`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`
`SAMSUNG BIOEPIS CO., LTD., Petitioner,
`
`
`v.
`
`
`GENENTECH, INC., Patent Owner.
`
`________________
`
`United States Patent No. 7,892,549
`Title: Treatment with Anti-ErbB2 Antibodies
`
`
`Case No.: IPR2017-01960
`
`________________
`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 7,892,549
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`
`
`
`
`
`
`
`
`
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 7,892,549
`
`TABLE OF CONTENTS
`
`Page(s)
`
`I.
`
`INTRODUCTION .......................................................................................... 1
`
`II. MANDATORY NOTICES ............................................................................ 2
`
`A.
`
`B.
`
`C.
`
`37 C.F.R. § 42.8(b)(1): Real Party-In-Interest ..................................... 2
`
`37 C.F.R. § 42.8(b)(2): Related Matters .............................................. 2
`
`37 C.F.R. § 42.8(b)(3) and (4): Lead and Back-Up Counsel ............... 3
`
`III. FEES (37 C.F.R. § 42.15(a)) .......................................................................... 3
`
`IV. REQUIREMENTS UNDER 37 C.F.R. § 42.104 ........................................... 4
`
`A. Grounds for Standing (37 C.F.R. § 42.104(a)) .................................... 4
`
`B.
`
`Statement of relief requested (37 C.F.R. § 42.104(b)) ......................... 4
`
`V.
`
`THE LEVEL OF ORDINARY SKILL IN THE RELEVANT ART ............. 7
`
`VI. THE SCOPE AND CONTENT OF THE PRIOR ART ................................. 8
`
`A.
`
`Chemotherapeutic Drug Combinations and Known Toxicity of
`Anthracyclines ...................................................................................... 8
`
`B.
`
`Prior Art Cited in the Petition .............................................................. 9
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`Baselga ’97 ................................................................................. 9
`
`Gelmon ’96 .............................................................................. 10
`
`Drebin ’88 ................................................................................ 11
`
`Presta ’97 .................................................................................. 11
`
`Baselga ’96 ............................................................................... 12
`
`Baselga ’94 ............................................................................... 13
`
`VII. THE ’549 PATENT ...................................................................................... 13
`
`VIII. CLAIM CONSTRUCTION ......................................................................... 19
`
`IX. DETAILED STATEMENT OF GROUNDS FOR UNPATENTABILITY 19
`
`
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`i
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`

`Petition for Inter Partes Review of U.S. Patent No. 7,892,549
`
`
`A. Ground 1: Claims 1-11 and 14-17 are unpatentable as obvious over
`Baselga ’97 and Gelmon ’96 .............................................................. 25
`
`1.
`
`Claim 1 ..................................................................................... 25
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`f.
`
`g.
`
`Preamble: “A method for the treatment of a human
`patient with breast cancer that overexpresses ErbB2
`receptor, comprising“ .................................................... 25
`
`Element [a]: “administering a combination of an
`antibody that binds ErbB2,” .......................................... 26
`
`Element [b]: “a taxoid” .................................................. 27
`
`Element [c]: “and a further growth inhibitory agent” ... 27
`
`Element [d]: “to the human patient” .............................. 29
`
`Element [e]: “in an amount effective to end the time
`to disease progression in the human patient” ................ 29
`
`Element [f]: “wherein the antibody binds to epitope
`4D5 within the ErbB2 extracellular sequence” ............. 31
`
`h.
`
`Conclusion ..................................................................... 31
`
`2.
`
`3.
`
`4.
`
`Claim 2: “The method of claim 1 wherein the antibody is a
`humanized 4D5 anti-ErbB2 antibody.” ................................... 32
`
`Claim 3: “The method of claim 1 wherein the antibody
`crossblocks binding of 4D5 to the ErbB2 extracellular
`domain sequence.” ................................................................... 32
`
`Claim 4: “The method of claim 1 wherein the antibody binds
`to amino acid residues in the region from about residue 529
`to about residue 625 of the ErbB2 extracellular domain
`sequence.” ................................................................................ 33
`
`5.
