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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`PFIZER, INC., and
`SAMSUNG BIOEPIS CO., LTD.,1
`Petitioners,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01489
`Patent 6,407,213
`____________
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`
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`PETITIONERS’ REPLY IN SUPPORT
`OF THEIR MOTION TO EXCLUDE EVIDENCE2
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`1 Samsung Bioepis Co. Ltd.’s IPR2017-02140 has been joined with this
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`proceeding. (IPR2017-02140, Paper 40.)
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`2 All emphases within are added.
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`IPR2017-01489: Petitioners’ Reply in Support of Motion to Exclude Evidence
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`TABLE OF CONTENTS
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`Page
`PETITIONERS’ MOTION IS PROCEDURALLY PROPER ........................ 1
`I.
`PO’S UNRELIABLE NOTEBOOKS / INTERNAL DOCUMENTS ............ 1
`II.
`PO’S UNRELIABLE “SECONDARY CONSIDERATIONS” ..................... 4
`III.
`IV. DR. WILSON’S UNRELIABLE VALIDITY OPINIONS ............................ 5
`V.
`IMPROPER ERRATA .................................................................................... 5
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`i
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`IPR2017-01489: Petitioners’ Reply in Support of Motion to Exclude Evidence
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`
`TABLE OF AUTHORITIES
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` Page(s)
`
`Cases
`Apator ApS v. Kamstrup,
`887 F.3d 1293 (Fed. Cir. 2018) ............................................................................ 1
`Chen v. Bouchard,
`347 F.3d 1299 (Fed. Cir. 2003) ............................................................................ 3
`Invitrogen Corp. v. Clontech Labs.,
`429 F.3d 1052 (Fed. Cir. 2005) ............................................................................ 3
`Medtronic, Inc. v. Norred,
`IPR2014-00110, Paper 46 (Apr. 23, 2015) ........................................................... 1
`Microsoft Corp. v. Surfcast, Inc.,
`IPR2013-00293, Paper 33 (Oct. 14, 2014) ........................................................... 1
`Neste Oil OYJ v. Reg Synthetic Fuels, LLC,
`IPR2013-00578, Paper 52 (March 12, 2015) ....................................................... 1
`NHK Seating of America, Inc. v. Lear Corp.,
`IPR2014-01200, Paper 29 (Feb. 2, 2016) ............................................................. 3
`SMF Holding Co. v. BASF,
`IPR2015-00600, Paper 41 (Apr. 7, 2016) ............................................................. 5
`Rules
`FRE 401 ..................................................................................................................... 1
`FRE 402 ..................................................................................................................... 1
`FRE 403 ..................................................................................................................... 1
`FRE 602 ..................................................................................................................... 1
`FRE 801 ..................................................................................................................... 1
`FRE 802 ..................................................................................................................... 1
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`
`
`ii
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`
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`IPR2017-01489: Petitioners’ Reply in Support of Motion to Exclude Evidence
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`FRE 803 ..................................................................................................................... 1
`FRE 901 ..................................................................................................................... 1
`FRE 902 ..................................................................................................................... 1
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`
`
`
`iii
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`IPR2017-01489: Petitioners’ Reply in Support of Motion to Exclude Evidence
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`I.
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`PETITIONERS’ MOTION IS PROCEDURALLY PROPER
`Petitioners’ motion clearly “present[s] an evidentiary basis to exclude” the
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`challenged exhibits, including FRE 901-02, 801-03, 602, 401-03, and supporting
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`caselaw excluding corroboration evidence. Mot. at 7-13. Petitioners timely objected
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`on these bases and “[i]dentif[ied] where in the record th[ose] objection[s]…w[ere]
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`made.” Id. at 4 (citing Papers 32 at 2-26; 44 at 2-4; 52 at 1). PO asserts
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`“corroboration” is not a basis for exclusion, but insufficient authentication, hearsay,
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`and lack of personal knowledge are, and “independent evidence of authenticity is
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`required” for antedation. Id. at 10, citing Neste Oil, IPR2013-00578, Paper 52, 4-5.
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`II.
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`PO’S UNRELIABLE NOTEBOOKS / INTERNAL DOCUMENTS
`PO’s opposition confirms its notebooks/internal documents are inadmissible.
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`For notebooks, PO relies on “the individuals who created the documents.” Opp. at
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`2-3. But PO provides no testimony from non-inventors Rowland, Hotaling and
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`Carver, whose notebooks (along with Brady’s, Exs. 2005–09) cannot corroborate as
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`they do not show the tested antibodies met the claims. See Medtronic, Inc. v. Norred,
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`IPR2014-00110, Paper 46 at 9 (Apr. 23, 2015). And having the inventors
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`authenticate their own unwitnessed notebooks (Exs. 2001-04) is the very “circular”
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`situation that is impermissible for corroboration. Neste Oil, IPR2013-00578, Paper
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`52 at 4 (Mar. 12, 2015); Microsoft, IPR2013-00293, Paper 33 at 52 (Oct. 14, 2014);
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`cf. Apator ApS v. Kamstrup, 887 F.3d 1293, 1297 (Fed. Cir. 2018)(“unwitnessed
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`laboratory notebook, alone, cannot corroborate an inventor’s testimony of
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`1
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`IPR2017-01489: Petitioners’ Reply in Support of Motion to Exclude Evidence
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`conception.”). PO’s assertion that the notebooks are “readily identifiable” and “dated
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`before the critical date” beg the questions raised by its failure to authenticate.
