Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 1 of 20 Page 10 #:1
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`MAYER BROWN LLP
`MICHAEL A. MOLANO (SBN 171 057)
`mmolaoo@mayerbrown.com
`Two Palo Alto Square, Suite 300
`3000 El Camino Real
`Palo Alto, CA 94306-2112
`Telephone: (650) 331-2000
`Facsimile: (650) 331-2060
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`LISA FERRI (to be admitted pro hac vice)
`lferri@mayerbrown.com
`RICHARD MCCORMICK (to be admitted pro hac vice)
`rmccormick@mayerbrown.com
`1675 Broadway
`NewYork, NY 10016-5820
`Telephone: (212) 506-2500
`Facsimile:
`(212) 262-1910
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`Attorneys for Plaintiff
`BRISTOL-MYERS SQUIBB COMPANY
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`UNITED STATES DISTRICT COURT
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`FOR THE NORTHERN DISTRICT OF CALIFORNIA
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`~DR
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`BRISTOL-MYERS SQUIBB COMPANY,
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`Plaintiff,
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`v.
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`GENENTECH, INC. and CITY OF HOPE,
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`CASE NO.
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`Cl3-2045
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`COMPLAINT FOR DE CLARA TORY
`JUDGMENT
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`Defendants.
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`DEMAND FOR JURY TRIAL
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`Plaintiff Bristol-Myers Squibb Company ("Bristol-Myers Squibb") for its Complaint
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`against Genentech, Inc. ("Genentech") and City of Hope (collectively, "Defendants"), alleges as
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`follows:
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`NATURE OF THE CASE
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`ln this action, Bristol-Myers Squibb seek a declaration that U.S. Patent No.
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`6,331,415 entitled "Methods of Producing Immunoglobulins, Vectors and Transformed Host
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`CeJls for Use Therein" (the "Cab illy II Patent," attached as Exhibit A), including the Ex Parte
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`Reexamination Certificate issued pursuant to Reexamination Nos. 90/007,542 and 90/007,859
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`COMPLAINT FOR DEC LARA TORY JUDGMENT
`CASE NO.: - - - - -
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`Sanofi/Regeneron Ex. 1 057, pg 1263
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`Merck Ex. 1057, pg 1289
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`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 2 of 20 Page ID #:2
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`(attached as Exhibit B), and U.S. Patent No. 7,923,221 , entitled "Methods of Making Antibody
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`Heavy and Light Chains Having Specificity for a Desired Antigen" (the "Cabilly III Patent,"
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`attached as Exhibit C) are invalid and not infringed by the manufacture, use, sale, offer to sell, or
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`importation of: (1) Erbitux® (cetuximab), an antibody product that Bristol-Myers Squibb sells in
`the United States pursuant to a commercial agreement with ImClone Systems LLC ("lmClone"),
`a wholly owned subsidiary of Eli Lilly and Company ("Lilly"); and (2) Plaintiff's Yervoye
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`(ipilimwnab) antibody product, which it manufactures and sells in the United States. (The
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`Cabilly II patent and Cab illy lli patent are collectively referred to as the "CabilJy Patents.")
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`2.
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`Bristol-Myers Squibb brings this action to lift the cloud created by the imminent
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`threat of Defendants' enforcement of the Cabilly Patents against Plaintiff. Without declaratory
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`relief, the threat of enforcement of the CabiUy Patents poses a substantial risk to Plaintiff as well
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`as to patients, nurses and doctors now using Erbitux and Yervoy. The continued existence and
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`enforcement of these patents impedes not only the development and sale of Erbitux and Yervoy,
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`but also the development and sale of other life-saving recombinant antibody products.
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`3.
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`Defendants have asserted that the Cab illy Patents broadly cover the use of certain
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`16 well-known, conventional recombinant methods to produce any antibody product in any type of
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`host cell. For example, according to Sean Johnston, then Genentech's Vice President of
`Intellectual Property, "[t]he recently issued [Cabilly IIJ patent broadly covers the co-expression
`of immunoglobulin heavy and light chain genes in a single host cell ... We do not believe that
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`the claims are limited by type of antibody (murine, humanized, or human) or by host cell type."
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`See Debra Robertson, "Genentech Awarded Critical Antibody Patent," Nature Biotechnology,
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`vol. 20, p. 108 (Feb. 2002) (attached as Exhibit D).
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`4.
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`Defendants have filed multiple infringement claims under the Cabilly Patents
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`against companies who have made and sold antibody products that, on information and belief,
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`25 were produced using recombinant methods similar to the methods used to make Erbitux and
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`26 Yervoy.
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`5.
