Case 1:19-cv-01489-RGA Document 1 Filed 05/02/19 Page 1 of 20 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`IL
`
`MERCK SHARP & DOHME CORP.,
`
`Plaintiff
`
`V.
`
`MAY , ,2 2019
`
`as.
`orsrRicr couRr-iiivivo
`WHEEL/NG, WV
`26003
`
`MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.,
`
`C.A. No. 1 (cid:9)
`
`1 ei
`
`(cid:9) I
`
`Defendants.
`
`16efje5LA
`
`Plaintiff Merck Sharp & Dohme Corp. ("Merck"), by its attorneys, for its Complaint,
`
`COMPLAINT
`
`alleges as follows:
`
`This is an action for patent infringement under the patent laws of the United
`
`States, Title 35, United States Code, and for a declaratory judgment of patent infringement under
`
`28 U.S.C. §§ 2201 and 2202 and the patent laws of the United States, Title 35, United States
`
`Code, that arises out of defendants' submission of Abbreviated New Drug Application
`
`("ANDA") Nos. 202473 and 202478 to the U.S. Food and Drug Administration ("FDA") seeking
`
`approval to commercially manufacture, use, offer for sale, sell, and/or import versions of
`
`JANUVIA® (sitagliptin phosphate) and JANUMET® (metformin hydrochloride; sitagliptin
`
`phosphate) prior to the expiration of U.S. Patent No. 7,326,708 ("the '708 patent") and U.S.
`
`Patent No. 8,414,921 ("the '921 patent").
`
`Mylan Pharmaceuticals Inc. notified Merck by letter dated December 28, 2010
`
`("Mylan's '473 Notice Letter") that it had submitted to the FDA ANDA No. 202473 ("Mylan's
`
`'473 ANDA"), seeking approval from the FDA to engage in the commercial manufacture, use,
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`Case 1:19-cv-01489-RGA Document 1 Filed 05/02/19 Page 2 of 20 PageID #: 2
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`offering for sale, sale, and/or importation of generic sitagliptin phosphate oral tablets ("Mylan's
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`'473 ANDA Product") prior to the expiration of the '708 patent.
`
`On information and belief, Mylan's '473 ANDA Product is a generic version of
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`Merck's JANUVIA® product.
`
`Mylan Pharmaceuticals Inc. notified Merck by letter dated December 28, 2010
`
`("Mylan's First '478 Notice Letter") that it had submitted to the FDA ANDA No. 202478
`
`("Mylan's '478 ANDA"), seeking approval from the FDA to engage in the commercial
`
`manufacture, use, offering for sale, sale, and/or importation of generic metformin hydrochloride
`
`and sitagliptin phosphate oral tablets ("Mylan's '478 ANDA Product") prior to the expiration of
`
`the '708 patent.
`
`Mylan Pharmaceuticals Inc. notified Merck by letter dated September 13, 2013
`
`("Mylan's Second '478 Notice Letter") that it had amended Mylan's '478 ANDA to additionally
`
`seek approval from the FDA to engage in the commercial manufacture, use, offering for sale,
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`sale, and/or importation of Mylan's '478 ANDA Product prior to the expiration of the '921
`
`patent.
`
`On information and belief, Mylan's '478 ANDA Product is a generic version of
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`Merck's JANUMET® product
`
`Mylan's '473 Notice Letter, Mylan's First '478 Notice Letter, and Mylan's
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`Second '478 Notice Letter are collectively referred to herein as "Mylan's Notice Letters."
`
`Mylan's '473 ANDA and Mylan's '478 ANDA are collectively referred to herein as "Mylan's
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`ANDAs." Mylan's '473 ANDA Product and Mylan's '478 ANDA Product are collectively
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`referred to herein as "Mylan's ANDA Products."
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`PARTIES
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`Plaintiff Merck is a corporation organized and existing under the laws of New
`
`Jersey, having its corporate offices and principal place of business at One Merck Drive,
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`Whitehouse Station, New Jersey 08889.
