Case 2:21-cv-14271 Document 1 Filed 07/28/21 Page 1 of 32 PageID: 1
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`
`
`Charles M. Lizza
`William C. Baton
`Sarah A. Sullivan
`SAUL EWING ARNSTEIN & LEHR LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Jazz Pharmaceuticals Ireland Limited
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
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`
`
`JAZZ PHARMACEUTICALS IRELAND
`LIMITED,
`
`
`
`
`Plaintiff,
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`
`v.
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`
`
`LUPIN LTD., LUPIN INC., and
`LUPIN PHARMACEUTICALS, INC.,
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`
`
`Civil Action No. ________________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
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`(Filed Electronically)
`
`
`
`Defendants.
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`
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`Plaintiff Jazz Pharmaceuticals Ireland Limited (“Jazz Pharmaceuticals”), by its
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`undersigned attorneys, for its Complaint against Defendants Lupin Ltd., Lupin Inc., and Lupin
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`Pharmaceuticals, Inc. (together, “Lupin” or “Defendants”), alleges as follows:
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`Nature of the Action
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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, 35 U.S.C. §100, et seq., arising from Lupin’s submission of Abbreviated New Drug
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`Application (“ANDA”) No. 215911 (“Lupin’s ANDA”) to the United States Food and Drug
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`Administration (“FDA”) seeking approval to manufacture, use, import, distribute, offer to sell,
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`and/or sell a generic version of Jazz Pharmaceuticals’s Xywav® drug products prior to the
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`1
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`

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`Case 2:21-cv-14271 Document 1 Filed 07/28/21 Page 2 of 32 PageID: 2
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`expiration of United States Patent Nos. 8,591,922 (“the ’922 patent”), 8,772,306 (“the ’306
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`patent”), 8,901,173 (“the ’173 patent”), 9,050,302 (“the ’302 patent”), 9,132,107 (“the ’107
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`patent”), 9,486,426 (“the ’426 patent”), 10,195,168 (“the ’168 patent”), 10,213,400 (“the ’400
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`patent”), 10,675,258 (“the ’258 patent”), and 10,864,181 (“the ’181 patent”) (collectively, “the
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`patents-in-suit”), all owned by Jazz Pharmaceuticals.
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`The Parties
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`2.
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`Plaintiff Jazz Pharmaceuticals Ireland Limited is a corporation organized and
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`existing under the laws of Ireland, having a principal place of business at Waterloo Exchange,
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`Waterloo Road, Dublin, Ireland 4.
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`3.
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`On information and belief, Defendant Lupin Ltd. is a corporation organized and
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`existing under the laws of India, having a place of business at B/4 Laxmi Towers, Bandra Kurla
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`Complex Bandra (E), Mumbai, 400 051, India, and its registered office at Kalpataru Inspire 3rd
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`Floor, Off Western Express Highway Santacruz (East), Mumbai 400 055, India.
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`4.
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`On information and belief, Defendant Lupin Inc. is a corporation organized and
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`existing under the laws of the State of Delaware, having places of business at 111 South Calvert
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`Street, 21st Floor, Baltimore, Maryland 21202 and 400 Campus Drive, Somerset, New Jersey
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`08873.
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`5.
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`On information and belief, Defendant Lupin Pharmaceuticals, Inc. is a
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`corporation organized and existing under the laws of the State of Delaware, having places of
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`business at 111 South Calvert Street, 21st Floor, Baltimore, Maryland 21202 and 400 Campus
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`Drive, Somerset, New Jersey 08873.
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`6.
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`On information and belief, Lupin Inc. and Lupin Pharmaceuticals, Inc. are wholly
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`owned subsidiaries of Lupin Ltd.
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`2
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`The Patents-in-Suit
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`7.
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`On November 26, 2013, the United States Patent and Trademark Office
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`(“USPTO”) duly and lawfully issued the ’922 patent, entitled, “Gamma-hydroxybutyrate
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`compositions and their use for the treatment of disorders,” to Jazz Pharmaceuticals as assignee.
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`A copy of the ’922 patent is attached hereto as Exhibit A.
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`8.