`
`Claim 5 ..................................................................................... 33
`
`a.
`
`b.
`
`Preamble: “A method for the treatment of a human
`patient with breast cancer characterized by
`overexpression of ErbB2 receptor, comprising” ........... 33
`
`Element [a]: “administering an effective amount of a
`combination of an anti-ErbB2 antibody which binds
`
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`Petition for Inter Partes Review of U.S. Patent No. 7,892,549
`
`
`epitope 4D5 within the ErbB2 extracellular domain
`sequence,” ...................................................................... 34
`
`Element [b]: “a taxoid” .................................................. 34
`
`Element [c]: “and a further therapeutic agent,” ............. 34
`
`Element [d]: “to the human patient.” ............................. 35
`
`Conclusion ..................................................................... 35
`
`c.
`
`d.
`
`e.
`
`f.
`
`Claim 6: “The method of claim 5 wherein the breast cancer
`is metastatic breast carcinoma.“ ............................................... 35
`
`Claim 7: “The method of claim 5 wherein the antibody is a
`humanized 4D5 anti-ErbB2 antibody.” ................................... 35
`
`Claim 8: “The method of claim 7 wherein the antibody is
`administered as a 4 mg/kg dose and then weekly
`administration of 2 mg/kg.” ..................................................... 35
`
`Claim 9: “The method of claim 5 wherein the taxoid is
`paclitaxel.” ............................................................................... 37
`
`6.
`
`7.
`
`8.
`
`9.
`
`10. Claim 10: “The method of claim 5 wherein efficacy is
`measured by determining the time to disease progression or
`the response rate.” .................................................................... 37
`
`11. Claim 11: “The method of claim 5 wherein the further
`therapeutic agent is selected from the group consisting of . . .
`growth inhibitory agent.” ......................................................... 38
`
`12. Claim 14: “The method of claim 5 wherein the further
`therapeutic agent is a growth inhibitory agent.” ...................... 38
`
`13. Claim 15: “The method of claim 14 wherein the growth
`inhibitory agent is a DNA alkylating agent.” .......................... 38
`
`14. Claim 16 ................................................................................... 38
`
`a.
`
`Preamble: “A method for the treatment of a human
`patient with ErbB2 overexpression breast cancer,
`comprising” .................................................................... 38
`
`
`
`
`iii
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`Petition for Inter Partes Review of U.S. Patent No. 7,892,549
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`b.
`
`c.
`
`d.
`
`e.
`
`f.
`
`g.
`
`
`Element [a]: “administering a combination of an
`antibody that binds epitope 4D5 within the ErbB2
`extracellular domain sequence,” .................................... 39
`
`Element [b]: “a taxoid” .................................................. 39
`
`Element [c]: “and a further growth inhibitory agent,” .. 39
`
`Element [d]: “in the absence of an anthracycline
`derivative,” ..................................................................... 39
`
`Element [e]: “to the human patient” .............................. 40
`
`Element [f]: “in an amount effective to extend the
`time to disease progression in the human patient.” ....... 40
`
`h.
`
`Conclusion ..................................................................... 40
`
`15. Claim 17: “The method of claim 16 wherein the breast
`cancer is metastatic breast carcinoma.” ................................... 41
`
`B. Ground 2: Claim 12 is unpatentable as obvious over Baselga ’97 in
`view of Gelmon ’96 and Drebin ’88 .................................................. 41
`
`C. Ground 3: Claim 13 is unpatentable as obvious over Baselga ’97 in
`view of Gelmon ’96 and Presta ’97 .................................................... 42
`
`D. Ground 4: Claims 1-11 and 14-17 are unpatentable as obvious over
`Baselga ’96 in view of Baselga ’94 and Gelmon ’96 ........................ 43
`
`1.
`
`Claim 1 ..................................................................................... 43
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`f.
