Case 2:22-cv-02745 Document 1 Filed 05/11/22 Page 1 of 37 PageID: 1
`
`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
`Abraxis BioScience, LLC
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`
`
`
`
`Plaintiff,
`
`
`
`v.
`
`
`ABRAXIS BIOSCIENCE, LLC
`
`
`
`
`
`JIANGSU HENGRUI
`PHARMACEUTICALS CO., LTD.,
`
`
`
`
`
`
`Defendant.
`
`
`
`Civil Action No. ________________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`Plaintiff Abraxis BioScience, LLC (“Abraxis” or “Plaintiff”), by its undersigned
`
`attorneys, for its Complaint against defendant Jiangsu Hengrui Pharmaceuticals Co., Ltd.
`
`(“Hengrui” or “Defendant”), 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 Hengrui’s filing of Abbreviated New Drug
`
`Application (“ANDA”) No. 212700 (“Hengrui’s ANDA”) with the United States Food and Drug
`
`Administration (“FDA”) seeking approval to commercially market a generic version of
`
`Plaintiff’s Abraxane® (paclitaxel protein-bound particles for injectable suspension) drug product
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`Case 2:22-cv-02745 Document 1 Filed 05/11/22 Page 2 of 37 PageID: 2
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`(“Hengrui’s ANDA Product”) prior to the expiration of United States Patent No. 7,820,788 (“the
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`ʼ788 Patent” or the “Patent-in-Suit”), owned by Plaintiff.
`
`The Parties
`
`2.
`
`Plaintiff Abraxis is a wholly owned subsidiary of Celgene Corporation, which is
`
`in turn a wholly owned subsidiary of the Bristol-Myers Squibb Company (“BMS”). Abraxis is a
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`corporation organized and existing under the laws of the State of Delaware, having a principal
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`place of business at 86 Morris Avenue, Summit, New Jersey 07901.
`
`3.
`
`On information and belief, Hengrui is a corporation organized and existing under
`
`the laws of China with its principal place of business at No. 7 Kunlunshan Road, Lianyungang
`
`Eco & Tech Development Zone, Lianyungang, Jiangsu 222002, China.
`
`The Patent-in-Suit
`
`4.
`
`On October 26, 2010, the United States Patent and Trademark Office (“USPTO”)
`
`duly and lawfully issued the ’788 Patent, titled, “Compositions and Methods of Delivery of
`
`Pharmacological Agents.” The ’788 Patent is assigned to Abraxis. A copy of the ’788 Patent is
`
`attached hereto as Exhibit A.
`
`The Abraxane® Drug Product
`
`5.
`
`Abraxis 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 paclitaxel
`
`protein-bound particles for injectable suspension (NDA No. 21-660), which it sells under the
`
`trade name Abraxane®. Abraxane® is an FDA-approved prescription medicine used for the
`
`treatment of certain hard-to-treat forms of cancer, including: (1) metastatic breast cancer (after
`
`failure of combination chemotherapy for metastatic disease or relapse within six months of
`
`adjuvant chemotherapy); (2) locally advanced or metastatic non-small cell lung cancer, as first-
`
`line treatment in combination with carboplatin, in patients who are not candidates for curative
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`surgery or radiation therapy; and (3) metastatic adenocarcinoma of the pancreas as first-line
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`treatment, in combination with gemcitabine. The claims of the Patent-in-Suit cover, inter alia,
`
`pharmaceutical compositions and methods of use and administration of paclitaxel protein-bound
`
`particles for injection, including Abraxane®. Abraxis owns the Patent-in-Suit.
`
`6.
`
`Pursuant to 21 U.S.C. § 355(b)(1) and attendant FDA regulations, the Patent-in-
`
`Suit is listed in the FDA publication, “Approved Drug Products with Therapeutic Equivalence
`
`Evaluations” (the “Orange Book”), with respect to Abraxane®.
`
`7.
`
`The labeling for Abraxane® instructs and encourages physicians, other healthcare
`
`workers, and patients to administer Abraxane® according to one or more of the methods claimed
`
`in the Patent-in-Suit.
`
`Jurisdiction and Venue
`
`8.
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`9.