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`Merck is the holder of New Drug Application ("NDA") No. 21995 for
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`JANUVIA® (sitagliptin phosphate), which has been approved by the FDA.
`
`Merck is the holder of NDA No. 22044 for JANUMET® (metformin
`
`hydrochloride; sitagliptin phosphate), which has been approved by the FDA.
`
`On information and belief, defendant Mylan Pharmaceuticals Inc. ("MPI") is a
`
`corporation organized and existing under the laws of the State of West Virginia, having its
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`principal place of business at 781 Chestnut Ridge Road, Morgantown, WV 26505. On
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`information and belief, MPI is in the business of, among other things, manufacturing and selling
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`generic versions of branded pharmaceutical drugs for the U.S. market.
`
`On information and belief, defendant Mylan Inc. is a corporation organized and
`
`existing under the laws of the State of Pennsylvania, having its principal place of business at
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`1000 Mylan Boulevard, Canonsburg, PA 15317. On information and belief, Mylan Inc. is in the
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`business of, among other things, manufacturing and selling generic versions of branded
`
`pharmaceutical drugs through various operating subsidiaries, including MPI.
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`On information and belief, MPI is a wholly owned subsidiary of Mylan Inc. MPI
`
`and Mylan Inc. are collectively referred to herein as "Mylan."
`
`On information and belief, MPI and Mylan Inc. acted in concert to prepare and
`
`submit Mylan's ANDAs to the FDA.
`
`On information and belief, MPI and Mylan Inc. know and intend that upon
`
`approval of Mylan's ANDAs, MPI and Mylan Inc. will manufacture, market, sell, and distribute
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`Mylan's ANDA Products throughout the United States, including in West Virginia. On
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`information and belief, MPI and Mylan Inc. are agents of each other and/or operate in concert as
`
`integrated parts of the same business group, including with respect to Mylan's ANDA Products,
`
`and enter into agreements that are nearer than arm's length. On information and belief, MPI and
`
`Mylan Inc. participated, assisted, and cooperated in carrying out the acts complained of herein.
`
`On information and belief, following any FDA approval of Mylan's ANDAs, MPI
`
`and Mylan will act in concert to distribute and sell Mylan's ANDA Products throughout the
`
`United States, including within West Virginia.
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`JURISDICTION
`
`This Court has jurisdiction over this action pursuant to 28 U.S.C. §§ 1331,
`
`1338(a), 2201, and 2202.
`
`This Court has personal jurisdiction over Mylan.
`
`MPI is subject to personal jurisdiction in West Virginia because, among other
`
`things, it has purposely availed itself of the benefits and protections of West Virginia's laws such
`
`that it should reasonably anticipate being haled into court here. In addition, on information and
`
`belief, MPI develops, manufactures, imports, markets, offers to sell,*and/or sells generic drugs
`
`throughout the United States, including in the State of, and therefore transacts business within
`
`the State of West Virginia related to Merck's claims, and/or has engaged in systematic and
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`continuous business contacts within the State of West Virginia
`
`Mylan Inc. is subject to personal jurisdiction in West Virginia because, among
`
`other things, Mylan Inc., itself and through its wholly owned subsidiary MPI, has purposefully
`
`availed itself of the benefits and protections of West Virginia's laws such that it should
`
`reasonably anticipate being haled into court here. On information and belief, Mylan Inc., itself
`
`and through its wholly owned subsidiary MPI, develops, manufactures, imports, markets, offers
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`to sell, and/or sells generic drugs throughout the United States, including in the State of West
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`Virginia, and therefore transacts business within the State of West Virginia, and/or has engaged
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`in systematic and continuous business contacts within the State of West Virginia. In addition,
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`Mylan Inc. is subject to personal jurisdiction in West Virginia because, on information and
`
`belief, it controls and dominates MPI, and therefore the activities of MPI in this jurisdiction are
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`attributed to Mylan Inc.