`
`Preamble: “A method for the treatment of a human
`patient with breast cancer that overexpresses ErbB2
`receptor, comprising“ .................................................... 43
`
`Element [a]: “administering a combination of an
`antibody that binds ErbB2,” .......................................... 44
`
`Element [b]: “a taxoid” .................................................. 45
`
`Element [c]: “and a further growth inhibitory agent” ... 46
`
`Element [d]: “to the human patient” .............................. 47
`
`Element [e]: “in an amount effective to extend the
`time to disease progression in the human patient” ........ 47
`
`
`iv
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`Petition for Inter Partes Review of U.S. Patent No. 7,892,549
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`g.
`
`
`Element [f]: “wherein the antibody binds to epitope
`4D5 within the ErbB2 extracellular sequence” ............. 48
`
`h.
`
`Conclusion ..................................................................... 49
`
`Claim 2: “The method of claim 1 wherein the antibody is a
`humanized 4D5 anti-ErbB2 antibody.” ................................... 50
`
`Claim 3: “The method of claim 1 wherein the antibody
`crossblocks binding of 4D5 to the ErbB2 extracellular
`domain sequence.” ................................................................... 50
`
`Claim 4: “The method of claim 1 wherein the antibody binds
`to amino acid residues in the region from about residue 529
`to about residue 625 of the ErbB2 extracellular domain
`sequence.” ................................................................................ 51
`
`2.
`
`3.
`
`4.
`
`5.
`
`Claim 5 ..................................................................................... 51
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`f.
`
`Preamble: “A method for the treatment of a human
`patient with breast cancer characterized by
`overexpression of ErbB2 receptor, comprising” ........... 51
`
`Element [a]: “administering an effective amount of a
`combination of an anti-ErbB2 antibody which binds
`epitope 4D5 within the ErbB2 extracellular domain
`sequence,” ...................................................................... 51
`
`Element [b]: “a taxoid” .................................................. 52
`
`Element [c]: “and a further therapeutic agent,” ............. 52
`
`Element [d]: “to the human patient.” ............................. 52
`
`Conclusion ..................................................................... 53
`
`6.
`
`7.
`
`8.
`
`Claim 6: “The method of claim 5 wherein the breast cancer
`is metastatic breast carcinoma.“ ............................................... 53
`
`Claim 7: “The method of claim 5 wherein the antibody is a
`humanized 4D5 anti-ErbB2 antibody.” ................................... 53
`
`Claim 8: “The method of claim 7 wherein the antibody is
`administered as a 4 mg/kg dose and then weekly
`administration of 2 mg/kg.” ..................................................... 53
`
`
`
`
`v
`
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 7,892,549
`
`9.
`
`
`Claim 9: “The method of claim 5 wherein the taxoid is
`paclitaxel.” ............................................................................... 55
`
`10. Claim 10: “The method of claim 5 wherein efficacy is
`measured by determining the time to disease progression or
`the response rate.” .................................................................... 55
`
`11. Claim 11: “The method of claim 5 wherein the further
`therapeutic agent is selected from the group consisting of . . .
`growth inhibitory agent.” ......................................................... 55
`
`12. Claim 14: “The method of claim 5 wherein the further
`therapeutic agent is a growth inhibitory agent.” ...................... 56
`
`13. Claim 15: “The method of claim 14 wherein the growth
`inhibitory agent is a DNA alkylating agent.” .......................... 56
`
`14. Claim 16 ................................................................................... 56
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`f.
`
`g.
`
`Preamble: “A method for the treatment of a human
`patient with ErbB2 overexpression breast cancer,
`comprising” .................................................................... 56
`
`Element [a]: “administering a combination of an
`antibody that binds epitope 4D5 within the ErbB2
`extracellular domain sequence,” .................................... 57
`
`Element [b]: “a taxoid” .................................................. 57
`
`Element [c]: “and a further growth inhibitory agent,” .. 57
`
`Element [d]: “in the absence of an anthracycline
`derivative,” ..................................................................... 57
`
`Element [e]: “to the human patient” .............................. 58
`
`Element [f]: “in an amount effective to extend the
`time to disease progression in the human patient.” ....... 58
`
`h.
