`#:1741
`
`Bruce G. Chapman (SB # 164258)
`bchaQman@cblh.com
`2 Keith D. Fraser (SB # 216279)
`kfraser@cblh.com
`3 CONNOLLY BOVE LODGE & HUTZ LLP
`333 S. Grand Ave. Suite 2300
`4 Los Angeles, California 90071
`Tel: (213) 787-2500; Fax: (213) 687-0498
`
`FILED
`CLERK, U.S. DISTF\ICT COURT
`
`J..l22009
`
`L OISTRICl OF CALIFORNIA
`OCPUfY
`
`r Plaintiff
`...._~5!,-,. ... ORTHO BIOTECH INC.
`
`UNITED STATES DISTRICT COURT
`
`RAL DISTRICT OF CALIFORNIA, WESTERN DIVISION
`
`.• ·H'" ' "" "
`
`, ,
`
`CENTOCOR ORTHO BIOTECH
`INC.
`
`Plaintiff,
`
`v.
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`-~·. '
`
`7
`
`18
`
`20
`
`21
`
`22
`
`23
`
`26
`
`27
`
`28
`
`Woo4totk Wu•Mrt LLP
`O~~e Lilxrty Plalx, 46 Floor
`Philadc:lpiU.t, PA 19103
`(ZU)WJ·JIOO
`
`) Case No. CV 08-03573 MRP (CTx)
`)
`) SECOND AMENDED COMPLAINT
`) FOR DECLARATORY JUDGMENT
`)
`)
`)
`)
`)
`)
`
`Defendants.
`------~~-------------
`
`GENENTECH, INC. and CITY
`24 OF HOPE,
`25
`
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1160
`
`Merck Ex. 1049, pg 1186
`
`
`
`Case 2:08-cv-03573-MRP -JEM Documen,t 106 Filed 07/02/09 Page 2 of 16 Page 10
`#:1742 .
`
`1
`
`Plaintiff Centocor Ortho Biotech Inc. ("Centocor"), for its second amended
`
`2 complaint, alleges as follows:
`
`3
`
`4
`
`5
`
`NATURE OF THE CASE
`
`1.
`
`In this action, Centocor seeks a declaration that U.S. Patent 6,331,415
`
`6 (the "Cabilly IT patent") is invalid, unenforceable and/or not infringed by
`
`7 Centocor' s abciximab and ustekinumab antibody products.
`
`8
`
`THE PARTIES
`
`9
`1 o
`11 Commonwealth of Pennsylvania with a principal place of business in Horsham,
`
`2.
`
`Centocor is a corporation organized under the laws of the
`
`12 Pennsylvania. Centocor's full name, Centocor Ortho Biotech Inc., is the new name
`
`13 of the surviving corporation of a merger effective December 29, 2008 between
`
`14 Centocor, Inc. and Ortho Biotech, Inc.
`3.
`
`15
`
`On information and belief, Genentech, Inc. ("Genentech") is a
`
`16 Delaware corporation with its principal place of business in South San Francisco,
`
`17 California.
`4.
`19 organization with its principal place of operation in Duarte, California.
`
`On information and belief, City of Hope is a California not-for-profit
`
`18
`
`20
`
`5.
`
`On information and belief, Genentech and City of Hope are co-
`
`21 assignees of the Cabilly II patent.
`
`22
`
`23
`
`24
`
`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
`
`-I-
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1161
`
`Merck Ex. 1049, pg 1187
`
`
`
`Case 2:08-cv-03573-MRP -JEM DocumeJ'1t 106 Filed 07/02/09 Page 3 of 16 Page ID
`#:1743 .
`
`7.
`1
`2 principal place of business in California. This Court has personal jurisdiction over
`
`T~is Court has personal jurisdiction over Genentech based on its
`
`3 City of Hope based on its organization under the laws of the state of California and
`
`4 because its principal place of operation is in California.
`
`5
`
`8.