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`In public statements, Genentech has specifically identified Erbitux as a potential
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`competitor to one ofGenentech's own antibody products, Avastin. See Genentech,lnc., 2008
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`COMPLAINT FOR DECLARATORY JUDGMENT
`CASE NO. : - - - - -
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`Sanofi/Regeneron Ex. 1 057, pg 1264
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`Merck Ex. 1057, pg 1290
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`

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`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 P.age 3 of 20 Page ID #: 3
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`I 0-K Annual Report (2-20-2009), retrieved ftom SEC EDGAR, at 13. On information and
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`belief, Genentecb's pipeline antibody product MPDL3280A is presently in clinical trials to test
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`its safety and effectiveness for the treatment of melanoma, non-small-cell lung carcinoma and
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`renal cell carcinoma. These indications overlap with those for Plaintitrs Yervoy product, which
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`is approved by the FDA for melanoma.
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`6.
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`Genentech bas stated that it expects to be involved in future litigations relating to
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`the enforcement of the Cab illy II patent. See Genentech, Inc., 2008 1 0-K Annual Report (2-20-
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`2009), retrieved from SEC EDGAR, at 25 , 39. The tenn of both of the Cabilly Patents expires in
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`9 December 2018.
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`7.
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`Given Defendants' past acts and statements, as set forth in further detail below,
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`the manufacture and sale ofErbitux and Yervoy in the United States creates a real, immediate
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`and substantial dispute between the parties concerning the Cabilly Patents, for which Bristol-
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`13 Myers Squibb now seeks declaratory relief.
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`PARTIES
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`8.
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`Bristol-Myers Squibb is a company organized and existing under the laws of the
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`State of Delaware, having its principal place ofbusiness at 345 Park Avenue, New York, New
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`17 York I 0154. Bristol-Myers Squibb maintains a research and development facility in Redwood
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`18 City, California, that houses biologics drug discovery activities focused on antibody therapeutics.
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`19 Bristol-Myers Squibb employs over 150 scientists at its Redwood City facility .
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`9.
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`On information and belief, Defendant Genentech, Inc. is a corporation duly
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`organized and existing under the laws of the State of Delaware, having its principal place of
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`business at 1 DNA Way, South San Francisco, California 94080-4990.
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`10.
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`On infonnation and belief, Defendant City of Hope is a California not-for-profit
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`organization duly organized and existing under the laws of the State of California, having its
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`principal place of business in Duarte, California. On information and belief, City of Hope has a
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`place of business in this District at 55 Hawthorne Street, Suite 450, San Francisco, California
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`94105.
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`COMPLAINT FOR DEC LARA TORY JUDGMENT
`CASE NO . : - - - - -
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`Sanofi/Regeneron Ex. 1057, pg 1265
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`Merck Ex. 1057, pg 1291
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`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 4 of 20 Page ID #:4
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`11.
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`On infonnation and belief, Genentech and City of Hope are co-assignees of the
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`2 Cabilly Patents.
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`JURISDICTION AND VENUE
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`12.
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`This action arises under the Declaratory Judgment Act of 1934 (28 U.S.C. §§
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`2201-2202), Title 28 of the United States Code, for the purposes of detennining an actual and
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`justiciable controversy between the parties, and the patent laws of the United States, Title 35 of
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`the United States Code. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331
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`and 1338(a).
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`13.
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`This Court has personal jurisdiction over Genentech based on ils principal place
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`of business in California. This Court has personal jurisdiction over City of Hope based on its
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`organization under the !aws of the State of California and because its principal place of operation
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`is in California.
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`14.
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`Venue is proper in this District pursuant to 28 U.S.C. § 1391 because both
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`14 Defendants reside in this District and because a substantial part of the events or omissions giving
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`rise to the claims occurred in this District.
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`INTRADISTRICT ASSIGNMENT
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`15.
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`Pursuant to Civil L.R. 3-2(c), this intellectual property action shall be assigned on
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`a district-wide basis.
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`RELATED CASE
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`16.
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`This action concerns substantially the same parties, property, transactions and/or
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`events as another action filed and presentl y pending in this District (Oakland Division), Eli Lilly
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`and Company and fmC/one Systems LLC v. Genentech, Inc. and City of Hope, Case No. CV13-
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`0919 (YGR). There will therefore be an unduly burdensome duplication oflabor and expense or
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`conflicting results if the cases are conducted before different Judges in this District.
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`THE CABILL Y PATENTS
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`17.
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`On April 8, 1983, Shmuel Cabilly, Herberl Heyneker, William Holmes, Arthur
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`27 Riggs, and Ronald Wetzel (collectively, the "Cabilly Applicants") filed a patent application in
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`the United States Patent and Trademark Office ("PTO") that issued on March 28, 1989, as U.S.
