throbber
FILED
`
`CLERK. U.S. DISTRICT COURT
`
`
`
`
`
`LDISTRICT OF CALIFORNIA
`DEPUTY
`
`
`
`1 Bruce G. Chapman (SB # 164258)
`bqha}]3) an@cblh.com
`2 Kelth
`. Fraser (SB # 216279)
`kfraser
`cb1h.com
`3 CONN
`LY BOVE _LODGE & HUTZ LLP
`-J
`333 S. Grand Ave. Su_1te 2300
`4 Los An eles, Callfomla 90071
`‘I
`: E Tel: (2 3) 787-2500; Fax: (213)687-0498
`(9T
`Dianne B. Elderkin (pro hac vice)
`elderkin woodcoc .com
`Cl‘:
`Barbara L.
`ullin (pro hac vice)
`mullin woodcoc .com
`.
`C
`Steven
`. Maslowskl (pro hac vice)
`8 maslowskj woodcock.com
`Amanda M.
`essel (pro hac vice)
`akessel woodcock_.com
`Aleksan er J. Goramn (pro hac vice)
`agoranin@woodcock.com
`Matthew A. Pearson (pro hac vice)
`woodcock.com
`
`9
`
`10
`
`6 7
`
`K WASIIBURN LLP
`
`RECEIVEDBUTNOTFILED
`
`UNITED STATES DISTRICT COURT
`
`--' RAL DISTRICT OF CALIFORNIA, WESTERN DIVISION
`
`) Case No. CV O8-03573 MRP (CTX)
`)
`) SECOND AMENDED COMPLAINT
`) FOR DECLARATORY JUDGMENT
`;
`)
`)
`>
`)
`
`
`
`_
`_
`Plaintiff,
`V.
`GENENTECH, INC. and CITY
`24 OF HOPE,
`25
`
`CENTOCOR ORTHO BIOTECH
`
`Defendants.
`
`26
`
`27
`
`28
`
`2¥;_:“£§::,‘§.£?§z=.%3,
`
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1160
`
`Mylan Ex. 1049, pg 1160
`
`

`
`Plaintiff Centocor Ortho Biotech Inc. (“Centocor”), for its second amended
`
`complaint, alleges as follows:
`
`NATURE OF THE CASE
`In this action, Centocor seeks a declaration that US. Patent 6,331,415
`1.
`(the “Cabilly II patent”) is invalid, unenforceable and/or not infringed by
`
`
`
`f
`
`2
`
`3 4
`
`5
`6
`
`7 5 Centocor’s abciximab and ustekinumab antibody products.
`
`THE PARTIES
`Centocor is a corporation organized under the laws ofthe
`
`2.
`
`,
`
`8 9
`
`10
`
`Commonwealth of Pennsylvania with a principal place of business in Horsham,
`
`3 Pennsylvania. Centocor’s full name, Centocor Ortho Biotech Inc., is the new name
`
`i of the surviving corporation of a merger effective December 29, 2008 between
`
`Centocor, Inc. and Ortho Biotech, Inc.
`
`3.
`
`On information and belief, Genentech, Inc. (“Genentech”) is a
`
`Delaware corporation with its principal place of business in South San Francisco,
`
`California.
`
`4.
`
`On information and belief, City of Hope is a California not-for-profit
`
`organization with its principal place of operation in Duarte, California.
`
`5.
`
`On information and belief, Genentech and City of Hope are co-
`
`assignees of the Cabilly II patent.
`
`JURISDICTION AND VENUE
`
`6.
`
`This action arises under the Declaratory Judgment Act, Title 28 of the
`
`25 United States Code, Chapter 151, for the purpose of determining an actual and
`
`26
`
`justiciable controversy between the parties hereto. The Court has subject matter
`
`27 jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1338(a).
`
`
`28
`
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`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1161
`
`Mylan Ex. 1049, pg 1161
`
`

