`DANIEL JOHNSON, JR. (SBN 57409)
`MICHAEL J. LYONS (SBN 202284)
`MICHAEL F. CARR (SBN 259911)
`WALTER SCOTT TESTER (SBN 287228)
`2 Palo Alto Square
`3000 El Camino Real, Suite 700
`Palo Alto, CA 94306-2122
`Tel:
`650.843.4000
`Fax:
`650.843.4001
`
`Email: djjohnson@morganlewis.com
`Email: mlyons@morganlewis.com
`Email: mcarr@morganlewis.com
`Email: stester@morganlewis.com
`
`ROBERT SMYTH, PH.D. (to be admitted pro hac vice)
`TODD B. BUCK, PH.D. (to be admitted pro hac vice)
`1 1 11 Pennsylvania Avenue, NW
`Washington, DC 20004
`Tel:
`202.739.3000
`Fax:
`202.739.3001
`
`Email: rsmyth@morganlewis.com
`Email: tbuck@m0rganlewis.com
`
`Filed
`
`FEB 2 5 ms
`
`RICHARD W. WIEKING
`CLERK. u.s. D!STRlCT COURT
`NORTHERN DISTRICT OF CALIFORNIA
`SAN JOSE
`'
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`_
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`.
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`5
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`5
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`tee W’
`g»,r@
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`ORIGINAL
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`Attorneys for Plaintiffs
`ELI LILLY AND COMPANY and IMCLONE SYSTEMS LLC
`
`UNITED STATES DISTRICT COURT"
`
`FOR THE NORTHERN DISTRICT OF CALIFORNIA
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`ELI LILLY AND COMPANY, an Indiana
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`corporation, and IMCLONE SYSTEMS LLC, a
`D§'laWafé limited liability company,
`
`0 9 1 9
`Yallfi —
`COMPLAINT FOR DECLARATORQR
`
`Plaintiffs,
`
`v.
`
`JUDGMENT OF INVALIDITY,
`UNENFORCEABILITY, AND
`NONINFRINGEMENT
`
`DEMAND FOR JURY TRIAL
`
`GEISENTECH, 'INC., a Delaware corporation,
`and.CITY OF HOPE, a California not-for-
`profit company,
`
`Defendants.
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`Plaintiffs Eli Lilly and Company and ImClone Systems LLC (collectively, “Lilly”), for
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`27
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`their Complaint against Genentech, Inc. (“Genentech”) and City of Hope (collectively,
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`“Defendants”), allege as follows:
`
`282-
`MORCAN, LEWIS &
`BOCKI US LLP
`Anomtvs AT LAW
`PALO ALTO
`
`COMPLAINT FOR
`DEC LARATORY JU DGMENT
`
`Sanofi/Regeneron Ex. 1055, pg 1216
`
`Mylan Ex. 1055, pg 1216
`
`
`
`
`
`NATURE OF THE CASE
`
`1.
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`Lilly seeks a declaration that U.S. Patent No. 6,331,415 titled “Methods of
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`Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein” (the “Cabilly
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`II patent” attached as Exhibit A), including the Ex Parte Reexamination Certificate issued
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`pursuant to merged Reexamination Nos. 90/007,542 and 90/007,859 (attached as Exhibit B), and
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`U.S. Patent No. 7,923,221 titled “Methods of Making Antibody Heavy and Light Chains Having
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`Specificity for a Desired Antigen” (the “Cabilly III patent” attached as Exhibit C) are invalid,
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`unenforceable, and not infringed by the manufacture, use, sale, offer to sell, or importation of
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`Lilly’s Erbitux® (cetuximab) product. (The Cabilly II patent and Cabilly 111 patent are
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`collectively referredto as the “Cabilly Patents”).
`2.
`I
`ImClone Systems Incorporated (“ImClone”) first received approval for Erbitux in
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`the United States in 2004 for the treatment of certain types of colorectal cancers. Beginning in
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`2006, ImClone received approval for Erbitux for the treatment of certain types of head and neck
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`cancers as well. Lilly has a commercial agreement with Bristol—Myers Squibb Company and E.R.
