Court Report - February 2015 #4

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

Novartis Vaccines and Diagnostics, Inc. et al. v. Pfizer, Inc.
2:15-cv-01283; filed February 18, 2015 in the District Court of New Jersey

• Plaintiffs:  Novartis Vaccines and Diagnostics, Inc.; Novartis Pharma AG
• Defendant:  Pfizer, Inc.

Infringement of U.S. Patent Nos. 7,576,176 ("Neisseria Meningitidis Antigens and Compositions," issued August 18, 2009), 8,524,251 (same title, issued September 3, 2013), 8,394,390 ("Neisserial Antigenic Peptides," issued March 12, 2013), 8,398,988 ("Adjuvanting Meningococcal Factor H Binding Protein," issued March 19, 2013), 8,840,907 ("Isolated Protein and Compositions Comprising the Protein," issued September 23, 2014), and 8,834,888 ("Adjuvanting Meningococcal Factor H Binding Protein," issued September 16, 2014) based on Pfizer's anticipated manufacture and sale of its recently approved Trumenba® product (a meningococcus B vaccine, bivalent rLP2086, used to vaccinate against meningitis).  View the complaint here.

Novartis AG et al. v. Ezra Ventures LLC
4:15-cv-00095; filed February 13, 2015 in the Eastern District of Arkansas

• Plaintiffs:  Novartis AG; Novartis Pharmaceuticals Corp.; Mitsubishi Tanabe Pharma Corp.; Mitsui Sugar Co. LTD
• Defendant:  Ezra Ventures LLC

Infringement of U.S. Patent No. 5,604,229 ("2-Amino-1,3-Propanediol Compound and Immunosuppressant," issued February 18, 1997) following a Paragraph IV certification as part of Ezra's filing of an ANDA to manufacture a generic version of Novartis' Gilenya® (fingolimod hydrochloride, used to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability in patients with relapsing forms of multiple sclerosis).  View the complaint here.

Forest Laboratories LLC et al. v. Alembic Pharmaceuticals Ltd. et al.
1:15-cv-00158; filed February 13, 2015 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories LLC; Forest Laboratories Holdings Ltd.
• Defendants:  Alembic Pharmaceuticals Ltd.; Alembic Global Holding SA; Alembic Pharmaceuticals Inc.

Infringement of U.S. Patent No. 5,763,476 ("Sublingual or Buccal Pharmaceutical Composition," issued June 9, 1998) following a Paragraph IV certification as part of Alembic's filing of an ANDA to manufacture a generic version of Forest's Saphris® (asenapine maleate, sublingual, used to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder).  View the complaint here.

AbbVie Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
1:15-cv-01402; filed February 13, 2015 in the Northern District of Illinois

• Plaintiffs:  AbbVie Inc.; AbbVie Deutschland GmbH & Co. KG
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan Laboratories Ltd.; Mylan Laboratories Inc.; Mylan Inc.

Infringement of U.S. Patent Nos. 8,025,899 ("Solid Pharmaceutical Dosage Form," issued September 27, 2011), 8,268,349 (same title, issued September 18, 2012), 8,309,613 (same title, issued November 13, 2012), 8,377,952 ("Solid Pharmaceutical Dosage Formulation," issued February 19, 2013), 8,399,015 ("Solid Pharmaceutical Dosage Form," issued March 19, 2013), 8,470,347 ("Self-emulsifying Active Substance Formulation and Use of this Formulation," issued June 25, 2013), and 8,691,878 ("Solid Pharmaceutical Dosage Form," issued April 8, 2014) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of AbbVie's Kaletra® (lopinavir and ritonavir, used to treat HIV infections).  View the complaint here.

Helsinn Healthcare S.A. et al. v. Gavis Pharma LLC
3:15-cv-01228; filed February 13, 2015 in the District Court of New Jersey

• Plaintiffs:  Helsinn Healthcare S.A.; Roche Palo Alto LLC
• Defendant:  Gavis Pharma LLC

Infringement of U.S. Patent Nos. 7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 24, 2011), 7,947,725 (same title, issued May 24, 2011), 7,960,424 (same title, issued June 14, 2011), 8,598,219 (same title, issued December 3, 2013), and 8,729,094 (same title, issued May 20, 2014) following a Paragraph IV certification as part of Gavis' 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.

Novo Nordisk Inc. et al. v. Sun Pharmaceutical Industries Ltd. et al.
3:15-cv-01287; filed February 12, 2015 in the District Court of New Jersey

• Plaintiffs:  Novo Nordisk Inc.; Novo Nordisk Femcare AG
• Defendants:  Sun Pharmaceutical Industries Ltd.; Sun Pharmaceutical Industries, Inc.

Infringement of U.S. Patent No. 7,018,992 ("Hormone Composition," issued March 28, 2006) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Novo Nordisk's Vagifem® (estradiol vaginal tablets, used to treat atrophic vaginitis due to menopause).  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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