`
`Conclusion ..................................................................... 58
`
`15. Claim 17: “The method of claim 16 wherein the breast
`cancer is metastatic breast carcinoma.” ................................... 59
`
`E.
`
`Ground 5: Claim 12 is unpatentable as obvious over Baselga ’96 in
`view of Baselga ’94, Gelmon ’96 and Drebin ’88 ............................. 59
`
`
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`vi
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 7,892,549
`
`F.
`
`
`Ground 6: Claim 13 is unpatentable as obvious over Baselga ’96 in
`view of Baselga ’94, Gelmon ’96, and Presta ’97 ............................. 60
`
`G.
`
`Secondary India do not support a finding of nonobviousness ........... 61
`
`X.
`
`CONCLUSION ............................................................................................. 65
`
`
`
`
`
`
`
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`vii
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`Petition for Inter Partes Review of U.S. Patent No. 7,892,549
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Page(s)
`
`Hospira UK Ltd. v. Genentech Inc.,
`Case No. A3 2015 3238, [2016] EWCA Civ 1185 (Nov. 30, 2016) ............... 3
`
`Hospira UK, Ltd. v. Genentech, Inc.,
`Case No. HP-2014-000034, [2015] EWHC (HC) 1796 (Pat), (Jun. 24, 2015)
` ......................................................................................................................... 2
`
`In re Woodruff,
`919 F.2d 1575 (Fed. Cir. 1990) .............................................................. 36, 54
`
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007).......................................................................................20
`
`Pozzoli Spa v. BDMO SA & Anor.,
`2007 WL 1685192, [2007] EWCA Civ. 588 (Jun. 22, 2007) .......................19
`
`Rasmusson v. SmithKline Beecham Corp.,
`413 F.3d 1318 (Fed. Cir. 2005) .....................................................................23
`
`Statutes
`
`35 U.S.C. § 102 ......................................................................................................5, 6
`
`35 U.S.C. § 103 ............................................................................................... 4, 5, 19
`
`35 U.S.C. § 112 ........................................................................................................23
`
`35 U.S.C. § 311 .......................................................................................................... 1
`
`35 U.S.C. § 312 .......................................................................................................... 1
`
`35 U.S.C. § 313 .......................................................................................................... 1
`
`35 U.S.C. § 314 .......................................................................................................... 1
`
`35 U.S.C. § 315 ......................................................................................................1, 4
`
`35 U.S.C. § 316 .......................................................................................................... 1
`
`
`
`
`viii
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`

`Petition for Inter Partes Review of U.S. Patent No. 7,892,549
`
`
`35 U.S.C. § 317 .......................................................................................................... 1
`
`35 U.S.C. § 318 .......................................................................................................... 1
`
`35 U.S.C. § 319 .......................................................................................................... 1
`
`Rules
`
`37 C.F.R. § 1.68 ......................................................................................................... 7
`
`37 C.F.R. § 42 ............................................................................................................ 1
`
`37 C.F.R. § 42.8 .....................................................................................................2, 3
`
`37 C.F.R. § 42.10 ....................................................................................................... 1
`
`37 C.F.R. § 42.15 ....................................................................................................... 3
`
`37 C.F.R. § 42.100 ...................................................................................................19
`
`37 C.F.R. § 42.104 ..................................................................................................... 4
`
`MPEP 2144.06 .........................................................................................................22
`
`MPEP 2159.01 ........................................................................................................... 4
`
`
`
`
`ix
`
`
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`

`

`Petition for Inter Partes Review of U.S. Patent No. 7,892,549
`
`
`
`
`
`
`Exhibit No.
