Court Report - June 2014 #4

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.

Cephalon Inc. v. Actavis Laboratories FL Inc. et al.
1:14-cv-00776; filed June 19, 2014 in the District Court of Delaware

• Plaintiff:  Cephalon Inc.
• Defendants:  Actavis Laboratories FL Inc.; Actavis Inc.; Actavis Pharma Inc.; Watson Laboratories Inc.

Infringement of U.S. Patent Nos. 6,200,604 ("Sublingual Buccal Effervescent," issued March 13, 2001), 6,974,590 (same title, issued December 13, 2005), and 8,119,158 ("Effervescent Oral Fentanyl Dosage Form and Methods of Administering Fentanyl," issued February 21, 2012) following a Paragraph IV certification as part of Actavis’ filing of an ANDA to manufacture a generic version of Cephalon's Fentora® (fentanyl citrate buccal tablets, used to treat breakthrough pain in adult patients with cancer).  View the complaint here.

Novartis AG et al. v. Glenmark Pharmaceuticals Ltd. et al.
1:14-cv-00771; filed June 18, 2014 in the District Court of Delaware

• Plaintiffs:  Novartis AG; Novartis Pharmaceuticals Corp.
• Defendants:  Glenmark Pharmaceuticals Ltd.; Glenmark Generics Ltd.; Glenmark Generics Inc.

Infringement of U.S. Patent Nos. 6,025,391 ("Enteric-Coated Pharmaceutical Compositions of Mycophenolate," issued February 15, 2000), 6,172,107 ("Entric-Coated Pharmaceutical Compositions," issued January 9, 2001), and 6,306,900 (same title, issued October 23, 2001) following a Paragraph IV certification as part of Glenmark’s filing of an ANDA to manufacture a generic version of Novartis' Myfortic® (mycophenolate sodium, used for the prophylaxis or prevention of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids).  View the complaint here.

Merck Sharp & Dohme Corp. v. Fresenius Kabi USA, LLC
3:14-cv-03917; filed June 18, 2014 in the District Court of New Jersey

Infringement of U.S. Patent No. 5,691,336 ("Morpholine Compounds Are Prodrugs Useful As Tachykinin Receptor Antagonists," issued November 25, 1997) following a Paragraph IV certification as part of Fresenius’ filing of an ANDA to manufacture a generic version of Merck's Emend® (fosaprepitant dimeglumine for injection, used in the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin, and to prevent nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy).  View the complaint here.

Amarin Pharma, Inc. et al. v. Andrx Labs, LLC et al.
3:14-cv-03924; filed June 18, 2014 in the District Court of New Jersey

• Plaintiffs: Amarin Pharma, Inc.; Amarin Pharmaceuticals Ireland Ltd.
• Defendants: Andrx Labs, LLC; Andrx Corporation; 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 Andrx’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.

Spectrum Pharmaceuticals, Inc. et al. v. Ben Venue Laboratories, Inc.
2:14-cv-00980; filed June 18, 2014 in the District Court of Nevada

• Plaintiffs:  Spectrum Pharmaceuticals, Inc.; University of Strathclyde
• Defendant:  Ben Venue Laboratories, Inc.

Infringement of U.S. Patent No. 6,500,829 ("Substantially Pure Diastereoisomers of Tetrahydrofolate Derivatives," issued December 31, 2002) following a Paragraph IV certification as part of Ben Venue’s filing of an ANDA to manufacture a generic version of Spectrum's Fusilev® (levoleucovorin, used to treat advanced metastatic colorectal cancer).  View the complaint here.

Vanda Pharmaceuticals Inc. v. Roxane Laboratories Inc.
1:14-cv-00757; filed June 16, 2014 in the District Court of Delaware

Infringement of U.S. Patent No. 8,586,610 (“Methods for the Administration of Iloperidone,” issued November 19, 2013) in conjunction with Roxane's filing of an ANDA to manufacture a generic version of Novartis' Fanapt® (iloperidone, used for the acute treatment of adults with schizophrenia).  View the complaint here.

ALZA Corp. et al. v. Sandoz Inc.
1:14-cv-03838; filed June 16, 2014 in the District Court of New Jersey

• Plaintiffs:  ALZA Corp.; Janssen Pharmaceuticals Inc.
• Defendant:  Sandoz Inc.

