Case 1:22-cv-01071-UNA Document 1 Filed 08/15/22 Page 1 of 10 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`MERCK SHARP & DOHME LLC.,
`
` Plaintiff,
`
`v.
`
`PRINSTON PHARMACEUTICAL INC.,
`
` Defendant.
`
`C.A. No. ________________________
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`COMPLAINT
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`Plaintiff Merck Sharp & Dohme LLC. (“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 States, Title 35, United States Code, and for a declaratory judgment of patent
`
`infringement under 28 U.S.C. §§ 2201 and 2202 and the patent laws of the United States, Title
`
`35, United States Code, that arises out of Defendant’s submission of Abbreviated New Drug
`
`Application (“ANDA”) No. 216886 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”).
`
`2.
`
`Prinston Pharmaceutical Inc. notified Merck by letter dated July 1, 2022
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`(“Prinston’s Notice Letter”) that Prinston Pharmaceutical Inc. had submitted to the FDA ANDA
`
`No. 216886 (“Prinston’s ANDA”), seeking approval from the FDA to engage in the commercial
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`ME1 41933614v.1
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`1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`MERCK SHARP & DOHME LLC.,
`
` Plaintiff,
`
`v.
`
`PRINSTON PHARMACEUTICAL INC.,
`
` Defendant.
`
`C.A. No. ________________________
`
`COMPLAINT
`
`Plaintiff Merck Sharp & Dohme LLC. (“Merck”), by its attorneys, for its Complaint,
`
`alleges as follows:
`
`1.
`
`This is an action for patent infringement under the patent laws of the
`
`United States, Title 35, United States Code, and for a declaratory judgment of patent
`
`infringement under 28 U.S.C. §§ 2201 and 2202 and the patent laws of the United States, Title
`
`35, United States Code, that arises out of Defendant’s submission of Abbreviated New Drug
`
`Application (“ANDA”) No. 216886 to the U.S. Food and Drug Administration (“FDA”) seeking
`
`approval to commercially manufacture, use, offer for sale, sell, and/or import versions of
`
`JANUVIA® (sitagliptin phosphate tablets) prior to the expiration of U.S. Patent No. 7,326,708
`
`(“the ’708 patent”).
`
`2.
`
`Prinston Pharmaceutical Inc. notified Merck by letter dated July 1, 2022
`
`(“Prinston’s Notice Letter”) that Prinston Pharmaceutical Inc. had submitted to the FDA ANDA
`
`No. 216886 (“Prinston’s ANDA”), seeking approval from the FDA to engage in the commercial
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`Case 1:22-cv-01071-UNA Document 1 Filed 08/15/22 Page 2 of 10 PageID #: 2
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`manufacture, use, offering for sale, sale, and/or importation of generic sitagliptin phosphate oral
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`tablets (“Prinston’s ANDA Product”) prior to the expiration of the ’708 patent.
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`3.
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`On information and belief, Prinston’s ANDA Product is a generic version
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`of 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 126 East Lincoln Ave,
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`P.O. Box 2000, Rahway, NJ 07065 USA.
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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 Prinston Pharmaceutical Inc.
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`(“Prinston”) is a corporation organized and existing under the laws of the State of Delaware, with
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`a place of business at 700 Atrium Drive Somerset, New Jersey 08873. Upon information and
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`belief, Prinston 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.
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`7.
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`On information and belief, Prinston knows and intends that upon approval
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`of Prinston’s ANDA, Prinston will manufacture, market, sell, and distribute Prinston’s ANDA
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`Product throughout the United States, including in Delaware.
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`8.
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`On information and belief, following any FDA approval of Prinston’s
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`ANDA, Prinston will distribute and sell Prinston’s ANDA Product throughout the United States,
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`including within Delaware.
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`JURISDICTION
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`9.
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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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`10.
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`11.
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`This Court has personal jurisdiction over Prinston.
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`Prinston Pharmaceutical Inc. is subject to personal jurisdiction in
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`Delaware because, among other things, it has purposely 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. Prinston Pharmaceutical Inc. is a corporation organized and existing under the laws of the
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`State of Delaware, is qualified to do business in Delaware, and has appointed a registered agent
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`for service of process in Delaware. It therefore has consented to general jurisdiction in Delaware.
