By Sherri Oslick --
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Shire LLC, Supernus Pharmaceuticals, Inc. et al. v. Impax Laboratories, Inc. et al.
3:10-cv-05467; filed December 2, 2010 in the Northern District of California
• Plaintiffs: Shire LLC; Supernus Pharmaceuticals, Inc.; Amy F.T Arnsten; Pasko Rakic; Robert D. Hunt
• Defendants: IMPAX Laboratories, Inc.; Watson Pharmaceuticals, Inc.; Watson Laboratories, Inc.-Florida; Watson Pharma, Inc.; Anda, Inc.
Infringement of U.S. Patent Nos. 5,854,290 ("Use of Guanfacine in the Treatment of Behavioral Disorders," issued December 19, 1998), 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) based on Impax'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.
Momenta Pharmaceuticals, Inc. et al. v. Teva Pharmaceuticals Industries Ltd. et al.
1:10-cv-12079; filed December 2, 2010 in the District Court of Massachusetts
• Plaintiffs: Momenta Pharmaceuticals, Inc.; Sandoz Inc.
• Defendants: Teva Pharmaceuticals Industries Ltd.; Teva Pharmaceuticals USA, Inc.
Infringement of U.S. Patent Nos. 7,575,886 ("Analysis of Sulfated Polysaccharides," issued August 19, 2009) and 7,790,466 ("Evaluating Mixtures of Low Molecular Weight Heparins By Chain Profiles Or Chain Mapping," issued September 17, 2010), both licensed to Sandoz, based on Teva's expected manufacture and sale of generic Lovenox® (enoxaparin sodium, used for the prophylaxis of deep vein thrombosis, and for treatment of acute deep vein thrombosis). View the complaint here.
Monsanto Co. et al. v. Sauceda
4:10-cv-02249; filed December 2, 2010 in the Eastern District of Missouri
• Plaintiffs: Monsanto Co.; Monsanto Technology LLC
• Defendant: Zeferino Sauceda
Infringement of U.S. Patent Nos. 5,352,605 ("Chimeric Genes for Transforming Plant Cells Using Viral Promoters," issued October 4, 1994) and RE39,247 ("Glyphosate-tolerant 5-enolpyruvylshikimate-3-phosphate Synthases," issued August 22, 2006) based on defendants' use of saved Roundup Ready® or Bollgard® seed. View the complaint here.
Cellectis S.A. v. Precision Biosciences Inc.
1:10-cv-01033; filed November 30, 2010 in the District Court of Delaware
Infringement of U.S. Patent No. 7,842,489 ("Use of Meganucleases For Inducing Homologous Recombination Ex Vivo and In Toto In Vertebrate Somatic Tissues and Application Thereof," issued November 30, 2010) based on Precision's use of its Directed Nuclease Editor technology. View the complaint here.
Regents of the University of California v. Kappos
1:10-cv-02031; filed November 29, 2010 in the District Court of the District of Columbia
Reversal of the decision of the BPAI in upholding the examiner's rejection of certain claims in the ex parte reexamination of U.S. Patent No. 5,916,912 ("Dietary Composition for Enhancing Metabolism and Alleviating Oxidative Stress," issued June 29, 1999). View the complaint here.
Hoffmann-La Roche Inc. v. Watson Laboratories, Inc. et al.
2:10-cv-06206; filed November 29, 2010 in the District Court of New Jersey
• Plaintiff: Hoffmann-La Roche Inc.
• Defendants: Watson Laboratories, Inc.; Watson Pharmaceuticals, Inc.; Watson Pharma, Inc.; Cobalt Pharmaceuticals Inc.; Cobalt Laboratories, Inc.
Infringement of U.S. Patent No. 7,718,634 ("Method of Treatment Using Bisphosphonic Acid," issued May 18, 2010) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Roche's Boniva® (ibandronate sodium, used to treat post-menopausal osteoporosis). View the complaint here.
Astrazeneca Pharmaceuticals LP et al. v. Mylan Pharmaceuticals Inc. et al.
1:10-cv-00199; filed November 29, 2010 in the Northern District of West Virginia
• Plaintiffs: Astrazeneca Pharmaceuticals LP; Astrazeneca UK Ltd.
• Defendants: Mylan Pharmaceuticals Inc.; Mylan Inc.
Infringement of U.S. Patent Nos. 4,879,288 ("Novel Dibenzothiazepine Antipsychotic," issued November 7, 1989) and 5,948,437 ("Pharmaceutical Compositions Using Thiazepine," issued September 7, 1999) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of AstraZeneca's Seroquel® XR (quetiapine fumarate, used to treat schizophrenia and bipolar disorder). View the complaint here.
Alza Corp. et al. v. Impax Laboratories Inc. et al.
1:10-cv-01024; filed November 24, 2010 in the District Court of Delaware
• Plaintiffs: Alza Corp.; Ortho-McNeil-Janssen Pharmaceuticals Inc.
• Defendants: Impax Laboratories Inc.; Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd.