`
`7.
`
`This Court has personal jurisdiction over Genentech based on its
`
`2 principal place of business in California. This Court has personal jurisdiction over
`3 A City of Hope based on its organization under the laws ofthe state of California and
`
`4 because its principal place of operation is in California.
`
`8.
`
`Venue is proper in this district pursuant to 28 U.S.C. §§ 139l(b), (c),
`
`THE CABILLY PATENTS
`
`9.
`
`On April 8, 1983, Shmuel Cabilly, Herbert Heyneker, William
`
`Holmes, Arthur Riggs and Ronald Wetzel (the “Cabilly Applicants”) filed a patent
`
`application in the United States Patent and Trademark Office (“PTO”) that issued
`
`on March 28, 1989, as U.S. Patent No. 4,816,567 (the “Cabilly I patent”). On
`
`information and belief, the Cabilly Applicants assigned their rights to Genentech
`
`: and/or City of Hope.
`
`_
`
`_
`
`_
`
`10. On the same day that the Cabilly I patent issued, U.S. Patent
`4,816,397 (the “Boss patent”) issued to Michael Boss, John Kenten, John Emtage
`
`Applicants assigned their rights to Celltech Therapeutics Limited (“Celltech”).
`
`Celltech is a British company with its principal place of business in Slough,
`i England.
`
`1 1. At the time that the Boss and Cabilly I patents issued, the Cabilly
`
`; Applicants had a continuation application pending in the PTO (the “Cabilly 11
`
`application”). The Cabilly Applicants copied claims from the Boss patent in order
`
`to provoke the PTO Board of Patent Appeals & Interferences to initiate an
`
`interference proceeding to determine priority — z'.e., to determine whether it was the
`
`Cabilly Applicants or the Boss Applicants who had made the purported invention
`
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`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1162
`
`Mylan Ex. 1049, pg 1162
`
`

`
` _
`
`12.
`In February 1991, the PTO Board declared a patent interference
`2 between the pending Cabilly II application and the Boss patent on the basis that
`both claimed the same purported invention.
`
`13. After years of adversarial proceedings in the PTO, in August 1998,
`the PTO Board found that the Boss patent was entitled to priority over the Cabilly
`II application. The Final Decision indicated that the Cabilly Applicants were “not
`
`3 entitled to a patent .
`
`.
`
`. .”
`
`14.
`
`In October 1998, Genentech filed a civil action to appeal the decision
`
`directing the PTO to vacate its determination that the Boss Applicants were
`
`15 ; entitled to priority, to revoke the Boss patent, and to issue a patent on the Cabilly II
`16
`
`application.
`
`17
`
`15.
`
`The Cabilly I patent expired in 2006. Were it not revoked, the Boss
`
`13
`
`19
`
`20
`
`patent also would have expired in 2006.
`
`16. After the district court issued its order to the PTO, the PTO referred
`
`I the Cabilly II application to an examiner for further action, including consideration
`
`of materials previously submitted to the PTO that had not clearly been considered
`
`17. One of the papers submitted by the Cabilly Applicants prior to
`
`; declaration of the interference was an Information Disclosure Statement that
`
`identified, among other references, Valle et al., Nature, 300271-74 (1982). In its
`
`Information Disclosure Statement, the Cabilly II Applicants characterized this
`
`27 ? reference as being cited as part of a group of references identified “in the interests
`
`
`
`-23
`
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`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1163
`
`Mylan Ex. 1049, pg 1163
`
`

`
`of good order” because it was cited during prosecution of the Cabilly I application.
`The Cabilly Applicants also expressly represented that the Valle (1982) work “is
`1 readily distinguishable from the instant claims in that the oocytes are not
`
`transformed with DNA, but instead are used to transiently express mRNA
`
`preparations.” (Sept. 18, 1991 IDS at page 2). This Infonnation Disclosure
`
`1 Statement was signed by a representative of Genentech. This representation,
`however, contradicted a representation Genentech had made about the Valle
`
`(1982) reference when it was opposing Celltech’s European Boss patent.
`
`18. During the time that Genentech and Celltech were involved in the
`
`with separate DNA sequences encoding polypeptide chains comprising at least the
`
`5 variable domains of the heavy and light chains and then expressing those chains
`
`V separately in the transformed host cell.
`
`19.
`
`As part of the grounds for opposition in the European proceeding,
`
`clearly teaches the production of an immunologically
`
`functional heterologous immunoglobulin molecule in
`
`eukaryotic cells transfected by separate DNA molecules
`
`encoding its heavy and light chains, respectively.
`
`In
`
`view of the broad implications evidenced by the Abstract,
`
`Woadurk Wadflnm u.9
`£.V;'::';';m
`am aim
`
`"' 4 _
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1164
`
`Mylan Ex. 1049, pg 1164
`
`