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`On July 8, 2014, the USPTO duly and lawfully issued the ’306 patent, entitled,
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`“Method of administration of gamma hydroxybutyrate with monocarboxylate transporters,” to
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`Jazz Pharmaceuticals as assignee. A copy of the ’306 patent is attached hereto as Exhibit B.
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`9.
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`On December 2, 2014, the USPTO duly and lawfully issued the ’173 patent,
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`entitled, “Gamma-hydroxybutyrate compositions and their use for the treatment of disorders,” to
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`Jazz Pharmaceuticals as assignee. A copy of the ’173 patent is attached hereto as Exhibit C.
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`10.
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`On June 9, 2015, the USPTO duly and lawfully issued the ’302 patent, entitled,
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`“Method of administration of gamma hydroxybutyrate with monocarboxylate transporters,” to
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`Jazz Pharmaceuticals as assignee. A copy of the ’302 patent is attached hereto as Exhibit D.
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`11.
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`On September 15, 2015, the USPTO duly and lawfully issued the ’107 patent,
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`entitled, “Gamma-hydroxybutyrate compositions and their use for the treatment of disorders,” to
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`Jazz Pharmaceuticals as assignee. A copy of the ’107 patent is attached hereto as Exhibit E.
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`12.
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`On November 8, 2016, the USPTO duly and lawfully issued the ’426 patent,
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`entitled, “Method of administration of gamma hydroxybutyrate with monocarboxylate
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`transporters,” to Jazz Pharmaceuticals as assignee. A copy of the ’426 patent is attached hereto
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`as Exhibit F.
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`3
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`13.
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`On February 5, 2019, the USPTO duly and lawfully issued the ’168 patent,
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`entitled, “Gamma-hydroxybutyrate compositions and their uses for the treatment of disorders,”
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`to Jazz Pharmaceuticals as assignee. A copy of the ’168 patent is attached hereto as Exhibit G.
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`14.
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`On February 26, 2019, the USPTO duly and lawfully issued the ’400 patent,
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`entitled, “Method of administration of gamma hydroxybutyrate with monocarboxylate
`
`transporters,” to Jazz Pharmaceuticals as assignee. A copy of the ’400 patent is attached hereto
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`as Exhibit H.
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`15.
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`On June 9, 2020, the USPTO duly and lawfully issued the ’258 patent, entitled,
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`“Method of using gamma-hydroxybutyrate compositions for the treatment of disorders,” to Jazz
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`Pharmaceuticals as assignee. A copy of the ’258 patent is attached hereto as Exhibit I.
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`16.
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`On December 15, 2020, the USPTO duly and lawfully issued the ’181 patent,
`
`entitled, “Method of administration of gamma hydroxybutyrate with monocarboxylate
`
`transporters,” to Jazz Pharmaceuticals as assignee. A copy of the ’181 patent is attached hereto
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`as Exhibit J.
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`The Xywav® Drug Product
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`17.
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`Jazz Pharmaceuticals holds an approved New Drug Application (“NDA”) under
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`Section 505(a) of the Federal Food Drug and Cosmetic Act (“FFDCA”), 21 U.S.C. § 355(a), for
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`calcium, magnesium, potassium, and sodium oxybates oral solution (NDA No. 212690), which it
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`sells under the trade name Xywav®. The claims of the patents-in-suit cover, inter alia, methods
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`of use and administration of calcium, magnesium, potassium, and sodium oxybates, or
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`pharmaceutical compositions containing calcium, magnesium, potassium, and sodium oxybates.
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`4
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`18.
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`Pursuant to 21 U.S.C. § 355(b)(1) and attendant FDA regulations, the patents-in-
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`suit are listed in the FDA publication, “Approved Drug Products with Therapeutic Equivalence
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`Evaluations” (the “Orange Book”), with respect to Xywav®.
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`19.
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`The labeling for Xywav® instructs and encourages physicians, pharmacists, other
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`healthcare workers, and patients to administer Xywav® for the treatment of cataplexy or
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`excessive daytime sleepiness in patients with narcolepsy .
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`20.
