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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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`SAMSUNG BIOEPIS CO., LTD., Petitioner,
`
`
`v.
`
`
`GENENTECH, INC., Patent Owner.
`
`________________
`
`United States Patent No. 7,371,379
`Title: Dosages for treatment with Anti-ErbB2 Antibodies
`
`
`Case No.: IPR2017-01959
`
`________________
`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 7,371,379
`
`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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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`TABLE OF CONTENTS
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`Page(s)
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`I.
`
`INTRODUCTION .......................................................................................... 1
`
`II. MANDATORY NOTICES ............................................................................ 2
`
`A.
`
`Petitioner and Real Party in Interest (37 C.F.R. § 42.8(b)(1)) ............. 2
`
`B. Matters (37 C.F.R. § 42.8(b)(2)) .......................................................... 2
`
`C.
`
`Counsel and Service Information (37 C.F.R. § 42.8(b)(3) and (4)) ..... 3
`
`III. FEES (37 C.F.R. § 42.15(a)) .......................................................................... 4
`
`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)) ......................... 5
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`V.
`
`THE LEVEL OF ORDINARY SKILL IN THE RELEVANT ART ........... 11
`
`VI. THE SCOPE AND CONTENT OF THE PRIOR ART ............................... 11
`
`A. Oncology and Pharmacokinetics ........................................................ 11
`
`B.
`
`Prior Art Cited in the Petition ............................................................ 14
`
`1.
`
`2.
`
`3.
`
`4.
`
`The Herceptin Label................................................................. 14
`
`Baselga ’96 ............................................................................... 16
`
`Pegram ’98 ............................................................................... 17
`
`Pegram ’95 and Vogel ’98 ....................................................... 17
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`VII. THE ’379 PATENT ...................................................................................... 18
`
`VIII. CLAIM CONSTRUCTION ......................................................................... 24
`
`IX. DETAILED STATEMENT OF GROUNDS FOR UNPATENTABILITY 25
`
`A.
`
`Claims 1–3, 5, 7, 9–11, 16-28, and 30-40 are Obvious Over the
`Herceptin Label in View of Baselga ’96, Pegram ’98, and the
`Knowledge of a Person of Ordinary Skill in the Art .......................... 30
`
`1.
`
`Claim 1 ..................................................................................... 30
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`a.
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`b.
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`c.
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`d.
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`e.
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`Claim 1, preamble: “A method for the treatment of a
`human patient diagnosed with cancer characterized by
`overexpression of ErbB2 receptor, comprising
`administering an effective amount of an anti-ErbB2
`antibody to the human patient, the method
`comprising:” .................................................................. 30
`
`Claim 1, element [a]: “administering to the patient an
`initial dose of at least approximately 5 mg/kg of the
`anti-ErbB2 antibody; and” ............................................. 31
`
`Claim 1, element [b]: “administering to the patient a
`plurality of subsequent doses of the antibody in an
`amount that is approximately the same or less than the
`initial dose” .................................................................... 33
`
`Claim 1, element [c]: “wherein the subsequent doses
`are separated in time from each other by at least two
`weeks.” ........................................................................... 34
`
`Claim 1, element [d]: “further comprising
`administering an effective amount of a
`chemotherapeutic agent to the patient.” ........................ 43
`
`2.
`
`3.
`
`4.
`
`5.
`
`Claim 2: “The method of claim 1, wherein the initial dose is
`at least approximately 6 mg/kg.” ............................................. 45
`
`Claim 3: “The method of claim 2, wherein the initial dose is
`at least approximately 8 mg/kg.” ............................................. 46
`
`Claim 5: “The method of claim 1, wherein the subsequent
`doses are separated in time from each other by at least three
`weeks.” ..................................................................................... 46
`
`Claim 7: “The method of claim 1, wherein the initial dose is
`administered by intravenous injection, wherein at least two
`subsequent doses are administered, and wherein each
`subsequent dose is administered by a method selected from
`the group consisting of intravenous injection and
`subcutaneous injection.” .......................................................... 46
`
`6.
