By Sherri Oslick --
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories, Inc.
2:13-cv-07184; filed November 27, 2013 in the District Court of New Jersey
• Plaintiffs: Novartis Pharmaceuticals Corp.; Novartis Pharma AG; Aventisub II Inc.
• Defendant: Roxane Laboratories, Inc.
Novartis Pharmaceuticals Corp. et al. v. Roxane Laboratories Inc.
1:13-cv-01973; filed November 25, 2013 in the District Court of Delaware
• Plaintiffs: Novartis Pharmaceuticals Corp.; Novartis Pharma AG; Aventisub II Inc.
• Defendant: Roxane Laboratories Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. RE39,198 ("Heteroarylpiperidines, Pyrrolidines and Piperazines and Their Use as Antipsychotics and Analgesics," issued July 18, 2006), licensed to Novartis, following a Paragraph IV certification as part of 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 Delaware complaint here.
Otsuka Pharmaceutical Co. Ltd. v. Par Pharmaceutical Inc.
1:13-cv-01979; filed November 26, 2013 in the District Court of Delaware
Declaratory judgment that Par's Paragraph IV certifications are improper, null, void, and without legal effect (because Par did not have an accepted ANDA application) and also infringement of U.S. Patent Nos. 5,753,677 ("Benzoheterocyclic Compounds," issued May 19, 1998) and 8,501,730 ("Process for Preparing Bezazepine Compounds or Salts Thereof," issued August 6, 2013) in conjunction with Par's filing of an ANDA to manufacture a generic version of Otsuka's Samsca® (tolvaptan, used hyponatremia). View the complaint here.
Novartis Pharmaceuticals Corp. v. Accord Healthcare Inc.
2:13-cv-07178; filed November 26, 2013 in the District Court of New Jersey
Infringement of U.S. Patent No. 8,324,189 ("Use of Zolendronate for the Manufacture of a Medicament for the Treatment of Bone Metabolism Diseases," issued December 4, 2012) following a Paragraph IV certification as part of Accord's filing of an ANDA to manufacture a generic version of Novartis' Zometa® (zoledronic acid, used for the prevention of skeletal-related complications associated with cancer). View the complaint here.
Invitae Corp. v. Myriad Genetics, Inc
3:13-cv-05495; filed November 26, 2013 in the Northern District of California
Declaratory judgment of noninfringement and invalidity 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 4, 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), and 7,563,571 (same title, issued July 21, 2009) based on Invitae's use and and sale of its BRCA1 and BRCA2 gene testing analytical services. View the complaint here.
University of Utah Research Foundation et al. v. Invitae
2:13-cv-01049; filed November 25, 2013 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: Invitae
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 4, 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), and 7,563,571 (same title, issued July 21, 2009) based on Invitae's use and and sale of its BRCA1 and BRCA2 gene testing analytical services. View the complaint here.
Shire LLC et al. v. Apotex, Inc. et al.
1:13-cv-01965; filed November 21, 2013 in the District Court of Delaware
• Plaintiffs: Shire LLC; Shire Development LLC; Supernus Pharmaceuticals Inc.
• Defendants: Apotex, Inc.; Apotex Corp.
Infringement of U.S. Patent Nos. 6,287,599 ("Sustained Release Pharmaceutical Dosage Forms with Minimized pH Dependent Dissolution Profiles," issued September 11, 2001) and 6,811,794 (same title, issued November 2, 2004) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Shire's Intuniv (guanfacine, used to treat attention-deficit hyperactivity disorder). View the complaint here.
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center v. Eli Lilly and Company et al.
2:13-cv-08567; filed November 20, 2013 in the Central District of California
• Plaintiff: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
• Defendants: Eli Lilly and Company; Lilly USA LLC
Infringement of U.S. Patent No. 8,133,903 ("Methods of Use of Inhibitors of Phosphodiesterases and Modulators of Nitric Oxide-Reactive Oxygen Species, and Metalloproteinases in the Treatment of Peyronie's Disease, Arteriosclerosis and Other Fibrotic Diseases," issued March 13,2012) based on Eli Lilly's manufacture and sale of its Cialis® product (tadalafil, used on an as-needed basis to treat erectile dysfunction). View the complaint here.
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