Cas 2:13-cv-07248-MRP~J EM Document 1 Filed 02/28/13 Page 1 of 43 Page ID #:1
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`MORGAN, LEWIS & BOCKIUS LLP
`DANIEL JOHNSON, JR. (SBN 57409)
`MICHAEL J. LYONS (SBN 202284)
`MICHAEL F. CARR (SBN 25991 1)
`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:
`650.843.400 I
`Email: djjohnson@morganlewis.com
`Email: mlyons@morganlewis.com
`Email: mcarr@morganlewis.com
`Email: stester@morganlewis.com
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`ROBERT SMYTH, PH.D. (to be admitted pro hac vice)
`TODD B. BUCK, PH.D. (to be admitted pro hac vice)
`I I 11 Pennsylvania A venue, NW
`W a.Shington, DC 20004
`Tel:
`202.739.3000
`Fax:
`202.739.300I
`Email: rsmyth@morganlewis.com
`Email: tbuck@morganlewis.com
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`Filed
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`FEB 2 0 ZU13
`
`RICHARD W. WIEKING
`CLERK, U.S. D!STRI CT COURT
`NORTHERN DI STRI CT OF CALl FORNI ...
`SAN JOSE
`.
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`Attorneys for Plaintiffs
`ELI LlLL Y AND COMPANY and 1M CLONE SYSTEMS LLC
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`UNITED STATES DISTRICT COURT .
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`FOR THE NORTHERN DISTRICT OF CALIFORNIA
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`09 19
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`1Tl'l
`Y~
`~a M-
`COMPLAINT FOR DECLARATOR\""R
`JUDGMENT OF INVALIDITY,
`UNENFORCEABILITY, AND
`NONINFRINGEMENT
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`DEMAND FOR JURY TRIAL
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`ELI LILLY AND COMPANY, an Indiana
`corpor(!tjon, and lMCLONE SYSTEMS LLC, a
`Pyla~re limited liability company,
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`. .
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`Plaintiffs,
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`.. -
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`v .
`:\J,:!"; ~ ... ·~~
`Gij::rsl;'NTECH; INC., a Delaware corporation,
`and . CITY OF HOPE, a California not-for(cid:173)
`profit company,
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`Defendants.
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`Plaintiffs Eli Lilly and Company and ImClone Systems LLC (collectively, "Lilly"), for
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`their Complaint against Genentech, Inc. ("Genentech") and City of Hope (collectively,
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`"Defendants"), allege as follows :
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`M ORGA N, LEWIS &
`BOCK JUS LLP
`Anc>RN £VSATl.AW
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`PAI.OA LTO
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`COMPLAINT FOR
`DECLARATORY JUDGMENT
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`Sanofi/Regeneron Ex. 1 055, pg 1216
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`Merck Ex. 1055, pg 1242
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`

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`Cas 2:13-cv-07248-MRP-JEM Document 1 Filed 02/28/13 Page 2 of 43 Page ID #:2
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`NATURE OF THE CASE
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`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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`6 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 III patent are
`1 o collectively referred to as the "Cabilly Patents").
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`2.
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`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 colo rectal 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 ofErbitux in bulk-form active pharmaceutical ingredient ("API") for clinical and
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`conunercial use in the U.S. and Canada. BMS purchases all of its requirements of API for
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`conunercial 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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`sale of Erbitux, but also the development and sale of other life-saving recombinant antibody
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`I·
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`products.
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`MORGAN, LEWIS &
`BOCKIUS LLP
`AlTORNF."''SAT !J.W
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`PALO A LTO
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`2
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`COMPLAINT FOR
`DECLARATORY JUDGMENT
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`Sanofi/Regeneron Ex. 1 055, pg 1217
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`Merck Ex. 1055, pg 1243
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`