`
`Venue is proper in this district pursuant to 28 U.S.C. §§ 139l(b), (c),
`
`6 and (d).
`
`7
`
`8
`
`9
`
`THE CABILLY PATENTS
`
`9.
`
`On AprilS, 1983, Shmuel Cabilly, Herbert Heyneker, William
`
`10 Holmes, Arthur Riggs and Ronald Wetzel (the "Cabilly Applicants") filed a patent
`
`11 application in the United States Patent and Trademark Office ("PTO") that issued
`
`12 on March 28, 1989, as U.S. Patent No. 4,816,567 (the "Cabilly I patent"). On
`
`13
`
`information and belief, the Cabilly Applicants assigned their rights to Genentech
`
`14 and/or City of Hope.
`
`15
`
`10. On the same day that the Cabilly I patent issued, U.S. Patent
`
`16 4,816,397 (the "Boss patent") issued to Michael Boss, John Kenten, John Emtage
`
`17 and Clive Wood (the "Boss Applicants"). On information and belief, the Boss
`
`18 Applicants assigned their rights to Celltech Therapeutics Limited ("Celltech").
`
`19 Celltech is a British company with its principal place of business in Slough,
`
`20 England.
`
`21
`
`11. At the time that the Boss and Cabilly I patents issued, the Cabilly
`
`22 Applicants had a continuation application pending in the PTO (the "Cabilly II
`
`23 application"). The Cabilly Applicants copied claims from the Boss patent in order
`
`24
`
`25
`
`to provoke the PTO Board of Patent Appeals & Interferences to initiate an
`
`interference proceeding to determine priority- i.e., to determine whether it was the
`
`26 Cabilly Applicants or the Boss Applicants who had made the purported invention
`
`27
`
`first.
`
`28
`
`-2-
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1162
`
`Merck Ex. 1049, pg 1188
`
`
`
`Case 2:()8-cv-03573-MRP -JEM Docume11t 106 Filed 07/02/09 Page 4 of 16 Page 10
`#:1744 .
`
`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
`
`3 both claimed the same purported invention.
`13. After years of adversarial proceedings in the PTO, in August 1998,
`
`4
`
`5
`
`6
`
`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
`
`7 entitled to a patent .... "
`
`8
`
`14.
`
`In October 1998, Genentech filed a civil action to appeal the decision
`
`9 of the PTO Board awarding priority to the Boss patent ( Genentech, Inc. v. Celltech
`
`10 Ltd., Case no. C98-3926 (N.D. Cal.)). In March 2001, the parties to that action
`
`11
`
`filed a notice of settlement and joint request for entry of settlement instruments.
`
`12 As part of their settlement, the parties asked the district court to find that
`
`13 Genentech won the priority contest. The district court then issued an order
`
`14 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.
`15. The Cabilly I patent expired in 2006. Were it not revoked, the Boss
`
`17
`
`18 patent also would have expired in 2006.
`
`19
`
`16. After the district court issued its order to the PTO, the PTO referred
`
`20
`
`the Cabilly II app1i~ation to an examiner for further action, including consideration
`
`21 of materials previously submitted to the PTO that had not clearly been considered
`
`22 by the examiner.
`
`23
`
`17. One of the papers submitted by the Cabilly Applicants prior to
`
`24 declaration of the interference was an Information Disclosure Statement that
`
`identified, among other references, Valle et al., Nature, 300:71-74 (1982). In its
`
`Information Disclosure Statement, the Cabilly II Applicants characterized this
`
`reference as being cited as part of a group of references identified "in the interests
`
`25
`
`26
`
`27
`
`28
`
`-3-
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1163
`
`Merck Ex. 1049, pg 1189
`
`
`
`Case 2:08-cv-03573-MRP -JEM Docume~t 106 Filed 07/02/09 Page 5 of 16 Page 10
`#:1745'
`
`1 of good order" because it was cited during prosecution of the Cab illy I application.
