Case 1:19-cv-00319-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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`MERCK SHARP & DOHME CORP.,
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`Plaintiff,
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`SUN PHARMA GLOBAL FZE, and SUN
`PHARMACEUTICAL INDUSTRIES LTD.,
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`v.
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`C.A. No. _____________________
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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. 202423, 205078, and 207823 to the U.S. Food and Drug Administration
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`(“FDA”) seeking approval to commercially manufacture, use, offer for sale, sell, and/or import
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`versions of JANUVIA® (sitagliptin phosphate), JANUMET XR® (metformin hydrochloride;
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`sitagliptin phosphate extended release tablets), and JANUMET® (metformin hydrochloride;
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`sitagliptin phosphate) prior to the expiration of U.S. Patent No. 7,326,708 (“the ’708 patent”) and
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`U.S. Patent No. 8,414,921 (“the ’921 patent”).
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`2.
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`Sun Pharma Global FZE notified Merck by letter dated December 31, 2010
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`(“Sun’s ’423 Notice Letter”) that it had submitted to the FDA ANDA No. 202423 (“Sun’s ’423
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`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 sitagliptin phosphate oral tablets (“Sun’s
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`’423 ANDA Product”) prior to the expiration of the ’708 patent.
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`3.
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`On information and belief, Sun’s ’423 ANDA Product is a generic version of
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`Merck’s JANUVIA®.
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`4.
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`Sun Pharma Global FZE notified Merck by letters dated June 24, 2013, and
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`August 30, 2013 (“Sun’s ’078 Notice Letters”) that it had submitted to the FDA ANDA No.
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`205078 (“Sun’s ’078 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 (“Sun’s ’078 ANDA Product”) prior to the expiration of the
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`’708 patent.
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`5.
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`On information and belief, Sun’s ’078 ANDA Product is a generic version of
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`Merck’s JANUMET XR®.
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`6.
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`Sun Pharma Global FZE notified Merck by letter dated February 10, 2015 (“Sun’s
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`’823 Notice Letter”) that it had submitted to the FDA ANDA No. 207823 (“Sun’s ’823
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`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 (“Sun’s ’823 ANDA Product”) prior to the expiration of
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`the ’708 patent and the ’921 patent.
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`7.
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`On information and belief, Sun’s ’823 ANDA Product is a generic version of
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`Merck’s JANUMET®.
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`8.
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`Sun’s ’423 Notice Letter, Sun’s ’078 Notice Letters, and Sun’s ’823 Notice Letter
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`are collectively referred to herein as “Sun’s Notice Letters.” Sun’s ’423 ANDA, Sun’s ’078
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`ANDA, and Sun’s ’823 ANDA are collectively referred to herein as “Sun’s ANDAs.” Sun’s
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`’423 ANDA Product, Sun’s ’078 ANDA Product, and Sun’s ’823 ANDA Product are
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`collectively referred to herein as “Sun’s ANDA Products.”
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`PARTIES
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`9.
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`Plaintiff Merck is a corporation organized and existing under the laws of the State
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`of New Jersey, having its corporate offices and principal place of business at One Merck Drive,
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`Whitehouse Station, New Jersey 08889.
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`10. 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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`11. 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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`12. 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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`13.
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`On information and belief, defendant Sun Pharma Global FZE (“Sun FZE”) is a
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`corporation organized and existing under the laws of the United Arab Emirates, having its
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`corporate offices and principal places of business at Office #43, Block Y, SAIF Zone, P.O. Box.
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`No. 122304, Sharjah, United Arab Emirates, and DMCC Branch, 704 Jumeirah Business Center
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`1, Cluster G, JLT, P.O. Box No. 643561, Dubai, United Arab Emirates. On information and
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`belief, Sun FZE is in the business of, among other things, manufacturing and selling generic
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`versions of branded pharmaceutical drugs for the U.S. market, including through various
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`operating affiliates and subsidiaries.
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`14.
