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`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. 7,846,441
`Title: Treatment with Anti-ErbB2 Antibodies
`
`Case No. IPR2018-00192
`
`________________
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 7,846,441
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
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`

`

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`
`TABLE OF CONTENTS
`
`Page
`
` I.
`
` MANDATORY NOTICES – 37 C.F.R. §42.8(A)(1) AND (B) ..................... 2 II.
`
`INTRODUCTION ........................................................................................... 1
`
`A.
`37 C.F.R. §42.8(b)(1): Real Party-In-Interest ...................................... 2
`B.
`37 C.F.R. §42.8(b)(2): Related Matters ............................................... 2
`C.
`37 C.F.R. §42.8(b)(3): Lead And Back-Up Counsel ........................... 4
`D.
`37 C.F.R. §42.8(b)(4): Service Information ......................................... 5
`III.
` PAYMENT OF FEES – 37 C.F.R. §42.103 .................................................... 5
` GROUNDS FOR STANDING – 37 C.F.R. §42.104(A) ................................ 5
`IV.
`IDENTIFICATION OF CHALLENGE –37 C.F.R. §42.104(B) .................... 5
`
`V.
`VI.
` THE LEVEL OF ORDINARY SKILL IN THE RELEVANT ART .............. 7
`
` THE SCOPE AND CONTENT OF THE PRIOR ART .................................. 7 VII.
`A.
`The State Of The Art ............................................................................. 7
`1.
`rhuMAb HER2 and Paclitaxel .................................................... 7
`2.
`Chemotherapeutic Combinations and Anthracyclines ................ 8
`The Prior Art ....................................................................................... 10
`1.
`Lottery ....................................................................................... 10
`2.
`Hayes ......................................................................................... 11
`3.
`Baselga ʼ96 ................................................................................ 12
`4.
`Gelmon ...................................................................................... 13
`5.
`Baselga ʼ94 ................................................................................ 15
`VIII.
` THE ‘441 PATENT AND ITS PROSECUTION HISTORY ....................... 15
` LEGAL STANDARDS FOR OBVIOUSNESS ............................................ 18
`IX.
`CLAIM CONSTRUCTION .......................................................................... 21
`
`X.
`XI.
` DETAILED STATEMENT OF GROUNDS FOR UNPATENTABILITY . 21
`A. Ground 1: Claims 1–14 Are Invalid Based On Lottery, In View Of
`Hayes And/Or Baselga ’96, And Gelmon ........................................... 21
` Claim 1 ...................................................................................... 24
`(1)
`
`B.
`
`
`
`
`i
`
`
`
`
`
`

`

`
`
`
`
`
`a.
`
`b.
`
`c.
`d.
`
`e.
`f.
`
`g.
`
`Preamble: “A method for the treatment of a human
`patient with a malignant progressing tumor or cancer
`characterized by over-expression of ErbB2 receptor,
`comprising” ..................................................................... 24
`Element [a]: “administering a combination of an intact
`antibody which binds to epitope 4D5 within the ErbB2
`extracellular domain sequence” ...................................... 25
`Element [b]: “a taxoid” .................................................. 27
`Element [c]: “in the absence of an anthracycline
`derivative” ....................................................................... 29
`Element [d]: “to the human patient” .............................. 31
`Element [e]: “in an amount effective to extend the
`time to disease progression in the human patient” ......... 32
`Element [f]: “without increase in overall severe
`adverse events” ............................................................... 34
` Claim 2 ...................................................................................... 35
`(2)
`“The method of claim 1 wherein said patient has a malignant
`tumor” ............................................................................. 35
`(3)
` Claim 3 ...................................................................................... 35
`“The method of claim 1 wherein said patient has cancer” ....... 35
`(4)
` Claim 4 ...................................................................................... 35
`“The method of claim 3 wherein said cancer is selected from
`the group consisting of breast cancer [and other
`cancers]” ......................................................................... 35
` Claim 5 ...................................................................................... 36
`(5)
`“The method of claim 4 wherein said cancer is breast cancer” 36
`(6)
` Claim 6 ...................................................................................... 36
`“The method of claim 5 wherein said cancer is metastatic
`breast carcinoma” ........................................................... 36
` Claim 7 ...................................................................................... 36
`(7)
`“The method of claim 1 wherein said antibody is a
`humanized 4D5 anti-ErbB2 antibody” ........................... 36
` Claim 8 ...................................................................................... 37
`(8)
`
`ii
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`

