Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 1 of 132 PageID: 1
`
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiffs
`Abraxis BioScience, LLC and
`Celgene Corporation
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`ABRAXIS BIOSCIENCE, LLC and
`CELGENE CORPORATION,
`
`v.
`
`CIPLA LTD.,
`
`Plaintiffs,
`
`Defendant.
`
`Civil Action No. ____________________
`
`COMPLAINT FOR
`PATENT INFRINGEMENT
`
`(Filed Electronically)
`
`Plaintiffs Abraxis BioScience, LLC (“Abraxis”) and Celgene Corporation (“Celgene
`
`Corp.”) (collectively, “Celgene”), by their undersigned attorneys, for their Complaint against
`
`defendant Cipla Ltd. (“Cipla”), allege 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 Cipla’s filing of Abbreviated New Drug Application
`
`(“ANDA”) No. 209657 (“Cipla’s ANDA”) with the United States Food and Drug Administration
`
`(“FDA”) seeking approval to commercially market a generic version of Celgene’s ABRAXANE®
`
`drug product prior to the expiration of United States Patent Nos. 7,820,788 (the “’788 patent”),
`
`

`

`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 2 of 132 PageID: 2
`
`7,923,536 (the “’536 patent”), 8,138,229 (the “’229 patent”), and 8,853,260 (the “’260 patent”),
`
`all owned by Abraxis (collectively, the “patents-in-suit”).
`
`The Parties
`
`2.
`
`Plaintiff Celgene Corp. is a biopharmaceutical company committed to improving
`
`the lives of patients worldwide. Celgene Corp. focuses on the discovery and development of
`
`products for the treatment of cancer and other severe conditions. Celgene Corp. is 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.
`
`Plaintiff Abraxis is a wholly owned subsidiary of Celgene Corp. Abraxis is a
`
`corporation organized and existing under the laws of the State of Delaware, having a principal
`
`place of business at 11755 Wilshire Boulevard, 20th Floor, Los Angeles, California 90025.
`
`4.
`
`On information and belief, Defendant Cipla Ltd. is a corporation organized under
`
`the laws of India, maintaining its headquarters at Cipla House, Peninsula Business Park,
`
`Ganpatrao Kadam Marg, Lower Parel, Mumbai – 400 013, India.
`
`Jurisdiction and Venue
`
`5.
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`6.
`
`This Court has personal jurisdiction over Cipla because of, inter alia, its
`
`systematic and continuous contacts with the State of New Jersey. On information and belief,
`
`Cipla is in the business of manufacturing, marketing, importing, and selling pharmaceutical
`
`products, including generic drug products. On information and belief, Cipla directly or indirectly
`
`manufactures, markets, and sells generic drug products throughout the United States and in this
`
`Judicial District. Upon information and belief, Cipla is registered as a wholesaler in the State of
`
`New Jersey (No. 5004658) under the trade name “Cipla USA, Inc. – North America.” See NJ
`
`- 2 -
`
`

`

`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 3 of 132 PageID: 3
`
`Drug Registration Verification at http://web.doh.state.nj.us/apps2/FoodDrugLicense/fdList.aspx,
`
`last viewed December 7, 2016. Upon information and belief, Cipla USA, Inc. is the U.S.
`
`subsidiary of Cipla Limited, through which Cipla does business in the United States. On
`
`information and belief, Cipla has purposefully conducted and continues to conduct business in
`
`this Judicial District, including the purposeful sale and distribution of generic drug products.
`
`7.
`
`This Court also has specific jurisdiction over Cipla in connection with this matter.
`
`Cipla has already taken the significant step of filing Cipla’s ANDA seeking approval to market
`
`its infringing generic drug prior to the expiration of the patents-in-suit, and as described below,
`
`provided notice of its ANDA filing to Celgene in New Jersey. Cipla’s ANDA seeks approval to
`
`sell its generic drug throughout the United States, including in the State of New Jersey. On
`
`information and belief, Cipla plans to direct sales of the infringing generic drug product
`
`described in Cipla’s ANDA into this Judicial District, where it would cause harm to Celgene.
`
`Therefore, this cause of action arises out of Cipla’s contacts with the State of New Jersey.
`
`8.
`
`On information and belief, Cipla is a large, global generic manufacturer that has
`
`previously submitted to the jurisdiction of this Court and has availed itself of the legal
`
`protections of the State of New Jersey, having asserted counterclaims in this jurisdiction,
`
`including in at least the matters of: Janssen Prods., L.P. v. Cipla Ltd., No. 15-2549; Merck,
`
`Sharp & Dohme Corp., v. Cipla USA, Inc., No. 13-4017; Prometheus Labs., Inc. v. Roxane
`
`Labs., Inc., No. 11-1241; Janssen Prods, L.P. v. Lupin Ltd., No. 10-5954; AstraZeneca AB v.
`
`Ivax Corp., No. 08-4993; and AstraZeneca AB v. Ranbaxy Pharm., Inc., No. 05-5553.
`
`9.
`
`The State of New Jersey has an interest in providing a forum to resolve disputes,
`
`like this one, that involve the unlawful marketing of infringing generic drug products in the State
`
`- 3 -
`
`