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`On information and belief, defendant Sun Pharmaceutical Industries Ltd. (“Sun
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`Ltd.”) is a corporation organized and existing under the laws of India with its principal place of
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`business at Sun House, CTS No. 201 B/1, Western Express Highway, Goregaon (East), Mumbai,
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`Maharashtra 400063, India. On information and belief, Sun Ltd. is in the business of, among
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`other things, manufacturing and selling generic versions of branded pharmaceutical products
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`through various operating affiliates and subsidiaries, including Sun FZE.
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`15.
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`On information and belief, Sun FZE is a wholly owned subsidiary of Sun Ltd.
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`Sun FZE and Sun Ltd. are collectively referred to herein as “Sun.”
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`16.
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`On information and belief, Sun FZE and Sun Ltd. acted in concert to prepare and
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`submit Sun’s ANDAs to the FDA.
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`17.
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`On information and belief Sun FZE and Sun Ltd. know and intend that upon
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`approval of Sun’s ANDAs, Sun FZE and Sun Ltd. will manufacture, market, sell, and distribute
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`Sun’s ANDA Products throughout the United States, including in Delaware. On information and
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`belief, Sun FZE and Sun Ltd. are agents of each other and/or operate in concert as integrated
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`parts of the same business group, including with respect to Sun’s ANDA Products, and enter into
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`agreements that are nearer than arm’s length. On information and belief, Sun FZE and Sun Ltd.
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`participated, assisted, and cooperated in carrying out the acts complained of herein.
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`18.
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`On information and belief, following any FDA approval of Sun’s ANDAs, Sun
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`FZE and Sun Ltd. will act in concert to distribute and sell Sun’s ANDA Products throughout the
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`United States, including within Delaware.
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`JURISDICTION
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`19.
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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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`20.
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`21.
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`This Court has personal jurisdiction over Sun.
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`Sun FZE is subject to personal jurisdiction in Delaware because, among other
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`things Sun has purposefully availed itself of the benefits and protections of Delaware's laws such
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`that it should reasonably anticipate being haled into court here. On information and belief, Sun
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`FZE develops, manufactures, imports, markets, offers to sell, and/or sells generic drugs
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`throughout the United States, including in the State of Delaware, and therefore transacts business
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`within the State of Delaware, and/or has engaged in systematic and continuous business contacts
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`within the State of Delaware.
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`22.
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`Sun Ltd. is subject to personal jurisdiction in Delaware because, among other
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`things, Sun Ltd., itself and through its wholly owned subsidiary Sun FZE, has purposely availed
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`itself of the benefits and protections of Delaware’s laws such that it should reasonably anticipate
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`being haled into court here. On information and belief, Sun Ltd., itself and through its wholly
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`owned subsidiary Sun FZE, develops, manufactures, imports, markets, offers to sell, and/or sells
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`generic drugs throughout the United States, including in the State of Delaware, and therefore
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`transacts business within the State of Delaware related to Merck’s claims, and/or has engaged in
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`systematic and continuous business contacts within the State of Delaware. In addition, Sun Ltd.
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`is subject to personal jurisdiction in Delaware because, on information and belief, it controls and
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`dominates Sun FZE and therefore the activities of Sun FZE in this jurisdiction are attributed to
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`Sun Ltd.
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`23.
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`In addition, this Court has personal jurisdiction over Sun because Sun FZE and
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`Sun Ltd. 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., Sun Pharma Global FZE v. Teva Pharm. Indus. Ltd., No. 18- 1552-RGA,
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`D.I. 1 (D. Del. Oct. 9, 2018) (Sun FZE); Pharmacylics LLC v. Sun Pharma Global FZE, No. 18-
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`1543-CFC, D.I. 9 (D. Del. Oct. 31, 2018) (Sun FZE and Sun Ltd.); Bristol-Myers Squibb Co. v.
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`Sun Pharma Indus., Inc., No. 17- 409-LPS, D.I. 10 (D. Del. May 12, 2017) (Sun FZE); Amgen v.
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`Sun Pharm. Indus., Ltd., No. 16-882-GMS, D.I. 15 (D. Del. Nov. 16, 2016) (Sun FZE and Sun
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`Ltd.).
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`24.
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`On information and belief, if Sun’s ANDAs are approved, Sun FZE and Sun Ltd.
