Case 1:19-cv-00318-UNA Document 1 Filed 02/13/19 Page 1 of 23 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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`
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`Plaintiff,
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`
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`TEVA PHARMACEUTICALS USA, INC.,
`and TEVA PHARMACEUTICAL
`INDUSTRIES LTD.,
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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 defendants’ submission of Abbreviated New Drug Application
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`(“ANDA”) Nos. 202487, 202488, 204524, and 204591 to the U.S. Food and Drug
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`Administration (“FDA”) seeking approval to commercially manufacture, use, offer for sale, sell,
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`and/or import versions of JANUVIA® (sitagliptin phosphate), JANUMET® (metformin
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`hydrochloride; sitagliptin phosphate), JUVISYNC® (simvastatin; sitagliptin phosphate), and
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`JANUMET XR® (metformin hydrochloride; sitagliptin phosphate extended release tablets) prior
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`to the expiration of U.S. Patent No. 7,326,708 (“the ’708 patent”).
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`2.
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`Teva Pharmaceuticals USA, Inc. notified Merck by letter dated December 14,
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`2010 (“Teva’s ’487 Notice Letter”) that it had submitted to the FDA ANDA No. 202487
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`(“Teva’s ’487 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 sitagliptin phosphate oral
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`tablets (“Teva’s ’487 ANDA Product”) prior to the expiration of the ’708 patent.
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`3.
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`On information and belief, Teva’s ’487 ANDA Product is a generic version of
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`Merck’s JANUVIA® product.
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`4.
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`Teva Pharmaceuticals USA, Inc. notified Merck by letter dated December 14,
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`2010 (“Teva’s ’488 Notice Letter”) that it had submitted to the FDA ANDA No. 202488
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`(“Teva’s ’488 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 (“Teva’s ’488 ANDA Product”) prior to the expiration of
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`the ’708 patent.
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`5.
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`On information and belief, Teva’s ’488 ANDA Product is a generic version of
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`Merck’s JANUMET® product.
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`6.
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`Teva Pharmaceuticals USA, Inc. notified Merck by letter dated December 3, 2012
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`(“Teva’s ’524 Notice Letter”), that it had submitted to the FDA ANDA No. 204524 (“Teva’s
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`’524 ANDA”), seeking approval from the FDA to engage in the commercial manufacture, use,
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`offering for sale, sale, and/or importation of generic simvastatin and sitagliptin phosphate oral
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`tablets (“Teva’s ’524 ANDA Product”) prior to the expiration of the ’708 patent.
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`7.
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`On information and belief, Teva’s ’524 ANDA Product is a generic version of
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`Merck’s JUVISYNC® product.
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`8.
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`Teva Pharmaceuticals USA, Inc. notified Merck by letter dated March 1, 2013
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`(“Teva’s ’591 Notice Letter”) that it had submitted to the FDA ANDA No. 204591 (“Teva’s
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`’591 ANDA”), seeking approval from the FDA to engage in the commercial manufacture, use,
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`offering for sale, sale, and/or importation of generic metformin hydrochloride and sitagliptin
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`phosphate extended release oral tablets (“Teva’s ’591 ANDA Product”) prior to the expiration of
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`the ’708 patent.
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`9.
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`On information and belief, Teva’s ’591 ANDA Product is a generic version of
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`Merck’s JANUMET XR® product.
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`10.
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`Teva’s ’487 Notice Letter, Teva’s ’488 Notice Letter, Teva’s ’524 Notice Letter,
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`and Teva’s ’591 Notice Letter are collectively referred to herein as “Teva’s Notice Letters.”
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`Teva’s ’487 ANDA, Teva’s ’488 ANDA, Teva’s ’524 ANDA, and Teva’s ’591 ANDA are
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`collectively referred to herein as “Teva’s ANDAs.” Teva’s ’487 ANDA Product, Teva’s ’488
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`ANDA Product, Teva’s ’524 ANDA Product, and Teva’s ’591 ANDA Product are collectively
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`referred to herein as “Teva’s ANDA Products.”
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`PARTIES
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`11.
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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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`12. 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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`13. 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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`14. Merck is the holder of NDA No. 202343 for JUVISYNC® (simvastatin; sitagliptin
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`phosphate), which has been approved by the FDA.
