Case 1:20-cv-00847-RGA Document 1 Filed 06/24/20 Page 1 of 16 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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`v.
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`DR. REDDY’S LABORATORIES, INC. and
`DR. REDDY’S LABORATORIES, LTD.,
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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. 214700 and 214685 to the U.S. Food and Drug Administration (“FDA”) seeking
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`approval to commercially manufacture, use, offer for sale, sell, and/or import a version of
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`JANUVIA® (sitagliptin phosphate) and JANUMET® (metformin hydrochloride; sitagliptin
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`phosphate) prior to the expiration of U.S. Patent No. 7,326,708 (“the ’708 patent”).
`
`2.
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`Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. notified Merck
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`by letter dated May 14, 2020 (“Dr. Reddy’s ’700 Notice Letter”) that they had submitted to the
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`FDA ANDA No. 214700 (“Dr. Reddy’s ’700 ANDA”), seeking approval from the FDA to
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`engage in the commercial manufacture, use, offering for sale, sale, and/or importation of generic
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`sitagliptin phosphate oral tablets (“Dr. Reddy’s ’700 ANDA Product”) prior to the expiration of
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`the ’708 patent.
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`3.
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`On information and belief, Dr. Reddy’s ’700 ANDA Product is a generic version
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`of Merck’s JANUVIA®.
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`4.
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`Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. notified Merck
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`by letter dated June 16, 2020 (“Dr. Reddy’s ’685 Notice Letter”) that they had submitted to the
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`FDA ANDA No. 214685 (“Dr. Reddy’s ’685 ANDA”), seeking approval from the FDA to
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`engage in the commercial manufacture, use, offering for sale, sale, and/or importation of generic
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`metformin hydrochloride and sitagliptin phosphate oral tablets (“Dr. Reddy’s ’685 ANDA
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`Product”) prior to the expiration of the ’708 patent.
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`5.
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`On information and belief, Dr. Reddy’s ’685 ANDA Product is a generic version
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`of Merck’s JANUVIA®.
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`6.
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`Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. are collectively
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`referred to as “Dr. Reddy’s.” Dr. Reddy’s ’700 Notice Letter and Dr. Reddy’s ’685 Notice
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`Letter are collectively referred to herein as “Dr. Reddy’s Notice Letters.” Dr. Reddy’s ’700
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`ANDA and Dr. Reddy’s ’685 ANDA are collectively referred to herein as “Dr. Reddy’s
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`ANDAs.” Dr. Reddy’s ’700 ANDA Product and Dr. Reddy’s ’685 ANDA Product are
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`collectively referred to herein as “Dr. Reddy’s ANDA Products.”
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`PARTIES
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`7.
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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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`8.
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`Merck is the holder of NDA No. 021995 for JANUVIA® (sitagliptin phosphate),
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`which has been approved by the FDA.
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`9.
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`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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`10.
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`On information and belief, defendant Dr. Reddy’s Laboratories, Inc. is a
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`corporation organized and existing under the laws of the State of New Jersey, having its principal
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`place of business at 107 College Road East, Princeton, New Jersey 08540. On information and
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`belief, Dr. Reddy’s Laboratories, Inc. is in the business of, among other things, manufacturing
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`and selling generic versions of branded pharmaceutical drugs for the U.S. market.
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`11.
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`On information and belief, defendant Dr. Reddy’s Laboratories, Ltd. is a
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`corporation organized and existing under the laws of India, with a principal place of business of
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`business at 8-2-337, Road No. 3, Banjara Hills, Hyderabad, Telenangana 500034, India. Upon
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`information and belief, Dr. Reddy’s Laboratories, Ltd. is in the business of, among other things,
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`manufacturing and selling generic versions of branded pharmaceutical drugs through various
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`operating subsidiaries, including Dr. Reddy’s Laboratories, Inc.
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`12.
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`On information and belief, Dr. Reddy’s Laboratories, Inc. is a wholly owned
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`subsidiary of Dr. Reddy’s Laboratories, Ltd.
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`13.
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`On information and belief, Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s
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`Laboratories, Ltd. acted in concert to prepare and submit Dr. Reddy’s ANDAs to the FDA.
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`14.
