[author: Sherri Oslick]
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
GlaxoSmithKline LLC v. Apotex Inc.
1:12-cv-01090; filed August 31, 2012
Infringement of U.S. Patent Nos. 5,565,467 ("Androstenone Derivative," issued October 15, 1996) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of GSK's Avodart® (dutasteride, used to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate). View the complaint here.
Life Technologies Corp. et al. v. Ebioscience, Inc.
3:12-cv-02156; filed August 30, 2012 in the Southern District of California
• Plaintiffs: Life Technologies Corp.; Molecular Probes, Inc.; Regents of the University of California
• Defendant: Ebioscience, Inc.
Infringement of U.S. Patent Nos. 8,071,359 ("Semiconductor Nanocrystal Probes for Biological Applications and Process for Making and Using Such Probes," issued December 6, 2011), 8,071,360 (same title, issued December 6, 2011), and 8,071,361 (same title, issued December 6, 2011) based on Ebioscience's manufacture, sale, and offer for sale of certain eFluor® products, including eFluor® Nanocrystals Products. View the complaint here.
Mallinckrodt LLC et al. v. Apotex Inc. et al.
1:12-cv-01087; filed August 30, 2012 in the District Court of Delaware
• Plaintiffs: Mallinckrodt LLC; Mallinckrodt Inc.; Nuvo Research Inc.
• Defendants: Apotex Inc.; Apotex Corp.; Lupin Ltd.; Lupin Pharmaceuticals Inc.
Infringement of U.S. Patent No. 8,217,078 ("Treatment of Pain with Topical Diclofenac," issued July 10, 2012) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Mallinckrodt's Pennsaid® (diclofenac sodium topical solution, used for the treatment of signs and symptoms of osteoarthritis of the knee(s)). View the complaint here.
AbbVie Inc. et al. v. Amneal Pharmaceuticals LLC et al.
1:12-cv-01088; filed August 30, 2012 in the District Court of Delaware
• Plaintiffs: AbbVie Inc.; Abbott Respiratory LLC
• Defendants: Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals Co. India Pvt. Ltd.
Infringement of U.S. Patent Nos. 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 Kremers' filing of an ANDA to manufacture a generic version of Abbott's Niaspan® (niacin extended-release tablets, used to treat hypercholesterolemia). View the complaint here.
Danisco US, Inc v. Novozymes A/S et al.
3:12-cv-04502; filed August 27, 2012 in the Northern District of California
• Plaintiff: Danisco US, Inc.
• Defendants: Novozymes A/S; Novozymes North America, Inc.
Danisco US Inc. v. Novozymes A/S et al.
1:12-cv-00085; filed August 27, 2012 in the Northern District of Iowa
• Plaintiff: Danisco US, Inc.
• Defendants: Novozymes A/S; Novozymes North America, Inc.
The complaints in these cases are substantially identical. Declaratory judgment of non-infringement, invalidity of U.S. Patent No. 8,252,573 ("Alpha-Amylase Variant with Altered Properties," issued August 28, 2012) or in the alternative, priority of invention of U.S. Patent No. 8,084,240 ("Geobacillus Stearothermophilus Alpha-Amylase (AMYS) Variants with Improved Properties," issued December 27, 2011) relating to Danisco's Rapid Starch Liquefaction alpha-amylase products. View the Iowa complaint here.
Genetic Technologies Ltd. v. Reproductive Genetics Institute, Inc.
1:12-cv-06857; filed August 27. 2012 in the Northern District of Illinois
Infringement of U.S. Patent No. 5,612,179 ("Intron Sequence Analysis Method for Detection of Adjacent Locus Alleles as Haplotypes," issued March 18, 1997) based on RGI's manufacture, use, sale, and offer for sale of preimplantation genetic diagnosis services. View the complaint here.
Merck & Co., Inc. et al. v. Sun Pharmaceutical Industries, Ltd. et al.