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`The labeling for Xywav® instructs and encourages physicians, pharmacists, other
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`healthcare workers, and patients to modify the dose of Xywav® for patients receiving calcium,
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`magnesium, potassium, and sodium oxybates when divalproex sodium (valproate) is
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`concomitantly administered.
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`21.
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`The labeling for Xywav® instructs and encourages physicians, pharmacists, other
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`healthcare workers, and patients to administer Xywav® according to one or more of the methods
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`claimed in the patents-in-suit.
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`Acts Giving Rise To This Suit
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`22.
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`Pursuant to Section 505 of the FFDCA, Lupin submitted Lupin’s ANDA seeking
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`approval to engage in the commercial manufacture, use, sale, or offer for sale in, or importation
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`into, the United States of 0.5 g/mL calcium, magnesium, potassium, and sodium oxybates oral
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`solution (“Lupin’s Proposed Product”) before the patents-in-suit expire.
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`23.
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`On information and belief, following FDA approval of Lupin’s ANDA, Lupin will
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`make, use, sell, or offer to sell Lupin’s Proposed Product throughout the United States, or import
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`such generic products into the United States.
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`24.
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`On information and belief, in connection with the submission of Lupin’s ANDA
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`as described above, Lupin provided written certifications to the FDA pursuant to Section 505 of
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`5
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`the FFDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Lupin’s Paragraph IV Certification”), alleging
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`that the claims of the patents-in-suit are invalid and/or will not be infringed by the activities
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`described in Lupin’s ANDA.
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`25.
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`No earlier than June 16, 2021, Lupin sent a written notice of its Paragraph IV
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`Certification to Jazz Pharmaceuticals (“Lupin’s Notice Letter”). Lupin’s Notice Letter alleged
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`that the claims of the patents-in-suit are invalid and/or will not be infringed by the activities
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`described in Lupin’s ANDA. Lupin’s Notice Letter also informed Jazz Pharmaceuticals that
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`Lupin seeks approval to market Lupin’s Proposed Product before the patents-in-suit expire.
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`Jurisdiction and Venue
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`26.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
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`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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`27.
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`On information and belief, Lupin Ltd. derives substantial revenue from directly or
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`indirectly selling generic pharmaceutical products and/or active pharmaceutical ingredient(s)
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`used in generic pharmaceutical products sold throughout the United States, including in this
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`Judicial District.
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`28.
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`This Court has personal jurisdiction over Lupin Ltd. because, inter alia, it: (1) has
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`purposefully availed itself of the privilege of doing business in the State of New Jersey,
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`including directly or indirectly through its subsidiaries, agents, and/or alter egos, Lupin Inc. and
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`Lupin Pharmaceuticals, Inc., companies with a regular and established place of business in New
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`Jersey; and (2) maintains extensive and systematic contacts with the State of New Jersey,
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`including through the marketing, distribution, and/or sale of generic pharmaceutical drugs in
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`New Jersey including through, directly or indirectly, Lupin Inc. and Lupin Pharmaceuticals, Inc.
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`6
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`29.
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`On information and belief, Lupin Inc. derives substantial revenue from directly or
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`indirectly selling generic pharmaceutical products and/or active pharmaceutical ingredient(s)
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`used in generic pharmaceutical products sold throughout the United States, including in this
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`Judicial District.
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`30.
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`This Court has personal jurisdiction over Lupin Inc. because, inter alia, it: (1) on
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`information and belief, maintains a regular and established, physical place of business at 400
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`Campus Drive, Somerset, New Jersey 08873; (2) has purposefully availed itself of the privilege
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`of doing business in the State of New Jersey, including directly or indirectly through its
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`subsidiary, agent, and/or alter ego, Lupin Pharmaceuticals, Inc., a company with a regular and
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`established place of business in New Jersey; and (3) maintains extensive and systematic contacts
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`with the State of New Jersey, including through the marketing, distribution, and/or sale of
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`generic pharmaceutical drugs in New Jersey including through, directly or indirectly, Lupin
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`Pharmaceuticals, Inc. By virtue of its physical presence in New Jersey, this Court has personal
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`jurisdiction over Lupin Inc. On information and belief, Lupin Inc. purposefully has conducted
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`and continues to conduct business in this Judicial District.