`

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`
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`“The method of claim 1 wherein said taxoid is paclitaxel” ...... 37
`(9)
` Claim 9 ...................................................................................... 37
`“The method of claim 8 wherein the effective amount of said
`combination is lower than the sum of the effective
`amounts of said anti-ErbB2 antibody and said taxoid,
`when administered individually, as single agents” ........ 37
` Claim 10 .................................................................................... 38
`(10)
`“The method of claim 1 wherein efficacy is further measured
`by determining the response rate” .................................. 38
` Claim 11 .................................................................................... 39
`(11)
`a.
`Preamble: “A method for the treatment of a human
`patient with ErbB2 overexpressing progressing
`metastatic breast cancer, comprising” ............................ 39
`Element [a]: “administering a combination of a
`humanized 4D5 anti-ErbB2 antibody” ........................... 39
`Element [b]: “a taxoid” .................................................. 40
`Element [c]: “in the absence of an anthracycline
`derivative” ....................................................................... 40
`Element [d]: “to the human patient” .............................. 40
`Element [e]: “in an amount effective to extent the time
`to disease progression in said human patient” ................ 40
`Element [f]: “without increase in overall severe
`adverse events” ............................................................... 40
` Claim 12 .................................................................................... 40
`(12)
`“The method of claim 11, wherein said taxoid is paclitaxel” ... 40
`(13)
` Claim 13 .................................................................................... 41
`a.
`Preamble: “A method for the treatment of a human
`patient with a progressing malignant tumor or cancer
`characterized by overexpression of ErbB2 receptor,
`comprising” ..................................................................... 41
`Element [a]: “administering a combination of a
`humanized 4D5 anti-ErbB2 antibody which comprises
`a human Fc region that binds to epitope 4D5 within the
`
`iii
`
`b.
`
`c.
`d.
`
`e.
`f.
`
`g.
`
`b.
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`
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`
`
`

`

`
`
`
`
`
`c.
`d.
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`e.
`f.
`
`g.
`
`b.
`
`c.
`d.
`
`e.
`f.
`
`g.
`
`b.
`
`ErbB2 extracellular domain sequence” .......................... 41
`Element [b]: “and a taxoid” ........................................... 42
`Element [c]: “in the absence of an anthracycline
`derivative” ....................................................................... 42
`Element [d]: “to the human patient” .............................. 42
`Element [e]: “in an amount effective to extend the
`time to disease progression in said human patient” ....... 42
`Element [f]: “without increase in overall severe
`adverse events.” .............................................................. 43
` Claim 14 .................................................................................... 43
`(14)
`a.
`Preamble: “A method for the treatment of a human
`patient with ErbB2 expressing progressing metastatic
`breast cancer, comprising” ............................................. 43
`Element [a]: “administering a combination of an
`antibody which binds to epitope 4D5 within the
`extracellular domain sequence” ...................................... 43
`Element [b]: “and a taxoid,” .......................................... 43
`Element [c]: “in the absence of an anthracycline
`derivative,” ...................................................................... 43
`Element [d]: “to the human patient.” ............................. 43
`Element [e]: “in an amount effective to extend the
`time to disease progression in said human patient.” ...... 44
`Element [f]: “without increase in overall severe
`adverse events.” .............................................................. 44
`B. Ground 2: Claims 1–14 Are Invalid Based On Baselga ʼ96 In View
`Of Baselga ’94 And Gelmon ............................................................... 44
` Claim 1 ...................................................................................... 44
`(1)
`a.
`Preamble: “A method for the treatment of a human
`patient with a malignant progressing tumor or cancer
`characterized by over-expression of ErbB2 receptor,
`comprising” ..................................................................... 44
`Element [a]: “administering a combination of an intact
`antibody which binds to epitope 4D5 within the ErbB2
`
`iv
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`
`
`