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`On information and belief, Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s
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`Laboratories, Ltd. know and intend that upon approval of Dr. Reddy’s ANDAs, Dr. Reddy’s will
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`manufacture, market, sell, and distribute Dr. Reddy’s ANDA Products throughout the United
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`States, including in Delaware. On information and belief, Dr. Reddy’s Laboratories, Inc. and Dr.
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`Reddy’s Laboratories, Ltd. are agents of each other and/or operate in concert as integrated parts
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`of the same business group, including with respect to Dr. Reddy’s ANDA Products, and enter
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`into agreements that are nearer than arm’s length. On information and belief, Dr. Reddy’s
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`Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. participated, assisted, and cooperated in
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`carrying out the acts complained of herein.
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`15.
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`On information and belief, following any FDA approval of Dr. Reddy’s ANDAs,
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`Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. will act in concert to distribute
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`and sell Dr. Reddy’s ANDA Products throughout the United States, including within Delaware.
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`JURISDICTION
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`16.
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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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`17.
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`18.
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`This Court has personal jurisdiction over Dr. Reddy’s.
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`Dr. Reddy’s Laboratories, Inc. is subject to personal jurisdiction in Delaware
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`because, among other things, it has purposely availed itself of the benefits and protections of
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`Delaware’s laws such that it should reasonably anticipate being haled into court here. In
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`addition, on information and belief, Dr. Reddy’s Laboratories, Inc. develops, manufactures,
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`imports, markets, offers to sell, and/or sells generic drugs throughout the United States, including
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`in the State of Delaware, and therefore transacts business within the State of Delaware related to
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`Merck’s claims, and/or has engaged in systematic and continuous business contacts within the
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`State of Delaware.
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`19.
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`Dr. Reddy’s Laboratories, Ltd. is subject to personal jurisdiction in Delaware
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`because, among other things, Dr. Reddy’s Laboratories, Ltd., itself and through its wholly owned
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`subsidiary Dr. Reddy’s Laboratories, Inc., has purposefully availed itself of the benefits and
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`protections of Delaware’s laws such that it should reasonably anticipate being haled into court
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`here. On information and belief, Dr. Reddy’s Laboratories, Ltd., itself and through its wholly
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`owned subsidiary Dr. Reddy’s Laboratories, Inc., develops, manufactures, imports, markets,
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`offers to sell, and/or sells generic drugs throughout the United States, including in the State of
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`Delaware, and therefore transacts business within the State of Delaware, and/or has engaged in
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`systematic and continuous business contacts within the State of Delaware. In addition, Dr.
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`Reddy’s Laboratories, Ltd. is subject to personal jurisdiction in Delaware because, on
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`information and belief, it controls and dominates Dr. Reddy’s Laboratories, Inc., and therefore
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`the activities of Dr. Reddy’s Laboratories, Inc. in this jurisdiction are attributed to Dr. Reddy’s
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`Laboratories, Ltd.
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`20.
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`In addition, this Court has personal jurisdiction over Dr. Reddy’s because Dr.
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`Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. regularly engage in patent
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`litigation concerning FDA-approved branded drug products in this district, do not contest
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`personal jurisdiction in this district, and have purposefully availed themselves of the rights and
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`benefits of this district by asserting claims and/or counterclaims in this district. See, e.g.,
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`Genzyme Corp. et al. v. Dr. Reddy’s Labs., Inc. and Dr. Reddy’s Labs., Ltd, No. 19-2045-CFC
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`(D. Del. Nov. 20, 2019); Boehringer Ingelheim Pharmaceuticals Inc. v. Dr. Reddy’s Labs., Inc.
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`and Dr. Reddy’s Labs., Ltd., No. 19-1495-CFC (D. Del. Sep. 4, 2019); Genzyme Corp. et al. v.
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`Dr. Reddy’s Labs., Inc. and Dr. Reddy’s Labs., Ltd., No. 18-1839-CFC (D. Del. Jan. 16, 2019);
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`Pfizer Inc. et al. v. Dr. Reddy’s Labs., Inc. and Dr. Reddy’s Labs., Ltd., No. 19-750-CFC (D.
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`Del. Jul. 15, 2019), D.I. 12; Onyx Therapeutics, Inc. v. Dr. Reddy’s Labs., Inc. and Dr. Reddy’s
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`Labs., Ltd., No. 17-1811-LPS (D. Del. Jan. 23, 2018); Viiv Healthcare Co., Shionogi & Co., Ltd.,
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`and Viiv Healthcare UK (No. 3) Ltd. v. Dr. Reddy’s Labs., Inc. and Dr. Reddy’s Labs., Ltd., No.
