About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Purdue Pharma L.P. et al. v. Actavis Laboratories FL, Inc.
1:15-cv-00686; filed August 5, 2015 in the District Court of Delaware
• Plaintiffs: Purdue Pharma L.P.; Purdue Pharmaceuticals L.P.; The P.F. Laboratories Inc.; Grunenthal GmbH
• Defendant: Actavis Laboratories FL, Inc.
Purdue Pharma L.P. et al. v. Alvogen Pine Brook, Inc.
1:15-cv-00687; filed August 5, 2015 in the District Court of Delaware
• Plaintiffs: Purdue Pharma L.P.; Purdue Pharmaceuticals L.P.; The P.F. Laboratories Inc.; Grunenthal GmbH
• Defendant: Alvogen Pine Brook Inc.
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 6,733,783 ("Controlled Release Hydrocodone Formulations," issued May 11, 2004), 8,361,499 (same title, issued January 29, 2013), 8,551,520 (same title, issued October 8, 2013), 8,647,667 (same title, issued February 11, 2014), 9,023,401 (same title, issued May 5, 2015), 8,529,948 ("Pharmaceutical Formulation Containing Gelling Agent," issued September 10, 2013), 8,808,740 ("Encased Tamper Resistant Controlled Release Dosage Forms," issued August 19, 2014), and 8,309,060 ("Abuse-Proofed Dosage Form," issued November 13, 2012) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Purdue's Hysingla® ER (hydrocodone bitartrate, used for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate). View the Actavis complaint here.
Eli Lilly and Company v. Uropep Biotech GBR
1:15-cv-01222; filed August 5, 2015 in the Southern District of Indiana
Declaratory judgment of non-infringement and invalidity of U.S. Patent No. 8,791,124 ("Use of Phosphodiesterase Inhibitors in the Treatment of Prostatic Diseases," issued July 29, 2014) based on Lilly's manufacture and sale of its Cialis® product (tadalafil) for the treatment of benign prostatic hyperplasia (BPH). View the complaint here. [NB: The complaint was voluntarily dismissed.]
AstraZeneca AB et al. v. HEC Pharm Co., Ltd. et al.
3:15-cv-06025; filed August 5, 2015 in the District Court of New Jersey
• Plaintiffs: AstraZeneca AB; Aktiebolaget Hassle; AstraZeneca LP; Zeneca Inc.
• Defendants: HEC Pharm Co., Ltd.; HEC Pharm Group; HEC Pharm USA Inc.
Infringement of U.S. Patent Nos. 6,369,085 ("Form of S-omeprazole," issued April 9, 2002), 7,411,070 (same title, issued August 12, 2008), and 8,466,175 (same title, issued June 18, 2013) following a Paragraph IV certification as part of HEC's filing of an ANDA to manufacture a generic version of AstraZeneca's Nexium® (esomeprazole magnesium, used for the treatment of gastroesophageal reflux disease). View the complaint here.
Boehringer Ingelheim Pharmaceuticals Inc. et al. v. HEC Pharm Co., Ltd. et al.
3:15-cv-05982; filed August 4, 2015 in the District Court of New Jersey
• Plaintiffs: Boehringer Ingelheim Pharmaceuticals Inc.; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Corp.; Boehringer Ingelheim Pharma GmbH & Co. KG
• Defendants: HEC Pharm Group; HEC Pharm Co., Ltd.; HEC Pharm USA; Mylan Pharmaceuticals Inc.; Mylan Inc.; Mylan Laboratories Ltd.; Intas Pharmaceuticals Ltd.; Accord Healthcare, Inc.; Aurobindo Pharma Ltd.; Aurobindo Pharma USA, Inc.; Dr. Reddys Laboratories, Ltd.; Dr. Reddys Laboratories, Inc.; Zydus Pharmaceuticals USA, Inc.; Cadila Healthcare Ltd.; MSN Laboratories Private Ltd.; MSN Pharmaceuticals, Inc.; Prinston Pharmaceutical Inc.; Solco Healthcare U.S., LLC; Huahai US Inc.; Zhejiang Huahai Pharmaceutical Co., Ltd.; Invagen Pharmaceuticals Inc.; Sun Pharmaceutical Industries Ltd.; Sun Pharma Global FZE; Sun Pharmaceutical Industries, Inc.
Infringement of U.S. Patent Nos. 7,407,955 ("8-[3-Aminopeperidin-1-yl-]xanthines, The Preparation Thereof And Their Use As Pharmaceutical Compositions," issued August 5, 2008), 8,119,648 (same title, issued February 21, 2012), 8,178,541 (same title, issued May 15, 2012), 8,673,927 ("Uses of DPP-IV Inhibitors," issued March 18, 2014), 8,846,695 ("Treatment For Diabetes In Patients With Inadequate Glycemic Control Despite Metformin Therapy Comprising A DPP-IV Inhibitor," issued September 30, 2014), and 8,853,156 ("Treatment For Diabetes In Patients Inappropriate For Metformin Therapy," issued October 7, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Boehringer's Tradjenta® (linagliptin, used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus) and Jentadueto® (linagliptin and metformin hydrochloride, used an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate) products. View the complaint here.
Janssen Biotech, Inc. et al. v. Mylan Pharmaceuticals Inc. et al.
1:15-cv-00130; filed August 4, 2015 in the Northern District of West Virginia
• Plaintiffs: Janssen Biotech, Inc.; Janssen Oncology, Inc.; Janssen Research & Development, LLC
• Defendants: Mylan Pharmaceuticals Inc.; Mylan, Inc.
Infringement of U.S. Patent No. 8,822,438 ("Methods and Compositions for Treating Cancer," issued September 2, 2014) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Janssen's Zytiga® (abiraterone acetate, used in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer). View the complaint here.
