`TanyaL. Hunter(SBN: 197761)
`DEWEY BALLANTINE LLP
`333 South Grand Avenue
`Los Angeles, California 90071-1530
`Telephone: (213) 621-6000
`Facsimile: (213) 621-6100
`
`Harvey Kurzweil
`Joseph Angland
`Aldo A. Badini
`Henry J. Ricardo
`Paul T. Olszowka
`Brian S. McGrath
`DEWEY BALLANTINE LLP
`1301 A venue of the Americas
`New York. New York 10019-6092
`Telephone: (212) 259-8000
`Facsimile: (212) 259-6333
`
`Elliot M. Olstein
`CARELLA, BYRNE, BAIN,
`GILFILLAN, CECCHI, STEW ART
`& OLSTEIN, P.C.
`Six Becker Farm Road
`Roseland, New Jersey 07068-1739
`Telephone: (973) 994-1700
`Facsimile: (973) 994-17 44
`
`Attorneys for Plaintiff
`MEDIMMUNE, INC.
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`UNITED STATES DISTRICT COURT
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`CENTRAL DISTRICT OF CALIFORNIA
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`MEDIMMUNE, INC.
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`Plaintiff,
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`vs.
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`GENENTECH, INC., CITY OF HOPE, and
`23 CELLTECH R&D LTD.
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`Defendants.
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`) Case No. 03-2567 MRP (CTX)
`)
`)
`) PLAINTIFF :MEDIMMUNE, INC.'S FIRST
`) AMENDED COMPLAINT FOR:
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`1. Declaratory Judgment;
`)
`) 2. Patent Invalidity;
`) 3. Patent Unenforceability;
`) 4. Non-Infiingement;
`) 5. Section 1 of the Shennan Act;
`) 6. Section 2 of the Sherman Act;
`)
`7. The Ca.rt\Vr:ight Act; and
`8. Section 17200 of the Cal. Bus. & Profs.
`)
`)
`Code.
`)
`) DEMANDFORRmYTruAL
`)
`
`GNE-GSK 00061405
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`Sanofi/Regeneron Ex. 1047, pg 1115
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`Merck Ex. 1047, pg 1141
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`
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`JURISDICTION AND VENUE
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`1.
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`PlaintiffMedlmmune, Inc. ("Medlmmunen) seeks declaratory relief
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`pursuant to Fed. R. Civ. P. 57 and 28 U.S.C. §§ 2201 and 2202. This Court has subject matter
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`jurisdiction pursuant to 28 U.S.C. §§ 1331, 1337 and 1338(a). This Court has jurisdiction over
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`the state law claims asserted hereunder pursuant to 28 U.S.C. § 1367. This Court has personal
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`jurisdiction over defendant Genentech, Inc. ("Genentech") based on its principal place of
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`business in California. This Court has personal jurisdiction over defendant City of Hope
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`("COH") based on its organization under the laws of the state of California and because its
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`principal place of operation is in California This Court has personal jurisdiction over defendant
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`Cell tech R&D Ltd. ("Celltech") based on its activities in this jurisdiction, including, but not
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`limited to, Celltech's filing of a suit against Genentech under 35 U.S.C. § 146 in the Northern
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`District of California captioned Celltech R&D Ltd. v. Genentech, Inc., Civ. Act Ol-3560JCS
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`(N.D. Cal. 2001).
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`2.
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`Venue is proper in this district pursuant to 28 U.S. C.§§ ]39l(b), (c), (d),
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`and 15 U.S.C. §§ 15, 22.
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`THE PARTIES
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`3.
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`PlaintiffMedlmmune, by and through its undersigned attorneys, brings
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`this action under antitrust, patent, and unfair competition laws against defendants Genentech,
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`COH and Celltech (collectively, "Defendants") seeking to challenge an illegal and
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`anticompetitive agreement between Genentech and Celltech to secure the issuance of an invalid
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`and unenforceable patent. Medlmmune seeks declaratory relief that the patent is invalid,
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`unenforceable and/or not infringed by Medlmmune's Synagis® product and that Medlmmune
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`owes no payments under license agreements with Genentech.
