Case 2:17-cv-03159-ES-MAH Document 1 Filed 05/04/17 Page 1 of 135 PageID: 1
`
`Charles M. Lizza
`William C. Baton
`Saul Ewing LLP
`One Riverfront Plaza, Suite 1520
`Newark, NJ 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Celgene Corporation
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`CELGENE CORPORATION,
`
`Plaintiff,
`
`v.
`
`PAR PHARMACEUTICAL, INC., PAR
`PHARMACEUTICAL COMPANIES, INC.,
`TEVA PHARMACEUTICALS USA, INC.,
`and TEVA PHARMACEUTICAL
`INDUSTRIES LIMITED,
`
`Defendants.
`
`Civil Action No. ________________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`Plaintiff Celgene Corporation (“Celgene”), by its undersigned attorneys, for its
`
`Complaint against defendants Par Pharmaceutical, Inc. (“Par Pharmaceutical”), Par
`
`Pharmaceutical Companies, Inc. (“Par Pharmaceutical Cos.”) (Par Pharmaceutical and Par
`
`Pharmaceutical Cos. together, “Par”), Teva Pharmaceuticals USA, Inc. (“Teva USA”), and Teva
`
`Pharmaceutical Industries Limited (“Teva Ltd.”) (Teva USA and Teva Ltd. together, “Teva”)
`
`(collectively, “Defendants”) alleges as follows:
`
`Nature of the Action
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, 35 U.S.C. §100, et seq., arising from the Defendants’ filing of their respective
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`Abbreviated New Drug Applications (“ANDAs”), Nos. 210245 (“Par’s ANDA”) and 209956
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`(“Teva’s ANDA”), with the United States Food and Drug Administration (“FDA”) seeking
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`approval to commercially market generic versions of Celgene’s POMALYST® drug products prior
`
`to the expiration of United States Patent Nos. 8,198,262 (the “’262 patent”), 8,673,939 (the “’939
`
`patent), 8,735,428 (the “’428 patent”), and 8,828,427 (the “’427 patent”), all owned by Celgene
`
`(collectively, “the patents-in-suit”).
`
`The Parties
`
`2.
`
`Plaintiff Celgene is a biopharmaceutical company committed to improving the
`
`lives of patients worldwide. Celgene focuses on, and invests heavily in, the discovery and
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`development of products for the treatment of severe and life-threatening conditions, including
`
`cancer. Celgene is a world leader in the treatment of many such diseases, including cancer.
`
`Celgene is a corporation organized and existing under the laws of the State of Delaware, having
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`a principal place of business at 86 Morris Avenue, Summit, New Jersey 07901.
`
`3.
`
`On information and belief, Defendant Par Pharmaceutical is a corporation
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`organized and existing under the laws of Delaware, having a principal place of business at One
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`Ram Ridge Road, Chestnut Ridge, NY 10977.
`
`4.
`
`On information and belief, Defendant Par Pharmaceutical Cos. is a corporation
`
`organized and existing under the laws of Delaware, having a principal place of business at One
`
`Ram Ridge Road, Chestnut Ridge, NY 10977.
`
`5.
`
`On information and belief, Par Pharmaceutical is a wholly owned subsidiary of
`
`Par Pharmaceutical Cos.
`
`6.
`
`On information and belief, Defendant Teva Pharmaceuticals USA, Inc. is a
`
`corporation organized and existing under the laws of Delaware, having a principal place of
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`business at 1090 Horsham Road, North Wales, PA 19454.
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`7.
`
`On information and belief, Defendant Teva Pharmaceutical Industries Limited
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`is a company organized and existing under the laws of Israel, having a principal place of
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`business at 5 Basel Street, Petach Tikva 49131 Israel.
`
`8.
`
`On information and belief, Teva USA is a wholly owned subsidiary of Teva
`
`Ltd.
`
`The Patents-in-Suit
`
`9.
`
`On June 12, 2012, the United States Patent and Trademark Office (“USPTO”)
`
`duly and lawfully issued the ’262 patent, entitled, “Methods for treating multiple myeloma using
`
`4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-1,3-dione,” to Celgene as assignee of the
`
`inventor Jerome B. Zeldis. A copy of the ’262 patent is attached hereto as Exhibit A.
`
`10.