`

`
`
`
`
`
`c.
`d.
`
`e.
`f.
`
`g.
`
`extracellular domain sequence” ...................................... 45
`Element [b]: “a taxoid,” ................................................. 46
`Element [c]: “in the absence of an anthracycline
`derivative,” ...................................................................... 47
`Element [d]: “to the human patient,” ............................. 49
`Element [e]: “in an amount effective to extend the
`time to disease progression in the human patient,” ........ 49
`Element [f]: “without increase in overall severe
`adverse events.” .............................................................. 50
` Claim 2 ...................................................................................... 51
`(2)
`“The method of claim 1 wherein said patient has a malignant
`tumor.” ............................................................................ 51
` Claim 3 ...................................................................................... 51
`(3)
`“The method of claim 1 wherein said patient has cancer.” ...... 51
`(4)
` Claim 4 ...................................................................................... 52
`“The method of claim 3 wherein said cancer is selected from
`the group consisting of breast cancer [and other
`cancers].” ........................................................................ 52
` Claim 5 ...................................................................................... 52
`(5)
`“The method of claim 4 wherein said cancer is breast
`cancer.” ........................................................................... 52
`(6)
` Claim 6 ...................................................................................... 52
`“The method of claim 5 wherein said cancer is metastatic
`breast carcinoma.” .......................................................... 52
` Claim 7 ...................................................................................... 52
`(7)
`“The method of claim 1 wherein said antibody is a
`humanized 4D5 anti-ErbB2 antibody.” .......................... 52
` Claim 8 ...................................................................................... 53
`(8)
`“The method of claim 1 wherein said taxoid is paclitaxel.” ..... 53
`(9)
` Claim 9 ...................................................................................... 53
`“The method of claim 8 wherein the effective amount of said
`combination is lower than the sum of the effective
`
`v
`
`
`
`
`
`

`

`
`
`
`
`
`amounts of said anti-ErbB2 antibody and said taxoid,
`when administered individually, as single agents.” ....... 53
` Claim 10 .................................................................................... 54
`(10)
`“The method of claim 1 wherein efficacy is further measured
`by determining the response rate.” ................................. 54
` Claim 11 .................................................................................... 54
`(11)
`a.
`Preamble: “A method for the treatment of a human
`patient with ErbB2 overexpressing progressing
`metastatic breast cancer, comprising” ............................ 54
`Element [a]: “administering a combination of a
`humanized 4D5 anti-ErbB2 antibody,” .......................... 55
`Element [b]: “a taxoid,” ................................................. 55
`Element [c]: “in the absence of an anthracycline
`derivative,” ...................................................................... 55
`Element [d]: “to the human patient.” ............................. 55
`Element [e]: “in an amount effective to extent the time
`to disease progression in said human patient.” ............... 55
`Element [f]: “without increase in overall severe
`adverse events.” .............................................................. 55
` Claim 12 .................................................................................... 56
`(12)
`“The method of claim 11, wherein said taxoid is paclitaxel.” .. 56
`(13)
` Claim 13 .................................................................................... 56
`a.
`Preamble: “A method for the treatment of a human
`patient with a progressing malignant tumor or cancer
`characterized by overexpression of ErbB2 receptor,
`comprising” ..................................................................... 56
`Element [a]: “administering a combination of a
`humanized 4D5 anti-ErbB2 antibody which comprises
`a human Fc region that binds to epitope 4D5 within the
`ErbB2 extracellular domain sequence” .......................... 56
`Element [b]: “and a taxoid,” .......................................... 57
`Element [c]: “in the absence of an anthracycline
`derivative,” ...................................................................... 57
`
`vi
`
`
`
`
`
`b.
`
`c.
`d.
`
`e.
`f.
`
`g.
`
`b.
`
`c.
`d.
`
`

