Court Report - May 2014

by McDonnell Boehnen Hulbert & Berghoff LLP
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Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Otsuka Pharmaceutical Co. v. Aurobindo Pharma Ltd. et al.
1:14-cv-03306; filed May 23, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co.
• Defendants:  Aurobindo Pharma Ltd.; Aurobindo Pharma USA, Inc.; Aurolife Pharma LLC

Infringement of U.S. Patent Nos. 8,017,615 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued September 13, 2011), 8,580,796 (same title, issued November 12, 2013), and 8,642,760 (same title, issued February 4, 2014) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  View the complaint here.

Allergan, Inc. v. Actavis plc et al.
2:14-cv-00638; filed May 22, 2014 in the Eastern District of Texas

• Plaintiff:  Allergan, Inc.
• Defendants:  Actavis plc; Actavis, Inc.; Watson Laboratories, Inc.; Actavis Pharma, Inc.

Declaratory judgment of false Paragraph IV notification (because Actavis did not have an accepted ANDA application) or in the alternative infringement of U.S Patent Nos. 8,633,162 ("Methods of Providing Therapeutic Effects Using Cyclosporine Components," 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 Actavis' 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.

Amarin Pharma, Inc. et al. v. Watson Laboratories, Inc. et al.
3:14-cv-03259; filed May 21, 2014 in the District Court of New Jersey

• Plaintiffs:  Amarin Pharma, Inc.; Amarin Pharmaceuticals Ireland Ltd.
• Defendants:  Watson Laboratories, Inc.; Actavis, Inc.

Infringement of U.S. Patent Nos. 8,293,728 ("Methods of Treating Hypertriglyceridemia," issued October 23, 2012), 8,318,715 (same title, issued November 27, 2012), 8,357,677 (same title, issued January 22, 2013), 8,367,652 (same title, issued February 5, 2013), 8,377,920 (same title, issued February 19, 2013), 8,399,446 (same title, issued March 19, 2013), 8,415,335 (same title, issued April 9, 2013), 8,426,399 (same title, issued April 23, 2013), 8,431,560 (same title, issued April 30, 2013), 8,440,650 (same title, issued May 14, 2013), 8,501,225 ("Stable Pharmaceutical Composition and Methods of Using Same," issued August 6, 2013), 8,518,929 ("Methods of Treating Hypertriglyceridemia," issued August 27, 2013), 8,524,698 (same title, issued September 3, 2013), 8,546,372 (same title, issued October 1, 2013), 8,551,521 ("Stable Pharmaceutical Composition and Methods of Using Same," issued October 8, 2013), and 8,617,594 (same title, issued December 31, 2013) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Amarin's Vascepa® (icosapent ethyl, used as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia).  View the complaint here.

Alcon Research Ltd. v. Watson Laboratories Inc. et al.
1:14-cv-00647; filed May 20, 2014 in the District Court of Delaware

• Plaintiff:  Alcon Research Ltd.
• Defendants:  Watson Laboratories Inc.; Actavis Inc.; Actavis Pharma Inc.

Infringement of U.S. Patent Nos. 8,268,299 ("Self Preserved Aqueous Pharmaceutical Compositions," issued September 18, 2012), 8,323,630 (same title, issued December 4, 2012), and 8,388,941 (same title, issued March 5, 2013) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Alcon's Travatan Z® (travoprost ophthalmic solution, used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertention).  View the complaint here.

Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC
2:14-cv-03235; filed May 20, 2014 in the District Court of New Jersey

Infringement of U.S. Patent No. 8,589,182 (same title, issued November 19, 2013) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy).  View the complaint here.

Dr. Reddy's Laboratories, Inc. et al. v. Purdue Pharmaceutical Products L.P. et al.
2:14-cv-03230; filed May 20, 2014 in the District Court of New Jersey

• Plaintiffs:  Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.
• Defendants:  Purdue Pharmaceutical Products L.P.; Purdue Pharma L.P.; Transcept Pharmaceuticals, Inc.

Declaratory judgment of non-infringement of U.S. Patent No. 7,658,945 ("Compositions for Delivering Hypnotic Agents Across the Oral Mucosa and Methods of Use Thereof," issued February 9, 2010) in conjunction with Dr. Reddy's Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of Purdue's Intermezzo® (sublingual zolpidem tartrate, used to treat insomnia when middle-of-the-night awakening is followed by difficulty returning to sleep).  View the complaint here.

Otsuka Pharmaceutical Co. v. Zydus Pharmaceuticals USA Inc. et al.
1:14-cv-03168; filed May 16, 2014 in the District Court of New Jersey

• Plaintiff:  Otsuka Pharmaceutical Co.
• Defendants:  Zydus Pharmaceuticals USA Inc.; Cadila Healthcare Ltd.

Infringement of U.S. Patent Nos. 8,017,615 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued September 13, 2011), 8,580,796 (same title, issued November 12, 2013), 8,642,760 (same title, issued February 4, 2014), and 8,518,421 ("Flashmelt Oral Dosage Formulation," issued August 27, 2013) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia).  View the complaint here.

Celgene Corp. v. Natco Pharma Ltd. et al.
2:14-cv-03126; filed May 14, 2015 in the District Court of New Jersey

• Plaintiff:  Celgene Corp.
• Defendants:  Natco Pharma Ltd.; Arrow International Ltd.; Actavis, Inc.; Watson Laboratories, Inc.; Watson Pharma, Inc.; Anda, Inc.

Infringement of U.S. Patent Nos. 8,530,498 ("Methods For Treating Multiple Myeloma With 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl) Piperidine-2,6-Dione," issued September 10, 2013), 8,589,188 ("Methods for Delivering a Drug to a Patient While Preventing the Exposure of a Foetus or Other Contraindicated Individual to the Drug," issued November 19, 2013), 8,626,531 ("Methods for Delivering a Drug to a Patient While Restricting Access to the Drug By Patients For Whom the Drug May Be Contraindicated," issued January 7, 2014), and 8,648,095 ("Methods For Treating Multiple Myeloma Using 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl) piperidine-2,6-Dione In Combination With Proteasome Inhibitor," issued February 11, 2014) following a Paragraph IV certification as part of Natco's filing of an ANDA to manufacture a generic version of Celgene's Revlimid® (lenalidomide, used in the treatment of multiple myeloma patients who have received at least one prior therapy, and in the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality).  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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