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`On information and belief, if Mylan's ANDAs are approved, Mylan will
`
`manufacture, market, sell, and/or distribute Mylan's ANDA Products within the United States,
`
`including in West Virginia, consistent with Mylan's practices for the marketing and distribution
`
`of other generic pharmaceutical products. On information and belief, Mylan regularly does
`
`business in West Virginia, and its practices with other generic pharmaceutical products have
`
`involved placing those products into the stream of commerce for distribution throughout the
`
`United States, including in West Virginia. On information and belief, Mylan's generic
`
`pharmaceutical products are used and/or consumed within and throughout the United States,
`
`including in West Virginia. On information and belief, Mylan's ANDA Products will be
`
`prescribed by physicians practicing in West Virginia, dispensed by pharmacies located within
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`West Virginia, and used by patients in West Virginia. Each of these activities would have a
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`substantial effect within West Virginia and would constitute infringement of Merck's patent in
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`the event that Mylan's ANDA Products are approved before the patent expires. Each of these
`
`activities would have a substantial effect within West Virginia and would constitute infringement
`
`of Merck's patent rights in the even that Mylan's ANDA Product is approved before
`
`On information and belief, Mylan derives substantial revenue from generic
`
`pharmaceutical products that are used and/or consumed within West Virginia, and that are
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`manufactured by Mylan and/or for which MPI and/or Mylan Inc. is/are the named applicant(s)
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`on approved ANDAs. On information and belief, various products for which MPI and/or Mylan
`
`Inc. is/are the named applicant(s) on approved ANDAs are available at retail pharmacies in West
`
`Virginia.
`
`herein.
`
`VENUE
`
`Merck incorporates each of the preceding paragraphs 1-22 as if fully set forth
`
`Venue is proper in this district as to MPI under 28 U.S.C. § 1400(b) because MPI
`
`is a corporation organized and existing under the laws of the State of West Virginia and is
`
`subject to personal jurisdiction in this judicial district.
`
`Venue is proper in this district as to Mylan Inc. under 28 U.S.C. § 1400(b)
`
`because Mylan Inc. is subject to personal jurisdiction in this judicial district, has previously
`
`consented to venue in this judicial district, and on information and belief will consent to venue
`
`for the purpose of this case.
`
`THE '708 PATENT
`
`Merck incorporates each of the preceding paragraphs 1-25 as if fully set forth
`
`herein.
`
`The inventors named on the '708 patent are Stephen Howard Cypes, Alex Minhua
`
`Chen, Russell R. Ferlita, Karl Hansen, Ivan Lee, Vicky K. Vydra, and Robert M. Wenslow, Jr.
`
`The '708 patent, entitled "Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV
`
`Inhibitor" (attached as Exhibit A), was duly and legally issued on February 5, 2008.
`
`Merck is the owner and assignee of the '708 patent.
`
`The '708 patent claims, inter alia, a dihydrogenphosphate salt of 4-oxo-4-[3-
`
`(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-y1]-1-(2,4,5-
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`trifluorophenyl)butan-2-amine of structural formula I, or a hydrate thereof, as recited in claim 1
`
`of the '708 patent.
`
`JANUVIA®, as well as methods of using JANUVIA®, are covered by one or more
`
`claims of the '708 patent, including claim 1 of the '708 patent, and the '708 patent has been
`
`listed in connection with JANUVIA® in the FDA's Orange Book.
`
`JANUMET®, as well as methods of using JANUMET®, are covered by one or
`
`more claims of the '708 patent, including claim 1 of the '708 patent, and the '708 patent has been
`
`listed in connection with JANUMET® in the FDA's Orange Book.
`
`THE '921 PATENT
`
`Merck incorporates each of the preceding paragraphs 1-32 as if fully set forth
`
`herein.
`
`The inventors named on the '921 patent are Ashkan Kamali, Laman Alani, Kyle
`
`A. Fliszar, Soumojeet Ghosh, and Monica Tijerina.
