Case 1:19-cv-00317-UNA Document 1 Filed 02/13/19 Page 1 of 21 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`v.
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`C.A. No. _____________________
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`MERCK SHARP & DOHME CORP.,
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`Plaintiff,
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`
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`WATSON LABORATORIES, INC., TEVA
`PHARMACEUTICALS USA, INC., and
`TEVA PHARMACEUTICAL INDUSTRIES
`LTD.,
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`
`
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`
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`Defendants.
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`COMPLAINT
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`Plaintiff Merck Sharp & Dohme Corp. (“Merck”), by its attorneys, for its Complaint,
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`alleges as follows:
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`1.
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`This is an action for patent infringement under the patent laws of the United
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`States, Title 35, United States Code, and for a declaratory judgment of patent infringement under
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`28 U.S.C. §§ 2201 and 2202 and the patent laws of the United States, Title 35, United States
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`Code, that arises out of defendant’s submission of Abbreviated New Drug Application
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`(“ANDA”) Nos. 202327 and 202365 to the U.S. Food and Drug Administration (“FDA”) seeking
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`approval to commercially manufacture, use, offer for sale, sell, and/or import versions of
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`JANUVIA® (sitagliptin phosphate) and JANUMET® (metformin hydrochloride; sitagliptin
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`phosphate) prior to the expiration of U.S. Patent No. 7,326,708 (“the ’708 patent”) and U.S.
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`Patent No. 8,414,921 (“the ’921 patent”).
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`2.
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`Watson Laboratories, Inc. notified Merck by letter dated January 6, 2011
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`(“Watson’s ’327 Notice Letter”) that it had submitted to the FDA ANDA No. 202327
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`(“Watson’s ’327 ANDA”), seeking approval from the FDA to engage in the commercial
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`ME1 29533305v.1
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`1
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`Merck Sharp & Dohme Corp. Exhibit 2042
`Teva Pharmaceuticals. v. Merck Sharp and Dohme Corp.
`IPR2020-01045
`Page 1
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`manufacture, use, offering for sale, sale, and/or importation of generic sitagliptin phosphate oral
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`tablets (“Watson’s ’327 ANDA Product”) prior to the expiration of the ’708 patent.
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`3.
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`On information and belief, Watson’s ’327 ANDA Product is a generic version of
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`Merck’s JANUVIA®.
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`4.
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`Watson Laboratories, Inc. notified Merck by letter dated February 7, 2011
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`(“Watson’s First ’365 Notice Letter”) that it had submitted to the FDA ANDA No. 202365
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`(“Watson’s ’365 ANDA”), seeking approval from the FDA to engage in the commercial
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`manufacture, use, offering for sale, sale, and/or importation of generic metformin hydrochloride
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`and sitagliptin phosphate oral tablets (“Watson’s ’365 ANDA Product”) prior to the expiration of
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`the ’708 patent.
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`5.
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`Watson Laboratories, Inc. notified Merck by letter dated October 29, 2014
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`(“Watson’s Second ’365 Notice Letter”) it had amended Watson’s ’365 ANDA to additionally
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`seek approval from the FDA to engage in the commercial manufacture, use, offering for sale,
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`sale, and/or importation of Watson’s ’365 ANDA Product prior to the expiration of the ’921
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`patent.
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`6.
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`On information and belief, Watson’s ’365 ANDA Product is a generic version of
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`Merck’s JANUMET®.
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`7.
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`Watson’s ’327 Notice Letter, Watson’s First ’365 Notice Letter, and Watson’s
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`Second ’365 Notice Letter are collectively referred to herein as “Watson’s Notice Letters.”
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`Watson’s ’327 ANDA and Watson’s ’365 ANDA are collectively referred to herein as
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`“Watson’s ANDAs.” Watson’s ’327 ANDA Product and Watson’s ’365 ANDA Product are
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`collectively referred to herein as “Watson’s ANDA Products.”
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`ME1 29533305v.1
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`Merck Sharp & Dohme Corp. Exhibit 2042
`Teva Pharmaceuticals. v. Merck Sharp and Dohme Corp.
`IPR2020-01045
`Page 2
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`PARTIES
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`8.
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`Plaintiff Merck is a corporation organized and existing under the laws of New
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`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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`9.
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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.