`
`On March 18, 2014, the USPTO duly and lawfully issued the ’939 patent,
`
`entitled, “Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-
`
`isoindoline-1,3-dione,” to Celgene as assignee of the inventor Jerome B. Zeldis. A copy of the
`
`’939 patent is attached hereto as Exhibit B.
`
`11.
`
`On May 27, 2014, the USPTO duly and lawfully issued the ’428 patent, entitled,
`
`“Methods for treating multiple myeloma with 4-(amino)-2-(2,6-dioxo(3-piperidyl))-
`
`isoindoline-1,3-dione,” to Celgene as assignee of the inventor Jerome B. Zeldis. A copy of the
`
`’428 patent is attached hereto as Exhibit C.
`
`12.
`
`On September 9, 2014, the USPTO duly and lawfully issued the ’427 patent,
`
`entitled, “Formulations of 4-amino-2-(2,6-dioxopiperidine-3-YL)isoindoline-1,3-dione,” to
`
`Celgene as assignee of the inventors Anthony Tutino and Michael T. Kelly. A copy of the
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`’427 patent is attached hereto as Exhibit D.
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`The POMALYST® Drug Product
`
`13.
`
`Celgene holds an approved New Drug Application (“NDA”) under Section
`
`505(a) of the Federal Food Drug and Cosmetic Act (“FFDCA”), 21 U.S.C. § 355(a), for
`
`pomalidomide capsules (NDA No. 204026), which it sells under the trade name POMALYST®.
`
`POMALYST® is an FDA-approved medication used for the treatment of multiple myeloma.
`
`14.
`
`The claims of the patents-in-suit cover, inter alia, methods of use and
`
`administration of pomalidomide, or pharmaceutical compositions containing pomalidomide.
`
`15.
`
`Pursuant to 21 U.S.C. § 355(b)(1) and attendant FDA regulations, the
`
`patents-in-suit are listed in the FDA publication, “Approved Drug Products with Therapeutic
`
`Equivalence Evaluations” (the “Orange Book”), with respect to POMALYST®.
`
`16.
`
`The labeling for POMALYST® instructs and encourages physicians, pharmacists,
`
`and other healthcare workers and patients to administer POMALYST® according to one or more of
`
`the methods claimed in the patents-in-suit.
`
`Jurisdiction and Venue
`
`17.
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`18.
`
`Venue is proper in this Judicial District pursuant to 28 U.S.C. §§ 1391 and
`
`1400(b).
`
`Personal Jurisdiction: Par
`
`19.
`
`This Court has personal jurisdiction over Par Pharmaceutical by virtue of, inter
`
`alia, its systematic and continuous contacts with the State of New Jersey. On information and
`
`belief, Par Pharmaceutical is registered with the State of New Jersey’s Division of Revenue and
`
`Enterprise Services as a business operating in New Jersey under Business Id. No. 0100071541.
`
`On information and belief, Par Pharmaceutical is registered with the State of New Jersey’s
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`Department of Health as a manufacturer and wholesaler of drugs under Registration No.
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`5004032. On information and belief, Par Pharmaceutical purposefully has conducted and
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`continues to conduct business in this Judicial District. By virtue of its physical presence in New
`
`Jersey, this Court has personal jurisdiction over Par Pharmaceutical.
`
`20.
`
`On information and belief, Par Pharmaceutical is in the business of, among
`
`other things, manufacturing, marketing, importing, offering for sale, and selling pharmaceutical
`
`products, including generic drug products, throughout the United States, including in this
`
`Judicial District. On information and belief, this Judicial District will be a destination for the
`
`generic drug product described in Par’s ANDA. On information and belief, Par Pharmaceutical
`
`also prepares and/or aids in the preparation and submission of ANDAs to the FDA.
`
`21.
`
`This Court has personal jurisdiction over Par Pharmaceutical Cos. because, inter
`
`alia, it: (1) has purposely availed itself of the privilege of doing business in New Jersey,
`
`including directly or indirectly through its subsidiary, agent, and/or alter ego, Par
`
`Pharmaceutical, a company registered with the State of New Jersey’s Department of Health as a
`
`drug manufacturer and wholesaler; and (2) maintains extensive and systematic contacts with the
`
`State of New Jersey, including the marketing, distribution, and/or sale of generic pharmaceutical
`
`drugs in New Jersey including through, directly or indirectly, Par Pharmaceutical.