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`COMPLAINT FOR DEC LARA TORY JUDGMENT
`CASE NO . : - - - - -
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`Sanofi/Regeneron Ex. 1057, pg 1266
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`Merck Ex. 1057, pg 1292
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`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 5 of 20 Page ID #:5
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`Patent No. 4,8 I 6,567 (the "Cabilly J Patent"). On its face, the Cab illy I Patent is assigned to
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`2 Genentech and, by certificate of correction, is also assigned to City of Hope. The Cabilly I
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`patent expired on March 28, 2006.
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`18.
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`At the time the Cabilly I Patent issued, the Cabilly Applicants had a continuation
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`application pending in the PTO, which issued on December 18, 200 I, as the Cabilly II Patent.
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`6 On its face, the Cabilly II Patent is assigned to Genentech and, by certificate of correction, is also
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`assigned to City ofHope.
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`19.
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`At the time the Cabilly ll Patent issued, the CabiUy Applicants had a continuation
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`application pending in the PTO, which issued on April 12, 2011, as the Cabilly HI Patent. The
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`I 0 Cabilly III Patent is assigned to Genentech and City of Hope.
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`20.
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`The Cabilly II Patent and Cabilly Ill Patent relate to recombinant techniques for
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`12 manufacturing antibody therapeutics. Both patents claim priority to the Cabilly I Patent
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`application, filed on April 8, 1983, in the early days of monoclonal antibodies.
`The Cabilly n Patent was the subject of a nine-year patent interference and two
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`reexaminations. The Cabilly III Patent has also been through a patent interference.
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`22.
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`The nine-year Cabilly II Patent interference caused the claims of the Cabilly II
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`Patent to have an effective patent life of 3 5 years after the date the Cab illy I Patent application
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`18 was filed, with an expiration date on December 18, 2018. The Cab illy III Patent is subject to a
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`terminal disclaimer, and thus the Cabilly III Patent claims will have the same expiration date as
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`the Cabilly II Patent claims.
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`BRISTOL-MYERS SQUIBB'S AND LILLY'S ERBITUX®
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`{CETUXJMAB> PRODUCT
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`23.
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`Erbitux"' (cetuximab) is a recombinant, mouse/human chimeric monoclonal
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`antibody that binds to the extracellular domain of human epidermal growth factor receptor
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`("EGFR"). Erbitux was ftrst approved by the FDA in 2004 for the treatment of colorectal cancer
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`and, in 2006, for the treatment of head and neck cancer.
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`24.
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`Erbitux was initially developed by ImCione. Lilly, through its wholly owned
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`subsidiary lmClone, has a commercial agreement with Bristol-Myers Squibb relating to Erbitux.
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`COMPLAINT FOR DECLARATORY JUDGMENT
`CASE·NO.: ____ _
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`Sanofi/Regeneron Ex. 1 057, pg 1267
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`Merck Ex. 1057, pg 1293
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`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 6 of 20 Page ID #:6
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`Lilly is responsible for the manufacture and supply of all requirements of Erbitux in bulk-form
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`active pharmaceutical ingredient ("API") for clinical and commercial use in the United States
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`and Canada. Bristol-Myers Squibb purchases all of its requirements of API for commercial use
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`from Lilly and exclusively sells Erbitux in the United States and Canada.
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`25.
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`FoUowing FDA approval, Bristol-Myers Squibb, in partnership with lmClone and
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`6 Lilly, began marketing and selling Erbitux in the United States, physicians began prescribing
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`7 Erbitux and patients began taking Erbitux to treat the above-mentioned forms of cancer.
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`26.
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`Bristol-Myers Squibb, along with Lilly, has expended substantial revenues
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`researching and developing Erbitux. Bristol-Myers Squibb also has expended substantial
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`revenues launching and commercializing Erbitux.
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`27.
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`On January 25, 2005, ImClone entered into an agreement v.ith Genentech under
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`12 which it received, inter alia, a non-exclusive license to the Cabilly Patents to make, have made,
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`use, sell and have sold, offer for sale, import and export products which, but for the license, may
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`infringe one or more claims ofthe Cabilly Patents (the "lmCione-Genentech Agreement"). On
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`information and belief, as a result of Lilly's acquisition oflmClone in 2008, Lilly became a
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`licensee to the Cabilly Patents and remains a licensee to date. On information and belief,
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`lmClone, and now Lilly, has paid, and Genentech has accepted, royalties on sales ofErbitux.
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`18 Based on the commercial agreement between Bristol-Myers Squibb and ImClone relating to
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`19 Erbitux, Bristol-Myers Squibb, through Lilly, has paid, and Genentech has accepted, royalties on
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`sales of Erbitux.
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`28.
