Court Report - June 2014 #5

by McDonnell Boehnen Hulbert & Berghoff LLP

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

Novartis Pharmaceuticals Corp. et al. v. Mylan Inc. et al.
1:14-cv-00777; filed June 19, 2014 in the District Court of Delaware

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; LTS Lohmann Therapie-Systeme AG
• Defendants:  Mylan Inc.; Mylan Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 6,316,023 ("TTS Containing an Antioxidant," issued November 13, 2001) and 6,335,031 (same title, issued January 1, 2002) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Novartis' Exelon® Patch (rivastigmine tartrate, used to treat mild to moderate dementia of the Alzheimer's type, and mild to moderate dementia associated with Parkinson's disease).  View the complaint here.

Allos Therapeutics Inc. et al. v. Teva Pharmaceuticals USA Inc. et al.
1:14-cv-00778; filed June 19, 2014 in the District Court of Delaware

• Plaintiffs:  Allos Therapeutics Inc.; Sloan-Kettering Institute for Cancer Research; Southern Research Institute; SRI International Inc.
• Defendants:  Teva Pharmaceuticals USA Inc.; Sandoz Inc.; Fresenius Kabi USA LLC; Dr Reddy's Laboratories Ltd; Dr Reddy's Laboratories Inc.

Infringement of U.S. Patent Nos. 6,028,071 ("Purified Compositions of 10-propargyl-10-deazaaminopterin and Methods of Using Same in the Treatment of Tumors," issued February 22, 2000), 7,622,470 ("Treatment of T-cell Lymphoma Using 10-porpargyl-10-deazaaminopterin," issued November 24, 2009), and 8,200,078 (same title, issued October 30, 2012) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Allos' Folotyn® (pralatrexate, used to treat patients with relapsed or refractory peripheral T-cell lymphoma).  View the complaint here.

Pfizer Inc. et al. v. CFT Pharmaceuticals LLC
1:14-cv-00781; filed June 19, 2014 in the District Court of Delaware

• Plaintiffs:  Pfizer Inc.; Wyeth LLC; Pfizer Pharmaceuticals LLC; PF Prism C.V.; Pfizer Manufacturing Holdings LLC
• Defendant:  CFT Pharmaceuticals LLC

Infringement of U.S. Patent Nos. 7,879,828 ("Tigecycline Compositions and Methods of Preparation," issued February 1, 2011) and 8,372,995 ("Crystalline Solid Forms of Trigecycline and Methods of Preparing Same," issued February 12, 2013), licensed to Pfizer, following a Paragraph IV certification as part of CFT's filing of an ANDA to manufacture a generic version of Pfizer's Tygacil® (tigecycline injectible, used for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia).  View the complaint here.

Janssen Pharmaceuticals, Inc. et al. v. Roxane Laboratiores, Inc.
2:14-cv-03941; filed June 19, 2014 in the District Court of New Jersey

• Plaintiffs:  Janssen Pharmaceuticals, Inc.; Grunenthal GmbH
• Defendant:  Roxane Laboratiores, Inc.

Infringement of U.S. Patent Nos. RE39,593 ("1-Phenyl-3-Dimethylaminopropane Compounds With a Pharmacological Effects," issued April 24, 2007), 7,994,364 ("Crystalline Forms of (-)-(1R,2R)-3-(3-Dimethylamino-1-Ethyl-2-Methylpropyl)-Phenol Hydrochloride," issued August 9, 2011), and 8,536,130 (""Use of 1 Phenyl-3-Dimethylamino-Propane Compounds for Treating Neuropathic Pain," issued September 17, 2013), licensed to Janssen, following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Janssen's Nucynta® (tapentadol hydrochloride, used for the management of moderate to severe acute pain in adults).  View the complaint here.

Cephalon, Inc. v. Actavis Laboratories FL, Inc. et al.
2:14-cv-03936; filed June 19, 2014 in the District Court of New Jersey

• Plaintiff:  Cephalon, Inc.
• Defendants:  Actavis Laboratories FL, Inc.; Actavis Inc.; Actavis Pharma, Inc.; Watson Laboratories, Inc.

Infringement of U.S. Patent Nos. 6,200,604 ("Sublingual Buccal Effervescent," issued March 13, 2001), 6,264,981 ("Oral Transmucosal Drug Dosage Using Solid Solution," issued July 24, 2001), and 8,119,158 ("Effervescent Oral Fentanyl Dosage Form and Methods of Administering Fentanyl," issued February 21, 2012) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Cephalon's Fentora® (fentanyl citrate buccal tablets, used to treat breakthrough pain in adult patients with cancer).  View the complaint here.

Teva Women's Health, Inc. et al. v. Watson Laboratories, Inc. et al.
1:14-cv-04439; filed June 19, 2014 in the Southern District of New York

• Plaintiffs:  Teva Women's Health, Inc.; Teva Branded Pharmaceutical Products R&D, Inc.
• Defendants:  Watson Laboratories, Inc.; Actavis Pharma, Inc.; Actavis, Inc.

Infringement of U.S. Patent Nos. 8,415,332 ("Methods of Hormonal Treatment Utilizing Ascending-Dose Extended Cycle Regimens," issued April 9, 2013) and 8,450,299 (same title, issued May 28, 2013) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Teva's Quartette® (levonorgestrel/ethinyl estradiol and ethinyl estradiol, used for oral contraception).  View the complaint here.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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