`
`22.
`
`This Court has personal jurisdiction over Par because, inter alia, it has
`
`committed an act of patent infringement under 35 U.S.C. § 271(e)(2), and has sent notice of that
`
`infringement to Celgene in the State of New Jersey. On information and belief, Par intends a
`
`future course of conduct that includes acts of patent infringement in New Jersey. These acts
`
`have led and will continue to lead to foreseeable harm and injury to Celgene in New Jersey and
`
`in this Judicial District.
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`23.
`
`Endo International PLC acquired Par Pharmaceutical Holdings, Inc. on
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`September 25, 2015. Endo International’s 2015 Form 10-K states, “Immediately following the
`
`closing, Par Pharmaceutical Holdings, Inc. changed its name to Par Pharmaceutical Companies,
`
`Inc. (Par).” See Endo Form 10-K at 3. The Endo Form 10-K also states that “Par has operated in
`
`two business segments, (i) Par Pharmaceutical, which includes generic products … and (ii) Par
`
`Specialty Pharmaceuticals, which markets three branded products.” Id.
`
`24.
`
`On information and belief, Par Pharmaceutical and Par Pharmaceutical Cos.
`
`work in concert with respect to the regulatory approval, manufacturing, marketing, sale, and
`
`distribution of generic pharmaceutical products throughout the United States, including in this
`
`Judicial District.
`
`25.
`
`On information and belief, Par Pharmaceutical acts at the direction, and for the
`
`benefit, of Par Pharmaceutical Cos., and is controlled and/or dominated by Par Pharmaceutical
`
`Cos.
`
`26.
`
`On information and belief, both Par Pharmaceutical and Par Pharmaceutical
`
`Cos. have previously been sued in this Judicial District and have not challenged personal
`
`jurisdiction. See, e.g., Alcon Labs. Inc., et al. v. Dr. Reddy’s Labs. Ltd., et al., Civil Action No.
`
`16-6775 (PGS)(DEA) (D.N.J.); Jazz Pharmaceuticals, Inc., et al. v. Par Pharmaceutical, Inc.,
`
`Civil Action No. 15-7580 (ES)(JAD) (D.N.J.); Shire LLC v. Par Pharmaceutical Companies,
`
`Inc. and Par Pharmaceutical, Inc., Civil Action No. 15-1454 (RMB)(JS) (D.N.J.); Supernus
`
`Pharm., Inc. v. Par Pharmaceutical Companies, Inc. and Par Pharmaceutical, Inc., Civil Action
`
`No. 15-326 (SDW)(LDW) (D.N.J.).
`
`27.
`
`Par Pharmaceutical has further availed itself of the jurisdiction of this Court by
`
`previously initiating litigation in this Judicial District. See, e.g., Par Pharm., Inc. et al. v.
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`Luitpold Pharm., Inc. et al., Civil Action No. 16-2290 (WHW)(CLW) (D.N.J.); Par Pharm.,
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`Inc. v. Breckenridge Pharm., Inc., Civil Action No. 13-4000 (RMB)(JS) (D.N.J.).
`
`Personal Jurisdiction: Teva
`
`28.
`
`This Court has personal jurisdiction over Teva USA by virtue of, inter alia, its
`
`systematic and continuous contacts with the State of New Jersey. On information and belief,
`
`Teva USA is registered with the State of New Jersey’s Division of Revenue and Enterprise
`
`Services as a business operating in New Jersey under Business Id. No. 0100250184. On
`
`information and belief, Teva USA is registered with the State of New Jersey’s Department of
`
`Health as a drug manufacturer and wholesaler under Registration Nos. 5000583 and 5003436.
`
`On information and belief, Teva USA purposefully has conducted and continues to conduct
`
`business in this Judicial District. By virtue of its physical presence in New Jersey, this Court has
`
`personal jurisdiction over Teva USA.
`
`29.
`
`On information and belief, Teva USA is in the business of, among other things,
`
`manufacturing, marketing, importing, offering for sale, and selling pharmaceutical products,
`
`including generic drug products, throughout the United States, including in this Judicial District.
`
`On information and belief, this Judicial District will be a destination for the generic drug product
`
`described in Teva’s ANDA. On information and belief, Teva USA also prepares and/or aids in
`
`the preparation and submission of ANDAs to the FDA.