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`There is an actual and justiciable controversy between Bristol-Myers Squibb and
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`22 Defendants with respect to whether making, using, and selling Erbitux infringes any valid claim
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`of the Cabilly Patents.
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`BRJSTOL-.MYERS SQUIBB'S
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`YERVOv® (lPILIMUMAB> PRODUCT
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`29.
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`Yervoy~ (ipilimumab) is a recombinantly engineered fully human antibody that
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`binds to cytotoxic T-lymphocyte antigen 4 ("CTLA-4"). Yervoy was first approved by the FDA
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`in 2011 for the treatment of patients with unresectable or metastatic melanoma.
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`COMPLAINT FOR DECLARATORY JUDGMENT
`CASE NO . : - - - - -
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`Sanofi/Regeneron Ex. 1 057, pg 1268
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`Merck Ex. 1057, pg 1294
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`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 7 of 20 Page ID #:7
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`30.
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`Yervoy binds to CTLA-4 and inhibits the interaction ofCTLA-4 with its ligands,
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`2 CD80/CD86. Blocking CTLA-4 has been shown to augment T -cell activation and proliferation,
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`3 which, in turn, initiates aT-cell mediated anti-tumor immune response. Following FDA
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`approval, Bristol-Myers Squibb began marketing and selling Yervoy in the United States,
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`5 physicians began prescribing Yervoy and patients began taking Yervoy to treat unresectable or
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`6 metastatic melanoma.
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`31.
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`Bristol-Myers Squibb has expended substantial revenues researching and
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`developing Yervoy. Bristol-Myers Squibb also has expended substantial revenues launching and
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`commercializing Yervoy.
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`32.
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`Yervoy was initially developed by Medarex, Inc. in Milpitas and Sunnyvale,
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`11 California. Documents associated with the creation, design and development ofYervoy are now
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`located in Bristol-Myers Squibb's facility in Redwood City, California, as are many ofthe
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`scientists who were involved in the creation, design and development ofYervoy. ln particular,
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`three inventors on a U.S. patent covering Yervoy are presently in Redwood City.
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`33.
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`On October 25, 2004, Medarex, Inc. entered into an agreement with Genentech
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`under which it received, inter alia, a non-exclusive license to the Cabilly Patents to make, have
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`17 made, use, sell, offer for sale, and import products which, but for the license, may infringe one or
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`18 more claims of the Cabilly Patents (the "Medarex-Genentech Agreement'). As a result of
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`19 Bristol-Myers Squibb's acquisition of Medarex, Inc. in 2009, Bristol-Myers Squibb became a
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`licensee to the Cabilly Patents.
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`34.
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`Bristol-Myers Squibb has paid, and Genentech has accepted, royalties on sales of
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`22 Yervoy.
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`35.
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`There is an actual and justiciable controversy between Plaintiff and Defendants
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`24 with respect to whether making, using, and seUing Yervoy infringes any valid claim ofthe
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`25 Cabilly Patents.
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`PLAINTIFF'S DISPUTE WJTH GENENTECH
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`REGARDING THE CABILLY PATENTS
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`COMPLAINT FOR DECLARATORY JUDGMENT
`CASE NO. : - - - - -
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`Sanofi/Regeneron Ex. 1 057, pg 1269
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`Merck Ex. 1057, pg 1295
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`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 8 of 20 Page ID #:8
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`36.
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`Through its statements and actions, Genentech has made clear to the
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`biopharmaceutical industry generally, and to Plaintiff in particular, that it contends that the
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`claims of the Cab illy Patents effectively preclude others from commercially manufacturing
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`recombinant monoclonal antibodies without Genentech' s permission. In 2002, after the Cabilly
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`II Patent issued, Sean Johnston, then Genentech's Vice President of Intellectual Property and
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`now Genentech's Senior Vice President and General Counsel said:
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`"The recently issued patent broadly covers the co-expression of immunoglobulin
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`heavy and light chain genes in a single host cell .. , We do not believe that the
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`claims are limited by type of antibody (murine, humanized [90% human
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`sequence], or human) or by host cell type."
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`"Genentech Awarded Critical Antibody Patent," Nature Biotechnology, vol. 20, p. 108 (Feb.
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`2002) (Exhibit D).
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`37.
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`According to Defendants, the manufacturing method claimed in the Cabilly Il
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`Patent is ''the backbone ofrecombinant production in the biotech industry." Centocor, Inc. v.
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`15 Genentech, Inc., Case No. 08-cv-03573 (C.D. Cal.) (Opening Brief of Claim Construction,
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`16 March 24, 2009, at 2), Docket No. 78.
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`38.
