Case 1:17-cv-00986-TWP-DKL Document 1 Filed 03/30/17 Page 1 of 8 PageID #: 1
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF INDIANA
`INDIANAPOLIS DIVISION
`
`ELI LILLY AND COMPANY,
`
`Plaintiff
`
`v.
`
`AMNEAL PHARMACEUTICALS LLC,
`
`Defendant.
`
`Civil Action No. 1:17-cv-986
`
`Plaintiff Eli Lilly and Company (“Lilly”), by its attorneys, hereby alleges as follows:
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`COMPLAINT
`
`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 Amneal
`
`Pharmaceuticals LLC (“Amneal”) of an Abbreviated New Drug Application (“ANDA”) with the
`
`U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture and sell its
`
`Pemetrexed for Injection 100 mg/vial and 500 mg/vial products (“Amneal’s ANDA Products”)
`
`prior to the expiration of U.S. Patent No. 7,772,209 (“the ’209 patent”). Amneal notified Lilly
`
`that it had submitted to the FDA NDA No. 210047 for Amneal’s ANDA Products by letter dated
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`February 28, 2017 (“Amneal’s Notice Letter” or “Notice Letter”). Upon information and belief,
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`Amneal’s ANDA Products will be marketed as competing products to ALIMTA®, a
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`chemotherapy agent developed and distributed by Lilly and used for the treatment of various
`
`types of cancer.
`
`
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF INDIANA
`INDIANAPOLIS DIVISION
`
`ELI LILLY AND COMPANY,
`
`Plaintiff
`
`v.
`
`AMNEAL PHARMACEUTICALS LLC,
`
`Defendant.
`
`Civil Action No. 1:17-cv-986
`
`Plaintiff Eli Lilly and Company (“Lilly”), by its attorneys, hereby alleges as follows:
`
`COMPLAINT
`
`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 Amneal
`
`Pharmaceuticals LLC (“Amneal”) of an Abbreviated New Drug Application (“ANDA”) with the
`
`U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture and sell its
`
`Pemetrexed for Injection 100 mg/vial and 500 mg/vial products (“Amneal’s ANDA Products”)
`
`prior to the expiration of U.S. Patent No. 7,772,209 (“the ’209 patent”). Amneal notified Lilly
`
`that it had submitted to the FDA NDA No. 210047 for Amneal’s ANDA Products by letter dated
`
`February 28, 2017 (“Amneal’s Notice Letter” or “Notice Letter”). Upon information and belief,
`
`Amneal’s ANDA Products will be marketed as competing products to ALIMTA®, a
`
`chemotherapy agent developed and distributed by Lilly and used for the treatment of various
`
`types of cancer.
`
`
`
`Case 1:17-cv-00986-TWP-DKL Document 1 Filed 03/30/17 Page 2 of 8 PageID #: 2
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`PARTIES
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`2.
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`Lilly is a corporation organized and existing under the laws of the State of
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`Indiana, having its corporate offices and place of business at Lilly Corporate Center,
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`Indianapolis, Indiana 46285.
`
`3.
`
`Upon information and belief, Amneal Pharmaceuticals LLC is a corporation
`
`organized and existing under the laws of the State of Delaware, having a place of business at 400
`
`Crossing Boulevard, Third Floor, Bridgewater, New Jersey 08807.
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`JURISDICTION AND VENUE
`
`4.
`
`This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331, 1338(a),
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`2201, and 2202.
`
`5.
`
`6.
`
`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`Upon information and belief, Amneal is engaged in the manufacturing, marketing,
`
`and sale of generic pharmaceutical products for the U.S. prescription drug market with products
`
`for sale in the United States. According to its website, “Amneal ranks as the seventh largest
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`generic manufacturer in the United States, by prescription volume.” Amneal further states on its
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`website that “primary distribution & sales operations facilities in the United States are centrally
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`situated in Glasgow, Kentucky. With over 215,000 square feet of space, they are strategically
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`located in close proximity to the UPS hub and within the Central time zone, enabling it provide
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`one-day ground delivery to more than 75% of the American population.”
`
`7.
`
`Upon information and belief, those products are then marketed, sold, and
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`distributed to oncologists, clinics, and hospitals throughout the United States, including in
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`Indiana, as well as to wholesalers, including in Indiana.
`
`8.
`
`Upon information and belief, Amneal has directly entered into a distribution
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`agreement with an Indiana wholesale distributor. According to the website for Amneal, Amneal
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`2
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`Case 1:17-cv-00986-TWP-DKL Document 1 Filed 03/30/17 Page 3 of 8 PageID #: 3
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`lists A.F. Hauser, Inc. as one of its authorized distributors of record of its products. Upon
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`information and belief, A.F. Hauser, Inc. is located at 4401 East U.S. Hwy. 30, Valparaiso,
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`Indiana 46383.