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`10. Merck is the holder of NDA No. 22044 for JANUMET® (metformin
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`hydrochloride; sitagliptin phosphate), which has been approved by the FDA.
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`11.
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`On information and belief, defendant Watson Laboratories, Inc. (“Watson”) is a
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`corporation organized and existing under the laws of State of Nevada, having its principal place
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`of business at Morris Corporate Center III, 400 Interspace Parkway, Parsippany, New Jersey
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`07054. On information and belief, Watson is in the business of, among other things,
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`manufacturing and selling generic versions of branded pharmaceutical drugs for the U.S. market.
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`12.
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`On information and belief, defendant Teva Pharmaceuticals USA, Inc. (“Teva
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`USA”) is a corporation organized and existing under the laws of State of Delaware, having its
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`principal place of business at 425 Privet Road, Horsham, Pennsylvania 19044, and 1090
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`Horsham Road, North Wales, Pennsylvania 19454. On information and belief, Teva USA is in
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`the business of, among other things, manufacturing and selling generic versions of branded
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`pharmaceutical drugs for the U.S. market, including through various operating subsidiaries,
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`including Watson.
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`13.
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`On information and belief, defendant Teva Pharmaceutical Industries Ltd. (“Teva
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`Israel”) is a corporation organized and existing under the laws of Israel, having its principal place
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`of business at 5 Basel Street, P.O. Box 3190, Petach Tikva, 49131, Israel. On information and
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`belief, Teva Israel is in the business of, among other things, manufacturing and selling generic
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`ME1 29533305v.1
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`Merck Sharp & Dohme Corp. Exhibit 2042
`Teva Pharmaceuticals. v. Merck Sharp and Dohme Corp.
`IPR2020-01045
`Page 3
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`versions of branded pharmaceutical drugs through various operating subsidiaries, including Teva
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`USA and Watson.
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`14.
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`On information and belief, Watson is a wholly owned subsidiary of Teva USA,
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`and Teva USA is a wholly owned subsidiary of Teva Israel. Teva USA and Teva Israel are
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`collectively referred to herein as “Teva.” Watson, Teva USA, and Teva Israel are collectively
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`referred to herein as “Defendants.”
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`15.
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`On information and belief, Watson and/or Teva prepared and submitted Watson’s
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`ANDAs to the FDA, and have acted in concert to seek FDA approval of Watson’s ANDAs.
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`16.
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`On information and belief, Watson and Teva know and intend that upon approval
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`of Watson’s ANDAs, Watson and Teva will act in concert to manufacture, market, sell, and
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`distribute Watson’s ANDA Products throughout the United States, including in Delaware. On
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`information and belief, Watson and Teva are agents of each other and/or operate in concert as
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`integrated parts of the same business group, including with respect to Watson’s ANDA Products,
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`and enter into agreements that are nearer than arm’s length. On information and belief, Watson
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`and Teva participated, assisted, and cooperated in carrying out the acts complained of herein.
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`17.
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`On information and belief, following any FDA approval of Watson’s ANDAs,
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`Watson and Teva will act in concert to distribute and sell Watson’s ANDA Products throughout
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`the United States, including within Delaware.
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`JURISDICTION
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`18.
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`This Court has jurisdiction over this action pursuant to 28 U.S.C. §§ 1331,
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`1338(a), 2201, and 2202.
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`19.
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`This Court has personal jurisdiction over each of Defendants.
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`20. Watson is subject to personal jurisdiction in Delaware because, among other
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`things, it has purposely availed itself of the benefits and protections of Delaware’s laws such that
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`ME1 29533305v.1
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`Merck Sharp & Dohme Corp. Exhibit 2042
`Teva Pharmaceuticals. v. Merck Sharp and Dohme Corp.
`IPR2020-01045
`Page 4
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`it should reasonably anticipate being haled into court here. On information and belief, Watson
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`develops, manufactures, imports, markets, offers to sell, and/or sells generic drugs throughout
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`the United States, including in the State of Delaware, and therefore transacts business within the
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`State of Delaware related to Merck’s claims, and/or has engaged in systematic and continuous
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`business contacts within the State of Delaware.
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`21.