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`In addition, on information and belief, Prinston Pharmaceutical 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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`12.
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`In addition, this Court has personal jurisdiction over Prinston because
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`Prinston engages in patent litigation concerning FDA-approved branded drug products in this
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`district, does not contest personal jurisdiction in this district, and has purposefully availed itself
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`of the rights and benefits of this Court by asserting claims and/or counterclaims in this Court.
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`See, e.g., Astellas Pharma Inc. et al v. Sandoz Inc. et al., 20-1589-JFB-CJB (D. Del. 2020);
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`Otsuka Pharmaceutical Co. Ltd. et al v. Prinston Pharmaceutical Inc.. 20-1502-LPS (D. Del.
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`2020).
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`13.
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`On information and belief, if Prinston’s ANDA is approved, Prinston will
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`manufacture, market, sell, and/or distribute Prinston’s ANDA Product within the United States,
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`including in Delaware, consistent with Prinston’s practices for the marketing and distribution of
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`other generic pharmaceutical products. On information and belief, Prinston 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, Prinston’s generic pharmaceutical products
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`are used and/or consumed within and throughout the United States, including in Delaware. On
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`information and belief, Prinston’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 Prinston’s ANDA Product is approved before
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`the patent expires.
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`14.
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`On information and belief, Prinston 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 Prinston and/or for which Prinston is the named applicant on approved
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`ANDAs. On information and belief, various products for which Prinston is the named applicant
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`on approved ANDAs are available at retail pharmacies in Delaware.
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`VENUE
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`15. Merck incorporates each of the preceding paragraphs 1–14 as if fully set
`
`forth herein.
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`16.
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`Venue is proper in this district as to Prinston Pharmaceutical Inc. under 28
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`U.S.C. § 1400(b) because Prinston Pharmaceutical Inc. is a corporation organized and existing
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`under the laws of the State of Delaware and is subject to personal jurisdiction in this judicial
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`district.
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`forth herein.
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`THE ’708 PATENT
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`17. Merck incorporates each of the preceding paragraphs 1–16 as if fully set
`
`18.
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`The inventors named on the ’708 patent are Stephen Howard Cypes, Alex
`
`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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`19.
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`The ’708 patent, entitled “Phosphoric Acid Salt of a Dipeptidyl Peptidase-
`
`IV Inhibitor” (attached as Exhibit A), was duly and legally issued on February 5, 2008.
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`20. Merck is the owner and assignee of the ’708 patent.
`
`21.
`
`The ’708 patent claims, inter alia, a dihydrogenphosphate salt of 4-oxo-4-
`
`[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-
`
`trifluorophenyl)butan-2-amine of structural formula I, or a hydrate thereof, as recited in claim 1
`
`of the ’708 patent.
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`22.
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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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`23. Merck incorporates each of the preceding paragraphs 1–22 as if fully set
`
`forth herein.
`
`24.
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`In Prinston’s Notice Letter, Prinston notified Merck of the submission of
`
`Prinston’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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`Prinston’s ANDA Product prior to the expiration of the ’708 patent.
`
`25.
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`In Prinston’s Notice Letter, Prinston also notified Merck that, as part of its
`
`ANDA, Prinston 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, Prinston 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 Prinston’s
`
`ANDA Product.
`
`26.
`
`In Prinston’s Notice Letter, Prinston stated that Prinston’s ANDA Product
`
`contains sitagliptin phosphate as an active ingredient.
`
`27.
`
`Prinston’s ANDA Product, and the use of Prinston’s ANDA Product, is
`
`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 Prinston’s
`
`ANDA Product.
`
`28.
`
`In Prinston’s Notice Letter, Prinston did not contest infringement of claim
`
`1 of the ’708 patent.
`
`29.
`
`Prinston’s submission of Prinston’s ANDA for the purpose of obtaining
`
`approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
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`Prinston’s 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).
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`30.
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`On information and belief, Prinston will engage in the manufacture, use,
`
`offer for sale, sale, marketing, distribution, and/or importation of Prinston’s ANDA Product
`
`immediately and imminently upon approval of its ANDA.
`
`31.
`
`The manufacture, use, sale, offer for sale, or importation of Prinston’s
`
`ANDA Product would infringe one or more claims of the ’708 patent, including at least claim 1
`
`of the ’708 patent.
