`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 1 of 20 Page ID #:1
`"H
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`MAYER BROWN LLP
`
`; MICHAEL A. MOLANO (SBN171057)
`mmolano@mayerbrown.com
`Two Palo Alto Square, Suite 300
`‘ 3000 E1Camino Real
`, Palo Alto, CA 94306-2112
`3 Telephone: (650) 331-2000
`, Facsimile:
`(650) 331-2060
`
`’ LISA FERRI (to be admitted pro hac vice)
`lferri@mayerbrown.com
`: RICHARD MCCORMICK (to be admitted pro hac vice)
`rmccormick@mayerbrown.com
`‘ 1675 Broadway
`' New.York, NY 10016-5820
`_ Telephone: (212) 506-2500
`Facsimile:
`(212) 262-1910
`
`‘ Attorneys for Plaintiff
`. BRISTOL-MYERS SQUIBB COMPANY
`
`UNITED STATES DISTRICT COURT
`
`FOR THE NORTHERN DISTRICT OF CALIFORNIA
`
`BRISTOL-MYERS SQUIBB COMPANY,
`Plaintiff,
`
`CASE NO.
`1 3 —
`
`4 5
`
`v.
`
`GENENTECH, INC. and CITY OF HOPE,
`Defendants.
`
`COMPLAINT FOR DECLARATORY
`JUDGMENT
`
`DEMAND FOR JURY TRIAL
`
`Plaintiff Bristol-Myers Squibb Company (“Bristol-Myers Squibb”) for its Complaint
`
`‘ against Genentech, Inc. (“Genentech”) and City of Hope (collectively, “Defendants”), alleges as
`
`;
`
`follows:
`
`NATURE OF THE CASE
`
`1.
`
`In this action, Bristol-Myers Squibb seek a declaration that U.S. Patent No.
`
`6,331,415 entitled “Methods of Producing Immunoglobulins, Vectors and Transformed Host
`
`* Cells for Use Therein” (the “Cabilly II Patent,” attached as Exhibit A), including the Ex Parte
`
`, Reexamination Certificate issued pursuant to Reexamination Nos. 90/007,542 and 90/007,859
`
`COMPLAINT FOR DECLARATORY JUDGMENT
`CASE NO.:
`
`Sanofi/Regeneron Ex. 1057, pg 1263
`
`
`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 2 of 20 Page ID #:2
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 2 of 20 Page ID #:2
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`(attached as Exhibit B), and U.S. Patent No. 7,923,221, entitled ‘;Methods of Making Antibody
`
`- Heavy and Light Chains Having Specificity for a Desired Antigen” (the “Cabilly III Patent,”
`
`I attached as Exhibit C) are invalid and not infringed by the manufacture, use, sale, offer to sell, or
`
`importation of: (1) Erbitux® (cetuximab), an antibody product that Bristol-Myers Squibb sells in ,
`the United States pursuant to a commercial agreement with ImClone Systems LLC (“ImClone”),
`
`3
`
`3 a wholly owned subsidiary of Eli Lilly and Company (“Lilly”); and (2) Plaintiffs Yervoy®
`
`'
`
`'
`
`.‘
`
`(ipilimurnab) antibody product, which it manufactures and sells in the United States. (The
`
`Cabilly II patent and Cabilly III patent are collectively referred to as the “Cabilly Patents.”)
`
`2.
`
`Bristol-Myers Squibb brings this action to lift the cloud created by the imminent
`
`threat of Defendants’ enforcement of the Cabilly Patents against Plaintiff. Without declaratory
`
`relief, the threat of enforcement of the Cabilly Patents poses a substantial risk to Plaintiff as well
`
`as to patients, nurses and doctors now using Erbitux and Yervoy. The continued existence and
`
`I enforcement of these patents impedes not only the development and sale of Erbitux and Yervoy,
`
`‘ but also the development and sale of other life-saving recombinant antibody products.
`
`3.