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`31.
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`This Court has personal jurisdiction over Lupin Pharmaceuticals, Inc. by virtue of,
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`inter alia, its systematic and continuous contacts with the State of New Jersey. On information
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`and belief, Lupin Pharmaceuticals, Inc. maintains a regular and established, physical place of
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`business at 400 Campus Drive, Somerset, New Jersey 08873. On information and belief, Lupin
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`Pharmaceuticals, Inc. is registered with the State of New Jersey’s Division of Revenue and
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`Enterprise Services as a business operating in New Jersey under Business ID No. 0101043376.
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`On information and belief, Lupin Pharmaceuticals, Inc. is registered with the State of New
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`Jersey’s Department of Health as a drug manufacturer and wholesaler under Registration No.
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`7
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`5005159. By virtue of its physical presence in New Jersey, this Court has personal jurisdiction
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`over Lupin Pharmaceuticals, Inc. On information and belief, Lupin Pharmaceuticals, Inc.
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`purposefully has conducted and continues to conduct business in this Judicial District.
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`32.
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`On information and belief, Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals,
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`Inc. are in the business of, among other things, manufacturing, marketing, importing, offering for
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`sale, and selling pharmaceutical products, including generic drug products, throughout the
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`United States, including in this Judicial District. On information and belief, Lupin Ltd., Lupin
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`Inc., and Lupin Pharmaceuticals, Inc. also prepare and/or aid in the preparation and submission
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`of ANDAs to the FDA, including Lupin’s ANDA.
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`33.
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`On information and belief, this Judicial District is a likely destination for the
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`generic drug products described in Lupin’s ANDA.
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`34.
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`On information and belief, Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals,
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`Inc. derive substantial revenue from directly or indirectly selling generic pharmaceutical
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`products and/or active pharmaceutical ingredient(s) used in generic pharmaceutical products sold
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`throughout the United States, including in this Judicial District.
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`35.
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`This Court also has personal jurisdiction over Lupin Ltd., Lupin Inc., and Lupin
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`Pharmaceuticals, Inc. because, inter alia, they have committed an act of patent infringement
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`under 35 U.S.C. § 271(e)(2). On information and belief, Lupin Ltd., Lupin Inc., and Lupin
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`Pharmaceuticals, Inc. intend a future course of conduct that includes acts of patent infringement
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`in New Jersey. These acts have led and will continue to lead to foreseeable harm and injury to
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`Jazz Pharmaceuticals in New Jersey and in this Judicial District.
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`36.
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`In the alternative, this Court has personal jurisdiction over Lupin Ltd. because the
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`requirements of Federal Rule of Civil Procedure 4(k)(2) are met as (a) Jazz Pharmaceuticals’s
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`8
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`claims arise under federal law; (b) Lupin Ltd. is a foreign defendant not subject to general
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`personal jurisdiction in the courts of any state; and (c) Lupin Ltd. has sufficient contacts with the
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`United States as a whole, including, but not limited to, preparing and submitting ANDAs to the
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`FDA and/or manufacturing, importing, offering to sell, and/or selling pharmaceutical products
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`that are distributed throughout the United States, such that this Court’s exercise of jurisdiction
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`over Lupin Ltd. satisfies due process.
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`37.
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`On information and belief, Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals,
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`Inc. work in privity and/or concert either directly or indirectly through one or more of their
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`wholly owned subsidiaries with respect to the regulatory approval, manufacturing, use,
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`importation, marketing, offer for sale, sale, and distribution of generic pharmaceutical products
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`throughout the United States, including in this Judicial District.
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`38.
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`On information and belief, each of Lupin Ltd., Lupin Inc., and Lupin
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`Pharmaceuticals, Inc. actively participated in the submission of Lupin’s ANDA. On information
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`and belief, Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc. will work in privity and/or
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`concert with one another and/or other related entities towards the regulatory approval,
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`manufacturing, use, importation, marketing, offer for sale, sale, and distribution of generic
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`pharmaceutical products, including Lupin’s Proposed Product, throughout the United States,
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`including in New Jersey and in this Judicial District, prior to the expiration of the patents-in-suit.
