Case 1:21-cv-01173-UNA Document 1 Filed 08/12/21 Page 1 of 12 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,
`v.
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`LAURUS LABS LIMITED and LAURUS
`GENERICS INC.,
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` Defendants.
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`C.A. No. ________________________
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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
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`United States, Title 35, United States Code, and for a declaratory judgment of patent
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`infringement under 28 U.S.C. §§ 2201 and 2202 and the patent laws of the United States, Title
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`35, United States Code, that arises out of Defendants’ submission of Abbreviated New Drug
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`Application (“ANDA”) No. 216057 to the U.S. Food and Drug Administration (“FDA”) seeking
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`approval to commercially manufacture, use, offer for sale, sell, and/or import versions of
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`JANUVIA® (sitagliptin phosphate tablets) prior to the expiration of U.S. Patent No. 7,326,708
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`(“the ’708 patent”).
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`2.
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`Laurus Labs Limited notified Merck by letter dated July 8, 2021
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`(“Laurus’s Notice Letter”) that Laurus Labs Limited had submitted to the FDA ANDA No.
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`216057 (“Laurus’s ANDA”), seeking approval from the FDA to engage in the commercial
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`manufacture, use, offering for sale, sale, and/or importation of generic sitagliptin phosphate oral
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`tablets (“Laurus’s ANDA Product”) prior to the expiration of the ’708 patent.
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`3.
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`On information and belief, Laurus’s ANDA Product is a generic version of
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`Merck’s JANUVIA® product.
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`PARTIES
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`4.
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`Plaintiff Merck is a corporation organized and existing under the laws of
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`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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`5.
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`Merck is the holder of New Drug Application (“NDA”) No. 21995 for
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`JANUVIA® (sitagliptin phosphate), which has been approved by the FDA.
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`6.
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`On information and belief, defendant Laurus Generics Inc. (“Laurus
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`Generics”) is a corporation organized and existing under the laws of the State of Delaware,
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`having its principal place of business at 400 Connell Dr., Berkeley Heights, New Jersey 07922.
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`On information and belief, Laurus Generics. is in the business of, among other things,
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`manufacturing and selling generic versions of branded pharmaceutical drugs for the U.S. market.
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`7.
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`On information and belief, defendant Laurus Labs Limited (“Laurus
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`Labs”) is a corporation organized and existing under the laws of India, with a principal place of
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`business at Serene Chambers, Road No. 7, Banjara Hills, Hyderabad-500 034, India. Upon
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`information and belief, Laurus Labs is in the business of, among other things, manufacturing and
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`selling generic versions of branded pharmaceutical drugs through various operating subsidiaries,
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`including Laurus Generics.
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`8.
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`On information and belief, Laurus Generics is a wholly owned subsidiary
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`of Laurus Labs. Laurus Labs and Laurus Generics are herein collectively referred to “Laurus.”
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`9.
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`On information and belief, Laurus Labs and Laurus Generics acted in
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`concert to prepare and submit Laurus’s ANDA to the FDA.
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`10.
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`On information and belief, Laurus Labs and Laurus Generics know and
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`intend that upon approval of Laurus’s ANDA, Laurus will manufacture, market, sell, and
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`distribute Laurus’s ANDA Product throughout the United States, including in Delaware. On
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`information and belief, Laurus Labs and Laurus Generics are agents of each other and/or operate
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`in concert as integrated parts of the same business group, including with respect to Laurus’s
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`ANDA Product, and enter into agreements that are nearer than arm’s length. On information
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`and belief, Laurus Labs and Laurus Generics participated, assisted, and cooperated in carrying
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`out the acts complained of herein.
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`11.
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`On information and belief, following any FDA approval of Laurus’s
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`ANDA, Laurus Labs and Laurus Generics will act in concert to distribute and sell Laurus’s
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`ANDA Product throughout the United States, including within Delaware.
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`JURISDICTION
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`12.
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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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`13.
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`14.
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`This Court has personal jurisdiction over Laurus.