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`Squibb & Sons, LLC (collectively “BMS”) relating to Erbitux. Lilly co-develops Erbitux in the
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`U.S. and Canada with BMS. Lilly is responsible for the manufacture and supply of all
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`requirements of Erbitux in bulk—forrn active pharmaceutical ingredient (“API”) for clinical and
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`commercial use in the U.S. and Canada. BMS purchases all of its requirements of API for
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`commercial use from Lilly and exclusively sells Erbitux in the U.S. and Canada. Eli Lilly and
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`Company acquired ImClone in 2008 and ImClone currently operates as a wholly-owned
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`subsidiary of Eli Lilly and Company.
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`3.
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`Lilly brings this action to lift the cloud created by the imminent threat of
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`Defendants’ enforcement of the Cabilly Patents against Lilly. Without declaratory relief, the
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`threat of enforcement of the Cabilly Patents poses a substantial risk of injury to Lilly as well as
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`the patients, nurses, and physicians now using Erbitux for treatment. The continued existence and
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`enforcement of these invalid and unenforceable patents impedes not only the development and
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`27
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`sale of Erbitux, but also the development and sale of other life-saving recombinant antibody
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`28
`MORCA N, LEWIS &
`BOCKIUS LLP
`A‘|'I'DRN|-.‘!SAT LAW
`PALO ALTO
`
`products.
`
`_ 2
`
`COMPLAINT FOR
`DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1055, pg 1217
`
`Mylan Ex. 1055, pg 1217
`
`
`
` 1
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`Defendants have asserted that the Cabilly ll patent broadly covers the use of
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`4.
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`certain well-known, conventional recombinant methods to produce any antibody product in any
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`type of host cell. For example, according to Sean Johnson, Genentech’s then Vice President of
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`Intellectual Property, “[t]he recently issued [Cabilly II] patent broadly covers the co—expression of
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`immunoglobulin heavy and light chain genes in a single host. We do not believe the claims are
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`limited by the type of antibody. .. or by [the] host cell type.” See Debra Robertson, “Genentech
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`awarded critical antibody patent,” Nature Biotechnology 20, 108 (2002) (attached as Exhibit D).
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`Defendants have filed infringement claims under the Cabilly ll patent against companies who
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`have made and sold antibody products that were produced using recombinant methods similar to
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`the recombinant methods used by Lilly to make Erbitux.
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`5.
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`In public statements, Defendant Genentech has specifically identified the Erbitux
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`product as a potential competitor to one of Genentech’s own products, and has stated that it
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`expects to be involved in future litigation relating to the enforcement of the Cabilly Il patent. See
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`Genentech, Inc. (2009), l0—K Annual Report 2008, Retrieved from SEC EDGAR at 13, 25, 39.
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`6.
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`In response to the Defendants’ position that ImClone required a license under the
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`Cabilly Patents to make and sell two antibody products, including a product produced by a similar
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`process as Erbitux, ImClone entered into an agreement with Genentech on January 25, 2005
`
`under which it received, inter alia, a non-exclusive license to the Cabilly Patents to make, have
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`19 made, use, sell and have sold, offer for sale, import and export substances which, but for the
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`23
`MORGAN, LEWIS &
`
`BOCKIUSI-U’
`A"'3'ZT§”f;§,ZL‘W
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`license, may infringe one or more claims of the Cabilly Patents (the “Genentech Agreement”).
`
`As a result of Eli Lilly and Company’s acquisition of ImClone in 2008, Eli Lilly and Company
`
`became a licensee to the Cabilly Patents and remains a licensee to date.
`
`7.
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`Lilly has paid, and Genentech has accepted, royalties on sales of Erbitux under the
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`Genentech Agreement.
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`8.
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`Based on the allegations detailed below, Lilly contends that it has no obligation to
`
`pay royalties on the sales of Erbitux, or on any other therapeutic, on any of the Cabilly Patents
`
`due to the Cabilly Patents being invalid, unenforceable, and, in any event, not infringed by Lilly.
`
`9.