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`4.
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`Medlmmune is a Delaware corporation with its principal place of business
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`in Gaithersburg, Maryland. Medlmrnune uses biotechnology to develop and produce antibody
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`therapies.
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`5.
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`Medluunune's most successful product, Synagis®, is used for the
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`prevention of serious lower respiratory tract disease caused by respiratory syncytial virus
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`GNE-GSK 00061406
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`Sanofi/Regeneron Ex. 1 04 7, pg 1116
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`Merck Ex. 1047, pg 1142
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`("RSY") in pediatric patients at high risk ofRSV disease. RSV infection can be fatal in certain
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`high-risk pediatric patients.
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`6.
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`Defendant Genentech is a Delaware corporation with its principal place of
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`business in South San Francisco, California.
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`7.
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`Defendant COH is a California non-for-profit organization with its
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`principal place of operation in Duarte, California. COH is an assignee of the patent at issue in
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`this case.
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`8.
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`Upon information and belief, Celltech is a British company with its
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`principal place of business in Slough, England. Through an intermediary, the Medical Research
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`Counsel, Celltech sub-licensed Medlmmune to use the technology patented in U.S. Patent No.
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`4,816,397 (the "Boss Patent").
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`SVMMARYOFnnsAcnoN
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`9.
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`Medimmune has filed this action to challenge an illegal and
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`anticompetitive agreement (the "Agreement") between Genentech and Celltech, two large
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`biotechnology companies, which has the effect of creating a 29-year patent monopoly over what
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`Genentech now claims is the "fundamental technology" required for the artificial synthesis of
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`antibody molecules. Medimmune likewise seeks a declaration that the patent improperly created
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`by this Agreement is invalid, unenforceable and/or not infringed by Medlmmune's sale of its
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`antibody product, Synagis®, and that Medlmmune owes no payments under license agreements
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`with Genentech.
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`10.
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`Genentech and Celt tech have conceded the existence of the Agreement but
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`to date have refused to make it public. Their refusal to disclose the Agreement is purportedly
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`based on confidentiality grounds, notwithstanding the fact that the alleged "invention" at issue is
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`already twenty years old and is described in issued patents. Nonetheless, the parties' own press
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`releases and public filings about the terms of the Agreement have demonstrated its collusive
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`nature and the fact that it benefits only Cell tech and Genentech, while hamting competition.
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`11.
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`The Agreement between Celltcc:h and Gcncntcc:h was reached in the
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`context of a dispute that began in the United States Patent and Trademark Office (''PTO")
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`3
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`GNE-GSK 00061407
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`Sanofi/Regeneron Ex. 1 047, pg 1117
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`Merck Ex. 1047, pg 1143
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`between Genentech and Celltech regarding priority of invention. Simply put, Genentech asserted
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`that its assignors had invented the same subject matter claimed by the Boss Patent before
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`Celltech's assignors. Thus, Genentech asserted that the Boss Patent held by Cell tech (which had
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`been in effect since 1989) should never have issued and that, instead, a new patent should be
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`granted to Genentech covering this same technology. At the time the Agreement was entered
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`into, the PTO had already rejected Genentech's assertion that it, and not Celltech, was entitled to
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`a patent after conducting an administrative proceeding, known as an interference, that lasted
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`seven years. Additionally, a federal court that considered Genentech's appeal had already
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`rejected Genentech's attempts to obtain smnmary judgment in its favor.
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`12.
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`Notwithstanding Celltech's legal victories over Genentech in this
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`controversy, some time prior to March 16, 2001 Celltech and Genentech entered into the
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`Agreement, pursuant to which (a) Genentech was declared the winner of the legal dispute
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`between them and awarded priority of invention; (b) the PTO would immediately be asked to
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`revoke Celltech's Boss Patent; and (c) the PTO would be asked to issue simultaneously a new
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`patent to Genentech substantially identical to the Boss Patent (the "New Cabilly Patent"), but
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`with a fresh 17-year life.