`
`The '921 patent, entitled "Pharmaceutical Compositions of Combinations of
`
`Dipeptidyl Peptidase-4 Inhibitors with Metformin" (attached as Exhibit B), was duly and legally
`
`issued on April 9, 2013.
`
`Merck is the owner and assignee of the '921 patent.
`
`The '921 patent claims, inter alia, a pharmaceutical composition comprising: (a)
`
`about 3 to 20% by weight of sitagliptin, or a pharmaceutically acceptable salt thereof; (b) about
`
`25 to 94% by weight of metformin hydrochloride; (c) about 0.1 to 10% by weight of a lubricant;
`
`(d) about 0 to 35% by weight of a binding agent; (e) about 0.5 to 1% by weight of a surfactant;
`
`and (0 about 5 to 15% by weight of a diluent, as recited in claim 1 of the '921 patent.
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`38. (cid:9)
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`JANUMET®, as well as methods of using JANUMET®, are covered by one or
`
`more claims of the '921 patent, including claim 1 of the '921 patent, and the '921 patent has been
`
`listed in connection with JANUMET® in the FDA's Orange Book.
`
`COUNT I — INFRINGEMENT OF THE '708 PATENT
`(MYLAN'S '473 ANDA PRODUCT)
`
`Merck incorporates each of the preceding paragraphs 1-38 as if fully set forth
`
`herein.
`
`In Mylan's '473 Notice Letter, Mylan notified Merck of the submission of
`
`Mylan's '473 ANDA to the FDA. The purpose of this submission was to obtain approval under
`
`the FDCA to engage in the commercial manufacture, use, offer for sale, sale and/or importation
`
`of Mylan's '473 ANDA Product prior to the expiration of the '708 patent.
`
`In Mylan's '473 Notice Letter, Mylan also notified Merck that, as part of its
`
`ANDA, Mylan had filed certifications 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), with respect to the '708 patent. On information
`
`and belief, Mylan submitted its ANDA to the FDA containing certifications pursuant to 21
`
`U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the '708 patent is invalid, unenforceable, and/or will
`
`not be infringed by the manufacture, use, offer for sale, sale, and/or importation of Mylan's '473
`
`ANDA Product.
`
`In Mylan's '473 Notice Letter, Mylan stated that Mylan's '473 ANDA Product
`
`contains sitagliptin phosphate as an active ingredient.
`
`Mylan's '473 ANDA Product, and the use of Mylan's '473 ANDA Product, are
`
`covered by one or more claims of the '708 patent, including at least claim 1 of the '708 patent,
`
`because claim 1 of the '708 patent covers the sitagliptin phosphate contained in Mylan's '473
`
`ANDA Product.
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`In Mylan's '473 Notice Letter, Mylan did not contest infringement of claim 1 of
`
`the '708 patent.
`
`Mylan's submission of Mylan's '473 ANDA for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
`
`Mylan's '473 ANDA Product before the expiration of the '708 patent was an act of infringement
`
`of the '708 patent under 35 U.S.C. § 271(e)(2)(A).
`
`On information and belief, Mylan will engage in the manufacture, use, offer for
`
`sale, sale, marketing, distribution, and/or importation of Mylan's '473 ANDA Product
`
`immediately and imminently upon approval of its ANDA.
`
`The manufacture, use, sale, offer for sale, or importation of Mylan's '473 ANDA
`
`Product would infringe one or more claims of each of the '708 patent, including at least claim 1
`
`of the '708 patent.
`
`On information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Mylan's '473 ANDA Product in accordance with, and as directed by, its proposed
`
`product labeling would infringe one or more claims of the '708 patent, including at least claim 1
`
`of the '708 patent.