`
`This Court has personal jurisdiction over Hengrui by virtue of, inter alia, its
`
`systematic and continuous contacts with the State of New Jersey. On information and belief,
`
`Hengrui 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, through its own actions and through the actions
`
`of its agents and subsidiaries. On information and belief, Hengrui has purposefully conducted
`
`and continues to conduct business in this Judicial District, including the purposeful sale and
`
`distribution of drug products. On information and belief, Hengrui regularly and continuously
`
`transacts business in New Jersey. On information and belief, this Judicial District will be a
`
`destination for the generic drug products described in Hengrui’s ANDA.
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`10.
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`On information and belief, Hengrui prepares and/or aids in the preparation and
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`submission of ANDAs to the FDA. On information and belief, Hengrui actively participated in
`
`the preparation and/or filing of Hengrui’s ANDA.
`
`11.
`
`On information and belief, Hengrui derives substantial revenue from selling
`
`generic products throughout the United States, including in this Judicial District.
`
`12.
`
`This Court has personal jurisdiction over Hengrui because, inter alia, it: (1) has
`
`purposefully availed itself of the privilege of doing business in New Jersey, including directly or
`
`indirectly through its subsidiaries, agents, and/or alter egos, including HengRui USA, a company
`
`with a place of business in Princeton, New Jersey and that is registered with the State of New
`
`Jersey’s Division of Revenue and Enterprise Services (ID No. 0100953752); and (2) maintains
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`extensive and systematic contacts with the State of New Jersey, including the marketing,
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`distribution, and/or sale of generic pharmaceutical drugs in New Jersey, including through,
`
`directly or indirectly, HengRui USA.
`
`13.
`
`On information and belief, HengRui USA is a wholly owned subsidiary of
`
`Hengrui. See “About HengRui USA,” available at https://www.hengruius.com/about-
`
`hengrui.html (last visited, May 11, 2022).
`
`14.
`
`On information and belief, HengRui USA acts at the direction, and for the benefit,
`
`of Hengrui, and is controlled and/or dominated by Hengrui.
`
`15.
`
`On information and belief, Hengrui, directly or indirectly through at least
`
`HengRui USA, maintains a regular and established place of business in this Judicial District at
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`400 Alexander Park Drive, Princeton, New Jersey 08540.
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`16.
`
`On information and belief, HengRui USA “operates as the U.S. hub” for Hengrui.
`
`See “About HengRui USA,” available at https://www.hengruius.com/about-hengrui.html (last
`
`visited, May 11, 2022).
`
`17.
`
`This Court has personal jurisdiction over Hengrui because, inter alia, it has
`
`committed an act of patent infringement under 35 U.S.C. § 271(e)(2), and, on information and
`
`belief, Hengrui 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
`
`Abraxis in New Jersey and in this Judicial District. For example, on information and belief,
`
`Hengrui will work alone or in concert with a subsidiary, agent, and/or alter ego, HengRui USA,
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`towards the regulatory approval, manufacturing, use, importation, marketing, sale, offer for sale,
`
`and distribution of generic pharmaceutical products, including Hengrui’s ANDA Product,
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`throughout the United States, including in New Jersey and in this Judicial District, prior to the
`
`expiration of the Patent-in-Suit.
`
`18.
`
`In the alternative, this Court has personal jurisdiction over Hengrui because the
`
`requirements of Federal Rule of Civil Procedure 4(k)(2) are met as (a) Plaintiff’s claims arise
`
`under federal law; (b) Hengrui is a foreign defendant not subject to general personal jurisdiction
`
`in the courts of any state; and (c) Hengrui has sufficient contacts with the United States as a
`
`whole, including, but not limited to, preparing and submitting ANDAs to the FDA and/or
`
`manufacturing, importing, offering to sell, and/or selling pharmaceutical products that are
`
`distributed throughout the United States, such that this Court’s exercise of jurisdiction over
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`Hengrui satisfies due process.
`
`19.
`
`On information and belief, Hengrui seeks approval from the FDA to sell
`
`Hengrui’s ANDA Product throughout the United States, including in this Judicial District, and
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`intends to market, sell, and/or distribute Hengrui’s ANDA Product to residents of New Jersey
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`upon approval of Hengrui’s ANDA, either directly or through at least one of its wholly-owned
`
`subsidiaries or agents.
`
`20.
`
`On information and belief, Hengrui has previously been sued in this Judicial
`
`District and has not challenged personal jurisdiction. See Janssen Prods., L.P., et al. v. eVenus
`
`Pharm. Labs. Inc., et al., No. 20-cv-9369 (D.N.J.).