`
`2 The Cabilly Applicants also expressly represented that the Valle (1982) work "is
`
`3 readily distinguishable from the instant claims in that the oocytes are not
`
`4
`
`transformed with DNA, but instead are used to transiently express mRNA
`
`5 preparations." (Sept. 18, 1991 IDS at page 2). This Information Disclosure
`
`6 Statement was signed by a representative of Genentech. This representation,
`
`7 however, contradicted a representation Genentech had made about the Valle
`
`8 (1982) reference when it was opposing CeJitech's European Boss patent.
`
`9
`
`18. During the time that Genentech and Celltech were involved in the
`
`10
`
`interference proceeding, Genentech submitted an opposition to Celltech's
`
`11 European patent (EP-B-0120694), the European patent corresponding to the Boss
`
`12 patent. The claims in the Celltech European Boss patent and the claims in the
`
`13 Cabilly II application were both directed, inter alia, to processes for producing a
`
`14 heterologous lg molecule in a single host cell comprising transforming the host cell
`
`15 with separate DNA sequences encoding polypeptide chains comprising at least the
`
`16 variable domains of the heavy and light chains and then expressing those chains
`
`17 separately in the transformed host cell.
`
`18
`
`19. As part of the grounds for opposition in the European proceeding,
`
`19 Genentech identified the Valle (1982) publication as a reference that anticipated
`
`20
`
`the Boss European patent. Contrary to the characterization of this reference during
`
`21
`
`the Cabilly II application prosecution, Genentech specifically represented to the
`
`22 European Patent Office that Valle (1982):
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`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,
`
`-4-
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1164
`
`Merck Ex. 1049, pg 1190
`
`
`
`Case 2:08-cv-03573-MRP -JEM Documel"!t 106 Filed 07/02/09 Page 6 of 16 Page ID
`#:1746 '
`
`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
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7 Celltech's European Boss patent, Genentech took the position that the Valle (1982)
`
`8 reference clearly teaches the production of an immunologically functional
`
`9 heterologous immunoglobulin molecule in eukaryotic cells transfected by separate
`
`10 DNA molecules encoding its heavy and light chains, whereas during the
`
`11 prosecution of the Cab illy II application, it was asserted that the Valle (1982)
`
`12
`
`reference was "readily distinguishable" because the oocytes were not transformed
`
`13 withDNA.
`
`14
`
`21. The Valle (1982) reference was, by Genentech's own assertions,
`
`15 material to the patentability of at least some of the subject matter common to the
`
`16 Cabilly II application and Boss patent claims. But the Cabilly Applicants did not
`
`17 advise the Examiner that Genentech had relied upon this Valle (1982) reference in
`
`18 opposing the Boss European patent, nor did it advise the Examiner of the contrary
`19 positions that it had taken in the European opposition proceeding with respect to
`
`20
`
`the teachings of the Valle (1982) reference.
`
`21
`
`22. The Information Disclosure Statement submitted by the Cabilly
`
`22 Applicants prior to declaration of the interference also identified, among other
`
`23
`
`24
`
`references, Rice et al., Proc. Natl. Acad. Sci. 77:7862-7865 (1982). In its
`
`Information Disclosure Statement, the Cabilly IT Applicants characterized this
`
`25
`
`reference as being cited as part of a group of references identified "in the interests
`
`26 of good order" because it was cited during prosecution of the Cab illy I application
`
`27 and indicated that they were not providing a copy of this reference.
`
`28
`
`-5-
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1165
`
`Merck Ex. 1049, pg 1191
`
`
`
`Case 2:08-cv-03573-MRP--JEM Documen~ 106 Filed 07/02/09 Page 7 of 16 Page 10
`#:1747
`
`1
`
`23. The citation provided to the PTO was, however, in error. When
`
`2 opposing the Cell tech European Boss patent, Genentech cited Rice et al., Proc.
`
`3 Natl. Acad. Sci. 79:7862-7865 (1982), and argued that the subject matter of the
`
`4 European Boss patent did not involve an inventive step over this disclosure in view
`
`5 of other references.