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`15. Merck is the holder of NDA No. 202270 for JANUMET XR® (metformin
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`hydrochloride; sitagliptin phosphate extended release tablets), which has been approved by the
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`FDA.
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`16.
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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
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`places of business at 425 Privet Road, Horsham, Pennsylvania 19044, and 1090 Horsham Road,
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`North Wales, Pennsylvania 19454. On information and belief, Teva USA is in the business of,
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`among other things, manufacturing and selling generic versions of branded pharmaceutical drugs
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`for the U.S. market.
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`17.
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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 the Israel, having its principal
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`place of business at 5 Basel Street, P.O. Box 3190, Petach Tikva, 49131, Israel. On information
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`and belief, Teva Israel is in the business of, among other things, manufacturing and selling
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`generic versions of branded pharmaceutical drugs through various operating subsidiaries,
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`including Teva USA.
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`18.
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`On information and belief, Teva USA is a wholly owned subsidiary of Teva
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`Israel. Teva USA and Teva Israel are collectively referred to herein as “Teva.”
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`19.
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`On information and belief, Teva USA and Teva Israel acted in concert to prepare
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`and submit Teva’s ANDAs to the FDA.
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`20.
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`On information and belief Teva USA and Teva Israel know and intend that upon
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`approval of Teva’s ANDAs, Teva USA and Teva Israel will act in concert to manufacture,
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`market, sell, and distribute Teva’s ANDA Products throughout the United States, including in
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`Delaware. On information and belief, Teva USA and Teva Israel are agents of each other and/or
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`operate in concert as integrated parts of the same business group, including with respect to
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`Teva’s ANDA Products, and enter into agreements that are nearer than arm’s length. On
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`information and belief, Teva USA and Teva Israel participated, assisted, and cooperated in
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`carrying out in the acts complained of herein.
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`21.
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`On information and belief, following any FDA approval of Teva’s ANDAs, Teva
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`USA and Teva Israel will act in concert to distribute and sell Teva’s ANDA Products throughout
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`the United States, including within Delaware.
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`JURISDICTION
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`22.
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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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`23.
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`24.
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`This Court has personal jurisdiction over Teva.
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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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`25.
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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 subsidiary Teva USA, has purposefully
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`availed itself of the benefits and protections of Delaware’s laws such that it should reasonably
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`anticipate being haled into court here. On information and belief, Teva Israel, itself and through
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`its wholly owned subsidiary Teva USA, develops, manufactures, imports, markets, offers to sell,
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`and/or sells generic drugs throughout the United States, including in the State of Delaware, and
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`therefore transacts business within the State of Delaware, and/or has engaged in systematic and
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`continuous business contacts within the State of Delaware. In addition, Teva Israel is subject to
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`personal jurisdiction in Delaware because, on information and belief, it controls and dominates
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`Teva USA and therefore the activities of Teva USA in this jurisdiction are attributed to Teva
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`Israel.
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`26.
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`In addition, this Court has personal jurisdiction over Teva because Teva USA and
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`Teva Israel regularly engage in patent litigation concerning FDA-approved branded drug
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`products in this district, do not contest personal jurisdiction in this district, and/or have
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`purposefully availed themselves of the rights and benefits of this Court by asserting claims
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`and/or counterclaims in this Court. See. e.g., Teva Pharms. USA, Inc. v. Amneal
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`Pharmaceuticals LLC, No. 17-992-GMS, D.I. 1 (D. Del. Jan. 25, 2017) (Teva USA and Teva
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`Israel); see also, e.g., Valeant Pharms. Int’l v. Actavis Labs. FL, Inc., No. 18-1288-LPS, D.I. 33
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`(D. Del. Sept. 17, 2018) (Teva USA and Teva Israel); Galderma Labs. L.P. v. Teva Pharms.
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`USA, Inc., No. 17-1783-RGA, D.I. 70 (D. Del. Jan. 5, 2018) (Teva USA); Onyx Therapeutics,
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`Inc. v. Teva Pharms USA, Inc., No. 17-449-LPS, D.I. 9 (D. Del. May 17, 2017) (Teva USA);
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`BioDelivery Sciences Int’l, Inc. v. Teva Pharms USA, Inc., No. 17-282-GMS, D.I. 8, 10 (D. Del.
