Case 2:22-cv-03753 Document 1 Filed 06/13/22 Page 1 of 166 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
`Celgene Corporation
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`
`CELGENE CORPORATION,
`
`
`
`
`Plaintiff,
`
`
`v.
`
`
`Civil Action No. ________________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
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`
`
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`
`
`
`QILU PHARMACEUTICAL CO. LTD.,
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`
`
`
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`
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`Defendant.
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`Plaintiff Celgene Corporation (“Celgene”), by its undersigned attorneys, for its
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`Complaint against Defendant Qilu Pharmaceutical Co. Ltd. (“Qilu”), 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 Qilu’s submission of Abbreviated New Drug
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`Application (“ANDA”) No. 217265 (“Qilu’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 generic versions of Celgene’s Revlimid® drug products prior to the expiration of
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`United States Patent Nos. 7,465,800 (the “’800 patent”) and 7,855,217 (the “’217 patent”)
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`(together, “the patents-in-suit”), both owned by Celgene.
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`
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`1
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`The Parties
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`2.
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`Plaintiff Celgene is a biopharmaceutical company committed to improving the
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`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. Celgene is a
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`world leader in the treatment of many such diseases, including cancer. Celgene is a corporation
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`organized and existing under the laws of the State of Delaware, having a principal place of
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`business at 86 Morris Avenue, Summit, New Jersey 07901.
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`3.
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`On information and belief, Defendant Qilu Pharmaceutical Co. Ltd. is a
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`corporation organized and existing under the laws of China, having a principal place of business
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`at 8888 Lvyou Road, High-tech Zone, Jinan, 250104, China.
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`The Patents-in-Suit
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`4.
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`On December 16, 2008, the United States Patent and Trademark Office
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`(“USPTO”) duly and lawfully issued the ’800 patent, entitled, “Polymorphic Forms of 3-(4-
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`amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione.” A copy of the ’800 patent is
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`attached hereto as Exhibit A.
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`5.
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`On December 21, 2010, the USPTO duly and lawfully issued the ’217 patent,
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`entitled, “Polymorphic Forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-
`
`dione.” A copy of the ’217 patent is attached hereto as Exhibit B.
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`The Revlimid® Drug Product
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`6.
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`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
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`capsules (NDA No. 021880), which it sells under the trade name Revlimid®. The claims of the
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`2
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`patents-in-suit cover, inter alia, solid forms of lenalidomide and pharmaceutical compositions
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`containing lenalidomide.
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`7.
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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 Revlimid®.
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`Jurisdiction and Venue
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`8.
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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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`9.
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`This Court has personal jurisdiction over Qilu by virtue of, inter alia, its
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`systematic and continuous contacts with the State of New Jersey. On information and belief,
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`Qilu’s subsidiary, Qilu Healthcare Inc., maintains a regular and established, physical place of
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`business in Princeton, New Jersey.
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`10.
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`On information and belief, Qilu Healthcare Inc. is registered with the State of
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`New Jersey’s Division of Revenue and Enterprise Services as a business operating in New Jersey
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`under Business ID No. 101042575. On information and belief, Qilu Healthcare Inc. is registered
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`with the State of New Jersey’s Department of Health as a drug manufacturer and wholesaler
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`under Registration No. 5005245.
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`11.
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`On information and belief, Qilu purposefully has conducted and continues to
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`conduct business in this Judicial District.
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`12.
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`On information and belief, Qilu is in the business of, among other things,
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`manufacturing, marketing, importing, offering for sale, and selling pharmaceutical products,
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`including generic drug products, throughout the United States, including in this Judicial District.
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`3
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`On information and belief, Qilu also prepares and/or aids in the preparation and submission of
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`ANDAs to the FDA, including Qilu’s ANDA.
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`13.
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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 Qilu’s ANDA.
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`14.
