By Sherri
Oslick --
About
Court
Report: Each week we will report briefly on recently filed
biotech and pharma cases.
Roche Palo Alto LLC et al. v. Lupin Pharmaceuticals, Inc. et al.
1:10-cv-01988; filed July 20, 2010 in the District
Court of Maryland
• Plaintiffs: Roche Palo Alto LLC; Gilead Palo
Alto, Inc.; Gilead Sciences, Inc.
• Defendants: Lupin Pharmaceuticals, Inc.; Lupin
Ltd.
Roche Palo Alto LLC et al. v. Lupin Pharmaceuticals, Inc. et al.
2:10-cv-03561; filed July 14, 2010 in the District
Court of New Jersey
• Plaintiffs: Roche Palo Alto LLC; Gilead Palo
Alto, Inc.; Gilead Sciences, Inc.
• Defendants: Lupin Pharmaceuticals, Inc.; Lupin
Ltd.
The
complaints in these cases are substantially identical. Infringement of U.S. Patent Nos.
6,303,607 ("Method for Administering a Sustained Release Ranolazine
Formulation," issued October 16, 2001), 6,479,496 ("Methods for Treating
Angina with Ranolazine," issued November 12, 2002), 6,503,911 ("Sustained
Release Ranolazine Formulations," issued January 7, 2003), 6,525,057 (same
title, issued February 25, 2003), 6,562,826 (same title, issued May 13, 2003),
6,617,328 (same title, issued September 9, 2003), 6,620,814 (same title, issued
September 16, 2003), 6,852,724 (same title, issued February 8, 2005), and
6,864,258 (same title, issued March 8, 2005), all licensed to Gilead, following
a Paragraph IV certification as part of Lupin's filing of an ANDA to
manufacture a generic version of Gilead's Ranexa® (ranolazine, used to treat
chronic angina). View the New
Jersey complaint here.
Bayer Schering Pharma AG et al. v. Teva Pharmaceuticals USA Inc.
et al.
1:10-cv-00616; filed July 20, 2010 in the District
Court of Delaware
• Plaintiffs: Bayer Schering Pharma AG; Bayer
HealthCare Pharmaceuticals Inc.; Schering Corp.
• Defendants: Teva Pharmaceuticals USA Inc.; Teva
Pharmaceuticals Industries Ltd.
Infringement of U.S. Patent No. 7,696,206 ("2-phenyl
Substituted Imidazotriazinones as Phosphodiesterase Inhibitors," issued April
13, 2010) following a Paragraph IV certification as part of Teva's filing of an
ANDA to manufacture a generic version of plaintiffs' Levitra® (vardenafil hydrochloride,
used to treat erectile dysfunction). View the complaint here.
Promote Innovation LLC v. K-V Pharmaceutical Co. et al.
2:10-cv-00254; filed July 20, 2010 in the Eastern
District of Texas
• Plaintiff: Promote Innovation LLC
• Defendants: K-V Pharmaceutical Co.; Ther-Rx
Corp.
False marking based on defendants' marking of their
Gynazole-1® products indicating that these products are covered by U.S. Patent
Nos. 4,078,071 ("Derivatives of substituted N-alkyl imidazoles,"
issued March 7, 1978), 4,551,148 ("Vaginal delivery systems and their
methods of preparation and use," issued November 5, 1985), and 4,636,202 ("Medicament
applicator with plunger assembly and automatically-openable closure therefore,"
issued January 13, 1987), which are expired. View the complaint here.
Promote Innovation LLC v. Schering Corp. et al.
2:10-cv-00248; filed July 19, 2010 in the Eastern
District of Texas
• Plaintiff: Promote Innovation LLC
• Defendants: Schering Corp.; Merck &
Co., Inc.; Cima Labs Inc.
False marking based on defendants' marking of their
Clarinex® products indicating that these products are covered by U.S. Patent
Nos. 4,659,716 ("Antihistaminic 8-(halo)-substituted
6,11-dihydro-11-(4-piperidylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridines,"
issued April 21, 1987) and 4,863,931 ("Antihistaminic fluoro substituted
benzocycloheptapyridines," issued September 5, 1989), which are
expired. View the complaint here.