`
`On information and belief, Mylan plans and intends to, and will, actively induce
`
`infringement of the '708 patent when Mylan's '473 ANDA is approved, and plans and intends
`
`to, and will, do so immediately and imminently upon approval. Mylan's activities will be done
`
`with knowledge of the '708 patent and specific intent to infringe that patent.
`
`On information and belief, Mylan knows that Mylan's '473 ANDA Product and
`
`its proposed labeling are especially made or adapted for use in infringing the '708 patent, that
`
`Mylan's '473 ANDA Product is not a staple article or commodity of commerce, and that
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`Mylan's '473 ANDA Product and its proposed labeling are not suitable for substantial
`
`noninfringing use. On information and belief, Mylan plans and intends to, and will, contribute to
`
`infringement of the '708 patent immediately and imminently upon approval of Mylan's '473
`
`ANDA.
`
`Notwithstanding Mylan's knowledge of the claims of the '708 patent, Mylan has
`
`continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import Mylan's
`
`'473 ANDA Product with its product labeling following FDA approval of Mylan's '473 ANDA
`
`prior to the expiration of the '708 patent.
`
`The foregoing actions by Mylan constitute and/or will constitute infringement of
`
`the '708 patent; active inducement of infringement of the '708 patent; and contribution to the
`
`infringement by others of the '708 patent.
`
`On information and belief, Mylan has acted with full knowledge of the '708
`
`patent and without a reasonable basis for believing that it would not be liable for infringement of
`
`the '708 patent; active inducement of infringement of the '708 patent; and/or contribution to the
`
`infringement by others of the '708 patent.
`
`Merck will be substantially and irreparably damaged by infringement of the '708
`
`patent.
`
`Unless Mylan is enjoined from infringing the '708 patent, actively inducing
`
`infringement of the '708 patent, and contributing to the infringement by others of the '708
`
`patent, Merck will suffer irreparable injury. Merck has no adequate remedy at law.
`
`COUNT II— DECLARATORY JUDGMENT
`OF INFRINGEMENT OF THE '708 PATENT
`(MYLAN'S '473 ANDA PRODUCT)
`
`Merck incorporates each of the preceding paragraphs 1-55 as if fully set forth
`
`herein.
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`The Court may declare the rights and legal relations of the parties pursuant to
`
`28 U.S.C. §§ 2201 and 2202 because there is a case of actual controversy between Merck on the
`
`one hand and Mylan on the other regarding Mylan's infringement, active inducement of
`
`infringement, and contribution to the infringement by others of the '708 patent.
`
`The Court should declare that the commercial manufacture, use, sale, offer for
`
`sale or importation of Mylan's '473 ANDA Product with its proposed labeling, or any other
`
`Mylan drug product that is covered by or whose use is covered by the '708 patent, will infringe,
`
`induce the infringement of, and contribute to the infringement by others of the '708 patent, and
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`that the claims of the '708 patent are valid.
`
`COUNT III — INFRINGEMENT OF THE '708 PATENT
`(MYLAN'S '478 ANDA PRODUCT)
`
`Merck incorporates each of the preceding paragraphs 1-58 as if fully set forth
`
`herein.
`
`• In Mylan's First '478 Notice Letter, Mylan notified Merck of the submission of
`
`Mylan's '478 ANDA to the FDA. The purpose of this submission was to obtain approval under
`
`the FDCA to engage in the commercial manufacture, use, offer for sale, sale and/or importation
`
`of Mylan's '478 ANDA Product prior to the expiration of the '708 patent.
`
`In Mylan's First '478 Notice Letter, Mylan also notified Merck that, as part of its
`
`ANDA, Mylan had filed certifications 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), with respect to the '708 patent. On information
`
`and belief, Mylan submitted its ANDA to the FDA containing certifications pursuant to 21
`
`U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the '708 patent is invalid, unenforceable, and/or will
`
`not be infringed by the manufacture, use, offer for sale, sale, and/or importation of Mylan's '478
`
`ANDA Product.