`

`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 4 of 132 PageID: 4
`
`of New Jersey and harm to companies, like Celgene, that have a principal places of business in,
`
`and are doing business in, the State of New Jersey.
`
`10.
`
`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`The Patents-in-suit
`
`11.
`
`On October 26, 2010, the United States Patent and Trademark Office (“PTO”)
`
`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.
`
`12.
`
`On April, 12, 2011, the PTO duly and lawfully issued the ’536 patent, titled
`
`“Compositions and Methods of Delivery of Pharmacological Agents.” The ’536 patent is
`
`assigned to Abraxis. A copy of the ’536 patent is attached hereto as Exhibit B.
`
`13.
`
`On March 20, 2012, the PTO duly and lawfully issued the ’229 patent, titled
`
`“Compositions and Methods of Delivery of Pharmacological Agents.” The ’229 patent is
`
`assigned to Abraxis. A copy of the ’229 patent is attached hereto as Exhibit C.
`
`14.
`
`On October 7, 2014, the PTO duly and lawfully issued the ’260 patent, titled
`
`“Formulations of Pharmacological Agents, Methods for the Preparation Thereof and Methods for
`
`the Use Thereof.” The ’260 patent is assigned to Abraxis. A copy of the ’260 patent is attached
`
`hereto as Exhibit D.
`
`The ABRAXANE® Drug Product
`
`15.
`
`Celgene Corp. 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
`
`- 4 -
`
`

`

`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 5 of 132 PageID: 5
`
`(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
`
`surgery or radiation therapy; and (3) metastatic adenocarcinoma of the pancreas as first-line
`
`treatment, in combination with gemcitabine. The claims of the patents-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 patents-in-suit.
`
`16.
`
`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 ABRAXANE®.
`
`17.
`
`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 patents-in-suit.
`
`Acts Giving Rise to This Suit
`
`18.
`
`Pursuant to Section 505 of the FFDCA, Cipla filed Cipla’s ANDA seeking
`
`approval to engage in the commercial manufacture, use, offer for sale, sale, or importation of
`
`paclitaxel protein-bound particles for injectable suspension, 100 mg/ml (“Cipla’s Proposed
`
`Product”), before the patents-in-suit expire.
`
`19.
`
`On information and belief, in connection with the filing of Cipla’s ANDA as
`
`described in the preceding paragraph, Cipla 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) (“Cipla’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 Cipla’s ANDA.
`
`- 5 -
`
`

