Court Report

by McDonnell Boehnen Hulbert & Berghoff LLP

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

Novartis Pharmaceuticals Corp. et al. v. Dr. Reddy's Laboratories Ltd. et al.
1:14-cv-00387; filed March 26, 2014 in the District Court of Delaware

• Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
• Defendants:  Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.

Infringement of U.S. Patent No. 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 Dr. Reddy'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.

AbbVie Inc. v. Gilead Sciences Inc. et al.
1:14-cv-00379; filed March 25, 2014 in the District Court of Delaware

• Plaintiff:  AbbVie Inc.
• Defendants:  Gilead Sciences Inc.; Gilead Pharmasset LLC; Gilead Sciences Ltd.

Infringement of U.S. Patent No. 8,680,106 ("Methods for Treating HCV," issued March 25, 2014) based on Gilead's anticipated manufacture and sale of its combination therapy for the treatment of HCV using sofosbuvir and ledipasvir.  View the (redacted) complaint here (original filed under seal).

Bausch & Lomb Inc. et al. v. Akorn, Inc. et al.
1:14-cv-01866; filed March 24, 2014 in the District Court of New Jersey

• Plaintiffs:  Bausch & Lomb Inc.; Bausch & Lomb Pharma Holdings Corp.; Mitsubishi Tanabe Pharma Corp.; Ube Industries, Ltd.
• Defendants:  Akorn, Inc.; Akorn Ophthalmics, Inc.

Infringement of U.S. Patent No. 6,780,877 ("Acid Addition Salt of Optically Active Piperidine Compound and Process for Preparing the Same," issued August 24, 2004) following a Paragraph IV certification as part of Akorn'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.

ViiV Healthcare UK Ltd. et al. v. Lupin Ltd. et al.
1:14-cv-00369; filed March 21, 2014 in the District Court of Delaware

• Plaintiffs:  ViiV Healthcare UK Ltd.; ViiV Healthcare Co.
• Defendants:  Lupin Ltd.; Lupin Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 6,417,191 ("Synergistic Combinations of Zidovudine, 1592U89 and 3TC," issued July 9, 2002) and 6,294,540 ("Carbocyclic Nucleoside Hemisulfate and its Use in Treating Viral Infections," issued September 25, 2001) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Viiv's Epzicom® (abacavir sulfate and lamivudine, used to HIV infection in humans).  View the complaint here.

Bayer Pharma AG et al. v. Watson Laboratories, Inc. et al.
2:14-cv-01804; filed March 21, 2014 in the District Court of New Jersey

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

Novartis Pharmaceuticals Corp. v. Gland Pharma Ltd.
2:14-cv-01841; filed March 21, 2014 in the District Court of New Jersey

Infringement of U.S. Patent No. 8,052,987 ("Method of Administering Bisphosphonates," issued November 8, 2011) following a Paragraph IV certification as part of Gland's filing of an ANDA to manufacture a generic versions of Novartis' Reclast® (zoledronic acid injection, once-yearly treatment for postmenopausal osteoporosis).  View the complaint here.

UCB, Inc. et al. v. CorePharma, L.L.C.
2:14-cv-01788; filed March 20, 2014 in the District Court of New Jersey

• Plaintiffs:  UCB, Inc.; UCB Manufacturing, Inc.
• Defendant:  CorePharma, L.L.C.

Infringement of U.S. Patent No. 6,344,215 ("Methylphenidate Modified Release Formulations," issued February 5, 2005) following a Paragraph IV certification as part of CorePharma's filing of an ANDA to manufacture a generic version of UCB's Metadate CD® (methylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  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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