`
`Claim 9: “The method of claim 1, wherein the initial dose is
`selected from the group consisting of approximately 6
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`mg/kg, 8 mg/kg, or 12 mg/kg, wherein the plurality of
`subsequent doses are at least approximately 2 mg/kg.” .......... 47
`
`Claim 10: “The method of claim 9, wherein the plurality of
`subsequent doses are separated in time from each other by at
`least three weeks.”.................................................................... 49
`
`Claim 11: “The method of claim 10, wherein the initial dose
`is approximately 8 mg/kg, and wherein at least one
`subsequent dose is approximately 6 mg/kg. ............................ 49
`
`Claim 16: “The method of claim 1, wherein said cancer is
`selected from the group consisting of breast cancer [and
`other cancers].” ........................................................................ 50
`
`7.
`
`8.
`
`9.
`
`10. Claim 17: “The method of claim 17, wherein said cancer is
`breast cancer.” .......................................................................... 51
`
`11. Claim 18: “The method of claim 17, wherein said cancer is
`metastatic breast carcinoma.” .................................................. 51
`
`12. Claim 19: “The method of claim 1, wherein said antibody
`binds to the extracellular domain of the ErbB2 receptor.” ...... 52
`
`13. Claim 20: “The method of claim 19, wherein said antibody
`binds to epitope 4D5 within the ErbB2 extracellular domain
`sequence.” ................................................................................ 53
`
`14. Claim 21: “The method of claim 20, wherein said antibody
`is a humanized 4D5 anti-ErbB2 antibody.” ............................. 53
`
`15. Claim 22: “The method of claim 1, wherein the
`chemotherapeutic agent is a taxoid.” ....................................... 54
`
`16. Claim 23: “The method of claim 22, wherein said taxoid is
`paclitaxel or docetaxel.” ........................................................... 54
`
`17. Claim 24: “The method of claim 1, wherein the effective
`amount of the anti-ErbB2 antibody and the effective amount
`of the chemotherapeutic agent as a combination is lower
`than the sum of the effective amounts of said anti-ErbB2
`antibody and said chemotherapeutic agent, when
`administered individually, as single agents.” .......................... 55
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`18. Claim 25: “The method of claim 1, wherein the
`chemotherapeutic agent is an anthracycline.”.......................... 56
`
`19. Claim 26: “The method of claim 25, wherein the
`anthracycline is doxorubicin or epirubicin.”............................ 57
`
`20. Claim 27: “The method of claim 25, wherein the method
`further comprises administration of a cardioprotectant.” ........ 57
`
`21. Claim 28: “The method of claim 1, wherein efficacy is
`measured by determining the time to disease progression or
`the response rate.” .................................................................... 57
`
`22. Claim 30 ................................................................................... 59
`
`23. Claim 31: “The method of claim 30, wherein the first dose
`and a first subsequent dose are separated from each other in
`time by at least about three weeks.” ........................................ 60
`
`24. Claim 32: “The method of claim 30, wherein the first dose
`and subsequent doses are each from about 2 mg/kg to about
`16 mg/kg.” ................................................................................ 61
`
`25. Claim 33: “The method of claim 32, wherein the first dose
`and subsequent doses are each from about 4 mg/kg to about
`12 mg/kg.” ................................................................................ 61
`
`26. Claim 34: “The method of claim 33, wherein the first dose
`and subsequent doses are each from about 6 mg/kg to about
`12 mg/kg.” ................................................................................ 62
`
`27. Claim 35: “The method of claim 30, wherein from about
`two to about ten subsequent doses of the antibody are
`administered to the patient.” .................................................... 62
`
`28. Claim 36: “The method of claim 30, wherein the subsequent
`doses are separated in time from each other by at least about
`three weeks.” ............................................................................ 63
`
`29. Claim 37: “The method of claim 30, wherein the two or
`more subsequent doses are each from about 2 mg/kg to
`about 16 mg/kg.” ...................................................................... 63
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`30. Claim 38: “The method of claim 30, wherein the two or
`more subsequent doses are each from about 4 mg/kg to
`about 12 mg/kg.” ...................................................................... 64
`
`31. Claim 39: “The method of claim 30, wherein the two or
`more subsequent doses are each from about 6 mg/kg to
`about 12 mg/kg.” ...................................................................... 64
`
`32. Claim 40: “The method of claim 30, wherein the
`chemotherapeutic agent is a taxoid.” ....................................... 64
`
`B.