`
`30.
`
`This Court has personal jurisdiction over Teva Ltd. because, inter alia, it: (1)
`
`has purposely availed itself of the privilege of doing business in New Jersey, including directly
`
`or indirectly through its subsidiary, agent, and/or alter ego, Teva USA, a company registered
`
`with the State of New Jersey’s Department of Health as a drug manufacturer and wholesaler; and
`
`(2) maintains extensive and systematic contacts with the State of New Jersey, including the
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`marketing, distribution, and/or sale of generic pharmaceutical drugs in New Jersey including
`
`through, directly or indirectly, Teva USA.
`
`31.
`
`This Court has personal jurisdiction over Teva because, inter alia, it has
`
`committed an act of patent infringement under 35 U.S.C. § 271(e)(2), and has sent notice of that
`
`infringement to Celgene in the State of New Jersey. On information and belief, Teva intends a
`
`future course of conduct that includes acts of patent infringement in New Jersey. These acts
`
`have led and will continue to lead to foreseeable harm and injury to Celgene in New Jersey and
`
`in this Judicial District.
`
`32.
`
`Teva Ltd.’s Annual Securities and Exchange Commission filing states that it is
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`“the leading generic drug company in the United States” and that it markets “over 500 generic
`
`products in more than 2,000 dosage strengths and packaging sizes, including oral, injectable and
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`inhaled products” in the United States. See Teva Ltd. Annual Securities and Exchange
`
`Commission Form 20-F (2016-17) (“Teva Ltd. Form 20-F”) at 27. The Teva Ltd. Form 20-F
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`further states that its annual “[r]evenues of generic medicines in the United States, our largest
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`generic market, were $4.6 billion.” Id. at 60. The Teva Ltd. Form 20-F further states that Teva
`
`Ltd. “launched generic versions” of 32 branded products in the United States in 2016. Id. at 62.
`
`33.
`
`Teva USA’s website (http://www.tevausa.com/TevaGlobal.aspx) states that
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`“Teva Pharmaceutical Products Ltd. is the parent company of Teva Pharmaceuticals in the
`
`United States.”
`
`34.
`
`On information and belief, Teva USA and Teva Ltd. work in concert with
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`respect to the regulatory approval, manufacturing, marketing, sale, and distribution of generic
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`pharmaceutical products throughout the United States, including in this Judicial District.
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`35.
`
`On information and belief, Teva USA acts at the direction, and for the benefit,
`
`of Teva Ltd., and is controlled and/or dominated by Teva Ltd.
`
`36.
`
`On information and belief, both Teva USA and Teva Ltd. have previously been
`
`sued in this Judicial District and have not challenged personal jurisdiction. See, e.g., Boehringer
`
`Ingelheim Pharma GMBH & Co., et al. v. Teva Pharmaceuticals USA, Inc., et al., Civil Action
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`No. 14-7811 (MLC)(TJB) (D.N.J.); Janssen Prods., L.P., et al. v . Teva Pharmaceuticals USA,
`
`Inc. et al., Civil Action No. 13-7576 (WHW)(CLW) (D.N.J.).
`
`37.
`
`Teva USA and Teva Ltd. have further availed themselves of the jurisdiction of
`
`this Court by previously initiating litigation in this Judicial District. See, e.g., Teva
`
`Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries Ltd., and Teva Neuroscience, Inc. v.
`
`Sandoz Inc. et al., Civil Action No. 17-275 (FLW)(DEA) (D.N.J.); Teva Pharmaceuticals USA,
`
`Inc., Teva Pharmaceutical Industries Ltd., and Teva Neuroscience, Inc. v. Dr. Reddy’s
`
`Laboratories, Ltd., Civil Action No. 17-517 (FLW)(DEA) (D.N.J.); Teva Neuroscience, Teva
`
`Pharmaceutical Industries Ltd., Teva Pharmaceutical USA, Inc., and Yeda Research and
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`Development Co., Ltd. v. Dr. Reddy’s Laboratories, Inc., et al., Civil Action No. 14-5672
`
`(MAS)(TJB) (D.N.J.).
`
`Acts Giving Rise To This Suit
`
`38.