`
`the fact that the actual experiment was performed with
`
`microinjected mRNAs is not relevant.
`
`In any event,
`
`because the messenger RNA carries the information from
`
`DNA to the ribosomal sites of protein synthesis,
`
`it is
`
`functionally equivalent to DNA.
`
`20.
`
`Thus, when it was in its interest to do so during its opposition to
`
`5 Celltech’s European Boss patent, Genentech took the position that the Valle (1982)
`
`heterologous immunoglobulin molecule in eukaryotic cells transfected by separate
`
`10 L DNA molecules encoding its heavy and light chains, whereas during the
`11
`prosecution ofthe Cabilly II application, it was asserted that the Valle (1982)
`
`12
`
`reference was “readily distinguishable” because the oocytes were not transformed
`
`13 -
`
`with DNA.
`
`21.
`
`The Valle (1982) reference was, by Genentech’s own assertions,
`
`material to the patentability of at least some of the subject matter common to the
`
`Cabilly II application and Boss patent claims. But the Cabilly Applicants did not
`
`advise the Examiner that Genentech had relied upon this Valle (1982) reference in
`
`opposing the Boss European patent, nor did it advise the Examiner of the contrary
`
`positions that it had taken in the European opposition proceeding with respect to
`
`the teachings of the Valle (1982) reference.
`
`22.
`
`The Information Disclosure Statement submitted by the Cabilly
`
`Applicants prior to declaration of the interference also identified, among other
`E references, Rice et al., Proc. Natl. Acad. Sci. 77:7862-7865 (1982). In its
`
`Information Disclosure Statement, the Cabilly H Applicants characterized this
`
`25
`
`26
`
`27
`
`, 23
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`reference as being cited as part of a group of references identified “in the interests
`
`of good order” because it was cited during prosecution of the Cabilly I application
`
`and indicated that they were not providing a copy of this reference.
`
`_ 5 _
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1165
`
`Mylan Ex. 1049, pg 1165
`
`

`
`23.
`
`The citation provided to the PTO was, however, in error. When
`
`2 opposing the Celltech European Boss patent, Genentech cited Rice et al., Proc.
`3 5 Natl. Acad. Sci. 79:7862-7865 (1982), and argued that the subject matter of the
`
`European Boss patent did not involve an inventive step over this disclosure in view
`
`common to the Cabilly II application and Bess patent claims, the Cabilly
`
`, Applicants did not advise the Examiner that: (a) Genentech had relied upon this
`Rice (1982) reference in opposing the Boss European patent; (b) that Genentech
`A argued that the Boss European patent did not involve an inventive step in view of
`
`this and other references; or (c) that it had mis-cited this reference in its
`
`10
`
`ll
`
`12
`
`13 1 Information Disclosure Statement. This information was material to the
`
`14 prosecution of the Cabilly II patent.
`
`15
`
`16
`
`l7
`
`l8
`
`19
`
`20
`
`-25. Also, during this post-interference and post-district court action
`
`prosecution of the Cabilly 11 application (the “post-proceeding prosecution”), the
`
`' Cabilly Applicants submitted a substantial amount of material to the PTO,
`
`including listings of numerous pleadings from the litigation as well as numerous
`
`prior art references. Pursuant to the express provisions of the Manual of Patent
`
`Examining Procedure, submission of such long lists should be avoided but, if
`
`21 ,. necessary, then Applicants are directed to “highlight” the documents known to be
`of most significance. MPEP 2004(13). The Cabilly 11 Applicants did not do so.
`
`22
`
`23
`24
`25
`
`26. Although the Cabilly II Applicants dumped numerous references on
`the PTO, they failed to identify critical prior art, including U.S. Patent 4,399,216,
`‘ issued to Axel et. al. on August 16, 1983, assigned on its face to The Trustees of
`
`Columbia University (“the ‘21 6 patent”). On information and belief, the ‘216
`
`26 3
`27 1 patent was known to Genentech, and its materiality to the Cabilly II claims and
`
`
`
`28
`
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`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1166
`
`Mylan Ex. 1049, pg 1166
`
`