Promote Innovation LLC v. Roche Diagnostics Corp. et al.
2:10-cv-00249; filed July 19, 2010 in the Eastern
District of Texas
• Plaintiff: Promote Innovation LLC
• Defendants: Roche Diagnostics Corp.; Roche
Diagnostics Operations, Inc.
False marking based on defendants' marking of their
Accu-Chek® products indicating that these products are covered by U.S. Patent
Nos. RE36,268 ("Method and apparatus for amperometric diagnostic analysis,"
issued August 17, 1999), 4,999,582 ("Biosensor electrode excitation
circuit," issued March 12, 1991), 4,924,879 ("Blood lancet device,"
issued May 15, 1990), and 5,053,199 ("Electronically readable information
carrier," issued October 1, 1991), which are either unenforceable or
expired. View the complaint here.
Promote Innovation LLC v. Gloucester Pharmaceuticals, Inc. et
al.
2:10-cv-00241; filed July 16, 2010 in the Eastern
District of Texas
• Plaintiff: Promote Innovation LLC
• Defendants: Gloucester Pharmaceuticals, Inc.;
Celgene Corp.
False marking based on defendants' marking of their
Istodax® products indicating that these products are covered by U.S. Patent No.
4,977,138 ("FR901228 substance and preparation thereof," issued
December 11, 1990), which is expired. View the complaint here.
Promote Innovation LLC v. Pfizer Inc. et al.
2:10-cv-00242; filed July 16, 2010 in the Eastern
District of Texas
• Plaintiff: Promote Innovation LLC
• Defendants: Pfizer Inc.; Pharmacia & Upjohn
Co., Inc.; Bayer Healthcare Pharmaceuticals Inc.
False marking based on defendants' marking of their
Glyset® products indicating that these products are covered by U.S. Patent No. 4,639,436
("Antidiabetic 3,4,5-trihydroxypiperidines," issued January 27, 1987),
which is expired. View the
complaint here.
Promote Innovation LLC v. Abbott Laboratories Inc. et al.
2:10-cv-00246; filed July 16, 2010 in the Eastern
District of Texas
• Plaintiff: Promote Innovation LLC
• Defendants: Abbott Laboratories Inc.; Takeda
Pharmaceutical Co. Ltd.
False marking based on defendants' marking of their
Lupron® products indicating that these products are covered by U.S. Patent Nos.
4,652,441 ("Prolonged release microcapsule and its production,"
issued March 24, 1987), 4,677,191 ("Copolymer and method for producing the
same," issued June 20. 1987), 4,728,721 ("Polymer, production and use
thereof," issued March 1, 1988), 4,849,228 (same title, issued July 18,
1989), 4,917,893 ("Prolonged release microcapsules," issued April 17,
1990), 4,005,063 ("[Des-gly].sup.10 -GnRH nonapeptide anide analogs in
position 6 having ovulation-inducing activity," issued January 25, 1977),
and 4,005,194 ("Treatment of prostatic hyperplasia," issued January
25, 1977) which are expired. View
the complaint here.
Bayer Schering Pharma AG et al v. Lupin Ltd. et al.
1:10-cv-01914; filed July 15, 2010 in the District
Court of Maryland
• Plaintiffs: Bayer Schering Pharma AG; Bayer
Healthcare Pharmaceuticals Inc.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals,
Inc.
Infringement of U.S. Patent Nos. RE37,564 ("Composition
for Contraception," issued February 26, 2002), RE37,838 (same title,
issued September 10, 2002), RE38,253 (same title, issued September 16, 2003),
and 5,569,652 ("Dihydrospirorenone as an antiandrogen," issued
October 29, 1996) following a Paragraph IV certification as part of Lupin's
filing of ANDAs to manufacture a generic version of Bayer's Yaz® (drospirenone and
ethinyl estradiol, used for oral contraception) and Bayer's Yasmin®
(drospirenone and ethinyl estradiol, used for oral contraception). View the complaint here.
