Court Report - July 2015

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

Fresenius Kabi USA, LLC. v. Par Sterile Products, LLC et al.
2:15-cv-03852; filed June 9, 2015 in the District Court of New Jersey

• Plaintiff:  Fresenius Kabi USA, LLC
• Defendants:  Par Sterile Products, LLC; Par Pharmaceutical, Inc.; Par Pharmaceutical Companies, Inc.

Infringement of U.S. Patent No. 9,006,289 ("Levothyroxine Formulations," issued April 14, 2015) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Fresenius' levothyroxine sodium powder for injection product (levothyroxine sodium, used as replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis).  View the complaint here.

Actavis Laboratories UT, Inc. v. UCB, Inc.
2:15-cv-01001; filed June 8, 2015 in the Eastern District of Texas

Infringement of U.S. Patent No. 7,921,999 ("Peelable Pouch for Transdermal Patch and Method for Packaging," issued April 12, 2011) based on UCB's manufacture and sale of its Neupro® (rotigotine transdermal systm, used to treat the signs and symptoms of idiopathic Parkinson's disease and moderate-to-severe Restless Legs Syndrome).  View the complaint here.

Bayer Pharma AG et al. v. Macleods Pharmaceuticals Ltd. et al.
1:15-cv-00464; filed June 5, 2012 in the District Court of Delaware

• Plaintiffs:  Bayer Pharma AG; Bayer Intellectual Property GmbH; Bayer HealthCare Pharmaceuticals Inc.
• Defendants:  Macleods Pharmaceuticals Ltd.; Macleods Pharma USA, 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 Macleods filing of an ANDA to manufacture a generic version of Bayer's Staxyn® (vardenafil hydrochloride, used to treat erectile dysfunction).  View the complaint here.

Mallinckrodt LLC et al. v. Watson Laboratories, Inc.- Florida et al.
2:15-cv-03800; filed June 5, 2015 in the District Court of New Jersey

• Plaintiffs:  Mallinckrodt LLC; Mallinckrodt Inc.; Depomed, Inc.
• Defendants:  Watson Laboratories, Inc.- Florida; Actavis Laboratories FL, Inc.

Infringement of U.S. Patent Nos. 8,597,681 ("Methods of Producing Stabilized Solid Dosage Pharmaceutical Compositions Containing Morphinans," issued December 3, 2013), 8,658,631 ("Combination Composition Comprising Oxycodone and Acetaminophen for Rapid Onset and Extended Duration of Analgesia," issued February 25, 2014), 8,741,885 ("Gastric Retentive Extended Release Pharmaceutical Compositions," issued June 3, 2014), 8,980,319 ("Methods of Production Stabilized Solid Dosage Pharmaceutical Composition Containing Morphinans," issued March 17, 2015), 8,992,975 ("Methods of Producing Stabilized Solid Dosage Pharmaceutical Compositions Containing Morphinans," issued December 3, 2013), 7,976,870 ("Gastric Retentive Oral Dosage Form with Restricted Drug Release in the Lower Gastrointestinal Tract," issued July 12, 2011), and 8,668,929 ("Gastric Retentive Extended-Release Dosage Forms Comprising Combinations of a Non-Opioid Analgesic and an Opioid Analgesic," issued March 11, 2014) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Mallinckrodt's Xartemis XR (acetaminophen and oxycodone, used for the management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate).  View the complaint here.

Bausch & Lomb Inc. et al. v. Apotex Inc. et al.
1:15-cv-03879; filed June 5, 2015 in the District Court of New Jersey

• Plaintiffs:  Bausch & Lomb Inc.; Bausch & Lomb Pharma Holdings Corp.; Senju Pharmaceutical Co., Ltd.
• Defendants:  Apotex Inc.; Apotex Corp.

Infringement of U.S. Patent Nos. 8,784,789 ("Aqueous Liquid Preparations and Light-Stabilized Aqueous Liquid Preparations," issued July 22, 2014) and 8,877,168 (same title, issued November 4, 2014) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Bausch & Lomb's Bepreve® (bepotastine besilate ophthalmic solution, used for the treatment of itching associated with allergic conjunctivitis).  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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