`
`Defendants’ past acts and public statements show that Defendants believe
`
`3
`
`COMPLAINT FOR
`DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1055, pg 1218
`
`Mylan Ex. 1055, pg 1218
`
`
`
` 1
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`therapeutics like Erbitux fall within the scope of the Cabilly Patents, that Defendants believe they
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`MORGAN, LEWl5&
`
`BOCKIUSU-P
`“"‘;';f§’jf;,“"
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`are entitled to royalties on the Cabilly Patents, and that Defendants intend to pursue an aggressive
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`litigation policy to protect against alleged infringement of the Cabilly Patents. See 1111 106-118
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`infra. Indeed, prior to Lilly’s acquisition of l1nClone, lmClone temporarily ceased payments of
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`royalties for the license to the Cabilly Patents under the Genentech Agreement and Genentech
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`threatened to pursue litigation against ImClone for this temporary failure to pay royalties. As
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`such, a real, immediate, and substantial dispute exists between the parties concerning the Cabilly
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`Patents for which Lilly now seeks declaratory relief, specifically, whether the manufacture,
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`importation, offer to sell, sale, or use of Erbitux in the United States infringes any valid and
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`enforceable claim of the Cabilly Patents.
`
`THE PARTIES
`
`10.
`
`Plaintiff Eli Lilly and Company is an Indiana corporation having its principal place
`
`of business at Lilly Corporate Center, Indianapolis, Indiana 46285. Eli Lilly and Company is
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`engaged in the business of research, development, manufacture, and sale of pharmaceutical
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`products throughout the world.
`
`11.
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`Plaintiff lmClone Systems LLC is a Delaware limited liability company having its
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`principal place of business at 440 Route 22 East, Bridgewater, New Jersey 08807.
`
`lmClone
`
`Systems LLC is a wholly owned subsidiary of Eli Lilly and Company.
`
`12.
`
`Defendant Genentech is a Delaware corporation having its principal place of
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`business at 1 DNA Way, South San Francisco, California 94080-4990.
`
`13.
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`Defendant City of Hope is a California not-for—profit organization 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,
`
`94105.
`
`14.
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`On information and belief, Genentech and City of Hope are co-assignees of the
`
`Cabilly Patents.
`
`-
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`JURISDICTION AND VENUE
`
`15.
`
`This action arises under the Declaratory Judgment Act of 1934 (28 U.S.C. §§
`
`4
`
`COMPLAINT FOR
`DEC LARA-TORY JUDGMENT
`
`sanofi/Regeneron Ex. 1055, pg 1219
`
`Mylan Ex. 1055, pg 1219
`
`
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`2201-2202), Title 28 of the United States Code, for the purposes of determining 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
`
`and 1338(a).
`
`16.
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`This Court has personal jurisdiction over Genentech based on its principal place of
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`business in California and also based on Genentech consenting to jurisdiction of this Court in the
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`Genentech Agreement. This Court has personal jurisdiction over City of Hope based on its
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`organization under the laws of the State of California and because its principal place of operation
`is in California.
`I
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`17.
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`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391 (b), (c), and (d)
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`. 11
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`because both Defendants reside in this District and a substantial part of the events or omissions
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`12
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`MORGAN, LEWIS 8:
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`Bocnus LLP
`‘“:jf§jf;““'
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`giving rise to the claims occurred in this District. In addition, pursuant to the Genentech
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`Agreement, Genentech stipulated and agreed that any disputes arising out of or related to the
`
`Genentech Agreement must "be brought in this District.
`
`INTRADISTRICT ASSIGNMENT
`
`'
`
`18.
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`A substantial part of the events or omissions giving rise to the claims occurred in
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`the San Francisco Division.
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`The Cabilly II Patent Interference
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`19.
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`On March 25, 1983, Michael Boss, John Kenton, John Emtage, and Clive Wood
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`(the “Celltech applicants”) filed their initial application for a patent in the United Kingdom (the
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`“British Patent Application”), presumptively entitling the patent to priority on that date.
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`20.
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`On March 28, 1989, the U.S. Patent and Trademark Office (“PTO”) issued U.S.