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`May 2 & 4, 2017) (Teva USA and Teva Israel); Arena Pharms., Inc. v. Teva Pharms. USA, Inc.
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`No. 17-231-RGA (D. Del. Mar. 28, 2017) (Teva USA); Bayer HealthCare LLC v. Teva Pharms.
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`USA, Inc., No. 16-1221-LPS, D.I. 10 (D. Del. Feb. 21, 2017) (Teva USA); Novartis Pharms.
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`Corp. v. Teva Pharms. USA, Inc., No. 16-648-RGA, D.I. 13 (D. Del. Aug. 19, 2016) (Teva
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`USA).
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`27.
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`On information and belief, if Teva’s ANDAs are approved, Teva will
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`manufacture, market, sell, and/or distribute Teva’s ANDA Products within the United States,
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`including in Delaware, consistent with Teva’s practices for the marketing and distribution of
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`other generic pharmaceutical products. On information and belief, Teva regularly does business
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`in Delaware, and its practices with other generic pharmaceutical products have involved placing
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`those products into the stream of commerce for distribution throughout the United States,
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`including in Delaware. On information and belief, Teva’s generic pharmaceutical products are
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`used and/or consumed within and throughout the United States, including in Delaware. On
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`information and belief, Teva’s ANDA Products will be prescribed by physicians practicing in
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`Delaware, dispensed by pharmacies located within Delaware, and used by patients in Delaware.
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`Each of these activities would have a substantial effect within Delaware and would constitute
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`infringement of Merck’s patent in the event that Teva’s ANDA Products are approved before the
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`patent expires.
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`28.
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`On information and belief, Teva derives substantial revenue from generic
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`pharmaceutical products that are used and/or consumed within Delaware, and that are
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`manufactured by Teva and/or for which Teva USA and/or Teva Israel is/are the named
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`applicant(s) on approved ANDAs. On information and belief, various products for which Teva
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`USA and/or Teva Israel 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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`29. Merck incorporates each of the preceding paragraphs 1–28 as if fully set forth
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`herein.
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`30.
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`Venue is proper in this district as to Teva USA under 28 U.S.C. §1400(b) because
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`Teva USA is a corporation organized and existing under the laws of the State of Delaware.
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`31.
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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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`32. Merck incorporates each of the preceding paragraphs 1–31 as if fully set forth
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`herein.
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`33.
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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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`34.
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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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`35. Merck is the owner and assignee of the ’708 patent.
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`36.
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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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`37.
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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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`38.
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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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`39.
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`JUVISYNC®, as well as methods of using JUVISYNC ®, 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 JUVISYNC ® in the FDA’s Orange Book.
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`40.
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`JANUMET XR®, as well as methods of using JANUMET XR®, are covered by
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`one or more claims of the ’708 patent, including claim 1 of the ’708 patent, and the ’708 patent
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`has been listed in connection with JANUMET XR® in the FDA’s Orange Book.
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`COUNT I – INFRINGEMENT OF THE ’708 PATENT
`(TEVA’S ’487 ANDA PRODUCT)
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`41. Merck incorporates each of the preceding paragraphs 1–40 as if fully set forth
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`herein.
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`42.
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`In Teva’s ’487 Notice Letter, Teva notified Merck of the submission of Teva’s
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`’487 ANDA to the FDA. The purpose of this submission was to obtain approval under the
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`FDCA to engage in the commercial manufacture, use, offer for sale, sale and/or importation of
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`Teva’s ’487 ANDA Product prior to the expiration of the ’708 patent.
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`43.
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`In Teva’s ’487 Notice Letter, Teva also notified Merck that, as part of its ANDA,
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`Teva had filed certifications of the type described in Section 505(j)(2)(A)(vii)(IV) of the FDCA,
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`21 U.S.C. § 355 (j)(2)(A)(vii)(IV), with respect to the ’708 patent. On information and belief,
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`Teva submitted its ANDA to the FDA containing certifications pursuant to 21 U.S.C.
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`§ 355(j)(2)(A)(vii)(IV) asserting that the ’708 patent is invalid, unenforceable, and/or will not be
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`infringed by the manufacture, use, offer for sale, sale, and/or importation of Teva’s ’487 ANDA
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`Product.
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`44.
