About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Horizon Therapeutics, Inc. v. Lupin Ltd. et al.
1:16-cv-04438; filed July 21, 2016 in the District Court of New Jersey
• Plaintiff: Horizon Therapeutics, Inc.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals Inc.
Infringement of U.S. Patent Nos. 9,254,278 ("Methods of Therapeutic Monitoring of Nitrogen Scavenging Drugs," issued February 9, 2016) and 9,326,966 (same title, issued May 3, 2016) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Horizon's Ravicti® (glycerol phenylbutyrate oral liquid, used as a nitrogen binding agent for chronic management of adult and pediatric patients ≥ 2 years of age with urea cycle disorders that cannot be managed by dietary protein restriction and/or amino acid supplementation alone). View the complaint here.
Allergan, Inc. v. TWi Pharmaceuticals, Inc. et al.
2:16-cv-00820; filed July 21, 2016 in the Eastern District of Texas
• Plaintiff: Allergan, Inc.
• Defendants: TWi Pharmaceuticals, Inc.; TWi Pharmaceuticals USA, Inc.
Allergan, Inc. v. TWi Pharmaceuticals, Inc. et al.
1:16-cv-00620; filed July 20, 2016 in the District Court of Delaware
• Plaintiff: Allergan, Inc.
• Defendants: TWi Pharmaceuticals, Inc.; TWi Pharmaceuticals USA, Inc.
The complaints in these cases are substantially identical. Infringement of U.S Patent Nos. 8,629,111 ("Methods of Providing Therapeutic Effects Using Cyclosporine Components," issued January 14, 2014), 8,633,162 (same title, issued January 21, 2014), 8,642,556 (same title, issued February 4, 2014), 8,648,048 (same title, issued February 11, 2014), 8,685,930 (same title, issued April 1, 2014), and 9,248,191 (same title, issued February 2, 2016) following a Paragraph IV certification as part of TWi's filing of an ANDA to manufacture a generic version of Allergan's Restasis® (cyclosporine ophthalmic emulsion, 0.05%, used to treat dry eye). View the Delaware complaint here.
AstraZeneca AB et al. v. Aurobindo Pharma Ltd. et al.
3:16-cv-04414; filed July 20, 2016 in the District Court of New Jersey
• Plaintiffs: AstraZeneca AB; Aktiebolaget Hassle; AstraZeneca LP; Zeneca Inc.
• Defendants: Aurobindo Pharma Ltd.; Aurobindo Pharma USA Inc.
Infringement of U.S. Patent Nos. 6,369,085 ("Form of S-omeprazole," issued April 9, 2002) and 7,411,070 (same title, issued August 12, 2008) following a Paragraph IV certification as part of Aurobindo's filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium 24HR® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease). View the complaint here.
Valeant Pharmaceuticals Luxembourg S.A.R.L. et al. v. Actavis Laboratories UT. Inc. et al.
2:16-cv-04344; filed July 15, 2016 in the District Court of New Jersey
• Plaintiffs: Valeant Pharmaceuticals Luxembourg S.A.R.L.; Valeant Pharmaceuticals North America LLC
• Defendants: Actavis Laboratories UT. Inc.; Actavis, Inc.; Allergan PLC
Infringement of U.S. Patent No. 6,670,335 ("Fluorouracil-Containing Formulation," issued December 30, 2003) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Valeant's Carac® (fluorouracil 0.5% cream, used to treat multiple actinic or solar keratoses of the face and anterior scalp). View the complaint here.
Shionogi Inc. et al. v. Actavis Laboratories UT, Inc.
1:16-cv-00606; filed July 14, 2016 in the District Court of Delaware
• Plaintiffs: Shionogi Inc.; Concordia Pharmaceuticals Inc.
• Defendant: Actavis Laboratories UT, Inc.
Infringement of U.S. Patent Nos. 6,793,931 ("Ectoparasite Asphyxiator Compositions and Methods for their Applications," issued September 21, 2004) and 7,294,342 (same title, issued November 13, 2007) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Shionogi's Ulesfia® (benzyl alcohol lotion, 5%, for the topical treatment of head lice infestation in patients 6 months of age and older). View the complaint here.
Actavis Elizabeth LLC v. Novartis Corp. et al.
1:16-cv-00604; filed July 13, 2016 in the District Court of Delaware
• Plaintiff: Actavis Elizabeth LLC
• Defendants: Novartis Corp.; Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG
Declaratory judgment of noninfringement of U.S. Patent No. 9,283,209 ("Oral Formulations of Deferasirox," issued March 15, 2016) based on Activis' Paragraph IV certification as part of its filing of an ANDA to manufacture a generic version of Novartis' Jadenu® (deferasirox, used for the treatment of chronically elevated levels of iron in the blood caused by repeated blood transfusions). View the complaint here.
Helsinn Healthcare S.A. v. Zydus Pharmaceuticals (USA) Inc. et al.
3:16-cv-04239; filed July 13, 2016 in the District Court of New Jersey
• Plaintiff: Helsinn Healthcare S.A.
• Defendants: Zydus Pharmaceuticals (USA) Inc.; Cadila Healthcare Ltd.
Infringement of U.S. Patent Nos. 7,947,724 ("Liquid Pharmaceutical Formulations of Palonosetron," issued May 24, 2011), 7,947,725 (same title, issued May 24, 2011), 7,960,424 (same title, issued June 14, 2011), 8,598,219 (same title, issued December 3, 2013), and 8,729,094 (same title, issued May 20, 2014) following a Paragraph IV certification as part of Zydus' filing of an ANDA to manufacture a generic version of Helsinn's Aloxi® (palonosetron hydrochloride intravenous solution, used to prevent chemotherapy induced nausea and vomiting). View the complaint here.
DSM IP Assets, B.V. et al. v. Lallemand Specialties, Inc. et al.
3:16-cv-00497; filed July 13, 2016 in the Western District of Wisconsin
• Plaintiffs: DSM IP Assets, B.V.; DSM Bio-Based Products & Services B.V.
• Defendants: Lallemand Specialties, Inc.; Mascoma LLC
Infringement of U.S. Patent No. 8,795,998 ("Fermentative Glycerol-Free Ethanol Production," issued August 5, 2014) based on defendants' manufacture and sale of certain transgenic yeast cells, including their TransFerm Yield+ product. View the complaint here.