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`Teva USA is subject to personal jurisdiction in Delaware because, among other
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`things, it has purposely availed itself of the benefits and protections of Delaware’s laws such that
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`it should reasonably anticipate being haled into court here. Teva USA is a corporation organized
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`and existing under the laws of the State of Delaware, is qualified to do business in Delaware, and
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`has appointed a registered agent for service of process in Delaware. It therefore has consented to
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`general jurisdiction in Delaware. In addition, on information and belief, Teva USA develops,
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`manufactures, imports, markets, offers to sell, and/or sells generic drugs throughout the United
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`States, including in the State of Delaware, and therefore transacts business within the State of
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`Delaware related to Merck’s claims, and/or has engaged in systematic and continuous business
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`contacts within the State of Delaware
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`22.
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`Teva Israel is subject to personal jurisdiction in Delaware because, among other
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`things, Teva Israel, itself and through its wholly owned subsidiaries Teva USA and Watson, has
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`purposefully availed itself of the benefits and protections of Delaware’s laws such that it should
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`reasonably anticipate being haled into court here. On information and belief, Teva Israel, itself
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`and through its wholly owned subsidiaries Teva USA and Watson, develops, manufactures,
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`imports, markets, offers to sell, and/or sells generic drugs throughout the United States, including
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`in the State of Delaware, and therefore transacts business within the State of Delaware, and/or
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`has engaged in systematic and continuous business contacts within the State of Delaware. In
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`ME1 29533305v.1
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`Merck Sharp & Dohme Corp. Exhibit 2042
`Teva Pharmaceuticals. v. Merck Sharp and Dohme Corp.
`IPR2020-01045
`Page 5
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`addition, Teva Israel is subject to personal jurisdiction in Delaware because, on information and
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`belief, it controls and dominates Teva USA and Watson and therefore the activities of Teva USA
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`and Watson in this jurisdiction are attributed to Teva Israel.
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`23.
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`In addition, this Court has personal jurisdiction over Defendants because Watson
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`and Teva regularly engage in patent litigation concerning FDA-approved branded drug products
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`in this district, do not contest personal jurisdiction in this district, and have purposefully availed
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`themselves of the rights and benefits of this Court by asserting claims and/or counterclaims in
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`this Court. See, e.g., Sanofi-Aventis U.S. LLC v. Watson Labs., Inc., No. 16-1298-GMS, D.I. 16
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`(D. Del. Feb. 24, 2017); Amgen, Inc. v. Watson Labs., Inc., No. 16-855-MSG, D.I. 14 (D. Del.
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`Nov. 18, 2016); AstraZeneca LP v. Watson Labs., Inc., No. 16-338-RGA, D.I. 10 (D. Del. May
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`20, 2016); Alcon Research, Ltd. v. Watson Labs., Inc., No. 16-238-RGA, D.I. 15 (D. Del. June 7,
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`2016); see also, e.g., Teva Pharms. USA, Inc. v. Amneal Pharmaceuticals LLC, No. 17-992-
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`GMS, D.I. 1 (D. Del. Jan. 25, 2017) (Teva USA and Teva Israel); see also, e.g., Valeant Pharms.
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`Int’l v. Actavis Labs. FL, Inc., No. 18-1288-LPS, D.I. 33 (D. Del. Sept. 17, 2018) (Teva USA
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`and Teva Israel); Galderma Labs. L.P. v. Teva Pharms. USA, Inc., No. 17-1783-RGA, D.I. 70
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`(D. Del. Jan. 5, 2018) (Teva USA); Onyx Therapeutics, Inc. v. Teva Pharms USA, Inc., No. 17-
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`449-LPS, D.I. 9 (D. Del. May 17, 2017) (Teva USA); BioDelivery Sciences Int’l, Inc. v. Teva
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`Pharms USA, Inc., No. 17-282-GMS, D.I. 8, 10 (D. Del. May 2 & 4, 2017) (Teva USA and Teva
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`Israel); Arena Pharms., Inc. v. Teva Pharms. USA, Inc. No. 17-231-RGA (D. Del. Mar. 28,
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`2017) (Teva USA); Bayer HealthCare LLC v. Teva Pharms. USA, Inc., No. 16-1221-LPS, D.I.
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`10 (D. Del. Feb. 21, 2017) (Teva USA); Novartis Pharms. Corp. v. Teva Pharms. USA, Inc., No.
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`16-648-RGA, D.I. 13 (D. Del. Aug. 19, 2016) (Teva USA).
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`ME1 29533305v.1
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`Merck Sharp & Dohme Corp. Exhibit 2042
`Teva Pharmaceuticals. v. Merck Sharp and Dohme Corp.