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`Patent No. 4,816,397 (the “Boss patent”), which arose from the March 25, 1983 British Patent
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`Application, with Celltech Ltd. (“Celltech”) listed as assignee.
`
`21.
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`On April 8, 1983, Shmuel Cabilly, Herbert Heyneker, William Holmes, Arthur
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`Riggs, and Ronald Wetzel (the “Cabilly applicants”) filed a patent application in the PTO (“the
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`Cabilly I application”) that issued on March 28, 1989, as U.S. Patent 4,816,567 (the “Cabilly I
`
`patent”). Messrs. Heyneker, Holmes, and Wetzel were affiliated with Genentech, and Messrs.
`
`5
`
`COMPLAINT FOR
`DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1055, pg 1220
`
`Mylan Ex. 1055, pg 1220
`
`
`
` 1
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`Cabilly and Riggs were affiliated with City of Hope. The Cabilly applicants assigned their rights
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`to Genentech and the City of Hope.
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`I
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`22.
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`Before the Cabillyl patent issued, the Cabilly applicants filed a continuation
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`application that claimed priority to the Cabilly I application (the “Cabilly ll application”). The
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`Cabilly applicants copied claims from the Boss patent into their then-pending Cabilly II
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`application in order to provoke the PTO Board of Patent Appeals and Interferences (“the Board”)
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`to declare an interference proceeding to determine who was entitled to priority for the invention
`
`claimed in the Boss patent.
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`23.
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`In February 1991, the Board declared an interference between the pending Cabilly
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`11 application and the Boss patent on the grounds that both the Boss patentees and the Cabilly
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`applicants claimed the same purported invention.
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`12 .
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`24.
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`Celltech argued that the subject matter at issue in the interference fell “under the
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`doctrine of conception and simultaneous reduction to practice because of the unpredictability of
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`the technology.” Cabilly v. Boss, 55 U.S.P.Q.2d 1238, 1256 (B.P.A.l. 1998). According to the
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`Boss patentees, therefore, conception of the invention could not occur without an actual reduction
`
`to practice of the invention.
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`25..
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`As discussed below, Defendants, the Cabilly applicants, and their representatives,
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`disagreed, arguing, while under a duty of candor to the PTO, that it would be sufficient to
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`establish a complete conception of the subject matter ofthe claimed invention merely by showing
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`inventor testimony evidencing nothing more than a strategy for reduction to practice for
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`constructing a bacterial strain for coexpression of both heavy and light chain genes for .
`
`coexpression of an immunoglobulin molecule.
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`26.
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`Notably, after termination of the interference, but during subsequent reexamination
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`proceedings related to the Cabilly ll patent, while also under a duty of candor to the PTO,
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`Defendants took a diametrically opposed position and made inconsistent representations to the
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`PTO and to the examiners. The Reexamination examiners were: Examiners Padmashri Ponnaluri,
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`Deborah D. Jones, Bennett Celsa, and Evelyn M. Huang.‘ Defendants were aware that the
`
`MORGAN “W538
`A1'mKNI~:vsA'rL.\w
`Boc»<u3sLu>
`PALO ALTO
`
`1 Examiner Huang replaced primary examiner Celsa during the course of the Reexamination.
`'
`6
`COMPLAINT FOR
`DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1055, pg 1221
`
`Mylan Ex. 1055, pg 1221
`
`
`
` 1
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`Reexamination examiners had not previously been involved in any aspect of the Cabilly ll patent
`
`-l>bJl\.)