`

`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 6 of 132 PageID: 6
`
`20.
`
`No earlier than October 25, 2016, Celgene received written notice of Cipla’s
`
`Paragraph IV Certification (“Cipla’s Notice Letter”) pursuant to 21 U.S.C. § 355(j)(2)(B).
`
`Cipla’s Notice Letter alleged that the claims of the patents-in-suit are invalid, unenforceable,
`
`and/or will not be infringed by the activities described in Cipla’s ANDA. Cipla’s Notice Letter
`
`also informed Celgene that Cipla seeks approval to market Cipla’s Proposed Product before the
`
`patents-in-suit expire. Cipla specifically directed Cipla’s Notice Letter to Celgene Corp. in
`
`Berkeley Heights, New Jersey, in this Judicial District.
`
`Count I: Infringement of the ’788 Patent
`
`21.
`
`22.
`
`Celgene repeats and realleges the foregoing allegations as if fully set forth herein.
`
`Cipla’s submission of its ANDA to obtain approval to engage in the commercial
`
`manufacture, use, offer for sale, sale, or importation into the United States of Cipla’s Proposed
`
`Product, prior to the expiration of the ’788 patent, constitutes infringement of one or more of
`
`claims 1–12 of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`23.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’788 patent.
`
`24.
`
`Unless enjoined by this Court, upon FDA approval of Cipla’s ANDA, Cipla will
`
`infringe one or more of claims 1–12 of the ’788 patent under 35 U.S.C. § 271(a) by making,
`
`using, offering to sell, selling, and/or importing Cipla’s Proposed Product in the United States.
`
`25.
`
`Unless enjoined by this Court, upon FDA approval of Cipla’s ANDA, Cipla will
`
`induce infringement of one or more of claims 1–12 of the ’788 patent under 35 U.S.C. § 271(b)
`
`by making, using, offering to sell, selling, and/or importing Cipla’s Proposed Product in the
`
`United States. On information and belief, upon FDA approval of Cipla’s ANDA, Cipla will
`
`intentionally encourage acts of direct infringement with knowledge of the ’788 patent and
`
`knowledge that its acts are encouraging infringement.
`
`- 6 -
`
`

`

`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 7 of 132 PageID: 7
`
`26.
`
`Unless enjoined by this Court, upon FDA approval of Cipla’s ANDA, Cipla will
`
`contributorily infringe one or more of claims 1–12 of the ’788 patent under 35 U.S.C. § 271(c)
`
`by making, using, offering to sell, selling, and/or importing Cipla’s Proposed Product in the
`
`United States. On information and belief, Cipla has had and continues to have knowledge that
`
`Cipla’s Proposed Product is especially adapted for a use that infringes one or more of claims 1–
`
`12 of the ’788 patent and that there is no substantial non-infringing use for Cipla’s Proposed
`
`Product.
`
`27.
`
`Celgene will be substantially and irreparably damaged and harmed if Cipla’s
`
`infringement of the ’788 patent is not enjoined.
`
`28.
`
`29.
`
`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 ’536 Patent
`
`30.
`
`31.
`
`Celgene repeats and realleges the foregoing allegations as if fully set forth herein.
`
`Cipla’s submission of its ANDA to obtain approval to engage in the commercial
`
`manufacture, use, offer for sale, sale, or importation into the United States of Cipla’s Proposed
`
`Product, prior to the expiration of the ’536 patent, constitutes infringement of one or more of
`
`claims 1–16 of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`32.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’536 patent.
`
`33.
`
`Unless enjoined by this Court, upon FDA approval of Cipla’s ANDA, Cipla will
`
`infringe one or more of claims 1–16 of the ’536 patent under 35 U.S.C. § 271(a) by making,
`
`using, offering to sell, selling, and/or importing Cipla’s Proposed Product in the United States.
`
`- 7 -
`
`

`

`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 8 of 132 PageID: 8
`
`34.
`
`Unless enjoined by this Court, upon FDA approval of Cipla’s ANDA, Cipla will
`
`induce infringement of one or more of claims 1–16 of the ’536 patent under 35 U.S.C. § 271(b)
`
`by making, using, offering to sell, selling, and/or importing Cipla’s Proposed Product in the
`
`United States. On information and belief, upon FDA approval of Cipla’s ANDA, Cipla will
`
`intentionally encourage acts of direct infringement with knowledge of the ’536 patent and
`
`knowledge that its acts are encouraging infringement.
`
`35.
`
`Unless enjoined by this Court, upon FDA approval of Cipla’s ANDA, Cipla will
`
`contributorily infringe one or more of claims 1–16 of the ’536 patent under 35 U.S.C. § 271(c)
`
`by making, using, offering to sell, selling, and/or importing Cipla’s Proposed Product in the
`
`United States. On information and belief, Cipla has had and continues to have knowledge that
`
`Cipla’s Proposed Product is especially adapted for a use that infringes one or more of claims 1–
`
`16 of the ’536 patent and that there is no substantial non-infringing use for Cipla’s Proposed
`
`Product.
`
`36.
`
`Celgene will be substantially and irreparably damaged and harmed if Cipla’s
`
`infringement of the ’536 patent is not enjoined.
`
`37.
`
`38.
`
`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 ’229 Patent
`
`39.
`
`40.
`
`Celgene repeats and realleges the foregoing allegations as if fully set forth herein.
`
`Cipla’s submission of its ANDA to obtain approval to engage in the commercial
`
`manufacture, use, offer for sale, sale, or importation into the United States of Cipla’s Proposed
`
`Product, prior to the expiration of the ’229 patent, constitutes infringement of one or more of
`
`claims 1–48 of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`- 8 -
`
`