Infringement of U.S. Patent No. 6,930,129 (same title, issued August 16, 2005) following a Paragraph IV certification as part of Impax's amendment to its ANDA to manufacture a generic version of Alza's Concerta® (methylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder). View the complaint here.
Abbott Laboratories et al. v. Impax Laboratories Inc.
1:10-cv-01029; filed November 24, 2010 in the District Court of Delaware
• Plaintiffs: Abbott Laboratories; Abbott Respiratory LLC
• Defendants: Impax Laboratories Inc.
Infringement of U.S. Patent Nos. 6,129,930 ("Methods and Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia at Night," issued October 10, 2000), 6,406,715 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Urinary Metabolite Profiles," issued June 18, 2002), 6,676,967 ("Methods for Reducing Flushing in Individuals Being Treated with Nicotinic Acid for Hyperlipidemia," issued January 13, 2004), 6,746,691 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia Having Unique Biopharmaceutical Characteristics," issued June 8, 2004), 7,011,848 ("Hydrophobic Component Free Sustained Release Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued March 14, 2006), 6,818,229 ("Intermediate Release Nicotinic Acid Compositions for Treating Hyperlipidemia," issued November 16, 2004), 6,080,428 ("Nicotinic Acid Compositions for Treating Hyperlipidemia and Related Methods Therefor," issued June 27, 2000), and 6,469,035 ("Methods of Pretreating Hyperlipidemic Individuals with a Flush Inhibiting Agent Prior to the Start of Single Daily Dose Nicotinic Acid Therapy to Reduce Flushing Provoked by Nicotinic Acid," issued October 22, 2002) following a Paragraph IV certification as part of Impax's filing of an ANDA to manufacture a generic version of Abbott's Simcor® (niacin extended release / simvastatin tablets, used to treat hypercholesterolemia). View the complaint here.
Jazz Pharmaceuticals, Inc. v. Roxane Laboratories, Inc.
2:10-cv-06108; filed November 22, 2010 in the District Court of New Jersey
Infringement of U.S. Patent Nos. 6,780,889 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued August 24, 2004), 7,262,219 (same title, issued August 28, 2007), 7,668,730 ("Sensitive Drug Distribution System and Method," issued February 23, 2010), and 7,765,106 (same title, issued July 27, 2010) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy). View the complaint here.
Daiichi Sankyo Inc. et al. v. Impax Laboratories Inc. et al.
1:10-cv-00997; filed November 19, 2010 in the District Court of Delaware
• Plaintiffs: Daiichi Sankyo Inc.; Genzyme Corp.
• Defendants: Impax Laboratories Inc.; Glenmark Generics Inc. USA; Glenmark Generics Ltd.; Glenmark Pharmaceuticals Ltd.
Infringement of U.S. Patent Nos. 5,607,669 ("Amine Polymer Sequestrant and Method of Cholesterol Depletion," issued March 4, 1997) and 5,693,675 ("Alkylated Amine Polymers," issued December 2, 1997) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of plaintiffs' Welchol® (colesevelam hydrochloride, used to treat primary hyperlipidemia and type 2 diabetes mellitus). View the complaint here.
Abbott Laboratories et al. v. Roxane Laboratories Inc.
1:10-cv-00998; filed November 19, 2010 in the District Court of Delaware
• Plaintiffs: Abbott Laboratories; Wisconsin Alumni Research Foundation
• Defendants: Roxane Laboratories Inc.
Infringement of U.S. Patent No. 5,587,497 ("19-nor-Vitamin D Compounds," issued December 24, 1996) following a Paragraph IV certification as part of Roxane's filing of an ANDA to manufacture a generic version of Abbott's Zemplar® (paricalcitol, used to treat secondary hyperparathyroidism in patients with kidney failure). View the complaint here.
Merck & Co., Inc. et al. v. Hetero Drugs Ltd., Unit III et al.
2:10-cv-06111; filed November 19, 2010 in the District Court of New Jersey
• Plaintiffs: Merck & Co., Inc.; Merck Sharp & Dohme Corp.
• Defendants: Hetero Drugs Ltd., Unit III; Hetero USA Inc.
Merck & Co., Inc. et al. v. Hetero Drugs Ltd., Unit III et al.
2:10-cv-05370; filed November 19, 2010 in the Eastern District of New York
• Plaintiffs: Merck & Co., Inc.; Merck Sharp & Dohme Corp.
• Defendants: Hetero Drugs Ltd., Unit III; Invagen Pharmaceuticals, Inc.
These complaints are substantially identical. Infringement of U.S. Patent Nos. 5,571,817 ("Methods of Treating Androgenic Alopecia with Finasteride [17β-N-mono-substituted-carbamoyl-4-aza-5-α-androst-1-en-ones]," issued November 5, 1996), 5,547,957 ("Method of Treating Androgenic Alopecia with 5-α Reductase Inhibitors," issued August 20, 1996), and 5,886,184 ("Finasteride Processes," issued March 23, 1999) following a Paragraph IV certification as part of Hetero's filing of an ANDA to manufacture a generic version of Merck's Propecia ® (finasteride, used to treat androgenic alopecia). View the New Jersey complaint here.
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