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`In Teva’s ’487 Notice Letter, Teva stated that Teva’s ’487 ANDA Product
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`contains sitagliptin phosphate as an active ingredient.
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`45.
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`Teva’s ’487 ANDA Product, and the use of Teva’s ’487 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 Teva’s ’487
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`ANDA Product.
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`46.
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`In Teva’s ’487 Notice Letter, Teva did not contest infringement of claim 1 of the
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`’708 patent.
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`47.
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`Teva’s submission of Teva’s ’487 ANDA for the purpose of obtaining approval to
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`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Teva’s
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`’487 ANDA Product before the expiration of the ’708 patent was an act of infringement of the
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`’708 patent under 35 U.S.C. § 271(e)(2)(A).
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`48.
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`On information and belief, Teva will engage in the manufacture, use, offer for
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`sale, sale, marketing, distribution, and/or importation of Teva’s ’487 ANDA Product
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`immediately and imminently upon approval of its ANDA.
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`49.
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`The manufacture, use, sale, offer for sale, or importation of Teva’s ’487 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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`50.
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`On information and belief, the manufacture, use, sale, offer for sale, or
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`importation of Teva’s ’487 ANDA Product in accordance with, and as directed by, its proposed
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`product labeling would infringe one or more claims of the ’708 patent, including at least claim 1
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`of the ’708 patent.
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`51.
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`On information and belief, Teva plans and intends to, and will, actively induce
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`infringement of the ’708 patent when Teva’s ’487 ANDA is approved, and plans and intends to,
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`and will, do so immediately and imminently upon approval. Teva’s activities will be done with
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`knowledge of the ’708 patent and specific intent to infringe that patent.
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`52.
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`On information and belief, Teva knows that Teva’s ’487 ANDA Product and its
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`proposed labeling are especially made or adapted for use in infringing the ’708 patent, that
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`Teva’s ’487 ANDA Product is not a staple article or commodity of commerce, and that Teva’s
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`’487 ANDA Product and its proposed labeling are not suitable for substantial noninfringing use.
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`On information and belief, Teva plans and intends to, and will, contribute to infringement of the
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`’708 patent immediately and imminently upon approval of Teva’s ’487 ANDA.
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`53.
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`Notwithstanding Teva’s knowledge of the claims of the ’708 patent, Teva has
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`continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import Teva’s
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`’487 ANDA Product with its product labeling following FDA approval of Teva’s ’487 ANDA
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`prior to the expiration of the ’708 patent.
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`54.
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`The foregoing actions by Teva constitute and/or will constitute infringement of
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`the ’708 patent; active inducement of infringement of the ’708 patent; and contribution to the
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`infringement by others of the ’708 patent.
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`55.
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`On information and belief, Teva has acted with full knowledge of the ’708 patent
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`and without a reasonable basis for believing that it would not be liable for infringement of the
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`’708 patent; active inducement of infringement of the ’708 patent; and/or contribution to the
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`infringement by others of the ’708 patent.
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`56. Merck will be substantially and irreparably damaged by infringement of the ’708
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`patent.
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`57.
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`Unless Teva is enjoined from infringing the ’708 patent, actively inducing
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`infringement of the ’708 patent, and contributing to the infringement by others of the ’708
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`patent, Merck will suffer irreparable injury. Merck has no adequate remedy at law.
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`COUNT II – DECLARATORY JUDGMENT
`OF INFRINGEMENT OF THE ’708 PATENT
`(TEVA’S ’487 ANDA PRODUCT)
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`58. Merck incorporates each of the preceding paragraphs 1–57 as if fully set forth
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`herein.
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`59.
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`The Court may declare the rights and legal relations of the parties pursuant to
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`28 U.S.C. §§ 2201 and 2202 because there is a case of actual controversy between Merck on the
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`one hand and Teva on the other regarding Teva’s infringement, active inducement of
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`infringement, and contribution to the infringement by others of the ’708 patent.
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`60.
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`The Court should declare that the commercial manufacture, use, sale, offer for
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`sale or importation of Teva’s ’487 ANDA Product with its proposed labeling, or any other Teva
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`drug product that is covered by or whose use is covered by the ’708 patent, will infringe, induce
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`the infringement of, and contribute to the infringement by others of the ’708 patent, and that the
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`claims of the ’708 patent are valid.
