Court Report

By Sherri Oslick --

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

Astellas US LLC et al. v. Fresenius Kabi USA LLC
1:12-cv-01699; filed December 12, 2012 in the District Court of Delaware

• Plainitffs:  Astellas US LLC; Astellas Pharma US, Inc.; Item Development AB
• Defendant:  Fresenius Kabi USA LLC

Infringement of U.S. Patent No. 5,731,296 ("Selective Vasodilation by Continuous Adenosine Infusion," issued March 24, 1998), licensed to Astellas, following a Paragraph IV certification as part of Fesenius' filing of an ANDA to manufacture a generic version of Astellas' Adenoscan® product (adenosine injection, used as a diagnostic for myocardial reperfusion injury).  View the complaint here.

Endo Pharmaceuticals Inc. v. Actavis Inc. et al.
1:12-cv-08985; filed December 11, 2012 in the Southern District of New York

• Plaintiff:  Endo Pharmaceuticals Inc.
• Defendants:  Actavis Inc.; Actavis South Atlantic LLC

Infringement of U.S. Patent No. 7,851,482 ("Method for Making Analgesics," issued December 14, 2010), 8,309,122 ("Oxymorphone Controlled Release Formulations," issued November 13, 2012), and 8,329,216 (same title, issued December 11, 2012) based on Actavis' manufacture and sale of 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.

OSI Pharmaceuticals LLC et al. v. Roxane Laboratories Inc.
1:12-cv-01669; filed December 7, 2012 in the District Court of Delaware

• Plaintiffs:  OSI Pharmaceuticals LLC; Pfizer Inc.; Genentech Inc.
• Defendant:  Roxane Laboratories Inc.

Infringement of U.S. Patent Nos. RE41,065 ("Alkynyl and Azido-Substituted 4-Anilinoquinazoline," issued May 5, 1998), 6,900,221 ("Stable Polymorph on N-(3-Ethynylpheny1)-6, 7-Bis(2MethoxyEthoxy)-4-Quinazolinamine Hydrochloride, Methods of Production, and Pharmaceutical Uses Thereof," issued May 31, 2005), and 7,087,613 ("Treating Abnormal Cell Growth With A Stable Polymorph on N-(3-Ethynylpheny1)-6,7-Bis(2MethoxyEthoxy)-4-Quinazolinamine Hydrochloride," issued August 8, 2006) following a Paragraph IV certification as part of Roxane's amendment to its ANDA (to add additional dosage forms) to manufacture a generic version of OSI's Tarceva® (erlotinib, used to treat non-small cell lung cancer and advanced pancreatic cancer).  View the complaint here.

Alkermes Pharma Ireland Ltd. v. Mylan Pharmaceuticals Inc.
1:12-cv-01673; filed December 7, 2012 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,228,398 ("Multiparticulate Modified Release Composition," issued May 8, 2001) and 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a Paragraph IV certification as part of Mylan's  filing of an ANDA to manufacture a generic version of Novartis' Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Celgene Corp. et al. v. Mylan Pharamaceuticals, Inc.
2:12-cv-07590; filed December 7, 2012 in the District Court of New Jersey

• Plaintiffs:  Celgene Corp.; Novartis Pharmaceuticals Corp.; Novartis Pharma AG
• Defendant:  Mylan Pharamaceuticals, Inc.

Infringement of U.S. Patent Nos. 5,908,850 ("Method of Treating Attention Deficit Disorders with d-Threo Methylphenidate," issued June 1, 1999), 6,355,656 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 12, 2002, with a reexamination certificate issued March 27, 2007), 6,528,530 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 4, 2003), 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998), 6,635,284 (same title, issued October 21, 2003), and 7,431,944 ("Delivery of Multiple Doses of Medications," issued October 7, 2008) all licensed exclusively to Novartis in certain fields of use, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Novartis' Focalin XR® (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the complaint here.

Regents of the University of California v. Kappos
1:12-cv-01410; filed December 7, 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. 8,197,872 ("Human Milk Oligosaccharides to Promote Growth of Beneficial Gut Bacteria," issued June 12, 2012).  View the complaint here.

Medicis Pharmaceutical Corp. v. Alkem Laboratories Ltd. et al.
3:12-cv-07493; filed December 6, 2012 in the District Court of New Jersey

• Plaintiff:  Medicis Pharmaceutical Corp.
• Defendants:  Alkem Laboratories Ltd.; The Pharma Network, LLC.; Ascend Laboratories, LLC

Infringement of U.S. Patent Nos. 5,908,838 ("Method for the Treatment of Acne," issued June 1, 1999), 7,790,705 ("Minocycline Oral Dosage Forms for the Treatment of Acne," issued September 7, 2010), and 8,268,804 ("Method for the Treatment of Acne," issued September 18, 2012) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Medics' Solodyn® (minocycline hydrochloride extended release tablets, used to treat acne).  View the complaint here.

Oncothyreon Inc. v. Kappos
1:12-cv-01404; filed December 6, 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. 8,198,400 ("Vaccine For Modulating Between Tl and T2 Immune Responses," issued June 12, 2012).  View the complaint here.

Eli Lilly and Company v. Kappos
1:12-cv-01396; filed December 6, 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. 8,114,901 ("Crystalline 2,5-dione-3-(1-methyl-1H-indol-3-yl)-4-[1-(pyridin-2-ylmethyl)piperidin-4-yl]-1H-indol-3-yl]-1H-pyrrole mono-hydrochloride," issued February 14, 2012).  View the complaint here.