Court Report

By Sherri Oslick --

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

Lupin Atlantis Holdings S.A. v. Ranbaxy Laboratories Ltd. et al.
2:10-cv-03897; filed August 4, 2010 in the Eastern District of Pennsylvania

• Plaintiff:  Lupin Atlantis Holdings S.A.
• Defendants:  Ranbaxy Laboratories Ltd.; Ranbaxy Pharmaceuticals Inc.; Ranbaxy, Inc.; Ethypharm S.A.

Infringement of U.S. Patent No. 7,101,574 ("Pharmaceutical Composition Containing Fenofibrate and the Preparation Method," issued September 5, 2006) following a Paragraph IV certification as part of Ranbaxy's filing of an ANDA to manufacture a generic version of Lupin's Antara® (fenofibrate, used to treat hypercholesterolemia and hypertriglyceridemia).  View the complaint here.

Illumina Inc. et al. v. Complete Genomics Inc.
1:10-cv-00649; filed August 3, 2010 in the District Court of Delaware

• Plaintiffs:  Illumina Inc.; Solexa Inc.
• Defendant:  Complete Genomics Inc.

Infringement of U.S. Patent Nos. 6,306,597 ("DNA Sequencing by Parallel Oligonucleotide Extensions," issued October 23, 2001), 7,232,656 ("Arrayed Biomolecules and Their Use in Sequencing," issued June 19, 2007), and 7,598,035 ("Method and Compositions for Ordering Restriction Fragments," issued October 6, 2009) based on defendant's manufacture and sale of its Complete Genomics Analysis Platform products and services.  View the complaint here.

OptiGen, LLC v. Animal Genetics, Inc.
5:10-cv-00940; filed August 3, 2010 in the Northern District of New York

Infringement of U.S. Patent Nos. 5,804,388 ("Chromosome 9 and Progressive Rod-Cone Degeneration Disease Genetic Markers and Assays," issued September 8, 1998) and 7,312,037 ("Identification of the Gene and Mutation Responsible for Progressive Rod-Cone Degeneration in Dog and a Method for Testing Same," issued December 25, 2007), both licensed to OptiGen, based on defendant's making, sale, offering for sale, and/or use of testing methods for PRCD.  View the complaint here.

Daiichi Sankyo Inc. et al. v. Lupin Ltd. et al.
1:10-cv-00644; filed July 30, 2010 in the District Court of Delaware

• Plaintiffs:  Daiichi Sankyo Inc.; Genzyme Corp.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 5,607,669 ("Amine Polymer Sequestrant and Method of Cholesterol Depletion," issued March 4, 1997) and 5,693,675 ("Alkylated Amine Polymers," issued December 2, 1997) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of plaintiffs' Welchol® (colesevelam hydrochloride, used to treat primary hyperlipidemia and type 2 diabetes mellitus).  View the complaint here.

Pfizer Inc., et al. v. Teva Pharmaceuticals USA Inc.
1:10-cv-05794; filed July 30, 2010 in the Southern District of New York

• Plaintiffs:  Pfizer Inc.; Pfizer Ireland Pharmaceuticals
• Defendants:  Teva Pharmaceuticals USA Inc.

Infringement of U.S. Patent No. 6,110,940 ("Salts of an Anti-Migraine Indole Derivative," issued August 29, 2000) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Pfizer's Relpax® (eletriptan hydrobromide, used for the acute treatment of migraine with our without aura).  View the complaint here.

KV Pharmaceutical Co. et al. v. Perrigo Israel Pharmaceuticals Ltd. et al.
1:10-cv-00641; filed July 29, 2010 in the District Court of Delaware

• Plaintiffs:  KV Pharmaceutical Co.; FP1096 Inc.
• Defendants:  Perrigo Israel Pharmaceuticals Ltd.; Perrigo Co.; Femmepharma Holding Co. Inc.

Infringement of U.S. Patent No. 5,993,856 ("Pharmaceutical Preparations and Methods for Their Administration," issued November 30, 1999) following a Paragraph IV certification as part of Perrigo's filing of an ANDA to manufacture a generic version of KV's Gynazole-1® (butoconzaole nitrate, used to treat vaginal yeast infections).  View the complaint here.

Comments

[EG]

Kevin,

As other briefs besides BIO's have said, there is essentially no unformity, much less fairness, in how the standard for inequitable conduct is applied by the courts and especially what the correct standard is in the eyes of the Federal Circuit. As much as several Federal Circuit judges have lamented this "plague," those laments, with all due respect, sound hypocritical with the reality of how the Federal Circuit has applied and especially failed to enunciate a consistent, logical, and rational standard for what is inequitable conduct. The fact remains that Federal Circuit's "fuzzy" approach to this question has created this jurisprudential mess, and only they can rectify that mess. We can only hope that the en banc ruling in Therasense will do that, once and for all time.