`

`
`
`
`e.
`f.
`
`g.
`
`b.
`
`Element [d]: “to the human patient.” ............................. 57
`Element [e]: “in an amount effective to extend the
`time to disease progression in said human patient.” ...... 57
`Element [f]: “without increase in overall severe
`adverse events.” .............................................................. 57
` Claim 14 .................................................................................... 58
`(14)
`a.
`Preamble: “A method for the treatment of a human
`patient with ErbB2 expressing progressing metastatic
`breast cancer, comprising” ............................................. 58
`Element [a]: “administering a combination of an
`antibody which binds to epitope 4D5 within the
`extracellular domain sequence” ...................................... 58
`Element [b]: “and a taxoid,” .......................................... 58
`Element [c]: “in the absence of an anthracycline
`derivative,” ...................................................................... 58
`Element [d]: “to the human patient.” ............................. 58
`Element [e]: “in an amount effective to extend the
`time to disease progression in said human patient.” ...... 58
`Element [f]: “without increase in overall severe
`adverse events.” .............................................................. 59
` THERE ARE NO SECONDARY CONSIDERATIONS OF
`XII.
`NONOBVIOUSNESS ................................................................................... 59
`XIII.
` CONCLUSION .............................................................................................. 61
`
`
`
`
`c.
`d.
`
`e.
`f.
`
`g.
`
`
`
`
`
`
`vii
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`
`

`

`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`Abbvie Inc. v. Kennedy Trust for Rheumatology Research,
`No. 13 Civ. 1358(PAC), 2014 WL 3360722 (S.D.N.Y. July 9, 2014),
`aff’d 599 Fed. App’x. 956 (Fed. Cir. 2015) ............................................ 26, 45
`
`Dawson v. Dawson,
`710 F.3d 1347 (Fed. Cir. 2013) ..................................................................... 21
`
`Dome Patent L.P. v. Lee,
`799 F.3d 1372 (Fed. Cir. 2015) ..................................................................... 19
`
`Ex parte Gillis,
`No. 2010-09318 (B.P.A.I. Nov. 21, 2011) .................................................... 20
`
`Ex parte Litwin, No.
`No. 2009-011704, 2011 WL 3414500 (B.P.A.I. Aug. 2, 2011) .................... 20
`
`In re Kubin,
`561 F.3d 1351 (Fed. Cir. 2009) ............................................................. passim
`
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007)................................................................................ 18, 19
`
`Ortho-McNeil Pharm. Inc. v. Kali Labs. Inc.,
`482 F. Supp. 2d 478 (D.N.J. 2007),
`vacated on other grounds, 344 Fed. App’x 595 (Fed. Cir. 2009) ................. 19
`
`Santarus, Inc. v. Par Pharm., Inc.,
`694 F.3d 1344 (Fed. Cir. 2012) ............................................................. passim
`
`Statutes
`
`§ 102(b) ...................................................................................................................... 6
`
`35 U.S.C. § 103 ............................................................................................... 5, 6, 18
`
`35 U.S.C. § 311 .......................................................................................................... 1
`
`35 U.S.C. § 315 .......................................................................................................... 5
`
`
`
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`viii
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`

`

`
`
`
`
`Rules
`
`37 C.F.R. §1.68 .......................................................................................................... 7
`
`37 C.F.R. §42.8 ................................................................................................. 2, 4, 5
`
`37 C.F.R. § 42.10 ....................................................................................................... 5
`
`37 C.F.R. § 42.15 ....................................................................................................... 5
`
`37 C.F.R. § 42.100 .............................................................................................. 1, 21
`
`37 C.F.R. §42.104 ...................................................................................................... 5
`
`Other Authorities
`
`3-8 Chisum on Patents §8.06 ................................................................................... 20
`
`T. Brody, Negative Limitations in Patent Claims,
`41 Am. Intell. Prop. Q.J. 29 (2013) ............................................................... 20
`
`
`
`
`
`
`
`
`ix
`
`
`
`
`
`