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`This Court has personal jurisdiction over Qilu because, inter alia, it: (1) has
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`purposefully availed itself of the privilege of doing business in New Jersey, including directly or
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`indirectly through its subsidiary, agent, and/or alter egos, including Qilu Healthcare, Inc., a
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`company with its principal place of business in New Jersey; and (2) maintains extensive and
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`systematic contacts with the State of New Jersey, including through the marketing, distribution,
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`and/or sale of generic pharmaceutical drugs in New Jersey, including through, directly or
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`indirectly, Qilu Healthcare, Inc.
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`15.
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`On information and belief, Qilu 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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`16.
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`In the alternative, this Court has personal jurisdiction over Qilu because the
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`requirements of Federal Rule of Civil Procedure 4(k)(2) are met as (a) Celgene’s claims arise
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`under federal law; (b) Qilu is a foreign defendant not subject to general personal jurisdiction in
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`the courts of any state; and (c) Qilu has sufficient contacts with the United States as a whole,
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`including, but not limited to, preparing and submitting ANDAs to the FDA and/or
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`manufacturing, importing, offering to sell, and/or selling pharmaceutical products that are
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`distributed throughout the United States, such that this Court’s exercise of jurisdiction over Qilu
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`satisfies due process.
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`4
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`17.
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`On information and belief, Qilu works in privity and/or concert either directly or
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`indirectly through one or more of its wholly owned subsidiaries with respect to the regulatory
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`approval, manufacturing, use, importation, marketing, offer for sale, sale, and distribution of
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`generic pharmaceutical products throughout the United States, including in this Judicial District.
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`18.
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`On information and belief, Qilu submitted and/or actively participated in the
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`submission of its ANDA. On information and belief, Qilu will work in privity and/or concert
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`with Qilu Healthcare, Inc., 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 the 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg
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`lenalidomide capsules that are the subject of Qilu’s ANDA (“Qilu’s Proposed Products”),
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`throughout the United States, including in New Jersey and in this Judicial District, prior to the
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`expiration of the patents-in-suit.
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`19.
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`On information and belief, Qilu intends to benefit directly if its ANDA is
`
`approved by participating in the manufacture, importation, distribution, and/or sale of the generic
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`drug products that are the subject of Qilu’s ANDA.
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`20.
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`Venue is proper in this Judicial District for Qilu pursuant to 28 U.S.C. §§ 1391
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`and/or 1400(b), including, for example, because Qilu is a company organized and existing under
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`the laws of China and may be sued in any judicial district.
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`Acts Giving Rise To This Suit
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`21.
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`Pursuant to Section 505 of the FFDCA, Qilu submitted its ANDA seeking
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`approval to engage in the commercial manufacture, use, sale, offer for sale, or importation into
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`the United States of Qilu’s Proposed Products before the patents-in-suit expire.
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`5
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`22.
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`On information and belief, following FDA approval of Qilu’s ANDA, Qilu will
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`make, use, sell, or offer to sell Qilu’s Proposed Products throughout the United States, or import
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`such generic products into the United States.
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`23.
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`On information and belief, in connection with the submission of its ANDA as
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`described above, Qilu provided a written certification to the FDA pursuant to Section 505 of the
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`FFDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (“Qilu’s Paragraph IV Certification”), alleging that
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`the claims of the patents-in-suit are invalid and/or will not be infringed by the activities
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`described in Qilu’s ANDA.
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`24.
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`No earlier than April 29, 2022, Qilu sent a written notice of its Paragraph IV
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`Certification to Celgene (“Qilu’s Notice Letter”). Qilu’s Notice Letter alleged that the claims of
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`the ’800 and ’217 patents are invalid and/or will not be infringed by the activities described in
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`Qilu’s ANDA. Qilu’s Notice Letter also informed Celgene that Qilu seeks approval to market
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`Qilu’s Proposed Products before the patents-in-suit expire. Qilu specifically directed Qilu’s
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`Notice Letter to Celgene’s headquarters in Summit, New Jersey, in this Judicial District.
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`Count I: Infringement of the ’800 Patent
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`25.
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`Celgene repeats and realleges the allegations of the preceding paragraphs as if
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`fully set forth herein.
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`26.