`
`‘ recombinant production of antibodies in general was known to Genentech, at least
`
`2 based on the fact that Genentech had taken a license of this patent for which it paid
`
`. substantial royalties.
`
`27.
`
`The Cabilly II patent issued on December 18, 2001, and is assigned on
`
`its face to Genentech.
`
`
`
`28.
`Two different requests to have the Cabilly II patent reexamined were
`submitted to the PTO in 2005. (Request for Reexamination of U.S. Patent No.
`7
`6,331,415, December 23, 2005, Reexamination Control No. 90/007,859; Request
`3
`for Reexamination ofU.S. Patent No. 6,331,415, May 13, 2005, Reexamination
`9
`10 Control No. 90/007,542).
`29.
`The PTO concluded that the prior art submitted by the requesters
`
`raised substantial new questions of patentability with respect to each of the claims
`
`of the Cabilly II patent and commenced separate reexamination proceedings on
`
`July 7, 2005 and January 23, 2006. (Decision Granting Ex Parte Reexamination,
`
`1 Reexamination Control No. 90/007,859; Decision Granting Ex Parte
`Reexamination, Reexamination Control No. 90/007,542). The separate
`
`reexamination proceedings were merged on June 6, 2006 (Decision Merging
`
`18
`
`’ Reexamination Proceedings, Reexamination Control Nos. 90/007,859 and
`
`19
`
`20
`
`21
`
`22
`
`23
`
`90/007,542).
`
`30. At present, and as has been the case for nearly three years, all of the
`
`claims in the Cabilly II patent stand rejected in the PTO as invalid. At this point,
`
`the rejection is final. (Ex Parte Reexamination Advisory Action, Reexamination
`l Control Nos. 90/007,859 and 90/007,542 (July 19, 2008)). The bases for rejection
`
`24 1
`
`25
`
`include obviousness-type double patenting.
`
`31.
`
`That the Rice (1982) reference is material to the patentability of the
`
`26 Cabilly II patent claims is confirmed by the fact that it is has been relied upon by
`
`27
`
`28
`
`
`
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`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1167
`
`Mylan Ex. 1049, pg 1167
`
`

`
`
`
`the PTO in rejecting the Cabilly II patent claims during the reexamination
`
`* proceeding.
`
`32.
`
`That the ‘216 patent is material to the patentability of the Cabilly I1
`
`rejecting the Cabilly II patent claims during the reexamination proceeding.
`
`33.
`
`The foregoing provides examples of actions demonstrating that,
`
`during examination of the Cabilly II Application, while under a duty of candor to
`
`the PTO, Genentech and/or the Cabilly Applicants intended to mislead the PTO
`
`9 ! and did not act in good faith in dealing with the PTO. Intent can be inferred at
`
`least from the fact that Genentech failed to disclose statements and references
`
`* which, by its own assertions in the Boss European Opposition proceedings, were
`
`12 material to the patentability of the Cabilly II application claims.
`
`.3 r
`
`14
`
`15 E
`16 E
`
`17 I
`18
`
`THE LICENSE AGREEMENTS
`
`Abciximab (ReoPro®)
`
`34. On December 5, 1994, Centocor entered into an Agreement with
`
`Genentech under which it received, inter alia, a license under the Cabilly I patent
`
`and under the application which ultimately issued as the Cabilly II patent to make,
`19 I have made, use, and sell substances capable of binding to the GPIIb IIIa receptor
`
`20
`
`which, but for the license, would infiinge one or more claims of the patents (the
`
`“Genentech Agreement”). Centocor has paid, and Genentech has accepted,
`
`. royalties on sales of abciximab, an antibody fragment which binds to the
`
`E glycoprotein GPIIb IIIa of human platelets and inhibits platelet aggregation.
`
`35.
`
`There is an actual and justiciable controversy between Centocor,
`
`26 ‘ abciximab infringes any valid and enforceable claim of the Cabilly II patent.
`
`27
`
`28
`
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`
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`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1168
`
`Mylan Ex. 1049, pg 1168
`
`