`
`Description
`
`PETITIONER’S EXHIBIT LIST
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`U.S. Patent No. 7,892,549
`
`Assignment to Genentech, Inc. filed in U.S. Patent No. 7,846,441
`
`Eur. Patent Specification No. 1,037,926 B1
`
`Hospira UK, Ltd. v. Genentech, Inc., Case No. HP-2014-000034,
`[2015] EWHC (CH) 1796 (Pat), (Jun. 24, 2015), Approved
`Judgment
`
`Baselga et al., Phase II Study of Weekly Intravenous Recombinant
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`
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`
`
`x
`
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`
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`

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`Petition for Inter Partes Review of U.S. Patent No. 7,892,549
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`
`
`
`
`Exhibit No.
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`1024
`
`1025
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`1026
`
`1027
`
`1028
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`1029
`
`1030
`
`1031
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`Before the European Patent Office in Munich on 02 May 2016,
`Application No. 98,963,840.8 (Jun. 13, 2016)
`
`Declaration of Scott Weingaertner
`
`Reserved
`
`Reserved
`
`Reserved
`
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`
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`
`1038
`
`Reserved
`
`
`xii
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`
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`

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`Petition for Inter Partes Review of U.S. Patent No. 7,892,549
`
`Exhibit No.
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`
`
`
`
`PETITIONER’S EXHIBIT LIST
`
`Description
`
`Reserved
`
`Pegram et al., Monoclonal Antibody to HER-2/neu Gene Product
`Potentiates Cytotoxicity of Carboplatin and Doxorubicin in
`Human Breast Tumor Cells, 33 PROCEEDINGS OF THE AMERICAN
`ASSOCIATION FOR CANCER RESEARCH, 442 (Abstract 2639) (1992)
`(“Pegram ʼ92”)
`
`Pegram et al., The Effect of HER-2/neu Overexpression on
`Chemotherapeutic Drug Sensitivity in Human Breast and Ovarian
`Cancer Cells, 15(5) ONCOGENE 537–47 (1997) (“Pegram ʼ97”)
`
`Shan et al., Anthracycline-Induced Cardiotoxicity, 125(1) ANN.
`INTERN. MED. 47–58, (1996) (“Shan ’96”)
`
`Mendelsohn et al., Epidermal Growth Factor Receptor Family and
`Chemosensitization, 89(5) J. NATL. CANCER INSTITUTE 341–43
`(1997) (“Mendelsohn ʼ97”)
`
`U.S. Environmental Protection Agency, National Center for
`Environmental Assessment (NCEA), Office of Research and
`Development (ORD), Exposure Factors Handbook (1997)
`https://ofmpub.epa.gov/eims/eimscomm.getfile?p_download_id=5
`03445
`
`Jones et al., Replacing the Complementarity-Determining Regions
`in a Human Antibody With Those From a Mouse, 321(6069)
`NATURE 522–25 (1986) (“Jones ’86”)
`
`Declaration of Simon Cohen, filed in connection with IPR 2017-
`00737
`
`Miller et al., Reporting Results of Cancer Treatment, 47(1)
`CANCER 207–14 (1981) (“Miller ’81”)
`
`Johnson et al., Food and Drug Administration Requirements for
`Approval of New Anticancer Drugs, 69(10) CANCER TREATMENT
`REPORTS 1155–57 (1985)
`
`Hospira UK Ltd. v. Genentech Inc., Case No. A3 2015 3238,
`[2016] EWCA Civ 1185, (Nov. 30, 2016), Approved Judgment
`
`Library of Congress Copyright Record for Baselga ʼ96
`
`Library of Congress Copyright Record for Baselga ʼ97
`
`
`xiii
`
`
`
`
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 7,892,549
`
`
`
`
`
`
`
`Exhibit No.