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`13.
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`By entering the Agreement, Celltech obtained more benefits than it ever
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`could have achieved simply by prevailing in the lawsuit with Genentech. Significantly, a
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`Celltech Annual Report revealed that Genentech agreed to provide Celltech with a ''preferential"
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`license to the New Cabilly Patent. Moreover, although Celltech agreed to an inunediate
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`revocation of its Boss Patent, upon information and belief, it suffered no monetary harm from
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`doing so. According to a Celltech press release, Genentech agreed to make Celltech whole for
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`any royalties Celltech would have received had its Boss Patent remained in existence until2006,
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`when it was to expire. Thus, as pan of the Agreement, Genentech agreed to pay Celltech, the
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`nominal "loser" in the legal dispute, the royalties that Cclltcch would have received had Celltech
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`won. Additionally, Celltech benefits to the extent that Genentech uses the New Cabilly Patent to
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`hann competitors of Cell tech.
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`GNE-GSK 00061408
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`Sanofi/Regeneron Ex. 1047, pg 1118
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`Merck Ex. 1047, pg 1144
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`14.
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`The Agreement thus provided Genentech with monopoly power based on
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`a brand new patent with a full17-year life that would enable Genentech to deny competitors
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`access to what it asserts to be fundamental technology necessary for the production of
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`monoclonal antibodies.
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`15.
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`The Agreement has profoundly and fundamentally altered the competitive
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`landscape in the biotechnology industry. Before the Agreement, Celltech had granted its
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`competitors broad access to this technology by liberally licensing its Boss Patent. Upon
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`infonnation and belief, in reliance upon the permissive licensing policy ofCelltech and the
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`expectation that the patent would expire in 2006, numerous biotechnology companies, including
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`Medlmmune, launched research programs to develop monoclonal antibody products that
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`potentially could provide great health benefits to society .
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`16. Many of these health and life-enhancing products are now in clinical trials
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`to obtain FDA approval and are being prepared for commercialization. Genentech's New Cabilly
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`Patent is an obstacle that can prevent these new antibody products from coming to market.
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`17.
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`Genentech is thus in a position to demand a much higher royalty for use of
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`this technology until2018 (when the New Cabilly Patent will expire). Thus, the Agreement
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`allows Genentech to exclude competitors from the market until2018 or reap monopoly profits
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`from any licenses which it may choose to grant. Cell tech also benefits from this state of affairs
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`because it has "preferential access" to the New Cabilly Patent and to the extent that the New
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`Cabilly Patent may be used to exclude fums that compete with Celltech.
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`18. With its New Cabilly Patent in hand, Genentech immediately exercised its
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`illegally obtained monopoly by advising Medhnmune that the New Cabilly Patent covers
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`Medlmmune's Synagis® product. As a consequence of this assertion, Medlmm~me began to
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`make and continues to make significant payments to Genentech under an agreement entered into
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`by Medlmmunc:: and Genc::ntech on or about June 5, 1997 (the "1997 License Agreement"). This
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`1997 License Agreement provided rights to various intellectual property, including the patent
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`application that later matured into the New Cabilly Parent. After issuance of the New Cabilly
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`Patent, Medlmmune was forced to obtain additional license agreements from Genentech on or
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`GNE-GSK 00061409
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`Sanofi/Regeneron Ex. 1047, pg 1119
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`Merck Ex. 1047, pg 1145
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`about February 7, 2003 -- at substantial cost -- to cover seven new products that MedimmUIJe has
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`been developing (the "2003 License Agreements") (collectively the 1997 and 2003 License
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`Agreements are referred to herein as the "License Agreements").