`IPR2020-01045
`Page 6
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`24.
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`On information and belief, if Watson’s ANDAs are approved, Watson and Teva
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`will act in concert to manufacture, market, sell, and/or distribute Watson’s ANDA Products
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`within the United States, including in Delaware, consistent with Watson and Teva’s practices for
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`the marketing and distribution of other generic pharmaceutical products. On information and
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`belief, Watson and Teva regularly do business in Delaware, and their practices with other generic
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`pharmaceutical products have involved placing those products into the stream of commerce for
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`distribution throughout the United States, including in Delaware. On information and belief,
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`Watson and Teva’s generic pharmaceutical products are used and/or consumed within and
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`throughout the United States, including in Delaware. On information and belief, Watson’s
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`ANDA Products will be prescribed by physicians practicing in Delaware, dispensed by
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`pharmacies located within Delaware, and used by patients in Delaware. Each of these activities
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`would have a substantial effect within Delaware and would constitute infringement of Merck’s
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`patent in the event that Watson’s ANDA Products are approved before the patent expires.
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`25.
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`On information and belief, Watson and Teva derive substantial revenue from
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`generic pharmaceutical products that are used and/or consumed within Delaware, and which are
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`manufactured by Watson and/or Teva, and/or for which Watson and/or Teva is/are the named
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`applicant(s) on approved ANDAs. On information and belief, various products for which
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`Watson and/or Teva is/are the named applicant(s) on approved ANDAs are available at retail
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`pharmacies in Delaware.
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`VENUE
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`26. Merck incorporates each of the preceding paragraphs 1–25 as if fully set forth
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`herein.
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`27.
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`Venue is proper in this district as to Watson under 28 U.S.C. § 1391 because
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`Watson is subject to personal jurisdiction in this judicial district, has previously consented to
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`ME1 29533305v.1
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`Merck Sharp & Dohme Corp. Exhibit 2042
`Teva Pharmaceuticals. v. Merck Sharp and Dohme Corp.
`IPR2020-01045
`Page 7
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`venue in this judicial district, and on information and belief will consent to venue for the purpose
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`of this case.
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`28.
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`Venue is proper in this district as to Teva USA under 28 U.S.C. § 1400(b)
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`because Teva USA is a corporation organized and existing under the laws of the State of
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`Delaware and is subject to personal jurisdiction in this judicial district.
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`29.
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`Venue is proper in this district as to Teva Israel under 28 U.S.C. § 1391 because
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`Teva Israel is a corporation organized and existing under the laws of Israel and is subject to
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`personal jurisdiction in this judicial district.
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`THE ’708 PATENT
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`30. Merck incorporates each of the preceding paragraphs 1–29 as if fully set forth
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`herein.
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`31.
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`The inventors named on the ’708 patent are Stephen Howard Cypes, Alex Minhua
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`Chen, Russell R. Ferlita, Karl Hansen, Ivan Lee, Vicky K. Vydra, and Robert M. Wenslow, Jr.
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`32.
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`The ’708 patent, entitled “Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV
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`Inhibitor” (attached as Exhibit A), was duly and legally issued on February 5, 2008.
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`33. Merck is the owner and assignee of the ’708 patent.
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`34.
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`The ’708 patent claims, inter alia, a dihydrogenphosphate salt of 4-oxo-4-[3-
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`(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-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
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`of the ’708 patent.
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`35.
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`JANUVIA®, as well as methods of using JANUVIA®, are covered by one or more
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`claims of the ’708 patent, including claim 1 of the ’708 patent, and the ’708 patent has been
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`listed in connection with JANUVIA® in the FDA’s Orange Book.
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`ME1 29533305v.1
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`Merck Sharp & Dohme Corp. Exhibit 2042
`Teva Pharmaceuticals. v. Merck Sharp and Dohme Corp.
`IPR2020-01045
`Page 8
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`36.
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`JANUMET®, as well as methods of using JANUMET®, are covered by one or
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`more claims of the ’708 patent, including claim 1 of the ’708 patent, and the ’708 patent has been
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`listed in connection with JANUMET® in the FDA’s Orange Book.
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`THE ’921 PATENT
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`37. Merck incorporates each of the preceding paragraphs 1–36 as if fully set forth
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`herein.
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`38.