`
`Defendants have asserted that the Cabilly Patents broadly cover the use of certain
`
`: well-known, conventional recombinant methods to produce any antibody product in any type of
`
`'0 host cell. For example, according to Sean Johnston, then Genentech’s Vice President of
`‘
`Intellectual Property, “[t]he recently issued [Cabilly II] patent broadly covers the co-expression
`
`I of immunoglobulin heavy and light chain genes in a single host cell We do not believe that
`
`l
`
`the claims are limited by type of antibody (murine, humanized, or human) or by host cell type.”
`
`See Debra Robertson, “Genentech Awarded Critical Antibody Patent,” Nature Biotechnology,
`
`vol. 20, p. 108 (Feb. 2002) (attached as Exhibit D).
`
`4.
`
`Defendants have filed multiple infringement claims under the Cabilly Patents
`
`. against companies who have made and sold antibody products that, on information and belief,
`
`were produced using recombinant methods similar to the methods used to make Erbitux and
`
`Yervoy.
`
`5.
`
`In public statements, Genentech has specifically identified Erbitux as a potential
`
`competitor to one of Genentech’s own antibody products, Avastin. See Genentech, Inc., 2008
`-2-
`
`COMPLAINT FOR DECLARATORY JUDGMENT -.
`CASE NO.:
`«
`
`Sanofi/Regeneron Ex. 1057, pg 1264
`
`
`
`i I
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`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 3 of 20 Page ID #:3
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 3 of 20 Page ID #:3
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`10-K Annual Report (2-20-2009), retrieved from SEC EDGAR, at 13. On information and
`
`belief, Genentech’s pipeline antibody product MPDL3280A is presently in clinical trials to test
`
`its safety and effectiveness for the treatment of melanoma, non-small-cell lung carcinoma and
`
`renal cell carcinoma. These indications overlap with those for Plaintiffs Yervoy product, which
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`is approved by the FDA for melanoma.
`
`6.
`
`Genentech has stated that it expects to be involved in future litigations relating to
`
`the enforcement of the Cabilly II patent. See Genentech, Inc., 2008 10-K Annual Report (2-20-
`
`2009), retrieved from SEC EDGAR, at 25, 39. The term of both of the Cabilly Patents expires in I
`
`: December 2018.
`
`7.
`
`Given Defendants’ past acts and statements, as set forth in further detail below,
`
`i
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`the manufacture and sale of Erbitux and Yervoy in the United States creates a real, immediate
`
`I and substantial dispute between the parties concerning the Cabilly Patents, for which Bristol-
`
`l Myers Squibb now seeks declaratory relief.
`
`PARTIES
`
`8.
`Bristol-Myers Squibb is a company organized and existing under the laws of the
`. State of Delaware, having its principal place of business at 345 Park Avenue, New York, New
`
`' York 10154. Bristol-Myers Squibb maintains a research and development facility in Redwood
`
`City, California, that houses biologics drug discovery activities focused on antibody therapeutics.
`
`Bristol-Myers Squibb employs over 150 scientists at its Redwood City facility.
`
`A
`
`9.
`
`On information and belief, Defendant Genentech, Inc. is a corporation duly
`
`: organized and existing under the laws of the State of Delaware, having its principal place of
`
`* business at 1 DNA Way, South San Francisco, California 94080-4990.
`
`10.
`
`On information and belief, Defendant City of Hope is a California not-for-profit
`
`organization duly organized and existing under the laws of the State of California, having its
`
`, principal place of business in Duarte, California. On information and belief, City of Hope has a
`
`place of business in this District at 55 Hawthorne Street, Suite 450, San Francisco, California
`
`, 94105.
`
`-3-
`
`COMPLAINT FOR DECLARATORY JUDGMENT
`CASE NO.:
`
`Sanofi/Regeneron Ex. 1057, pg 1265
`
`
`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 4 of 20 Page ID #:4
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13"Page 4 of 20 Page ID #:4
`‘E.
`.
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`11.
`
`On information and belief, Genentech and City of Hope are co-assignees of the
`
`Cabilly Patents.
`
`JURISDICTION AND VENUE
`
`12.
`
`This action arises under the Declaratory Judgment Act of 1934 (28 U.S.C. §§
`
`2201-2202), Title 28 of the United States Code, for the purposes of determining an actual and
`
`justiciable controversy between the parties, and the patent laws of the United States, Title 35 of
`
`the United States Code. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331
`
`1 and l338(a).