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`will manufacture, market, sell, and/or distribute Sun’s ANDA Products within the United States,
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`including in Delaware, consistent with Sun’s practices for the marketing and distribution of other
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`generic pharmaceutical products. On information and belief, Sun regularly does business in
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`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, Sun’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, Sun’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 patents in the event that Sun’s ANDA Products are approved before the
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`patents expire.
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`25.
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`On information and belief, Sun derives substantial revenue from generic
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`pharmaceutical products that are used and/or consumed within Delaware, and which are
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`manufactured by Sun and/or for which Sun FZE and/or Sun Ltd. is/are the named applicant(s) on
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`approved ANDAs. On information and belief, various products for which Sun FZE and/or Sun
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`Ltd. is/are the named applicant(s) on approved ANDAs are available at retail pharmacies in
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`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 Sun FZE under 28 U.S.C. § 1391 because
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`Sun FZE is a corporation organized and existing under the laws of the United Arab Emirates and
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`is subject to personal jurisdiction in this judicial district.
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`28.
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`Venue is proper in this district as to Sun Ltd. under 28 U.S.C. § 1391 because Sun
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`Ltd. is a corporation organized and existing under the laws of India and is subject to personal
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`jurisdiction in this judicial district.
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`THE ’708 PATENT
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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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`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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`31.
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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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`32. Merck is the owner and assignee of the ’708 patent.
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`33.
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`The ’708 patent claims, inter alia, 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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`34.
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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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`35.
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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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`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
`(SUN’S ’423 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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`44.
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`In Sun’s ’423 Notice Letter, Sun notified Merck of the submission of Sun’s ’423
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`ANDA to the FDA. The purpose of this submission was to obtain approval under the FDCA to
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`engage in the commercial manufacture, use, offer for sale, sale and/or importation of Sun’s ’423
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`ANDA Product prior to the expiration of the ’708 patent.
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`45.
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`In Sun’s ’423 Notice Letter, Sun also notified Merck that, as part of its ANDA,
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`Sun 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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`Sun 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 Sun’s ’423 ANDA
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`Product.
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`46.
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`In Sun’s ’423 Notice Letter, Sun stated that Sun’s ’423 ANDA Product contains
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`sitagliptin phosphate as an active ingredient.
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`47.
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`Sun’s ’423 ANDA Product, and the use of Sun’s ’423 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 Sun’s ’423
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`ANDA Product.
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`48.
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`In Sun’s ’423 Notice Letter, Sun did not contest infringement of claim 1 of the
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`’708 patent.
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`49.
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`Sun’s submission of Sun’s ’423 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 Sun’s ’423
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`ANDA Product before the expiration of the ’708 patent was an act of infringement of the ’708
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`patent under 35 U.S.C. § 271(e)(2)(A).
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`50.
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`On information and belief, Sun will engage in the manufacture, use, offer for sale,
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`sale, marketing, distribution, and/or importation of Sun’s ’423 ANDA Product immediately and
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`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 Sun’s ’423 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 Sun’s ’423 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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`53.
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`On information and belief, Sun plans and intends to, and will, actively induce
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`infringement of the ’708 patent when Sun’s ’423 ANDA is approved, and plans and intends to,
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`and will, do so immediately and imminently upon approval. Sun’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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`54.
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`On information and belief, Sun knows that Sun’s ’423 ANDA Product and its
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`proposed labeling are especially made or adapted for use in infringing the ’708 patent, that Sun’s
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`’423 ANDA Product is not a staple article or commodity of commerce, and that Sun’s ’423
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`ANDA Product and its proposed labeling are not suitable for substantial noninfringing use. On
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`information and belief, Sun plans and intends to, and will, contribute to infringement of the ’708
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`patent immediately and imminently upon approval of Sun’s ’423 ANDA.
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`55.
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`Notwithstanding Sun’s knowledge of the claims of the ’708 patent, Sun has
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`continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import Sun’s
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`’423 ANDA Product with its product labeling following FDA approval of Sun’s ’423 ANDA
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`prior to the expiration of the ’708 patent.
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`56.
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`The foregoing actions by Sun constitute and/or will constitute infringement of the
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`’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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`57.