`
`Secondary Considerations do not Support the Nonobviousness of
`the ’379 Patent Claims ....................................................................... 65
`
`X.
`
`CONCLUSION ............................................................................................. 65
`
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`TABLE OF AUTHORITIES
`
`Cases
`
`Page(s)
`
`Biomarin Pharm., Inc. v. Genzyme Therapeutic Prods., LP,
`IPR2013-00537, Paper 79 (P.T.A.B. Feb. 23, 2015) (Ex. 1025),
`aff’d Genzyme Therapeutic Prods. LP v. Biomarin Pharm. Inc.,
`825 F.3d 1360 (Fed. Cir. 2016) .....................................................................28
`
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131 (2016) ...................................................................................24
`
`Hoffman-La Roche Inc. v. Apotex Inc.,
`748 F.3d 1326 (Fed. Cir. 2014) .....................................................................34
`
`Hospira UK Ltd. v. Genentech Inc.,
`Case No. A3 2014 1800, [2015] WECA (Civ) 57 (Feb. 6, 2015) ................... 3
`
`Hospira UK Ltd. v. Genentech Inc.,
`Case No. HC12C03487 [2014] EWHC (CH) 1094 (Pat) (Apr. 10, 2014) ...... 3
`
`In re Applied Materials, Inc.,
`692 F.3d 1289 (Fed. Cir. 2012) .....................................................................26
`
`In re Williams,
`36 F.2d 436 (CCPA 1929) .............................................................................26
`
`In re Woodruff,
`919 F.2d 1575 (Fed. Cir. 1990) ........................................................ 33, 48, 50
`
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007).......................................................................................25
`
`Phigenix, Inc. v. Immunogen, Inc.,
`IPR2014-00676, Paper 11 (P.T.A.B. Oct. 29, 2014) ....................................... 7
`
`Pozzoli Spa v. BDMO SA & Anor.,
`2007 WL 1685192, [2007] EWCA Civ. 588 ¶ 23 (Jun. 22, 2007) ...............22
`
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`
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`Statutes
`
`21 U.S.C. § 352 .......................................................................................................... 6
`
`35 U.S.C. § 102 ......................................................................................................7, 8
`
`35 U.S.C. § 103 ............................................................................................. 5, 25, 26
`
`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
`
`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 ......................................................................................................... 9
`
`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 ....................................................................................................... 4
`
`37 C.F.R. § 42.104 .................................................................................................4, 5
`
`MPEP 2144.05 .........................................................................................................26
`
`MPEP 2159.01 ........................................................................................................... 5
`
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`
`
`PETITIONER’S EXHIBIT LIST
`
`Description
`
`Exhibit
`No.
`1001 U.S. Patent No. 7,371,379
`1002 Declaration of Allan Lipton, M.D., as filed in IPR2017-00805
`1003 Declaration of William Jusko, Ph.D., as filed in IPR2017-00805
`1004 Assignment to Genentech, Inc. as filed in related U.S. Patent No.
`6,627,196
`Eur. Patent Specification No. 1 210 115 B1 (“EP ’115 patent”)
`1005
`1006 Hospira UK Ltd. v. Genentech Inc., Case No. HC12C03487 [2014]
`EWHC (CH) 1094 (Pat), Apr. 10, 2014, Approved Judgment
`1007 Hospira UK Ltd. v. Genentech Inc., Case No. A3 2014 1800, [2015]
`WECA (Civ) 57, Feb. 6, 2015, Approved Judgment
`1998 FDA Approved Label for Herceptin® (“Herceptin Label”)
`Eur. Patent No. EP 1 210 115 B1, Application No. 00 959 423.5,
`Decision revoking the European Patent (May 4, 2012)
`1010 Drugs@FDA: FDA Approved Drug Products for HERCEPTIN,
`http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overvi
`ew.process&ApplNo=103792
`Press Release, Genentech, Inc. Biotechnology Breakthrough In Breast
`Cancer Wins FDA Approval (Sept. 25, 1998) (on file at Genentech
`company website)
`1012 Genentech, Inc. Annual Report (Form 10-K) (Jan. 22, 1999)
`1013 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 ’96”)
`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 ’98”)
`
`1008
`1009
`
`1011
`
`1014
`
`
`
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`
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`PETITIONER’S EXHIBIT LIST
`
`Description
`
`Exhibit
`No.