`
`32.
`
`On information and belief, the manufacture, use, sale, offer for sale, or
`
`importation of Prinston’s 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.
`
`33.
`
`On information and belief, Prinston plans and intends to, and will, actively
`
`induce infringement of the ’708 patent when Prinston’s ANDA is approved, and plans and
`
`intends to, and will, do so immediately and imminently upon approval. Prinston’s activities will
`
`be done with knowledge of the ’708 patent and specific intent to infringe that patent.
`
`34.
`
`On information and belief, Prinston knows that Prinston’s ANDA Product
`
`and its proposed labeling are especially made or adapted for use in infringing the ’708 patent,
`
`that Prinston’s ANDA Product is not a staple article or commodity of commerce, and that
`
`Prinston’s ANDA Product and its proposed labeling are not suitable for substantial noninfringing
`
`use. On information and belief, Prinston plans and intends to, and will, contribute to
`
`infringement of the ’708 patent immediately and imminently upon approval of Prinston’s
`
`ANDA.
`
`35.
`
`Notwithstanding Prinston’s knowledge of the claims of the ’708 patent,
`
`Prinston has continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or
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`import Prinston’s ANDA Product with its product labeling following FDA approval of Prinston’s
`
`ANDA prior to the expiration of the ’708 patent.
`
`36.
`
`The foregoing actions by Prinston 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.
`
`37.
`
`On information and belief, Prinston 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.
`
`38. Merck will be substantially and irreparably damaged by infringement of
`
`the ’708 patent.
`
`39.
`
`Unless Prinston 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 II – DECLARATORY JUDGMENT
`OF INFRINGEMENT OF THE ’708 PATENT
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`40. Merck incorporates each of the preceding paragraphs 1–39 as if fully set
`
`forth herein.
`
`41.
`
`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 Prinston on the other regarding Prinston’s infringement, active inducement of
`
`infringement, and contribution to the infringement by others of the ’708 patent.
`
`42.
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`The Court should declare that the commercial manufacture, use, sale, offer
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`for sale or importation of Prinston’s ANDA Product with its proposed labeling, or any other
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`Case 1:22-cv-01071-UNA Document 1 Filed 08/15/22 Page 9 of 10 PageID #: 9
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`Prinston 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
`
`patent, and 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)
`
`by Prinston’s submission to the FDA of Prinston’s ANDA;
`
`(b) A judgment ordering that the effective date of any FDA approval of the
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`commercial manufacture, use, or sale of Prinston’s ANDA Product, or any other drug product
`
`that 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
`
`exclusivity;
`
`(c) A preliminary and permanent injunction enjoining Prinston, and all persons acting
`
`in concert with Prinston, from the commercial manufacture, use, sale, offer for sale, or
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`importation into the United States of Prinston’s ANDA Product, or any other drug product
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`covered by or whose use is covered by the ’708 patent, prior to the expiration of the ’708 patent,
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`inclusive of 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 Prinston’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
`
`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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`Case 1:22-cv-01071-UNA Document 1 Filed 08/15/22 Page 10 of 10 PageID #: 10
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`(f)
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`Costs and expenses in this action; and
`
`(g)
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`Such further and other relief as this Court may deem just and proper.
`
`Dated: August 15, 2022
`
` Respectfully submitted,
`
`MCCARTER & ENGLISH, LLP
`
`/s/ Daniel M. Silver
`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, DE 19801
`T: (302) 984-6300
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`Attorneys for Plaintiff
`Merck Sharp & Dohme LLC.
`
`OF COUNSEL:
`
`Bruce R. Genderson
`Stanley E. Fisher
`Elise M. Baumgarten
`Alexander S. Zolan
`Shaun P. Mahaffy
`Anthony H. Sheh
`Sarahi Uribe
`Vanessa Omoroghomwan
`Jihad Komis
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue SW,
`Washington, DC 20024
`T: (202) 434-5000
`F: (202) 434-5029
`bgenderson@wc.com
`sfisher@wc.com
`ebaumgarten@wc.com
`azolan@wc.com
`smahaffy@wc.com
`asheh@wc.com
`suribe@wc.com
`vomoroghomwan@wc.com
`jkomis@wc.com
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