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`COUNT III – INFRINGEMENT OF THE ’708 PATENT
`(TEVA’S ’488 ANDA PRODUCT)
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`61. Merck incorporates each of the preceding paragraphs 1–60 as if fully set forth
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`herein.
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`62.
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`In Teva’s ’488 Notice Letter, Teva notified Merck of the submission of Teva’s
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`’488 ANDA to the FDA. The purpose of this submission was to obtain approval under the
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`FDCA to engage in the commercial manufacture, use, offer for sale, sale and/or importation of
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`Teva’s ’488 ANDA Product prior to the expiration of the ’708 patent.
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`63.
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`In Teva’s ’488 Notice Letter, Teva also notified Merck that, as part of its ANDA,
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`Teva had filed certifications of the type described in Section 505(j)(2)(A)(vii)(IV) of the FDCA,
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`21 U.S.C. § 355 (j)(2)(A)(vii)(IV), with respect to the ’708 patent. On information and belief,
`
`Teva submitted its ANDA to the FDA containing certifications pursuant to 21 U.S.C.
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`§ 355(j)(2)(A)(vii)(IV) asserting that the ’708 patent is invalid, unenforceable, and/or will not be
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`infringed by the manufacture, use, offer for sale, sale, and/or importation of Teva’s ’488 ANDA
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`Product.
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`Case 1:19-cv-00318-UNA Document 1 Filed 02/13/19 Page 13 of 23 PageID #: 13
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`
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`64.
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`In Teva’s ’488 Notice Letter, Teva stated Teva’s ’488 ANDA Product contains
`
`sitagliptin phosphate as an active ingredient.
`
`65.
`
`Teva’s ’488 ANDA Product, and the use of Teva’s ’488 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 Teva’s ’488
`
`ANDA Product.
`
`66.
`
`In Teva’s ’488 Notice Letter, Teva did not contest infringement of claim 1 of the
`
`’708 patent.
`
`67.
`
`Teva’s submission of Teva’s ’488 ANDA for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Teva’s
`
`’488 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).
`
`68.
`
`On information and belief, Teva will engage in the manufacture, use, offer for
`
`sale, sale, marketing, distribution, and/or importation of Teva’s ’488 ANDA Product
`
`immediately and imminently upon approval of its ANDA.
`
`69.
`
`The manufacture, use, sale, offer for sale, or importation of Teva’s ’488 ANDA
`
`Product would infringe one or more claims of the ’708 patent, including at least claim 1 of the
`
`’708 patent.
`
`70.
`
`On information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Teva’s ’488 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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`Case 1:19-cv-00318-UNA Document 1 Filed 02/13/19 Page 14 of 23 PageID #: 14
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`
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`71.
`
`On information and belief, Teva plans and intends to, and will, actively induce
`
`infringement of the ’708 patent when Teva’s ’488 ANDA is approved, and plans and intends to,
`
`and will, do so immediately and imminently upon approval. Teva’s activities will be done with
`
`knowledge of the ’708 patent and specific intent to infringe that patent.
`
`72.
`
`On information and belief, Teva knows that Teva’s ’488 ANDA Product and its
`
`proposed labeling are especially made or adapted for use in infringing the ’708 patent, that
`
`Teva’s ’488 ANDA Product is not a staple article or commodity of commerce, and that Teva’s
`
`’488 ANDA Product and its proposed labeling are not suitable for substantial noninfringing use.
`
`On information and belief, Teva plans and intends to, and will, contribute to infringement of the
`
`’708 patent immediately and imminently upon approval of Teva’s ’488 ANDA.
`
`73.
`
`Notwithstanding Teva’s knowledge of the claims of the ’708 patent, Teva has
`
`continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import Teva’s
`
`’488 ANDA Product with its product labeling following FDA approval of Teva’s ’488 ANDA
`
`prior to the expiration of the ’708 patent.
`
`74.
`
`The foregoing actions by Teva 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.
`
`75.
`
`On information and belief, Teva 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.
`
`76. Merck will be substantially and irreparably damaged by infringement of the ’708
`
`patent.
`
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`Case 1:19-cv-00318-UNA Document 1 Filed 02/13/19 Page 15 of 23 PageID #: 15
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`
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`77.