`
`13.
`
`This Court has personal jurisdiction over Genentech based on its principal place
`
`of business in California. This Court has personal jurisdiction over City of Hope based on its
`
`organization under the laws of the State of California and because its principal place of operation
`
`M
`
`‘
`
`is in California.
`
`14.
`
`Venue is proper in this District pursuant to 28 U.S.C. § 1391 because both
`
`Defendants reside in this District and because a substantial part of the events or omissions giving
`
`rise to the claims occurred in this District.
`
`INTRADISTRICT ASSIGNMENT
`
`15.
`
`Pursuant to Civil L.R. 3-2(c), this intellectual property action shall be assigned on
`
`M a district-wide basis.
`
`RELATED CASE
`
`16.
`
`This action concerns substantially the same parties, property, transactions and/or
`
`events as another action filed and presently pending in this District (Oakland Division), Eli Lilly
`
`and Company and ImClone Systems LLC v, Genentech, Inc. and City ofHope, Case No. CV13-
`
`0919 (YGR). There will therefore be an unduly burdensome duplication of labor and expense or
`
`V
`
`~ conflicting results if the cases are conducted before different Judges in this District.
`1
`THE CABILLY PATENTS
`
`17.
`
`On April 8, 1983, Shmuel Cabilly, Herbert Heyneker, William Holmes, Arthur
`
`Riggs, and Ronald Wetzel (collectively, the “Cabil1y Applicants”) filed a patent application in
`
`1
`
`the United States Patent and Trademark Office (“PTO”) that issued on March 28, 1989, as U.S.
`-4-
`
`COMPLAINT FOR DECLARATORY JUDGMENT
`CASE NO.:
`
`Sanofi/Regeneron Ex. 1057, pg 1266
`
`
`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 5 of 20 Page ID #:5
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 5 of 20 Page ID #:5
`"hr
`'-J’
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`‘ Patent No. 4,816,567 (the “Cabilly I Patent”). On its face, the Cabilly 1 Patent is assigned to
`
`M Genentech and, by certificate of correction, is also assigned to City of Hope. The Cabilly I
`
`patent expired on March 28, 2006.
`
`18.
`
`At the time the Cabilly I Patent issued, the Cabilly Applicants had a continuation
`
`application pending in the PTO, which issued on December 18, 2001, as the Cabilly II Patent.
`
`On its face, the Cabilly II Patent is assigned to Genentech and, by certificate of correction, is also
`
`I assigned to City of Hope.
`
`19.
`
`At the time the Cabilly II Patent issued, the Cabilly Applicants had a continuation
`
`application pending in the PTO, which issued on April 12, 2011, as the Cabilly III Patent. The
`
`Cabilly III Patent is assigned to Genentech and City of Hope.
`
`20.
`
`The Cabilly II Patent and Cabilly III Patent relate to recombinant techniques for
`
`‘ manufacturing antibody therapeutics. Both patents claim priority to the Cabilly I Patent
`
`application, filed on April 8, 1983, in the early days of monoclonal antibodies.
`
`21.
`
`The Cabilly II Patent was the subject of a nine-year patent interference and two
`
`reexaminations. The Cabilly III Patent has also been through a patent interference.
`
`22.
`
`The nine-year Cabilly II Patent interference caused the claims of the Cabilly II
`
`‘ Patent to have an effective patent life of 35 years afier the date the Cabilly I Patent application ‘
`
`,1 was filed, with an expiration date on December 18, 2018. The Cabilly III Patent is subject to a
`
`terminal disclaimer, and thus the Cabilly III Patent claims will have the same expiration date as
`
`i
`
`1
`
`the Cabilly II Patent claims.
`
`BRISTOL-MYERS SQUIBB’S AND LlLLY’S ERBITUX®
`
`§CETUXIMAB) PRODUCT
`
`23.
`
`Erbitux® (cetuximab) is a recombinant, mouse/human chimeric monoclonal
`
`antibody that binds to the extracellular domain of human epidermal growth factor receptor
`
`(“EGFR”). Erbitux was first approved by the FDA in 2004 for the treatment of colorectal cancer
`
`‘ and, in 2006, for the treatment of head and neck cancer.