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`Qilu’s submission of its ANDA, with the accompanying Paragraph IV
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`Certification and notice to Celgene of same, to engage in the commercial manufacture, use, sale,
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`offer for sale, or importation into the United States of Qilu’s Proposed Products, prior to the
`
`expiration of the ’800 patent, constitutes infringement of one or more of the claims of that patent
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`under 35 U.S.C. § 271(e)(2)(A).
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`6
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`27.
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`There is a justiciable controversy between the parties hereto as to the infringement
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`of the ’800 patent.
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`28.
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`Unless enjoined by this Court, upon FDA approval of Qilu’s ANDA, Qilu will
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`infringe one or more claims of the ’800 patent under 35 U.S.C. § 271(a) by making, using,
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`offering to sell, selling, and/or importing Qilu’s Proposed Products in the United States.
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`29.
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`Unless enjoined by this Court, upon FDA approval of Qilu’s ANDA, Qilu will
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`induce infringement of one or more claims of the ’800 patent under 35 U.S.C. § 271(b) by
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`making, using, offering to sell, selling, and/or importing Qilu’s Proposed Products in the United
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`States. On information and belief, upon FDA approval of Qilu’s ANDA, Qilu will intentionally
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`encourage acts of direct infringement with knowledge of the ’800 patent and knowledge that its
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`acts are encouraging infringement.
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`30.
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`Unless enjoined by this Court, upon FDA approval of Qilu’s ANDA, Qilu will
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`contributorily infringe one or more claims of the ’800 patent under 35 U.S.C. § 271(c) by
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`making, using, offering to sell, selling, and/or importing Qilu’s Proposed Products in the United
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`States. On information and belief, Qilu has had and continues to have knowledge that Qilu’s
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`Proposed Products are especially adapted for a use that infringes one or more claims of the ’800
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`patent and that there is no substantial non-infringing use for Qilu’s Proposed Products.
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`31.
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`Celgene will be substantially and irreparably damaged and harmed if Qilu’s
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`infringement of the ’800 patent is not enjoined.
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`32.
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`33.
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`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.
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`
`
`7
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`Count II: Infringement of the ’217 Patent
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`34.
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`Celgene repeats and realleges the allegations of the preceding paragraphs as if
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`fully set forth herein.
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`35.
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`Qilu’s submission of its ANDA, with the accompanying Paragraph IV
`
`Certification and notice to Celgene of same, to engage in the commercial manufacture, use, sale,
`
`offer for sale, or importation into the United States of Qilu’s Proposed Products, prior to the
`
`expiration of the ’217 patent, constitutes infringement of one or more of the claims of that patent
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`under 35 U.S.C. § 271(e)(2)(A).
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`36.
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`There is a justiciable controversy between the parties hereto as to the infringement
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`of the ’217 patent.
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`37.
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`Unless enjoined by this Court, upon FDA approval of Qilu’s ANDA, Qilu will
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`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 Qilu’s Proposed Products in the United States.
`
`38.
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`Unless enjoined by this Court, upon FDA approval of Qilu’s ANDA, Qilu will
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`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 Qilu’s Proposed Products in the United
`
`States. On information and belief, upon FDA approval of Qilu’s ANDA, Qilu will intentionally
`
`encourage acts of direct infringement with knowledge of the ’217 patent and knowledge that its
`
`acts are encouraging infringement.
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`39.
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`Unless enjoined by this Court, upon FDA approval of Qilu’s ANDA, Qilu will
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`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 Qilu’s Proposed Products in the United
`
`States. On information and belief, Qilu has had and continues to have knowledge that Qilu’s
`
`
`
`8
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`Proposed Products are especially adapted for a use that infringes one or more claims of the ’217
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`patent and that there is no substantial non-infringing use for Qilu’s Proposed Products.
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`40.
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`Celgene will be substantially and irreparably damaged and harmed if Qilu’s
`
`infringement of the ’217 patent is not enjoined.
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`41.
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`42.
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`Celgene does not have an adequate remedy at law.