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`The inventors named on the ’921 patent are Ashkan Kamali, Laman Alani, Kyle
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`A. Fliszar, Soumojeet Ghosh, and Monica Tijerina.
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`39.
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`The ’921 patent, entitled “Pharmaceutical Compositions of Combinations of
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`Dipeptidyl Peptidase-4 Inhibitors with Metformin” (attached as Exhibit B), was duly and legally
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`issued on April 9, 2013.
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`40. Merck is the owner and assignee of the ’921 patent.
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`41.
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`The ’921 patent claims, inter alia, a pharmaceutical composition comprising: (a)
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`about 3 to 20% by weight of sitagliptin, or a pharmaceutically acceptable salt thereof; (b) about
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`25 to 94% by weight of metformin hydrochloride; (c) about 0.1 to 10% by weight of a lubricant;
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`(d) about 0 to 35% by weight of a binding agent; (e) about 0.5 to 1% by weight of a surfactant;
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`and (f) about 5 to 15% by weight of a diluent, as recited in claim 1 of the ’921 patent.
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`42.
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`JANUMET®, as well as methods of using JANUMET®, are covered by one or
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`more claims of the ’921 patent, including claim 1 of the ’921 patent, and the ’921 patent has been
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`listed in connection with JANUMET® in the FDA’s Orange Book.
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`COUNT I – INFRINGEMENT OF THE ’708 PATENT
`(WATSON’S ’327 ANDA PRODUCT)
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`43. Merck incorporates each of the preceding paragraphs 1–42 as if fully set forth
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`herein.
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`ME1 29533305v.1
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`Merck Sharp & Dohme Corp. Exhibit 2042
`Teva Pharmaceuticals. v. Merck Sharp and Dohme Corp.
`IPR2020-01045
`Page 9
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`44.
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`In Watson’s ’327 Notice Letter, Defendants notified Merck of the submission of
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`Watson’s ’327 ANDA to the FDA. The purpose of this submission was to obtain approval under
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`the FDCA to engage in the commercial manufacture, use, offer for sale, sale and/or importation
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`of Watson’s ’327 ANDA Product prior to the expiration of the ’708 patent.
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`45.
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`In Watson’s ’327 Notice Letter, Defendants also notified Merck that, as part of its
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`ANDA, Defendants had filed certifications of the type described in Section 505(j)(2)(A)(vii)(IV)
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`of the FDCA, 21 U.S.C. § 355 (j)(2)(A)(vii)(IV), with respect to the ’708 patent. On information
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`and belief, Defendants submitted Watson’s ’327 ANDA to the FDA containing certifications
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`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the ’708 patent is invalid,
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`unenforceable, and/or will not be infringed by the manufacture, use, offer for sale, sale, and/or
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`importation of Watson’s ’327 ANDA Product.
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`46.
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`In Watson’s ’327 Notice Letter, Defendants stated that Watson’s ’327 ANDA
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`Product contains sitagliptin phosphate as an active ingredient.
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`47. Watson’s ’327 ANDA Product, and the use of Watson’s ’327 ANDA Product, are
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`covered by one or more claims of the ’708 patent, including at least claim 1 of the ’708 patent,
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`because claim 1 of the ’708 patent covers the sitagliptin phosphate contained in Watson’s ’327
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`ANDA Product.
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`48.
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`In Watson’s ’327 Notice Letter, Defendants did not contest infringement of claim
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`1 of the ’708 patent.
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`49.
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`Defendants’ submission of Watson’s ’327 ANDA for the purpose of obtaining
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`approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
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`Watson’s ’327 ANDA Product before the expiration of the ’708 patent was an act of
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`infringement of the ’708 patent under 35 U.S.C. § 271(e)(2)(A).
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`Merck Sharp & Dohme Corp. Exhibit 2042
`Teva Pharmaceuticals. v. Merck Sharp and Dohme Corp.
`IPR2020-01045
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`50.
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`On information and belief, Defendants will engage in the manufacture, use, offer
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`for sale, sale, marketing, distribution, and/or importation of Watson’s ’327 ANDA Product
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`immediately and imminently upon approval of its ANDA.
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`51.
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`The manufacture, use, sale, offer for sale, or importation of Watson’s ’327 ANDA
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`Product would infringe one or more claims of the ’708 patent, including at least claim 1 of the
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`’708 patent.