`
`24.
`
`Erbitux was initially developed by ImClone. Lilly, through its wholly owned
`
`subsidiary ImClone, has a commercial agreement with Bristol-Myers Squibb relating to Erbitux.
`-5.
`
`.
`COMPLAINT FOR DECLARATORY IUDGMENT 2
`CASE NO.:
`
`Sanofi/Regeneron Ex. 1057, pg 1267
`
`
`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 6 of 20 Page ID #:6
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 6 of 20 Page ID #:6
`‘hr
`«.1
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`Lilly is responsible for the manufacture and supply of all requirements of Erbitux in bulk-form
`
`active pharmaceutical ingredient ("API") for clinical and commercial use in the United States
`
`and Canada. Bristol-Myers Squibb purchases all of its requirements of API for commercial use
`
`i
`
`from Lilly and exclusively sells Erbitux in the United States and Canada.
`
`25.
`
`Following FDA approval, Bristol-Myers Squibb, in partnership with ImClone and
`
`Lilly, began marketing and selling Erbitux in the United States, physicians began prescribing
`
`Erbitux and patients began taking Erbitux to treat the above-mentioned forms of cancer.
`
`26.
`
`Bristol-Myers Squibb, along with Lilly, has expended substantial revenues
`
`researching and developing Erbitux. Bristol-Myers Squibb also has expended substantial
`
`revenues launching and commercializing Erbitux.
`
`27.
`
`On January 25, 2005, ImClone entered into an agreement with Genentech under
`
`which it received, inter alia, a non-exclusive license to the Cabilly Patents to make, have made,
`
`use, sell and have sold, offer for sale, import and export products which, but for the license, may
`
`infringe one or more claims of the Cabilly Patents (the “ImClone-Genentech Agreement”). On
`
`information and belief, as a result of Lilly’s acquisition of ImClone in 2008, Lilly became a
`
`2 3 4 5
`
`‘
`
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`16
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`.
`
`licensee to the Cabilly Patents and remains a licensee to date. On information and belief,
`
`7 3 9 0
`
`M
`
`sales of Erbitux.
`
`9..
`
`28.
`
`There is an actual and justiciable controversy between Bristol-Myers Squibb and
`
`Defendants with respect to whether making, using, and selling Erbitux infringes any valid claim
`
`. of the Cabilly Patents.
`
`BRISTOL-MYERS sg 2UIBB’S
`
`YERVOY® (IPILIMUMABQ PRODUCT
`
`29.
`
`Yervoy® (ipilimumab) is a recombinantly engineered fully human antibody that
`
`binds to cytotoxic T-lymphocyte antigen 4 (“CTLA-4"). Yervoy was first approved by the FDA
`
`in 2011 for the treatment of patients with unresectable or metastatic melanoma.
`.5-
`
`COMPLAINT FOR DECLARATORY JUDGMENT
`CASE No.:
`
`ImClone, and now Lilly, has paid, and Genentech has accepted, royalties on sales of Erbitux.
`
`V Based on the commercial agreement between Bristol-Myers Squibb and ImClone relating to
`
`1 Erbitux, Bristol-Myers Squibb, through Lilly, has paid, and Genentech has accepted, royalties on
`
`._¢
`
`._n
`
`._x
`
`Ix)
`
`Sanofi/Regeneron Ex. 1057, pg 1268
`
`
`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 7 of 20 Page ID #:7
`Case 2:13-cv-05400-MRPdEM Document 1 Filed 05/03/13vJ3age 7 of 20 Page ID #:7
`
`30.
`Yervoy binds to CTLA-4 and inhibits the interaction of CTLA-4 with its ligands,
`‘ CD80/CD86. Blocking CTLA-4 has been shown to augment T-cell activation and proliferation,
`
`which, in turn, initiates a T-cell mediated anti-tumor immune response. Following FDA
`approval, Bristol-Myers Squibb began marketing and selling Yervoy in the United States,
`
`physicians began prescribing Yervoy and patients began taking Yervoy to treat unresectable or
`
`metastatic melanoma.
