IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`ELI LILLY AND COMPANY and
`THE TRUSTEES OF PRINCETON
`UNIVERSITY,
`
`Plaintiffs,
`
`TEVA PARENTERAL MEDICINES, INC.,
`
`Defendant.
`
`)
`)
`)
`)
`)
`)
`) C.A. No,
`)
`)
`)
`)
`.)
`
`COMPLAINT
`
`Plaintiffs Eli Lilly and Company and The Trustees of Princeton University
`
`(collectively "Plaintiffs"), by their attorneys, for their Complaint, allege as follows:
`
`1.
`
`This is an action for patent infringement under the patent laws of the
`
`United States, Title 35, United States Code, that arises out of the filing by defendant Teva
`
`Pm’enteral Medicines, Inc. ("Teva") of an Abbreviated New Drug Application ("ANDA’) with
`
`the U.S. Food and Drug Administration ("FDA") seeking appl’oval to manufacture and sell a
`
`generic version of ALIMTA® prior to the expiration of UoS. Patent No. 5,344,932.
`
`PARTIES
`
`2,
`
`Plaintiff’ Eli Lilly and Company ("Lilly") is a corporation organized and
`
`existing under the laws of the State of Indiana, having its corporate offices and principal place of
`
`business at Lilly Corporate Center, Indianapolis, Indiana 46285.
`
`Plaintiff The Trustees of Princeton University ("Princeton") is a not-for-
`
`profit educational institution organized and existing under the laws of the State of New Jersey,
`
`having a place of business at One Nassau Hall, Princeton, New Jersey 08540.
`
`RLF 1-3289806-1
`
`Sandoz Inc.
`Exhibit 1044-0001
`
`Teva – Fresenius
`Exhibit 1044-00001
`
`
`FOR THE DISTRICT OF DELAWARE
`
`ELI LILLY AND COMPANY and
`THE TRUSTEES OF PRINCETON
`UNIVERSITY,
`
`Plaintiffs,
`
`TEVA PARENTERAL MEDICINES, INC.,
`
`Defendant.
`
`)
`)
`)
`)
`)
`)
`) C.A. No,
`)
`)
`)
`)
`.)
`
`COMPLAINT
`
`Plaintiffs Eli Lilly and Company and The Trustees of Princeton University
`
`(collectively "Plaintiffs"), by their attorneys, for their Complaint, allege as follows:
`
`1.
`
`This is an action for patent infringement under the patent laws of the
`
`United States, Title 35, United States Code, that arises out of the filing by defendant Teva
`
`Pm’enteral Medicines, Inc. ("Teva") of an Abbreviated New Drug Application ("ANDA’) with
`
`the U.S. Food and Drug Administration ("FDA") seeking appl’oval to manufacture and sell a
`
`generic version of ALIMTA® prior to the expiration of UoS. Patent No. 5,344,932.
`
`PARTIES
`
`2,
`
`Plaintiff’ Eli Lilly and Company ("Lilly") is a corporation organized and
`
`existing under the laws of the State of Indiana, having its corporate offices and principal place of
`
`business at Lilly Corporate Center, Indianapolis, Indiana 46285.
`
`Plaintiff The Trustees of Princeton University ("Princeton") is a not-for-
`
`profit educational institution organized and existing under the laws of the State of New Jersey,
`
`having a place of business at One Nassau Hall, Princeton, New Jersey 08540.
`
`RLF 1-3289806-1
`
`Sandoz Inc.
`Exhibit 1044-0001
`
`Teva – Fresenius
`Exhibit 1044-00001
`
`
`
`4,
`
`Upon infom~ation and belief, defendant reva is a corporation organized
`
`and existing under the laws of the State of Delaware, having its principal place of business at 19
`
`Hughes, Irvine, California 92618.
`
`JURISDICTION AND VENUE
`
`5o
`
`Jurisdiction and venue are proper in this district pursuant to 28 ILSoC.
`
`§§ 1331, 1338(a), 1391, and 1400(b), Yeva is subject to personal jurisdiction in DeIaware
`
`because, among other things, -feva is a resident and citizen of the State of Delaware and has
`
`submitted itself to the rjUrisdiction of courts in Delaware by virtue of its incorporation under
`
`Delaware law.
`
`BACKGROUND
`
`6.
