Case 2:17-cv-02528-SDW-LDW Document 1 Filed 04/12/17 Page 1 of 330 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.
`
`ZYDUS PHARMACEUTICALS (USA)
`INC., ZYDUS INTERNATIONAL PVT.
`LTD., and CADILA HEALTHCARE
`LIMITED,
`
`Defendants.
`
`Civil Action No. ________________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`Plaintiff Celgene Corporation (“Celgene”), by its undersigned attorneys, for its
`
`Complaint against defendants Zydus Pharmaceuticals (USA) Inc. (“Zydus USA”), Zydus
`
`International Pvt. Ltd. (“Zydus International”), and Cadila Healthcare Limited (“Zydus Cadila”)
`
`(collectively with Zydus USA and Zydus International, “Zydus”) 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 Zydus’s filing of an Abbreviated New Drug
`
`Application (“ANDA”) No. 210154 (“Zydus’s ANDA”) with the United States Food and Drug
`
`Administration (“FDA”) seeking approval to commercially market generic versions of Celgene’s
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`

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`Case 2:17-cv-02528-SDW-LDW Document 1 Filed 04/12/17 Page 2 of 330 PageID: 2
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`2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg REVLIMID® drug products prior to the expiration
`
`of United States Patent Nos. 7,465,800 (the “’800 patent”), 7,855,217 (the “’217 patent”),
`
`7,968,569 (the “’569 patent”), 8,530,498 (the “’498 patent”), 8,648,095 (the “’095 patent”),
`
`9,101,621 (the “’621 patent”), and 9,101,622 (the “’622 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
`
`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
`
`a principal place of business at 86 Morris Avenue, Summit, New Jersey 07901.
`
`3.
`
`On information and belief, Defendant Zydus Pharmaceuticals (USA) Inc. is a
`
`corporation organized and existing under the laws of the State of New Jersey, having a principal
`
`place of business at 73 Route 31 North, Pennington, New Jersey 08534.
`
`4.
`
`On information and belief, Defendant Zydus International Pvt. Ltd. is a
`
`corporation organized and existing under the laws of Ireland, having a principal place of business
`
`at FDW House, Blackthorn Business Park, Coes Road, Dundalk, Co. Louth, Ireland.
`
`5.
`
`On information and belief, Defendant Cadila Healthcare Limited is a
`
`corporation organized and existing under the laws of India, having a principal place of business
`
`at Zydus Tower, Satellite Cross Roads, Ahmedabad 380015, Gujarat, India.
`
`6.
`
`On information and belief, the parent corporation of Zydus Pharmaceuticals
`
`(USA) Inc. is Zydus International Pvt. Ltd., which is a wholly owned subsidiary of Cadila
`
`Healthcare Limited (d/b/a “Zydus Cadila”).
`
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`The Patents-in-Suit
`
`7.
`
`On December 16, 2008, the United States Patent and Trademark Office
`
`(“USPTO”) duly and lawfully issued the ’800 patent, entitled, “Polymorphic Forms of 3-(4-
`
`amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione,” to Celgene as assignee of the
`
`inventors Markian S. Jaworsky, Roger Shen-Chu Chen, and George W. Muller. A copy of the
`
`’800 patent is attached hereto as Exhibit A.
`
`8.
`
`On December 21, 2010, the USPTO duly and lawfully issued the ’217 patent,
`
`entitled, “Polymorphic Forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-
`
`dione,” to Celgene as assignee of the inventors Markian S. Jaworsky, Roger Shen-Chu Chen, and
`
`George W. Muller. A copy of the ’217 patent is attached hereto as Exhibit B.
`
`9.
`
`On June 28, 2011, the USPTO duly and lawfully issued the ’569 patent, entitled,
`
`“Methods For Treatment of Multiple Myeloma Using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-
`
`2-yl)-piperidine-2,6-dione,” to Celgene as assignee of the inventor Jerome B. Zeldis. A copy
`
`of the ’569 patent is attached hereto as Exhibit C.
`
`10.
`
`On September 10, 2013, the USPTO duly and lawfully issued the ’498 patent,
`
`entitled, “Methods For Treating Multiple Myeloma With 3-(4-amino-1-oxo-1,3-dihydroisoindol-
`
`2-yl) piperidine-2,6-dione,” to Celgene as assignee of the inventor Jerome B. Zeldis. A copy of
`
`the ’498 patent is attached hereto as Exhibit D.
`
`11.
`
`On February 11, 2014, the USPTO duly and lawfully issued the ’095 patent,
`
`entitled, “Methods For Treating Multiple Myeloma Using 3-(4-amino-1-oxo-1,3-
`
`dihydroisoindol-2-yl)-piperidine-2,6-dione In Combination With Proteasome Inhibitor,” to
`
`Celgene as assignee of the inventor Jerome B. Zeldis. A copy of the ’095 patent is attached
`
`hereto as Exhibit E.
`
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`12.
`
`On August 11, 2015, the USPTO duly and lawfully issued the ’621 patent,
`
`entitled, “Methods For Treating Multiple Myeloma With 3-(4-amino-1-oxo-1,3-dihydro-
`
`isoindol-2-yl)-piperidine-2,6-dione After Stem Cell Transplantation,” to Celgene as assignee of
`
`the inventor Jerome B. Zeldis. A copy of the ’621 patent is attached hereto as Exhibit F.
`
`13.
`
`On August 11, 2015, the USPTO duly and lawfully issued the ’622 patent,
`
`entitled, “Methods For Treating Newly-Diagnosed Multiple Myeloma 3-(4-amino-1-oxo-1,3-
`