`
`6
`
`24. Thus, a1though the Rice (1982) reference was, by Genentech's own
`
`7 assertions, material to the patentability of at least some of the subject matter
`
`8 common to the Cabilly II application and Boss patent claims, the Cabilly
`
`9 Applicants did not advise the Examiner that: (a) Genentech had relied upon this
`
`10 Rice (1982) reference in opposing the Boss European patent; (b) that Genentech
`
`11 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
`
`12
`
`13
`
`Information Disclosure Statement. This information was material to the
`
`14 prosecution of the Cabilly II patent.
`
`15
`
`. 25. Also, during this post-interference and post-district court action
`
`16 prosecution of the Cabilly II application (the ''post-proceeding prosecution"), the
`
`17 Cabilly Applicants submitted a substantial amount of material to the PTO,
`
`18
`
`including listings of numerous pleadings from the litigation as well as numerous
`
`19 prior art references. Pursuant to the express provisions of the Manual of Patent
`
`20 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
`
`22 of most significance. MPEP 2004( 13 ). The Cabilly II Applicants did not do so.
`
`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
`
`26 Columbia University ("the '216 patent"). On information and belief, the '216
`
`27 patent was known to Genentech, and its materiality to the Cabilly II claims and
`
`28
`
`-6-
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sano'fi/Regeneron Ex. 1049, pg 1166
`
`Merck Ex. 1049, pg 1192
`
`
`
`Case 2:08-cv-03573-MRP -JEM Document 106 Filed 07/02/09 Page 8 of 16 Page ID
`#:'1748
`
`recombinant production of antibodies in general was known to Genentech, at least
`1
`2 based on the fact that Genentech had taken a license of this patent for which it paid
`
`3 substantial royalties.
`
`4
`
`5
`
`27. The Cabilly II patent issued on December 18, 2001, and is assigned on
`
`its face to Genentech.
`
`6
`
`28. Two different requests to have the Cabilly II patent reexamined were
`7 submitted to the PTO in 2005. (Request for Reexamination of U.S. Patent No.
`
`8 6,331,415, December 23, 2005, Reexamination Control No. 90/007,859; Request
`
`9
`
`for Reexamination ofU.S. Patent No. 6,331,415, May 13,2005, Reexamination
`
`10 Control No. 90/007,542).
`
`11
`
`12
`
`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
`
`13 of the Cabilly II patent and commenced separate reexamination proceedings on
`
`14 July 7, 2005 and January 23, 2006. (Decision Granting Ex Parte Reexamination,
`
`15 Reexamination Control No. 90/007,859; Decision Granting Ex Parte
`
`16 Reexamination, Reexamination Control No. 90/007 ,542). The separate
`
`17
`
`reexamination proceedings were merged on June 6, 2006 (Decision Merging
`
`18 Reexamination Proceedings, Reexamination Control Nos. 90/007,859 and
`
`19 90/007 ,542).
`
`20
`
`30. At present, and as has been the case for nearly three years, all of the
`21 claims in the Cabilly II patent stand rejected in the PTO as invalid. At this point,
`
`22
`
`the rejection is final. (Ex Parte Reexamination Advisory Action, Reexamination
`
`23 Control Nos. 90/007,859 and 90/007,542 (July 19, 2008)). The bases for rejection
`
`24
`
`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 confinned by the fact that it is has been relied upon by
`
`27
`
`28
`
`IYoockortW" ...... lU
`Woockoric Wulllblrw UP
`l9lt .... do(cid:173)
`Phlladd>lllo.PAifl~
`(lU):!A·JIOO
`
`-7-
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1167
`
`Merck Ex. 1049, pg 1193
`
`
`
`Case 2:08-cv-03573-MRP--jEM Document 106 Filed 07/02/09 Page 9 of 16 Page 10
`#:'1749
`
`the PTO in rejecting the Cabilly II patent claims during the reexamination
`
`2 proceeding.
