Case 1:12-cv-00086-RLY-DKL Document 1 Filed 01/20/12 Page 1 of 7 PageID #: 1
`Case 1:12-cv-00086—li—DKL Document 1 Filed 01/20/16Page 1 of 7 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF INDIANA
`INDIANAPOLIS DIVISION
`
`, 7 H
`Ia
`
`,
`
`
`
`ELI LILLY AND COMPANY,
`
`v.
`
`Plaintiff,
`
`ACCORD HEALTHCARE, INC., USA,
`
`Defendant.
`
`vvvvvvvv
`
`Civil Action No.
`
`I :12 w—(lOSSHLY—DKL
`
`W
`
`Plaintiff Eli Lilly and Company (“Lilly”), by its attorneys, hereby alleges as
`
`follows:
`
`NATURE OF THE ACTION
`
`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 Accord
`
`Healthcare Inc., USA (“Accord”) of an Abbreviated New Drug Application (“ANDA”) with the
`
`U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture and sell generic
`
`versions of ALIMTA® prior to the expiration of U.S. Patent No. 7,772,209.
`
`PARTIES
`
`2.
`
`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.
`
`3.
`
`Upon information and belief, defendant Accord is a wholly owned
`
`subsidiary of Intas Pharmaceuticals Ltd.
`
`
`Case 1:12-cv-00086—li—DKL Document 1 Filed 01/20/16Page 1 of 7 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF INDIANA
`INDIANAPOLIS DIVISION
`
`, 7 H
`Ia
`
`,
`
`
`
`ELI LILLY AND COMPANY,
`
`v.
`
`Plaintiff,
`
`ACCORD HEALTHCARE, INC., USA,
`
`Defendant.
`
`vvvvvvvv
`
`Civil Action No.
`
`I :12 w—(lOSSHLY—DKL
`
`W
`
`Plaintiff Eli Lilly and Company (“Lilly”), by its attorneys, hereby alleges as
`
`follows:
`
`NATURE OF THE ACTION
`
`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 Accord
`
`Healthcare Inc., USA (“Accord”) of an Abbreviated New Drug Application (“ANDA”) with the
`
`U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture and sell generic
`
`versions of ALIMTA® prior to the expiration of U.S. Patent No. 7,772,209.
`
`PARTIES
`
`2.
`
`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.
`
`3.
`
`Upon information and belief, defendant Accord is a wholly owned
`
`subsidiary of Intas Pharmaceuticals Ltd.
`
`
`
`Case 1:12-cv-00086-RLY-DKL Document 1 Filed 01/20/12 Page 2 of 7 PageID #: 2
`Case 1:12-cv-00086-la-DKL Document 1 Filed 01/20/16Page 2 of 7 PageID #: 2
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`4.
`
`Upon information and belief, defendant Accord is a corporation organized
`
`and existing under the laws of the State of North Carolina, having a place of business at 1009
`
`Slater Road, Suite 210»B, Durham, NC, 27703.
`
`JURISDICTION AND VENUE
`
`5.
`
`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331,
`
`1338(a), 2201, and 2202.
`
`6.
`
`7.
`
`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`Upon information and belief, Accord is subject to personal jurisdiction in
`
`this District because, among other things, Accord markets, sells, and distributes generic drugs
`
`throughout the United States, including within the State of Indiana and the Southern District of
`
`Indiana. Upon information and belief, Accord has engaged in and maintained systematic and
`
`continuous business contacts within the State of Indiana and the Southern District of Indiana, and
`
`has purposefully availed itself of the benefits and protections of the laws of Indiana.
`
`8.
`
`Upon information and belief, and consistent with its practice with respect
`
`to other generic products, following any FDA approval of Accord’s ANDA No. 203485 for
`
`generic versions of ALIMTA®, Accord will market, distribute, and sell its generic products
`
`throughout the United States and within Indiana and the Southern District of Indiana, and knows
`
`that Lilly will be injured by such actions in Indiana and the Southern District of Indiana. Upon
`
`information and belief, following any FDA approval of ANDA No. 203485, Accord knows and
`
`intends that its generic products will be marketed, distributed, and sold in the United States and
`
`within the State of Indiana and the Southern District of Indiana, and knows that Lilly will be
`
`injured by such actions in Indiana and the Southern District of Indiana.
`
`
`
`Case 1:12-cv-00086-RLY-DKL Document 1 Filed 01/20/12 Page 3 of 7 PageID #: 3
`Case 1:12-cv-00086-W-DKL Document 1 Filed Ol/20/tPage 3 of 7 PageID #: 3
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`BACKGROUND
`
`9.