`

`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 9 of 132 PageID: 9
`
`41.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’229 patent.
`
`42.
`
`Unless enjoined by this Court, upon FDA approval of Cipla’s ANDA, Cipla will
`
`infringe one or more of claims 1–48 of the ’229 patent under 35 U.S.C. § 271(a) by making,
`
`using, offering to sell, selling, and/or importing Cipla’s Proposed Product in the United States.
`
`43.
`
`Unless enjoined by this Court, upon FDA approval of Cipla’s ANDA, Cipla will
`
`induce infringement of one or more of claims 1–48 of the ’229 patent under 35 U.S.C. § 271(b)
`
`by making, using, offering to sell, selling, and/or importing Cipla’s Proposed Product in the
`
`United States. On information and belief, upon FDA approval of Cipla’s ANDA, Cipla will
`
`intentionally encourage acts of direct infringement with knowledge of the ’229 patent and
`
`knowledge that its acts are encouraging infringement.
`
`44.
`
`Unless enjoined by this Court, upon FDA approval of Cipla’s ANDA, Cipla will
`
`contributorily infringe one or more of claims 1–48 of the ’229 patent under 35 U.S.C. § 271(c)
`
`by making, using, offering to sell, selling, and/or importing Cipla’s Proposed Product in the
`
`United States. On information and belief, Cipla has had and continues to have knowledge that
`
`Cipla’s Proposed Product is especially adapted for a use that infringes one or more of claims 1–
`
`48 of the ’229 patent and that there is no substantial non-infringing use for Cipla’s Proposed
`
`Product.
`
`45.
`
`Celgene will be substantially and irreparably damaged and harmed if Cipla’s
`
`infringement of the ’229 patent is not enjoined.
`
`46.
`
`47.
`
`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.
`
`- 9 -
`
`

`

`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 10 of 132 PageID: 10
`
`Count IV: Infringement of the ’260 Patent
`
`48.
`
`49.
`
`Celgene repeats and realleges the foregoing allegations as if fully set forth herein.
`
`Cipla’s submission of its ANDA to obtain approval to engage in the commercial
`
`manufacture, use, offer for sale, sale, or importation into the United States of Cipla’s Proposed
`
`Product, prior to the expiration of the ’260 patent, constitutes infringement of the one or more of
`
`claims 1–27 of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`50.
`
`There is a justiciable controversy between the parties hereto as to the infringement
`
`of the ’260 patent.
`
`51.
`
`Unless enjoined by this Court, upon FDA approval of Cipla’s ANDA, Cipla will
`
`infringe one or more of claims 1–27 of the ’260 patent under 35 U.S.C. § 271(a) by making,
`
`using, offering to sell, selling, and/or importing Cipla’s Proposed Product in the United States.
`
`52.
`
`Unless enjoined by this Court, upon FDA approval of Cipla’s ANDA, Cipla will
`
`induce infringement of one or more of claims 1–27 of the ’260 patent under 35 U.S.C. § 271(b)
`
`by making, using, offering to sell, selling, and/or importing Cipla’s Proposed Product in the
`
`United States. On information and belief, upon FDA approval of Cipla’s ANDA, Cipla will
`
`intentionally encourage acts of direct infringement with knowledge of the ’260 patent and
`
`knowledge that its acts are encouraging infringement.
`
`53.
`
`Unless enjoined by this Court, upon FDA approval of Cipla’s ANDA, Cipla will
`
`contributorily infringe one or more of claims 1–27 of the ’260 patent under 35 U.S.C. § 271(c)
`
`by making, using, offering to sell, selling, and/or importing Cipla’s Proposed Product in the
`
`United States. On information and belief, Cipla has had and continues to have knowledge that
`
`Cipla’s Proposed Product is especially adapted for a use that infringes one or more of claims 1–
`
`27 of the ’260 patent and that there is no substantial non-infringing use for Cipla’s Proposed
`
`Product.
`
`- 10 -
`
`