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`52.
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`On information and belief, the manufacture, use, sale, offer for sale, or
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`importation of Watson’s ’327 ANDA Product in accordance with, and as directed by its
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`proposed product labeling would infringe one or more claims of the ’708 patent, including at
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`least claim 1 of the ’708 patent.
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`53.
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`On information and belief, Defendants plan and intend to, and will, actively
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`induce infringement of the ’708 patent when Watson’s ’327 ANDA is approved, and plan and
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`intend to, and will, do so immediately and imminently upon approval. Defendants’ activities
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`will be done with knowledge of the ’708 patent and specific intent to infringe that patent.
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`54.
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`On information and belief, Defendants know that Watson’s ’327 ANDA Product
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`and its proposed labeling are especially made or adapted for use in infringing the ’708 patent,
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`that Watson’s ’327 ANDA Product is not a staple article or commodity of commerce, and that
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`Watson’s ’327 ANDA Product and its proposed labeling are not suitable for substantial
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`noninfringing use. On information and belief, Defendants plan and intend to, and will,
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`contribute to infringement of the ’708 patent immediately and imminently upon approval of
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`Watson’s ’327 ANDA.
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`55.
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`Notwithstanding Defendants’ knowledge of the claims of the ’708 patent,
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`Defendants have continued to assert its intent to manufacture, offer for sale, sell, distribute,
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`ME1 29533305v.1
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`Merck Sharp & Dohme Corp. Exhibit 2042
`Teva Pharmaceuticals. v. Merck Sharp and Dohme Corp.
`IPR2020-01045
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`and/or import Watson’s ’327 ANDA Product with its product labeling following FDA approval
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`of Watson’s ’327 ANDA prior to the expiration of the ’708 patent.
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`56.
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`The foregoing actions by Defendants 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.
`
`57.
`
`On information and belief, Defendants have acted with full knowledge of the ’708
`
`patent and without a reasonable basis for believing that Defendants 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.
`
`58. Merck will be substantially and irreparably damaged by infringement of the ’708
`
`patent.
`
`59.
`
`Unless Defendants are 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
`(WATSON’S ’327 ANDA PRODUCT)
`
`60. Merck incorporates each of the preceding paragraphs 1–59 as if fully set forth
`
`herein.
`
`61.
`
`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 Defendants on the other regarding Defendants’ infringement, active inducement of
`
`infringement, and contribution to the infringement by others of the ’708 patent.
`
`62.
`
`The Court should declare that the commercial manufacture, use, sale, offer for
`
`sale or importation of Watson’s ’327 ANDA Product with its proposed labeling, or any other
`
`ME1 29533305v.1
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`12
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`Teva Pharmaceuticals. v. Merck Sharp and Dohme Corp.
`IPR2020-01045
`Page 12
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`

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`Case 1:19-cv-00317-UNA Document 1 Filed 02/13/19 Page 13 of 21 PageID #: 13
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`
`
`drug product of Defendants 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 III – INFRINGEMENT OF THE ’708 PATENT
` (WATSON’S ’365 ANDA PRODUCT)
`
`63. Merck incorporates each of the preceding paragraphs 1–62 as if fully set forth
`
`herein.
`
`64.
`
`In Watson’s First ’365 Notice Letter, Defendants notified Merck of the
`
`submission of Watson’s ’365 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 Watson’s ’365 ANDA Product prior to the expiration of the ’708 patent.
`
`65.
`
`In Watson’s First ’365 Notice Letter, Defendants also notified Merck that, as part
`
`of its ANDA, Defendants 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, Defendants submitted Watson’s ’365 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 Watson’s ’365 ANDA Product.
`
`66.
`
`In Watson’s First ’365 Notice Letter, Defendants stated that Watson’s ’365
`
`ANDA Product contains sitagliptin phosphate as an active ingredient.
`
`67. Watson’s ’365 ANDA Product, and the use of Watson’s ’365 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 Watson’s ’365
`
`ANDA Product.
`
`ME1 29533305v.1
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`13
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`Teva Pharmaceuticals. v. Merck Sharp and Dohme Corp.
`IPR2020-01045
`Page 13
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`

`

`Case 1:19-cv-00317-UNA Document 1 Filed 02/13/19 Page 14 of 21 PageID #: 14
`
`
`
`68.
