Court Report - Part II

by McDonnell Boehnen Hulbert & Berghoff LLP

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

Helsinn Healthcare S.A. et al. v. Cipla Ltd. et al.
1:14-cv-00427; filed April 7, 2014 in the District Court of Delaware

• Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendants:  Cipla Ltd.; Cipla USA Inc.

Infringement of U.S. Patent Nos. 8,598,218 ("Liquid Pharmaceutical Formulations of Palonosetron," issued December 3, 2013) and 8,598,219 (same title, issued December 3, 2013) following a Paragraph IV certification as part of Cipla's filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting).  View the complaint here.

Sanofi et al. v. Alembic Pharmaceuticals Ltd. et al.
1:14-cv-00424; filed April 4, 2014 in the District Court of Delaware

• Plaintiffs:  Sanofi; Sanofi-Aventis US LLC
• Defendants:  Alembic Pharmaceuticals Lt; Alembic Ltd.d.

Infringement of U.S. Patent Nos. 7,323,493 ("Solid Pharmaceutical Composition Containing Benzofuran Derivatives," issued January 29, 2008), 8,318,800 ("Solid Pharmaceutical Compositions Containing Benzofuran Derivatives," issued November 27, 2012), 8,410,167 ("Use of Dronedarone for the Preparation of a Medicament for Use in the Prevention of Cardiovascular Hospitalization or of Mortality," issued April 2, 2013), and 8,602,215 ("Methods for Reducing the Risk of an Adverse Dronedarone/Beta-Blockers Interaction in a Patient Suffering from Atrial Fibrillation," issued December 10, 2013) following a Paragraph IV certification as part of Alembic's filing of an ANDA to manufacture a generic version of Sanofi's Multaq® (dronedarone, used to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation).  View the complaint here.

Otsuka Pharmaceutical Co. Ltd. v. Hetero USA Inc. et al.
1:14-cv-00421; filed April 4, 2014 in the District Court of Delaware

• Plaintiff:  Otsuka Pharmaceutical Co. Ltd.
• Defendants:  Hetero USA Inc.; Hetero Labs Ltd.; Hetero Labs Ltd. Unit V

Infringement of U.S. Patent No. 8,501,730 ("Process for Preparing Bezazepine Compounds or Salts Thereof," issued August 6, 2013) following a Paragraph IV certification as part of Hetero's filing of an ANDA to manufacture a generic version of Otsuka's Samsca® (tolvaptan, used hyponatremia).  View the complaint here.

Reckitt Benckiser Pharmaceuticals Inc. et al. v. Par Pharmaceutical Inc. et al.
1:14-cv-00422; filed April 4, 2014 in the District Court of Delaware

• Plaintiffs:  Reckitt Benckiser Pharmaceuticals Inc.; RB Pharmaceuticals Limited; MonoSol Rx LLC
• Defendants:  Par Pharmaceutical Inc.; IntelGenX Technologies Corp.

Infringement of U.S. Patent Nos. 8,475,832 ("Sublingual and Buccal Film Compositions," issued July 2, 2013), 8,017,150 ("Polyethylene Oxide-Based Films and Drug Delivery Systems Made Therefrom," issued on September 13, 2011), and 8,603,514 ("Uniform Films for Rapid Dissolve Dosage Form Incorporating Taste-Masking Compositions," issued December 10, 2013) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Reckitt Benckiser's Suboxone® (buprenorphine hydrochloride and naloxone hydrochloride sublingual film, used for the maintenance treatment of opioid dependence).  View the complaint here.

Purdue Pharma L.P. et al. v. Teva Pharmaceuticals USA, Inc. et al.
1:14-cv-02357; filed April 3, 2014 in the Southern District of New York

• Plaintiffs:  Purdue Pharma L.P.; P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Board of Regents of the University of Texas System
• Defendants:  Teva Pharmaceuticals USA, Inc.

Infringement of U.S. Patent No. 6,488,963 ("Hot-Melt Extrudable Pharmaceutical Formulation," issued December 3, 2002) following a Paragraph IV certification as part of Teva's amendment of its ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain).  View the complaint here.

Bayer Pharma AG et al. v. Par Pharmaceutical, Inc. et al.
2:14-cv-02065; filed April 2, 2014 in the District Court of New Jersey

• Plaintiffs:  Bayer Pharma AG; Bayer Intellectual Property GmbH; Bayer Healthcare Pharmaceuticals Inc.
• Defendants:  Par Pharmaceutical, Inc.; Par Pharmaceutical Companies, Inc.

Infringement of U.S. Patent No. 8,613,950 ("Pharmaceutical Forms With Improved Pharmacokinetic Properties," issued December 4, 2013) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Bayer's Staxyn® (vardenafil hydrochloride, used to treat erectile dysfunction).  View the complaint here.

Arizona Board of Regents v. Seattle Genetics Inc.
2:14-cv-00653; filed March 31, 2014 in the District Court of Arizona

Infringement of U.S. Patent No. 5,635,483 ("Tumor Inhibiting Tetrapeptide Bearing Modified Phenethyl Amides," issued June 3, 1997) based on Seattle Genetics' manufacture and sale of its Adcetris® product (brentuximab vedotin, an antibody drug conjugate comprising monomethyl Auristatin E, used to treat Hodgkin lymphoma after failure of autologous stem cell transplant or in patients who are not autologous stem cell transplant candidates after failure of at least 2 multiagent chemotherapy regimens, and systemic anaplastic large cell lymphoma after failure of at least 1 multiagent chemotherapy regimen).  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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