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`17-1678-MSG (D. Del. Feb. 12, 2018).
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`21.
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`On information and belief, if Dr. Reddy’s ANDAs are approved, Dr. Reddy’s will
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`manufacture, market, sell, and/or distribute Dr. Reddy’s ANDA Products within the United
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`States, including in Delaware, consistent with Dr. Reddy’s practices for the marketing and
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`distribution of other generic pharmaceutical products. On information and belief, Dr. Reddy’s
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`regularly does business in Delaware, and its practices with other generic pharmaceutical products
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`have involved placing those products into the stream of commerce for distribution throughout the
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`United States, including in Delaware. On information and belief, Dr. Reddy’s generic
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`pharmaceutical products are used and/or consumed within and throughout the United States,
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`including in Delaware. On information and belief, Dr. Reddy’s ANDA Products will be
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`prescribed by physicians practicing in Delaware, dispensed by pharmacies located within
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`Delaware, and used by patients in Delaware. Each of these activities would have a substantial
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`effect within Delaware and would constitute infringement of Merck’s patent in the event that Dr.
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`Reddy’s ANDA Products are approved before the patent expires.
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`22.
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`On information and belief, Dr. Reddy’s 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 Dr. Reddy’s and/or for which Dr. Reddy’s Laboratories, Inc. and/or Dr.
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`Reddy’s Laboratories, Ltd. is/are the named applicant(s) on approved ANDAs. On information
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`and belief, various products for which Dr. Reddy’s Laboratories, Inc. and/or Dr. Reddy’s
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`Laboratories, Ltd. 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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`23. Merck incorporates each of the preceding paragraphs 1–22 as if fully set forth
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`herein.
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`24.
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`Venue is proper in this district as to Dr. Reddy’s under 28 U.S.C. § 1400(b)
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`because on information and belief, Dr. Reddy’s ANDA Product will be prescribed by physicians
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`practicing in Delaware, dispensed by pharmacies located within Delaware, and used by patients
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`in Delaware. Each of these activities would have a substantial effect within Delaware and would
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`constitute infringement of Merck’s patent in the event that Ajanta’s ANDA Product is approved
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`before the patent expires
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`25.
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`Venue is also proper in this district as to Dr. Reddy’s Laboratories, Ltd. under 28
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`U.S.C. § 1391 because Dr. Reddy’s Laboratories, Ltd. is a corporation organized and existing
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`under the laws of India and is subject to personal jurisdiction in this judicial district.
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`THE ’708 PATENT
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`26. Merck incorporates each of the preceding paragraphs 1–Error! Reference source
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`not found. as if fully set forth herein.
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`27.
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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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`28.
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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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`29. Merck is the owner and assignee of the ’708 patent.
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`30.
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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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`31.
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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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`32.
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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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`COUNT I – INFRINGEMENT OF THE ’708 PATENT
`(DR. REDDY’S ’700 ANDA PRODUCT)
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`33. Merck incorporates each of the preceding paragraphs 1–32 as if fully set forth
`
`herein.
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`34.
`
`In Dr. Reddy’s ’700 Notice Letter, Dr. Reddy’s notified Merck of the submission
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`of Dr. Reddy’s ’700 ANDA to the FDA. The purpose of this submission was to obtain approval
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`under the FDCA to engage in the commercial manufacture, use, offer for sale, sale and/or
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`importation of Dr. Reddy’s ’700 ANDA Product prior to the expiration of the ’708 patent.
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`35.
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`In Dr. Reddy’s ’700 Notice Letter, Dr. Reddy’s also notified Merck that, as part
`
`of its ANDA, Dr. Reddy’s had filed certifications of the type described in Section
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`505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C. § 355 (j)(2)(A)(vii)(IV), with respect to the ’708
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`patent. On information and belief, Dr. Reddy’s submitted its ANDA to the FDA containing
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`certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the ’708 patent is
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`invalid, unenforceable, and/or will not be infringed by the manufacture, use, offer for sale, sale,
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`and/or importation of Dr. Reddy’s ’700 ANDA Product.
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`36.