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`In Mylan's First '478 Notice Letter, Mylan stated that Mylan's '478 ANDA
`
`Product contains sitagliptin phosphate as an active ingredient.
`
`Mylan's '478 ANDA Product, and the use of Mylan's '478 ANDA Product, are
`
`covered by one or more claims of the '708 patent, including at least claim 1 of the '708 patent,
`
`because claim 1 of the '708 patent covers the sitagliptin phosphate contained in Mylan's '478
`
`ANDA Product.
`
`In Mylan's First '478 Notice Letter, Mylan did not contest infringement of claim
`
`1 of the '708 patent.
`
`Mylan's submission of Mylan's '478 ANDA for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
`
`Mylan's '478 ANDA Product before the expiration of the '708 patent was an act of infringement
`
`of the '708 patent under 35 U.S.C. § 271(e)(2)(A).
`
`On information and belief, Mylan will engage in the manufacture, use, offer for
`
`sale, sale, marketing, distribution, and/or importation of Mylan's '478 ANDA Product
`
`immediately and imminently upon approval of its ANDA.
`
`The manufacture, use, sale, offer for sale, or importation of Mylan's '478 ANDA
`
`Product would infringe one or more claims of the '708 patent, including at least claim 1 of the
`
`'708 patent.
`
`On information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Mylan's '478 ANDA Product in accordance with, and as directed by, its proposed
`
`product labeling would infringe one or more claims of the '708 patent, including at least claim 1
`
`of the '708 patent.
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`On information and belief, Mylan plans and intends to, and will, actively induce
`
`infringement of the '708 patent when Mylan's '478 ANDA is approved, and plans and intends
`
`to, and will, do so immediately and imminently upon approval. Mylan's activities will be done
`
`with knowledge of the '708 patent and specific intent to infringe that patent.
`
`On information and belief, Mylan knows that Mylan's '478 ANDA Product and
`
`its proposed labeling are especially made or adapted for use in infringing the '708 patent, that
`
`Mylan's '478 ANDA Product is not a staple article or commodity of commerce, and that
`
`Mylan's '478 ANDA Product and its proposed labeling are not suitable for substantial
`
`noninfringing use. On information and belief, Mylan plans and intends to, and will, contribute to
`
`infringement of the '708 patent immediately and imminently upon approval of Mylan's '478
`
`ANDA.
`
`Notwithstanding Mylan's knowledge of the claims of the '708 patent, Mylan has
`
`continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import Mylan's
`
`'478 ANDA Product with its product labeling following FDA approval of Mylan's '478 ANDA
`
`prior to the expiration of the '708 patent.
`
`The foregoing actions by Mylan constitute and/or will constitute infringement of
`
`the '708 patent; active inducement of infringement of the '708 patent; and contribution to the
`
`infringement by others of the '708 patent.
`
`On information and belief, Mylan has acted with full knowledge of the '708
`
`patent and without a reasonable basis for believing that it would not be liable for infringement of
`
`the '708 patent; active inducement of infringement of the '708 patent; and/or contribution to the
`
`infringement by others of the '708 patent.
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`74. (cid:9)
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`Merck will be substantially and irreparably damaged by infringement of the '708
`
`patent.
`
`75. (cid:9)
`
`Unless Mylan is enjoined from infringing the '708 patent, actively inducing
`
`infringement of the '708 patent, and contributing to the infringement by others of the '708
`
`patent, Merck will suffer irreparable injury. Merck has no adequate remedy at law.
`
`COUNT IV — DECLARATORY JUDGMENT
`OF INFRINGEMENT OF THE '708 PATENT
`(MYLAN'S '478 ANDA PRODUCT)
`
`Merck incorporates each of the preceding paragraphs 1-75 as if fully set forth
`
`herein.
`
`The Court may declare the rights and legal relations of the parties pursuant to
`
`28 U.S.C. §§ 2201 and 2202 because there is a case of actual controversy between Merck on the
`
`one hand and Mylan on the other regarding Mylan's infringement, active inducement of
`
`infringement, and contribution to the infringement by others of the '708 patent.