Bayer Schering Pharma AG et al v. Lupin Ltd et al.
2:10-cv-01166; filed July 15, 2010 in the District
Court of Nevada
• Plaintiffs: Bayer Schering Pharma AG; Bayer
Healthcare Pharmaceuticals Inc.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals,
Inc.
Infringement of U.S. Patent Nos. RE37,564 ("Composition
for Contraception," issued February 26, 2002), RE37,838 (same title,
issued September 10, 2002), and RE38,253 (same title, issued September 16,
2003) following a Paragraph IV certification as part of Lupin's filing of an
ANDA to manufacture a generic version of Bayer's Yaz® (drospirenone and ethinyl
estradiol, used for oral contraception). View the complaint here.
Bayer Schering Pharma AG et al. v. Lupin Ltd. et al.
1:10-cv-05423; filed July 15, 2010 in the Southern
District of New York
• Plaintiffs: Bayer Schering Pharma AG; Bayer
Healthcare Pharmaceuticals Inc.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals,
Inc.
Infringement of U.S. Patent No. 5,569,652 ("Dihydrospirorenone
as an antiandrogen," issued October 29, 1996) following a Paragraph IV
certification as part of Lupin's filing of an ANDA to manufacture a generic
version of Bayer's Yasmin® (drospirenone and ethinyl estradiol, used for oral
contraception). View the complaint here.
King
Pharmaceuticals, Inc. et al. v. Sandoz, Inc.
3:10-cv-03568; filed July 14, 2010 in the District
Court of New Jersey
• Plaintiffs: King Pharmaceuticals, Inc.; Meridian
Medical Technologies, Inc.
• Defendant: Sandoz, Inc.
Infringement
of U.S. Patent No. 7,449,012 ("Automatic Injector," issued November
11, 2008) following a Paragraph IV certification as part of Sandoz's filing of
an ANDA to manufacture a generic version of Meridian's EpiPen® Auto-Injector
(epinephrine, used to treat anaphylaxis). View the complaint here.
Genzyme Corp. v. Lupin Ltd. et al.
1:10-cv-01906; filed July 14, 2010 in the District
Court of Maryland
• Plaintiff: Genzyme Corp.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals,
Inc.
Genzyme Corp. v. Watson Laboratories, Inc.
1:10-cv-01863; filed July 9, 2010 in the District
Court of Maryland
The complaints in these cases are substantially
identical. Infringement of U.S.
Patent No. 5,667,775 ("Phosphate-Binding Polymers for Oral Administration,"
issued on September 16, 1997) following a Paragraph IV certification as part of
defendants' filing of an ANDA to manufacture a generic version of Genzyme's
Renvela® (sevelamer carbonate, used for the control of serum phosphorus in
patients with chronic kidney disease on dialysis). View the Watson Laboratories complaint here.
Stiefel Laboratories Inc. et al. v. Perrigo Israel
Pharmaceuticals Ltd. et al.
1:10-cv-00592; filed July 12, 2010 in the District
Court of Delaware
• Plaintiffs: Stiefel Laboratories Inc.; Stiefel
Research Australia Pty Ltd.
• Defendants: Perrigo Israel Pharmaceuticals Ltd.;
Perrigo Co.
Infringement of U.S. Patent Nos. 6,730,288 ("Mousse
Composition," issued May 4, 2004) and 7,029,659 (same title, issued April
18, 2006) following a paragraph IV certification as part of Perrigo's filing of
an ANDA to manufacture a generic version of Stiefel's OLUX-E® (clobetasol
propionate foam 0.05%, used to treat moderate to severe scalp dermatoses). View the complaint here.
Siemens Healthcare Diagnostics Inc. v. Enzo Life Sciences, Inc.