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`39.
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`On information and belief, Lupin Ltd. intends to benefit directly if Lupin’s
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`ANDA is approved by participating in the manufacture, importation, distribution, and/or sale of
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`the generic drug products that are the subject of Lupin’s ANDA.
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`9
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`40.
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`On information and belief, Lupin Inc. intends to benefit directly if Lupin’s ANDA
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`is approved by participating in the manufacture, importation, distribution, and/or sale of the
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`generic drug products that are the subject of Lupin’s ANDA.
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`41.
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`On information and belief, Lupin Pharmaceuticals, Inc. intends to benefit directly
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`if Lupin’s ANDA is approved by participating in the manufacture, importation, distribution,
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`and/or sale of the generic drug products that are the subject of Lupin’s ANDA.
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`42.
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`On information and belief, Lupin Inc. and Lupin Pharmaceuticals, Inc. act at the
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`direction, and for the benefit, of Lupin Ltd. and are controlled and/or dominated by Lupin Ltd.
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`43.
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`On information and belief, Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals,
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`Inc. act, operate, and/or hold themselves out to the public as a single integrated business.
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`44.
`
`On information and belief, Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals,
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`Inc. have previously been sued in this District and have not challenged personal jurisdiction.
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`See, e.g., AstraZeneca AB, et al. v. Lupin Ltd. and Lupin Pharm. Inc., Civ. Action No. 3:09-cv-
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`05404 (JAP)(TJB) (D.N.J.); Abbott Labs and Laboratories Fournier S.A. v. Lupin Ltd. and Lupin
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`Pharm. Inc., Civ. Action No. 2:09- cv-01007 (GEB)(MCA) (D.N.J.); Abbott Labs and
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`Laboratories Fournier S.A. v. Lupin Ltd. and Lupin Pharm. Inc., Civ. Action No. 2:10-cv-01578
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`(DMC)(JAD) (D.N.J.); Tibotec Inc. and Tibotec Pharm. v. Lupin Ltd., et al., Civ. Action No.
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`2:10-cv-05954 (WHW)(MAS) (D.N.J.); Novartis Corp., et al. v. Lupin Ltd. and Lupin Pharm.
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`Inc., Civ. Action No. 2:06-cv-05954 (GEB)(ES) (D.N.J.); Elan Int’l. Ltd. and Fournier
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`Laboratories Ireland Ltd. v. Lupin Ltd. and Lupin Pharm. Inc., Civ. Action No. 2:09-cv-01008
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`(GEB)(MCA) (D.N.J.), Jazz Pharmaceuticals, Inc., et al. v. Lupin Ltd., et al., Civ. Action No.
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`2:15-cv-06548 (ES)(JAD) (D.N.J.), Horizon Pharma Ireland Limited, et al. v. Lupin Ltd., et al.,
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`Civ. Action No. 1:15-cv-06935 (NLH)(AMD) (D.N.J.), Senju Pharmaceutical Co., Ltd, et al. v.
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`10
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`Lupin Ltd., et al., Civ. Action No. 1:16-cv-01097 (JBS)(KMW) (D.N.J.), Bausch Health Ireland
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`Ltd., et al. v. Lupin Ltd., et al., 1:20-cv-11039 (RMB)(KMW) (D.N.J.), Merck Sharp & Dohme
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`BV, et al. v. Lupin Ltd., et al., 2:20-cv-02786 (CCC)(MF) (D.N.J.), and Bristol-Myers Squibb Co.
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`v. Lupin Ltd., et al., 3:20-cv-07810 (MAS)(TJB) (D.N.J.).
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`45.
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`Venue is proper in this Judicial District pursuant to 28 U.S.C. §§ 1391 and/or
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`1400(b).
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`Count I: Infringement of the ’922 Patent
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`46.
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`Jazz Pharmaceuticals repeats and realleges the allegations of the preceding
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`paragraphs as if fully set forth herein.
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`47.