`

`
`
`Exhibit No.
`1001
`1002
`1003
`
`1004
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`1011
`1012
`
`PETITIONER’S EXHIBIT LIST
`Description
`
`U.S. Patent No. 7,846,441
`Assignment to Genentech, Inc. filed in U.S. Patent No. 7,846,441
`Hospira UK, Ltd. v. Genentech, Inc., Case No. HP-2014-000034,
`[2015] EWHC (CH) 1796 (Pat), (Jun. 24, 2015), Approved
`Judgment
`Eur. Patent Specification No. 1,037,926 B1
`Baselga et al., Phase II Study of Weekly Intravenous Recombinant
`Humanized Anti-p185HER2 Monoclonal Antibody in Patients with
`HER2/neu-Overexpressing Metastatic Breast Cancer, 14(3) J.
`CLIN. ONCOL. 737–44 (1996) (“Baselga ʼ96”)
`Baselga et al., Anti-HER2 Humanized Monoclonal Antibody (MAb)
`Alone and in Combination with Chemotherapy Against Human
`Breast Carcinoma Xenografts, 13 PROC. AM. SOC. CLIN. ONCOL. 63
`(Abstract 53) (1994) (“Baselga ʼ94”)
`Baselga et al., HER2 Overexpression and Paclitaxel Sensitivity in
`Breast Cancer: Therapeutic Implications, 11(3) (Suppl. 2) ONCOL.
`43–48 (1997) (“Baselga ʼ97”)
`Monmaney, T., A Lottery of Life, Death—and Hope, L.A. Times,
`Aug. 3, 1996, A1, A16–17 (“Lottery”)
`Hayes, D.T., Editorial: Should We Treat HER, Too? 14(3) J. CLIN.
`ONCOL. 697–99 (1996)
`U.S. Patent No. 7,892,549
`Declaration of Allan Lipton, M.D.
`U.S. Provisional Patent Application No. 60/069,346, Dec. 12, 1997
`
`
`
`
`x
`
`
`
`
`
`

`

`
`
`Exhibit No.
`1013
`
`1014
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`1020
`
`1021
`
`PETITIONER’S EXHIBIT LIST
`Description
`Pegram et al., Phase II Study of Intra Venous Recombinant
`Humanized Anti-p185 HER-2 Monoclonal Antibody (rhuMAb HER-
`2) Plus Cisplatin in Patients with HER-2/neu Overexpressing
`Metastatic Breast Cancer, 14 PROC. AM. SOC. CLIN. ONCOL. 106
`(Abstract 124) (1995) (“Pegram ʼ95”)
`Reserved
`Hudziak et al., p185HER2 Monoclonal Antibody has Antiproliferative
`Effects in Vitro and Sensitizes Human Breast Tumor Cells to Tumor
`Necrosis Factor, 9(3) MOLECULAR AND CELLULAR BIOLOGY 1165–
`72, (1989) (“Hudziak ʼ89”)
`Gelmon et al., Phase I/II Trial of Biweekly Paclitaxel and Cisplatin
`in the Treatment of Metastatic Breast Cancer, 14(4) J. CLIN.
`ONCOL. 1185–91 (1996) (“Gelmon”)
`Phillips et al., Targeting HER2-Positive Breast Cancer with
`Trastuzumab-DM1, an Antibody–Cytotoxic Drug Conjugate,
`68(22) CANCER RES. 280–90 (2008)
`Phillips et al., Dual Targeting of HER2-Positive Cancer with
`Trastuzumab Emtansine and Pertuzumab: Critical Role for
`Neuregulin Blockade in Antitumor Response to Combination
`Therapy, 20(2) CLIN. CANCER RES. 456–68 (2014)
`Certified File History of U.S. Patent No. 7,846,441 (9 Volumes)
`Eur. Patent File History for EP 1,037,926 B1, Decision to Revoke
`European Patent EP 1,037,926 B1 in Opposition Proceedings
`Before the European Patent Office in Munich on 02 May 2016,
`Application No. 98,963,840.8 (Jun. 13, 2016)
`Hospira UK Ltd. v. Genentech Inc., Case No. A3 2015 3238,
`[2016] EWCA Civ 1185, (Nov. 30, 2016), Approved Judgment
`
`
`
`
`xi
`
`
`
`
`
`