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`In Dr. Reddy’s ’700 Notice Letter, Dr. Reddy’s stated that Dr. Reddy’s ’700
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`ANDA Product contains sitagliptin phosphate as an active ingredient.
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`37.
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`Dr. Reddy’s ’700 ANDA Product, and the use of Dr. Reddy’s ’700 ANDA
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`Product, are covered by one or more claims of the ’708 patent, including at least claim 1 of the
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`’708 patent, because claim 1 of the ’708 patent covers the sitagliptin phosphate contained in Dr.
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`Reddy’s ’700 ANDA Product.
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`38.
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`In Dr. Reddy’s ’700 Notice Letter, Dr. Reddy did not contest infringement of
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`claim 1 of the ’708 patent.
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`39.
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`Dr. Reddy’s submission of its ’700 ANDA for the purpose of obtaining approval
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`to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Dr.
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`Reddy’s ’700 ANDA Product before the expiration of the ’708 patent was an act of infringement
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`of the ’708 patent under 35 U.S.C. § 271(e)(2)(A).
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`40.
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`On information and belief, Dr. Reddy’s will engage in the manufacture, use, offer
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`for sale, sale, marketing, distribution, and/or importation of Dr. Reddy’s ’700 ANDA Product
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`immediately and imminently upon approval of its ANDA.
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`41.
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`The manufacture, use, sale, offer for sale, or importation of Dr. Reddy’s ’700
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`ANDA Product 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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`42.
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`On information and belief, the manufacture, use, sale, offer for sale, or
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`importation of Dr. Reddy’s ’700 ANDA Product in accordance with, and as directed by its
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`proposed product labeling would infringe one or more claims of the ’708 patent, including at
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`least claim 1 of the ’708 patent.
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`43.
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`On information and belief, Dr. Reddy’s plans and intends to, and will, actively
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`induce infringement of the ’708 patent when Dr. Reddy’s ’700 ANDA is approved, and plans
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`and intends to, and will, do so immediately and imminently upon approval. Dr. Reddy’s
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`activities will be done with knowledge of the ’708 patent and specific intent to infringe that
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`patent.
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`44.
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`On information and belief, Dr. Reddy’s knows that Dr. Reddy’s ’700 ANDA
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`Product and its proposed labeling are especially made or adapted for use in infringing the ’708
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`patent, that Dr. Reddy’s ’700 ANDA Product is not a staple article or commodity of commerce,
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`and that Dr. Reddy’s ’700 ANDA Product and its proposed labeling are not suitable for
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`substantial noninfringing use. On information and belief, Dr. Reddy’s plans and intends to, and
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`will, contribute to infringement of the ’708 patent immediately and imminently upon approval of
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`Dr. Reddy’s ’700 ANDA.
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`45.
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`Notwithstanding Dr. Reddy’s knowledge of the claims of the ’708 patent, Dr.
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`Reddy’s has continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or
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`import Dr. Reddy’s ’700 ANDA Product with its product labeling following FDA approval of
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`Dr. Reddy’s ’700 ANDA prior to the expiration of the ’708 patent.
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`46.
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`The foregoing actions by Dr. Reddy’s constitute and/or will constitute
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`infringement of the ’708 patent; active inducement of infringement of the ’708 patent; and
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`contribution to the infringement by others of the ’708 patent.
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`47.
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`On information and belief, Dr. Reddy’s 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
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`infringement by others of the ’708 patent.
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`48. Merck will be substantially and irreparably damaged by infringement of the ’708
`
`patent.
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`49.
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`Unless Dr. Reddy’s 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
`(DR. REDDY’S ’700 ANDA PRODUCT)
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`50. Merck incorporates each of the preceding paragraphs 1–49 as if fully set forth
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`herein.
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`51.
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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 Dr. Reddy’s on the other regarding Dr. Reddy’s infringement, active inducement
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`of infringement, and contribution to the infringement by others of the ’708 patent.
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`52.
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`The Court should declare that the commercial manufacture, use, sale, offer for
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`sale, or importation of Dr. Reddy’s ’700 ANDA Product with its proposed labeling, or any other
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`Dr. Reddy’s drug product that is covered by or whose use is covered by the ’708 patent, will
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`infringe, induce the infringement of, and contribute to the infringement by others of the ’708
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`patent, and that the claims of the ’708 patent are valid.