`1015
`
`Pegram, et al., Phase II Study of Intravenous Recombinant Humanized
`Anti-p185 HER-2 Monoclonal Antibody (rhuMAb HER-2) Plus
`Cisplatin in Patients with HER-2/neu Overexpressing Metastatic Breast
`Cancer, 14 PROCEEDINGS OF THE AMERICAN SOCIETY OF CLINICAL
`ONCOLOGY 106 (Abstract 124) (1995) (“Pegram ’95”)
`1016 Vogel, et al., Efficacy and Safety of HerceptinTM (Trastuzumab,
`Humanized Anti-HER2 Antibody) As A Single Agent in First-Line
`Treatment of HER2 Overexpressing Metastatic Breast Cancer
`(HER2+/MBC), 50(1) BREAST CANCER RESEARCH AND TREATMENT 232
`(Abstract 23) (1998) (“Vogel ’98”)
`In re Fischkoff, IPR2016-00172, Paper 2, (Ex. 1006, Declaration of
`Sharon Baughman, Ph.D.) (Nov. 5, 2015)
`Jones, et al., Replacing the Complementarity-determining Regions in a
`Human Antibody With Those From a Mouse, NATURE 321 (6069) 522–
`23 (1986) (“Jones ’86”)
`1019 Coates, et al., Quality of Life in Oncology Practice: Prognostic Value
`of EORTC QLQ-C30 Scores in Patients with Advanced Malignancy,
`33(7) EUROPEAN JOURNAL OF CANCER 1025–30 (1997)
`1020 Aaronson, et al., The European Organization for Research and
`Treatment of Cancer QLQ-C30: A Quality-of-Life Instrument for Use in
`International Clinical Trials in Oncology, 85(5) J. NAT’L. CANCER
`INSTITUTE 365–76 (1993)
`Ferrell, Quality of Life in Breast Cancer, 4(6) CANCER PRACTICE 331–
`40 (1996) (“Ferrell ’96”)
`1022 Rowland, et al., Clinical Pharmacokinetics: Concepts and Applications
`LIPPINCOTT WILLIAMS & WILKINS (3rd ed. 1995) (4 Volumes)
`(“Rowland ’95”)
`1023 Reserved
`1024 Certified File History for U.S. Patent No. 7,371,379
`Biomarin Pharm., Inc. v. Genzyme Therapeutic Prods., LP, IPR2013-
`1025
`00537, Paper 79 (P.T.A.B. Feb. 23, 2015)
`
`1017
`
`1018
`
`1021
`
`
`
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`
`
`PETITIONER’S EXHIBIT LIST
`
`Description
`
`Exhibit
`No.
`1026 Walpole, et al., The weight of nations: an estimation of adult human
`biomass, 12:439 BMC PUBLIC HEALTH (2012)
`https://bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-
`12-439
`1027 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=503445
`1028 Gibaldi, et al., Pharmacokinetics, INFORMA HEALTHCARE USA, INC. (2nd
`ed. 1982) (“Gibaldi ’82”)
`1029 King, Applications and Engineering of Monoclonal Antibodies, TAYLOR
`& FRANCIS LTD. (1998)
`1030 Declaration of Scott T. Weingaertner
`1031 Declaration of Christopher Lowden, as filed in IPR2017-00805
`1032 Declaration of Simon Charles Cohen, as filed in IPR2017-00805
`1033
`Library of Congress Copyright Record for Baselga ’96
`1034
`Library of Congress Copyright Record for Pegram ’98
`1035
`Library of Congress Copyright Record for Jones ’86
`1036
`Library of Congress Copyright Record for Ferrell ’96
`1037
`Library of Congress Copyright Record for Rowland ’95
`1038
`Library of Congress Copyright Record for Gibaldi ’82
`1039 Declaration of Professor Hilary Calvert
`
`
`
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`
`x
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
`
`
`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 1–3, 5, 7, 9–11, 16-28, and 30-40 (the “Challenged
`
`Claims”) of U.S. Patent No. 7,371,379 (“’379 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 methods of treating patients
`
`diagnosed with cancer characterized by overexpression of the ErbB2 receptor with
`
`an anti-ErbB2 antibody given at certain time intervals. 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 IPR2017-00805 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 IPR2017-00805.