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`19. Medlmmwte now seeks relief from Genentech and Cell tech for their
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`activities in violation of Sections I and 2 of the Sherman Act, Section 16720 of the California
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`Cartwright Act and Section 17200 of the California Business & Professions Code in connection
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`with the illegal and anticompetitive Agreement.
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`20. Medlmmwte also seeks a declaration that: (a) the New Cabilly Patent
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`(which is co-owned by Genentech and COH) is invalid; (b) the New Cabilly Patent is
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`wtenforceable; (c) Medlmmwte's sales of its Synagis® product do not infringe any valid claim of
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`the New Cabilly Patent; and (d) Medimmune owes no payments to Genentech under the License
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`Agreements.
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`GENENTECH AND CELL TECH REACH THEIR AGREEMENT
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`AND CREATE mE NEW CABILLY PATENT
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`21.
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`On April 8, 1983, Slunuel Cabilly, Herbert L Heyneker, William E.
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`Holmes, Arthur D. Riggs and Ronald B. Wetzel (collectively, the "Applicants") filed U.S. Patent
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`Application No. 483,457 (the "Old Cabilly Application"). Upon information and belief, Shmuel
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`Cabilly and Arthur D. Riggs were ~liated with COH, while Herbert L Heyneker, William E.
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`Holmes and Ronald B. Wetzel were affiliated with Genentech. Upon information and belief,
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`interests in this application and any subsequently issued patents were·assigned to Genentech and
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`COH.
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`22.
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`Based on the Old Cabilly Application, on March 28, 1989 the PTO issued
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`U.S. Patent No. 4,816,567 (the "Old Cabilly Patent") to the above named Applicants.
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`23.
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`On June 10, 1988 the Applicants filed U.S. Patent Application No.
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`205,419 (the "New Cabilly Application") as a continuation to the Old CabiUy Application.
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`24.
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`On the same day the Old Cabilly Patent was issued, March 28, 1989,
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`Celltech was issued the Boss Patent.
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`GNE-GSK 00061410
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`Sanofi/Regeneron Ex. 1 04 7, pg 1120
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`Merck Ex. 1047, pg 1146
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`25.
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`After the Boss Patent was issued. Genentech sought to claim the pwported
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`invention of the Boss Patent as its own. Genentech therefore amended its New Cab illy
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`Application by including claims copied from the Boss Patent, which caused the PTO Board of
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`Patent Appeals & Interferences (the "PTO Board"). to initiate an interference proceeding to
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`determine priority of invention, i.e., who .was first purportedly to invent the subject matter
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`claimed by both Celltech and Genentech.
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`The Seven Year PTO Interference
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`26.
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`On February 28, 1991 the PTO Board declared a patent interference
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`between Genentech's New Cabilly Application and the Boss Patent on the basis that both
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`claimed the same pwported invention.
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`27.
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`Genentech and Cell tech then spent the next seven years in an adversarial
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`interference proceeding before the PTO Board, each arguing that it was the first to make the
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`puiported invention at issue.
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`On August 13, 1998 the PTO Board held that Genentech had failed to
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`carry its burden of proving that it was the first to make the purported invention and therefore
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`held that Celltech's Boss Patent was entitled to priority over the New Cabilly Application.
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`Genenteeb Appeals and Discovers "New" Evidence
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`29.
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`Faced with its loss before the PTO Board, on October 9, 1998 Genentech
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`commenced a civil action, Genentech, Inc. v. Celltech R & D Ltd., Case No. C98-3926 MMC
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`("Civil Action"), in the United States District Court for the Northern District of California wtder
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`35 U.S.C. § 146 to appeal the decision of the PTO Board awarding priority of invention to
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`Celltech.
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`30.
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`The Civil Action lasted for more than two years, and included extensive
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`depositions, document production and expert disclosure.