`dihydro-isoindol-2-yl)-piperidine-2,6-dione In Combination With Dexamethasone,” to Celgene
`
`as assignee of the inventor Jerome B. Zeldis. A copy of the ’622 patent is attached hereto as
`
`Exhibit G.
`
`The REVLIMID® Drug Product
`
`14.
`
`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
`
`lenalidomide capsules (NDA No. 21-880), which it sells under the trade name REVLIMID®.
`
`REVLIMID® is an FDA-approved medication used for the treatment of certain forms of cancer,
`
`including multiple myeloma (MM), in combination with dexamethasone. The claims of the
`
`patents-in-suit cover, inter alia, solid forms of lenalidomide, pharmaceutical compositions
`
`containing lenalidomide, and methods of use and administration of lenalidomide or
`
`pharmaceutical compositions containing lenalidomide.
`
`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 REVLIMID®.
`
`16.
`
`The labeling for REVLIMID® instructs and encourages physicians, pharmacists,
`
`and other healthcare workers and patients to administer REVLIMID® according to one or more of
`
`the methods claimed in the patents-in-suit.
`
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`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.
`
`This Court has personal jurisdiction over Zydus USA by virtue of, inter alia, its
`
`systematic and continuous contacts with the State of New Jersey. On information and belief,
`
`Zydus USA’s principal place of business is in Pennington, New Jersey. On information and
`
`belief, Zydus 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. 0100915422.
`
`On information and belief, Zydus USA is registered with the State of New Jersey’s Department
`
`of Health as a wholesaler under Registration No. 5003171. On information and belief, Zydus
`
`USA purposefully has conducted and continues to conduct business in this Judicial District. On
`
`information and belief, Zydus USA is a corporation organized and existing under the laws of the
`
`State of New Jersey. By virtue of its incorporation in New Jersey, this Court has personal
`
`jurisdiction over Zydus USA.
`
`19.
`
`On information and belief, Zydus 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. This Judicial District is a likely destination for the generic drug product
`
`described in Zydus’s ANDA. On information and belief, Zydus USA also prepares and/or aids
`
`in the preparation and submission of ANDAs to the FDA.
`
`20.
`
`This Court has personal jurisdiction over Cadila Healthcare Limited and Zydus
`
`International Pvt. Ltd. because, inter alia, they: (1) have purposely availed themselves of the
`
`privilege of doing business in New Jersey, including directly or indirectly through their
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`subsidiary, agent, and/or alter ego, Zydus Pharmaceuticals (USA) Inc., a company incorporated
`
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`in New Jersey, with its principal place of business in New Jersey; and (2) maintain extensive and
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`systematic contacts with the State of New Jersey, including the marketing, distribution, and/or
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`sale of generic pharmaceutical drugs in New Jersey including through, directly or indirectly,
`
`Zydus Pharmaceuticals (USA) Inc.
`
`21.
`
`This Court has personal jurisdiction over Zydus 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
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`infringement to Celgene in the State of New Jersey. On information and belief, Zydus intends a
`
`future course of conduct that includes acts of patent infringement in New Jersey. These acts
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`have led and will continue to lead to foreseeable harm and injury to Celgene in New Jersey and
`
`in this Judicial District.
`
`22.
`
`Zydus Cadila’s Annual Report 2015-16 states that “US is the world’s largest
`
`pharmaceutical market, both for branded and generic drugs, accounting for around one third of
`
`the global market,” and that “[t]he Company is present in the [US] generic pharmaceuticals
`
`market through its wholly owned subsidiary, Zydus Pharmaceuticals (USA) Inc.” Cadila
`
`Healthcare Limited Annual Report 2015-16 (“Zydus Cadila Annual Report”) at 9. The Zydus
`
`Cadila Annual Report further states that “the Company is ranked amongst the top 10 generics
`
`companies in the US based on prescriptions.” Id. The Zydus Cadila Annual Report further
`
`states that “[t]he Company launched 3 new products in the US market during the year,” and that
`
`“[i]n terms of ANDA filings, 30 more ANDAs were filed with the USFDA during the year,
`
`taking the cumulative number of ANDA filings to 269.” Id. at 10. The Zydus Cadila Annual
`
`Report further states that “[g]oing forward, the Company’s focus will continue to be on
`
`launching complex, difficult-to-make oral solids and formulations of other dosage forms like
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`injectables, nasals, creams and ointments in order to enhance its share in the US generics
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`market.” Id.
`
`23.
`