`
`9.
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`Upon information and belief, Amneal has sought approval in ANDA No. 210047
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`to distribute its ANDA Products in the United States, including in Indiana (and in this District),
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`and will do so upon approval of ANDA No. 210047. The filing of ANDA No. 210047 is
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`therefore tightly tied, in purpose and planned effect, to the deliberate making of sales in Indiana
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`and this District, and reliably indicates plans to engage in marketing of Amneal’s ANDA
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`Products in this State and District.
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`10.
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`Upon information and belief, Amneal has availed itself of the legal protections of
`
`the state of Indiana by filing claims or counterclaims affirmatively seeking relief in other prior
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`actions in this Court.
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`11.
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`Upon information and belief, with knowledge of the processes described in the
`
`FDCA and the Hatch-Waxman Act, Amneal directed its Notice Letter to Lilly, an entity
`
`incorporated in Indiana, at its corporate headquarters in Indiana, and alleged in the Notice Letter
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`the invalidity, unenforceability, and/or non-infringement of Lilly’s ’209 patent. Upon
`
`information and belief, Amneal deliberately challenged Lilly’s patent rights, and knew when it
`
`did so that it was triggering a forty-five-day period for Lilly to bring an action for patent
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`infringement under the FDCA. Moreover, upon information and belief, Amneal knew that other
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`FDCA and/or Hatch-Waxman Act infringement actions relating to the ’209 patent had been
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`brought and litigated in Indiana.
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`12.
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`Because Lilly is incorporated and has its principal place of business in Indiana,
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`the injury and consequences of Amneal’s filing of ANDA No. 210047, challenging Lilly’s patent
`
`3
`
`
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`Case 1:17-cv-00986-TWP-DKL Document 1 Filed 03/30/17 Page 4 of 8 PageID #: 4
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`rights, are suffered in Indiana. Upon information and belief, Amneal knew that it was
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`deliberately challenging the patent rights of an Indiana entity and seeking to challenge
`
`intellectual property held in Indiana and that the effects of any successful challenge of the ’209
`
`patent would be felt by Lilly in Indiana.
`
`13.
`
`Upon information and belief, Amneal derives substantial revenue from
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`pharmaceutical products that are used and/or consumed within Indiana, and which are
`
`manufactured by Amneal or its affiliates and/or for which Amneal is the named applicant on
`
`approved NDAs or ANDAs. Upon information and belief, various products for which Amneal,
`
`or its affiliates, is the named applicant on approved NDAs and ANDAs are available at
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`pharmacies in Indiana.
`
`14.
`
`Upon information and belief, if ANDA No. 210047 is approved, Amneal’s
`
`ANDA Products, under the direction and control of physicians practicing in Indiana, will be
`
`administered to patients of Indiana. These activities, as well as Amneal’s marketing, selling,
`
`and/or distributing of Amneal’s ANDA Products, would have a substantial effect within Indiana
`
`and would constitute infringement of Lilly’s patent in the event that Amneal’s ANDA Products
`
`are approved before the ’209 patent expires.
`
`15.
`
`For the reasons described above, among others, the filing of ANDA No. 210047
`
`was suit-related conduct with a substantial connection to Indiana and this District, the exercise of
`
`personal jurisdiction in this Court does not offend traditional notions of fair play and substantial
`
`justice, and this Court may properly exercise personal jurisdiction over Amneal.
`
`BACKGROUND
`
`16.
`
`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-
`
`4
`
`
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`Case 1:17-cv-00986-TWP-DKL Document 1 Filed 03/30/17 Page 5 of 8 PageID #: 5
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`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.
`
`17.
`
`Lilly sells ALIMTA® in the United States pursuant to a New Drug Application
`
`that has been approved by the FDA.
`
`18.
`
`The ’209 patent, titled “Antifolate Combination Therapies,” was duly and legally
`
`issued on August 10, 2010. The ’209 patent is attached as Exhibit A hereto.
`
`19.
`
`20.
`
`Lilly is the assignee of the ’209 patent.
`
`An actual case or controversy exists between Lilly and Amneal with respect to
`
`infringement of the ’209 patent.
`
`21.
`
`This action is being filed within 45 days of Lilly’s receipt of Amneal’s Notice
`
`Letter.
`
`22.
`
`23.
`
`disodium.