`\OOO\lO‘\kI1
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`prosecution, including the interference proceeding, or the parent Cabilly I patent prosecution, and
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`that the examiners would have thus expected candor to accurately describe any conflicting
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`statements or “mistakes” in the decades-long, and many-thousands-of-pages-long, file wrapper
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`histories. As more fully detailed below, Defendants acted with intent to deceive the PTO by
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`making contradictory factual assertions at a stage of prosecution when the PTO was unable to
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`fully consider the effects of the new and inconsistent positions on patentability. For example,
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`Cabilly applicants, Heyneker and Riggs, testified during the interference proceedings and in
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`subsequent litigation regarding the Cabilly II patent that co-transformation of heavy and light
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`chains in a single host cell was “quite doable” and “had a good chance” ofsuccess as of the
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`11
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`12
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`priority date. By contrast, in attempting to overcome a final obviousness—type double patenting
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`rejection during reexamination, Defendants represented that the subject matter of the claimed
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`invention was a “pioneering advance” in a nascent field of art, i. e. , that the claimed invention was
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`14 made “during the infancy of the biotechnology industry” and that at the time, skilled workers
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`“had only begun to scratch the surface of the understandings necessary to realize [the] potential”
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`of genetic engineering. This inconsistency in Defendants’ positions and representations to the
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`PTO is but one example of an extensive pattern of like behavior, detailed more fully below, that
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`evidences Defendants’ knowing and deliberate intent to deceive the PTO into allowing the
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`Cabilly II and III patents.
`
`27.
`
`Dur_ing the interference and in subsequent prosecution, the factual
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`21 misrepresentations made by Defendants went well beyond attorney argument and included
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`22
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`23
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`percipient witness declarations by Cabilly applicants Shmuel Cabilly, William E. Holmes, Arthur
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`D. Riggs, Ronald D. Wetzel, and other Genentech scientists, including Paul J. Carter, Michael B.
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`24 Mumford, L. Jeanne Perry, Michael W. Rey, and City of Hope scientist John E. Shively,
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`25
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`concerning their interpretations of scientifrc data and scientific publications. These
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`26 misrepresentations, detailed infra, were extensive and, when viewed as a whole, demonstrate a
`
`27
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`pattern of behavior that evidences Defendants’ intent to violate their duty of candor and to
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`23
`MORGAN, LEWIS 8:
`A1'TDRN'B’S AT LAW
`BOCKWS Lu’
`,,,,,,,,,,
`
`deceive the PTO into issuing the Cabilly II patent. As set out further below, this information was
`
`7
`
`COMPLAINT FOR
`DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1055, pg 1222
`
`Mylan Ex. 1055, pg 1222
`
`
`
`
`
`1
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`2
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`3
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`4
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`material to the prosecution and reexamination of the Cabilly ll patent, particularly since
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`Defendants knew that positions they took during the interference were diametrically opposed to
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`and inconsistent with the positions they then took during the reexamination.
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`28.
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`As set out further below, the misrepresentations and withheld information were
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`5 material to the prosecution and the reexamination of the Cabilly ll patent and to the interference,
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`MORGAN, LEWIS 5!
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`Boc»<uusLu=
`‘"‘;,j“;j:;jj“"
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`particularly since Defendants’ counsel knew that positions they took during the interference were
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`diametrically opposed to and inconsistent with the factual positions they then took during the
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`reexamination. The misrepresentations and withheld information would have been material to the
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`PTO’s examination of the Cabilly 11 claims and, for several reasons, the PTO would not have
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`issued the Cabilly ll patent had it known the complete and accurate factual record at the
`appropriate time. The demonstrated pattern of deception described herein, by making inaccurate
`
`representations to the PTO during prosecution, by hiding information from the PTO and the
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`public, and by repeatedly failing to make the necessary inquiry into the underlying facts and
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`circumstances of the case at the appropriate times, evidences inequitable conduct in the
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`prosecution of the Cabilly II patent.
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`29.
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`The PTO rejected Defendant’s arguments raised in the interference regarding the
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`state of the art and the sufficiency of the disclosure to show a completed conception and reduction
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`to practice. Thus, after seven years of adversarial proceedings in the PTO, on August 13, 1998,
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`the Board found that the Boss patentees were entitled to priority over the Cabilly applicants. See
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`Cabilly v. Boss, 55 U.S.P.Q.2d 1238 (B.P.A.I. 1998). In its ruling, the Board stated explicitly that
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`“[w]e agree with Boss et al. that on the record before us, this case is one where conception and
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`reduction to practice must be concurrent.” Id. at 1256. The Board concluded that “there is no
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`evidence that immunoglobulins, multiple chains proteins, had been produced by recombinant
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`DNA techniques from a single host cell prior to March 25, 1983. Rather the evidence of record
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`establishes that Riggs had but a research plan.” Id. (internal citation omitted).