`
`ALIMTA® is a chemotherapy agent used for the treatment of’ various
`
`types of cancer. ALIMTA® is indicated (in combination with cisplatin) for the treatment of
`
`patients with malignant pleural mesothelioma and is also indicated as a single-agent for’ the
`
`treatment of patients with locally advanced or metastatic non-small celt lung cancer after prior
`
`chemotherapy,
`
`7.
`
`Lilly sells ALIMTA® in the United States pursuant to a New Drug
`
`Application that has been approved by the FDA~
`
`COUNT I - U.S. PATENT NO. 5,344,932
`
`8.
`
`Plaintiffs incorporate each of the preceding paragraphs 1-7 as if fully set
`
`forth herein.
`
`9.
`
`United States Patent Noo 5,344,932 ("the ’932 patent"), entitled "N-
`
`(pyrrolo(2,3-d)pyrimidin-3-ylacyl)-Glutamic Acid Derivatives" (Exhibit A heleto), was duly and
`
`legally issued on September 6, I994 to Princeton, as assignee of Edward C. Taylor.
`
`RLF1-3289806~l
`
`2
`
`Sandoz Inc.
`Exhibit 1044-0002
`
`Teva – Fresenius
`Exhibit 1044-00002
`
`
`
`10. Princeton owns the ’932 patent. Princeton will be substantially and
`
`irreparably damaged by infringement of the ’932 patent.
`
`11. Lilly has been granted an exclusive license under the ’932 patent. Lilly
`
`will be substantially and irreparably damaged by infringement of the ’932 patent.
`
`12. ALIM-fA® is covered by one or more claims of’ the ’932 patent, and the
`
`’932 patent has been listed in connection with that drug product in the FDA’s publication,
`
`Approved Drug Products ~.l,ith Therapeutic Equivalence Evaluations°
`
`13. By letter dated April 24, 2008 (the "Notice Letter"), ]-eva notified Lilly
`
`and Princeton that Teva had submitted to the FDA an ANDA, No. 90-352, for -i-eva’s
`
`Pemetrexed Disodium for Injection, Eq. 500 mg Base/Vial, a drug product that is a generic
`
`version of ALIMTA® ("Yeva’s ANDA Product"). 1-he purpose of the ANDA was to obtain
`
`approval under the Federal Food, Drug, and Cosmetic Act ("FDCA") to engage in the
`
`commercial manufacture, use, offer for sale, and/or sale of Teva’s ANDA Product prior to the
`
`expiration of, inter alia, the ’932 patent°
`
`14. In the Notice Letter, -Ieva also notified Lilly and Princeton that, as part of
`
`its ANDA, Teva had filed certifications of the type described in Section 505(i)(2)(A)(vii)(lV) of
`
`the FDCA, 21 U.SCo § 355(j)(2)(A)(vii)(IV), with respect to, inter alia, the ’932 patent. Upon
`
`information m~d belief, Teva submit-ted ANDA No. 90-352 to the FDA containing a certification
`
`pursuant to 21 ILS.C. § 355(i)(2)(A)(vii)(IV) asserting that the ’932 patent is invalid,
`
`unenforceable, and!or will not be infiinged by the manufacture, use, offer for sale, or sale of
`
`Yeva’s ANDA Product.
`
`15. Teva’s ANDA Product is covered by one or more claims ot the ’932
`
`patent.
`
`RLF1-3289806-I
`
`Sandoz Inc.
`Exhibit 1044-0003
`
`Teva – Fresenius
`Exhibit 1044-00003
`
`
`
`16.
`
`17.
`
`Teva has l~aowledge of the ’932 patent.
`
`-feva’s filing of ANDA No. 90-352 t~r the pin,pose of obtaining approval
`
`to engage in the commercial manufacture, use, offer for sale, and/or sale of Yeva’s ANDA
`
`Product before the expiration of the ’932 patent is an act of infringement of the ’932 patent~
`
`18. The manufacture, use, offer for sale, sale, marketing, distribution, and/or
`
`impo~tation of Teva’s ANDA Product would infringe one or more claims of’932 patent.
`
`19. Upon information and belief, Teva will engage in the manufacture, use,
`
`offer for sale, sale, marketing, distribution, and/or importation of Teva’s ANDA Product
`
`immediately and imminently upon approval ofANDA No~ 90-352.
`
`20~ Upon information and belief, use of Teva’s ANDA Product in accordance
`
`with and as directed by Teva’s proposed labeling for’ that product would infringe one or more
`
`claims of the ’932 patent°
`
`21. Upon information and belief, -feva will engage in the manufacture, use,
`
`offer for sale, sale, marketing, distribution, and/or importation of Teva’s ANDA Product with its
`
`proposed labeling immediately and imminently upon approval of ANDA No. 90-352~
`
`22.