`
`COUNT I
`(Infringement of U.S. Patent No. 7,772,209)
`
`Lilly incorporates each of the preceding paragraphs as if fully set forth herein.
`
`Upon information and belief, Amneal’s ANDA Products contain pemetrexed
`
`24.
`
`Upon information and belief, the proposed labeling for Amneal’s ANDA Products
`
`involves administration of folic acid and vitamins B12.
`
`25.
`
`Upon information and belief, the use of Amneal’s ANDA Products in accordance
`
`with and as directed by Amneal’s proposed labeling for those products will infringe claims 1-22
`
`of the ’209 patent.
`
`5
`
`
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`Case 1:17-cv-00986-TWP-DKL Document 1 Filed 03/30/17 Page 6 of 8 PageID #: 6
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`26.
`
`Upon information and belief, Amenal filed as part of ANDA No. 210047 a
`
`certification of the type described in Section 505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(IV), 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 Amneal’s ANDA Products.
`
`27.
`
`The purpose of ANDA No. 210047 was to obtain approval under the FDCA to
`
`engage in the commercial manufacture, use, offer for sale, and/or sale of Amneal’s ANDA
`
`Products prior to the expiration of the ’209 patent.
`
`28.
`
`Amneal’s submission of ANDA No. 210047 for the purpose of obtaining approval
`
`to engage in the commercial manufacture, use, offer for sale, and/or sale of Amneal’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).
`
`29.
`
`Upon information and belief, Amneal intends to engage in the manufacture, use,
`
`offer for sale, sale, marketing, distribution, and/or importation of Amneal’s ANDA Products and
`
`the proposed labeling therefor immediately and imminently upon approval of ANDA
`
`No. 210047, i.e., prior to the expiration of the ’209 patent.
`
`30.
`
`Upon information and belief, Amneal has knowledge of the claims of the ’209
`
`patent. Notwithstanding this knowledge, Amneal has continued to assert its intent to engage in
`
`the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of Amneal’s
`
`ANDA Products and the proposed labeling therefor immediately and imminently upon approval
`
`of ANDA No. 210047.
`
`31.
`
`Upon information and belief, Amneal 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.
`
`6
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`Case 1:17-cv-00986-TWP-DKL Document 1 Filed 03/30/17 Page 7 of 8 PageID #: 7
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`32.
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`Upon information and belief, Amenal knows that Amneal’s ANDA Products are
`
`especially made or adapted for use in infringing the ’209 patent, and that Amneal’s ANDA
`
`Products are not suitable for substantial noninfringing use. Upon information and belief, Amneal
`
`plans and intends to, and will, contribute to infringement of the ’209 patent immediately and
`
`imminently upon approval of ANDA No. 210047.
`
`33.
`
`The foregoing actions by Amneal 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.
`
`34.
`
`Unless Amneal 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 Amneal 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
`
`Amenal to make, use, offer for sale, sell, market, distribute, or import Amneal’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 extension(s) and additional period(s) of
`
`exclusivity;
`
`(c)
`
`A preliminary and permanent injunction enjoining Amenal, and all
`
`persons acting in concert with Amneal, from making, using, selling, offering for sale, marketing,
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`distributing, or importing Amneal’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
`
`7
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`
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`Case 1:17-cv-00986-TWP-DKL Document 1 Filed 03/30/17 Page 8 of 8 PageID #: 8
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`expiration date of the ’209 patent, inclusive of any extension(s) and additional period(s) of
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`exclusivity;
`
`(d)
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`A judgment declaring that making, using, selling, offering for sale,
`
`marketing, distributing, or importing of Amneal’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)
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`A declaration that this is an exceptional case and an award of attorneys’
`
`fees pursuant to 35 U.S.C. § 285;
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`An award of Lilly’s costs and expenses in this action; and
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`Such further and other relief as this Court may deem just and proper.
`
`(f)
`
`(g)
`
`(h)
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`OF COUNSEL:
`
`Bruce R. Genderson
`Adam L. Perlman
`Dov P. Grossman
`David M. Krinsky
`Galina I. Fomenkova
`Alec T. Swafford
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, NW
`Washington, DC 20005
`Telephone: (202) 434-5000
`
`Respectfully submitted,
`
`/s/ Anne N. DePrez
`Anne DePrez
`(No. 4728-49)
`BARNES & THORNBURG LLP
`11 South Meridian Street
`Indianapolis, IN 46204
`Telephone: (317) 236-1313
`FAX: (317) 231-7433
`Email: Anne.DePrez@btlaw.com
`
`Attorneys for Plaintiff Eli Lilly and Company
`
`DMS AZD 4884075v1
`
`8
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