`
`31.
`
`Bristol-Myers Squibb has expended substantial revenues researching and
`
`M developing Yervoy. Bristol-Myers Squibb also has expended substantial revenues launching and
`
`up commercializing Yervoy.
`
`32.
`
`Yervoy was initially developed by Medarex, Inc. in Milpitas and Surmyvale,
`
`California. Documents associated with the creation, design and development of Yervoy are now
`
`;
`
`e
`
`located in Bristol-Myers Squibb’s facility in Redwood City, California, as are many of the
`
`scientists who were involved in the creation, design and development of Yervoy. In particular,
`
`three inventors on a U.S. patent covering Yervoy are presently in Redwood City.
`
`33.
`
`On October 25, 2004, Medarex, Inc. entered into an agreement with Genentech
`
`I under which it received, inter alia, a non-exclusive license to the Cabilly Patents to make, have
`
`made, use, sell, offer for sale, and import products which, but for the license, may infringe one or
`
`more claims of the Cabilly Patents (the “Medarex-Genentech Agreement”). As a result of
`
`I Bristol-Myers Squibb’s acquisition of Medarex, Inc. in 2009, Bristol-Myers Squibb became a
`
`licensee to the Cabilly Patents.
`
`34.
`
`Bristol-Myers Squibb has paid, and Genentech has accepted, royalties on sales of
`
`. Yervoy.
`
`35.
`
`There is an actual and justiciable controversy between Plaintiff and Defendants
`
`* with respect to whether making, using, and selling Yervoy infringes any valid claim of the
`
`1‘ Cabilly Patents.
`
`PLAINTIFF’S DISPUTE WITH GENENTECH
`
`REGARDING THE CABILLY PATENTS
`
`-7-
`
`COMPLAINT FOR DECLARATORY JUDGMENT
`CASE NO.:
`
`Sanofi/Regeneron Ex. 1057, pg 1269
`
`
`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 8 of 20 Page ID #:8
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 8 of 20 Page ID #:8
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`36.
`
`Through its statements and actions, Genentech has made clear to the
`
`biopharmaceutical industry generally, and to Plaintiff in particular, that it contends that the
`
`claims of the Cabilly Patents effectively preclude others from commercially manufacturing
`recombinant monoclonal antibodies without Genentech’s permission. In 2002, after the Cabilly
`
`II Patent issued, Sean Johnston, then Genentech’s Vice President of Intellectual Property and
`
`now Genentech’s Senior Vice President and General Counsel said:
`
`“The recently issued patent broadly covers the co-expression of immunoglobulin
`
`heavy and light chain genes in a single host cell We do not believe that the
`
`claims are limited by type of antibody (murine, humanized [90% human
`
`sequence], or human) or by host cell type.”
`
`“Genentech Awarded Critical Antibody Patent,” Nature Biotechnology, vol. 20, p. 108 (Feb.
`
`2002) (Exhibit D).
`
`37.
`
`According to Defendants, the manufacturing method claimed in the Cabilly II
`
`Patent is “the backbone of recombinant production in the biotech industry.” Centocor, Inc. v.
`
`Genentech, Inc., Case No. 08-cv—03573 (C.D. Cal.) (Opening Brief of Claim Construction,
`
`March 24, 2009, at 2), Docket No. 78.
`
`38.
`
`In its 2008 Annual Report l0-K filing with the Securities and Exchange
`
`Commission, Genentech made public statements about pursuing an aggressive litigation policy to
`
`protect its products against competition and to protect against infringement of the Cabilly
`
`Patents:
`
`“Intellectual property protection of our products is crucial to our business. Loss
`
`of effective intellectual property protection could result in lost sales to competing
`
`products and loss of royalty payments (for example, royalty income associated
`
`with the Cabilly patent) from licenses. We are often involved in disputes over
`
`contracts and intellectual property, and we work to resolve these disputes in
`
`confidential negotiations or litigation. We expect legal challenges in this area to
`
`continue. We plan to continue to build upon and defend our intellectual property
`
`position.” (Emphasis added).