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`Laurus Generics is subject to personal jurisdiction in Delaware because,
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`among other things, it has purposely availed itself of the benefits and protections of Delaware’s
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`laws such that it should reasonably anticipate being haled into court here. Laurus Generics is a
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`corporation organized and existing under the laws of the State of Delaware, is qualified to do
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`business in Delaware, and has appointed a registered agent for service of process in Delaware. It
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`therefore has consented to general jurisdiction in Delaware. In addition, on information and
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`belief, Laurus Generics 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.
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`15.
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`Laurus Labs is subject to personal jurisdiction in Delaware because,
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`among other things, Laurus Labs, itself and through its wholly owned subsidiary Laurus
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`Generics, 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
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`Laurus Labs, itself and through its wholly owned subsidiary Laurus Generics, develops,
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`manufactures, imports, markets, offers to sell, and/or sells generic drugs throughout the United
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`States, including in the State of Delaware, and therefore transacts business within the State of
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`Delaware, and/or has engaged in systematic and continuous business contacts within the State of
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`Delaware. In addition, Laurus Labs is subject to personal jurisdiction in Delaware because, on
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`information and belief, it controls and dominates Laurus Generics, and therefore the activities of
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`Laurus Generics in this jurisdiction are attributed to Laurus Labs.
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`16.
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`In addition, this Court has personal jurisdiction over Laurus because
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`Laurus Labs and Laurus Generics regularly engage in patent litigation concerning FDA-
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`approved branded drug products in this district, do not contest personal jurisdiction in this
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`district, and have purposefully availed themselves of the rights and benefits of this Court by
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`asserting claims and/or counterclaims in this Court. See, e.g., Genentech, Inc. et al v. Laurus
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`Labs Ltd. et al., 19-104-RGA (D. Del. 2019); Novartis Pharmaceuticals Corporation v. Alkem
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`Laboratories Ltd. et al., 19-1979-LPS (D. Del. 2019); Boehringer Ingelheim Pharmaceuticals
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`Inc. et al v. Laurus Labs Ltd. et al., 18-1758-CFC-SRF (D. Del. 2018).
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`17.
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`On information and belief, if Laurus’s ANDA is approved, Laurus will
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`manufacture, market, sell, and/or distribute Laurus’s ANDA Product within the United States,
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`including in Delaware, consistent with Laurus’s practices for the marketing and distribution of
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`other generic pharmaceutical products. On information and belief, Laurus regularly does
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`business in Delaware, and its practices with other generic pharmaceutical products have involved
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`placing those products into the stream of commerce for distribution throughout the United States,
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`including in Delaware. On information and belief, Laurus’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, Laurus’s ANDA Product will be prescribed by physicians practicing in
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`Delaware, dispensed by pharmacies located within Delaware, and used by patients in Delaware.
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`Each of these activities would have a substantial effect within Delaware and would constitute
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`infringement of Merck’s patent in the event that Laurus’s ANDA Product is approved before the
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`patent expires.
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`18.
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`On information and belief, Laurus derives substantial revenue from
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`generic pharmaceutical products that are used and/or consumed within Delaware, and which are
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`manufactured by Laurus and/or for which Laurus Labs and/or Laurus Generics is/are the named
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`applicant(s) on approved ANDAs. On information and belief, various products for which Laurus
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`Labs and/or Laurus Generics is/are the named applicant(s) on approved ANDAs are available at
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`retail pharmacies in Delaware.
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`VENUE
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`19. Merck incorporates each of the preceding paragraphs 1–18 as if fully set
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`forth herein.
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`20.
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`Venue is proper in this district as to Laurus Generics under 28 U.S.C. §
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`1400(b) because Laurus Generics is a corporation organized and existing under the laws of the
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`State of Delaware and is subject to personal jurisdiction in this judicial district.
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`21.
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` Venue is also proper in this district as to Laurus Labs under 28 U.S.C.