`
`21.
`
`Venue is proper in this Judicial District pursuant to 28 U.S.C. §§ 1391 and/or
`
`1400(b).
`
`22.
`
`Venue is proper in this district for Hengrui pursuant to 28 U.S.C. §§ 1391 and
`
`1400(b) because, inter alia, Hengrui is a company organized and existing under the laws of
`
`China and may be sued in any judicial district. 28 U.S.C. § 1391(c)(3).
`
`Acts Giving Rise To This Suit
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`23.
`
`Pursuant to Section 505 of the FFDCA, Hengrui filed Hengrui’s ANDA seeking
`
`approval to engage in the commercial manufacture, use, offer for sale, sale, or importation in or
`
`into the United States of Hengrui’s ANDA Product before the Patent-in-Suit expires.
`
`24.
`
`On information and belief, following FDA approval of Hengrui’s ANDA,
`
`Hengrui will make, use, offer for sale, or sell Hengrui’s ANDA Product throughout the United
`
`States, or import such generic products into the United States.
`
`25.
`
`On information and belief, in connection with the filing of its ANDA as described
`
`above, Hengrui provided a written certification to the FDA, pursuant to 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(IV) (“Hengrui’s Paragraph IV Certification”), alleging that the claims of the
`
`Patent-in-Suit are invalid, unenforceable, and/or will not be infringed by the activities described
`
`in Hengrui’s ANDA.
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`26.
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`No earlier than March 25, 2022, Hengrui sent written notice of its Paragraph IV
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`Certification to Abraxis (“Hengrui’s Notice Letter”). Hengrui’s Notice Letter alleged that the
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`claims of the Patent-in-Suit are invalid and/or will not be infringed by the activities described in
`
`Hengrui’s ANDA. Hengrui’s Notice Letter also informed Abraxis that Hengrui seeks approval
`
`to market Hengrui’s ANDA Product before the Patent-in-Suit expires.
`
`Count I: Infringement of the ’788 Patent
`
`27.
`
`Abraxis repeats and realleges the allegations of the preceding paragraphs as if
`
`fully set forth herein.
`
`28.
`
`Hengrui, by the submission of Hengrui’s Paragraph IV Certification as part of its
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`ANDA to the FDA, has indicated that it seeks approval to engage in the commercial
`
`manufacture, use, offer for sale, sale, or importation in or into the United States of Hengrui’s
`
`ANDA Product, prior to the expiration of the ’788 Patent.
`
`29.
`
`Hengrui’s ANDA has been pending before the FDA since at least March 25,
`
`2022, the date that Hengrui sent Hengrui’s Notice Letter to Abraxis.
`
`30.
`
`Hengrui’s submission of its ANDA to engage in the commercial manufacture,
`
`use, offer for sale, sale, or importation in or into the United States of Hengrui’s ANDA Product,
`
`prior to the expiration of the ’788 Patent, constitutes infringement of one or more of the claims of
`
`that patent under 35 U.S.C. § 271(e)(2)(A).
`
`31.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’788 Patent.
`
`32.
`
`Unless enjoined by this Court, upon FDA approval of Hengrui’s ANDA, Hengrui
`
`will infringe one or more claims of the ’788 Patent under 35 U.S.C. § 271(a) by making, using,
`
`offering to sell, selling, and/or importing Hengrui’s ANDA Product in or into the United States.
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`33.
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`Unless enjoined by this Court, upon FDA approval of Hengrui’s ANDA, Hengrui
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`will induce infringement of one or more claims of the ’788 Patent under 35 U.S.C. § 271(b) by
`
`making, using, offering to sell, selling, and/or importing Hengrui’s ANDA Product in or into the
`
`United States. On information and belief, upon FDA approval of Hengrui’s ANDA, Hengrui
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`will intentionally encourage acts of direct infringement with knowledge of the ’788 Patent and
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`knowledge that its acts are encouraging infringement.
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`34.
