Court Report -- Part II - July 2014

by McDonnell Boehnen Hulbert & Berghoff LLP

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

Otsuka Pharmaceutical Co. Ltd. v. Par Pharmaceutical Inc.
1:14-cv-00789; filed June 20, 2014 in the District Court of Delaware

Infringement of U.S. Patent Nos. 5,753,677 ("Benzoheterocyclic Compounds," issued May 19, 1998) and 8,501,730 ("Process for Preparing Bezazepine Compounds or Salts Thereof," issued August 6, 2013) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Otsuka's Samsca® (tolvaptan, used to treat hyponatremia).  View the complaint here.

Amarin Pharmaceuticals Ireland Ltd. v. Omthera Pharmaceuticals Inc. et al.
1:14-cv-00791; filed June 20, 2014 in the District Court of Delaware

• Plaintiff:  Amarin Pharmaceuticals Ireland Ltd.
• Defendants:  Omthera Pharmaceuticals Inc.; AstraZeneca Pharmaceuticals LP

Infringement of U.S. Patent No. 8,663,662 ("Stable Pharmaceutical Compositions and Methods of Using Same" issued March 4, 2014) based on AstraZeneca's anticipated marketing and sale of their recently FDA-approved Epanova™ (mixture of polyunsaturated free fatty acids derived from fish oils for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (= 500 mg/dL) hypertriglyceridemia).  View the complaint here.

Avanir Pharmaceuticals Inc. v. Ranbaxy Laboratories Ltd. et al.
1:14-cv-00792; filed June 20, 2014 in the District Court of Delaware

• Plaintiff:  Avanir Pharmaceuticals Inc.
• Defendants:  Ranbaxy Laboratories Ltd.; Ranbaxy Inc.

Infringement of U.S. Patent Nos. 7,659,282 ("Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorder," issued February 9, 2010) and 8,227,484 ("Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorder," issued July 24, 2012) following a Paragraph IV certification as part of Ranbaxy's filing of an ANDA to manufacture a generic version of Avanir's Nuedexta® (dextromethorphan hydrobromide/quinidine sulfate, used to treat pseudobulbar affect).  View the complaint here.  [NB: The complaint was voluntarily dismissed 10 days after it was filed.]

Senju Pharmaceutical Co. et al. v. Metrics, Inc. et al.
1:14-cv-03962; filed June 20, 2014 in the District Court of New Jersey

• Plaintiffs:  Senju Pharmaceutical Co.; Bausch & Lomb, Inc.; Bausch & Lomb Pharma Holdings Corp.
• Defendants:  Metrics, Inc.; Pharmaceuticals, Inc.; Mayne Pharma Group Ltd.; Mayne Pharma (USA), Inc.; Coastal Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 8,129,431 ("Aqueous Liquid Preparation Containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid," issued March 6, 2012), 8,669,290 (same title, issued March 1, 2014), and 8,754,131 (same title, issued June 17, 2014) following a Paragraph IV certification as part of Metrics' filing of an ANDA to manufacture a generic version of B&L's Prolensa® (bromfenac ophthalmic solution, used to treat postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery).  View the complaint here.

Otsuka Pharmaceutical Co. v. Intas Pharmaceuticals Ltd. et al.
1:14-cv-03996; filed June 20, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co.
• Defendants:  Intas Pharmaceuticals Ltd.; Accord Healthcare, Inc.; Accord Healthcare Ltd.; Astron Research Ltd.; Hetero Labs Ltd.

Infringement of U.S. Patent Nos. 8,017,615 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued September 13, 2011), 8,580,796 (same title, issued November 12, 2013), and 8,642,760 (same title, issued February 4, 2014) following a Paragraph IV certification as part of Accord's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  View the complaint here.

Medicine Store Pharmacy Inc v. AfGin Pharma LLC
3:14-cv-02255; filed June 20, 2014 in the Northern District of Texas

• Plaintiff:  Medicine Store Pharmacy Inc d/b/a RXpress Pharmacy
• Defendant:  AfGin Pharma LLC

Declaratory judgment of non-infringement and invalidity of U.S. Patent No. 8,329,734 ("Topical Therapy for Migraine," issued December 11, 2012) based on RXpress' manufacture and sale of its "Migraine Cream" product(s).  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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