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`Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc.’s submission of their
`
`ANDA to obtain approval to engage in the commercial manufacture, use, sale, or offer for sale
`
`in, or importation into, the United States of Lupin’s Proposed Product, prior to the expiration of
`
`the ’922 patent, constitutes infringement of one or more of the claims of that patent under 35
`
`U.S.C. § 271(e)(2)(A).
`
`48.
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`There is a justiciable controversy between the parties hereto as to the infringement
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`of the ’922 patent.
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`49.
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`Unless enjoined by this Court, upon FDA approval of Lupin’s ANDA, Lupin Ltd.,
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`Lupin Inc., and Lupin Pharmaceuticals, Inc. will infringe one or more claims of the ’922 patent
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`under 35 U.S.C. § 271(a) by making, using, offering to sell, selling, and/or importing Lupin’s
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`Proposed Product in or for the United States.
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`50.
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`Unless enjoined by this Court, upon FDA approval of Lupin’s ANDA, Lupin Ltd.,
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`Lupin Inc., and Lupin Pharmaceuticals, Inc. will induce infringement of one or more claims of
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`the ’922 patent under 35 U.S.C. § 271(b) by making, using, offering to sell, selling, and/or
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`11
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`importing Lupin’s Proposed Product in or for the United States. On information and belief, upon
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`FDA approval of Lupin’s ANDA, Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc. will
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`intentionally encourage acts of direct infringement with knowledge of the ’922 patent and
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`knowledge that their acts are encouraging infringement.
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`51.
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`Unless enjoined by this Court, upon FDA approval of Lupin’s ANDA, Lupin Ltd.,
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`Lupin Inc., and Lupin Pharmaceuticals, Inc. will contributorily infringe one or more claims of
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`the ’922 patent under 35 U.S.C. § 271(c) by making, using, offering to sell, selling, and/or
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`importing Lupin’s Proposed Product in or for the United States. On information and belief,
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`Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc. have had and continue to have
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`knowledge that Lupin’s Proposed Product is especially adapted for a use that infringes one or
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`more claims of the ’922 patent and that there is no substantial non-infringing use for Lupin’s
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`Proposed Product.
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`52.
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`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
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`Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc.’s infringement of the ’922 patent is not
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`enjoined.
`
`53.
`
`54.
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`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
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`of its reasonable attorneys’ fees under 35 U.S.C. § 285.
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`Count II: Infringement of the ’306 Patent
`
`55.
`
`Jazz Pharmaceuticals repeats and realleges the allegations of the preceding
`
`paragraphs as if fully set forth herein.
`
`56.
`
`Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc.’s submission of their
`
`ANDA to obtain approval to engage in the commercial manufacture, use, sale, or offer for sale
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`12
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`in, or importation into, the United States of Lupin’s Proposed Product, prior to the expiration of
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`the ’306 patent, constitutes infringement of one or more of the claims of that patent under 35
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`U.S.C. § 271(e)(2)(A).
`
`57.
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`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’306 patent.
`
`58.
`
`Unless enjoined by this Court, upon FDA approval of Lupin’s ANDA, Lupin Ltd.,
`
`Lupin Inc., and Lupin Pharmaceuticals, Inc. will infringe one or more claims of the ’306 patent
`
`under 35 U.S.C. § 271(a) by making, using, offering to sell, selling, and/or importing Lupin’s
`
`Proposed Product in or for the United States.
`
`59.
`
`Unless enjoined by this Court, upon FDA approval of Lupin’s ANDA, Lupin Ltd.,
`
`Lupin Inc., and Lupin Pharmaceuticals, Inc. will induce infringement of one or more claims of
`
`the ’306 patent under 35 U.S.C. § 271(b) by making, using, offering to sell, selling, and/or
`
`importing Lupin’s Proposed Product in or for the United States. On information and belief, upon
`
`FDA approval of Lupin’s ANDA, Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc. will
`
`intentionally encourage acts of direct infringement with knowledge of the ’306 patent and
`
`knowledge that their acts are encouraging infringement.
`
`60.