`Zydus Pharmaceuticals (USA) Inc.’s website, http://www.zydususa.com/who-
`
`is-zydus/, states that Zydus Pharmaceuticals (USA) Inc. “is the U.S. division of Cadila
`
`Healthcare.”
`
`24.
`
`On information and belief, Zydus USA, Zydus International, and/or Zydus
`
`Cadila work in concert either directly or indirectly through one or more of their wholly owned
`
`subsidiaries with respect to the regulatory approval, manufacturing, marketing, sale, and
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`distribution of generic pharmaceutical products throughout the United States, including in this
`
`Judicial District.
`
`25.
`
`On information and belief, Zydus USA acts at the direction, and for the benefit,
`
`of Zydus International and/or Zydus Cadila, and is controlled and/or dominated by Zydus
`
`International and/or Zydus Cadila.
`
`26.
`
`On information and belief, Zydus Pharmaceuticals (USA) Inc. and Cadila
`
`Healthcare Limited have previously been sued in this Judicial District and have not challenged
`
`personal jurisdiction. See, e.g., Helsinn Healthcare S.A. v. Zydus Pharms. (USA) Inc. and Cadila
`
`Healthcare Ltd. (d/b/a Zydus Cadila), No. 16-4239 (MLC)(DEA) (D.N.J.); AstraZeneca AB, et
`
`al. v. Zydus Pharms. (USA) Inc. and Cadila Healthcare Ltd. (dba Zydus Cadila), No. 15-7415
`
`(MLC)(TJB) (D.N.J.); Supernus Pharms., Inc. v. Zydus Pharms. (USA) Inc. and Cadila
`
`Healthcare Ltd., No. 14-7272 (SDW)(LDW) (D.N.J.); Otsuka Pharm. Co., Ltd. v. Zydus Pharms.
`
`(USA) Inc. and Cadila Healthcare Ltd. , No. 14-7252 (JBS)(KMW) (D.N.J.); Otsuka Pharm.
`
`Co., Ltd. v. Zydus Pharms. (USA) Inc. and Cadila Healthcare Ltd., No. 14-3168 (JBS)(KMW)
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`(D.N.J.).
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`27.
`
`Zydus Pharmaceuticals (USA) Inc. has also admitted that it is subject to
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`personal jurisdiction in this Judicial District. See, e.g., Takeda Pharm. Co. Ltd., et al. v. Zydus
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`Pharms. (USA) Inc. and Cadila Healthcare Ltd., No. 10-1723 (Answer to Complaint, Dkt. No.
`
`29, ¶ 12; Answer to Amended Complaint, Dkt. No. 99, ¶ 12).
`
`28.
`
`Cadila Healthcare Limited has also admitted that it is subject to personal
`
`jurisdiction in this Judicial District. See, e.g., Takeda Pharm. Co. Ltd., et al. v. Zydus Pharms.
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`(USA) Inc. and Cadila Healthcare Ltd., No. 10-1723 (Answer to Complaint, Dkt. No. 29, ¶¶ 13,
`
`18; Answer to Amended Complaint, Dkt. No. 99, ¶¶ 13, 18).
`
`29.
`
`Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Limited have further
`
`availed themselves of the jurisdiction of this Court by previously initiating litigation in this
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`Judicial District. See, e.g., Zydus Pharms. (USA) Inc. and Cadila Healthcare Ltd. v. Gilead
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`Scis., Inc., No. 14-7080 (FLW)(LHG) (D.N.J.). Zydus Pharmaceuticals (USA) Inc. has further
`
`availed itself of the jurisdiction of this Court by previously initiating litigation in this Judicial
`
`District. See, e.g., Zydus Pharms. USA, Inc. v. Eli Lilly and Co., No. 10-5584 (DMC)(JAD)
`
`(D.N.J.).
`
`30.
`
`Venue is proper in this Judicial District pursuant to 28 U.S.C. §§ 1391 and
`
`1400(b).
`
`Acts Giving Rise To This Suit
`
`31.
`
`Pursuant to Section 505 of the FFDCA, Zydus filed Zydus’s ANDA seeking
`
`approval to engage in the commercial manufacture, use, sale, offer for sale, or importation into
`
`the United States of lenalidomide capsules 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg
`
`(“Zydus’s Proposed Products”), before the patents-in-suit expire.
`
`32.
`
`On information and belief, following FDA approval of Zydus’s ANDA, Zydus
`
`USA, Zydus International, and/or Zydus Cadila will work in concert with one another to make,
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`use, sell, or offer to sell Zydus’s Proposed Products throughout the United States, or import such
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`generic products into the United States.
`
`33.
`
`On information and belief, in connection with the filing of its ANDA as
`
`described above, Zydus 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) (“Zydus’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 Zydus’s ANDA.
`
`34.
`
`No earlier than February 27, 2017, Zydus sent written notice of its Paragraph IV
`
`Certification to Celgene (“Zydus’s Notice Letter”). Zydus’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
`
`Zydus’s ANDA. Zydus’s Notice Letter also informed Celgene that Zydus seeks approval to
`
`market Zydus’s Proposed Products before the patents-in-suit expire. Zydus specifically directed
`
`Zydus’s Notice Letter to Celgene’s headquarters in Summit, New Jersey, in this Judicial District.
`
`Count I: Infringement of the ’800 Patent
`
`35.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`36.
`
`Zydus’s submission of its ANDA to engage in the commercial manufacture,
`