`
`Description
`
`PETITIONER’S EXHIBIT LIST
`
`1052
`
`1053
`
`1054
`
`1055
`
`1056
`
`1057
`
`1058
`
`1059
`
`1060
`
`1061
`
`1062
`
`1063
`
`1064
`
`1065
`
`1066
`
`1067
`
`1068
`
`1069
`
`1070
`
`Library of Congress Copyright Record for Drebin ʼ88
`
`Library of Congress Copyright Record for Presta ʼ97
`
`Library of Congress Copyright Record for Hudziak ʼ89
`
`Library of Congress Copyright Record for Carter ʼ92
`
`Library of Congress Copyright Record for Gelmon ʼ96
`
`Reserved
`
`Library of Congress Copyright Record for Slamon ʼ87
`
`Library of Congress Copyright Record for Slamon ʼ89
`
`Library of Congress Copyright Record for Nicolaou ’96
`
`Library of Congress Copyright Record for Pegram ʼ92
`
`Library of Congress Copyright Record for Shan ’96
`
`Library of Congress Copyright Record for Mendelsohn ʼ97
`
`Library of Congress Copyright Record for Jones ’86
`
`Library of Congress Copyright Record for Miller ’81
`1998 FDA Approved Label for Taxol®
`Drugs@FDA: FDA Approved Drug Products for TAXOL,
`http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=o
`verview.process&ApplNo= 020262
`
`Pegram et al., Phase II Study of Receptor-Enhanced
`Chemosensitivity Using Recombinant Humanized Anti-p185HER2/neu
`Monoclonal Antibody Plus Cisplatin in Patients with HER2/neu-
`Overexpressing Metastatic Breast Cancer Refractory to
`Chemotherapy Treatment, 16(8) J. CLIN. ONCOL. 2659–71 (1998)
`(“Pegram ʼ98”)
`
`Library of Congress Copyright Record for Pegram ʼ98
`
`Declaration of Professor Hilary Calvert
`
`
`xiv
`
`
`
`
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 7,892,549
`
`
`I.
`
`INTRODUCTION
`
`Pursuant to 35 U.S.C. §§ 311-319 and 37 C.F.R. § 42, Petitioner Samsung
`
`Bioepis Co., Ltd. (“Bioepis” or “Petitioner”) respectfully requests inter partes
`
`review (“IPR”) of claims 10-17 (the “Challenged Claims”) of U.S. Patent No.
`
`7,892,549 (“’549 patent”), which is attached to this Petition as Exhibit 1001.1
`
`Concurrently filed with the petition is a power of attorney pursuant to 37 C.F.R. §
`
`42.10(b).
`
`The Challenged Claims are directed to a method of treating human patients
`
`with breast cancer that overexpress the ErbB2 receptor by administering, a
`
`combination of an anti-ErbB2 antibody, a taxoid, and a further growth inhibitory
`
`agent. This petition shows, by a preponderance of the evidence, that the
`
`Challenged Claims are unpatentable as obvious over the prior art.
`
`A motion for joinder with IPR2017-00737 is being filed concurrently with
`
`this petition. For the sake of completeness and efficiency, the present petition is a
`
`practical copy of the petition in IPR2017-00737, which was instituted on July 27,
`
`2017.
`
`USPTO assignment records indicate that the ’549 patent is assigned to
`
`Genentech, Inc. (“Genentech”). (See Ex. 1002)
`
`1 All references to exhibits, e.g., “Exhibit” or “Ex.,” are to the table of exhibits
`
`attached hereto as Petitioner’s Exhibit List.
`
`
`
`
`1
`
`
`
`
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 7,892,549
`
`
`II. MANDATORY NOTICES
`
`A. Real Party-In-Interest (37 C.F.R. § 42.8(b)(1))
`
`Bioepis is the Real Party in Interest. Bioepis is a corporation organized and
`
`existing under the laws of the Republic of Korea, having its principal place of
`
`business at 107, Cheomdan-daero, Yeonsu-gu, Incheon 21987, Republic of Korea.
`
`B. Related Matters (37 C.F.R. § 42.8(b)(2))
`
`Bioepis is unaware of any litigation related to the ’549 patent.
`
`Bioepis is aware of three previously filed IPR petitions related to the ’549
`
`patent. Hospira, Inc. filed IPR 2017-00737 and IPR2017-00739 on January 20,
`
`2017. IPR2017-00737 was instituted on July 27, 2017. Celltrion, Inc.