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`§ 1391 because Laurus Labs is a corporation organized and existing under the laws of India and
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`is subject to personal jurisdiction in this judicial district.
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`THE ’708 PATENT
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`22. Merck incorporates each of the preceding paragraphs 1–21 as if fully set
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`forth herein.
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`23.
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`The inventors named on the ’708 patent are Stephen Howard Cypes, Alex
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`Minhua Chen, Russell R. Ferlita, Karl Hansen, Ivan Lee, Vicky K. Vydra, and Robert M.
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`Wenslow, Jr.
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`24.
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`The ’708 patent, entitled “Phosphoric Acid Salt of a Dipeptidyl Peptidase-
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`IV Inhibitor” (attached as Exhibit A), was duly and legally issued on February 5, 2008.
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`25. Merck is the owner and assignee of the ’708 patent.
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`26.
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`The ’708 patent claims, inter alia, a dihydrogenphosphate salt of 4-oxo-4-
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`[3-(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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`27.
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`JANUVIA®, as well as methods of using JANUVIA®, 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 JANUVIA® in the FDA’s Orange Book.
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`COUNT I – INFRINGEMENT OF THE ’708 PATENT
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`28. Merck incorporates each of the preceding paragraphs 1–27 as if fully set
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`forth herein.
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`29.
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`In Laurus’s Notice Letter, Laurus notified Merck of the submission of
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`Laurus’s ANDA to the FDA. The purpose of this submission was to obtain approval under the
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`FDCA to engage in the commercial manufacture, use, offer for sale, sale and/or importation of
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`Laurus’s ANDA Product prior to the expiration of the ’708 patent.
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`30.
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`In Laurus’s Notice Letter, Laurus also notified Merck that, as part of its
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`ANDA, Laurus had filed certifications of the type described in Section 505(j)(2)(A)(vii)(IV) of
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`the FDCA, 21 U.S.C. § 355 (j)(2)(A)(vii)(IV), with respect to the ’708 patent. On information
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`and belief, Laurus submitted its ANDA to the FDA containing certifications pursuant to 21
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`U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the ’708 patent is invalid, unenforceable, and/or will
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`not be infringed by the manufacture, use, offer for sale, sale, and/or importation of Laurus’s
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`ANDA Product.
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`31.
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`In Laurus’s Notice Letter, Laurus stated that Laurus’s ANDA Product
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`contains sitagliptin phosphate as an active ingredient.
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`32.
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`Laurus’s ANDA Product, and the use of Laurus’s ANDA Product, is
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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 Laurus’s ANDA
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`Product.
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`33.
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`In Laurus’s Notice Letter, Laurus did not contest infringement of claim 1
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`of the ’708 patent.
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`34.
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`Laurus’s submission of Laurus’s ANDA for the purpose of obtaining
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`approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
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`Laurus’s ANDA Product before the expiration of the ’708 patent was an act of infringement of
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`the ’708 patent under 35 U.S.C. § 271(e)(2)(A).
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`35.
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`On information and belief, Laurus will engage in the manufacture, use,
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`offer for sale, sale, marketing, distribution, and/or importation of Laurus’s ANDA Product
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`immediately and imminently upon approval of its ANDA.
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`36.
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`The manufacture, use, sale, offer for sale, or importation of Laurus’s
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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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`37.
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`On information and belief, the manufacture, use, sale, offer for sale, or
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`importation of Laurus’s 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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`38.
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`On information and belief, Laurus plans and intends to, and will, actively
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`induce infringement of the ’708 patent when Laurus’s ANDA is approved, and plans and intends
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`to, and will, do so immediately and imminently upon approval. Laurus’s activities will be done
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`with knowledge of the ’708 patent and specific intent to infringe that patent.
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`39.
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`On information and belief, Laurus knows that Laurus’s ANDA Product
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`and its proposed labeling are especially made or adapted for use in infringing the ’708 patent,
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`that Laurus’s ANDA Product is not a staple article or commodity of commerce, and that
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`Laurus’s ANDA Product and its proposed labeling are not suitable for substantial noninfringing
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`use. On information and belief, Laurus plans and intends to, and will, contribute to infringement
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`of the ’708 patent immediately and imminently upon approval of Laurus’s ANDA.