`
`Unless enjoined by this Court, upon FDA approval of Hengrui’s ANDA, Hengrui
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`will contributorily infringe one or more claims of the ’788 Patent under 35 U.S.C. § 271(c) by
`
`making, using, offering to sell, selling, and/or importing Hengrui’s ANDA Product in or into the
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`United States. On information and belief, Hengrui has had and continues to have knowledge that
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`Hengrui’s ANDA Product is especially adapted for a use that infringes one or more claims of the
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`’788 Patent and that there is no substantial non-infringing use for Hengrui’s ANDA Product.
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`35.
`
`Abraxis will be substantially and irreparably damaged and harmed if Hengrui’s
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`infringement of the ’788 Patent is not enjoined.
`
`36.
`
`37.
`
`Abraxis does not have an adequate remedy at law.
`
`This case is an exceptional one, and Abraxis is entitled to an award of its
`
`reasonable attorneys’ fees under 35 U.S.C. § 285.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiff Abraxis respectfully requests the following relief:
`
`(A) A Judgment that Hengrui has infringed the Patent-in-Suit by submitting ANDA
`
`No. 212700;
`
`(B) A Judgment that Hengrui has infringed, and that Hengrui’s making, using,
`
`offering to sell, selling, or importing Hengrui’s ANDA Product will infringe one or more claims
`
`of the Patent-in-Suit;
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`(C) An Order that the effective date of FDA approval of ANDA No. 212700 be a date
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`which is not earlier than the later of the expiration of the Patent-in-Suit, or any later expiration of
`
`exclusivity to which Abraxis is or becomes entitled;
`
`(D)
`
`Preliminary and permanent injunctions enjoining Hengrui and its officers, agents,
`
`attorneys and employees, and those acting in privity or concert with them, from making, using,
`
`offering to sell, selling, or importing Hengrui’s ANDA Product until after the expiration of the
`
`Patent-in-Suit, or any later expiration of exclusivity to which Abraxis is or becomes entitled;
`
`(E) A permanent injunction, pursuant to 35 U.S.C. § 271(e)(4)(B), restraining and
`
`enjoining Hengrui, its officers, agents, attorneys and employees, and those acting in privity or
`
`concert with them, from practicing any paclitaxel protein-bound particles for injectable
`
`suspension or compositions claimed in the Patent-in-Suit, or from actively inducing or
`
`contributing to the infringement of any claim of the Patent-in-Suit, until after the expiration of
`
`the Patent-in-Suit, or any later expiration of exclusivity to which Hengrui is or becomes entitled;
`
`(F)
`
`A Judgment that the commercial manufacture, use, importation into the United
`
`States, offer for sale, and/or sale of Hengrui’s ANDA Product will directly infringe, induce
`
`and/or contribute to infringement of the Patent-in-Suit;
`
`(G)
`
`To the extent that Hengrui has committed any acts with respect to the paclitaxel
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`protein-bound particles of injectable suspension compositions claimed in the Patent-in-Suit,
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`other than those acts expressly exempted by 35 U.S.C. § 271(e)(1), a Judgment awarding
`
`Abraxis damages for such acts;
`
`(H)
`
`If Hengrui engages in the commercial manufacture, use, importation into the
`
`United States, offer for sale, and/or sale of Hengrui’s ANDA Product prior to the expiration of
`
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`the Patent-in-Suit, a Judgment awarding damages to Abraxis resulting from such infringement,
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`together with interest;
`
`(I)
`
`(J)
`
`A Judgment declaring that the Patent-in-Suit remains valid and enforceable;
`
`A Judgment that this is an exceptional case pursuant to 35 U.S.C. § 285 and
`
`awarding Abraxis its attorneys’ fees incurred in this action;
`
`(K) A Judgment awarding Abraxis its costs and expenses incurred in this action; and
`
`(L)
`
`Such further and other relief as this Court may deem just and proper.
`
`
`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, NJ 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Abraxis BioScience, LLC
`
`
`Dated: May 11, 2022
`
`Of Counsel:
`
`F. Dominic Cerrito
`Eric C. Stops
`Andrew S. Chalson
`Evangeline Shih
`Catherine T. Mattes
`Daniel C. Wiesner
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 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, Suite 3500
`Chicago, IL 60601
`(312) 782-3939
`
`
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`CERTIFICATION PURSUANT TO L. CIV. R. 11.2
`
`I hereby certify that the matter in controversy involves one of the same Plaintiffs, the
`
`same drug product, and one of the same patents (i.e., United States Patent No. 7,820,788) that
`
`were at issue in the matters captioned Abraxis Bioscience, LLC, et al. v. Actavis LLC, Civil
`
`Action No. 16-1925 (JMV)(MF), Abraxis Bioscience, LLC, et al. v. Cipla Ltd., Civil Action No.
