Court Report - March 2016 #2

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

Unimed Pharmaceuticals LLC et al. v. Lupin Atlantis Holdings SA et al.
1:15-cv-00904; filed October 9, 2015 in the District Court of Delaware

• Plaintiffs:  Unimed Pharmaceuticals LLC; Besins Healthcare Inc.; Besins Healthcare Luxenbourg SARL
• Defendants:  Lupin Atlantis Holdings SA; Lupin Ltd.; Lupin Pharmaceuticals, Inc.

Infringement of U.S. Patent Nos. 6,503,894 ("Pharmaceutical Composition and Method for Treating Hypogonadism," issued January 7, 2003), 8,466,136 ("Testosterone Gel and Method of Use," issued June 18, 2013), 8,466,137 (same title, issued June 18, 2013), 8,466,138 (same title, issued June 18, 2013), 8,486,925 (same title, issued July 16, 2013), 8,729,057 (same title, issued May 20, 2014), 8,741,881 (same title, issued June 3, 2014), 8,754,070 (same title, issued June 17, 2014), and 8,759,329 (same title, issued June 24, 2014), 9,125,816 ("Pharmaceutical Composition and Method for Treating Hypogonadism," issued September 8, 2015), 9,132,089 (same title, issued September 15, 2015) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of AbbVie's AndroGel® (testosterone gel, used to treat conditions associated with a deficiency or absence of endogenous testosterone).  View the complaint here.

Bayer Intellectual Property GmbH et al. v. Aurobindo Pharma Ltd. et al.
1:15-cv-00902; filed October 9, 2015 in the District Court of Delaware

• Plaintiffs:  Bayer Intellectual Property GMBH; Bayer Pharma AG; Janssen Pharmaceuticals Inc.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.; Breckenridge Pharmaceutical Inc.; Micro Labs Ltd.; Micro Labs USA Inc.; Mylan Pharmaceuticals Inc.; Mylan Inc.; Prinston Pharmaceutical Inc.; Sigmapharm Laboratories LLC; Torrent Pharmaceuticals Limited; Torrent Pharma Inc.; InvaGen Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 7,157,456 ("Substituted Oxazolidinones and Their Use in the Field of Blood Coagulation," issued January 2, 2007), 7,585,860 (same title, issued September 8, 2009), and 7,592,339 (same title, issued September 22, 2009) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Bayer's Xarelto® (rivaroxaban, used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and for the reduction in the risk of recurrence of DVT and of PE, and for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery).  View the complaint here.

AstraZeneca AB v. Teva Pharmaceuticals USA, Inc.
1:15-cv-00909; filed October 9, 2015 in the District Court of Delaware

Infringement of U.S. Patent No. 8,628,799 ("Coated Tablet Formulation and Method," issued January 14, 2014) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of AstraZeneca's Kombiglyze XR (saxagliptin and metformin hydrochloride, extended-release, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus).  View the complaint here.

Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories, Inc. et al.
1:15-cv-00908; filed October 9, 2015 in the District Court of Delaware et al.

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
• Defendants:  Roxane Laboratories, Inc.; Boehringer Ingelheim Roxane, Inc.

Infringement of U.S. Patent Nos. 6,894,051 ("Crystal Modification of a N-phenyl-2-pyrimidineamine Derivative, Processes for Its Manufacture and Its Use," issued May 17, 2005) and RE43,932 ("Crystal Modification of a N-phenyl-2-pyrimidineamine Derivative, Processes for Its Manufacture and Its Use," issued January 15, 2013) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Novartis' Gleevec® (imatinib mesylate, used for various indications, including treatment of myeloid leukemia).  View the complaint here.

Forest Laboratories LLC et al. v. Accord Healthcare Inc. et al.
1:15-cv-00903; filed October 9, 2015 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories LLC; Forest Laboratories Holdings Ltd.; Adamas Pharmaceuticals Inc.
• Defendants:  Accord Healthcare Inc.; Intas Pharmaceuticals Ltd.

Infringement of U.S. Patent Nos. 8,039,009 ("Modified Release Formulations of Memantine Oral dosage Forms," issued October 18, 2011), 8,168,209 ("Method and Composition for Administering an NMDA Receptor Antagonist to a Subject," issued May 1, 2012), 8,173,708 (same title, issued May 8, 2012), 8,283,379 ("Method and Compositions for the Treatment of CNS-Related Conditions," issued October 9, 2012), 8,329,752 ("Composition for Administering an NMDA Receptor Antagonist to a Subject," issued December 11, 2012), 8,362,085 ("Method for Administering an NMDA Receptor Antagonist to a Subject," issued January 29, 2013), and 8,598,233 ("Method for Administering an NMDA Receptor Antagonist To A Subject," issued December 3, 2013) following a Paragraph IV certification as part of Accord's filing of an ANDA to manufacture a generic version of Forest's Namenda XR® (memantine hydrochloride, used for the treatment of moderate to severe dementia of the Alzheimer's type).  View the complaint here.

AstraZeneca AB et al. v. Zydus Pharmaceuticals (USA) Inc. et al.
3:15-cv-07415; filed October 9, 2015 in the District Court of New Jersey

• Plaintiffs:  AstraZeneca AB; Aktiebolaget Hassle; AstraZeneca LP; Zeneca Inc.
• Defendants:  Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.

Infringement of U.S. Patent Nos. 6,369,085 ("Form of S-omeprazole," issued April 9, 2002), 7,411,070 (same title, issued August 12, 2008), and 8,466,175 (same title, issued June 18, 2013) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease).  View the complaint here.

Salix Pharmaceuticals, Inc et al. v. Taro Pharmaceutical U.S.A., Inc. et al.
1:15-cv-07980; filed October 9, 2015 in the District Court of New York

• Plaintiffs:  Salix Pharmaceuticals, Inc; Norgine B.V.
• Defendants:  Taro Pharmaceutical U.S.A., Inc.; Taro Pharmaceuticals Industries Ltd.

Infringement of U.S. Patent Nos. 7,169,381 ("Colon Cleansing Compositions and Methods," issued January 30, 2007) and 7,658,914 ("Colon Cleansing Compositions," issued February 9, 2010) following a paragraph IV certification as part of Taro's filing of an ANDA to manufacture a generic version of Salix's MoviPrep® (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid oral solution, used for cleansing of the colon as a preparation for colonoscopy).  View the complaint here.  [NB: The complaint was later voluntarily dismissed.]

Flamel Ireland, Ltd. v. Mylan Pharmaceuticals Inc. et al.
1:15-cv-00178; filed October 9, 2015 in the Northern District of West Virginia

• Plaintiff:  Flamel Ireland, Ltd.
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan, Inc.; SmithKline Beecham (Cork) Ltd.

Infringement of U.S. Patent No. 8,101,209 ("Microparticulate Oral Galenical Form for the Delayed and Controlled Release of Pharmaceutical Active Principles," issued January 24, 2012) following a paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of GSK's Coreg CR® (carvedilol phosphate extended release capsules , used to treat congestive heart failure).  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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