`
`This case is an exceptional one, and Celgene is entitled to an award of its
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`reasonable attorneys’ fees under 35 U.S.C. § 285.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiff Celgene respectfully requests the following relief:
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`(A) A Judgment that Qilu has infringed the patents-in-suit by submitting ANDA
`
`No. 217265 with the accompanying Paragraph IV Certification and notice to Celgene of same;
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`(B) A Judgment that Qilu has infringed, and that Qilu’s making, using, selling,
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`offering to sell, or importing Qilu’s Proposed Products will infringe one or more claims of the
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`patents-in-suit;
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`(C) An Order that the effective date of FDA approval of ANDA No. 217265 be a date
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`which is not earlier than the later of the expiration of the patents-in-suit, or any later expiration of
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`exclusivity to which Celgene is or becomes entitled;
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`(D) Preliminary and permanent injunctions enjoining Qilu and its officers, agents,
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`attorneys and employees, and those acting in privity and/or concert with them, from making,
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`using, offering to sell, selling, or importing Qilu’s Proposed Products until after the expiration of
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`the patents-in-suit, or any later expiration of exclusivity to which Celgene is or becomes entitled;
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`(E) A permanent injunction, pursuant to 35 U.S.C. § 271(e)(4)(B), restraining and
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`enjoining Qilu, its officers, agents, attorneys and employees, and those acting in privity and/or
`
`
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`9
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`
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`concert with them, from practicing any solid forms of lenalidomide or compositions claimed in
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`the patents-in-suit, or from actively inducing or contributing to the infringement of any claim of
`
`the patents-in-suit, until after the expiration of the patents-in-suit, or any later expiration of
`
`exclusivity to which Celgene is or becomes entitled;
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`(F) A Judgment that the commercial manufacture, use, offer for sale, sale, and/or
`
`importation into the United States of Qilu’s Proposed Products will directly infringe, induce
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`infringement of, and/or contribute to infringement of the patents-in-suit;
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`(G) To the extent that Qilu, its officers, agents, attorneys and/or employees, or those
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`acting in privity and/or concert with them, has committed any acts with respect to the solid forms
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`of lenalidomide or compositions, other than those acts expressly exempted by 35 U.S.C.
`
`§ 271(e)(1), a Judgment awarding Celgene damages for such acts;
`
`(H)
`
`If Qilu, its officers, agents, attorneys, and/or employees, or those acting in privity
`
`and/or concert with them, engages in the commercial manufacture, use, offer for sale, sale,
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`and/or importation into the United States of Qilu’s Proposed Products prior to the expiration of
`
`the patents-in-suit, a Judgment awarding damages to Celgene resulting from such infringement,
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`together with interest;
`
`(I)
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`A Judgment declaring that the patents-in-suit remain valid and enforceable;
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`(J) A Judgment that this is an exceptional case pursuant to 35 U.S.C. § 285 and
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`awarding Celgene its attorneys’ fees incurred in this action;
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`(K) A Judgment awarding Celgene its costs and expenses incurred in this action; and
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`(L)
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`Such further and other relief as this Court may deem just and proper.
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`10
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`Case 2:22-cv-03753 Document 1 Filed 06/13/22 Page 11 of 166 PageID: 11
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`
`
`By: s/ Charles M. Lizza
`Charles M. Lizza
`William C. Baton
`Sarah A. Sullivan
`SAUL EWING ARNSTEIN & LEHR LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Celgene Corporation
`
`Dated: June 13, 2022
`
`Of Counsel:
`
`F. Dominic Cerrito
`Eric C. Stops
`Andrew S. Chalson
`QUINN EMANUEL URQUHART & SULLIVAN,
`LLP
`51 Madison Avenue, 22nd Floor
`New York, New York 10010
`(212) 849-7000
`
`Anthony M. Insogna
`Cary Miller, Ph.D.
