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UNITED STATES PATENT AND TRADEMARK OFFICE
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`GENENTECH, INC. AND CITY OF HOPE,
`Patent Owners
`
`————————————————
`
`U.S. Patent No. 6,331,415
`Appl. No. 07/205,419, filed June 10, 1998
`Issued: Dec. 18, 2001
`
`Title: Methods of Producing Immunoglobulins, Vectors
`and Transformed Host Cells for Use Therein
`
`————————————————
`
`Inter Partes Review No.: IPR2016-00710
`
`————————————————
`
`PETITIONER’S EXHIBIT LIST
`
`
`
`
`
`

`
`Exhibit
`No.
`
`Description
`
`1001 U.S. Patent No. 6,331,415
`
`1002 U.S. Patent No. 4,495,280
`
`1003
`
`Riggs and Itakura, Synthetic DNA and Medicine,
`American Journal of Human Genetics, 31:531-538
`(1979)
`
`1004
`
`Southern and Berg, Transformation of Mammalian
`Cells to Antibiotic Resistance with a Bacterial Gene
`Under Control of the SV40 Early Region Promoter,
`Journal of Molecular and Applied Genetics, 1:327-
`341 (1982)
`
`1005 U.S. Patent No. 4,237,224
`
`1006
`
`Declaration of Jefferson Foote, Ph.D., in Support of
`Sanofi And Regeneron's Petition for Inter Partes
`Review of U.S. Patent No. 6,331,415
`
`1007 U.S. Patent No. 4,816,657
`
`‘415 patent reexamination, Office Action dated
`2/16/07
`
`‘415 patent reexamination, Owners’ Resp. dated
`Owners’ Resp.
`11/25/05
`(11/25/05)
`‘415 patent reexamination, Owners’ Resp. (5/21/07) Owners’ Resp.
`(5/21/07)
`
`Abbreviation
`
`The ‘415 patent
`
`Bujard, or the
`Bujard Patent
`
`Riggs & Itakura
`
`Southern
`
`Cohen & Boyer,
`or the Cohen &
`Boyer patent
`
`Foote Decl.
`
`The Cabilly I
`patent
`
`Office Action
`(2/16/07)
`
`Office Action
`(9/13/05)
`
`The Boss patent
`
`1008
`
`1009
`
`1010
`
`1011
`
`‘415 patent reexamination, Office Action dated
`9/13/05
`
`1012 U.S. Patent No. 4,816,397
`
`- 1 -
`
`
`
`

`
`Description
`
`Abbreviation
`
`Exhibit
`No.
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`‘415 patent file history, paper no. 17
`
`‘415 patent file history, paper no. 14
`
`‘415 patent file history, paper no. 18
`
`‘415 patent reexamination, Office Action dated
`8/16/06
`
`‘415 patent reexamination, Office Action dated
`2/25/08
`
`-
`
`-
`
`-
`
`Office Action
`(8/16/06)
`
`Office Action
`(2/25/08)
`
`Axel, or the
`Axel patent
`
`Moore, or the
`Moore patent
`
`Rice &
`Baltimore
`
`Ochi (I)
`
`Owners’ Resp.
`(10/30/06)
`
`Owners’ Resp.
`(6/6/08)
`
`Appeal Brief
`
`1018 U.S. Patent No. 4,399,216
`
`1019 U.S. Patent No. 5,840,545
`
`Rice and Baltimore, Regulated Expression of an
`Immunoglobulin K Gene Introduced into a Mouse
`Lymphoid Cell Line, Proceedings of the National
`Academy of Sciences USA, 79:7862-7865 (1982)
`
`Ochi et al., Transfer of a Cloned Immunoglobulin
`Light-Chain Gene to Mutant Hybridoma Cells
`Restores Specific Antibody Production, Nature,
`302:340-342 (1983)
`
`‘415 patent reexamination, Owners’ Resp. dated
`10/30/06
`
`‘415 patent reexamination, Owners’ Resp. dated
`6/6/08
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`‘415 patent reexamination, Appeal Brief
`
`1025
`
`‘415 patent reexamination, Notice of Intent to Issue
`Ex Parte Reexamination
`
`NIRC
`
`
`
`- 2 -
`
`

`
`Exhibit
`No.
`
`Description
`
`1026
`
`‘415 reexamination, Ex Parte Reexamination
`Certificate
`1027 T.J.R. Harris, Expression of Eukaryotic Genes in E.
`Coli, in Genetic Engineering 4, 127-185 (1983)
`
`1028
`
`‘415 patent reexamination, Declaration of Dr.
`Timothy John Roy Harris under 37 C.F.R. § 1.132
`1029 Kabat et al., Sequences of Proteins of Immunological
`Interest (1983) (excerpt)
`1030 Cohen, Recombinant DNA: Fact and Fiction,
`Science, 195:654-657 (1977)
`
`1031
`
`Oi et al., Immunoglobulin Gene Expression in
`Transformed Lymphoid Cells, Proceedings of the
`National Academy of Sciences USA, 80:825-829
`(1983)
`1032 European Patent Application Publication No.
`0044722 A1, published 1/27/82
`
`1033 U.S. Patent No. 4,487,835
`
`1034 U.S. Patent No. 4,371,614
`
`1035 U.S. Patent No. 4,762,785
`
`1036 U.S. Patent No. 4,476,227
`
`1037 U.S. Patent No. 4,362,867
`
`1038 U.S. Patent No. 4,396,601
`
`1039
`
`Milstein, Monoclonal Antibodies from Hybrid
`Myelomas, Proceedings of the Royal Society of
`London, 211:393-412 (1981)
`
`
`
`- 3 -
`
`Abbreviation
`
`Reexam Cert.
`
`Harris
`
`Harris Decl.
`
`Kabat
`
`Cohen
`
`Oi
`
`Kaplan
`
`-
`
`-
`
`-
`
`-
`
`-
`
`-
`
`
`
`