`
`i Infliximab (Remicade®)
`
`36. On March 31, 1998, Centocor entered into a Patent License
`
`Agreement with Celltech under which it received, inter alia, a non-exclusive
`
`' sublicense under the “Genentech Licensed Patents,” which included the Cabilly I
`
`patent and any patents maturing from applications that were continuations of the
`: Cabilly I patent, which includes the later—issued Cabilly II patent (the “Celltech
`
`Agreement”). This was a license to develop, make, have made, use and sell a
`
`pharmaceutical product containing a recombinant engineered antibody or antibody
`
`fragment capable of binding specifically to TNF-alpha, being both the product later
`
`whose research and development was conducted under the direction of Centocor
`
`by itself or in collaboration with a third party.
`
`37. On information and belief, at least a portion of the royalties that
`i
`J Centocor pays to Celltech based on its infliximab (Remicade®) product are passed
`
`V through, or paid by, Celltech to Genentech and/or City of Hope.
`
`Ustekinumab (CNTO-1275)
`
`38. Ustekinumab (CNTO 1275) is a new, human monoclonal antibody
`
`developed by Centocor which targets the cytokines interleukin—12 (IL-12) and
`interleukin-23 (IL-23), naturally occurring proteins that are important in regulating
`
`immune responses and that are thought to be associated with some immune-
`
`‘ mediated inflammatory disorders, including psoriasis.
`
`39. All Phase III clinical trials believed necessary to support an
`
`application for approval to sell ustekinumab in the United States have been
`5 completed.
`In February 2008, the Biologics License Application (BLA) for
`i ustekinumab (CNTO 1275) was accepted for review by the U.S. Food and Drug
`
`J Administration for the treatment of chronic moderate-to-severe plaque psoriasis in
`
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`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1169
`
`Mylan Ex. 1049, pg 1169
`
`

`
`|—|
`
`O\O0O\lO\U\-P-UJI\J
`
`._n
`
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`
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`
`adults. Centocor expects to obtain regulatory approval to market and sell
`
`ustekinumab in the United States within the next year.
`
`40.
`
`Centocor has been making substantial preparations to market and sell
`
`‘ ustekinumab in the United States upon receipt of regulatory approval to do so. It
`
`has hired and been training key management, support and sales personnel to
`
`' market and sell ustekinumab; retaining outside consultants and vendors to assist in
`
`its marketing and sale of ustekinumab in the United States; has retained suppliers
`
`l and advertising agencies to prepare for the launch of the product; has prepared
`
`promotional materials for the launch of the product; has initiated planning for
`
`medial affairs and pharmacovigilance activities associated with the marketing of
`
`the product; has built supply capacity; and is completing manufacturing and
`
`12 I distribution launch preparations.
`.
`41. Genentech has advised Centocor that its existing licenses would not
`
`' cover the marketing and sale of ustekinumab and has acknowledged that Centocor
`
`will need an additional license from Genentech under the Cabilly II patent for
`
`‘ ustekinumab. There is an actual and justiciable controversy between Centocor,
`
`' Genentech, and City of Hope with respect to whether Centocor’s making, using
`
`and selling of ustekinumab will infringe any valid and enforceable claim of the
`
`Cabilly II patent.
`
`FIRST CAUSE OF ACTION
`
`PATENT INVALIDITY
`
`42.
`
`Centocor incorporates the allegations of paragraphs 1 through 41 as if
`
`fully set forth herein.
`43. An actual controversy has arisen and now exists between the parties
`
`concerning the validity of the Cabilly 11 patent.
`
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`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1170
`
`Mylan Ex. 1049, pg 1170
`
`