`
`Unless enjoined by this Court, upon FDA approval of Lupin’s ANDA, Lupin Ltd.,
`
`Lupin Inc., and Lupin Pharmaceuticals, Inc. will contributorily infringe one or more claims of
`
`the ’306 patent under 35 U.S.C. § 271(c) by making, using, offering to sell, selling, and/or
`
`importing Lupin’s Proposed Product in or for the United States. On information and belief,
`
`Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc. have had and continue to have
`
`knowledge that Lupin’s Proposed Product is especially adapted for a use that infringes one or
`
`
`
`13
`
`

`

`Case 2:21-cv-14271 Document 1 Filed 07/28/21 Page 14 of 32 PageID: 14
`
`
`
`more claims of the ’306 patent and that there is no substantial non-infringing use for Lupin’s
`
`Proposed Product.
`
`61.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc.’s infringement of the ’306 patent is not
`
`enjoined.
`
`62.
`
`63.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
`
`of its reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count III: Infringement of the ’173 Patent
`
`64.
`
`Jazz Pharmaceuticals repeats and realleges the allegations of the preceding
`
`paragraphs as if fully set forth herein.
`
`65.
`
`Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc.’s submission of their
`
`ANDA to obtain approval to engage in the commercial manufacture, use, sale, or offer for sale
`
`in, or importation into, the United States of Lupin’s Proposed Product, prior to the expiration of
`
`the ’173 patent, constitutes infringement of one or more of the claims of that patent under 35
`
`U.S.C. § 271(e)(2)(A).
`
`66.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’173 patent.
`
`67.
`
`Unless enjoined by this Court, upon FDA approval of Lupin’s ANDA, Lupin Ltd.,
`
`Lupin Inc., and Lupin Pharmaceuticals, Inc. will infringe one or more claims of the ’173 patent
`
`under 35 U.S.C. § 271(a) by making, using, offering to sell, selling, and/or importing Lupin’s
`
`Proposed Product in or for the United States.
`
`
`
`14
`
`

`

`Case 2:21-cv-14271 Document 1 Filed 07/28/21 Page 15 of 32 PageID: 15
`
`
`
`68.
`
`Unless enjoined by this Court, upon FDA approval of Lupin’s ANDA, Lupin Ltd.,
`
`Lupin Inc., and Lupin Pharmaceuticals, Inc. will induce infringement of one or more claims of
`
`the ’173 patent under 35 U.S.C. § 271(b) by making, using, offering to sell, selling, and/or
`
`importing Lupin’s Proposed Product in or for the United States. On information and belief, upon
`
`FDA approval of Lupin’s ANDA, Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc. will
`
`intentionally encourage acts of direct infringement with knowledge of the ’173 patent and
`
`knowledge that their acts are encouraging infringement.
`
`69.
`
`Unless enjoined by this Court, upon FDA approval of Lupin’s ANDA, Lupin Ltd.,
`
`Lupin Inc., and Lupin Pharmaceuticals, Inc. will contributorily infringe one or more claims of
`
`the ’173 patent under 35 U.S.C. § 271(c) by making, using, offering to sell, selling, and/or
`
`importing Lupin’s Proposed Product in or for the United States. On information and belief,
`
`Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc. have had and continue to have
`
`knowledge that Lupin’s Proposed Product is especially adapted for a use that infringes one or
`
`more claims of the ’173 patent and that there is no substantial non-infringing use for Lupin’s
`
`Proposed Product.
`
`70.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc.’s infringement of the ’173 patent is not
`
`enjoined.
`
`71.
`
`72.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
`
`of its reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`
`
`15
`
`

`

`Case 2:21-cv-14271 Document 1 Filed 07/28/21 Page 16 of 32 PageID: 16
`
`
`
`Count IV: Infringement of the ’302 Patent
`
`73.
`
`Jazz Pharmaceuticals repeats and realleges the allegations of the preceding
`
`paragraphs as if fully set forth herein.
`
`74.
`
`Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc.’s submission of their
`
`ANDA to obtain approval to engage in the commercial manufacture, use, sale, or offer for sale
`
`in, or importation into, the United States of Lupin’s Proposed Product, prior to the expiration of
`
`the ’302 patent, constitutes infringement of one or more of the claims of that patent under 35
`
`U.S.C. § 271(e)(2)(A).
`
`75.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’302 patent.
`
`76.