`JONES DAY
`4655 Executive Drive
`San Diego, CA 92121
`(858) 314-1200
`
`Matthew J. Hertko
`JONES DAY
`77 W. Wacker Drive
`Chicago, IL 60601
`(312) 782-3939
`
`
`
`11
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`CERTIFICATION PURSUANT TO L. CIV. R. 11.2 & 40.1
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`Pursuant to Local Civil Rules 11.2 and 40.1, I hereby certify that the matter captioned
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`Celgene Corporation v. Alembic Pharmaceuticals Ltd., Civil Action 21-20099 (SDW)(LDW)
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`(D.N.J.) is related to the matter in controversy because the matter in controversy involves the
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`same plaintiff and some of the same patents, and because Qilu is seeking FDA approval to
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`market generic versions of the same pharmaceutical product.
`
`I further certify that, to the best of my knowledge, the matter in controversy is not the
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`subject of any other action pending in any court, or of any pending arbitration or administrative
`
`proceeding.
`
`Dated: June 13, 2022
`
`Of Counsel:
`
`F. Dominic Cerrito
`Eric C. Stops
`Andrew S. Chalson
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, New York 10010
`(212) 849-7000
`
`Anthony M. Insogna
`Cary Miller, Ph.D.
`JONES DAY
`4655 Executive Drive
`San Diego, CA 92121
`(858) 314-1200
`
`Matthew J. Hertko
`JONES DAY
`77 W. Wacker Drive
`Chicago, IL 60601
`(312) 782-3939
`
`
`
`
`
`By: s/ Charles M. Lizza
`Charles M. Lizza
`William C. Baton
`Sarah A. Sullivan
`SAUL EWING ARNSTEIN & LEHR LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Celgene Corporation
`
`
`
`12
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`Case 2:22-cv-03753 Document 1 Filed 06/13/22 Page 13 of 166 PageID: 13
`Case 2:22-cv-03753 Document1 Filed 06/13/22 Page 13 of 166 PagelD: 13
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`EXHIBIT A
`EXHIBIT A
`
`

`

`Case 2:22-cv-03753 Document 1 Filed 06/13/22 Page 14 of 166 PageID: 14
`case 222-0-08758 Docume.MUTAO
`
`US007465800B2
`
`(12) United States Patent
`US 7,465,800 B2
`(0) Patent No.:
`Dec. 16, 2008
`(45) Date of Patent:
`Jaworskyetal.
`
`(54)
`
`(75)
`
`POLYMORPHIC FORMS OF
`
`3-(4-AMINO-1-OXO-1,3
`DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-
`2,6-DIONE
`
`Inventors: Markian S. Jaworsky, Hopewell, NJ
`(US); Roger Shen-Chu Chen, Edison,
`NJ (US); George W. Muller,
`Bridgewater, NJ (US)
`
`(73)
`
`Assignee: Celgene Corporation, Summit, NJ (US)
`
`(*)
`
`Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 596 days.
`
`(21)
`
`Appl. No.: 10/934,863
`
`(22)
`
`Filed:
`
`Sep. 3, 2004
`
`(65)
`
`(60)
`
`(51)
`
`(52)
`(58)
`
`(56)
`
`Prior Publication Data
`
`US 2005/0096351 Al
`
`May 5, 2005
`
`Related U.S. Application Data
`
`Provisional application No. 60/499,723, filed on Sep.
`4, 2003.
`
`Int. Cl.
`
`(2006.01)
`CO7D 401/04
`US. Ch. occ ccc ccescneneeeeee 546/200; 514/323
`Field of Classification Search.
`................. 546/200;
`514/323
`
`See application file for complete search history.
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3,536,809
`3,598,123
`3,845,770
`3,916,899
`4,008,719
`4,810,643
`4,999,291
`
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`5,391,485 A
`5,393,870 A
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`(Continued)
`FOREIGN PATENT DOCUMENTS
`
`WO
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`
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`
`(Continued)
`OTHER PUBLICATIONS
`
`Seddon “Pseudopolymorph: a polemic” Crystal Growth & design
`v.4(6) 1087, Web release Oct. 19, 2004.*
`
`(Continued)
`
`Primary Examiner—Celia Chang
`(74) Attorney, Agent, or Firm—Jones Day
`
`(57)
`
`ABSTRACT
`
`Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoin-
`dol-2-yl)-piperidine-2,6-dione are disclosed. Compositions
`comprising the polymorphic forms, methods of making the
`polymorphic forms and methods of their use are also dis-
`closed.