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`On information and belief, Sun 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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`58. Merck will be substantially and irreparably damaged by infringement of the ’708
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`patent.
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`59.
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`Unless Sun 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
`(SUN’S ’423 ANDA PRODUCT)
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`60. Merck incorporates each of the preceding paragraphs 1–59 as if fully set forth
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`herein.
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`61.
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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 Sun on the other regarding Sun’s infringement, active inducement of infringement,
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`and contribution to the infringement by others of the ’708 patent.
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`62.
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`The Court should declare that the commercial manufacture, use, sale, offer for
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`sale, or importation of Sun’s ’423 ANDA Product with its proposed labeling, or any other Sun
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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
`(SUN’S ’078 ANDA PRODUCT)
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`63. Merck incorporates each of the preceding paragraphs 1–62 as if fully set forth
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`herein.
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`64.
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`In Sun’s ’078 Notice Letters, Sun notified Merck of the submission of Sun’s ’078
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`ANDA to the FDA. The purpose of this submission was to obtain approval under the FDCA to
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`engage in the commercial manufacture, use, offer for sale, sale and/or importation of Sun’s ’078
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`ANDA Product prior to the expiration of the ’708 patent.
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`65.
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`In Sun’s ’078 Notice Letters, Sun also notified Merck that, as part of its ANDA,
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`Sun 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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`Sun 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 Sun’s ’078 ANDA
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`Product.
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`66.
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`In Sun’s ’078 Notice Letters, Sun stated that Sun’s ’078 ANDA Product contains
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`sitagliptin phosphate as an active ingredient.
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`67.
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`Sun’s ’078 ANDA Product, and the use of Sun’s ’078 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 Sun’s ’078
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`ANDA Product.
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`68.
`
`In Sun’s ’078 Notice Letters, Sun did not contest infringement of claim 1 of the
`
`’708 patent.
`
`69.
`
`Sun’s submission of Sun’s ’078 ANDA for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Sun’s ’078
`
`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, Sun will engage in the manufacture, use, offer for sale,
`
`sale, marketing, distribution, and/or importation of Sun’s ’078 ANDA Product immediately and
`
`imminently upon approval of its ANDA.
`
`71.
`
`The manufacture, use, sale, offer for sale, or importation of Sun’s ’078 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 Sun’s ’078 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, Sun plans and intends to, and will, actively induce
`
`infringement of the ’708 patent when Sun’s ’078 ANDA is approved, and plans and intends to,
`
`and will, do so immediately and imminently upon approval. Sun’s activities will be done with
`
`knowledge of the ’708 patent and specific intent to infringe that patent.
`
`74.
`
`On information and belief, Sun knows that Sun’s ’078 ANDA Product and its
`
`proposed labeling are especially made or adapted for use in infringing the ’708 patent, that Sun’s
`
`’078 ANDA Product is not a staple article or commodity of commerce, and that Sun’s ’078
`
`ME1 29533230v.1
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`Case 1:19-cv-00319-UNA Document 1 Filed 02/13/19 Page 14 of 23 PageID #: 14
`
`
`
`ANDA Product and its proposed labeling are not suitable for substantial noninfringing use. On
`
`information and belief, Sun plans and intends to, and will, contribute to infringement of the ’708
`
`patent immediately and imminently upon approval of Sun’s ’078 ANDA.
`
`75.
`
`Notwithstanding Sun’s knowledge of the claims of the ’708 patent, Sun has
`
`continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import Sun’s
`
`’078 ANDA Product with its product labeling following FDA approval of Sun’s ’078 ANDA
`
`prior to the expiration of the ’708 patent.
`
`76.
`
`The foregoing actions by Sun 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, Sun 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.
`
`78. Merck will be substantially and irreparably damaged by infringement of the ’708
`
`patent.
`
`79.
`
`Unless Sun 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
`(SUN’S ’078 ANDA PRODUCT)
`
`80. Merck incorporates each of the preceding paragraphs 1–79 as if fully set forth
`
`herein.