`
`44.
`
`The Cabilly II patent is invalid because it is anticipated and/or
`
`2 obvious under 35 U.S.C. §§ 102 and 103.
`I
`45.
`The Cabilly H patent is invalid based on the judicially created doctrine
`
`of obviousness type double patenting and/or under 35 U.S.C. §§ 101 and/or 103.
`
`46.
`
`47.
`
`The Cabilly II patent is invalid under 35 U.S.C. §112.
`
`Centocor hereby seeks a declaratory judgment that the Cabilly HI
`
`9
`
`10 I
`11
`
`12
`
`SECOND CAUSE OF ACTION
`I PATENT UNENFORCEABILITY
`
`48.
`
`Centocor incorporates the allegations of paragraphs 1 through 47 as if
`
`fully set forth herein.
`
`49. An actual controversy has arisen and now exists between the parties
`concerning the enforceability of the Cabilly II patent.
`
`50.
`
`The Cabilly II patent is unenforceable due to inequitable conduct
`
`22
`
`and/or Genentech withheld this material information and made these material
`
`23 E representations with intent to deceive the patent examiner.
`
`51.
`
`Centocor hereby seeks a declaratory judgment that the Cabilly II
`
`
`
`25 patent is unenforceable due to inequitable conduct.
`
`24
`
`26
`
`27
`
`28 1
`
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`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1171
`
`Mylan Ex. 1049, pg 1171
`
`

`
`THIRD CAUSE OF ACTION
`
`NON-INFRINGEMENT
`
`52.
`
`Centocor incorporates the allegations of paragraphs 1 through 51 as if
`
`fully set forth herein.
`
`53. An actual controversy has arisen and now exists between the parties
`
`FOURTH CAUSE. OF ACTION
`
`PROSECUTION LACHES
`
`55.
`
`Centocor incorporates the allegations of paragraphs 1 through 54 as if
`
`prosecution of the reexamination proceedings involving the Cabilly II patent.
`
`58.
`Centocor hereby seeks a declaratory judgment that the Cabilly II
`patent is unenforceable due to prosecution laches.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiff Centocor requests that judgment be entered in
`
`favor of Centocor and against Defendants:
`
`amawawnua.
`znsmusm
`Pluflodolphh VA 19136
`(H5)
`I-Jim
`
`‘ 12”
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1172
`
`Mylan Ex. 1049, pg 1172
`
`

`
`I.
`
`2.
`
`3.
`
`Declaring that the Cabilly II patent is invalid;
`
`Declaring that the Cabilly II patent is not enforceable;
`
`Declaring that Centocor’s abciximab and ustekinurnab products
`
`do not infringe any valid and enforceable claim of the Cabilly II
`patent;
`
`4.
`
`Bnj oining Gcnentech and City of Hope from enforcing the
`
`Cabilly II patent;
`
`5.
`
`6.
`
`Awarding Centocor its costs and attorneys’ fees; and
`
`Awarding Centocor such other and further relief as the Court
`
`may deem just and proper under the circumstances.
`
`I 2
`
`3
`
`4 3
`5
`
`5
`
`7
`
`8 9
`
`10
`
`-_.
`
`I—d
`
`12 Dated: June 15, 2009
`
`Respectfully submitted,
`
`wooococrc WASHBURN LLP
`
`By:
`
`'
`
`-
`
`.-
`
`Aleksander J. Goranin for Dianne B.
`Elderkin
`
`Attorneys for Plaintiff
`CBNTOCOR ORTHO BIOTECH
`INC.
`
`13
`
`14
`
`15
`
`16
`
`17
`18
`
`19
`20
`
`I
`21 i
`
`22
`
`23
`24 '
`
`25 l
`
`26
`
`27 J
`
`28 I
`
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`nmud Ia. mu
`am am
`
`_ 13 "
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1173
`
`Mylan Ex. 1049, pg 1173
`
`