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`40.
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`Notwithstanding Laurus’s knowledge of the claims of the ’708 patent,
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`Laurus has continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or
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`import Laurus’s ANDA Product with its product labeling following FDA approval of Laurus’s
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`ANDA prior to the expiration of the ’708 patent.
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`41.
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`The foregoing actions by Laurus 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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`42.
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`On information and belief, Laurus has acted with full knowledge of the
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`’708 patent and without a reasonable basis for believing that it would not be liable for
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`infringement of the ’708 patent; active inducement of infringement of the ’708 patent; and/or
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`contribution to the infringement by others of the ’708 patent.
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`43. Merck will be substantially and irreparably damaged by infringement of
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`the ’708 patent.
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`44.
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`Unless Laurus is enjoined from infringing the ’708 patent, actively
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`inducing infringement of the ’708 patent, and contributing to the infringement by others of the
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`’708 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
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`45. Merck incorporates each of the preceding paragraphs 1–44 as if fully set
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`forth herein.
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`46.
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`The Court may declare the rights and legal relations of the parties pursuant
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`to 28 U.S.C. §§ 2201 and 2202 because there is a case of actual controversy between Merck on
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`the one hand and Laurus on the other regarding Laurus’s infringement, active inducement of
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`infringement, and contribution to the infringement by others of the ’708 patent.
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`47.
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`The Court should declare that the commercial manufacture, use, sale, offer
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`for sale or importation of Laurus’s ANDA Product with its proposed labeling, or any other
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`Laurus drug product that is covered by or whose use is covered by the ’708 patent, will infringe,
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`induce the infringement of, and contribute to the infringement by others of the ’708 patent, and
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`that the claims of the ’708 patent are valid.
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`PRAYER FOR RELIEF
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`WHEREFORE, Merck requests the following relief:
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`(a) A judgment that the ’708 patent has been infringed under 35 U.S.C. § 271(e)(2)
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`by Laurus’s submission to the FDA of Laurus’s ANDA;
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`(b) A judgment ordering that the effective date of any FDA approval of the
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`commercial manufacture, use, or sale of Laurus’s ANDA Product, or any other drug product that
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`infringes or the use of which infringes the ’708 patent, be not earlier than the latest of the
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`expiration date of the ’708 patent, inclusive of any extension(s) and additional period(s) of
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`exclusivity;
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`(c) A preliminary and permanent injunction enjoining Laurus, and all persons acting
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`in concert with Laurus, from the commercial manufacture, use, sale, offer for sale, or importation
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`into the United States of Laurus’s ANDA Product, or any other drug product covered by or
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`whose use is covered by the ’708 patent, prior to the expiration of the ’708 patent, inclusive of
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`any extension(s) and additional period(s) of exclusivity;
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`(d) A judgment declaring that the commercial manufacture, use, sale, offer for sale or
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`importation of Laurus’s ANDA Product, or any other drug product that is covered by or whose
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`use is covered by the ’708 patent, prior to the expiration of the ’708 patent, will infringe, induce
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`the infringement of, and contribute to the infringement by others of, the ’708 patent;
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`(e) A declaration that this is an exceptional case and an award of attorney’s fees
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`pursuant to 35 U.S.C. § 285;
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`(f)
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`Costs and expenses in this action; and
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`(g)
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`Such further and other relief as this Court may deem just and proper.
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`Dated: August 12, 2021
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` 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
`Sarahi Uribe
`Vanessa Omoroghomwan
`Jihad Komis*
`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
`suribe@wc.com
`vomoroghomwan@wc.com
`jkomis@wc.com
`
`*Admitted only in Michigan. Practice
`supervised by D.C. Bar members pursuant
`to D.C. Court of Appeals Rule 49(c)(8).
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