`
`subsequently filed IPR2017-01122 on March 21, 2017, which is active and
`
`awaiting an institution decision.
`
`EP 1,037,926 B1 (the “EP ʼ926 patent”, Ex. 1003),2 a European patent
`
`within the same family as the ʼ549 patent, was recently invalidated and revoked in
`
`two separate European proceedings as obvious in light of certain references
`
`asserted here. Hospira UK, Ltd. v. Genentech, Inc., Case No. HP-2014-000034,
`
`[2015] EWHC (HC) 1796 (Pat), (Jun. 24, 2015), Approved Judgment (Ex. 1004);
`
`Decision to Revoke European Patent EP 1,037,926, Application No. 98,963,840.8
`
`
`2 The EP ʼ926 patent and the ʼ549 patent both claim priority to U.S. Provisional
`
`Application No. 60/069,346.
`
`
`
`
`2
`
`
`
`
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 7,892,549
`
`
`(Jun. 13, 2016) (Ex. 1026). The judgment of the UK Court was affirmed on
`
`appeal. Hospira UK Ltd. v. Genentech Inc., Case No. A3 2015 3238, [2016]
`
`EWCA Civ 1185 (Nov. 30, 2016), Approved Judgment (Ex. 1049).
`
`Bioepis is not aware of any other judicial or administrative matters that
`
`would affect, or be affected by, a decision in the proceeding.
`
`C.
`
`Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3) and (4))
`
`Bioepis designates the following counsel:
`
`Lead Counsel
`
`Backup Counsel
`
`Dimitrios T. Drivas
`White & Case LLP
`1221 Avenue of the Americas
`New York, New York 10020
`Tel: (212) 819-8200
`Fax: (212) 354-8113
`ddrivas@whitecase.com
`USPTO Reg. No. 32,218
`
`
`
`Scott T. Weingaertner
`White & Case LLP
`1221 Avenue of the Americas
`New York, New York 10020
`Tel: (212) 819-8200
`Fax: (212) 354-8113
`scott.weingaertner@whitecase.com
`USPTO Reg. No. 37,756
`
`Please address all correspondence to lead and backup counsel. Bioepis consents to
`
`service by email at the following addresses: ddrivas@whitecase.com and
`
`scott.weingaertner@whitecase.com.
`
`III. FEES (37 C.F.R. § 42.15(A))
`
`Bioepis authorizes the United States Patent and Trademark Office to charge
`
`the fees enumerated in 37 C.F.R. § 42.15(a) regarding this Petition and any
`
`
`
`
`3
`
`
`
`
`
`

`

`Petition for Inter Partes Review of U.S. Patent No. 7,892,549
`
`
`additional fees that may be due in connection with this Petition from Deposit
`
`Account No. 50-3672.
`
`IV. REQUIREMENTS UNDER 37 C.F.R. § 42.104
`
`A. Grounds for Standing (37 C.F.R. § 42.104(a))
`
`Bioepis certifies that the ’549 patent is available for IPR and that Bioepis is
`
`not barred or estopped from requesting IPR on the grounds identified herein. 35
`
`U.S.C. § 315.
`
`B.
`
`Statement of relief requested (37 C.F.R. § 42.104(b))
`
`The ’549 patent application was filed on February 3, 2003, and therefore this
`
`Petition is governed by pre-AIA 35 U.S.C. § 103. See MPEP 2159.01. Pursuant to
`
`37 C.F.R. §§ 42.104(b)(1) and (2), Petitioner requests review of the Challenged
`
`Claims on the following grounds:
`
`Ground
`
`Proposed Statutory Rejections for the ’549 Patent
`Baselga ʼ97 (Ex. 1007) in view of Gelmon ʼ96 (Ex. 1025) renders
`
`1
`
`2
`
`3
`
`
`
`obvious claims 1–11 and 14–17 under 35 U.S.C. § 103.
`
`Baselga ʼ97 (Ex. 1007) in view of Gelmon ʼ96 (Ex. 1025) and Drebin