`
`The Court should declare that the commercial manufacture, use, sale, offer for
`
`sale or importation of Mylan's '478 ANDA Product with its proposed labeling, or any other
`
`Mylan drug product that is covered by or whose use is covered by the '708 patent, will infringe,
`
`induce the infringement of and contribute to the infringement by others of, the '708 patent, and
`
`that the claims of the '708 patent are valid.
`
`COUNT V — INFRINGEMENT OF THE '921 PATENT
`(MYLAN'S '478 ANDA PRODUCT)
`
`Merck incorporates each of the preceding paragraphs 1-78 as if fully set forth
`
`herein.
`
`In Mylan's Second '478 Notice Letter, Mylan notified Merck of the submission of
`
`Mylan's '478 ANDA to the FDA. The purpose of this submission was to obtain approval under
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`Case 1:19-cv-01489-RGA Document 1 Filed 05/02/19 Page 15 of 20 PageID #: 15
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`the FDCA to engage in the commercial manufacture, use, offer for sale, sale and/or importation
`
`of Mylan's '478 ANDA Product prior to the expiration of the '921 patent.
`
`In Mylan's Second '478 Notice Letter, Mylan also notified Merck that, as part of
`
`its ANDA, Mylan had filed certifications 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), with respect to the '921 patent. On information
`
`and belief, Mylan submitted its ANDA to the FDA containing certifications pursuant to 21
`
`U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the '921 patent is invalid, unenforceable, and/or will
`
`not be infringed by the manufacture, use, offer for sale, sale, and/or importation of Mylan's '478
`
`ANDA Product.
`
`Mylan's '478 ANDA Product, and the use of Mylan's '478 ANDA Product, are
`
`covered by one or more claims of the '921 patent, including at least claim 1 of the '921 patent,
`
`because the composition of Mylan's '478 ANDA Product includes the same or equivalent
`
`ingredients as recited in claim 1 of the '921 patent in the same or equivalent amounts.
`
`Mylan's submission of Mylan's '478 ANDA for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
`
`Mylan's '478 ANDA Product before the expiration of the '921 patent was an act of infringement
`
`of the '921 patent under 35 U.S.C. § 271(e)(2)(A).
`
`On information and belief, Mylan will engage in the manufacture, use, offer for
`
`sale, sale, marketing, distribution, and/or importation of Mylan's '478 ANDA Product
`
`immediately and imminently upon approval of its ANDA.
`
`The manufacture, use, sale, offer for sale, or importation of Mylan's '478 ANDA
`
`Product would infringe one or more claims of the '921 patent, including at least claim 1 of the
`
`'921 patent.
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`Case 1:19-cv-01489-RGA Document 1 Filed 05/02/19 Page 16 of 20 PageID #: 16
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`On information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Mylan's '478 ANDA Product in accordance with, and as directed by, its proposed
`
`product labeling would infringe one or more claims of the '921 patent, including at least claim 1
`
`of the '921 patent.
`
`On information and belief, Mylan plans and intends to, and will, actively induce
`
`infringement of the '921 patent when Mylan's '478 ANDA is approved, and plans and intends
`
`to, and will, do so immediately and imminently upon approval. Mylan's activities will be done
`
`with knowledge of the '921 patent and specific intent to infringe that patent.
`
`On information and belief, Mylan knows that Mylan's '478 ANDA Product and
`
`its proposed labeling are especially made or adapted for use in infringing the '921 patent, that
`
`Mylan's '478 ANDA Product is not a staple article or commodity of commerce, and that
`
`Mylan's '478 ANDA Product and its proposed labeling are not suitable for substantial
`
`noninfringing use. On information and belief, Mylan plans and intends to, and will, contribute to
`
`infringement of the '921 patent immediately and imminently upon approval of Mylan's '478
`
`ANDA.