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`In its 2008 Annual Report I 0-K filing with the Securities and Exchange
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`18 Commission, Genentech made public statements about pursuing an aggressive litigation policy to
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`protect its products against competition and to protect against infringement of the Cab illy
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`Patents:
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`"Intellectual property protection of our products is crucial to our business. Loss
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`of effective intellectual property protection could resull in lost sales to competing
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`products and loss of royalty payments (for example, royalty income associated
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`with the Cabilly patent) from licenses. We are often involved in disputes over
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`contracts and intellectual property, and we work to resolve these disputes in
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`confidential negotiations or litigation. We expect legal challenges in this area to
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`continue. We plan to continue to build upon and defend our intellectual property
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`position." (Emphasis added).
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`COMPLAINT FOR DECLARATORY JUDGMENT
`CASE NO.: - - - - - -
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`Sanofi/Regeneron Ex. 1 057, pg 1270
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`Merck Ex. 1057, pg 1296
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`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 9 of 20 Page ID #:9
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`Genentech also states: "We have in the past been, are currently, and may in tbe futu re be
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`involved in material litigation and other legal proceedings related to our proprietary rights,
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`such as tbe Cabilly patent litigation .... " (Emphasis added).
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`39.
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`Oenentech has asserted the Cabilly Patents in litigation against other
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`5 manufacturers of recombinant monoclonal antibodies, including Medlmmune, Inc.
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`("Medlmrnune"), Centocor Inc. ("Centocor"), GlaxoSmithKline LLC ("GSK''), and Human
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`7 Genome Sciences Inc. ("HGS"). On information and belief, the recombinant methods used to
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`produce Erbitux and Yervoy are similar to the methods used by Medlmmune, Centocor, GSK
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`and HGS to produce the monoclonal antibody products that were the subject of those parties'
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`respective infringemenllav.rsuits concerning the Cab illy Patents.
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`40.
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`On infonnation and belief, Genentech contends that the process and certain
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`starting materials used to produce Erbitux and Yervoy infringe one or more claims of the Cabilly
`
`Patents.
`
`41.
`
`For example, the Erbitux and Yervoy antibody products (on the one hand) and
`
`12
`
`13
`
`14
`
`15 Medimmune's Synagise, Cenlocor's ReoPro®, GSK's Arzerra®, and GSK's and HGS's
`
`16 Benlysta® antibody products (on the other hand) are all made by genetically engineering
`
`17 mammalian host cells to produce the desired antibody in cell culture.
`
`18
`
`42.
`
`On further information and belief, Synagis, ReoPro, Arzerra and Benlysta are
`
`19 manufactured using the same or similar transformation and manufacturing processes that are
`
`20
`
`used to manufacture Erbitux and Yervoy.
`
`21
`
`43 .
`
`On information and belief, Genentech has alleged that the corresponding
`
`22
`
`recombinant methods and starting materials used to produce its Avastin®, Herceptin® and
`
`23 Rituxan® antibody products fall within the scope of the Cabilly Patents. Like Erbitux and
`
`24 Yervoy, on information and belief, Genentech's Avastin, Herceptin and Rituxan are made by
`
`25
`
`genetically engineering manunalian host cells to produce the desired antibody in cell culture. If
`
`26 Genentech contends that the manufacturing process to produce Avastin, Herceptin and Rituxan
`
`27
`
`falls within the scope of the Cabilly Patents, then Plaintiff is informed and believe that
`
`28
`
`-9-
`
`COMPLAINTFORDECLARATORY JUDGMENT
`CASE NO.: ____ _
`
`Sanofi!Regeneron Ex. 1 057, pg 1271
`
`Merck Ex. 1057, pg 1297
`
`

`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 10 of 20 Page ID #:10
`
`Genentech also contends that the manufacturing process used to produce Erbitux and Yervoy for
`
`2 Plaintiff also falls within the scope of the Cab illy Patents.
`
`3
`
`4
`
`5
`
`44.
`
`Because Defendants have consistently alleged that the use of well-known,
`
`conventional recombinant methods to produce monoclonal antibodies in mammalian cell culture
`
`is within the scope of the Cabilly Patents and have asserted the Cabilly Patents against others
`
`6 who are similarly situated to Plaintiff, Defendants' prior statements and conduct necessarily
`
`7
`
`8
`
`9
`
`10
`
`1 1
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`establish an actual and substantial dispute between Plaintiff and Defendants regarding the
`
`invalidity and non-infringement of the claims of the Cabilly Patents. Therefore Plaintiff has a
`
`reasonable apprehension of suit by Genentech and City of Hope regarding the Cabilly Patents.
`
`FIRST CAUSE OF ACTION
`
`THE CABILL Y PATENTS ARE INVALID
`
`45 .
`
`Plaintiff incorporates the allegations of paragraph 1 through 44 as if fully set forth
`
`herein.
