About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Spectrum Pharmaceuticals, Inc. et al. v. Amneal Pharmaceuticals LLC
2:15-cv-01697; filed September 3, 2015 in the District Court of Nevada
• Plaintiffs: Spectrum Pharmaceuticals, Inc.; University of Strathclyde
• Defendant: Amneal Pharmaceuticals LLC
Infringement of U.S. Patent No. 6,500,829 ("Substantially Pure Diastereoisomers of Tetrahydrofolate Derivatives," issued December 31, 2002) following a Paragraph IV certification as part of Amneal’s filing of an ANDA to manufacture a generic version of Spectrum's Fusilev® (levoleucovorin, used to treat advanced metastatic colorectal cancer). View the complaint here.
OSI Pharmaceuticals, LLC et al. v. Apotex Inc. et al.
1:15-cv-00772; filed September 2, 2015 in the District Court of Delaware
• Plaintiffs: OSI Pharmaceuticals, LLC; Genentech, Inc.
• Defendants: Apotex Inc.; Apotex Corp.
Infringement of U.S. Patent No. 6,900,221 ("Stable Polymorph on N-(3-Ethynylpheny1)-6, 7-Bis(2MethoxyEthoxy)-4-Quinazolinamine Hydrochloride, Methods of Production, and Pharmaceutical Uses Thereof," issued May 31, 2005) following a Paragraph IV certification as part of Apotex’s filing of an ANDA to manufacture a generic version of OSI's Tarceva® (erlotinib, used to treat non-small cell lung cancer and advanced pancreatic cancer). View the complaint here.
Merck Sharp & Dohme Corp. et al. v. Actavis Laboratories FL, Inc. et al.
0:15-cv-61858; filed September 2, 2015 in the Southern District of Florida
• Plaintiffs: Merck Sharp & Dohme Corp.; Cubist Pharmaceuticals LLC; Optimer Pharmaceuticals LLC; MSD Investment Holdings (Ireland); MSD International GmbH
• Defendants: Actavis Laboratories FL, Inc.; Actavis Pharma, Inc.; Actavis, Inc.
Infringement of U.S. Patent Nos. 7,906,489 ("18-Membered Macrocycles and Analogs Thereof," issued March 15, 2011), 8,586,551 (same title, issued November 19, 2013), 7,378,508 ("Polymorphic Crystalline Forms of Tiacumicin B," issued May 27, 2008), 7,863,249 ("Macrolide Polymorphs, Compositions Comprising Such Polymorphs, and Methods of Use and Manufacture Thereof," issued January 4, 2011), and 8,859,510 (same title, issued October 14, 2014) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Merck's Dificid® (fidaxomicin, used for the treatment of Clostridium difficileassociated diarrhea in adults 18 years of age or older). View the complaint here.
Jazz Pharmaceuticals, Inc. et al. v. Amneal Pharmaceuticals, LLC
2:15-cv-06562; filed September 2, 2015 in the District Court of New Jersey
• Plaintiffs: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Ltd.
• Defendant: Amneal Pharmaceuticals, LLC
Infringement of U.S. Patent No. 9,050,302 (“Method of Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters,” issued June 9, 2015) following a Paragraph IV certification as part of Amneal’s filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy). View the complaint here.
AstraZeneca AB et al. v. Alkem Laboratories Ltd. et al.
3:15-cv-06609; filed September 2, 2015 in the District Court of New Jersey
• Plaintiffs: AstraZeneca AB; Aktiebolaget Hassle; AstraZeneca LP; Zeneca Inc.
• Defendants: Alkem Laboratories Ltd.; Ascend Laboratories, LLC
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), 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 Alkem’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.
AstraZeneca AB et al. v. Actavis Elizabeth LLC et al.
3:15-cv-06610; filed September 2, 2015 in the District Court of New Jersey
• Plaintiffs: AstraZeneca AB; Aktiebolaget Hassle; AstraZeneca LP; Zeneca Inc.
• Defendants: Actavis Elizabeth LLC; Actavis, 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 Actavis’ 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.
Janssen Pharmaceutica, N.V. et al. v. Mylan Pharmaceuticals, Inc. et al.
1:15-cv-00152; filed September 2, 2015 in the Northern District of West Virginia
• Plaintiffs: Janssen Pharmaceutica, N.V.; Janssen Sciences Ireland UC; Gilead Sciences, Inc.; Gilead Sciences Ireland UC
• Defendants: Mylan Pharmaceuticals, Inc.; Mylan, Inc.
Infringement of U.S. Patent Nos. 8,841,310 ("Combinations of a Pyrimidine Containing NNRTI with RT Inhibitors," issued September 23, 2014), 7,125,879 ("HIV Inhibiting Pyrimidines Derivatives" issued October 24, 2006), and 8,101,629 (""Salt of 4-[[4-[[4-(2-Cyanoethenyl)-2,6-Dimethylphenyl]amino]-2-Pyrimidinyl]Amino]Benzonitrile" issued January 24, 2012), all licensed to Gilead, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Gilead's Complera® (emtricitabine, rilpivirine, and tenofovir disoproxil fumarate, used to treat HIV-1 in adults who have never taken HIV-1 medicines before and who have no more than 100,000 copies/mL of virus in their blood). View the complaint here.
Jazz Pharmaceuticals, Inc. et al. v. Lupin Ltd. et al.
2:15-cv-06548; filed September 1, 2015 in the District Court of New Jersey
• Plaintiffs: Jazz Pharmaceuticals, Inc.; Jazz Pharmaceuticals Ireland Ltd.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals Inc.; Lupin Inc.
Infringement of U.S. Patent Nos. 6,472,431 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued October 29, 2002), 6,780,889 (same title, issued August 24, 2004), 7,262,219 (same title, issued August 28, 2007), 7,851,506 (same title, issued December 14, 2010 ("Sensitive Drug Distribution System and Method" issued February 22, 2011), 8,263,650 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued September 11, 2012), 8,324,275 (same title, issued December 4, 2012), 8,461,203 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued June 11, 2013), 7,668,730 ("Sensitive Drug Distribution System and Method," issued February 23, 2010), 7,765,106 (same title, issued July 27, 2010), 7,765,107 (same title, issued July 27, 2010), 7,895,059 (same title, issued February 22, 2011), 8,457,988 (same title, issued June 4, 0213), 8,589,182 (same title, issued November 19, 2013), 8,731,963 (same title, issued May 20, 2014), 8,772,306 ("Method of Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters," issued July 8, 2014), 8,859,619 ("Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy," issued October 14, 2014), 8,952,062 (same title, issued February 10, 2015), and 9,050,302 (“Method of Administration of Gamma Hydroxybutyrate with Monocarboxylate Transporters,” issued June 9, 2015) following a Paragraph IV certification as part of Lupin’s filing of an ANDA to manufacture a generic version of Jazz's Xyrem® (sodium oxybate, used to treat narcolepsy). View the complaint here.