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`31. More than nine years into the dispute, sometime in early 2000, Shmuel
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`Cabilly claimed to have found - for the very first time - a draft patent application dated
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`February 25, 1963 (the "Draft Cabilly Application") in his files in Israel that, according to
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`Genentech, established that Cabilly and his colleagu~ had mvented the technology a mere 30
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`GNE-GSK 00061411
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`Sanofi/Regeneron Ex. 1 04 7, pg 1121
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`Merck Ex. 1047, pg 1147
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`days before the invention date accorded to the Boss Patent based on its March 25, 1983 British
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`2 Patent Application (the "British Patent Application") filing date.
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`32.
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`Based on the late and highly convenient unearthing of this allegedly
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`critical evidence, Genentech moved the District Court for summary judgment that it should be
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`entitled to priority of invention over Celltech. Genentech argued that because the Draft Cabilly
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`Application contained each and every element of the claimed invention, and was dated earlier
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`than the Boss priority date of March 25, 1983, Genentech should be awarded priority of
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`invention over Boss because Genentech allegedly demonstrated "conception" of the invention by
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`no later than the date of the draft. Further, Genentech argued that it was "reasonably diligent" in
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`preparing and filing the application, which it conceded was a legal prerequisite to being awarded
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`priority. However, in the Civil Action, Genentech was relying on the alleged diligence of its
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`attorneys in preparing the patent application and "constructive" reduction to practice, which was
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`different from the theory of inventor diligence and actual reduction to practice it had argued
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`before the PTO Board.
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`Motive to CoUude
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`33.
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`In opposing Genentech's priority argwnent in the Civil Action based on
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`the Draft Cabilly Application, Celltech asserted that the draft fell short of satisfying the legal
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`requirements for "conception" in that it did not set forth each and every element of the invention.
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`Additionally, Celltech argued that Genentech had changed its basic theory of the case from what
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`it asserted before the PTO Board, a tactic which is not permitted in appeals from PTO
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`interference proceedings.
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`34.
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`~entech responded by pointing out that the Draft Cabilly Application
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`contained at least as much detail as Celltech's March 25, 1983 British Patent Application.
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`24 Separately, Genentech also moved for swnmary judgment that Celltech was not entitled to the
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`25 March 25, 1983 priority date because of defects in the British Patent Application. Genentech's
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`26 motion thus called into question whether Celltech had actually invented the disputed technology .
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`Thus, the dispute over the Draft Cabilly Application caused each party to
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`argue that the other was not in possession of the "invention" at issue in early 1983. This new
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`GNE-GSK 00061412
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`Sanofi/Regeneron Ex_ 1 04 7, pg 1122
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`Merck Ex. 1047, pg 1148
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`posture meant that Genentech and Celltech each argued that the other was not entitled to the
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`patent in question. Genentech and Celltech, which had waged this priority dispute for nine years,
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`should have appreciated the possibility that at the end of a protracted legal battle, neither side
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`4 would end up with a valid patent. This realization provided a strong motive for the Agreement
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`that they entered.
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`36.
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`The illegal and anticompetitive Agreement was reduced to writing by
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`7 Genentech and Celltech sometime after July 31,2000, when the Court denied Genentech's
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`8 motions for summary judgment. Upon information and belief, Genentech and Celltech entered
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`into the Agreement with a bad faith intent to limit and injure competition as illustrated by the
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`fact that the Agreement called for Celltech to concede defeat to Genentech and sacrifice the Boss
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`Patent. Celltech did so, notwithstanding the facts that it had just defeated Genentech's summary
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`judgment motions based on the "newly discovered" evidence, and that Celltech had established
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`priority in the PTO after a seven-year proceeding.
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`According to publicly available statements, the Agreement required
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`< ...
`=-1,1
`:>< £ i 15 Genentech to make Celltech whole by compensating Celltech for the royalties it would have
`~::: ~
`received under the Boss Patent. Such "reverse payments" (so-called because they were made by
`...: 16
`1o1
`.§
`Q
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`17 Genentech, the nominal winner in the "settlement," to Celltech, the nominal loser) thus provided
`
`18 Cell tech all the benefits it would have received had it preserved the victory it had earned at the
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`19
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`20
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`21
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`PTO Board.