3:12-cv-05374; filed August 27, 2012 in the District Court of New Jersey
• Plaintiffs: Merck & Co., Inc.; Organon USA Inc.; MSD Oss B.V.; Roche Palo Alto LLC
• Defendants: Sun Pharmaceutical Industries, Ltd.; Sun Pharmaceutical Industries, Inc.; Caraco Pharmaceutical Laboratories, Inc.
Infringement of U.S. Patent Nos. 5,757,082 ("Nonapeptide and Decapeptide Analogs of LHRH Useful as LHRH Antagonists," issued June 16, 1998) and 6,653,286 ("Gonadotropin Releasing Hormone Antagonist," issued November 25, 2003) following a Paragraph IV certification as part of Sun's filing of an ANDA to manufacture a generic version of Merck's Ganirelix Acetate Injection (ganirelix acetate, used for the inhibition of premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation). View the complaint here.
Purdue Pharmaceutical Products, L.P. et al. v. Watson Pharmaceuticals, Inc. et al.
2:12-cv-05390; filed August 27, 2012 in the District Court of New Jersey
• Plaintiffs: Purdue Pharmaceutical Products L.P.; Purdue Pharma L.P.; Transcept Pharmaceuticals, Inc.
• Defendants: Watson Pharmaceuticals, Inc.; Watson Pharma, Inc.; Watson Laboratories, Inc. - Florida
Purdue Pharmaceutical Products L.P. et al. v. Actavis Elizabeth LLC
2:12-cv-05311; filed August 23, 2012 in the District Court of New Jersey
• Plaintiffs: Purdue Pharmaceutical Products L.P.; Purdue Pharma L.P.; Transcept Pharmaceuticals, Inc.
• Defendant: Actavis Elizabeth LLC
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 7,682,628 ("Compositions for Delivering Hypnotic Agents Across the Oral Mucosa and Methods of Use Thereof," issued March 23, 2010) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Purdue's Intermezzo® (sublingual zolpidem tartrate, used to treat insomnia when middle-of-the-night awakening is followed by difficulty returning to sleep). View the Actavis complaint here.
Janssen Products, L.P. et al. v. Lupin Ltd. et al.
2:12-cv-05358; filed August 24, 2012 in the District Court of New Jersey
• Plaintiffs: Janssen Products, L.P.; Janssen R&D Ireland; G.D. Searle, LLC
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals USA, Inc.; Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.; Mylan Pharmaceuticals Inc.; Mylan Inc.
Infringement of U.S. Patent No. RE43,596 ("α- and β-Amino Acid Hydroxyethylamino Sulfonamides Useful as Retroviral Protease Inhibitors," issued May 9, 2000) in conjunction with defendants' filing of an ANDA to manufacture a generic version of Janssen's Prezista® (darunavir, used to treat human immunodeficiency virus (HIV-1) infection). View the complaint here.
Metabolon, Inc. v. Stemina Biomarker Discovery, Inc.
3:12-cv-00618; filed August 24, 2012 in the Western District of Wisconsin
Infringement of U.S. Patent Nos. 7,550,258 ("Methods for Drug Discovery, Disease Treatment, and Diagnosis Using Metabolomics," issued June 23, 2009) and 7,910,301 (same title, issued March 22, 2011) based on Stemina's offer, sale and provision in the United States metabolomics services, including services utilizing brain tumor stem cells, human embryonic stem cells and human and animal tissue and fluid. View the complaint here.
Cepheid v. Roche Molecular Systems, Inc. et al.
3:12-cv-04411; filed August 21, 2012 in the Northern District of California
• Plaintiff: Cepheid
• Defendants: Roche Molecular Systems, Inc.; F. Hoffman-La Roche, Ltd.
Declaratory judgment of invalidity, unenforceability, expiration, and non-infringement of U.S. Patent Nos. 5,804,375 ("Reaction Mixtures for Detection of Target nucleic Acids," issued September 8, 1998) and 6,127,155 ("Stabilized Thermostable Nucleic Acid Polymerase Compositions Containing Non-ionic Polymeric Detergents," issued October 3, 2000) based on Cepheid's manufacture and sale of its Xpert® diagnostic kits. View the complaint here.