`
`Notwithstanding Mylan's knowledge of the claims of the '921 patent, Mylan has
`
`continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import Mylan's
`
`'478 ANDA Product with its product labeling following FDA approval of Mylan's '478 ANDA
`
`prior to the expiration of the '921 patent.
`
`The foregoing actions by Mylan constitute and/or will constitute infringement of
`
`the '921 patent; active inducement of infringement of the '921 patent; and contribution to the
`
`infringement by others of the '921 patent.
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`On information and belief, Mylan has acted with full knowledge of the '921
`
`patent and without a reasonable basis for believing that it would not be liable for infringement of
`
`the '921 patent; active inducement of infringement of the '921 patent; and/or contribution to the
`
`infringement by others of the '921 patent.
`
`Merck will be substantially and irreparably damaged by infringement of the '921
`
`patent.
`
`Unless Mylan is enjoined from infringing the '921 patent, actively inducing
`
`infringement of the '921 patent, and contributing to the infringement by others of the '921
`
`patent, Merck will suffer irreparable injury. Merck has no adequate remedy at law.
`
`COUNT VI— DECLARATORY JUDGMENT OF
`INFRINGEMENT OF THE '921 PATENT
`(MYLAN'S '478 ANDA PRODUCT)
`
`Merck incorporates each of the preceding paragraphs 1-93 as if fully set forth
`
`herein.
`
`The Court may declare the rights and legal relations of the parties pursuant to
`
`28 U.S.C. §§ 2201 and 2202 because there is a case of actual controversy between Merck on the
`
`one hand and Mylan on the other regarding Mylan's infringement, active inducement of
`
`infringement, and contribution to the infringement by others of the '921 patent.
`
`The Court should declare that the commercial manufacture, use, sale, offer for
`
`sale or importation of Mylan's '478 ANDA Product with its proposed labeling, or any other
`
`Mylan drug product that is covered by or whose use is covered by the '921 patent, will infringe,
`
`induce the infringement of, and contribute to the infringement by others of the '921 patent, and
`
`that the claims of the '921 patent are valid.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Merck requests the following relief:
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`Case 1:19-cv-01489-RGA Document 1 Filed 05/02/19 Page 18 of 20 PageID #: 18
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`A judgment that the '708 patent has been infringed under 35 U.S.C. § 271(e)(2)
`
`by Mylan's submissions to the FDA of Mylan's ANDAs;
`
`A judgment ordering that the effective date of any FDA approval of the
`
`commercial manufacture, use, or sale of Mylan's ANDA Products, or any other drug product that
`
`infringes or the use of which infringes the '708 patent, be not earlier than the latest of the
`
`expiration date of the '708 patent, inclusive of any extension(s) and additional period(s) of
`
`exclusivity;
`
`A preliminary and permanent injunction enjoining Mylan, and all persons acting
`
`in concert with Mylan, from the commercial manufacture, use, sale, offer for sale, or importation
`
`into the United States of Mylan's ANDA Products, or any other drug product covered by or
`
`whose use is covered by the '708 patent, prior to the expiration of the '708 patent, inclusive of
`
`any extension(s) and additional period(s) of exclusivity;
`
`A judgment declaring that the commercial manufacture, use, sale, offer for sale or
`
`importation of Mylan's ANDA Products, or any other drug product that is covered by or whose
`
`use is covered by the '708 patent, prior to the expiration of the '708 patent, will infringe, induce
`
`the infringement of, and contribute to the infringement by others of, the '708 patent;
`
`A judgment that the '921 patent has been infringed under 35 U.S.C. § 271(e)(2)
`
`by Mylan's submission to the FDA of Mylan's '478 ANDA;
`
`(0 (cid:9)
`
`A judgment ordering that the effective date of any FDA approval of commercial
`
`manufacture, use, or sale of Mylan's '478 ANDA Product, or any other drug product that
`
`infringes or the use of which infringes the '921 pa