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`30.
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`The Board concluded that the Cabilly applicants had failed to establish conception
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`or reduction to practice of the claimed inventions prior to March 25, 1983, the filing date of the
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`Boss patent. According to the Board, “there is no evidence that immunoglobulins, multiple chain
`
`8
`
`COMPLAINT FOR
`DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1055, pg 1223
`
`Mylan Ex. 1055, pg 1223
`
`
`
`
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`proteins, had been produced by recombinant DNA techniques from a single host cell prior to
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`March 25, 1983.” Moreover, “the evidence indicates that Cabilly et a]. had but a hope or wish to
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`produce active antibodies in bacteria; and, there is no supporting evidence to establish the
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`development of the means to accomplish that result or evidence of a disclosure to a third party of
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`a complete conception.” Id. The Final Decision therefore indicated that the Cabilly applicants
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`were “not entitled to a patent.” Id.
`
`Defendants’ Civil Action to Appeal PTO Board Decision
`
`31.
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`After losing in the PTO, on October 9, 1998, Genentech filed an action under 35
`
`U.S.C. § 146 against Celltech, the owner of the Boss patent, to appeal the decision of the Board
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`awarding priority to the Boss patent. Genentech, Inc. v. Celltech Ltd., 3: 1998-cv-03926 (N .D.
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`Cal. Oct. 9, 1998).’
`
`32.
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`Celltech answered the complaint and alleged the affirmative defenses of priority of
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`invention by Celltech and-a lack of corroboration by Genentech. Specifically, Celltech alleged
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`that “Genentech should not recover on its claim because Genentech has failed to present
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`sufficient evidence to corroborate any alleged conception or alleged actual reduction to practice."
`33.
`While pursuing that action, in early 2000 (two years after Celltech’s allegations of
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`affirmative defenses regarding a lack of corroboration and nine years after the PTO declared an
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`interference to decide the ultimate question of priority of invention), Defendants, through counsel
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`R. Danny Huntington and potentially others, first requested that Dr. Shmuel Cabilly, the lead
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`Cabilly applicant, produce documents in his possession potentially relevant to the question of
`priority. Dr. Cabilly produced for the first time a purported draft patent application dated
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`February 25, 1983 (the “February Draft Cabilly 11 Application”) from his files in Israel. It is not
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`clear in which country this uncorroborated February Draft Cabilly 11 Application originated.
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`Though Dr. Cabilly alleges to have had the February Draft Cabilly 11 Application in his
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`possession at all times since leaving City of Hope, Dr. Cabilly has testified that Defendants never
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`asked him to produce the draft application until after termination of the interference, during the
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`civil action, about nine years into the dispute, and approximately seventeen years after the alleged
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`MORGAN, LEWIS :3:
`BOCKIUS LLP
`A1'n:>nNnsAr LAW
`PALO Ana
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`9
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`COMPLAINT FOR
`DECLARATORY JUDGMENT
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`Sanofi/Regeneron Ex. 1055, pg 1224
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`Mylan Ex. 1055, pg 1224
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` 1
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`According to Defendants, the February Draft Cabilly II Application established
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`34.
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`MORGAN, Lawns £2
`ATTORNEYS AT LAW
`30CK|U5 LU’
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`that the Cabilly applicants had conceived of the invention 30 days before the priority date
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`accorded to the Boss patent, based on the filing date for Boss’s March 25, 1983 British Patent
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`Application.
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`35.
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`Taking full advantage of this belated unearthing of evidence, Genentech moved for
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`summary judgment that it was entitled to priority of invention" over Celltech. Genentech argued
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`that, because the February Draft Cabilly II application contained every element of the claimed
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`invention, and was dated earlier than the Boss British Patent Application of March 25, 1983,
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`Genentech should be awarded priority of invention.
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`36.