`
`There are no USPTO assignment records for the ’379 patent. The face of the
`
`’379 patent, however,
`
`indicates
`
`that
`
`it
`
`is assigned
`
`to Genentech, Inc.
`
`(“Genentech”). The Certified File History for the ’379 patent also indicates an
`
`
`1 All references to exhibits, e.g., “Exhibit” or “Ex.,” are to the table of exhibits
`
`attached hereto as Petitioner’s Exhibit List.
`
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`assignment to Genentech is on record in parent application no. 09/648,067, which
`
`issued as U.S. Patent No. 6,627,196. (Ex. 1024 at 2-3) A copy of this assignment
`
`is attached to this petition. (See Ex. 1004)
`
`II. MANDATORY NOTICES
`
`A.
`
`Petitioner and 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. Matters (37 C.F.R. § 42.8(b)(2))
`
`Bioepis is unaware of any litigation related to the ’379 patent.
`
`Bioepis is aware of two previously filed IPR petitions related to the ’379
`
`patent. Hospira, Inc. filed IPR2017-00805 on January 30, 2017, which was
`
`instituted on July 27, 2017. Celltrion, Inc. subsequently filed IPR2017-01140 on
`
`March 24, 2017, which is active and awaiting an institution decision.
`
`Bioepis is also aware of two previously filed IPR petitions concerning the
`
`related 6,627,196 patent. Hospira filed IPR2017-00804 on January 30, 2017,
`
`which was instituted on July 27, 2017. Celltrion subsequently filed IPR2017-
`
`001139 on March 24, 2017, which is active and awaiting an institution decision.
`
`The UK designation of European Patent 1 210 115 B1 (“EP ’115”) (Ex.
`
`
`
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`2
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`1005), a European counterpart to the ʼ379 patent,2 was recently invalidated in UK
`
`proceedings as obvious in light of one or more of the references asserted here; the
`
`court’s judgment was affirmed on appeal. (See Hospira UK Ltd. v. Genentech Inc.,
`
`Case No. HC12C03487 [2014] EWHC (CH) 1094 (Pat) (Apr. 10, 2014), Approved
`
`Judgment (Ex. 1006); Hospira UK Ltd. v. Genentech Inc., Case No. A3 2014 1800,
`
`[2015] WECA (Civ) 57 (Feb. 6, 2015), Approved Judgment (Ex. 1007))
`
`EP ’115 was also invalidated and revoked across Europe by the EPO on the
`
`grounds that it failed to disclose the invention in a manner sufficiently clear and
`
`complete for it to be carried out by the skilled person. (See Eur. Patent No. EP 1
`
`210 115 B1, Application No. 00 959 423.5, Decision revoking the Eur. Patent
`
`(May 4, 2012) (Ex. 1009) at 5, 18)
`
`Bioepis is not aware of any other judicial or administrative matters that
`
`would affect, or be affected by, a decision in the proceeding.
`
`C. Counsel and Service Information (37 C.F.R. § 42.8(b)(3) and (4))
`
`Bioepis designates the following counsel:
`
`
`2 The EP ’115 patent and the ’379 patent both claim priority to U.S. Provisional
`
`Application Nos. 60/213,822 and 60/151,018, filed on June 23, 2000 and
`
`August 27, 1999, respectively.
