Court Report - November 2015 #6

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

Forest Laboratories LLC et al. v. Amneal Pharmaceuticals LLC et al.
1:15-cv-00756; filed August 27, 2015 in the District Court of Delaware

• Plaintiffs:  Forest Laboratories LLC; Forest Laboratories Holdings Ltd.; Adamas Pharmaceuticals Inc.
• Defendants:  Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York LLC; Par Pharmaceutical, Inc.

Infringement of U.S. Patent Nos. 8,039,009 ("Modified Release Formulations of Memantine Oral dosage Forms," issued October 18, 2011), 8,058,291 ("Methods and Compositions For the Treatment of CNS-Related Conditions," issued November 15, 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), 8,293,794 (same title, issued October 23, 2012), 8,329,752 ("Composition for Administering an NMDA Receptor Antagonist to a Subject," issued December 11, 2012), 8,338,485 ("Compositions for the Treatment of CNS-Related Conditions," issued December 25, 2012), 8,338,486 ("Methods for the Treatment of CNS-Related Conditions," issued December 25, 2012), 8,362,085 ("Method for Administering an NMDA Receptor Antagonist to a Subject," issued January 29, 2013), 8,580,858 ("Compositions For the Treatment of CNS-Related Conditions," issued November 12, 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 Amneal's filing of an ANDA to manufacture a generic version of Forest's Namzaric ® (memantine hydrochloride extended-release and donepezil hydrochloride, used for the treatment of moderate to severe dementia of the Alzheimer's type).  View the complaint here.

The Medicines Company v. Sagent Pharmaceuticals, Inc.
1:15-cv-07507; filed August 26, 2015 in the Northern District of Illinois

Infringement of U.S. Patent Nos. 7,582,727 ("Pharmaceutical Formulations of Bivalirudin and Process of Making the Same," issued September 1, 2009) and 7,598,343 (same title, issued October 6, 2009) following a Paragraph IV certification as part of Sagent's filing of an ANDA to manufacture a generic version of The Medicines Company's Angiomax® (bivalirudin, used as an anticoagulant in patients with unstable angina undergoing percutaneous translurninal coronary angioplasty).  View the complaint here.

Cephalon Inc. v. Panacea Biotec, Ltd.
1:15-cv-00735; filed August 25, 2015 in the District Court of Delaware

Infringement of U.S. Patent Nos. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013), 8,791,270 (same title, issued July 29, 2014), 8,669,279 ("Solid Forms of Bendamustine Hydrochloride," issued March 11, 2014), 8,883,836 (same title, issued November 11, 2014), and 8,895,756 ("Bendamustine Pharmaceutical Compositions," issued November 25, 2014) following a Paragraph IV certification as part of Panacea's filing of an ANDA to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma).  View the complaint here.

Boehringer Ingelheim Pharmaceuticals, Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
1:15-cv-00145; filed August 25, 2015 in the Northern District of West Virginia

• Plaintiffs:  Boehringer Ingelheim Pharmaceuticals, Inc.; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Corp.; Boehringer Ingelheim Pharma GmbH & Co. KG
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.; Mylan Laboratories Ltd.

Infringement of U.S. Patent Nos. 8,673,927 ("Uses of DPP-IV Inhibitors," issued March 18, 2014), 8,846,695 ("Treatment For Diabetes In Patients With Inadequate Glycemic Control Despite Metformin Therapy Comprising A DPP-IV Inhibitor," issued September 30, 2014), and 8,853,156 ("Treatment For Diabetes In Patients Inappropriate For Metformin Therapy," issued October 7, 2014) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Boehringer's Tradjenta® (linagliptin, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus) and Jentadueto® (linagliptin and metformin hydrochloride, used an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate) products.  View the complaint here.

Sumitomo Dainippon Pharma Co., Ltd. et al. v. Teva Pharmaceuticals USA, Inc. et al.
2:15-cv-06401; filed August 24, 2015 in the District Court of Delaware

• Plaintiffs:  Sumitomo Dainippon Pharma Co., Ltd.; Sunovion Pharmaceuticals Inc.
• Defendants:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.

Infringement of U.S. Patent No. 5,532,372 ("Imide Derivatives, and Their Production and Use," issued July 2, 1996) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Sumitomo's Latuda® (lurasidone hydrochloride, used to treat depressive episodes associated with Bipolar I Disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate and used for the treatment of schizophrenia).  View the complaint here.

Allergan, Inc. v. Teva Pharmaceuticals USA, Inc. et al.
2:15-cv-01455; filed August 24, 2015 in the Eastern District of Texas

• Plaintiff:  Allergan, Inc.
• Defendants:  Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.; Apotex, Inc.; Apotex Corp.; Akorn, Inc.; Mylan Pharmaceuticals, Inc.; Mylan, Inc.

Infringement of U.S Patent Nos. 8,629,111 ("Methods of Providing Therapeutic Effects Using Cyclosporine Components," issued January 14, 2014), 8,633,162 (same title, issued January 21, 2014), 8,642,556 (same title, issued February 4, 2014), 8,648,048 (same title, issued February 11, 2014), and 8,685,930 (same title, issued April 1, 2014) following a Paragraph IV certification as part of defenants' filing of an ANDA to manufacture a generic version of Allergan's Restasis® (cyclosporine ophthalmic emulsion, 0.05%, used to treat dry eye).  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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