`
`Pursuant to Section 505 of the FFDCA, Par filed Par’s ANDA seeking approval
`
`to engage in the commercial manufacture, use, sale, offer for sale, or importation into the United
`
`States of pomalidomide capsules 2 mg, 3 mg, and 4 mg (“Par’s Proposed Products”), before the
`
`patents-in-suit expire.
`
`39.
`
`On information and belief, following FDA approval of Par’s ANDA,
`
`Defendants Par Pharmaceutical and Par Pharmaceutical Cos. will work in concert with one
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`another to make, use, sell, or offer to sell Par’s Proposed Products throughout the United States,
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`or import such generic products into the United States.
`
`40.
`
`On information and belief, in connection with the filing of its ANDA as
`
`described above, Par provided a written certification to the FDA, as called for by Section 505 of
`
`the FFDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Par’s Paragraph IV Certification”), alleging that
`
`the claims of the patents-in-suit are invalid, unenforceable, and/or will not be infringed by the
`
`activities described in Par’s ANDA.
`
`41.
`
`No earlier than April 12, 2017, Par sent written notice of its Paragraph IV
`
`Certification to Celgene (“Par’s Notice Letter”). Par’s Notice Letter alleged that the claims of
`
`the patents-in-suit are invalid and/or will not be infringed by the activities described in Par’s
`
`ANDA. Par’s Notice Letter also informed Celgene that Par seeks approval to market Par’s
`
`Proposed Products before the patents-in-suit expire. Par specifically directed Par’s Notice Letter
`
`to Celgene’s headquarters in Summit, New Jersey, in this Judicial District.
`
`42.
`
`Pursuant to Section 505 of the FFDCA, Teva filed Teva’s ANDA seeking
`
`approval to engage in the commercial manufacture, use, sale, offer for sale, or importation into
`
`the United States of pomalidomide capsules 1 mg, 2 mg, 3 mg, and 4 mg (“Teva’s Proposed
`
`Products”), before the patents-in-suit expire.
`
`43.
`
`On information and belief, following FDA approval of Teva’s ANDA,
`
`Defendants Teva USA and Teva Ltd. will work in concert with one another to make, use, sell, or
`
`offer to sell Teva’s Proposed Products throughout the United States, or import such generic
`
`products into the United States.
`
`44.
`
`On information and belief, in connection with the filing of its ANDA as
`
`described above, Teva provided a written certification to the FDA, as called for by Section 505
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`of the FFDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Teva’s Paragraph IV Certification”), alleging
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`that the claims of the patents-in-suit are invalid, unenforceable, and/or will not be infringed by
`
`the activities described in Teva’s ANDA.
`
`45.
`
`No earlier than March 30, 2017, Teva sent written notice of its Paragraph IV
`
`Certification to Celgene (“Teva’s Notice Letter”). Teva’s Notice Letter alleged that the claims
`
`of the patents-in-suit are invalid and/or will not be infringed by the activities described in Teva’s
`
`ANDA. Teva’s Notice Letter also informed Celgene that Teva seeks approval to market Teva’s
`
`Proposed Products before the patents-in-suit expire. Teva specifically directed Teva’s Notice
`
`Letter to Celgene’s headquarters in Summit, New Jersey, in this Judicial District.
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`Count I: Infringement of the ’262 Patent by Par
`
`46.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`47.
`
`Par’s submission of its ANDA to engage in the commercial manufacture, use,
`
`sale, offer for sale, or importation into the United States of Par’s Proposed Products, prior to the
`
`expiration of the ’262 patent, constitutes infringement of one or more of the claims of that patent
`
`under 35 U.S.C. § 271(e)(2)(A).
`
`48.
`
`There is a justiciable controversy between Celgene and Par as to the
`
`infringement of the ’262 patent.
`
`49.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`infringe one or more claims of the ’262 patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Par’s Proposed Products in the United States.
`
`50.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`induce infringement of one or more claims of the ’262 patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Par’s Proposed Products in the United
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`States. On information and belief, upon FDA approval of Par’s ANDA, Par will intentionally
`
`encourage acts of direct infringement with knowledge of the ’262 patent and knowledge that its
`
`acts are encouraging infringement.