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`38.
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`Indeed, the Agreement put Celltech in a position better than any outcome
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`it could have obtained in litigation. Celltech has publicly admitted that Genentech agreed to give
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`22 Celltech and its products "preferential access" to Genentech's New Cabilly Patent, which could
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`23
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`keep competitors at bay, or at a competitive disadvantage, for twelve years longer than Celltech's
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`24 Boss Patent could have done so.
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`25
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`26
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`27
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`28
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`Genentecb and CeUtecb Submit a Deficient Proposed Order to the District Court
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`39.
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`The parties submitted a proposed order to the District Court in order to
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`implement their Agreement. The proposed order contained a "finding" that Genentech won the
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`priority controversy as a matter of law because the Draft Cab illy Application constituted
`
`9
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`GNE-GSK 00061413
`
`Sanofi/Regeneron Ex. 1 04 7, pg 1123
`
`Merck Ex. 1047, pg 1149
`
`
`
`evidence of"conception" prior to the Boss Patent. In fact, as Celltech had argued successfully in
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`opposition to Genentech's summary judgment motion, the Draft Cabilly Application did no such
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`thing in that it was missing certain key elements of the claimed invention. Having first
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`convinced the Court that the Draft Cabilly Application did not prove conception as a matter of
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`law, Celltech reversed course completely and asked the Court to find that it did.
`
`40. Moreover, the fmdings in the proposed order were insufficient as a matter
`
`of law to declare Genentech the prevailing party. In addition to the requirement that Genentech
`
`show "conception" before the Boss priority date, it also was necessary as a matter of well
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`established patent law for Genentech to show "reasonable diligence" during the critical period in
`
`2
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`3
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`4
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`5
`
`6
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`7
`
`8
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`9
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`10
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`order to pre-date the Boss Patent. Despite the fact that both Celltech and Genentech recognized
`
`and briefed this legal requirement in connection with the sununary judgment motions, the
`
`proposed order contained no finding with respect to the essential requirement of"reasonable
`
`diligence." Moreover, Celltech's concession was flatly inconsistent with Celltech's previous
`
`argument that Genentech was precluded from relying on its proffered theory of "attorney
`
`diligence," having failed to raise this issue in the PTO interference proceeding.
`
`41.
`
`Other than striking the word "proposed" in the title, the District Court on
`
`17
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`18
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`19
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`March 16, 2001 signed without change the proposed order that the parties had submitted jointly
`
`in order to implement their illegal and anticompetitive Agreement (the "Order").
`
`42.
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`The March 16,2001 Order (drafted by Genentech and Celltech) remanded
`
`20
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`the case back to the PTO Board for further action consistent with the Agreement. Specifically,
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`21
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`22
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`23
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`the Order directed the PTO Board to do three things: (a) "to vacate the PTO's decision in Cabilly,
`
`et al. v. Boss et al., Patent Interference No. 102,572"; (b) "to revoke and vacate United States
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`Patent No. 4,816,397, issued March 28, 1989 to Boss, et al."; and (c) "to grant and issue to
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`24 Genentech's Inventors (with Genentech as the assignee), with the issue date being the same as
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`the date ofrevocation of United States Patent No. 4,816,397 [the Boss Patent], a United States
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`patent .... " (Emphasis added).
`
`25
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`26
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`27
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`28
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`to
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`GNE-GSK 00061414
`
`Sanofi/Regeneron Ex. 1047, pg 1124
`
`Merck Ex. 1047, pg 1150
`
`
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`1
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`2
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`3
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`4
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`5
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`6
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`7
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`8
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`9
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`19
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`20
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`21
`
`22
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`23
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`24
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`25
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`26
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`27
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`28
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`PTO Board Expresses Concerns Regarding the Agreement
`
`43.