`
`CERTIFICATE OF SERVICE
`
`I, Dori Dellisanti, the undersigned, certify and declare that I am over the age
`of 18 years, employed. in the County of Los Angeles, State of California, and not a
`Iplaity to the above—ent1tled cause. My business address is Connolly_Bov_e Lod e &
`utz LLP, 333 South Grand Avenue, Suite 2300, Los Angeles, California 900 1.
`
`On July 2 2009, I served the foreéloin documents described as: SECOND
`AMENDED COMPLAINT 1}“OR DE _
`TORY JUDGMENT on the
`following person(s3 in this action by placing a true copy thereof enclosed in sealed
`envelope addresse as follows:
`
`
`
`David I Gindler
`Joseph M Lipner
`Irell and Manella
`
`gfigg Qovgnue “the Stars
`Los Angeles’ CA 90067-4276
`
`Mark A. Pals
`1l\</Iia1r(<ius(l13 Seirrfieil LLP
`T an an
`15
`300 North LaSalle Street
`ChiCa80,1L 60654
`
`
`. ~ - W Keker
`'lbert
`
`~
`: 710 Sansme '5»
`.
`'
`San Franc]
`’ A
`
`
`est
`
`. ‘
`
`
`
`Keker an
`
`.
`
`_
`Attorneys for Defendant and
`Counterclaimant City of Hope Medical
`Center
`
`Tel: 310-277-1010
`1Ear1r)i(ail,:1 (')l-i2(fi-0:3-r71i9r9ell.com;
`
`111
`
`CI‘
`
`ire .COITl
`
`0 .centoc0r.teamg@irell.com
`
`Attorneys for Defendant and
`Counterclaimant Genentech, Inc.
`T 1: 312-861-2000
`FSX; 312-361-2200
`Email: m als kirkland.com
`msernelEEEirEIan§.com
`
`‘ - u eys for Defendant a-
`Coun -
`'
`ant Gen -
`, Inc.
`
`.
`,
`
`Egg‘:$115.3.-3991'
`
`
`Email‘
`er 5 kvn.com
`S1 ert I
`n.com
`
`
`
`Attorneys for Defendant and
`Counterclaimant Genentech, Inc.
`
`
`
`
` ‘ D . n J. Durie
`Ryan
`ent
`_
`
`
`Efige Tangri Lemley Roberts & Kent
`
`
`20 332 Pine Street, Suite 200
`
` Email: ddurie 4 durietanricom
`San Francisco, CA 94104
`
`Tel: 415-362-6666
`
`r ent I urietan i.com
`
` 22
`
`[X] BY MAIL_ I am readily familiar with the_firm’s practice regarding collection
`and processi_n of correspondence for mailing. Under that practice it would be
`deposited wit U.S. Postal Service _on that same day with postage thereon fully
`prepaid at Los Angeles, California in the ordinary course of business.
`I am
`aware that on motion of the party served, service is presumed invalid if the
`postal_cancella_ti_on date or o_stage meter date 1S more than one day after date of
`deposit for mailing in affi avit.
`
`[
`
`[
`
`I caused such envelope to be delivered by hand
`] BY PERSONAL SERVICE:
`to the addresseelsi as stated above.
`
`I am readily familiar with the office practice of
`] FEDERAL EXPRESS:
`Connolly Bove Eodge 29¢ Hutz LLP or collecting and processing
`
`23
`
`24
`
`25
`
`25
`
`23
`
`\VoodcockWn: urnLLP
`;Z;‘;‘‘‘,t‘‘.‘..“s‘..":.. ‘”
`Philndelphin, PA mm
`(115) 568-3100
`
`-14-
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1174
`
`Mylan Ex. 1049, pg 1174
`
`

`
`1
`2
`3
`
`4
`
`5
`
`6
`
`7
`
`correspondence for overnight delivefiy by Federal Express. Such practice is that
`when correspondence for ovemiéht eliverly by Federal Express is deposited
`with the Connolly Bove Lod e Hutz LL personnel responsible fore
`deliverin correspondence to ederal Express, such corres ondence is
`delivere to a Fe eral Express location or to an authoriz
`courier or driver
`authorized by Federal Ex ress to receive documents or deposited at a facility
`regularlly maintained by ederal Express for receipt of documents on the same
`day int e ordinary course of business.
`
`[X] BY E-MAIL: Based on General Order 08-02, the attached document(s) was
`sent to the ersongs) at the e-mail addres(es) indicated through the Court’s
`Electronic iling ystem (ECF).
`
`[X] FEDERAL I declare thatl am employed in the office of a member of the bar
`of this court at whose direction the service was made.
`
`I hereby declare under penalt of erju
`9 Executed on July 2, 2009 at Los
`ge es,
`
`that the foregoing is true and correct.
`alifomia.
`
`10
`
`11 ?
`12
`Name
`Signature
`
`698678_l
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
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`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`Woodcock Wmhbmm um
`:¥.;".;*‘,.‘:'::;:;'i""“"“"
`Philndclp .a., PA moo
`(1lS)S6 - D0
`
`_ 1 5 _
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1175
`
`Mylan Ex. 1049, pg 1175

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