`
`46.
`
`An actual controversy has arisen and now exists between the parties concerning
`
`the validity of the Cabilly Patents.
`
`47.
`
`The Cabilly Patents are invalid because they are anticipated and/or obvious under
`
`35 U.S.C. §§ 102 and 103.
`
`48.
`
`The Cabilly Patents are invalid based on the judicially created doctrine of
`
`obviousness-type double patenting and/or under 35 U.S.C. §§ 101 and/or I 03.
`
`49.
`
`50.
`
`The Cabilly Patents are additionally invalid under 35 U.S.C. § 112.
`
`Plaintiff seeks a declaratory judgment that the Cabilly Patents are invalid under 35
`
`22 U.S.C. §§ 101, 102, 103 and 112 and/or based on the judicially created doctrine of obviousness-
`
`type double patenting.
`
`SECOND CAUSE OF ACTION
`
`THE CABILLY PATENTS ARE NOT INFRINGED
`
`51.
`
`Plaintiff incorporates the allegations of paragraph 1 through 50 as if fully set forth
`
`herein.
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`-10-
`
`COMPLAINT FOR DECLARATORY JUDGMENT
`CASE NO.: ____ _
`
`Sanofi/Regeneron Ex. 1 057, pg 1272
`
`Merck Ex. 1057, pg 1298
`
`

`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 11 of 20 Page ID #:11
`
`52.
`
`An actual controversy has arisen and now exists between the parties concerning
`
`2 whether the manufacture or sale of Erbitux and Yervoy antibody products infringes any valid and
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`enforceable claim of the Cabilly Patents.
`
`53.
`
`Plaintiff seeks a declaratory judgment that the making, using, importing, offering
`
`to sell, and selling of the Erbitux and Yervoy antibody products do not and will not infringe any
`
`valid and enforceable claim of the Cab illy Patents.
`
`THIRD CAUSE OF ACTION
`
`BRISTOL-MYERS SQUIBB OWES NO ROYALTIES
`
`54.
`
`Plaintiff incorporates the allegations of paragraph 1 through 53 as if fully set forth
`
`herein.
`
`55.
`
`An actual controversy has arisen and now exists between the parties concerning
`
`12 whether Plaintiff has any obligation to pay royalties to Defendants and/or whether Plaintiff is
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`entitled to recoup royalties paid to Defendants if the Cabilly Patents are deemed to be invalid
`
`and/or Wlenforceable.
`
`56.
`
`If the Cabilly Patents are declared to be invalid, Plaintiff is entitled to a
`
`declaratory judgment that it owes no royalties to Genentech and/or City of Hope.
`
`PRAYER FOR RELIEF
`
`WHEREFORE Plaintiff requests that judgment be entered in favor of Plaintiff and
`
`against Defendants Genentech, Inc. and City of Hope:
`
`a)
`
`Declaring that Plaintiff does not infringe any valid and enforceable claim of the
`
`21 Cabilly Patents;
`
`22
`
`23
`
`24
`
`25
`
`26
`
`b)
`
`c)
`
`Declaring the Cabilly Patents invalid;
`
`Declaring that the manufacture, use, sale, offer to sell, or importation of Erbitux
`
`and Yervoy antibody products do not infringe any valid and enforceable claim ofthe Cabilly
`
`Patents;
`
`d)
`
`Awarding Plaintiff damages at least equivalent to any amounts received by
`
`27 Genentech and/or City of Hope as royalties or other license fees due on accoWlt of the CabiUy
`
`28
`
`Patents;
`
`-11-
`
`COMl'LATNT FOR DECLARATORY JUDGMENT
`CASE NO . : - - - - -
`
`Sanofi/Regeneron Ex. 1 057, pg 1273
`
`Merck Ex. 1057, pg 1299
`
`

`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 12 of 20 Page ID #:12
`
`e)
`
`f)
`
`g)
`
`Enjoining Genentech, Inc. and City of Hope from enforcing the Cabilly Patents;
`
`Awarding Plaintiff its costs and attorneys' fees;
`
`Declaring Plaintiff's case to be exceptional and awarding Plaintiff its attorneys'
`
`fees and expenses under 35 U.S. C. § 285; and
`
`h)
`
`Awarding Plaintiff such other relief as the Court deems just and proper.
`
`DEMAND FOR JURY TRIAL
`
`Pursuant to Rule 38(b) of the Federal Rules of Civil Procedure, Plaintiff demands a trial
`
`by jury of all issues so triable.
`
`Dated: May 3, 2013
`
`Respectfully submitted,
`
`MAYER BROWN LLP
`
`By'-" .. '--" \.