`

`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 11 of 132 PageID: 11
`
`54.
`
`Celgene will be substantially and irreparably damaged and harmed if Cipla’s
`
`infringement of the ’260 patent is not enjoined.
`
`55.
`
`56.
`
`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.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Celgene respectfully requests the following relief:
`
`(A) A Judgment be entered that Cipla has infringed the patents-in-suit by submitting
`
`ANDA No. 209657;
`
`(B) A Judgment be entered that Cipla has infringed, and that Cipla’s making, using,
`
`offering to sell, selling, or importing Cipla’s Proposed Product, will infringe one or more claims
`
`of the patents-in-suit;
`
`(C) An Order be entered that the effective date of FDA approval of ANDA No.
`
`209657 be a date which is not earlier than the later of the expiration of the patents-in-suit, or any
`
`later expiration of exclusivity to which Celgene is or becomes entitled;
`
`(D)
`
`Preliminary and permanent injunctions be issued enjoining Cipla 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 Cipla’s Proposed Product until after the expiration of
`
`the patents-in-suit, or any later expiration of exclusivity to which Celgene is or becomes entitled;
`
`(E)
`
`A permanent injunction be issued, pursuant to 35 U.S.C. § 271(e)(4)(B),
`
`restraining and enjoining Cipla, its officers, agents, attorneys and employees, and those acting in
`
`privity or concert with them, from practicing any methods as claimed in the patents-in-suit, or
`
`from actively inducing or contributing to the infringement of any claim of the patents-in-suit,
`
`- 11 -
`
`

`

`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 12 of 132 PageID: 12
`
`until after the expiration of the patents-in-suit, or any later expiration of exclusivity to which
`
`Celgene is or becomes entitled;
`
`(F)
`
`A Judgment be issued that the commercial manufacture, use, offer for sale, sale,
`
`and/or importation into the United States of Cipla’s Proposed Product will directly infringe,
`
`induce and/or contribute to infringement of the patents-in-suit;
`
`(G)
`
`To the extent that Cipla has committed any acts with respect to the compositions
`
`and methods claimed in the patents-in-suit, other than those acts expressly exempted by 35
`
`U.S.C. § 271(e)(1), a Judgment be entered awarding Celgene damages for such acts;
`
`(H)
`
`If Cipla engages in the commercial manufacture, use, offer for sale, sale, and/or
`
`importation into the United States of Cipla’s Proposed Product prior to the expiration of the
`
`patents-in-suit, a Judgment be entered awarding damages to Celgene resulting from such
`
`infringement, together with interest;
`
`(I)
`
`A Judgment finding this to be an exceptional case pursuant to 35 U.S.C. § 285
`
`and awarding Celgene is attorneys’ fees incurred in this action;
`
`(J)
`
`A Judgment be entered awarding Celgene its costs and expenses incurred in this
`
`action; and
`
`(K)
`
`Such further and other relief as this Court may deem just and proper.
`
`- 12 -
`
`

`

`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 13 of 132 PageID: 13
`
`By: s/ Charles M. Lizza
`Charles M. Lizza
`William C. Baton
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiffs
`Abraxis BioScience, LLC and
`Celgene Corporation
`
`Dated: December 7, 2016
`
`Of Counsel:
`
`F. Dominic Cerrito
`Eric C. Stops
`Evangeline Shih
`Andrew S. Chalson
`Catherine T. Mattes
`QUINN EMANUEL URQUHART & SULLIVAN LLP
`51 Madison Avenue, 22nd Floor
`New York, New York 10010
`(212) 849-7000
`
`Anthony M. Insogna
`J. Patrick Elsevier, Ph.D.
`Cary Miller, Ph.D.
`JONES DAY
`12265 El Camino Real #200
`San Diego, CA 92130
`(858) 314-1200
`
`- 13 -
`
`