`

`
`
`Exhibit No.
`1022
`
`1023
`
`1024
`1025
`1026
`
`1027
`
`1028
`
`1029
`1030
`
`1031
`
`1032
`
`1033
`
`PETITIONER’S EXHIBIT LIST
`Description
`Sorenson et al., Analysis of Events Associated with Cell Cycle
`Arrest at G2 Phase and Cell Death Induced by Cisplatin, 82(9) J.
`NAT’L. CANCER INST. 749–55 (1990)
`Pietras et al., Antibody to HER-2/neu Receptor Blocks DNA Repair
`After Cisplatin in Human Breast and Ovarian Cancer Cells, 9(7)
`ONCOGENE 1829–38 (1994)
`Declaration of Christopher Lowden
`Declaration of Mark Sliwkowski, Ph.D, Oct. 15, 2009
`Slamon et al., Human Breast Cancer: Correlation of Relapse and
`Survival with Amplification of the HER-2/neu Oncogene, 235(4785)
`SCIENCE 177–82 (1987) (“Slamon ʼ87”)
`Slamon et al., Studies of the HER-2/neu Proto-Oncogene in Human
`Breast and Ovarian Cancer, 244(4905) SCIENCE 707–12 (1989)
`(“Slamon ʼ89”)
`Excerpt from Webster’s New World College Dictionary (3d ed.
`1996)
`Excerpt from The Oxford Dictionary and Thesaurus (Am. ed. 1996)
`Pegram et al., Monoclonal Antibody to HER-2/neu Gene Product
`Potentiates Cytotoxicity of Carboplatin and Doxorubicin in Human
`Breast Tumor Cells, 33 PROC. AM. ASS’N FOR CANCER RES., 442
`(Abstract 2639) (1992) (“Pegram ʼ92”)
`Shan et al., Anthracycline-Induced Cardiotoxicity, 125(1) ANN.
`INTERN. MED. 47–58, (1996) (“Shan ’96”)
`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)
`
`
`
`
`xii
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`

`
`
`Exhibit No.
`1034
`1035
`1036
`1037
`1038
`1039
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`
`1047
`
`PETITIONER’S EXHIBIT LIST
`Description
`Library of Congress Copyright Record for Baselga ʼ96
`Library of Congress Copyright Record for Baselga ʼ97
`Library of Congress Copyright Record for Hudziak ʼ89
`Library of Congress Copyright Record for Carter ʼ92
`Library of Congress Copyright Record for Gelmon
`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=ov
`erview.process&ApplNo= 020262 (last visited Dec. 22, 2016)
`Gianni et al., Paclitaxel and Doxorubicin in Metastatic Breast
`Cancer, 14(4) J. CLIN. ONCOL. 1403 (1996) (“Gianni ’96”)
`Holmes, F.A., Paclitaxel Combination Therapy in the Treatment of
`Metastatic Breast Cancer: A Review, 23(5)(Suppl. 11) SEMINARS
`ONCOL. 46–56 (1996) (“Holmes ’96”)
`Rodrigues et al., Development of a Humanized Disulfide-stabilized
`Anti-p185HER2 Fv-β-Lactamase Fusion Protein for Activation of a
`Cephalosporin Doxorubicin Prodrug, 55(1) CANCER RES., 63–70
`(1995)
`Park et al., Development of Anti-p185HER2 Immunoliposomes for
`Cancer Therapy, 92(5) PROC. NATL. ACAD. SCI. USA, 1327–31
`(1995)
`Harries et al., The Development and Clinical Use of Trastuzumab
`(Herceptin), ENDOCRINE-RELATED CANCER 9, 75–85 (2002)
`Antibody Showing Promise in Killing Cancer Cells, Chicago TR.,
`April 25, 1996
`Library of Congress Copyright Record for Slamon ʼ87
`
`
`
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`xiii
`
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`