`use, sale, offer for sale, or importation into the United States of Zydus’s Proposed Products, prior
`
`to the expiration of the ’800 patent, constitutes infringement of one or more of the claims of that
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`37.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’800 patent.
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`38.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will infringe one or more claims of the ’800 patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Zydus’s Proposed Products in the United States.
`
`39.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will induce infringement of one or more claims of the ’800 patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Zydus’s Proposed Products in the
`
`United States. On information and belief, upon FDA approval of Zydus’s ANDA, Zydus will
`
`intentionally encourage acts of direct infringement with knowledge of the ’800 patent and
`
`knowledge that its acts are encouraging infringement.
`
`40.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will contributorily infringe one or more claims of the ’800 patent under 35 U.S.C. § 271(c) by
`
`making, using, offering to sell, selling, and/or importing Zydus’s Proposed Products in the
`
`United States. On information and belief, Zydus has had and continues to have knowledge that
`
`Zydus’s Proposed Products are especially adapted for a use that infringes one or more claims of
`
`the ’800 patent and that there is no substantial non-infringing use for Zydus’s Proposed Products.
`
`41.
`
`Celgene will be substantially and irreparably damaged and harmed if Zydus’s
`
`infringement of the ’800 patent is not enjoined.
`
`42.
`
`43.
`
`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 ’217 Patent
`
`44.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
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`45.
`
`Zydus’s submission of its ANDA to engage in the commercial manufacture,
`
`use, sale, offer for sale, or importation into the United States of Zydus’s Proposed Products, prior
`
`to the expiration of the ’217 patent, constitutes infringement of one or more of the claims of that
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`46.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’217 patent.
`
`47.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will infringe one or more claims of the ’217 patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Zydus’s Proposed Products in the United States.
`
`48.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will induce infringement of one or more claims of the ’217 patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Zydus’s Proposed Products in the
`
`United States. On information and belief, upon FDA approval of Zydus’s ANDA, Zydus will
`
`intentionally encourage acts of direct infringement with knowledge of the ’217 patent and
`
`knowledge that its acts are encouraging infringement.
`
`49.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will contributorily infringe one or more claims of the ’217 patent under 35 U.S.C. § 271(c) by
`
`making, using, offering to sell, selling, and/or importing Zydus’s Proposed Products in the
`
`United States. On information and belief, Zydus has had and continues to have knowledge that
`
`Zydus’s Proposed Products are especially adapted for a use that infringes one or more claims of
`
`the ’217 patent and that there is no substantial non-infringing use for Zydus’s Proposed Products.
`
`50.
`
`Celgene will be substantially and irreparably damaged and harmed if Zydus’s
`
`infringement of the ’217 patent is not enjoined.
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`51.
`
`52.
`
`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 ’569 Patent
`
`53.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`54.
`
`Zydus’s submission of its ANDA to engage in the commercial manufacture,
`
`use, sale, offer for sale, or importation into the United States of Zydus’s Proposed Products, prior
`
`to the expiration of the ’569 patent, constitutes infringement of one or more of the claims of that
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`55.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’569 patent.
`
`56.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will infringe one or more claims of the ’569 patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Zydus’s Proposed Products in the United States.
`
`57.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will induce infringement of one or more claims of the ’569 patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Zydus’s Proposed Products in the
`
`United States. On information and belief, upon FDA approval of Zydus’s ANDA, Zydus will
`
`intentionally encourage acts of direct infringement with knowledge of the ’569 patent and
`
`knowledge that its acts are encouraging infringement.
`
`58.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will contributorily infringe one or more claims of the ’569 patent under 35 U.S.C. § 271(c) by
`
`making, using, offering to sell, selling, and/or importing Zydus’s Proposed Products in the
`
`- 12 -
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`