`
`16-9074 (JMV)(MF), and Abraxis Bioscience, LLC, et al. v. HBT Labs, Inc., Civil Action No.
`
`18-17304 (JMV)(MF). These cases were filed on April 6, 2016, December 7, 2016 and
`
`December 17, 2018, respectively, and dismissed by the Hon. John Michael Vazquez, U.S.D.J. on
`
`January 26, 2018, October 9, 2018, and February 7, 2019, respectively.
`
`I further certify that, to the best of my knowledge, the matter in controversy is not the
`
`subject of any other action pending in any court, or of any pending arbitration or administrative
`
`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, NJ 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiff
`Abraxis BioScience, LLC
`
`proceeding.
`
`
`
`Dated: May 11, 2022
`
`
`
`Of Counsel:
`
`F. Dominic Cerrito
`Eric C. Stops
`Andrew S. Chalson
`Evangeline Shih
`Catherine T. Mattes
`Daniel C. Wiesner
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`(212) 849-7000
`
`Anthony M. Insogna
`Cary Miller, Ph.D.
`JONES DAY
`4655 Executive Drive
`
`
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`Case 2:22-cv-02745 Document 1 Filed 05/11/22 Page 12 of 37 PageID: 12
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`San Diego, CA 92121
`(858) 314-1200
`
`Matthew J. Hertko
`JONES DAY
`77 W. Wacker Drive
`Chicago, IL 60601
`(312) 782-3939
`
`
`
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`Case 2:22-cv-02745 Document 1 Filed 05/11/22 Page 13 of 37 PageID: 13
`Case 2:22-cv-02745 Document1 Filed 05/11/22 Page 13 of 37 PagelD: 13
`
`EXHIBIT A
`EXHIBIT A
`
`

`

`Case 2:22-cv-02745 Document 1 Filed 05/11/22 Page 14 of 37 PageID: 14
`case 22z0r02748 Document imTHMFE
`
`US007820788B2
`
`US 7,820,788 B2
`(10) Patent No.:
`a2) United States Patent
`Desaietal.
`(45) Date of Patent:
`Oct. 26, 2010
`
`
`(54) COMPOSITIONS AND METHODS OF
`DELIVERY OF PHARMACOLOGICAL
`AGENTS
`
`(75)
`
`Inventors: Neil P. Desai, Los Angeles, CA (US);
`Patrick Soon-Shiong, Los Angeles, CA
`(US); Vuong Trieu, Calabasas, CA (US)
`
`;
`(*) Notice:
`
`(73) Assignee: Abraxis Bioscience, LLC, Los Angeles,
`CA (US)
`;
`.
`;
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b)by 85 days.
`(21) Appl. No.: 11/553,339
`
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`6,120,805 A
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`
`Filed:
`
`Oct. 26, 2006
`
`(65)
`
`Prior Publication Data
`US 2010/0226996 Al
`Sep. 9, 2010
`
`(Continued)
`FOREIGN PATENT DOCUMENTS
`
`(51)
`
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`
`Int. Cl.
`(2006.01)
`CO7K 14/76
`(52) US. Chee 530/350; 977/779; 977/906
`(58) Field of Classification Search............. 514/11-12;
`435/7.2; 424/178.1; 530/350; 977/779,
`_
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`—
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`
`ABSTRACT
`
`The present invention relates to a pharmaceutical composi-
`tion comprising a pharmaceutical agent and a pharmaceuti-
`cally acceptable carrier, which carrier comprises a protein, for
`example, human serum albumin and/or deferoxamine. The
`human serum albumin is present in an amounteffective to
`reduce one or moreside effects associated with administra-
`tion of the pharmaceutical composition. The invention also
`provides methods for reducing one or moreside effects of
`administration of the pharmaceutical composition, methods
`for inhibiting microbial growth and oxidation in the pharma-
`ical
`&
`oye
`tl
`hods f
`nhanci
`Pp.
`ceutica composition, an met ods
`for enhancing transport
`and binding of a pharmaceutical agentto a cell.
`
`12 Claims, No Drawings
`
`

`

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