receives FDA Approval for First-to-File Generic Depakote ER

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. FDA for its Abbreviated New Drug Application for Divalproex Sodium Extended-release (Divalproex ER) Tablets, 250 mg and 500 mg.

The details can be read here.

Teva Announces Approval of Generic Risperdal Oral Solution

Jan 30, 2009 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application to market its generic version of Janssen's antipsychotic agent Risperdal (Risperidone) Oral Solution, 1 mg/mL. Shipment of this product has commenced.

The details can be read here.

Apotex and Intas Biopharmaceuticals extend their collaborative development of biosimilars to include pegfilgrastim

January 30, 2009 -- Apotex Inc. of Canada and Intas Biopharmaceuticals Limited of India have extended their business agreement to develop a biosimilar version of pegfilgrastim, a protein that is used to treat neutropenia (a side effect of cancer chemotherapy).

the details can be read here.