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`' Because the interference turned on evidence of this exact issue, z'.e., whether the
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`Cabilly applicants could establish priority of invention prior to March 25, 1983, it is implausible
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`that Defendants and Dr. Cabilly were not aware of the need for evidence of conception and
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`reduction to practice that would have pre-dated the Boss British Patent Application during the
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`seven-year-long interference proceeding. The implausibility of Defendants having made no-prior
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`request for such evidence from the lead named inventor over all those years is reinforced by Dr.
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`Cabilly’s testimony in the form of sworn declarations to the PTO during the interference. There,
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`Dr. Cabilly testified about documents evidencing his work and that of the other Cabilly applicants
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`that was allegedly performed during February 1983 but never mentioned a February draft patent
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`application. The PTO’s ruling denying Cabilly priority and awarding the patent to Boss hinged
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`on the lack of corroborated evidence (and in particular written corroboration) that would have
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`supported the Cabilly applicants’ story regarding the February 1983 time frame. In its ruling, the
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`Board stated that “[s]tatements in the brief cannot take the place of evidence in the record” and
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`specifically cited Dr. Cabilly as himself failing to provide adequate written corroboration of his
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`testimony regarding “any date the work was done.” Cabilly v. Boss, 55 U.S.P.Q.2d 123 8, 1250-5]
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`(B.P.A.I. 1998).
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`37.
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`Based on the Board’s view that the Cabilly applicants failed to proffer sufficient
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`written documentation as corroboration of their alleged invention prior to March 25, 1983, and
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`because the later-produced February Draft Cabilly II Application purports to provide the much-
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`10
`
`COMPLAINT FOR
`DEC LA RATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1055, pg 1225
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`Mylan Ex. 1055, pg 1225
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` 1
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`needed proof of conception that was lacking throughout the entire seven-year interference
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`proceeding, any reliance on the truth of Defendants’ and Dr. Cabilly’s representations regarding
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`the February 25, 1983 Drafi Cabilly 11 Application is not reasonable. Dr. Cabilly had worked
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`with Defendants’ counsel, R. Danny Huntington, on the priority case during the interference. Dr.
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`Cabilly had previously submitted multiple sworn declarations on the exact subject of conception
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`and reduction to practice and produced notebooks and other information concerning the
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`development of expression vectors and their alleged use to cotransforrn single cells to express
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`heavy and light chains, yet he failed to disclose the February Draft'Cabilly II Application during
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`the entire course of the interference.
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`38.
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`From this evidence, the single most reasonable inference is that Defendants’
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`counsel, R. Danny Huntington, and Dr. Cabilly knew or should have known that the February
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`Draft Cabilly II application did not, in fact, support a finding of conception, see W 39-40, 50-53
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`infia, and that they withheld the February Draft Cabilly II application with an intent to deceive
`the PTO.
`I
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`39.
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`Celltech responded by demonstrating that the February Draft Cabilly ll
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`Application fell short of satisfying the legal requirements for conception, in that it did not set
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`forth each and every element of the invention.
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`In fact the February Draft Cabilly II application
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`had a section heading entitled “Reconstitution [refolding] of Antibody from Recombinant K and
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`Gamma Chains,” for which the corresponding section body was left completely blank. Therefore,
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`the February Draft Cabilly II Application that formed the entire basis of Genentech’s claim to
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`priority in the District Court action had absolutely no description or enabling teaching as to a
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`critical part of the purported invention. In particular, the February Draft Cabilly II Application
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`failed to describe or enable a single embodiment for producing functional antibodies in a single
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`host cell. In other words, the February Draft Cabilly II Application exposed the fact that
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`Defendants had neither successfully made an antibody as of February 1983, nor had they
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`conceived of how to do so at that time. Celltech also pointed out that Genentech had changed its
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`basic theory of conception and reduction to practice from what it had asserted before the PTO.
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`40.
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`Cabilly applicant Wetzel did not disagree with Celltech’s statements regarding the
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`1 1
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`COMPLAINT FOR
`DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1055, pg 1226
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`Mylan Ex. 1055, pg 1226
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`February Draft Cabilly II Application’s infirmities, i.e., that it showed Cabillydid not have a
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`Boc»<wsLLI>
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`complete conception of the alleged invention by the February 25, 1983 date.