`

`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 14 of 132 PageID: 14
`
`CERTIFICATION PURSUANT TO L. CIV. R. 11.2
`
`I hereby certify that the matter in controversy involves the same plaintiffs and the same
`
`patents (United States Patent Nos. 7,820,788, 7,923,536, 8,138,229, and 8,853,260) that are at
`
`issue in the matter captioned Abraxis Bioscience, LLC, et al. v. Actavis LLC, No. 16-1925
`
`(JMV)(MF), which is currently pending in this Judicial District.
`
`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
`SAUL EWING LLP
`One Riverfront Plaza, Suite 1520
`Newark, New Jersey 07102-5426
`(973) 286-6700
`clizza@saul.com
`
`Attorneys for Plaintiffs
`Abraxis BioScience, LLC and
`Celgene Corporation
`
`proceeding.
`
`Dated: December 7, 2016
`
`Of Counsel:
`
`F. Dominic Cerrito
`Eric C. Stops
`Evangeline Shih
`Andrew S. Chalson
`Catherine T. Mattes
`QUINN EMANUEL URQUHART & SULLIVAN LLP
`51 Madison Avenue, 22nd Floor
`New York, New York 10010
`(212) 849-7000
`
`Anthony M. Insogna
`J. Patrick Elsevier, Ph.D.
`Cary Miller, Ph.D.
`JONES DAY
`12265 El Camino Real #200
`San Diego, CA 92130
`(858) 314-1200
`
`- 14 -
`
`

`

`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 15 of 132 PageID: 15
`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 15 of 132 PageID: 15
`
`
`
`
`
`EXHIBIT A
`
`EXHIBIT A
`
`

`

`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 16 of 132 PageID: 16
`case 2:16'CV'09074'JMV'MF ”mm“ filllfilllllllilllfllflfiflllllfllflllflllfillllllflllllilllllllllll 16
`
`USOO7820788B2
`
`(12) United States Patent
`US 7,820,788 B2
`(10) Patent N0.:
`Desai et al.
`
`(45) Date of Patent: Oct. 26, 2010
`
`5,731,355 A
`5,731,356 A
`5,886,026 A
`5,916,596 A
`5,945,033 A
`5,977,163 A
`5,990,153 A
`5,994,341 A
`5,997,904 A
`6,028,108 A
`6,096,331 A
`6,100,302 A
`6,120,805 A
`6,143,276 A
`6,147,122 A
`6,150,423 A
`6,177,477 B1
`6,197,051 B1
`6,197,349 B1
`6,204,054 B1
`6,306,993 B1
`6,310,039 B1
`6,326,406 B1
`6,362,234 B1
`6,399,087 B1
`6,441,025 B2
`
`3/1998 Jones et a1.
`3/1998 Jones et a1.
`3/1999 Hunter et a1.
`6/1999 Desai et a1.
`8/1999 Yen
`11/1999 Li et a1.
`11/1999 Wood et a1.
`11/1999 Hunter et a1.
`12/1999 Magdassi et a1.
`2/2000 George
`8/2000 Desai et a1.
`8/2000 Pejaver et a1.
`9/2000 Spenlehauer et a1.
`11/2000 Unger
`11/2000 Mirejovsky et a1.
`11/2000 Carpenter
`1/2001 George et a1.
`3/2001 Zhong
`3/2001 Westesen et a1.
`3/2001 Sutton et a1.
`10/2001 Rothbard et a1.
`10/2001 Kratz
`12/2001 De Tomaso
`3/2002 Hendler
`6/2002 Zhang et a1.
`8/2002 Li et a1.
`
`(Continued)
`FOREIGN PATENT DOCUMENTS
`
`EP
`
`0 227 593 Al