`
`ALIMTA® is a chemotherapy agent used for the treatment of various types
`
`of cancer. ALIMTA® is indicated (in combination with cisplatin) (a) for the treatment of patients
`
`with malignant pleural mesothelioma, or (b) for the initial treatment of locally advanced or
`
`metastatic nonsquamous non-small cell lung cancer. ALIMTA® also is indicated as a single-
`
`agent for the treatment of patients with locally advanced or metastatic nonsquamous non-small
`
`cell lung cancer after prior chemotherapy. ALIMTA® also is indicated for maintenance
`
`treatment of patients with locally advanced or metastatic nonsquamous non-small cell lung
`
`cancer whose disease has not progressed after four cycles of platinum-based first-line
`
`chemotherapy.
`
`10.
`
`Lilly sells ALIMTA® in the United States pursuant to a New Drug
`
`Application that has been approved by the FDA.
`
`11.
`
`United States Patent No. 7,772,209 (“the ’209 patent”), entitled “Novel
`
`Antifolate Combination Therapies,” was duly and legally issued on August 10, 2010. The ’209
`
`patent is attached as Exhibit A hereto.
`
`12.
`
`Lilly is the assignee of the ’209 patent. As set forth in greater detail in the
`
`’209 patent, one or more claims of the ’209 patent, incorporated by reference herein, cover a
`
`method of administering pemetrexed disodium to a patient in need thereof that also involves
`
`administration of folic acid and vitamin B12.
`
`13.
`
`An actual case or controversy exists between Lilly and Accord with
`
`respect to infringement of the ’209 patent.
`
`
`
`
`
`Case 1:12-cv-00086-RLY-DKL Document 1 Filed 01/20/12 Page 4 of 7 PageID #: 4
`Case 1:12-cv-00086-W-DKL Document 1 Filed 01/20/16Page 4 of 7 PageID #: 4
`
`
`COUNT
`
`(Infringement of US. Patent No. 7,772,209)
`
`14.
`
`Lilly incorporates each of the preceding paragraphs as if fully set forth
`
`herein.
`
`15.
`
`By letter dated December 8, 2011 (“Accord’s Notice Letter”), Accord
`
`notified Lilly that it had submitted to the FDA ANDA No. 203485 for Accord’s Pemetrexed
`
`Disodium for Injection, 100 rug/vial and 500 mg/vial products (“Accord’s ANDA Products”).
`
`16.
`
`Accord’s ANDA Products are generic versions of ALIMTA®.
`
`17.
`
`Accord’s ANDA Products contain pemetrexed disodium.
`
`18.
`
`Upon information and belief, the use of Accord’s ANDA Products in
`
`accordance with Accord’s proposed labeling for Accord’s ANDA Products involves
`
`administration of folic acid and vitamin B12.
`
`19.
`
`Upon information and belief, the use of Accord’s ANDA Products in
`
`accordance with and as directed by Accord’s proposed labeling for those products will infringe
`
`one or more claims of the ’209 patent.
`
`20.
`
`Upon information and belief, Accord filed as a part of ANDA No. 203485
`
`a certification of the type described in Section 505(j)(2)(A)(vii)(IV) of the Food, Drug, and
`
`Cosmetic Act (“FDCA”), 21 U.S.C. § 3550)(2)(A)(vii)(IV), with respect to the ’209 patent,
`
`asserting that the claims of the ’209 patent are invalid, unenforceable, and/or not infringed by the
`
`manufacture, use, offer for sale, or sale of Accord’s ANDA Products.
`
`21.
`
`The purpose of ANDA No. 203485 was to obtain approval under the
`
`FDCA to engage in the commercial manufacture, use, offer for sale, and/or sale of Accord’s
`
`ANDA Products prior to the expiration of the ’209 patent.
`
`
`
`
`
`Case 1:12-cv-00086-RLY-DKL Document 1 Filed 01/20/12 Page 5 of 7 PageID #: 5
`Case 1:12-cv-00086-la-DKL Document 1 Filed 01/20/16Page 5 of 7 PageID #: 5
`
`22.
`
`Accord’s submission of ANDA No. 203485 for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, and/or sale of Accord’s
`
`ANDA Products prior to the expiration of the ’209 patent is an act of infringement of the ’209
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`23.
`
`Upon information and belief, Accord intends to engage in the
`
`manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of Accord’s
`
`ANDA Products and the proposed labeling therefor immediately and imminently upon approval
`
`of ANDA No. 203485, 1'. e. , prior to the expiration of the ’209 patent.
`
`24.