`
`Unless enjoined by this Court, upon FDA approval of Lupin’s ANDA, Lupin Ltd.,
`
`Lupin Inc., and Lupin Pharmaceuticals, Inc. will infringe one or more claims of the ’302 patent
`
`under 35 U.S.C. § 271(a) by making, using, offering to sell, selling, and/or importing Lupin’s
`
`Proposed Product in or for the United States.
`
`77.
`
`Unless enjoined by this Court, upon FDA approval of Lupin’s ANDA, Lupin Ltd.,
`
`Lupin Inc., and Lupin Pharmaceuticals, Inc. will induce infringement of one or more claims of
`
`the ’302 patent under 35 U.S.C. § 271(b) by making, using, offering to sell, selling, and/or
`
`importing Lupin’s Proposed Product in or for the United States. On information and belief, upon
`
`FDA approval of Lupin’s ANDA, Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc. will
`
`intentionally encourage acts of direct infringement with knowledge of the ’302 patent and
`
`knowledge that their acts are encouraging infringement.
`
`78.
`
`Unless enjoined by this Court, upon FDA approval of Lupin’s ANDA, Lupin Ltd.,
`
`Lupin Inc., and Lupin Pharmaceuticals, Inc. will contributorily infringe one or more claims of
`
`
`
`16
`
`

`

`Case 2:21-cv-14271 Document 1 Filed 07/28/21 Page 17 of 32 PageID: 17
`
`
`
`the ’302 patent under 35 U.S.C. § 271(c) by making, using, offering to sell, selling, and/or
`
`importing Lupin’s Proposed Product in or for the United States. On information and belief,
`
`Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc. have had and continue to have
`
`knowledge that Lupin’s Proposed Product is especially adapted for a use that infringes one or
`
`more claims of the ’302 patent and that there is no substantial non-infringing use for Lupin’s
`
`Proposed Product.
`
`79.
`
`Jazz Pharmaceuticals will be substantially and irreparably damaged and harmed if
`
`Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc.’s infringement of the ’302 patent is not
`
`enjoined.
`
`80.
`
`81.
`
`Jazz Pharmaceuticals does not have an adequate remedy at law.
`
`This case is an exceptional one, and Jazz Pharmaceuticals is entitled to an award
`
`of its reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count V: Infringement of the ’107 Patent
`
`82.
`
`Jazz Pharmaceuticals repeats and realleges the allegations of the preceding
`
`paragraphs as if fully set forth herein.
`
`83.
`
`Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc.’s submission of their
`
`ANDA to obtain approval to engage in the commercial manufacture, use, sale, or offer for sale
`
`in, or importation into, the United States of Lupin’s Proposed Product, prior to the expiration of
`
`the ’107 patent, constitutes infringement of one or more of the claims of that patent under 35
`
`U.S.C. § 271(e)(2)(A).
`
`84.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’107 patent.
`
`
`
`17
`
`

`

`Case 2:21-cv-14271 Document 1 Filed 07/28/21 Page 18 of 32 PageID: 18
`
`
`
`85.
`
`Unless enjoined by this Court, upon FDA approval of Lupin’s ANDA, Lupin Ltd.,
`
`Lupin Inc., and Lupin Pharmaceuticals, Inc. will infringe one or more claims of the ’107 patent
`
`under 35 U.S.C. § 271(a) by making, using, offering to sell, selling, and/or importing Lupin’s
`
`Proposed Product in or for the United States.
`
`86.
`
`Unless enjoined by this Court, upon FDA approval of Lupin’s ANDA, Lupin Ltd.,
`
`Lupin Inc., and Lupin Pharmaceuticals, Inc. will induce infringement of one or more claims of
`
`the ’107 patent under 35 U.S.C. § 271(b) by making, using, offering to sell, selling, and/or
`
`importing Lupin’s Proposed Product in or for the United States. On information and belief, upon
`
`FDA approval of Lupin’s ANDA, Lupin Ltd., Lupin Inc., and Lupin Pharmaceuticals, Inc. will
`
`intentionally encourage acts of direct infringement with knowledge of the ’107 patent and
`
`knowledge that their