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`Cas 2:13-cv-07248-MRP-JEM Document 1 R led 02/28/13 · Page 3 of 43 Page ID #:3
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`4.
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`Defendants have asserted that the Cabilly li patent broadly covers the use of
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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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`8 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), 10-K Aruma! Report 2008, Retrieved from SEC EDGAR at 13, 25, 39.
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`6.
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`ln response to the Defendants' position that ImClone required a license under the
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`16 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
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`under which it received, inter alia, a non-exclusive license to the Cab illy 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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`license, may infringe one or more claims of the Cabilly Patents (the "Genentech Agreement").
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`21 As a result of Eli Lilly and Company's acquisition of lmClone in 2008, Eli Lilly and Company
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`became a licensee to the Cabilly Patents and remains a licensee to date.
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`7.
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`Lilly has paid, and Genentech has accepted, royalties on sales ofErbitux under the
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`24 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
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`pay royalties on the sales of Erbitux, or on any other therapeutic, on any of the Cabilly Patents
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`due to the Cabilly Patents being invalid, unenforceable, and, in any event, not infringed by Lilly.
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`M ORGAN, LEWIS&
`BOCKIUSLLP
`AlTORNEYSAT LAW
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`PALO Al.lO
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`9.
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`Defendants' past acts and public statements show that Defendants believe
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`3
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`COMPLAINT FOR
`DECLARATORY JUDGMENT
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`Sanofi/Regeneron Ex. 1 055, pg 1218
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`Merck Ex. 1055, pg 1244
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`

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`Cas 2:13-cv-07248-MRP-JEM Document 1 Filed 02/28/13 Page 4 of 43 Page ID #:4
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`MORGAN, LEW IS&
`BocKIUSLLP
`ATTORNE'VS AT \...Aw
`PALO ALTO
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`therapeutics like Erbitux fall within the scope of the Cabilly Patents, that Defendants believe they
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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 Cab illy Patents. See ~~ 106-118
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`infra. Indeed, prior to Lilly ' s acquisition of ImClone, ImClone 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 ofErbitux in the United States infringes any valid and
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`enforceable claim ofthe Cabilly Patents.
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`THE PARTIES
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`10.
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`Plaintiff Eli Lilly and Company is an Indiana corporation having its principal place
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`of business at Lilly Corporate Center, Indianapolis, Indiana 46285. Eli Lilly and Company is
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`engaged in the business ofresearch, development, manufacture, and sale of pharmaceutical
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`products throughout the world.
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`11.
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`Plaintiff ImClone 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. ImClone
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`Systems LLC is a wholly owned subsidiary of Eli Lilly and Company.
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`12.
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`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.
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`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,
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`94105.
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`14.
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`On information and belief, Genentech and City of Hope are co-assignees of the
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`Cabilly Patents.
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`JURISDICTION AND VENUE
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`15.
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`This action arises under the Declaratory Judgment Act of 1934 (28 U.S.C . §§
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`4
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`COMPLA!NT FOR
`DECLARATORY JUDGMENT
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`Sanofi/Regeneron Ex. 1055, pg 1219
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`Merck Ex. 1055, pg 1245
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`

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`Cas 2:13-cv-07248-MRP-JEM Document 1 Rled 02/28/13 Page 5 of 43 Page ID #:5
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`220 1-2202), 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
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`and 1338(a).
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`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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`7 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
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`is in California.
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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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`because both Defendants reside in this District and a substantial part of the events or omissions
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`giving rise to the claims occurred in this District. In addition, pursuant to the Genentech
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`13 Agreement, Genentech stipulated and agreed that any disputes arising out of or related to the
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`14 Genentech Agreement must be brought in this District.
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`INTRADISTRICT ASSIGNMENT
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`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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`24 Application, with Celltech Ltd. ("Celltech") listed as assignee.
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`21.
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`On April 8, 1983, Shmuel Cabilly, Herbert Heyneker, William Holmes, Arthur
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`26 Riggs, and Ronald Wetzel (the "Cabilly applicants") filed a patent application in the PTO ("the
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`27 Cabilly I application") that issued on March 28, 1989, as U.S. Patent 4,816,567 (the "Cabilly I
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`MORG AN, LEWIS &
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`f'ALOALTU
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`patent"). Messrs. Heyneker, Holmes, and Wetzel were affiliated with Genentech, and Messrs.
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`COMPLAfNT FOR
`DECLARATORY JUDGMENT
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`Sanofi/Regeneron Ex. 1 055, pg 1220
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`Merck Ex. 1055, pg 1246
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`