`
`7/1987
`
`(Continued)
`OTHER PUBLICATIONS
`
`Damascelli, B., et a1. 2001 Cancer 92(10): 2592-2602.*
`
`(Continued)
`
`Primary ExamineriMaryam Monshipouri
`Assistant ExamineriMarsha M Tsay
`(74) Attorney, Agent, or FirmiMorrison & Foerster, LLP
`
`(57)
`
`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 amount effective to
`reduce one or more side effects associated with administra-
`
`tion of the pharmaceutical composition. The invention also
`provides methods for reducing one or more side effects of
`administration of the pharmaceutical composition, methods
`for inhibiting microbial growth and oxidation in the pharma-
`ceutical composition, and methods for enhancing transport
`and binding of a pharmaceutical agent to a cell.
`
`12 Claims, No Drawings
`
`(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)
`
`(73) Assignee: Abraxis Bioscience, LLC, Los Angeles,
`CA (US)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 85 days.
`
`(21) Appl.No.: 11/553,339
`
`(22)
`
`Filed:
`
`Oct. 26, 2006
`
`(65)
`
`Prior Publication Data
`
`US 2010/0226996 A1
`
`Sep. 9,2010
`
`Related US. Application Data
`
`(63) Continuation of application No. 10/731,224, filed on
`Dec. 9, 2003.
`
`(60) Provisional application No. 60/432,317, filed on Dec.
`9, 2002, provisional application No. 60/526,544, filed
`on Dec. 3, 2003, provisional application No. 60/526,
`773, filed on Dec. 4, 2003, provisional application No.
`60/527,177, filed on Dec. 5, 2003.
`
`(51)
`
`Int. Cl.
`(2006.01)
`C07K 14/76
`(52) US. Cl.
`........................ 530/350; 977/779; 977/906
`(58) Field of Classification Search ............. 514/11712;
`435/7.2; 424/178.1; 530/350; 977/779,
`977/906
`
`See application file for complete search history.
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`1/1984 Yokoyama et a1.
`2/1987 Takahashi et a1.
`12/1993 Ueda et a1.
`11/1994 Desai et a1.
`3/1995 Liversidge et a1.
`8/1995 Desai et a1.
`3/1996 Grinstaff et a1.
`4/1996 Grinstaff et a1.
`4/1996 Grinstaff et a1.
`4/1996 Grinstaff et a1.
`10/1996 Soon-Shiong et a1.
`4/1997 Kaufman et a1.
`5/1997 Brem et a1.
`6/1997 Grinstaff et a1.
`6/1997 Grinstaff et a1.
`7/1997 Grinstaff et a1.
`7/1997 Brem et a1.
`9/1997 Grinstaff et a1.
`9/1997 Grinstaff et al.
`10/1997 Trissel
`2/1998 Jones et a1.
`2/1998 Hunter et a1.
`
`4,425,319 A
`4,645,660 A
`5,272,171 A
`5,362,478 A
`5,399,363 A
`5,439,686 A
`5,498,421 A
`5,505,932 A
`5,508,021 A
`5,512,268 A
`5,560,933 A
`5,616,330 A
`5,626,862 A
`5,635,207 A
`5,639,473 A
`5,650,156 A
`5,651,986 A
`5,665,382 A
`5,665,383 A
`5,681,846
`5,714,520
`5,716,981
`
`AAA
`
`