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`Case 2:17-cv-02528-SDW-LDW Document 1 Filed 04/12/17 Page 13 of 330 PageID: 13
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`United States. On information and belief, Zydus has had and continues to have knowledge that
`
`Zydus’s Proposed Products are especially adapted for a use that infringes one or more claims of
`
`the ’569 patent and that there is no substantial non-infringing use for Zydus’s Proposed Products.
`
`59.
`
`Celgene will be substantially and irreparably damaged and harmed if Zydus’s
`
`infringement of the ’569 patent is not enjoined.
`
`60.
`
`61.
`
`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 ’498 Patent
`
`62.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`63.
`
`Zydus’s submission of its ANDA to engage in the commercial manufacture,
`
`use, sale, offer for sale, or importation into the United States of Zydus’s Proposed Products, prior
`
`to the expiration of the ’498 patent, constitutes infringement of one or more of the claims of that
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`64.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’498 patent.
`
`65.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will infringe one or more claims of the ’498 patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Zydus’s Proposed Products in the United States.
`
`66.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will induce infringement of one or more claims of the ’498 patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Zydus’s Proposed Products in the
`
`United States. On information and belief, upon FDA approval of Zydus’s ANDA, Zydus will
`
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`

`

`Case 2:17-cv-02528-SDW-LDW Document 1 Filed 04/12/17 Page 14 of 330 PageID: 14
`
`intentionally encourage acts of direct infringement with knowledge of the ’498 patent and
`
`knowledge that its acts are encouraging infringement.
`
`67.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will contributorily infringe one or more claims of the ’498 patent under 35 U.S.C. § 271(c) by
`
`making, using, offering to sell, selling, and/or importing Zydus’s Proposed Products in the
`
`United States. On information and belief, Zydus has had and continues to have knowledge that
`
`Zydus’s Proposed Products are especially adapted for a use that infringes one or more claims of
`
`the ’498 patent and that there is no substantial non-infringing use for Zydus’s Proposed Products.
`
`68.
`
`Celgene will be substantially and irreparably damaged and harmed if Zydus’s
`
`infringement of the ’498 patent is not enjoined.
`
`69.
`
`70.
`
`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 ’095 Patent
`
`71.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`72.
`
`Zydus’s submission of its ANDA to engage in the commercial manufacture,
`
`use, sale, offer for sale, or importation into the United States of Zydus’s Proposed Products, prior
`
`to the expiration of the ’095 patent, constitutes infringement of one or more of the claims of that
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`73.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’095 patent.
`
`- 14 -
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`