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`Cas 2:13-cv-07248-MR P-JEM Document 1 Filed 02/28/13 Page 6 of 43 Page 10 #:6
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`1 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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`22.
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`Before the Cabilly I patent issued, the Cabilly applicants filed a continuation
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`application that claimed priority to the Cabilly I application (the "Cabilly II application"). The
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`5 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
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`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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`II 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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`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.I. 1998). According to the
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`15 Boss patentees, therefore, conception of the invention could not occur without an actual reduction
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`to practice ofthe 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 .
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`coexpression of an immunoglobulin molecule.
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`Notably, after termination of the interference, but during subsequent reexamination
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`proceedings related to the Cabilly II 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. 1 Defendants were aware that the
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`M O RGAN, LEWIS &
`BocK! US LLP
`ATTO RN ~&: AT L~W
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`PALO AI.T'O
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`1 Examiner Huang replaced primary examiner Celsa during the course of the Reexamination.
`COMPLAINT FOR
`DECLARATORY JUDGMENT
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`6
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`Sanofi/Regeneron Ex. 1055, pg 1221
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`Merck Ex. 1055, pg 1247
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`

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`Cas 2:13-cv-07248-MRP-JEM Document 1 Filed 02/28/13 Page 7 of 43 Page ID #:7
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`Reexamination examiners had not previously been involved in any aspect of the Cabilly II patent
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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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`6 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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`8 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" of success as of the
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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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`ATTO!Vo~EYSAT LAW
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`PALO A LTO
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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.
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`27.
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`During the interference and in subsequent prosecution, the factual
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`misrepresentations made by Defendants went well beyond attorney argument and included
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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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`Mumford, L. Jeanne Perry, Michael W. Rey, and City of Hope scientist John E. Shively,
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`concerning their interpretations of scientific data and scientific publications. These
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`misrepresentations, detailed infra, were extensive and, when viewed as a whole, demonstrate a
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`pattern of behavior that evidences Defendants' intent to violate their duty of candor and to
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`deceive the PTO into issuing the Cabilly II patent. As set out further below, this information was
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`7
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`COMPLAINT FOR
`DECLARATORY JUDGM ENT
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`Sanofi/Regeneron Ex. 1055, pg 1222
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`Merck Ex. 1055, pg 1248
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`

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`Cas 2:13-cv-07248-MRP-JEM Document 1 Filed 02/28/13 Page 8 of 43 Page ID #:8
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`material to the prosecution and reexamination of the Cabilly II patent, particularly since
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`2 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 II patent and to the interference,
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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 II claims and, for several reasons, the PTO would not have
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`issued the Cabilly II patent had it known the complete and accurate factual record at the
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`appropriate time. The demonstrated pattern of deception described herein, by making inaccurate
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`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 ofthe 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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`20 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." !d. at 1256. The Board concluded that "there is no
`
`evidence that immunoglobulins, multiple chains proteins, had been produced by recombinant
`
`24 DNA techniques from a single host cell prior to March 25, 1983. Rather the evidence of record
`
`25
`
`establishes that Riggs had but a research plan." !d. (internal citation omitted).
`
`26
`
`27
`
`30.
`
`The Board concluded that the Cabilly applicants had failed to establish conception
`
`or reduction to practice ofthe claimed inventions prior to March 25, 1983, the filing date of the
`
`28 Boss patent. According to the Board, "there is no evidence that immunoglobulins, multiple chain
`MORGAN, LEWIS &
`BOCKIUS LLP
`ATTORNt"YSATLAW
`
`8
`
`PALO ALTO
`
`COMPLAINT FOR
`DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1 055, pg 1223
`
`Merck Ex. 1055, pg 1249
`
`