`
`3
`
`32. That the '216 patent is material to the patentability of the Cabilly II
`
`4 patent claims is confirmed by the fact that it is has been relied upon by the PTO in
`
`5
`
`rejecting the Cabilly II patent claims during the reexamination proceeding.
`
`33. The foregoing provides examples of actions demonstrating that,
`6
`7 during examination of the Cabilly II Application, while under a duty of candor to
`
`8
`
`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
`
`10
`
`least from the fact that Genentech failed to disclose statements and references
`
`11 which, by its own assertions in the Boss European Opposition proceedings, were
`12 material to the patentability of the Cab illy II application claims.
`
`13
`
`14
`
`THE LICENSE AGREEMENTS
`
`15 Abciximab (ReoPro®)
`
`16
`
`34. On December 5, 1994, Centocor entered into an Agreement with
`
`17 Genentech under which it received, inter alia, a license under the Cabilly I patent
`
`18 and under the application which ultimately issued as the Cabilly II patent to make,
`
`19 have made, use, and sell substances capable of binding to the GPIIb Ilia receptor
`
`20 which, but for the license, would infringe one or more claims of the patents (the
`
`21
`
`"Genentech Agreement"). Centocor has paid, and Genentech has accepted,
`
`22
`
`royalties on sales of abciximab, an antibody fragment which binds to the
`
`23 glycoprotein GPIIb Ilia of human platelets and inhibits platelet aggregation.
`
`24
`
`35. There is an actual and justiciable controversy between Centocor,
`
`25 Genentech and City of Hope with respect to whether making, using and selling
`
`26 abciximab infringes any valid and enforceable claim of the Cabilly II patent.
`
`27
`
`28
`
`-8-
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1 049, pg 1168
`
`Merck Ex. 1049, pg 1194
`
`
`
`Case 2:08-cv-03573-MRP ~JEM Documen~ 106 Filed 07/02/09 Page 10 of 16 Page 10
`#:1750 .
`
`1
`
`lnfliximab (Remicade®)
`
`2
`
`36. On March 31, 1998, Centocor entered into a Patent License
`
`3 Agreement with Celltech under which it received, inter alia, a non-exclusive
`
`4 sublicense under the "Genentech Licensed Patents," which included the Cabilly I
`
`5 patent and any patents maturing from applications that were continuations of the
`
`6 Cabilly I patent, which includes the later-issued Cabilly II patent (the "Celltech
`
`7 Agreement"). This was a license to develop, make, have made, use and sell a
`
`8 phannaceutical product containing a recombinant engineered antibody or antibody
`
`9 fragment capable of binding specifically to TNF-alpha, being both the product later
`
`10 marketed by Centocor as infliximab (Remicade®) and one additional product
`
`11 whose research and development was conducted under the direction of Centocor
`
`12 by itself or in collaboration with a third party.
`
`13
`
`37. On information and belief, at least a portion of the royalties that
`
`14 Centocor pays to Celltech based on its infliximab (Remicade®) product are passed
`
`15
`
`through, or paid by, Celltech to Genentech and/or City of Hope.
`
`16
`17 Ustekinumab (CNT0-1275)
`
`18
`
`38. Ustekinumab (CNTO 1275) is a new, human monoclonal antibody
`
`19 developed by Centocor which targets the cytokines interleukin-12 (IL-12) and
`
`20
`
`interleukin-23 (IL-23), naturally occurring proteins that are important in regulating
`
`21
`
`immune responses and that are thought to be associated with some immune-
`
`22 mediated inflammatory disorders, including psoriasis.
`
`23
`
`39. All Phase III clinical trials believed necessary to support an
`
`24 application for approval to sell ustekinumab in the United States have been
`
`25 completed. In February 2008, the Biologics License Application (BLA) for
`
`26 ustekinumab (CNTO 1275) was accepted for review by the U.S. Food and Drug
`
`27 Administration for the treatment of chronic moderate-to-severe plaque psoriasis in
`
`28
`
`-9-
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1169
`
`Merck Ex. 1049, pg 1195
`
`
`
`Case 2:08-cv-03573-MRP : jEM Document 106 Filed 07/02/09 Page 11 of 16 Page ID
`#:1751
`
`adults. Centocor expects to obtain regulatory approval to market and sell
`
`2 ustekinumab in the United States within the next year.