`
`Unless Teva 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
`(TEVA’S ’488 ANDA PRODUCT)
`
`78. Merck incorporates each of the preceding paragraphs 1–77 as if fully set forth
`
`herein.
`
`79.
`
`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 Teva on the other regarding Teva’s infringement, active inducement of
`
`infringement, and contribution to the infringement by others of the ’708 patent.
`
`80.
`
`The Court should declare that the commercial manufacture, use, sale, offer for
`
`sale or importation of Teva’s ’488 ANDA Product with its proposed labeling, or any other Teva
`
`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 ’708 PATENT
`(TEVA’S ’524 ANDA PRODUCT)
`
`81. Merck incorporates each of the preceding paragraphs 1–80 as if fully set forth
`
`herein.
`
`82.
`
`In Teva’s ’524 Notice Letter, Teva notified Merck of the submission of Teva’s
`
`’524 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
`
`Teva’s ’524 ANDA Product prior to the expiration of the ’708 patent.
`
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`Case 1:19-cv-00318-UNA Document 1 Filed 02/13/19 Page 16 of 23 PageID #: 16
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`
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`83.
`
`In Teva’s ’524 Notice Letter, Teva also notified Merck that, as part of its ANDA,
`
`Teva 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,
`
`Teva 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 Teva’s ’524 ANDA
`
`Product.
`
`84.
`
`In Teva’s ’524 Notice Letter, Teva stated that Teva’s ’524 ANDA Product
`
`contains sitagliptin phosphate as an active ingredient.
`
`85.
`
`Teva’s ’524 ANDA Product, and the use of Teva’s ’524 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 Teva’s ’524
`
`ANDA Product.
`
`86.
`
`In Teva’s ’524 Notice Letter, Teva did not contest infringement of claim 1 of the
`
`’708 patent.
`
`87.
`
`Teva’s submission of Teva’s ’524 ANDA for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Teva’s
`
`’524 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).
`
`88.
`
`On information and belief, Teva will engage in the manufacture, use, offer for
`
`sale, sale, marketing, distribution, and/or importation of Teva’s ’524 ANDA Product
`
`immediately and imminently upon approval of its ANDA.
`
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`Case 1:19-cv-00318-UNA Document 1 Filed 02/13/19 Page 17 of 23 PageID #: 17
`
`
`
`89.
`
`The manufacture, use, sale, offer for sale, or importation of Teva’s ’524 ANDA
`
`Product would infringe one or more claims of the ’708 patent, including at least claim 1 of the
`
`’708 patent.
`
`90.
`
`On information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Teva’s ’524 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.
`
`91.
`
`On information and belief, Teva plans and intends to, and will, actively induce
`
`infringement of the ’708 patent when Teva’s ’524 ANDA is approved, and plans and intends to,
`
`and will, do so immediately and imminently upon approval. Teva’s activities will be done with
`
`knowledge of the ’708 patent and specific intent to infringe that patent.
`
`92.
`
`On information and belief, Teva knows that Teva’s ’524 ANDA Product and its
`
`proposed labeling are especially made or adapted for use in infringing the ’708 patent, that
`
`Teva’s ’524 ANDA Product is not a staple article or commodity of commerce, and that Teva’s
`
`’524 ANDA Product and its proposed labeling are not suitable for substantial noninfringing use.
`
`On information and belief, Teva plans and intends to, and will, contribute to infringement of the
`
`’708 patent immediately and imminently upon approval of Teva’s ’524 ANDA.
`
`93.
`
`Notwithstanding Teva’s knowledge of the claims of the ’708 patent, Teva has
`
`continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import Teva’s
`
`’524 ANDA Product with its product labeling following FDA approval of Teva’s ’524 ANDA
`
`prior to the expiration of the ’708 patent.
`
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`Case 1:19-cv-00318-UNA Document 1 Filed 02/13/19 Page 18 of 23 PageID #: 18
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`
`
`94.
`
`The foregoing actions by Teva 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.
`
`95.
`
`On information and belief, Teva 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.
`
`96. Merck will be substantially and irreparably damaged by infringement of the ’708
`
`patent.
`
`97.
`
`Unless Teva is enjoined from infringing the ’708 patent, actively inducing
`
`infringement of the ’708 patent, and contributing to the infr