`

`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 17 of 132 PageID: 17
`Case 2:16-cv-09074-JMV-MF Document 1 Filed 12/07/16 Page 17 of 132 PagelD: 17
`
`US 7,820,788 B2
`
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`6,458,373
`6,469,069
`6,506,405
`6,528,067
`6,537,579
`6,565,842
`6,652,884
`6,743,826
`6,749,868
`6,753,006
`6,759,431
`7,119,124
`7,332,568
`2003/0185894
`2003/0187062
`2003/0199425
`2005/0004002
`2005/0009731
`2005/0064028
`2006/0073175
`2006/0083782
`2006/0121119
`2006/0199248
`2006/0257326
`2006/0263434
`2007/0020337
`2007/0082838
`2007/0087022
`2007/0092563
`2007/0093547
`2007/0116774
`2007/0117133
`2007/0117744
`2007/0117862
`2007/0117863
`2007/0128290
`2007/0129448
`2007/0166388
`2009/0098210
`2009/0263483
`
`B1
`B1
`B1
`B1
`B1
`B1
`B2
`B1
`B1
`B1
`B2
`B2
`B2
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`A1
`
`10/2002
`10/2002
`1/2003
`3/2003
`3/2003
`5/2003
`11/2003
`6/2004
`6/2004
`6/2004
`7/2004
`10/2006
`2/2008
`10/2003
`10/2003
`10/2003
`1/2005
`1/2005
`3/2005
`4/2006
`4/2006
`6/2006
`9/2006
`11/2006
`11/2006
`1/2007
`4/2007
`4/2007
`4/2007
`4/2007
`5/2007
`5/2007
`5/2007
`5/2007
`5/2007
`6/2007
`6/2007
`7/2007
`4/2009
`10/2009
`
`Lambert et a1.
`Mirejovsky et a1.
`Desai et a1.
`Magdassi et a1.
`Desai et a1.
`Sojomihardo et a1.
`Falciani
`Hegedus et a1.
`Desai et a1.
`Desai et a1.
`Hunter et a1.
`Hegedus et a1.
`Trieu et a1.
`Zenoni et a1.
`Zenoni et a1.
`Desai et a1.
`Desai et a1.
`Desai et a1.
`Hegedus et a1.
`Soon-Shiong et a1.
`Desai et a1.
`Zenoni et a1.
`Trieu et a1.
`Desai et a1.
`Desai et a1.
`Zenoni et a1.
`De et a1.
`Desai et a1.
`Desai et a1.
`Desai et a1.
`Desai et a1.
`Trieu et a1.
`Desai et a1.
`Desai et a1.
`Desai et a1.
`Desai et a1.
`Desai et a1.
`Desai et a1.
`Desai et a1.
`Desai et a1.
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`EP
`FR
`RU
`W0
`W0
`W0
`WO
`WO
`WO
`W0
`W0
`W0
`W0
`W0
`WO
`W0
`W0
`W0
`WO
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`W0
`
`0 544 292 A2
`0 544 292 A3
`2 775 900 A1
`2127606 C1
`WO 92/07259 A1
`WO 94/13300 A1
`WO 94/18954 A1
`WO-94/20072 A1
`WO-95/03036 A1
`WO-96/40829 A1
`WO 97/10850 A1
`WO 98/07410 A1
`WO 98/14174 A1
`WO 98/14175 A1
`WO 99/00113 A1
`WO-99/13914 A1
`WO 99/39696 A1
`WO 00/06152 A1
`WO 00/23117 A1
`WO-00/64437 A1
`WO 00/71079 A2
`WO 01/89522 A1
`W0 02/087545 A1
`W0 03/096944 A1
`WO 2004/007520 A1
`WO 2004/052401 A2
`WO 2004/052401 A3
`WO 2006/034147 A2
`
`6/1993
`6/1993
`9/1999
`3/1999
`4/1992
`6/1994
`9/1994
`9/1994
`2/1995
`12/1996
`3/1997
`2/1998
`4/1998
`4/1998
`1/1999
`3/1999
`8/1999
`2/2000
`4/2000
`11/2000
`11/2000
`11/2001
`11/2002
`11/2003
`1/2004
`6/2004
`6/2004
`3/2005
`
`W0
`W0
`W0
`
`WO 2006/034147 A3
`WO 2005/117952 A2
`WO 2005/117952 A3
`
`3/2005
`12/2005
`12/2005
`
`OTHER PUBLICATIONS
`
`Ibrahim, N., et a1. 2000 Proc Am Soc Clinc Oncol 19: abstract 609F
`(2 pages).*
`Altmayer, P. et a1. (1995). “Propofol Binding to Human Blood Pro-
`teins,”ArzneimittelForschung DrugResearch 45(II)(10):1053-1056.
`Calabresi, P et a1.
`(1996).
`Introduction of “Chemotherapy of
`Neoplastic Disease,” Section X in The Pharmacological Basis of
`Therapeutics, 9”“ ed., McGraW-Hill: NeWYork, pp. 1225-1230.
`Carter, D.C. et a1. (1994). “Structures of Serum Albumin,”Advances
`in Protein Chemistry. Schumaker, V.N., ed., Academic Press, Inc.:
`San Diego, CA, 45:153-203.
`Chuang, V. T. G. et al. (May 2002). “Pharmaceutical Strategies Uti-
`lizing Recombinant Human Serum Albumin,” Pharmaceutical
`Research 19(5):569-577.
`Curry et a1. (1998). “Crystal Structure of Human Serum Albumin
`Complexed With Fatty Acid Reveals an Asymmetric Distribution of
`Binding Sites,” Nature Structural Biology 5(9): 827-835.
`Curry, S. et a1. (Nov. 23, 1999). “FattyAcid Binding to Human Serum
`Albumin: New Insights From Crystallographic Studies,” Biochim.
`Biophys. Acta 1441(2-3):131-140.
`Fehske, K. J. et a1. (Jan. 1, 1981). “The Location of Drug Binding
`Sites in Human Serum Albumin,” Biochemical Pharmacologz
`30(1):687-692.
`Finlayson, J.S. (1980). “Albumin Products,” Seminars in Thrombosis
`and Hemostasis 6(2):85-120.
`Garrido, M.J. et a1. (1994). “Caracterizacion de la Fijacion de
`Propofol a las Proteinas Plasmaticas y Posibles Interacciones,” Rev.
`Esp