`
`3
`
`40. Centocor has been making substantial preparations to market and sell
`
`4 ustekinumab in the United States upon receipt of regulatory approval to do so. It
`
`5 has hired and been training key management, support and sales personnel to
`
`6 market and sell ustekinumab; retaining outside consultants and vendors to assist in
`
`7
`
`its marketing and sale ofustekinumab in the United States; has retained suppliers
`
`8 and advertising agencies to prepare for the launch of the product; has prepared
`
`9 promotional materials for the launch of the product; has initiated planning for
`1 o medial affairs and pharmacovigilance activities associated with the marketing of
`the product; has built supply capacity; and is completing manufacturing and
`11
`
`12 distribution launch preparations.
`
`13
`
`41 . Genentech has advised Centocor that its existing licenses would not
`
`14 cover the marketing and sale ofustekinumab and has acknowledged that Centocor
`
`15 will need an additional license from Genentech under the Cabilly II patent for
`
`16 ustekinumab. There is an actual and justiciable controversy between Centocor,
`
`17 Genentech, and City of Hope with respect to whether Centocor's making, using
`
`18 and selling of ustekinumab will infringe any valid and enforceable claim of the
`
`19 Cabilly II patent.
`
`20
`
`21
`
`22
`
`23
`
`FIRST CAUSE OF ACTION
`
`PATENT INVALIDITY
`
`42. Centocor incorporates the allegations of paragraphs 1 through 41 as if
`
`24
`
`fully set forth herein.
`
`25
`
`43. An actual controversy has arisen and now exists between the parties
`
`26 concerning the validity of the Cabilly II patent.
`
`27
`
`28
`
`- tO-
`SECOND AMEN bED COMPLAINT FOR DECLARATORY iuDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1170
`
`Merck Ex. 1049, pg 1196
`
`
`
`Case 2:08-cv-03573-MRP -jEM Document 106 Filed 07/02/09 Page 12 of 16 Page ID
`#:1752 .
`
`44. The Cabilly II patent is invalid because it is anticipated and/or
`
`2 obvious under 35 U.S.C. §§ 102 and 103.
`
`3
`
`45. The Cab illy II patent is invalid based on the judicially created doctrine
`
`4 of obviousness type double patenting and/or under 35 U.S.C. §§ 101 and/or 103.
`
`5
`
`6
`
`46. The Cabilly II patent is invalid under 35 U.S.C. §112.
`
`47. Centocor hereby seeks a declaratory judgment that the Cabilly III
`
`7 patent is invalid under 35 U.S.C. §§ 101, 102, 103, 112, et seq. and/or under the
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`judicially created doctrine of obviousness type double patenting.
`
`SECOND CAUSE OF ACTION
`
`PATENT UNENFORCEABILITY
`
`48.
`
`C~ntocor 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
`
`1 5 concerning the enforceability of the Cab illy II patent.
`
`16
`
`50. The Cabilly II patent is unenforceable due to inequitable conduct
`
`17 before the PTO. Such conduct includes, but is not limited to, hiding critical
`
`18
`
`references, failing to act with candor regarding the significance of certain prior art,
`
`19 and failing to advise the PTO of positions taken by Genentech in European patent
`
`20 proceedings that were inconsistent with representations made during prosecution of
`
`21
`
`the Cab illy II Application. On information and belief, the Cabilly Applicants
`
`22 and/or Genentech withheld this material information and made these material
`
`23
`
`representations with intent to deceive the patent examiner.
`
`24
`
`51. Centocor hereby seeks a declaratory judgment that the Cabilly II
`
`25 patent is unenforceable due to inequitable conduct.