`
`-3-
`
`COMPLAINT FOR DECLARATORY JUDGMENT
`CASE NO.:
`
`Sanofi/Regeneron Ex. 1057, pg 1270
`
`
`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 9 of 20 Page ID #:9
`Case 2:13-cv-05400-MRP_-JEM Document 1 Filed 05/03/13J3age 9 of 20 Page ID #:9
`has
`.
`
`Genentech also states: “We have in the past been, are currently, and may in the future be
`
`involved in material litigation and other legal proceedings related to our proprietary rights,
`
`such as the Cabilly patent litigation. ...” (Emphasis added).
`
`39.
`
`Genentech has asserted the Cabilly Patents in litigation against other
`
`manufacturers of recombinant monoclonal antibodies, including Medlmmune, Inc.
`
`(“Medlmmune”), Centocor Inc. (“Centocor”), GlaxoSmithKline LLC (“GSK”), and Human
`
`Genome Sciences, Inc. (“HGS”). On information and belief, the recombinant methods used to
`
`produce Erbitux and Yervoy are similar to the methods used by Medlmmune, Centocor, GSK
`
`and HGS to produce the monoclonal antibody products that were the subject of those parties’
`
`respective infringement lawsuits concerning the Cabilly Patents.
`
`40.
`
`On information and belief, Genentech contends that the process and certain
`
`starting materials used to produce Erbitux and Yervoy infringe one or more claims of the Cabilly
`
`Patents.
`
`41.
`
`For example, the Erbitux and Yervoy antibody products (on the one hand) and
`
`MedImmune’s Synagis®, Centocor’s ReoPro®, GSK’s Arzerra®, and GSK’s and HGS’s
`
`Benlysta® antibody products (on the other hand) are all made by genetically engineering
`
`mammalian host cells to produce the desired antibody in cell culture.
`
`42.
`
`On further information and belief, Synagis, ReoPro, Arzerra and Benlysta are
`
`manufactured using the same or similar transformation and manufacturing processes that are
`
`used to manufacture Erbitux and Yervoy.
`
`A
`
`43.
`
`On information and belief, Genentech has alleged that the corresponding
`
`recombinant methods and starting materials used to produce its Avastin®, Herceptin® and
`
`Rituxan® antibody products fall within the scope of the Cabilly Patents. Like Erbitux and
`
`Yervoy, on information and belief, Genentech’s Avastin, Herceptin and Rituxan are made by
`
`genetically engineering mammalian host cells to produce the desired antibody in cell culture. If
`
`Genentech contends that the manufacturing process to produce Avastin, Herceptin and Rituxan
`
`falls within the scope of the Cabilly Patents, then Plaintiff is informed and believe that
`
`-9-
`
`COMPLAINT FOR DECLARATORY JUDGMENT
`CASE NO.:
`
`Sanofi/Regeneron Ex. 1057, pg 1271
`
`
`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 10 of 20 Page ID #:10
`‘Case 2:13-cv-05400-MRP-JEFM Document 1 Filed 05/03/13 ‘Sage 10 of 20 Page ID #:10
`
`Genentech also contends that the manufacturing process used to produce Erbitux and Yervoy for
`
`Plaintiff also falls within the scope of the Cabilly Patents.
`
`44.
`
`Because Defendants have consistently alleged that the use of well-known,
`
`conventional recombinant methods to produce monoclonal antibodies in mammalian cell culture
`
`is within the scope of the Cabilly Patents and have asserted the Cabilly Patents against others
`
`who are similarly situated to Plaintiff, Defendants’ prior statements and conduct necessarily
`
`establish an actual and substantial dispute between Plaintiff and Defendants regarding the
`
`invalidity and non-infringement of the claims of the Cabilly Patents. Therefore Plaintiff has a
`reasonable apprehension of suit by Genentech and City of Hope regardingthe Cabilly Patents.
`
`FIRST CAUSE OF ACTION
`
`THE CABILLY PATENTS ARE INVALID
`
`45.
`
`Plaintiff incorporates the allegations of paragraph 1 through 44 as if fully set forth
`
`herein.
`
`46.
`
`An actual controversy has arisen and now exists between the parties concerning
`
`the validity of the Cabilly Patents.