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`COUNT III – INFRINGEMENT OF THE ’708 PATENT
`(DR. REDDY’S ’685 ANDA PRODUCT)
`
`53. Merck incorporates each of the preceding paragraphs 1–52 as if fully set forth
`
`herein.
`
`54.
`
`In Dr. Reddy’s ’685 Notice Letter, Dr. Reddy’s notified Merck of the submission
`
`of Dr. Reddy’s ’685 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 Dr. Reddy’s ’685 ANDA Product prior to the expiration of the ’708 patent.
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`55.
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`In Dr. Reddy’s ’685 Notice Letter, Dr. Reddy’s also notified Merck that, as part
`
`of its ANDA, Dr. Reddy’s had filed certifications of the type described in Section
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`505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C. § 355 (j)(2)(A)(vii)(IV), with respect to the ’708
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`patent. On information and belief, Dr. Reddy’s submitted its ANDA to the FDA containing
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`certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the ’708 patent is
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`invalid, unenforceable, and/or will not be infringed by the manufacture, use, offer for sale, sale,
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`and/or importation of Dr. Reddy’s ’685 ANDA Product.
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`Case 1:20-cv-00847-RGA Document 1 Filed 06/24/20 Page 12 of 16 PageID #: 12
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`56.
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`In Dr. Reddy’s ’685 Notice Letter, Dr. Reddy’s stated that Dr. Reddy’s ’685
`
`ANDA Product contains sitagliptin phosphate as an active ingredient.
`
`57.
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`Dr. Reddy’s ’685 ANDA Product, and the use of Dr. Reddy’s ’685 ANDA
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`Product, are covered by one or more claims of the ’708 patent, including at least claim 1 of the
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`’708 patent, because claim 1 of the ’708 patent covers the sitagliptin phosphate contained in Dr.
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`Reddy’s ’700 ANDA Product.
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`58.
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`In Dr. Reddy’s ’685 Notice Letter, Dr. Reddy did not contest infringement of
`
`claim 1 of the ’708 patent.
`
`59.
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`Dr. Reddy’s submission of its ’685 ANDA for the purpose of obtaining approval
`
`to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Dr.
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`Reddy’s ’685 ANDA Product before the expiration of the ’708 patent was an act of infringement
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`of the ’708 patent under 35 U.S.C. § 271(e)(2)(A).
`
`60.
`
`On information and belief, Dr. Reddy’s will engage in the manufacture, use, offer
`
`for sale, sale, marketing, distribution, and/or importation of Dr. Reddy’s ’685 ANDA Product
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`immediately and imminently upon approval of its ANDA.
`
`61.
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`The manufacture, use, sale, offer for sale, or importation of Dr. Reddy’s ’685
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`ANDA Product would infringe one or more claims of the ’708 patent, including at least claim 1
`
`of the ’708 patent.
`
`62.
`
`On information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Dr. Reddy’s ’685 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 1:20-cv-00847-RGA Document 1 Filed 06/24/20 Page 13 of 16 PageID #: 13
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`63.
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`On information and belief, Dr. Reddy’s plans and intends to, and will, actively
`
`induce infringement of the ’708 patent when Dr. Reddy’s ’685 ANDA is approved, and plans
`
`and intends to, and will, do so immediately and imminently upon approval. Dr. Reddy’s
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`activities will be done with knowledge of the ’708 patent and specific intent to infringe that
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`patent.
`
`64.
`
`On information and belief, Dr. Reddy’s knows that Dr. Reddy’s ’685 ANDA
`
`Product and its proposed labeling are especially made or adapted for use in infringing the ’708
`
`patent, that Dr. Reddy’s ’685 ANDA Product is not a staple article or commodity of commerce,
`
`and that Dr. Reddy’s ’685 ANDA Product and its proposed labeling are not suitable for
`
`substantial noninfringing use. On information and belief, Dr. Reddy’s plans and intends to, and
`
`will, contribute to infringement of the ’708 patent immediately and imminently upon approval of
`
`Dr. Reddy’s ’685 ANDA.
`
`65.
`
`Notwithstanding Dr. Reddy’s knowledge of the claims of the ’708 patent, Dr.
`
`Reddy’s has continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or
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`import Dr. Reddy’s ’685 ANDA Product with its product labeling following FDA approval of
`
`Dr. Reddy’s ’685 ANDA prior to the expiration of the ’708 patent.