`
`26
`
`27
`
`28
`
`-II-
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1 049, pg 1171
`
`Merck Ex. 1049, pg 1197
`
`
`
`Case 2:08-cv-03573-MRP =JEM Document 106 Filed 07/02/09 Page 13 of 16 Page ID
`#":1753 .
`
`1
`
`2
`
`3
`
`4
`
`5
`
`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
`
`6 concerning whether Centocor's abciximab or ustekinumab antibody products
`
`7
`
`infringe any valid and enforceable claim of the Cabilly II patent.
`
`8
`
`54. Centocor seeks a declaratory judgment that its making, using and
`9 selling of its abcbdmab and ustekinumab antibody products does not and will not
`
`10
`
`infringe any valid and enforceable claim of the Cabilly II patent.
`
`11
`
`12
`
`13
`
`FOURTH CAUSE OF ACTION
`
`PROSECUTION LACHES
`
`55. Centocor incorporates the allegations of paragraphs 1 through 54 as if
`
`14
`
`fully set forth herein.
`
`15
`
`56. An actual controversy has arisen and now exists between the parties
`
`16 concerning the enforceability of the Cabilly II patent.
`
`17
`
`57. The Cab illy II patent is unenforceable under the doctrine of
`
`18 prosecution laches. The Cabilly II patent issued after an unreasonable and
`
`19 unexplained delay in the interference proceedings between the Cabilly II
`
`20 application and the Boss patent Genentech has also unreasonably delayed the
`
`21 prosecution of the reexamination proceedings involving the Cabilly II patent.
`
`22
`
`58. Centocor hereby seeks a declaratory judgment that the Cabilly II
`
`23 patent is unenforceable due to prosecution laches.
`
`24
`
`25
`
`26
`
`PRAYER FOR RELIEF
`WHEREFORE, Plaintiff Centocor requests that judgment be entered m
`
`27
`
`favor of Centocor and against Defendants:
`
`28
`
`-12~
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1172
`
`Merck Ex. 1049, pg 1198
`
`
`
`Case 2:08-cv-03573-MRP ~JEM Document 106 Filed 07/02/09 Page 14 of 16 Page ID
`#:1754 .
`
`1.
`2.
`3.
`
`4.
`
`5.
`
`6.
`
`Declaring that the Cabi11y II patent is invalid;
`Declaring that the Cabilly II patent is not enforceable;
`
`Declaring that Centocorts abciximab and ustekinumab products
`
`do not infringe any valid and enforceable claim of the Cabilly II
`
`patent;
`Enjoining Genentech and City of Hope from enforcing the
`
`Cabilly II patent;
`Awarding Centocor its costs and attorneyst fees; and
`Awarding Centocor such other and further relief as the Court
`
`may deem just and proper under the circumstances.
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12 Dated: June 15t 2009
`
`Respectfully submitted,
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`WOODCOCK WASHBURN LLP
`
`By:~-~
`
`Aleksander J. Goranin for Dianne B.
`Elderkin
`
`Attorneys for Plaintiff
`CENTOCOR OR THO BIOTECH
`INC.
`
`- 13 -
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1173
`
`Merck Ex. 1049, pg 1199
`
`
`
`Case 2:08-cv-03573-MRP -JEM Document 106 Filed 07/02/09 Page 15 of 16 Page ID
`#:1755 .
`
`CERTIFICATE OF SERVICE
`
`I, Dori Dellisanti, the undersigned, certify and declare that I am over the age
`2 of 18 years, employed in the County of Los Angeles, State of California, and not a
`party to the above-entitled cause. My business address is Connolly Bove Lodge &
`3 Hutz LLP, 333 South Grand Avenue, Suite 2300, Los Angeles, California 90071.