`
`14 Claims, 48 Drawing Sheets
`
` XRPD PATTERN OF POLYMORPH B
`File: Process 274-100-C
`Date: 06-04-04 16:11 Step: 0.020° Cat Time: 0.500 Sec.
`cpg Range: 1.50 - 40,00 (Deg) Step Scan Rate: 2.40 Degimin
`
` {Ad
`
`
`VALSh |
`170 wn 23.0
`
`140
`
`q.
`
`26.0
`
`290
`
`320
`
`350
`
`380
`
`a2
`
`0
`
`50
`
`80 110
`
`

`

`Case 2:22-cv-03753 Document 1 Filed 06/13/22 Page 15 of 166 PageID: 15
`Case 2:22-cv-03753 Document1 Filed 06/13/22 Page 15 of 166 PagelD: 15
`
`US 7,465,800 B2
`
`Page 2
`
`U.S. PATENT DOCUMENTS
`
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`
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`6,380,239 Bl
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`6,395,754 Bl
`Man etal.
`patients with metastatic malignant melanoma and other advanced
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`6,403,613 Bl
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`6,458,810 Bl
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`et
`al.,“Doxil
`(D), vincristine
`(V),
`reduced frequency
`2001/0018445 Al
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`dexamethasone (d) and revlimid (R) (DVd-R) results in a high
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`Hwu
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`Celgene Corporation,
`“Additional clinical data presented on
`D’ Amato
`2002/0161023 Al
`10/2002
`Revimid™in myelodysplastic sydromesat the American Society of
`
`2002/0173658 Al=11/2002 Mulleretal.
`Hematology 45" annual meeting,” Press Release, Dec. 2003.
`
`2002/0183360 Al=12/2002 Mulleretal.
`Celgene Corporation, “Blood reports Revimid™ has anti-tumor
`2003/0013739 Al
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`Masferreret al.
`activity in patients with relapsed and refractory multiple myeloma,”
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`Celgene Corporation, “Celgene advances immunomodulatory drug
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`CIMiD™)clinical program,” Press Release, Feb. 2000.
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`Celgene Corporation, “Celgene announces plans to stop phase III
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`Celgene Corporation, “Celgene corporation advances ACTIMID™
`2003/0181428 Al
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`(CC-4047) into phase I] trial for prostate cancer,’ Press Release, Oct.
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`D’ Amato
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`2003/0235909 Al=12/2003 Hariri et al.
`Celgene Corporation, “Celgene Corporation announces fourth quar-
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`2004/0087546 Al
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`$30.5 million. Pivotal programs for THALOMID and REVIMID™
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`Zeldis
`finalized.
`Peer-reviewed
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`REVIMIDdata. First JNK inhibitor advanced. to Phase I clinical
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`
`WO
`WO
`
`WO
`WO
`WO
`
`WO 98/54170
`WO 01/70275
`WO 01/87307
`WO 02/059 106
`WO 02/064083
`PCT/US03/11578
`
`12/1998
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`OTHER PUBLICATIONS
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`Chenet al. “Polymorphic forms of...” CA 142:303619 (2005).*
`
`Celgene Corporation, “Celgene corporation reports record operating
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`Celgene Corporation, “Celgene corporation reports record operating
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`profits rise,” Press Release, Oct. 2003.
`
`

`

`Case 2:22-cv-03753 Document 1 Filed 06/13/22 Page 16 of 166 PageID: 16
`Case 2:22-cv-03753 Document1 Filed 06/13/22 Page 16 of 166 PagelD: 16
`
`US 7,465,800 B2
`
`Page 3
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`Celgene Corporation, “Celgene provides update on clinical pipeline.
`Celgene Announces
`first
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