`
`MICHAEL A. MOLANO
`
`Attorneys tbr Plaintiff
`Bristol-Myers Squibb Company
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16 OfCounsel:
`
`17 LISA FERRI (to be admitted pro hac vice)
`RICHARD MCCORMICK (to be admitted pro hac vice)
`18 MAYER BROWN LLP
`1675 Broadway
`19 New York, NY 10016-5820
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`-12-
`
`COMPLAINT FOR DECLARATORY JUDGME T
`CASE NO.: - - - - -
`
`Sanofi/Regeneron Ex. 1 057, pg 127 4
`
`Merck Ex. 1057, pg 1300
`
`

`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 13 of 20 Page ID #:13
`
`Sanofi/Regeneron Ex. 1 057, pg 127 5
`
`Merck Ex. 1057, pg 1301
`
`

`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 14 of 20 Page ID #:14
`
`EXHIBIT A
`
`Sanofi/Regeneron Ex. 1 057, pg 1276
`
`Merck Ex. 1057, pg 1302
`
`

`
`Case 2:13-cv-05400-MRP-JEM
`
`cu> United States Patent
`Cabilly et al.
`
`(tO) Patent No.:
`(45) Date of Patent:
`
`US 6,331,415 Bl
`Dec. 18. 2001
`
`(54) METHODS OJo' I'RODUCJNG
`IMMUNOGLOBUUNS, VECTORS AND
`TRANSFORMED HOST CELLS FOR USE
`THI':RErN
`
`(75)
`
`loveatorS: Shmuel Cabllly, Monrovia; Herbert L.
`Heyneker, Burlinpme; William E.
`Holmes, PaciJica; Arthur D. Riggs, La
`Verne; Ronald B. Wetzel, San
`Francisco, all of CA (US)
`
`(73) Assigoee: Genentecll. Inc., South San Frmcisco,
`CA(US)
`
`( • ) Notice:
`
`Sut>jcctiO any disclaimer, !he term of lbis
`pateol is extended or adjusted U.llder 35
`U.S.C. 154{b) t>y 0 days.
`
`(21) Appl. No.: 07/20!,419
`Jun. 10, 1988
`(22) Filed:
`
`Related U.S. Application Dota
`
`(63) Contimlalioo of .oppllaatioa No. 061483,457, fikd on Ajl<. 8,
`11183, AOW Pat. No. 4,816,567.
`
`(51)
`
`Inl. Cl.? ........ --.-- ........ CUN 15113; CL2N 15/00;
`C12N 15/63
`
`(52) U.S. Cl . ................... - 43!/69.6; 435/69.1; 435/69.7;
`435(70.1; 435n0.2l; 435(71.1; 435(71.2;
`4351320; 435/252.1; 435/252.3; 435!252.33;
`·435/254.11; 435/254.2; 435/254.21; 435/455;
`435/471; 435/4&3; 435/485
`
`.... ............. .. 435/69.1, 69.7,
`(58) Field of Seardl ........ -
`435/11.1, 70.1, 71.2, 320.261. 252.1, 252.3,
`81, 55, 56. 69.6, 252.33, 254.21, 483
`
`(56)
`
`Re!eren<ti Cited
`U.S. PATENT DOCUMENTS
`
`11/1979 Davis d al . .
`4,179,337
`12/19111 Co~ .
`4,237,224
`7{1982 Gilbort et al ..
`4,338,397
`8/1982 Ooeddel d al . •
`4,342,832
`9/1983 Hanley et al ..
`4,403,006
`4/1984 Paulu1 .
`4,4'14,878
`4/1985 POJI<s d al . •
`4,510,244
`4/1985 Joneo d .ol . •
`4,512,922
`5/1985 Mort d til..
`4,518,584
`2/1987 Moore <1111 . •
`4,642,334
`U/1987 llalnu• <.1 al ..
`4,704,362
`3/191!9 Doss et Ill . .
`4,816.397
`3/191!9 Cabilly et a[. .
`4,816,567
`5,215,539
`1/1993 Winter .
`811996 Page .
`5,545,403
`5,545,404
`8/1996 Page .
`811996 Page .
`5,545,405
`FOREIGN PATENT DOCUMENTS
`
`19498'2
`12417183
`B-26429/84
`46556/SS
`65981/86
`00:17723
`
`2/1983 (AU) .
`9/1983 (AU) .
`10/1984 (AU) .
`3{1986 (AU) .
`S/1987 (AU) .
`10)1981 (EP) '
`
`317Z3
`041313
`041767
`41313
`41767
`044m
`055945
`57107
`0068763
`68763
`0057107
`0073656
`015444
`73656
`75444
`A-0736$6
`088994
`88994
`003619
`0120694
`0125(]23
`194276
`196864
`Zl4S92
`2556!14
`324162
`550400
`08235
`62 201 581
`wo 116,01533
`
`10/1981 (EP) •
`12/1981 (EP) .