`
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`3
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`
`
`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
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`
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`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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`Please address all correspondence to lead and backup counsel. Bioepis consents to
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`service by email at the following addresses: ddrivas@whitecase.com and
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`scott.weingaertner@whitecase.com.
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`III. FEES (37 C.F.R. § 42.15(A))
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`Bioepis authorizes the United States Patent and Trademark Office to charge
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`the fees enumerated in 37 C.F.R. § 42.15(a) regarding this Petition and any
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`additional fees that may be due in connection with this Petition from Deposit
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`Account No. 50-3672.
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`IV. REQUIREMENTS UNDER 37 C.F.R. § 42.104
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`A. Grounds for Standing (37 C.F.R. § 42.104(a))
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`Bioepis certifies that the ’379 patent is available for IPR and that Bioepis is
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`not barred or estopped from requesting IPR on the grounds identified herein. 35
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`U.S.C. § 315.
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`B.
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`Statement of relief requested (37 C.F.R. § 42.104(b))
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`The application from which the ’379 patent issued was filed on June 20,
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`2003. Because the application was filed before March 16, 2013, this Petition is
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`governed by pre-AIA 35 U.S.C. § 103. See MPEP 2159.01. Pursuant to 37 C.F.R.
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`§§ 42.104(b)(1) and (2), Petitioner requests review of the Challenged Claims on
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`the following ground:
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`Ground
`1
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`Proposed Statutory Rejection of the ’379 Patent
`Claims 1–3, 5, 7, 9–11, 16-28, and 30-40 are obvious based on the
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`Herceptin Label in view of Baselga ’96, Pegram ’98, and the knowledge
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`of a person of ordinary skill in the art under 35 U.S.C. § 103.
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`The cited prior art is as follows:
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`
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`Herceptin Label. The 1998 FDA approved label for rhuMAb HER23 (the
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`“Herceptin Label”) is attached as Exhibit 1008. The Herceptin Label is a printed
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`publication that was accessible to the relevant public as of the earliest priority date
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`(August 27, 1999). It is dated “September 1998,” (id. at 2), and the FDA approved
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`rhuMAb HER2 on September 25, 1998. (Ex. 1010; Ex. 1011 at 1) Further, as
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`evidenced by Genentech’s SEC filings, Genentech manufactured and marketed
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`rhuMAb HER2 by at least 1998. (See Ex. 1012 at 4–5, 13, 36) In addition, the
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`3
`rhuMAb HER2 is also known as Herceptin® or trastuzumab. This Petition will
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`refer to these interchangeable terms as “rhuMAb HER2”.
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`5
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`FDA’s website makes available the Herceptin Label as well as a list of
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`supplements and modifications to the label. (See Ex. 1010 and image below)
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`According to 21 U.S.C. § 352(b) (effective 1998), drugs like rhuMAb HER2 if
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`intended for sale in the U.S. must include with their package the FDA-approved
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`label. As shown above, no changes to the label for rhuMAb HER2 were approved
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`until 2000, at the earliest. This means that the Herceptin Label must have been
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`6
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`included with any package of rhuMAb HER2 sold or available for sale in the U.S.
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`in 1998 and 1999. Further, during UK litigation involving EP ’115 claiming
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`priority to the same date of August 27, 1999, Genentech “accept[ed] the [Herceptin
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`Label] is prior art.” (Ex. 1006 ¶ 13) For all of these reasons, the Herceptin Label
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`is prior art to the ’379 patent claims under 35 U.S.C. § 102(a) as of August 27,
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`1999. See also Phigenix, Inc. v. Immunogen, Inc., IPR2014-00676, Paper 11 at
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`21–22 (P.T.A.B. Oct. 29, 2014) (instituting IPR based, in part, on the Herceptin
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`Label). (Ex. 1006 ¶ 68 (invalidating EP ’115 patent based, in part, on the
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`Herceptin Label); Ex. 1002 ¶¶ 10, 36 (describing administering rhuMAb HER2 to
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`patients including around the earliest possible priority date and reviewing the
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`Herceptin Label)
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`
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`Baselga ’96. Baselga, et al., Phase II Study of Weekly Intravenous
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`Recombinant Humanized Anti-p185HER2 Monoclonal Antibody in Patients with
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`HER2/neu-Overexpressing Metastatic Breast Cancer, 14(3) J. CLIN. ONCOL. 737–
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`44 (1996) (“Baselga ’96”) is attached as Exhibit 1013. Baselga ’96 is a printed
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`publication that was accessible to the relevant public as of the earliest possible
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`priority date of the ’379 patent (August 27, 1999). Baselga ’96 was published in
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`the Journal of Clinical Oncology on March 1, 1996. (See id. at 737) Thus,
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`Baselga ’96 is prior art to the ’379 patent claims under 35 U.S.C. § 102(b).
