By Sherri Oslick --
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Senju Pharmaceutical Co. Ltd. et al. v. Lupin Ltd. et al.
1:11-cv-00271; filed March 31, 2011 in the District Court of Delaware
• Plaintiffs: Senju Pharmaceutical Co. Ltd.; Kyorin Pharmaceutical Co. Ltd.; Allergan Inc.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals Inc.
Infringement of U.S. Patent Nos. 6,333,045 ("Aqueous Liquid Pharmaceutical Composition Comprised of Gatifloxacin," issued December 25, 2001) and 5,880,283 ("8-Alkoxyquinolonecarboxylic Acid Hydrate With Excellent Stability and Process for Producing the Same," issued March 9, 1999) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Allergan's Zymaxid® (gatifloxacin ophthalmic solution, used to treat bacterial conjunctivitis). View the complaint here.
Eurand Inc. et al. v. Anchen Pharmaceuticals Inc. et al.
1:11-cv-00268; filed March 30, 2011 in the District Court of Delaware
• Plaintiffs: Eurand Inc.; Anesta AG
• Defendants: Anchen Pharmaceuticals Inc.; Anchen Inc.
Infringement of U.S. Patent Nos. 7,820,203 ("Modified Release Dosage Forms of Skeletal Muscle Relaxants," issued October 26, 2010) and 7,829,121 (same title, issued November 9, 2010), licensed to Cephalon, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Cephalon's Amrix® (cyclobenzaprine hydrochloride, used for relief of muscle spasm associated with acute, painful musculoskeletal conditions). View the complaint here.
United States of America et al. v. Hetero Drugs, Ltd. et al.
2:11-cv-01750; filed March 28, 2011 in the District Court of New Jersey
• Plaintiffs: United States of America; Board of Trustees of The University of Illinois
• Defendants: Hetero Drugs, Ltd.; Unit III; Hetero USA Inc.
Infringement of U.S. Patent No. 7,470,506 ("Fitness Assay and Associated Method," issued December 30, 2008), licensed to Tibotec, following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Tibotec's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection). View the complaint here.
Oncolytics Biotech Inc. v. Kappos
1:11-cv-00621; filed March 25, 2011 in the District Court of the District of Columbia
Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,803,385 ("Reoviruses Having Modified Sequences," issued September 28, 2010). View the complaint here.
Abbott Laboratories et al. v. Watson Pharmaceuticals Inc. et al.
1:11-cv-00251; filed March 25, 2011 in the District Court of Delaware
• Plaintiffs: Abbott Laboratories; Abbott Respiratory LLC
• Defendants: Watson Pharmaceuticals Inc.; Watson Laboratories Inc. – Florida; Watson Pharma 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 Watson'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.
Celgene Corp. et al. v. Intellipharmaceutics Corp.
2:11-cv-01736; filed March 25, 2011 in the District Court of New Jersey
• Plaintiffs: Celgene Corp.; Novartis Pharmaceuticals Corp.; Novartis Pharma AG
• Defendant: Intellipharmaceutics Corp.
Infringement of U.S. Patent Nos. 5,908,850 ("Method of Treating Attention Deficit Disorders with d-Threo Methylphenidate," issued June 1, 1999), 6,355,656 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 12, 2002, with a reexamination certificate issued March 27, 2007), 6,528,530 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 4, 2003), 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998), 6,635,284 (same title, issued October 21, 2003), and 7,431,944 ("Delivery of Multiple Doses of Medications," issued October 7, 2008) all licensed exclusively to Novartis in certain fields of use, following a Paragraph IV certification as part of Intellipharmaceutics' filing of an ANDA to manufacture a generic version of Novartis' Focalin XR® (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder). View the complaint here.
Elan Corp. PLC et al. v. Intellipharmaceutics Corp. et al.
1:11-cv-00255; filed March 25, 2011 in the District Court of Delaware
• Plaintiffs: Elan Corp. PLC; Elan Pharma International Ltd.
• Defendants: Intellipharmaceutics Corp.; Intellipharmaceutics Ltd.; Par Pharmaceutical Inc.
Infringement of U.S. Patent Nos. 6,228,398 ("Multiparticulate Modified Release Composition," issued May 8, 2001) and 6,730,325 (same title, issued May 4, 2004), licensed to Novartis, following a Paragraph IV certification as part of Intellipharmaceutics' filing of an ANDA to manufacture a generic version of Novartis' Focalin® XR (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder). View the complaint here.
Tibotec Inc., et al. v. Hetero Drugs, Ltd.
2:11-cv-01696; filed March 24, 2011 in the District Court of New Jersey
• Plaintiffs: Tibotec Inc.; Tibotec Pharmaceuticals; G.D. Searle, LLC
• Defendants: Hetero Drugs, Ltd.; Unit 111; Hetero USA Inc.
Infringement of U.S. Patent Nos. 5,843,946 ("α- and β-Amino Acid Hydroxyethylamino Sulfonamides Useful as Retroviral Protease Inhibitors," issued December 1, 1998) and 6,248,775 (same title, issued June 19, 2001) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Tibotec's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection). View the complaint here.
Purdue Pharma LP et al. v. Andrx Labs LLC
1:11-cv-00248; filed March 24, 2011 in the District Court of Delaware
• Plaintiffs: Purdue Pharma LP; PF Laboratories Inc.; Purdue Pharmaceuticals LP; Rhodes Technologies; Board of Regents of the University of Texas System; Grunenthal GMBH
• Defendant: Andrx Labs LLC
Purdue Pharma L.P. et al. v. Actavis Elizabeth LLC
1:11-cv-02038; filed March 23, 2011 in the Southern District of New York
• Plaintiffs: Purdue Pharma L.P.; The P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies; Board of Regents of the University of Texas System; Grunenthal GMBH
• Defendant: Actavis Elizabeth LLC
Purdue Pharma L.P. et al. v. Watson Laboratories, Inc.- Florida et al.
1:11-cv-02036; filed March 23, 2011 in the Southern District of New York
• Plaintiffs: Purdue Pharma L.P.; The P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies; Board of Regentsof the University of Texas System; Grunenthal GMBH
• Defendants: Watson Laboratories, Inc.- Florida; Andrx Labs, LLC
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 6,488,963 ("Hot-Melt Extrudable Pharmaceutical Formulation," issued December 3, 2002), 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), 7,683,072 (same title, issued March 23, 2010), and 7,776,314 ("Abuse-Proofed Dosage System," issued August 17, 2010) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain). View the Watson complaint here.
Purdue Pharma L.P. et al. v. Teva Pharmaceuticals USA, Inc.
1:11-cv-02037; filed March 23, 2011 in the Southern District of New York
• Plaintiffs: Purdue Pharma L.P.; The P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies; Grunenthal GMBH; Board of Regents of the University of Texas System
• Defendant: Teva Pharmaceuticals USA, Inc.
Infringement of U.S. Patent Nos. 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), 7,683,072 (same title, issued March 23, 2010), and 7,776,314 ("Abuse-Proofed Dosage System," issued August 17, 2010) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain). View the complaint here.
Shire LLC et al. v. Mylan Inc. et al.
1:11-cv-02024; filed March 23, 2011 in the Southern District of New York
• Plaintiffs: Shire LLC; Supernus Pharmaceuticals, Inc.
• Defendants: Mylan Inc.; Mylan Pharmaceuticals Inc.
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) based on Mylan'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.
Noven Therapeutics, LLC v. Kappos
1:11-cv-00607; filed March 23, 2011 in the District Court of the District of Columbia
Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,598,271 ("Crystalline Paroxetine Methane Sulfonate," issued October 6, 2009). View the complaint here.
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