`
`66.
`
`The foregoing actions by Dr. Reddy’s constitute and/or will constitute
`
`infringement of the ’708 patent; active inducement of infringement of the ’708 patent; and
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`contribution to the infringement by others of the ’708 patent.
`
`67.
`
`On information and belief, Dr. Reddy’s has acted with full knowledge of the ’708
`
`patent and without a reasonable basis for believing that it would not be liable for infringement of
`
`the ’708 patent; active inducement of infringement of the ’708 patent; and/or contribution to the
`
`infringement by others of the ’708 patent.
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`Case 1:20-cv-00847-RGA Document 1 Filed 06/24/20 Page 14 of 16 PageID #: 14
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`68. Merck will be substantially and irreparably damaged by infringement of the ’708
`
`patent.
`
`69.
`
`Unless Dr. Reddy’s 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
`(DR. REDDY’S ’685 ANDA PRODUCT)
`
`70. Merck incorporates each of the preceding paragraphs 1–69 as if fully set forth
`
`herein.
`
`71.
`
`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 Dr. Reddy’s on the other regarding Dr. Reddy’s infringement, active inducement
`
`of infringement, and contribution to the infringement by others of the ’708 patent.
`
`72.
`
`The Court should declare that the commercial manufacture, use, sale, offer for
`
`sale, or importation of Dr. Reddy’s ’685 ANDA Product with its proposed labeling, or any other
`
`Dr. Reddy’s 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.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Merck requests the following relief:
`
`(a)
`
`A judgment that the ’708 patent has been infringed under 35 U.S.C. § 271(e)(2)
`
`by Dr. Reddy’s submission to the FDA of Dr. Reddy’s ANDAs;
`
`(b)
`
`A judgment ordering that the effective date of any FDA approval of the
`
`commercial manufacture, use, or sale of Dr. Reddy’s ANDA Products, or any other drug product
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`Case 1:20-cv-00847-RGA Document 1 Filed 06/24/20 Page 15 of 16 PageID #: 15
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`that infringes or the use of which infringes the ’708 patent, be not earlier than the latest of the
`
`expiration date of the ’708 patent, inclusive of any extension(s) and additional period(s) of
`
`exclusivity;
`
`(c)
`
`A preliminary and permanent injunction enjoining Dr. Reddy’s, and all persons
`
`acting in concert with Dr. Reddy’s, from the commercial manufacture, use, sale, offer for sale, or
`
`importation into the United States of Dr. Reddy’s ANDA Products, or any other drug product
`
`covered by or whose use is covered by the ’708 patent, prior to the expiration of the ’708 patent,
`
`inclusive of any extension(s) and additional period(s) of exclusivity;
`
`(d)
`
`A judgment declaring that the commercial manufacture, use, sale, offer for sale or
`
`importation of Dr. Reddy’s ANDA Products, or any other drug product that is covered by or
`
`whose use is covered by the ’708 patent, prior to the expiration of the ’708 patent, will infringe,
`
`induce the infringement of, and contribute to the infringement by others of, the ’708 patent;
`
`(e)
`
`A declaration that this is an exceptional case and an award of attorney’s fees
`
`pursuant to 35 U.S.C. § 285;
`
`(f)
`
`(g)
`
`Costs and expenses in this action; and
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`Such further and other relief as this Court may deem just and proper.
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`Case 1:20-cv-00847-RGA Document 1 Filed 06/24/20 Page 16 of 16 PageID #: 16
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`Dated: June 24, 2020
`
` Respectfully submitted,
`
`MCCARTER & ENGLISH, LLP
`
`/s/ Daniel M. Silver
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, DE 19801
`T: (302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`Attorneys for Plaintiff
`Merck Sharp & Dohme Corp.
`
`OF COUNSEL:
`
`Bruce R. Genderson
`Jessamyn S. Berniker
`Stanley E. Fisher
`Alexander S. Zolan
`Elise M. Baumgarten
`Shaun P. Mahaffy
`Anthony H. Sheh
`Jingyuan Luo
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`T: (202) 434-5000
`F: (202) 434-5029
`bgenderson@wc.com
`jberniker@wc.com
`sfisher@wc.com
`azolan@wc.com
`ebaumgarten@wc.com
`smahaffy@wc.com
`asheh@wc.com
`jluo@wc.com
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