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`7
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`
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`Pegram ʼ98. Pegram, et al., Phase II Study of Receptor-Enhanced
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`Chemosensitivity Using Recombinant Humanized Anti-p185HER2/neu Monoclonal
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`Antibody Plus Cisplatin in Patients with HER2/neu-Overexpressing Metastatic
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`Breast Cancer Refractory to Chemotherapy Treatment, 16(8) J. CLIN. ONCOL.
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`2659–71 (1998) (“Pegram ’98”) is attached as Exhibit 1014. Pegram ’98 is a
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`printed publication that was accessible to the relevant public as of the earliest
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`possible priority date of the ’379 patent. Pegram ’98 was published in the Journal
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`of Clinical Oncology in August 1998 and was available to the relevant public by at
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`least August 12, 1998 as evidenced by the Health Sciences Libraries stamp bearing
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`the same date. (See id. at Cover Page, Table of Contents) Thus, Pegram ’98 is
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`prior art to the ’379 patent claims under 35 U.S.C. § 102(b) as of August 27, 1999.
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`Below
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`is a detailed explanation of
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`the statutory ground for
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`the
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`unpatentability of each of the Challenged Claims that identifies examples of where
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`each element can be found in the cited prior art, and the relevance of that prior art.
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`Additional evidence is provided in the accompanying Declaration of Allan
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`Lipton, M.D. (Ex. 1002), Declaration of William Jusko, Ph.D. (Ex. 1003),4
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`4 The Lipton and Jusko Declarations are exact copies of the declarations
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`submitted by Drs. Lipton and Jusko in IPR2017-00805. These declarations are
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`cited in this petition to avoid unnecessary cost and to advance efficiency in this
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`instance. As mentioned above, this petition is presented along with a motion to
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`Petition for Inter Partes Review of U.S. Patent No. 7,371,379
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`Declaration of Professor Hilary Calvert (Ex. 1039), and other supporting exhibits.5
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`37 C.F.R. § 1.68. Dr. Lipton, Dr. Jusko, and Dr. Calvert were all persons of
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`ordinary skill in the art at the time of the alleged invention. (See Ex. 1002 ¶ 14;
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`Ex. 1003 ¶ 15; Ex. 1039 ¶ 12)
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`Dr. Allan Lipton is a Professor of Medicine and Oncology at the Milton S.
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`Hershey Medical Center of The Pennsylvania State University, with over 50 years
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`of experience in the medical field and extensive experience in clinical oncology.
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`(See Ex. 1002 ¶¶ 4, 6) Dr. Lipton has clinical experience prescribing rhuMAb
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`HER2 in combination with chemotherapy, and participated in the administration of
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`clinical trials that led to FDA approval of rhuMAb HER2. (See id. ¶¶ 7, 10)
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`Dr. William Jusko is a Distinguished Professor at the State University of
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`join IPR2017-00805, and by using the same declarations, Bioepis has
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`eliminated the need for analysis of another declaration or a new expert report.
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`To the extent Drs. Lipton or Jusko become unavailable in IPR2017-00805,
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`however, Bioepis will rely upon the Declaration of Professor Hilary Calvert.
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`5 Additional evidence authenticating various exhibits is provided in the
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`Declaration of Scott T. Weingaertner (Ex. 1030), the Declaration of Christopher
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`Lowden (Ex. 1031), and the Declaration o