`

`Case 2:17-cv-02528-SDW-LDW Document 1 Filed 04/12/17 Page 15 of 330 PageID: 15
`
`74.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will infringe one or more claims of the ’095 patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Zydus’s Proposed Products in the United States.
`
`75.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will induce infringement of one or more claims of the ’095 patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Zydus’s Proposed Products in the
`
`United States. On information and belief, upon FDA approval of Zydus’s ANDA, Zydus will
`
`intentionally encourage acts of direct infringement with knowledge of the ’095 patent and
`
`knowledge that its acts are encouraging infringement.
`
`76.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will contributorily infringe one or more claims of the ’095 patent under 35 U.S.C. § 271(c) by
`
`making, using, offering to sell, selling, and/or importing Zydus’s Proposed Products in the
`
`United States. On information and belief, Zydus has had and continues to have knowledge that
`
`Zydus’s Proposed Products are especially adapted for a use that infringes one or more claims of
`
`the ’095 patent and that there is no substantial non-infringing use for Zydus’s Proposed Products.
`
`77.
`
`Celgene will be substantially and irreparably damaged and harmed if Zydus’s
`
`infringement of the ’095 patent is not enjoined.
`
`78.
`
`79.
`
`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 ’621 Patent
`
`80.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`- 15 -
`
`

`

`Case 2:17-cv-02528-SDW-LDW Document 1 Filed 04/12/17 Page 16 of 330 PageID: 16
`
`81.
`
`Zydus’s submission of its ANDA to engage in the commercial manufacture,
`
`use, sale, offer for sale, or importation into the United States of Zydus’s Proposed Products, prior
`
`to the expiration of the ’621 patent, constitutes infringement of one or more of the claims of that
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`82.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’621 patent.
`
`83.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will infringe one or more claims of the ’621 patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Zydus’s Proposed Products in the United States.
`
`84.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will induce infringement of one or more claims of the ’621 patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Zydus’s Proposed Products in the
`
`United States. On information and belief, upon FDA approval of Zydus’s ANDA, Zydus will
`
`intentionally encourage acts of direct infringement with knowledge of the ’621 patent and
`
`knowledge that its acts are encouraging infringement.
`
`85.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will contributorily infringe one or more claims of the ’621 patent under 35 U.S.C. § 271(c) by
`
`making, using, offering to sell, selling, and/or importing Zydus’s Proposed Products in the
`
`United States. On information and belief, Zydus has had and continues to have knowledge that
`
`Zydus’s Proposed Products are especially adapted for a use that infringes one or more claims of
`
`the ’621 patent and that there is no substantial non-infringing use for Zydus’s Proposed Products.
`
`86.
`
`Celgene will be substantially and irreparably damaged and harmed if Zydus’s
`
`infringement of the ’621 patent is not enjoined.
`
`- 16 -
`
`

`

`Case 2:17-cv-02528-SDW-LDW Document 1 Filed 04/12/17 Page 17 of 330 PageID: 17
`
`87.
`
`88.
`
`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 VII: Infringement of the ’622 Patent
`
`89.
`
`Celgene repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`90.
`
`Zydus’s submission of its ANDA to engage in the commercial manufacture,
`
`use, sale, offer for sale, or importation into the United States of Zydus’s Proposed Products, prior
`
`to the expiration of the ’622 patent, constitutes infringement of one or more of the claims of that
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`91.
`
`There is a justiciable controversy between the parties hereto as to the
`
`infringement of the ’622 patent.
`
`92.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will infringe one or more claims of the ’622 patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Zydus’s Proposed Products in the United States.
`
`93.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will induce infringement of one or more claims of the ’622 patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Zydus’s Proposed Products in the
`
`United States. On information and belief, upon FDA approval of Zydus’s ANDA, Zydus will
`
`intentionally encourage acts of direct infringement with knowledge of the ’622 patent and
`
`knowledge that its acts are encouraging infringement.
`
`94.
`
`Unless enjoined by this Court, upon FDA approval of Zydus’s ANDA, Zydus
`
`will contributorily infringe one or more claims of the ’622 patent under 35 U.S.C. § 271(c) by
`
`making, using, offering to sell, selling, and/or importing Zydus’s Proposed Products in the
`
`- 17 -
`
`

`

`Case 2:17-cv-02528-SDW-LDW Document 1 Filed 04/12/17 Page 18 of 330 PageID: 18
`
`United States. On information and belief, Zydus has had and continues to have knowledge that
`
`Zydus’s Proposed Products are especially adapted for a use that infringes one or more claims of
`
`the ’622 patent and that there is no substantial non-infringing use for Zydus’s Proposed Products.
`
`95.
`
`Celgene will be substantially and irreparably damaged and harmed if Zydus’s
`
`infringement of the ’622 patent is not enjoined.
`
`96.
`
`97.
`
`Celgene does not have an adequate remedy at law.
`
`This case is an except