`
`47.
`
`The Cabilly Patents are invalid because they are anticipated and/or obvious under
`
`35 U.S.C. §§ 102 and 103.
`
`48.
`
`The Cabilly Patents are invalid based on the judicially created doctrine of
`
`obviousness-type double patenting and/or under 35 U.S.C. §§ 101 and/or 103.
`
`49.
`
`50.
`
`The Cabilly Patents are additionally invalid under 35 U.S.C. § 112.
`
`Plaintiff seeks a declaratory judgment that the Cabilly Patents are invalid under 35
`
`U.S.C. §§ 101, 102, 103 and 112 and/or based on the judicially created doctrine of obviousness-
`
`type double patenting.
`
`SECOND CAUSE OF ACTION
`
`THE CABILLY PATENTS ARE NOT INFRINGED
`
`51.
`
`Plaintiff incorporates the allegations of paragraph 1 through 50 as if fully set forth
`
`herein.
`
`- 1 0-
`
`COMPLAINT FOR DECLARATORY JUDGMENT
`CASE NO.:
`
`Sanofi/Regeneron Ex. 1057, pg 1272
`
`
`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 11 of 20 Page ID #:11
`Case 2:13-cv-05400-MRP-£'ErM Document 1 Filed 05/03/13 _‘F_’_age 11 of 20 Page ID #:11
`
`52.
`
`An actual controversy has arisen and now exists between the parties concerning
`
`whether the manufacture or sale of Erbitux and Yervoy antibody products infringes any valid and
`
`enforceable claim of the Cabilly Patents.
`
`53.
`
`Plaintiff seeks a declaratory judgment that the making, using, importing, offering
`
`to sell, and selling of the Erbitux and Yervoy antibody products do not and will not infringe any
`
`valid and enforceable claim of the Cabilly Patents.
`
`THIRD CAUSE OF ACTION
`
`BRISTOL-MYERS SQUIBB OWES NO ROYALTIES
`
`54.
`
`Plaintiff incorporates the allegations of paragraph 1 through 53 as if fully set forth
`
`herein.
`
`55.
`
`An actual controversy has arisen and now exists between the parties concerning
`
`whether Plaintiff has any obligation to pay royalties to Defendants and/or whether Plaintiff is
`
`entitled to recoup royalties paid to Defendants if the Cabilly Patents are deemed to be invalid
`
`and/or unenforceable.
`
`56.
`
`If the Cabilly Patents are declared to be invalid, Plaintiff is entitled to a
`
`declaratory judgment that it owes no royalties to Genentech and/or City of Hope.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiff requests that judgment be entered in favor of Plaintiff and
`
`against Defendants Genentech, Inc. and City of Hope:
`
`a)
`
`Declaring that Plaintiff does not infringe any valid and enforceable claim of the
`
`Cabilly Patents;
`
`b)
`
`c)
`
`Declaring the Cabilly Patents invalid;
`
`Declaring that the manufacture, use, sale, offer to sell, or importation of Erbitux
`
`and Yervoy antibody products do not infringe any valid and enforceable claim of the Cabilly
`
`Patents;
`
`(1)
`
`Awarding Plaintiff damages at least equivalent to any amounts received by
`
`Genentech and/or City of Hope as royalties or other license fees due on account of the Cabilly
`
`Patents;
`
`-11-
`
`COMPLAINT FOR DECLARATORY JUDGMENT
`CASE NO.:
`
`Sanofi/Regeneron Ex. 1057, pg 1273
`
`
`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 12 of 20 Page ID #:12
`Case 2:13-cv-05400-MRP-EM Document 1 Filed 05/03/13 ‘Fzpge 12 of 20 Page ID #:12
`
`e)
`
`f)
`
`g)
`
`Enjoining Genentech, Inc. and City of Hope from enforcing the Cabilly Patents;
`
`Awarding Plaintiff its costs and attorneys’ fees;
`
`Declaring Plaintiffs case to be exceptional and awarding Plaintiff its attorneys’
`
`fees and expenses under 35 U.S.C. § 285; and
`
`h)
`
`Awarding Plaintiff such other relief as the Court deems just and proper.