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`In response to the District Court's Order, the PTO Board revoked the Boss
`
`Patent, but refused to issue the New Cabilly Patent, noting that neither the parties nor the District
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`Court had any authority to compel the PTO to issue a patent, particularly when the administrative
`
`examination process had not been completed. ·
`
`44.
`
`The fact that the Agreement called for the instantaneous issuance of the
`
`New Cabilly Patent, when the parties well knew that the examination process had not been
`
`completed, is further evidence of their bad faith and their intent to prevent the PTO from
`
`examining the patentability of the alleged invention.
`
`45.
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`The PTO Board expressed concerns about the parties' Agreement. Among
`
`other things, the PTO Board noted that the Agreement effectively created a 29-year patent: "We
`
`will note that if a patent is issued to Cabilly, its term will begin to run now and the public has
`
`already been subject to patent rights of Boss since 1989, and that the interference has been
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`pending since 1991."
`
`46.
`
`Additionally, the PTO Board expressed concern that Celltech had
`
`seemingly abandoned a winning position. In particular, there was no indication that Celltech had
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`raised with the District Court the issue of whether Genentech's "newly discovered" Draft Cabilly
`
`Application should have been precluded from evidence because Genentech had not shown that it
`
`was diligent in locating this evidence during the more than seven year interference proceeding
`
`before the PTO Board.
`
`47.
`
`In response to the PTO's refusal to issue the New Cabilly Patent to
`
`Genentech at the same time it revoked the Boss Patent, CelJtech filed a new federal coun action
`
`in the United States District Court for the Northern District of California seeking an order
`
`directing the PTO to issue a patent to Genentech. Thus, it appears that Celltc:ch claimed to be
`
`aggrieved by the failure of the PTO to issue a patent to Genentech. Because of the Agreement,
`
`however, Cell tech's concern was understandable: Not only bad Genentech agreed to make
`
`Celltecb whole for any "lost" royalties from tlle Boss Patent, but Genentecb had also agreed to
`
`give Celltech "preferential access" to its New Cabilly Patent; thus, it was now in Celltecb's
`
`ll
`
`GNE-GSK 00061415
`
`Sanofi/Regeneron Ex. 1 04 7, pg 1125
`
`Merck Ex. 1047, pg 1151
`
`
`
`10
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`2
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`3
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`4
`
`5
`
`6
`
`7
`
`8
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`9
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`17
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`18
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`19
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`20
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`21
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`22
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`23
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`24
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`25
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`26
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`27
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`28
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`interest to have the New Cabilly Patent issue so that it could jointly dominate the market with
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`Genentech.
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`Examination of the New CabiUy AppUcation:
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`Inequitable Conduct
`
`48.
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`Despite its stated reservations, the PTO Board referred the New Cabilly
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`Applicati_on to a patent examiner to continue prosecution, given that a major impediment to the
`
`issuance of the patent (namely, the Boss Patent) had now been removed by the agreement
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`between Genentech and Celltech resolving the priority dispute.
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`49.
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`Given that the PTO had issued identical claims in 1989 in the form of the
`
`Boss Patent, the PTO had no reason to believe that the claims that Genentech sought in the New
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`Cabilly Application were unpatentable, nor was the PTO given any reason to consider this issue
`
`while the interference was still pending. Indeed, the only direction that the PTO Board gave to
`
`the PTO examiner was to consider certain references that Genentech had submitted in 1991, after
`
`the PTO had declared the interference. There is no indication that the PTO examiner handling
`
`the matter in 1991 ever considered these references.
`
`50.
`
`Thus, after the July 25,2001 PTO Board decision, prosecution of the New
`
`Cabilly Application resumed before a new patent examiner who had no familiarity with the
`
`previous prosecution of this application, much less with the interference proceeding in the PTO
`
`or the resulting Civil Action.
`
`51.
`
`During examination of the New Cabilly Application, while under a duty of
`
`candor to the PTO, Genentech and/or COH engaged in inequitable conduct with intent to mislead
`
`to PTO in an effort to obtain the New Cabilly Patent.