`12/1981 (EP) .
`11/1981 (EP) .
`11/1981 (EP) .
`l/1982 (EP)
`7/1982 (EP) '
`11/1.982 (EP) .
`1/l'l83 (EP) .
`l /1983 (EP) .
`3/1983 (I!P) .
`3/1983 (I!P) .
`3/1983 (I!P) .
`3/1983 (I!P) .
`3/1983 (EP) .
`3/1983 (HI').
`9/1983 (EP) •
`9/1983 (EP) .
`11/1983 (EP) .
`10/1984 (EP) .
`11/1984 (EP) .
`9/1986 (EP) .
`1.0/1986 (EP) .
`ll/1!187 (EP) .
`2/1988 (EP) .
`7/1989 (EP) '
`7/1993 (EP)'
`3/1987 (GB) •
`9/1987 (JP) •
`311986 (WO) .
`
`OTHER PUBUCATIONS
`
`Dolby et al Proc. Nall. Mad. Sci. 77(10): 6027~031
`(1980).
`Rice el al. Proc. Narl. Acad. Sci. 77:7862--7865 (1982).
`Accolla et •L Proc. NarL Acad. Sci. 77(1):563-566 (1980).
`Raso el ll. CIUICI!r Res. 41:2073-2078 (198!).
`Nisonotr el a.l. Arch. Bicchem. Biopllys. 93:460-462 (1960).
`Glcn.nic e1 Ill. Nature 295:712--714 {1982).
`Eisen Immunology Hlll'pcr &. Row, Publisbers, pp. 415 l.lld
`428-<t36 (1974).
`Hozumi et al Nuc. Ac:idr. Res. 5(6):1779-1799 (1978).
`Wetzel eta!. Gl!lll! !6:63-71 (1981).
`Williams el II]. Science 215:687-<>89 (1982).
`Fallaler et 1!. NaJrJ.re 298:286-288 (1982).
`Boss e t a!. Geni! ~ons-Proc. Cerw-UCLA Sympo·
`sium pp. 513-522, Mar. 26-Apr. 1, 1983.
`
`(List continued oa next page.)
`
`Primary E:mml.vr-Phillip Gatnbcl
`(74) Auarney, Agent, or Firm--Bums, Doane,. Swecker &
`Mathis, UP
`
`(5 7)
`
`ABSTRACf
`
`The invention rel•tcs 10 proCCiiSCS for producing ao immu·
`ooglot>ulin or ~o immunolo!Pca.lly functional immuooglo(cid:173)
`bwin flllgmeot cootaillini al least tbc variable doma.ins of
`tbe irnml1lloglobulin heavy and ligbt cbains. The processu
`ca.o u.se one or more vectot'll wbicb prod""" both tile bcavy
`aDd light chains or flagmeots thcrcor i n a single ceU. 'J'bc
`invention also relates to lbc vectors used 10 produce the
`immuooglobulin or fragment, and 10 ceiJs t.r.asfurmed wil.h
`the vectors.
`
`36 Clalrns, 19 Drawing Sheets
`
`Sanofi/Regeneron Ex. 1 057, pg 1277
`
`Merck Ex. 1057, pg 1303
`
`

`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 16 of 20 Page ID #:16
`
`US 6,331,415 Bl
`Paa-2
`
`OTIIER PUBUCKIJONS
`
`A=;ter et al. Nucleic Acid Researrh 8(9}:2DSS-2065 (1980).
`DeBoer et a.l., Rodriguez et al. (Ed.) Promoters %2--481
`(1982).
`Gough Tlbs 6(8):2.03-205 {Aug., 1981).
`Morrison J. of lmntUIJbiogy 123(2):793~00 (Aug., 1979).
`Kohler Proc. NatLAcad. Sci. n(4):2197-2199 (Apr.,l980).
`Roberts Promoters 452-461 (1982).
`~mp et al. Proc. Nail. Acad. Sci. 78(7);4520-4524 (Jul.,
`1981).
`Valle et al. Nmure 300:71- 74 (NOY. 4, 1982}.
`Microbiology 3rd editioq, Haper Lot. Ed. 338-379 (1980).
`Hilzema.n cl al. Sdence 219:62.0-{;25 (1983).
`Mercerca~jaloa ct al. in Exp~ioo o[ Eub.ryotic VU"al
`I.Dd Cellular Genes, Pcnerssoo et al . (ED) 295-303 (1981)
`Academic Press.
`Peucrsmn et al. {Ed.) 295-303 (1981) Academic Pr.
`Kcshct ct al. Nucleic Acid~ Res. 9