`
`DEMAND FOR JURY TRIAL
`
`Pursuant to Rule 38(b) of the Federal Rules of Civil Procedure, Plaintiff demands a trial
`
`by jury of all issues so triable.
`
`Respectfully submitted,
`
`Dated: May 3, 2013
`
`MAYER BROWN LLP
`
`By,‘/\ a\4 \
`
`MICHAEL A. MOLANO
`
`Attorneys for Plaintiff
`Bristol-Myers Squibb Company
`
`Of Counsel:
`
`LISA FERRI (to be admitted pro hac vice)
`RICHARD MCCORMICK (to be admitted pro hac vice)
`MAYER BROWN LLP
`1675 Broadway
`New York, NY 10016-5820
`
`-12-
`
`COMPLAINT FOR DECLARATORY JUDGMENT
`CASE NO.:
`
`Sanofi/Regeneron Ex. 1057, pg 1274
`
`
`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 13 of 20 Page ID #:13
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 13 of 20 Page ID #:13
`up"
`I’
`
`Sanofi/Regeneron Ex. 1057, pg 1275
`
`
`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 14 of 20 Page ID #:14
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 14 of 20 Page ID #:14
`at.
`‘C’
`
`EXHIBIT A
`
`Sanofi/Regeneron Ex. 1057, pg 1276
`
`
`
`Case 2:13-cv-05400-MRP-J EM Document
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 15 of 20 Page ID #:15
`~—
`illlliiililililiiiiiiiliitililfiiliiIiiiillliiiil
`‘D
`
`US006331415B1
`
`(12) United States Patent
`Cabilly et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 6,331,415 B1
`Dec. 18, 2001
`
`(54) METHODS OF PRODUCING
`IMMUNOGLOBULINS, VECTORS AND
`TRANSFORMED HOST CELLS FOR USE
`THEREIN
`
`Inventors: Shmuel Cnbllly, Monrovia; Herbert L.
`Heyneker, Burlingame; William E.
`Holmes, Pacifica; Arthur D. Riggs, La
`Verne; Ronald B. Wetzel, San
`Francisco, all of CA (US)
`
`Genentech, Inc., South San Francisco,
`CA (US)
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154-(b) by 0 days.
`
`Appl. No.: 07/205,419
`Filed:
`Jun. 10, 1988
`
`Related U.S. Application Data
`
`Continuation of application No. 06/483,457, filed on Apr. 8,
`1983, now Pat. No. 4,816,567.
`
`Int. Cl.’ ........................... C12N 15/13; C12N 15/00;
`C12N 15/63
`
`U.S. Cl.
`
`...................... 435/69.6; 435/69.1; 435/69.7;
`435/701; 435/70.21; 435f/1.1; 435/71.2;
`435/320; 435/252.1; 435/252.3; 435/252.33;
`‘435/254.11; 435/254.2; 435/254.21; 435/455;
`435/471; 435/483; 435/485
`
`Field of Search .................................. 435/69.1, 69.7,
`435/71.1, 70.1, 71.2, 320, 261, 252.1, 252.3,
`81, 55, 56, 69.6, 52.33, 254.21, 483
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`
`Primary Exanu'ner—Phi1lip Gambel
`(74) Attorney, Agent, or Firm—Burns, Doane, Swecker &
`Mathis, LLP
`
`ABSTRACT
`(57)
`The invention relates to processes for producing an immu-
`noglobulin or an immunologically functional immunoglo-
`bulin fragment containing at least the variable domains of
`the immunoglobulin heavy and light chains. The processes
`ca.n use one or more vectors which produce both the heavy
`and light chains or fragments thereof in a single cell. The
`invention also relat to the vectors used to produce the
`immunoglobulin or fragment, and to cells transformed with
`the vectors.
`
`36 Claims 19 Drawing Sheets
`
`Sanofi/Regeneron Ex. 1057, pg 1277
`
`
`
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 16 of 20 Page ID #:16
`Case 2:13-cv-05400-MRP-JEM Document 1 Filed 05/03/13 Page 16 of 20 Page ID #:16
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