`
`On July~ 2009, I served the foregoing documents described as: SECOND
`AMENDED CuMPLAINT FOR DECLARATORY JUDGMENT on the
`following person(s) in this action by placing a true copy thereof enclosed in sealed
`envelope addressed as follows:
`
`4
`
`5
`
`6
`
`11.---------------------------~----------------------------,
`David I Gindler
`Attorneys for Defendant and
`7 Joseph M Lipner
`Counterclaimant City of Hope Medical
`Irell and Manella
`Center
`8 1800 Avenue of the Stars
`Tel: 310-277-1010
`Suite 900
`Fax: 310-203-7199
`9 Los Angeles, CA 90067-4276
`Email: 'li ner
`irell.com;
`m er Ire .com
`10
`oh. centocor. team@irell.com
`11 Mark A. Pals
`Attorneys for Defendant and
`Counterclaimant Genentech, Inc.
`Marcus E Semel
`12 Kirkland and Ellis LLP
`Tel: 312-861-2000
`Fax: 312-861-2200
`13 300 North LaSalle Street
`Email: m als kirkland.com
`Chicago, IL 60654
`14~------------------------~----~====~======~----~
`15
`
`16
`
`17
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`Woodcocl; Wa.sbbW"'l u.p
`W oodcock W•NI:Mlr• LLP
`2?21 Arc;. Sired
`Phif.delphi1, PA 19104
`(llj)~S-3 1 00
`
`Yl1 J. Durie
`18 D
`Ryan Kent
`19 Durie Tangri Lemley Roberts & Kent
`LLP
`20 332 Pine Street, Suite 200
`San Francisco, CA 94104
`
`Email: ddurie durietan ri.com
`r ent
`unetan n .com
`[X] BY MAIL I am readily familiar with the firm's practice regarding collection
`and processing of correspondence for mailing. Under that practice 1t would be
`deposited witli U.S. Postal Service on that same day with postage thereon fully
`prepaid at Los Angeles, California in the ordinary course of busmess. I am
`aware that on motiOn of the party served, service is presumed invalid if the
`P.Ostal cancellation date or _postage meter date is more than one day after date of
`oeposit for mailing in affidavit.
`
`[ ] BY PERSONAL SERVICE: I caused such envelope to be delivered by hand
`to the addressee( s) as stated above.
`
`] FEDERAL EXPRESS: I am readily familiar with the office practice of
`Connolly Bove Lodge & Hutz LLP tor collecting and processing
`-14-
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1174
`
`Merck Ex. 1049, pg 1200
`
`
`
`Case 2:08-cv-03573-MRP-=-JEM Document 106 Filed 07/02/09 Page 16 of 16 Page 10
`#:1756 .
`
`correspondence for overnight delivery by Federal Express. Such practice is that
`when correspondence for overnight delivery by Federal Express 1s deposited
`with the Connolly Bove Lod~ & Hutz LLP personnel responsible fore
`delivering correspondence to Federal Express, such correspondence is
`deliveredto a Feaeral Express location or to an authorize<:[ courier or driver
`authorized by Federal Express to receive documents or deposited at a facility
`regularly mamtained by Federal Express for receipt of documents on the same
`day in the ordinary course of business.
`
`[X] BY E-MAIL: Based on General Order 08-02, the attached document( s) was
`sent to the person(s) at the e-mail addres(es) indicated through the Court's
`Electronic Filing System (ECF).
`[X] FEDERAL I declare that I am emp1oyed in the office of a member of the bar
`of th1s court at whose direction the service was made.
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`10
`
`I hereby declare under penalty of perjury that the foregoing is true and correct.
`9 Executed on July 2, 2009 at Los Angeles, California.
`.
`Dori Dellisanti ~~
`Signature
`Name
`
`11
`
`12
`
`698678 I
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`Woo«oct WM hb\lfllllLP
`WGOdcoek Wu.bur• LLP
`2.929 Arch Slleet
`Philaddpb~. PA 19104
`(2l .S) 568-1 100
`
`-15 -
`SECOND AMENDED COMPLAINT FOR DECLARATORY JUDGMENT
`
`Sanofi/Regeneron Ex. 1049, pg 1175
`
`Merck Ex. 1049, pg 1201