`
`Description
`
`Abbreviation
`
`Exhibit
`No.
`
`1040
`
`1041
`
`1042
`
`1043
`
`Ochi et al., Functional Immunoglobulin M
`Production after Transfection of Cloned
`Immunoglobulin Heavy and Light Chain Genes into
`Lymphoid Cells, Proceedings of the National
`Academy of Sciences USA, 80:6351-6355 (1983)
`
`MedImmune, Inc. v. Genentech, Inc., No. 03-02567
`(C.D. Cal. Aug. 17, 2007), Expert Report of E.
`Fintan Walton
`
`‘415 patent reexamination, Request for
`Reconsideration and/or Petition Under 37 C.F.R.
`§ 1.183 dated 5/15/09
`
`Feldman et al., Lessons from the Commercialization
`of the Cohen-Boyer Patents: The Stanford University
`Licensing Program, in Intellectual Property
`Management in Health and Agricultural Innovation:
`A Handbook of Best Practices, 1797-1807 (2007)
`
`Ochi (II)
`
`Walton Expert
`Rep.
`
`Request for
`Reconsideration
`
`Feldman
`
`ReoPro®
`Prescribing
`Info.
`
`Ghrayeb Aff.
`
`Walton Decl.
`
`-
`
`-
`
`-
`
`1044 ReoPro® Prescribing Information
`
`1045 Genentech v. Centocor, No. 94-01379 (N.D. Cal.),
`Affidavit of John Ghrayeb, Ph.D.
`
`1046
`
`‘415 patent reexamination, Declaration of Dr. E.
`Fintan Walton under 37 C.F.R. § 1.132
`1047 Complaint in MedImmune v. Genentech, No. 03-
`02567 (C.D. Cal.)
`1048 Stipulation and order of dismissal in MedImmune v.
`Genentech, No. 03-02567 (C.D. Cal.)
`1049 Complaint in Centocor v. Genentech, No. 08-CV-
`3573 (C.D. Cal.)
`
`
`
`- 4 -
`
`

`
`Description
`
`Exhibit
`No.
`1050 Order of dismissal in Centocor v. Genentech, No.
`08-CV-3573 (C.D. Cal.)
`1051 Complaint in Glaxo Group Ltd. v. Genentech, No.
`10-02764 (C.D. Cal.)
`1052 Order of dismissal in Glaxo Group Ltd. v.
`Genentech, No. 10-02764 (C.D. Cal.)
`1053 Complaint in Human Genome Sciences v.
`Genentech, No. 11-CV-6519 (C.D. Cal.)
`1054 Order of dismissal in Human Genome Sciences v.
`Genentech, No. 11-CV-6519 (C.D. Cal.)
`1055 Complaint in Eli Lilly and ImClone Systems LLC v.
`Genentech, No. 13-CV-7248 (C.D. Cal.)
`
`1056
`
`Stipulation of dismissal in Eli Lilly and ImClone
`Systems LLC v. Genentech, No. 13-CV-7248 (C.D.
`Cal.)
`1057 Complaint in Bristol-Myers Squibb v. Genentech,
`No. 13-CV-5400 (C.D. Cal.)
`1058 Stipulation of dismissal in Bristol-Myers Squibb v.
`Genentech, No. 13-CV-5400 (C.D. Cal.)
`
`Abbreviation
`
`-
`
`-
`
`-
`
`-
`
`-
`
`-
`
`-
`
`-
`
`-
`
`1059
`
`Declaration of Kathryn Calame, Ph.D., in Support of
`Mylan Pharmaceuticals Inc.’s Petition for Inter
`Partes Review of U.S. Patent No. 6,331,415
`
`Calame Decl.
`
`1060 Curriculum Vitae of Kathryn Calame, Ph.D.
`
`-
`
`
`
`- 5 -
`
`
`
`

`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that true and correct copies of the
`
`foregoing Petitioner’s Exhibit List were served on March 3, 2016, via FedEx
`
`Priority Overnight on the Patent Owners at the correspondence address of record
`
`for the ‘415 patent as evidenced in Public PAIR on March 3, 2016, namely:
`
`JEFFREY P. KUSHAN, ESQ.
`Sidley Austin LLP
`1501 K Street, N.W.
`Washington, D.C. 20005
`
`and
`
`SEAN JOHNSTON, ESQ.
`Genentech, Inc.
`1 DNA Way
`South San Francisco, CA 94080
`
`
`
`Respectfully submitted,
`
`
`
` /Deanne M. Mazzochi/
`Deanne M. Mazzochi (Reg. No. 50,158)
`dmazzochi@rmmslegal.com
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Telephone: (312) 222-6305
`Facsimile: (312) 222-6325
`
`
`
`Dated: March 3, 2016

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