4:10-cv-40124; filed July 9, 2010 in the District
Court of Massachusetts
Review of the decision of the Board of Patent
Appeals and Interferences awarding priority of invention to Enzo in the
interference between U.S. Patent Application No. 08/479,995 ("Assay Method
Utilizing Polynucleotide Sequences," filed June 7, 1995), assigned to Enzo
and U.S. Patent No. 5,124,246 ("Nucleic Acid Multimers and Amplified
Nucleic Acid Hybridization Assays Using Same," issued June 23, 1992),
assigned to Siemens. View the
complaint here.
Elan Pharma International Ltd. et al v. Teva Pharmaceuticals USA,
Inc.
2:10-cv-03495; filed July 9, 2010 in the District
Court of New Jersey
• Plaintiffs: Elan Pharma International Ltd.;
Fournier Laboratories Ireland Ltd.
• Defendant: Teva Pharmaceuticals USA, Inc.
Infringement of U.S. Patent Nos. 5,145,684 ("Surface
Modified Drug Nanoparticles," issued September 8, 1992), 7,276,249 ("Nanoparticulate
Fibrate Formulations," issued October 2, 2007), and 7,320,802 ("Methods
of Treatment Using Nanoparticulate Fenofibrate Compositions," issued
January 22, 2008), all licensed to Abbott, following a Paragraph IV
certification as part of Teva's filing of an ANDA to manufacture a generic
version of Abbott's Tricor® (fenofibrate, used in the treatment of increased
triglyceride levels). View the
complaint here.
Abbott Laboratories et al. v. Teva Pharmaceuticals USA, Inc.
2:10-cv-03482; filed July 9, 2010 in the District
Court of New Jersey
• Plaintiffs: Abbott Laboratories; Laboratories
Fournier S.A.
• Defendant: Teva Pharmaceuticals USA, Inc.
Infringement of U.S. Patent Nos. 6,277,405 ("Fenofibrate
Pharmaceutical Composition Having High Bioavailability and Method for Preparing
It," issued August 21, 2001), 7,037,529 (same title, issued May 2, 2006),
and 7,041,319 ("Fenofibrate Pharmaceutical Composition Having High
Bioavailabilty," issued May 9, 2006) following a Paragraph IV
certification as part of Teva's filing of an ANDA to manufacture a generic
version of Abbott's Tricor® (fenofibrate, used in the treatment of increased
triglyceride levels). View the
complaint here.
Pfizer, Inc. et al. v. Apotex Inc. et al.
1:10-cv-05272; filed July 9, 2010 in the Southern
District of New York
• Plaintiffs: Pfizer, Inc.; Pfizer Ireland
Pharmaceuticals
• Defendants: Apotex Inc.; Apotex Corp.
Infringement of U.S. Patent No. 6,110,940 ("Salts
of an Anti-Migraine Indole Derivative," issued August 29, 2000) following
a Paragraph IV certification as part of Apotex's filing of an ANDA to
manufacture a generic version of Pfizer's Relpax® (eletriptan hydrobromide,
used for the acute treatment of migraine with our without aura). View the complaint here.
AstraZeneca Pharmaceuticals LP et al. v. Torrent Pharmaceuticals
Ltd. et al.
1:10-cv-00584; filed July 8, 2010 in the District
Court of Delaware
• Plaintiffs: AstraZeneca Pharmaceuticals LP; IPR
Pharmaceuticals Inc.; AstraZeneca AB; Brigham and Women's Hospital Inc.
• Defendants: Torrent Pharmaceuticals Ltd.; Torrent
Pharma Inc.
Infringement of U.S. Patent Nos. 6,858,618 ("Use
of Rosuvastatin (ZD-4522) in the Treatment of Heterozygous Familial
Hypercholesterolemia," issued February 22, 2005) and 7,030,152 ("Systematic
Inflammatory Markers as Diagnostic Tools in the Prevention of Atherosclerotic
Diseases and as Tools to Aid in the Selection of Agents to be Used for the
Prevention and Treatment of Atherosclerotic Disease," issued April 18,
2006) certification as part of Torrent's filing of an amended ANDA to
manufacture a generic version of AstraZeneca's Crestor® (rosuvastatin calcium,
used to treat high cholesterol). View the complaint here.