`
`ME1 29533230v.1
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`Case 1:19-cv-00319-UNA Document 1 Filed 02/13/19 Page 15 of 23 PageID #: 15
`
`
`
`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 Sun on the other regarding Sun’s 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 Sun’s ’078 ANDA Product with its proposed labeling, or any other Sun
`
`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
`(SUN’S ’823 ANDA PRODUCT)
`
`83. Merck incorporates each of the preceding paragraphs 1–82 as if fully set forth
`
`herein.
`
`84.
`
`In Sun’s ’823 Notice Letter, Sun notified Merck of the submission of Sun’s ’823
`
`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 Sun’s ’823
`
`ANDA Product prior to the expiration of the ’708 patent.
`
`85.
`
`In Sun’s ’823 Notice Letter, Sun also notified Merck that, as part of its ANDA,
`
`Sun 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,
`
`Sun 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 Sun’s ’823 ANDA
`
`Product.
`
`ME1 29533230v.1
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`15
`
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`

`Case 1:19-cv-00319-UNA Document 1 Filed 02/13/19 Page 16 of 23 PageID #: 16
`
`
`
`86.
`
`In Sun’s ’823 Notice Letter, Sun stated that Sun’s ’823 ANDA Product contains
`
`sitagliptin phosphate as an active ingredient.
`
`87.
`
`Sun’s ’823 ANDA Product, and the use of Sun’s ’823 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 Sun’s ’823
`
`ANDA Product.
`
`88.
`
`In Sun’s ’823 Notice Letter, Sun did not contest infringement of claim 1 of the
`
`’708 patent.
`
`89.
`
`Sun’s submission of Sun’s ’823 ANDA for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Sun’s ’823
`
`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).
`
`90.
`
`On information and belief, Sun will engage in the manufacture, use, offer for sale,
`
`sale, marketing, distribution, and/or importation of Sun’s ’823 ANDA Product immediately and
`
`imminently upon approval of its ANDA.
`
`91.
`
`The manufacture, use, sale, offer for sale, or importation of Sun’s ’823 ANDA
`
`Product would infringe one or more claims of the ’708 patent, including at least claim 1 of the
`
`’708 patent.
`
`92.
`
`On information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Sun’s ’823 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.
`
`ME1 29533230v.1
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`16
`
`

`

`Case 1:19-cv-00319-UNA Document 1 Filed 02/13/19 Page 17 of 23 PageID #: 17
`
`
`
`93.
`
`On information and belief, Sun plans and intends to, and will, actively induce
`
`infringement of the ’708 patent when Sun’s ’823 ANDA is approved, and plans and intends to,
`
`and will, do so immediately and imminently upon approval. Sun’s activities will be done with
`
`knowledge of the ’708 patent and specific intent to infringe that patent.
`
`94.
`
`On information and belief, Sun knows that Sun’s ’823 ANDA Product and its
`
`proposed labeling are especially made or adapted for use in infringing the ’708 patent, that Sun’s
`
`’823 ANDA Product is not a staple article or commodity of commerce, and that Sun’s ’823
`
`ANDA Product and its proposed labeling are not suitable for substantial noninfringing use. On
`
`information and belief, Sun plans and intends to, and will, contribute to infringement of the ’708
`
`patent immediately and imminently upon approval of Sun’s ’823 ANDA.
`
`95.
`
`Notwithstanding Sun’s knowledge of the claims of the ’708 patent, Sun has
`
`continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import Sun’s
`
`’823 ANDA Product with its product labeling following FDA approval of Sun’s ’823 ANDA
`
`prior to the expiration of the ’708 patent.
`
`96.
`
`The foregoing actions by Sun 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.
`
`97.
`
`On information and belief, Sun 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.
`
`98. Merck will be substantially and irreparably damaged by infringement of the ’708
`
`patent.
`
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`
`17
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`Case 1:19-cv-00319-UNA Document 1 Filed 02/13/19 Page 18 of 23 PageID #: 18
`
`
`
`99.
`
`Unless Sun 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 VI – DECLARATORY JUDGMENT OF
`INFRINGEMENT OF THE ’708 PATENT
`(SUN’S ’823 ANDA PRODUCT)
`
`100. Merck incorporates each of the preceding paragraphs 1–99 as if fully set forth
`
`herein.
`
`101. 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 Sun on the other regardin