`
`51.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`contributorily infringe one or more claims of the ’262 patent under 35 U.S.C. § 271(c) by
`
`making, using, offering to sell, selling, and/or importing Par’s Proposed Products in the United
`
`States. On information and belief, Par has had and continues to have knowledge that Par’s
`
`Proposed Products are especially adapted for a use that infringes one or more claims of the ’262
`
`patent and that there is no substantial non-infringing use for Par’s Proposed Products.
`
`52.
`
`Celgene will be substantially and irreparably damaged and harmed if Par’s
`
`infringement of the ’262 patent is not enjoined.
`
`53.
`
`54.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count II: Infringement of the ’262 Patent by Teva
`
`55.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`56.
`
`Teva’s submission of its ANDA to engage in the commercial manufacture, use,
`
`sale, offer for sale, or importation into the United States of Teva’s Proposed Products, prior to
`
`the expiration of the ’262 patent, constitutes infringement of one or more of the claims of that
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`57.
`
`There is a justiciable controversy between Celgene and Teva as to the
`
`infringement of the ’262 patent.
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`58.
`
`Unless enjoined by this Court, upon FDA approval of Teva’s ANDA, Teva will
`
`infringe one or more claims of the ’262 patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Teva’s Proposed Products in the United States.
`
`59.
`
`Unless enjoined by this Court, upon FDA approval of Teva’s ANDA, Teva will
`
`induce infringement of one or more claims of the ’262 patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Teva’s Proposed Products in the United
`
`States. On information and belief, upon FDA approval of Teva’s ANDA, Teva will intentionally
`
`encourage acts of direct infringement with knowledge of the ’262 patent and knowledge that its
`
`acts are encouraging infringement.
`
`60.
`
`Unless enjoined by this Court, upon FDA approval of Teva’s ANDA, Teva will
`
`contributorily infringe one or more claims of the ’262 patent under 35 U.S.C. § 271(c) by
`
`making, using, offering to sell, selling, and/or importing Teva’s Proposed Products in the United
`
`States. On information and belief, Teva has had and continues to have knowledge that Teva’s
`
`Proposed Products are especially adapted for a use that infringes one or more claims of the ’262
`
`patent and that there is no substantial non-infringing use for Teva’s Proposed Products.
`
`61.
`
`Celgene will be substantially and irreparably damaged and harmed if Teva’s
`
`infringement of the ’262 patent is not enjoined.
`
`62.
`
`63.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count III: Infringement of the ’939 Patent by Par
`
`64.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`- 13 -
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`Case 2:17-cv-03159-ES-MAH Document 1 Filed 05/04/17 Page 14 of 135 PageID: 14
`
`65.
`
`Par’s submission of its ANDA to engage in the commercial manufacture, use,
`
`sale, offer for sale, or importation into the United States of Par’s Proposed Products, prior to the
`
`expiration of the ’939 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 Celgene and Par as to the
`
`infringement of the ’939 patent.
`
`67.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`infringe one or more claims of the ’939 patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Par’s Proposed Products in the United States.
`
`68.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`induce infringement of one or more claims of the ’939 patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Par’s Proposed Products in the United
`
`States. On information and belief, upon FDA approval of Par’s ANDA, Par will intentionally
`
`encourage acts of direct infringement with knowledge of the ’939 patent and knowledge that its
`
`acts are encouraging infringement.
`
`69.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`contributorily infringe one or more claims of the ’939 patent under 35 U.S.C. § 271(c) by
`
`making, using, offering to sell, selling, and/or importing Par’s Proposed Products in the United
`
`States. On information and belief, Par has had and continues to have knowledge that Par’s
`
`Proposed Products are especially adapted for a use that infringes one or more claims of the ’939
`
`patent and that there is no substantial non-infringing use for Par’s Proposed Products.
`
`70.
`
`Celgene will be substantially and irreparably damaged and harmed if Par’s
`
`infringement of the ’939 patent is not enjoined.
`
`- 14 -
`
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`

`Case 2:17-cv-03159-ES-MAH Document 1 Filed 05/04/17 Page 15 of 135 PageID: 15
`
`71.
`
`72.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count IV: Infringement of the ’939 Patent by Teva
`
`73.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`74.
`
`Teva’s submission of its ANDA to engage in the commercial manufacture, use,
`
`sale, offer for sale, or importation into the United States of Teva’s Proposed Products, prior to
`
`the expiration of the ’939 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 Celgene and Teva as to the
`
`infringement of the ’939 patent.