`
`Cas 2:13-cv-07248-MRP-JEM Document 1 Filed 02/28/13 Page 9 of 43 Page ID #:9
`
`proteins, had been produced by recombinant DNA techniques from a single host cell prior to
`
`2 March 25, 1983." Moreover, "the evidence indicates that Cabilly eta/. had but a hope or wish to
`
`3
`
`4
`
`5
`
`produce active antibodies in bacteria; and, there is no supporting evidence to establish the
`
`development of the means to accomplish that result or evidence of a disclosure to a third party of
`
`a complete conception." !d. The Final Decision therefore indicated that the Cabilly applicants
`
`6 were "not entitled to a patent." !d.
`
`7
`
`8
`
`Defendants' Civil Action to Appeal PTO Board Decision
`
`31.
`
`After losing in the PTO, on October 9, 1998, Genentech filed an action under 35
`
`9 U.S.C. § 146 against Celltech, the owner of the Boss patent, to appeal the decision of the Board
`
`IO
`
`awarding priority to the Boss patent. Genentech, Inc. v. Celltech Ltd., 3:I998-cv-03926 (N.D.
`
`II Cal. Oct. 9, I998).
`
`I2
`
`I3
`
`I4
`
`32.
`
`Celltech answered the complaint and alleged the affirmative defenses of priority of
`
`invention by Celltech and a lack of corroboration by Genentech. Specifically, Celltech alleged
`
`that "Genentech should not recover on its claim because Genentech has failed to present
`
`I !
`
`15
`
`sufficient evidence to corroborate any alleged conception or alleged actual reduction to practice."
`
`'
`
`16
`
`17
`
`33. While pursuing that action, in early 2000 (two years after Celltech's allegations of
`
`affirmative defenses regarding a lack of corroboration and nine years after the PTO declared an
`
`18
`
`interference to decide the ultimate question of priority of invention), Defendants, through counsel
`
`19 R. Danny Huntington and potentially others, first requested that Dr. Shmuel Cabilly, the lead
`
`20 Cabilly applicant, produce documents in his possession potentially relevant to the question of
`
`2I
`
`priority. Dr. Cabilly produced for the first time a purported draft patent application dated
`
`22
`
`February 25, 1983 (the "February Draft Cabilly II Application") from his files in Israel. It is not
`
`23
`
`clear in which country this uncorroborated February Draft Cabilly II Application originated.
`
`24 Though Dr. Cabilly alleges to have had the February Draft Cabilly II Application in his
`
`25
`
`possession at all times since leaving City of Hope, Dr. Cab illy has testified that Defendants never
`
`26
`
`asked him to produce the draft application until after termination of the interrerence, during the
`
`27
`
`civil action, about nine years into the dispute, and approximately seventeen years after the alleged
`
`invention.
`
`28
`M ORGAN, LEWIS &
`BOCKIUSLLP
`ArrDRNE"''SAT LAW
`
`PALO ALTO
`
`9
`
`COMPLAINT FOR
`DECLARATORY JUDGMENT
`
`i·
`
`Sanofi/Regeneron Ex. 1 055, pg 1224
`
`Merck Ex. 1055, pg 1250
`
`

