Indianapolis, Indiana – An Indiana patent attorney for Eli Lilly and Company of Indianapolis, Indiana; Daiichi Sankyo Co., Ltd of Tokyo, Japan; Daiichi Sankyo, Inc. of Parsippany, New Jersey; and Ube Industries, Ltd. of Yamaguchi, Japan sued in the Southern District of Indiana alleging that Panacea Biotec, Ltd. of New Delhi, India (“Panacea”) infringed Effient® products, Patent Nos. 8,404,703 and 8,569,325, which have been issued by the United States Patent Office.
This lawsuit adds another defendant, Panacea, to Lilly’s Indiana patent litigation. In these “Effient” patent-defense lawsuits, Lilly et al. assert allegations of infringement of Effient. At issue in the Panacea litigation are Effient-related patents 8,404,703 “Medicinal Compositions Containing Aspirin,” (the “‘703 patent”) and 8,569,325 “Method of Treatment with Coadministration of Aspirin and Prasugrel” (the “‘325 patent”).
This complaint asserts patent infringement arising out of the filing by Panacea of an Abbreviated New Drug Applications (“ANDA”) with the United States Food and Drug Administration (“FDA”) seeking approval to manufacture and sell generic versions of two pharmaceutical products – Effient 5mg and Effient 10mg tablets – prior to the expiration of the ‘703 patent and the ‘325 patent. These patents cover two Effient products and/or methods of using Effient products and for which Lilly claims an exclusively license.
Effient products were approved by the FDA for the reduction of thrombotic cardiovascular events in certain patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI, or angioplasty). Effient products contain prasugrel hydrochloride, which is also known as 5-[(1RS)-2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride or 2-acetoxy-5-(alpha-cyclopropylcarbonyl-2-fluorobenzy1)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine hydrochloride, and is covered by the ‘726 patent.
The instructions accompanying Effient products state that patients taking Effient products should also take aspirin. The use of Effient products in combination with aspirin for the reduction of thrombotic cardiovascular events in patients with ACS who are to be managed with PCI is allegedly covered by the claims of the ‘703 and ‘325 patents.
Panacea is accused of planning to infringe the patents-in-suit by including with its products instructions for use that substantially copy the instructions for Effient products, including instructions for administering Panacea’s products with aspirin as claimed in the ‘703 and ‘325 patents.
Plaintiffs contend that Panacea knows that the instructions that Panacea intends to include with its products will induce and/or contribute to others using those products in the allegedly infringing manner set forth in the instructions. Moreover, Lilly et al. also contend that Panacea specifically intends for health care providers, and/or patients to use Panacea’s products in accordance with the instructions provided by Panacea and that such use will directly infringe one or more claims of the ‘703 and ‘325 patents. Thus, state Plaintiffs, Panacea’s actions will actively induce and/or contribute to infringement of the ‘703 and ‘325 patents.
The complaint, filed by an Indiana patent lawyer, lists four counts:
• Count I: Infringement of U.S. Patent No. 8,404,703
• Count II: Declaratory Judgment of Infringement of U.S. Patent No. 8,404,703
• Count III: Infringement of U.S. Patent No. 8,569,325
• Count IV: Declaratory Judgment of Infringement of U.S. Patent No. 8,569,325
Plaintiffs ask the court for judgment:
• That Panacea has infringed the ‘703 patent and/or will infringe, actively induce infringement of, and/or contribute to infringement by others of one or more claims of the ‘703 patent;
• That Panacea has infringed the ‘325 patent and/or will infringe, actively induce infringement of, and/or contribute to infringement by others of one or more claims of the ‘325 patent;
• That, pursuant to 35 U.S.C. § 271(e)(4)(B), Panacea be permanently enjoined from making, using, selling or offering to sell any of its accused products within the United States, or, where applicable, importing accused products into the United States prior to the expiration of the ‘703 and ‘325 patents;
• That, pursuant to 35 U.S.C. § 271(e)(4)(A), the effective date of any approval of the Panacea ANDA under § 505(j) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)) shall not be earlier than the later of the expiration dates of the ‘703 and ‘325 patents, including any extensions;
• If Panacea commercially makes, uses, sells or offers to sell any accused product within the United States, or, where applicable, imports any accused product into the United States, prior to the expiration of either of the ‘703 and ‘325 patents, including any extensions, that Plaintiffs be awarded monetary damages for those infringing acts to the fullest extent allowed by law and be awarded prejudgment interest based on those monetary damages;
• That the case be deemed exceptional under 35 U.S.C. § 285;
• That the ‘703 patent remains valid and enforceable;
• That the ‘325 patent remains valid and enforceable; and
• That Plaintiffs be awarded reasonable attorney’s fees, costs and expenses.
Practice Tip: In March 2014, Lilly et al. filed a 101-page complaint making similar accusations against more than thirty defendants: Accord Healthcare, Inc. USA; Accord Healthcare, Inc.; Intas Pharmaceuticals Ltd.; Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals of New York, LLC; Amneal Pharmaceuticals Co. India Pvt. Ltd.; Aurobindo Pharma Limited; Aurobindo Pharma USA Inc.; Dr. Reddy’s Laboratories, Ltd; Dr. Reddy’s Laboratories, Inc.; Glenmark Generics Inc., USA; Glenmark Generics Ltd.; Glenmark Pharmaceuticals Ltd.; Hetero USA Inc.; Hetero Labs Limited; Hetero Labs Limited Unit V; Hetero Drugs Ltd.; Mylan Pharmaceuticals Inc.; Mylan Inc.; Mylan Laboratories Limited; Par Pharmaceutical Companies, Inc.; Par Pharmaceutical, Inc.; Sun Pharma Global FZE; Caraco Pharmaceutical Laboratories, Ltd.; Sun Pharma Global Inc.; Sun Pharmaceutical Industries, Ltd.; Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.; Watson Laboratories, Inc.; Actavis plc; Actavis, Inc.; Actavis Pharma, Inc.; Zydus Pharmaceuticals USA, Inc.; and Cadila Healthcare Ltd. d/b/a Zydus Cadila.
The case was filed by Jan M. Carroll of Barnes & Thornburg LLP in conjunction with Bruce R. Genderson, Adam L. Perlman, Ellen E. Oberwetter, Dov P. Grossman, Elise M. Baumgarten, and Carol J. Perry of Williams & Connolly LLP. The case was assigned to District Judge Sarah Evans Barker and Magistrate Judge Denise K. LaRue in the Southern District of Indiana and assigned Case No. 1:14-cv-01064-SEB-DKL.