`
`Upon infomaation and belief, -l-eva plans and intends to, and will, actively
`
`induce infiingement of the ’932 patent when its ANDA is approved, and plans and intends to,
`
`and will, do so immediately and imminently upon approval,
`
`23. Upon information and belief, Teva knows that Teva’s ANDA Product and
`
`its proposed labeling are especially made or adapted for use in infringing the ’932 patent, and
`
`that Teva’s ANDA Product and its proposed labeling are not suitable for substantial
`
`noninfringing use.. Upon information and belief, Teva plans and intends to, and will, contribute
`
`to infringement of the ’932 patent immediately and imminently upon approval of ANDA No~ 90-
`
`RLF1-3289806-I
`
`4
`
`Sandoz Inc.
`Exhibit 1044-0004
`
`Teva – Fresenius
`Exhibit 1044-00004
`
`
`
`352°
`
`24. The foregoing actions by Teva constitute and/or will constitute
`
`infringement of the ’932 patent, active inducement of infringement of the ’932 patent, and
`
`contribution to the infringement by others of the ’932 patent.
`
`25. Upon information and belief, Yeva acted without a reasonable basis for
`
`believing that it would not be liable fro’ infringing the ’932 patent, actively inducing infringement
`
`of the ’932 patent, and contributing to the infringement by others of the ’932 patent.
`
`26. Unless Teva is enjoined from infringing the ’932 patent, actively inducing
`
`infiingement of the ’932 patent, and contributing to the infringement by others of the ’932
`
`patent, Lilly and Princeton will suffer ineparable injury. Lilly and Princeton have no adequate
`
`remedy at law.
`
`WHEREFORE, Plaintiffs request the following relief!
`
`(a)
`
`(b)
`
`A.judgment that Teva has infringed the ’932 patent;
`
`A judgment ordering that the effective date of any FDA approval for Teva
`
`to make, use, offer for sale, sell, market, distribute, or import Teva’s ANDA Product, or any
`
`product or compound that infringes the ’932 patent, be not earlier than the expiration date of the
`
`’932 patent, inclusive of any extension(s) and additional period(s) of exclusivity;
`
`(c) A preliminary and permanent injunction enjoining Teva, and all persons
`
`acting in concert with Teva, from making, using, selling, offering for sale, marketing,
`
`distributing, o~’ importing -feva’s ANDA Product, or any product or compound that infringes the
`
`’932 patent, or the inducement of or the contribution to any of the foregoing, prior to the
`
`expiration date of the ’932 patent, inclusive of any extension(s) and additional period(s) of
`
`exclusivity;
`
`R121-3289806-I
`
`Sandoz Inc.
`Exhibit 1044-0005
`
`Teva – Fresenius
`Exhibit 1044-00005
`
`
`
`(d) A judgment declaring that making, using, selling, offering for’ sale,
`
`marketing, distributing, or importing Teva’s ANDA Product, or any product or compound that
`
`infringes the ’932 patent, prior to the expiration date of the ’932 patent, will infringe, actively
`
`induce infringement of, and contribute to the infiingement by others of the ’932 patent;
`
`(e) A declaration that this is an exceptional case and an award of attorneys’
`
`fees pursuant to 35 U.S.C. § 285;
`
`(f)
`
`(g)
`
`An award of Plaintiffs’ costs and expenses in this action; and
`
`Such fi~rther and other’ relief as this Court may deem just and proper.
`
`OF COUNSEL:
`Bruce R. Genderson
`Adam Lo Perhnan
`Ellen E. Oberwetter
`Dov P. Grossman
`David M. Krinsky
`Williams & Cmmolly LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
`(202) 434-5029 (Facsimile)
`
`Dated: June 5, 2008
`
`Frederick L. Cottrell, III (#~155)
`cottrell@rlflcom
`Anne Shea Gaza (#4093)
`gaza@rlf.com
`Richards, Layton & Finger, P.A.
`One Rodney Square
`920 N. King Street
`Wilmington, DE 19801
`(302) 651-7700
`(302) 651-7701 (Facsimile)
`
`Attorneys for Pta#~tiffs Eli Lilly and Company
`and The Trustees of Prh~ceton University
`
`RLF1-3289806-1
`
`Sandoz Inc.
`Exhibit 1044-0006
`
`Teva – Fresenius
`Exhibit 1044-00006
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