`
`
`Exhibit No.
`1048
`1049
`1050
`1051
`1052
`1053
`1054
`1055
`1056
`1057
`1058
`
`1059
`1060
`
`1061
`
`1062
`1063
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`PETITIONER’S EXHIBIT LIST
`Description
`Declaration of Simon Cohen
`Library of Congress Copyright Record for Slamon ʼ89
`Excerpts from Eur. Patent File History for EP 1,037,926 B1
`Library of Congress Copyright Record for Pegram ʼ92
`Library of Congress Copyright Record for Shan ʼ96
`Library of Congress Copyright Record for Monmaney
`Library of Congress Copyright Record for the Chicago Tribune
`Library of Congress Copyright Record for Miller ’81
`Library of Congress Copyright Record for Gianni ʼ96
`Library of Congress Copyright Record for Holmes ʼ96
`T. Brody, Negative Limitations in Patent Claims, 41 AM. INTELL.
`PROP. Q.J. 29, 58 (2013)
`3-8 Chisum on Patents §8.06
`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)
`DeVita et al., A History of Cancer Chemotherapy, 68(21) CANCER
`RES. 8643–53 (2008)
`U.S. Patent No. 5,677,171
`Carter, et al., Humanization of an Anti-p185HER2 Antibody for
`Human Cancer Therapy, 89(10) PROC. NATL. ACAD. SCI. USA
`4285–89 (1992) (“Carter ʼ92”)
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`xiv
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`Exhibit No.
`1064
`1065
`1098
`1099
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`PETITIONER’S EXHIBIT LIST
`Description
`Library of Congress Copyright Record for Baselga ʼ98
`Library of Congress Copyright Record for Hayes ʼ96
`Declaration of Scott Weingaertner
`Declaration of Hilary Calvert, M.D.
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`xv
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`Pursuant to 35 U.S.C. § 311 and 37 C.F.R. § 42.100, Petitioner Samsung
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`Bioepis Co., Ltd. (“Petitioner” or “Bioepis”) respectfully requests inter partes
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`review (“IPR”) of claims 1–14 (the “Challenged Claims”) of U.S. Patent No.
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`7,846,441 (the “’441 patent”), assigned to Genentech, Inc. (“Genentech” or “Patent
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`Owner” (“PO”)). The grounds raised in this petition are the same as those raised in
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`the petition filed by Pfizer Inc. on October 3, 2017, regarding the ’441 patent
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`(IPR2018-00016).
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`I.
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`INTRODUCTION
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`The alleged invention of the ’441 patent was to combine two known
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`treatments for HER2-overexpressing breast cancer: (i) the humanized 4D5, anti-
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`ErbB2 antibody Herceptin® (rhuMAb HER2) and (ii) the taxoid Taxol®
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`(paclitaxel). But the same combination was already under investigation in clinical
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`trials and was made public over a year before the ’441 patent was filed, in the LA
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`Times.
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`A Lottery of Life, Death—and Hope (“Lottery”) was published August 3,
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`1996 in one of the largest metropolitan newspapers in circulation. It is § 102(b)
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`prior art, and cannot be antedated. Lottery disclosed to the world that HER2-
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`overexpressing breast cancer patients were being
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`treated with
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`the same
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`combination therapy Patent Owner (“PO”) later claimed. In particular, Lottery
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`discloses a clinical trial in which, “[t]o test whether the HER2 antibody really
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`boosts the effectiveness of taxol, half the women in [the] study receive[d] taxol
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`plus antibody, while the other half receive[d] just taxol.” Ex. 1008 at 3. A
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`POSITA would have known this was the same antibody/taxoid combination of the
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`’441 patent and that this treatment was “in the absence of an anthracycline
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`derivative.” Lottery apparently was not identified by the Examiner’s prosecution
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`searches and was not cited during prosecution of the ‘441 patent.
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`The Challenged Claims are also obvious over Baselga ’96 in view of
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`Baselga ’94 and Gelmon. The Board recently instituted IPR on the ‘441 patent