`
`Case
`
`:13-cv-07248-MRP-JEM Document 1 Filed 02/28/13 Page 10 of 43 Page ID #:10
`
`34.
`
`According to Defendants, the February Draft Cabilly II Application established
`
`2
`
`3
`
`that the Cabilly applicants had conceived of the invention 30 days before the priority date
`
`accorded to the Boss patent, based on the filing date for Boss's March 25, 1983 British Patent
`
`4 Application.
`
`5
`
`6
`
`7
`
`8
`
`35.
`
`Taking full advantage of this belated unearthing of evidence, Genentech moved for
`
`summary judgment that it was entitled to priority of invention over Cell tech. Genentech argued
`
`that, because the February Draft Cabilly II application contained every element of the claimed
`
`invention, and was dated earlier than the Boss British Patent Application of March 25, 1983,
`
`9 Genentech should be awarded priority of invention.
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`36.
`
`Because the interference turned on evidence of this exact issue, i.e., whether the
`
`Cabilly applicants could establish priority of invention prior to March 25, 1983 , it is implausible
`
`that Defendants and Dr. Cabilly were not aware of the need for evidence of conception and
`
`reduction to practice that would have pre-dated the Boss British Patent Application during the
`
`seven-year-long interference proceeding. The implausibility of Defendants having made no prior
`
`request for such evidence from the lead named inventor over all those years is reinforced by Dr.
`
`16 Cabilly's testimony in the form of sworn declarations to the PTO during the interference. There,
`
`17 Dr. Cabilly testified about documents evidencing his work and that of the other Cabilly applicants
`
`18
`
`19
`
`that was allegedly performed during February 1983 but never mentioned a February draft patent
`
`application. The PTO's ruling denying Cabilly priority and awarding the patent to Boss hinged
`
`20
`
`on the lack of corroborated evidence (and in pat1icular written corroboration) that would have
`
`21
`
`supported the Cabilly applicants' story regarding the February I 983 time frame. In its ruling, the
`
`22 Board stated that"[ s ]tatements in the brief cannot take the place of evidence in the record" and
`
`23
`
`specifically cited Dr. Cabilly as himself failing to provide adequate written corroboration of his
`
`24
`
`testimony regarding "any date the work was done." Cabilly v. Boss, 55 U.S .P.Q.2d 1238, 1250-51
`
`25
`
`(B.P.A.I. 1998).
`
`26
`
`37.
`
`Based on the Board's view that the Cabilly applicants failed to proffer sufficient
`
`27 written documentation as corroboration of their alleged invention prior to March 25, 1983, and
`
`28
`MORGAN, L~WIS &
`BocKIUSLLP
`Ano RHD'SAT'LAW
`
`PA LOAI.TO
`
`because the later-produced February Draft Cabilly II Application purports to provide the much-
`
`10
`
`COMPLAINT FOR
`DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1 055, pg 1225
`
`Merck Ex. 1055, pg 1251
`
`

`
`Case
`
`:13-cv-07248-MRP-JEM Document 1 Filed 02/28/13 Page 11 of 43 Page ID #:11
`
`needed proof of conception that was lacking throughout the entire seven-year interference
`
`2
`
`3
`
`proceeding, any reliance on the truth of Defendants' and Dr. Cabilly's representations regarding
`
`the February 25, 1983 Draft Cabilly II Application is not reasonable. Dr. Cabilly had worked
`
`4 with Defendants' counsel, R. Danny Huntington, on the priority case during the interference. Dr.
`
`5 Cabilly had previously submitted multiple sworn declarations on the exact subject of conception
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`and reduction to practice and produced notebooks and other information concerning the
`
`development of expression vectors and their alleged use to cotransform single cells to express
`
`heavy and light chains, yet he failed to disclose the February Draft Cabilly II Application during
`
`the entire course of the interference.
`
`38.
`
`From this evidence, the single most reasonable inference is that Defendants'
`
`counsel, R. Danny Huntington, and Dr. Cabilly knew or should have known that the February
`
`12 Draft Cabilly II application did not, in fact, support a finding of conception, see~~ 39-40, 50-53
`
`13
`
`14
`
`15
`
`infra, and that they withheld the February Draft Cabilly II application with an intent to deceive
`
`the PTO.
`
`39.
`
`Celltech responded by demonstrating that the February Draft Cabilly II
`
`16 Application fell short of satisfying the legal requirements for conception, in that it did not set
`
`17
`
`18
`
`forth each and every element of the invention. In fact the February Draft Cab illy II application
`
`had a section heading entitled "Reconstitution [refolding] of Antibody from Recombinant K and
`
`19 Gamma Chains," for which the corresponding section body was left completely blank. Therefore,
`
`20
`
`the February Draft Cabilly II Application that formed the entire basis of Genentech's claim to
`
`21
`
`22
`
`23
`
`24
`
`priority in the District Court action had absolutely no description or enabling teaching as to a
`
`critical part of the purported invention. In particular, the February Draft Cabilly II Application
`
`failed to describe or enable a single embodiment for producing functional antibodies in a single
`
`host cell. In other words, the February Draft Cabilly II Application exposed the fact that
`
`25 Defendants had neither successfully made an antibody as of February 1983, nor had they
`
`26
`
`27
`
`28
`M ORGAN, L EWIS &
`BocKIUSLLP
`ATTORNEY'S AT L AW
`
`PA l-O ALTO
`
`conceived of how to do so at that time. Celltech also pointed out that Genentech had changed its
`
`I
`
`.
`
`basic theory of conception and reduction to practice from what it had asserted before the PTO.
`
`40.
`
`Cabilly applicant Wetzel did not disagree with Celltech's statements regarding the
`
`11
`
`COMPLAINT FOR
`DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1 055, pg 1226
`
`Merck Ex. 1055, pg 1252
`
`