ALZA Corp. et al. v. Sandoz Inc.
1:14-cv-00744; filed June 13, 2014 in the District Court of Delaware

• Plaintiffs:  ALZA Corp.; Janssen Pharmaceuticals Inc.
• Defendant:  Sandoz Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. 8,163,798 ("Methods and Devices for Providing Prolonged Drug Therapy," issued April 24, 2012) 8,629,179 (same title, issued January 14, 2014) following a Paragraph IV certification as part of Sandoz’s filing of an ANDA to manufacture a generic version of Alza's Concerta® (methylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder).  View the Delaware complaint here.

University of Utah Research Foundation et al. v. Pathway Genomics
2:14-cv-00442; filed June 13, 2014 in the District Court of Utah

• Plaintiffs:  University of Utah Research Foundation; Trustees of the University of Pennsylvania; HSC Research and Development Limited Partnership; Endorecherche; Myriad Genetics
• Defendant:  Pathway Genomics

Infringement of U.S. Patent Nos. 5,709,999 ("Linked Breast and Ovarian Cancer Susceptibility Gene," issued January 20, 1998), 5,747,282 ("17Q-Linked Breast and Ovarian Cancer Susceptibility Gene," issued May 5, 1998), 5,753,441 (same title, issued May 19, 1998), 5,837,492 ("Chromosome 13-Linked Breast Cancer Susceptibility Gene," issued November 17, 1998), 6,033,857 (same title, issued March 7, 2000), 6,051,379 ("Cancer susceptibility mutations of BRCA2," issued April 18, 2000), 6,951,721 ("Method for determining the haplotype of a human BRCA1 gene," issued October 5, 2005), 7,250,497 ("Large deletions in human BRCA1 gene and use thereof," issued July 31, 2007), 7,470,510 ("Methods for Diagnosing Cancer and Determining a Susceptibility for Developing Cancer," issued December 30, 2008), 7,622,258 ("Screening Methods and Sequences Relating Thereto," issued November 24, 2009), 7,838,237 (same title, issued November 23, 2010), 7,670,776 ("MYH Gene Variants and Use Thereof," issued March 2, 2010), 7,563,571 (same title, issued July 21, 2009), based on Pathway Genomic’s manufacture, sale, and offer for sale of its BRCATrue and ColoTrue products and services.  View the complaint here.

University of Utah Research Foundation et al. v. Counsyl
2:14-cv-00443; filed June 13, 2014 in the District Court of Utah

• Plaintiffs:  University of Utah Research Foundation; Trustees of the University of Pennsylvania; HSC Research and Development Limited Partnership; Endorecherche; Myriad Genetics
• Defendant:  Counsyl

Infringement of U.S. Patent Nos. 5,747,282 ("17Q-Linked Breast and Ovarian Cancer Susceptibility Gene," issued May 5, 1998), 5,753,441 (same title, issued May 19, 1998), 6,033,857(same title, issued March 7, 2000), 6,051,379 ("Cancer susceptibility mutations of BRCA2," issued April 18, 2000), 6,951,721 ("Method for determining the haplotype of a human BRCA1 gene," issued October 5, 2005), and 7,250,497 ("Large deletions in human BRCA1 gene and use thereof," issued July 31, 2007) based on Counsyl’s Inherited Cancer Screen, Inherited Cancer Screen, Counsyl Inherited Jewish Screen, Comprehensive BRCA Test, and BRCA1/2 Sequencing Test offerings.  View the complaint here.

Vivus, Inc. v. Actavis Laboratories FL, Inc. et al.
2:14-cv-03786; filed June 12, 2014 in the District Court of New Jersey

• Plaintiff: Vivus, Inc.
• Defendants: Actavis Laboratories FL, Inc.; Actavis, Inc.; Actavis PLC

Infringement of U.S. Patent Nos. 7,056,890 (“Combination Therapy for Effecting Weight Loss and Treating Obesity, issued June 6, 2006), 7,553,818 (same title, issued June 30, 2009), 7,659,256 (same title, issued February 9, 2010), 7,674,776 (same title, issued March 9, 2010), 8,580,298 (“Low Dose Topiramate/Phentermine Composition and Methods of Use Thereof,” issued November 12, 2013), and 8,580,299 (“Escalating Dosing Regimen for Effecting Weight Loss and Treating Obesity,” issued November 12, 2013) following a Paragraph IV certification as part of Actavis’ filing of an ANDA to manufacture a generic version of Vivus’ Qsymia® (phentermine and topiramate extended-release capsules, used as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management).  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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