`
`Patentability Defects
`
`52.
`
`Genentech failed to comply with its duty of candor to the PTO because it
`
`failed to provide to the PTO examiner meaningful disclosure of the significant, material issues as
`
`to the patentability of the claimed invention which became known to Genentech no later than
`
`during the course of the summary judgment briefing in the Civil Action.
`
`12
`
`GNE-GSK 00061416
`
`Sanofi/Regeneron Ex. 1 04 7, pg 1126
`
`Merck Ex. 1047, pg 1152
`
`
`
`53.
`
`During the course of the Civil Action, Celltech developed and presented
`
`2
`
`expert evidence that cast serious doubt upon whether Genentech's final (or draft) New Cabilly
`
`3 Application enabled the claimed invention, which is a requirement of section 112 of the patent
`
`4
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`5
`
`6
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`7
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`laws. Celltech's expert opined that "Genentech's pwported 'conception' lacked a critical
`
`component: the Genentech inventors never came up with a workable method for producing 'an
`
`Ig [immunoglobulin] molecule or an immunologically functional Ig fragment' as the
`
`[interference] Count requires. Celltech has presented expert testimony ... showing that
`
`8 Genentech's [final] patent application and laboratory notebooks are completely devoid of a
`
`9 workable conception because of this failing. In particular, Genentech lacked a method for
`
`I 0
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`17
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`
`18
`
`I9
`
`combining ('refolding') the recombinantly expressed heavy and light chain proteins into a
`
`functional molecule." Opposition to Genentech's Motion for Summary Adjudication that
`
`Genentech Conceived of the Invention Before March 25, 1983 at p. I. In other words, Celltech
`
`offered evidence that Genentech's final New Cabilly Application did not enable the disputed
`
`invention as required by 35 U.S.C. § 112.
`
`54.
`
`Additionally, Celltech's expert Dr. Jonathan S. Weissman concluded in his
`
`expert report (which was quoted in Cell tech's Opposition to Genentech's Motion for Summary
`
`Adjudication that Genentech Conceived of the Invention Before March 25, 1983) that
`
`"Expression of the heavy and light chains from cotransformed E. coli host cells as described in
`
`Genentech's patent application does not produce correctly folded Ig molecules or
`
`20
`
`inununogologically fimctional lg fragments .... (A]s of March 25, 1983, a scientist of ordinary
`
`21
`
`22
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`23
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`24
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`25
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`26
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`27
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`28
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`skill in the art would not, without extensive experimentation, have been able to arrive at
`
`refolding conditions capable of generating an immunologically fimctional protein. Indeed, even
`
`after extensive experimentation, proper folding conditions may not have been possible to find.
`
`Gcncntech never detennined such refolding conditions."
`
`55.
`
`A fortiori, ifGenentech's final New Cabilly Application was insufficient
`
`evidence of a complete conception because it Jacked a solution to the refolding problem, as
`
`Celltech urged, then the Draft Cabilly Application, which was the basis for the settlement, was
`
`also insufficient. Indeed, the Draft Cabilly Application had a section heading entitled
`
`13
`
`GNE-GSK 00061417
`
`Sanofi/Regeneron Ex. 1 04 7, pg 1127
`
`Merck Ex. 1047, pg 1153
`
`
`
`1
`
`2
`
`"Reconstitution [refolding] of Antibody from Recombinant K and Gamma Chains. • However,
`
`that section of the Draft Cabilly Application was completely blank. Therefore, the Draft Cabilly
`
`3 Application (which formed the basis of Genentech's priority claims in the Civil Action) had
`
`4
`
`5
`
`6
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`7
`
`8
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`9
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`absolutely no teaching on a critical part of the purported invention.
`
`56.
`
`Thus, no later than the summary judgment briefing, Genentech became
`
`aware of evidence raising issues as to the patentability of the New Cabilly Application claims
`
`because of a lack of enablement. Such infonnation was material beca