`
`Upon information and belief, Accord has knowledge of the claims of the
`
`’209 patent. Notwithstanding this knowledge, Accord has continued to assert its intent to engage
`
`in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of
`
`Accord’s ANDA Products and the proposed labeling therefor immediately and imminently upon
`
`approval of ANDA No. 203485.
`
`25.
`
`Upon information and belief, Accord plans and intends to, and will,
`
`actively induce infringement of the ’209 patent when its ANDA is approved, and plans and
`
`intends to, and will, do so immediately and imminently upon approval.
`
`26.
`
`Upon information and belief, Accord knows that Accord’s ANDA
`
`Products are especially made or adapted for use in infringing the ’209 patent, and that Accord’s
`
`ANDA Products are not suitable for substantial noninfringing use. Upon information and belief,
`
`Accord plans and intends to, and will, contribute to infringement of the ’209 patent immediately
`
`and imminently upon approval of ANDA No. 203485.
`
`
`
`
`
`Case 1:12-cv-00086-RLY-DKL Document 1 Filed 01/20/12 Page 6 of 7 PageID #: 6
`Case 1:12-cv-00086-li-DKL Document 1 Filed 01/20/16Page 6 of 7 PageID #: 6
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`27.
`
`The foregoing actions by Accord constitute and/or will constitute
`
`infringement of the ’209 patent, active inducement of infringement of the ”209 patent, and
`
`contribution to the infringement by others of the ’209 patent.
`
`28.
`
`Upon information and belief, Accord is without a reasonable basis for
`
`believing that it will not be liable for infringing the ’209 patent, actively inducing infringement
`
`of the ’209 patent, and/or contributing to the infringement by others of the ’209 patent.
`
`29.
`
`Unless Accord is enjoined from infringing the ’209 patent, actively
`
`inducing infringement of the ’209 patent, and contributing to the infringement by others of the
`
`’209 patent, Lilly will suffer irreparable injury. Lilly has no adequate remedy at law.
`
`WHEREFORE, Lilly requests the following relief:
`
`(a)
`
`A judgment that Accord has infringed the ’209 patent and/or will infringe,
`
`actively induce infringement of, and/or contribute to infringement by others of the ’209 patent;
`
`(b)
`
`A judgment ordering that the effective date of any FDA approval for
`
`Accord to make, use, offer for sale, sell, market, distribute, or import Accord’s ANDA Products,
`
`or any product the use of which infringes the ’209 patent, be not earlier than the expiration date
`
`of the ’209 patent, inclusive of any extensi0n(s) and additional period(s) of exclusivity;
`
`(c)
`
`A preliminary and permanent injunction enjoining Accord, and all persons
`
`acting in concert with Accord, from making, using, selling, offering for sale, marketing,
`
`distributing, or importing Accord’s ANDA Products, or any product the use of which infringes
`
`the ’209 patent, or the inducement of or contribution to any of the foregoing, prior to the
`
`expiration date of the ’209 patent, inclusive of any extension(s) and additional period(s) of
`
`exclusivity;
`
`
`
`Case 1:12-cv-00086-RLY-DKL Document 1 Filed 01/20/12 Page 7 of 7 PageID #: 7
`Case 1:12-cv-00086-li-DKL Document 1 Filed 01/20/16Page 7 of 7 PageID #: 7
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`(d)
`
`A judgment declaring that making, using, selling, offering for sale,
`
`marketing, distributing, or importing of Accord’s ANDA Products, or any product the use of
`
`which infringes the ’209 patent, prior to the expiration date of the ’209 patent, infringes, will
`
`infringe, will actively induce infringement of, and/or will contribute to the infringement by other
`
`of the ’209 patent;
`
`(e)
`
`A declaration that this is an exceptional case and an award of attorneys’
`
`fees pursuant to 35 U.S.C. § 285;
`
`(f)
`
`An award of Lilly’s costs and expenses in this action; and
`
`(g)
`
`Such further and other relief as this Court may deem just and proper.
`
`Dated: January 20, 2012
`
`Respectfully submitted,
`
`M. ’71 Chi/MUD!
`
`J
`B
`
`Carroll, No. 4187-49
`ES & THORNBURG LLP
`
`11 South Meridian Street
`
`Indianapolis, IN 46204
`(317) 236-1313
`jan.carroll@btlaw.com
`Attorneyfor Plaintiff
`Eli Lilly and Company
`
`OF COUNSEL:
`Bruce R. Genderson
`
`Adam L. Perlman
`
`Ellen E. Oberwetter
`Dov P. Grossman
`David M. Krinsky
`Megan A. Hughes
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, NW.
`Washington, DC 2005
`(202) 434-5000
`
`INDSOZ J'MC 1202829vl
`
`
`
`
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