Court Report - June 2015 #2

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

Janssen Pharmaceuticals Inc. v. Vintage Pharmaceuticals, LLC
1:15-cv-00429; filed May 28, 2015 in the District Court of Delaware

Janssen Pharmaceuticals, Inc. v. Vintage Pharmaceuticals, LLC
2:15-cv-03542; filed May 26, 2015 in the District Court of New Jersey

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,214,815 ("Triphasic Oral Contraceptive," issued April 10, 2001) following a Paragraph IV certification as part of Vintage's filing of an ANDA to manufacture a generic version of Janssen's Ortho Tri-Cyclen® Lo (norgestimate and ethinyl estradiol, used for oral contraception).  View the New Jersey complaint here.

Duchesnay Inc. et al. v. Mylan Pharmaceuticals Inc.
1:15-cv-00092; filed May 27, 2015 in the Northern District of West Virginia

• Plaintiffs:  Duchesnay Inc.; Duchesnay USA Inc.
• Defendant:  Mylan Pharmaceuticals Inc.; Mylan Pharmaceuticals Inc.

Infringement of U.S. Patent No. 6,340,695 ("Rapid Onset Formulation," issued January 22, 2002) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Duchesnay's Diclegis® (doxylamine succinate and pyridoxine hydrochloride delayed-release tablets, used for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management).  View the complaint here.

Takeda GmbH et al. v. Mylan Pharmaceuticals Inc.
1:15-cv-00093; filed May 27, 2015 in the Northern District of West Virginia

• Plaintiffs:  Takeda GmbH; Astrazeneca Pharmaceuticals LP; Astrazeneca UK Ltd.
• Defendant:  Mylan Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 5,712,298 ("Fluoroalkoxy-Substituted Benzamides And Their Use As Cyclic Nucleotide Phosphodiestrerase Inhibitors," issued January 27, 1998), 8,536,206 ("Process for the Preparation of Roflumilast," issued September 17, 2013), 8,604,064 (same title, issued December 10, 2013), and 8,618,142 (same title, issued December 31, 2013) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of AstraZeneca's Daliresp® (roflumilast, used to reduce the risk of COPD exacerbation in patients with severe COPD associated with chronic bronchitis and a history of exacerbation).  View the complaint here.

Cipla Ltd. v. Sunovion Pharmaceuticals Inc.
1:15-cv-00424; filed May 26, 2015 in the District Court of Delaware

Infringement of U.S. Patent No. RE43,984 ("Process for Preparing Isomers of Salbutamol," issued February 3, 2015) based on Sunovion's manufacture and sale of its Xopenex® HFA product (levalbuterol hydrochloride inhalation aerosol, used to treat bronchospasm caused by asthma and chronic obstructive pulmonary disease).  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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