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`based on Baselga ’96 and Baselga ’94. IPR2017-00731, Paper No. 29.
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`Furthermore, in instituting IPR2017-00737, the Board determined that the methods
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`of U.S. Patent No. 7,892,549—which are necessarily encompassed by the claims
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`of the ’441 patent—are likely invalid as obvious over this prior art combination.
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`IPR2017-00737, Paper No. 19. Accordingly, consistent with the Board’s
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`precedent, IPR should be instituted on Petitioner’s proposed grounds.
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` MANDATORY NOTICES – 37 C.F.R. §42.8(A)(1) AND (B)
`II.
`A.
`37 C.F.R. §42.8(b)(1): Real Party-In-Interest
`Bioepis is the real party-in-interest.
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`37 C.F.R. §42.8(b)(2): Related Matters
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`B.
`Petitioner identifies the following potentially related matters:
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`•
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`EP 1,037,926 B1 (Ex. 1004)1, the European counterpart to the ‘441
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`patent, was invalidated and revoked as obvious in two proceedings:
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`(1) Hospira UK, Ltd. v. Genentech, Inc., No. HP-2014-000034, [2015]
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`EWHC (HC) 1796 (Pat), (Jun. 24, 2015) (Ex. 1003), aff’d Hospira
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`UK, Ltd. v. Genentech, Inc., No. A3 2015 3238, [2016] EWCA Civ
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`1185 (Nov. 30, 2016) (Ex. 1021); and (2) Decision to Revoke
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`European Patent EP 1,037,926, Application No. 98,963,840.8 (Jun.
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`13, 2016) (Ex. 1020).
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`IPR2017-00731: Hospira Inc. (“Hospira”) submitted an IPR petition
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`on January 20, 2017, challenging the ’441 patent. Institution was
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`initially denied on July 27, 2017, but subsequently granted on October
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`26, 2017, following a Request for Rehearing.
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`IPR2017-01121: Celltrion, Inc. filed a petition challenging the ’441
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`patent on March 21, 2017. The Board instituted IPR on October 4,
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`2017.
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`IPR2018-00016: Pfizer Inc. filed a petition challenging the ‘441
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`patent on October 3, 2017. An institution decision has not yet been
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`entered.
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`•
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`1
`The EP ’926 patent and the ’441 patent both claim priority to U.S. Provisional
`Application No. 60/069,346 (Ex. 1012).
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`IPR2017-00737 and -00739: Hospira submitted IPR petitions on
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`January 20, 2017 challenging claims of U.S. Patent No. 7,892,549, a
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`continuation of the ’441 patent. On July 27, 2017, the Board granted
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`institution of IPR2017-00737 and denied institution of IPR2017-
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`00739.
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`IPR2017-01122: Celltrion Inc. filed an IPR petition challenging
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`claims of the ’549 patent on March 21, 2017. The Board instituted
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`IPR on October 4, 2017.
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`IPR2017-01960: Bioepis filed an IPR petition challenging claims of
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`the ’549 patent on August 25, 2017, and seeking joinder with
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`IPR2017-00737. An institution decision has not yet been entered.
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`37 C.F.R. §42.8(b)(3): Lead And Back-Up Counsel
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`C.
`Petitioner designates:
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`Lead 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
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`Back-up Counsel
`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
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`37 C.F.R. §42.8(b)(4): Service Information
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`D.
`Please address all correspondence to lead and backup counsel. Concurrently
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`filed with th