`
`Case
`
`:13-cv-07248-MRP-JEM Document 1 Filed 02/28/13 Page 12 of 43 Page ID #:12
`
`1
`
`2
`
`3
`
`4
`
`February Draft Cabilly II Application's infirmities, i.e., that it showed Cabillydid not have a
`
`complete conception of the alleged invention by the February 25, 1983 date. In fact, upon
`
`information and belief, Cabilly appliCant Wetzel did not remember being involved with any work
`
`underlying the alleged Cabilly II invention at the time the February Draft Cabilly II application
`
`5 was prepared, nor couJd Wetzel identify anything in the February Draft Cabilly II application that
`
`6 was representative of his work on reconstitution of separate heavy and light chains into a
`
`7
`
`8
`
`9
`
`10
`
`1 1
`
`complete immunoglobulin molecule. In fact, upon information and belief, Wetzel stated
`
`affirmatively, in a August 5, 2008 deposition: "I have no memory of [the February Draft Cabilly
`
`II] application."
`
`41.
`
`An intent to deceive the PTO on the issue of priority by Defendants, the Cabilly
`
`applicants, and their representatives, specifically Defendants' counsel, R. Danny Huntington, and
`
`12 Dr. Cabilly, is the most reasonable inference to be drawn from the fact that the February Draft
`
`13
`
`Cabilly II application was found and disclosed only to the District Comi and not the PTO at the
`
`14
`
`appropriate time during the first interference. Not only should the veracity and authenticity of the
`
`15
`
`16
`
`17
`
`February Draft Cabilly II application itself have been called into question by this late and
`
`selective disclosure, but its existence and contents were directly contradictory to evidence and
`
`testimony Defendants previously presented to the PTO. DefeQdants did not inform the District
`
`18 Court or the PTO of such contradictions when the February Draft Cabilly II application was
`
`19
`
`disclosed. In 1999, Dr. Cabilly was deposed and testified under oath that he had "no notes prior
`
`20
`
`to April 30th" that show a co-transformation of heavy and light chains. Dr. Cabilly also
`
`21
`
`affirmatively swore that "I couldn't find any evidence of coexpression of the FAB fragment" at
`
`22
`
`any time in February or March, 1983. An intent to deceive the PTO is the only plausible
`
`23
`
`24
`
`inference to be drawn from the entirely contradictory misrepresentations of material fact
`
`regarding conception, reduction to practice, and fundamentally, the patentability of the Cabilly IT
`
`I !
`
`!
`
`I .
`
`I
`
`i .
`
`I
`
`25
`
`patent.
`
`26
`
`27
`
`28
`MORGAN, lEWIS &
`BocKIUS LlP
`ATTORNF.YSAT L,I,W
`
`P,o,L.OAt.TO
`
`42.
`
`Genentech argued that the February Draft Cabilly II Application contained at l