`
`In Watson’s First ’365 Notice Letter, Defendants did not contest infringement of
`
`claim 1 of the ’708 patent.
`
`69.
`
`Defendants’ submission of Watson’s ’365 ANDA for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
`
`Watson’s ’365 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).
`
`70.
`
`On information and belief, Defendants will engage in the manufacture, use, offer
`
`for sale, sale, marketing, distribution, and/or importation of Watson’s ’365 ANDA Product
`
`immediately and imminently upon approval of its ANDA.
`
`71.
`
`The manufacture, use, sale, offer for sale, or importation of Watson’s ’365 ANDA
`
`Product would infringe one or more claims of the ’708 patent, including at least claim 1 of the
`
`’708 patent.
`
`72.
`
`On information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Watson’s ’365 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.
`
`73.
`
`On information and belief, Defendants plan and intend to, and will, actively
`
`induce infringement of the ’708 patent when Watson’s ’365 ANDA is approved, and plan and
`
`intend to, and will, do so immediately and imminently upon approval. Defendants’ activities
`
`will be done with knowledge of the ’708 patent and specific intent to infringe that patent.
`
`74.
`
`On information and belief, Defendants know that Watson’s ’365 ANDA Product
`
`and its proposed labeling are especially made or adapted for use in infringing the ’708 patent,
`
`that Watson’s ’365 ANDA Product is not a staple article or commodity of commerce, and that
`
`ME1 29533305v.1
`
`14
`
`Merck Sharp & Dohme Corp. Exhibit 2042
`Teva Pharmaceuticals. v. Merck Sharp and Dohme Corp.
`IPR2020-01045
`Page 14
`
`

`

`Case 1:19-cv-00317-UNA Document 1 Filed 02/13/19 Page 15 of 21 PageID #: 15
`
`
`
`Watson’s ’365 ANDA Product and its proposed labeling are not suitable for substantial
`
`noninfringing use. On information and belief, Defendants plan and intend to, and will,
`
`contribute to infringement of the ’708 patent immediately and imminently upon approval of
`
`Watson’s ’365 ANDA.
`
`75.
`
`Notwithstanding Defendants’ knowledge of the claims of the ’708 patent,
`
`Defendants have continued to assert its intent to manufacture, offer for sale, sell, distribute,
`
`and/or import Watson’s ’365 ANDA Product with its product labeling following upon FDA
`
`approval of Watson’s ’365 ANDA prior to the expiration of the ’708 patent.
`
`76.
`
`The foregoing actions by Defendants 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.
`
`77.
`
`On information and belief, Defendants have acted with full knowledge of the ’708
`
`patent and without a reasonable basis for believing that Defendants 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.
`
`78. Merck will be substantially and irreparably damaged by infringement of the ’708
`
`patent.
`
`79.
`
`Unless Defendants are 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
`(WATSON’S ’365 ANDA PRODUCT)
`
`80. Merck incorporates each of the preceding paragraphs 1–79 as if fully set forth
`
`herein.
`
`ME1 29533305v.1
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`15
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`Merck Sharp & Dohme Corp. Exhibit 2042
`Teva Pharmaceuticals. v. Merck Sharp and Dohme Corp.
`IPR2020-01045
`Page 15
`
`

`

`Case 1:19-cv-00317-UNA Document 1 Filed 02/13/19 Page 16 of 21 PageID #: 16
`
`
`
`81.
`
`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 Defendants on the other regarding Defendants’ infringement, active inducement of
`
`infringement, and contribution to the infringement by others of the ’708 patent.
`
`82.
`
`The Court should declare that the commercial manufacture, use, sale, offer for
`
`sale or importation of Watson’s ’365 ANDA Product with its proposed labeling, or any other
`
`drug product of Defendants 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
` (WATSON’S ’365 ANDA PRODUCT)
`
`83. Merck incorporates each of the preceding paragraphs 1–82 as if fully set forth
`
`herein.
`
`84.
`
`In Watson’s Second ’365 Notice Letter, Defendants notified Merck of the
`
`submission of Watson’s ’365 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 Watson’s ’365 ANDA Product prior to the expiration of the ’921 patent.
`
`85.
`
`In Watson’s Second ’365 Notice Letter, Defendants also notified Merck that, as
`
`part of its ANDA, Defendants 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, Defendants submitted Watson’s ’365 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,