`
`76.
`
`Unless enjoined by this Court, upon FDA approval of Teva’s ANDA, Teva will
`
`infringe one or more claims of the ’939 patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Teva’s Proposed Products in the United States.
`
`77.
`
`Unless enjoined by this Court, upon FDA approval of Teva’s ANDA, Teva will
`
`induce infringement of one or more claims of the ’939 patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Teva’s Proposed Products in the United
`
`States. On information and belief, upon FDA approval of Teva’s ANDA, Teva will intentionally
`
`encourage acts of direct infringement with knowledge of the ’939 patent and knowledge that its
`
`acts are encouraging infringement.
`
`78.
`
`Unless enjoined by this Court, upon FDA approval of Teva’s ANDA, Teva will
`
`contributorily infringe one or more claims of the ’939 patent under 35 U.S.C. § 271(c) by
`
`making, using, offering to sell, selling, and/or importing Teva’s Proposed Products in the United
`
`- 15 -
`
`

`

`Case 2:17-cv-03159-ES-MAH Document 1 Filed 05/04/17 Page 16 of 135 PageID: 16
`
`States. On information and belief, Teva has had and continues to have knowledge that Teva’s
`
`Proposed Products are especially adapted for a use that infringes one or more claims of the ’939
`
`patent and that there is no substantial non-infringing use for Teva’s Proposed Products.
`
`79.
`
`Celgene will be substantially and irreparably damaged and harmed if Teva’s
`
`infringement of the ’939 patent is not enjoined.
`
`80.
`
`81.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count V: Infringement of the ’428 Patent by Par
`
`82.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`83.
`
`Par’s submission of its ANDA to engage in the commercial manufacture, use,
`
`sale, offer for sale, or importation into the United States of Par’s Proposed Products, prior to the
`
`expiration of the ’428 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 Celgene and Par as to the
`
`infringement of the ’428 patent.
`
`85.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`infringe one or more claims of the ’428 patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Par’s Proposed Products in the United States.
`
`86.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`induce infringement of one or more claims of the ’428 patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Par’s Proposed Products in the United
`
`States. On information and belief, upon FDA approval of Par’s ANDA, Par will intentionally
`
`- 16 -
`
`

`

`Case 2:17-cv-03159-ES-MAH Document 1 Filed 05/04/17 Page 17 of 135 PageID: 17
`
`encourage acts of direct infringement with knowledge of the ’428 patent and knowledge that its
`
`acts are encouraging infringement.
`
`87.
`
`Unless enjoined by this Court, upon FDA approval of Par’s ANDA, Par will
`
`contributorily infringe one or more claims of the ’428 patent under 35 U.S.C. § 271(c) by
`
`making, using, offering to sell, selling, and/or importing Par’s Proposed Products in the United
`
`States. On information and belief, Par has had and continues to have knowledge that Par’s
`
`Proposed Products are especially adapted for a use that infringes one or more claims of the ’428
`
`patent and that there is no substantial non-infringing use for Par’s Proposed Products.
`
`88.
`
`Celgene will be substantially and irreparably damaged and harmed if Par’s
`
`infringement of the ’428 patent is not enjoined.
`
`89.
`
`90.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`Count VI: Infringement of the ’428 Patent by Teva
`
`91.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`92.
`
`Teva’s submission of its ANDA to engage in the commercial manufacture, use,
`
`sale, offer for sale, or importation into the United States of Teva’s Proposed Products, prior to
`
`the expiration of the ’428 patent, constitutes infringement of one or more of the claims of that
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`93.
`
`There is a justiciable controversy between Celgene and Teva as to the
`
`infringement of the ’428 patent.
`
`- 17 -
`
`

`

`Case 2:17-cv-03159-ES-MAH Document 1 Filed 05/04/17 Page 18 of 135 PageID: 18
`
`94.
`
`Unless enjoined by this Court, upon FDA approval of Teva’s ANDA, Teva will
`
`infringe one or more claims of the ’428 patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Teva’s Proposed Products in the United States.
`
`95.
`
`Unless enjoined by this Court, upon FDA approval of Teva’s ANDA, Teva will
`
`induce infringement of one or more claims of the ’428 patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Teva’s Proposed Products in the U