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`In fact, upon
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`information and belief, Cabilly applicant Wetzel did not remember being involved with any work
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`underlying the alleged Cabilly II invention at the time the February Draft Cabilly II application
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`was prepared, nor could Wetzel identify anything in the February Draft Cabilly ll application that
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`was representative of his work on reconstitution of separate heavy and light chains into a
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`complete immunoglobulin molecule.
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`In fact, upon information and belief, Wetzel stated
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`affirmatively, in a August 5, 2008 deposition: “I have no memory of [the February Draft Cabilly
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`11] application.”
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`41.
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`An intent to deceive the PTO on the issue of priority by Defendants, the Cabilly
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`applicants, and their representatives, specifically Defendants’ counsel, R. Danny Huntington, and
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`Dr. Cabilly, is the most reasonable inference to be drawn from the fact that the February Draft
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`Cabilly 11 application was found and disclosed only to the District Couit and not the PTO at the
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`appropriate time during the first interference. Not only should the veracity and authenticity of the
`February Draft Cabilly 11 application itself have been called into question by this late and
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`selective disclosure, but its existence and contents were directly contradictory to evidence and
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`testimony Defendants previously presented to the PTO. Defendants did not inform the District
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`Court or the PTO of such contradictions when the February Draft Cabilly 11 application was
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`disclosed. In 1999, Dr. Cabilly was deposed and testified under oath that he had “no notes prior
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`to April 30th” that show a co-transformation of heavy and light chains. Dr. Cabilly also
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`affirmatively swore that “I couldn’t find any evidence of coexpression of the FAB fragment” at
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`any time in February or March, 1983. An intent to deceive the PTO is the only plausible
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`inference to be drawn from the entirely contradictory misrepresentations of material fact
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`regarding conception, reduction to practice, and fundamentally, the patentability of the Cabilly ll
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`patent.
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`42.
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`Genentech argued that the February Draft Cabilly 11 Application contained at least
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`as much detail as Celltech’s own March 25, 1983 British Patent Application, and moved for
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`summary judgment that Celltech was not entitled to the March 25, 1983 priority date in view of
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`12
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`-
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`COMPLAINT FOR
`DECLARATORY JUDGMENT
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`Sanofi/Regeneron Ex. 1055, pg 1227
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`Mylan Ex. 1055, pg 1227
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`
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`the February Draft Cabilly 11 Application.
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`44.
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`Celltech challenged Genentech’s Summary Judgment Motion and prevailed.
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`Despite prevailing on Summary Judgment and with a clear indication that its Boss
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`patent had priority over the Cabilly applicants’ pending application, Celltech elected to enter into
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`a settlement agreement with Genentech wherein Celltech received royalty payments and other
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`considerations including future revenue streams when the term of patent protection for the
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`technology originally claimed in the Boss patent was extended until 2018 instead of expiring in
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`2006.
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`45.
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`The agreement was reduced to writing by Defendants and Celltech no later than
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`10 March 6, 2001. Genentech and Celltech entered into the “Settlement Agreement Between
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`11 I Genentech, Inc. and Celltech Chiroscience Limited,” the “Amended and Restated License
`12 Agreement Between Genentech, Inc. and Ce|.ltech Chiroscience Limited” and another license
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`agreement with Celltech, the terms of which were negotiated concurrently. Genentech and
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`Celltech entered into at least the following additional -agreements:
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`the “Settlement Negotiation
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`and Alternative Dispute Resolution Agreement,” dated September 18, 2000; and two untitled
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`agreements between Genentech and Celltech, each of which is dated March 1, 1991, and, as
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`pleaded by other parties challenging the Cabilly Patents, it was stated that each agreement
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`contained a provision that stated that the parties “anticipate that an interference proceeding may
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`be instituted in the United States Patent and Trademark Office involving the Boss and Cabilly
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`patents and patent applications and patents related thereto” and that they “shall enter into an
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`interference settlement agree