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`Nor has PO “separately show[n] through the testimony of its records custodian
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`[Ms. Loeffler] that the lab notebooks were kept in the ordinary course of business.”
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`Opp. at 6. Indeed, she had no personal knowledge as to how the notebooks were
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`“created and maintained.” Ex. 1700 at 18:2-20:6, 21:1-22:7, 23:18-27:24, 28:2-
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`38:11, 41:18-42:4, 46:14-50:3. And unlike the custodians in the cases PO cites, she
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`also could not identify any “record-keeping system;” rather, she testified that each
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`assignee was responsible for his or her own notebook. Id. And she conceded PO’s
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`notebook policies were not followed for the produced notebooks. Id. at 16:15–27:24;
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`28:2–38:11; 46:14–50:3.3 Thus, Ms. Loeffler’s testimony does not meet even the
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`minimum standards for a records custodian that PO itself admits “[t]he rules
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`require.” Opp. at 4. And without proper authentication, the notebooks cannot show
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`“ideas supporting conception” at any given time. Contra Opp. at 6.
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`With respect to PO’s other internal documents (Exs. 2010-15), it does not
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`3 The inventors already had the opportunity to testify, admitting they did not follow
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`PO’s notebook policies. Ex. 1699 66:3-67:5; 179:14-180:15; 1198 at 172:5-15,
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`172:16-22. PO’s untimely, prejudicial request to undo these admissions through
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`oral testimony from Dr. Carter at the hearing (Opp. at 10) should be denied.
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`2
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`IPR2017-01489: Petitioners’ Reply in Support of Motion to Exclude Evidence
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`dispute that Ms. Loeffler did not address them, and relies only on the inventors for
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`authentication. Opp. at 10-11. But PO itself concedes that the Federal Circuit has
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`affirmed exclusion in almost identical circumstances, “where there was no evidence
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`of a company’s policies regarding maintenance” of the challenged documents “and
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`the inventor attempted to authenticate the [documents] of a third party to corroborate
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`his invention story.” Id. at 5 (citing Chen v. Bouchard, 347 F.3d 1299, 1308 (Fed.
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`Cir. 2003)). Again, PO’s conclusory assertion that the exhibits have non-hearsay
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`legal significance is unavailing in the absence of adequate authentication.
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`Finally, PO does not dispute that, if the Board excludes any of Exs. 2001-15,
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`it also should exclude the portions of its declarations relying on them. Mot. at 12.
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`PO argues only that the inventors’ did not need to perform a “claim-by-claim
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`analysis.” Opp. at 11-12. But PO concedes that “a document purporting to show
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`prior invention must, in fact, disclose the elements of the prior invention.” Id. (citing
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`NHK, IPR2014-01200, Paper 29 at 15-16. Whether or not that requires a “claim-by-
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`claim analysis,” here the inventors and PO’s expert admittedly performed no
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`substantiating analysis. Exs. 1698, 37:19-39:15; 1699, 84:3-85:2; 1697, 256:12-
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`257:3. And although PO asserts such analysis is “in Patent Owner’s Response,”
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`“[u]nsubstantiated attorney argument regarding the meaning of technical evidence
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`is no substitute for competent, substantiated expert testimony.” Invitrogen Corp. v.
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`Clontech Labs., 429 F.3d 1052, 1068 (Fed. Cir. 2005); POR at 22-23, 34-43.
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`3
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`IPR2017-01489: Petitioners’ Reply in Support of Motion to Exclude Evidence
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`III. PO’S UNRELIABLE “SECONDARY CONSIDERATIONS”
`PO’s “evidence” does not “make it ‘more or less probable’…that [any]
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`unexpected results and commercial success…were attributable to the” claimed
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`invention. Opp. at 13. The ’213 does not claim “humanization techniques” or a
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`“consensus approach,” and the fact PO argues the alleged success and results are
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`attributable to these unclaimed processes is a concession that no nexus to the claimed
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`antibodies with their specifically claimed characteristics has been established. PO’s
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`substitution of an invitation to the Board to “evaluate” for itself “whether” PO’s
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`products “embody the challenged claims” in place of actual evidence is not well
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`taken. Id. PO bears the burden on nexus, and uses a higher standard when evaluating
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`prior art. And evidence that drugs include certain substitutions does not show they
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`embody the claims, which include Markush groups limiting substitutions and/or
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`require specific substitution combination. PO has not shown any commercial success
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`or “unexpected results” of any drug are attributable to its sequence substitutions.
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`PO’s argument that antibodies “unexpectedly lacked immunogenicity and
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`demonstrated superior binding affinity” (id.) also fails the nexus requirement. PO’s
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`expert did not attempt to compare the immunogenicity and/or affinity resulting from
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`the “consensus” and “best-fit” approaches. Ex. 1697 at 184:16-185:4. The only
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`comparison evidence in the record states there was “no clear advantage” to using
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`either approach. Id. at 191:18-192:6; 1694 at 9; 1699 at 136:9-14; 1696 at 5-6.
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`4
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`IPR2017-01489: Petitioners’ Reply in Support of Motion to Exclude Evidence
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`IV. DR. WILSON’S UNRELIABLE VALIDITY OPINIONS
`PO concedes that the challenged claims “encompass antibodies with any one
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`of the recited framework substitutions,” and does not dispute Dr. Wilson testified he
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`instead required every recited substitution to be disclosed or obvious. Opp. at 14; Ex.
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`1697, 84:11-15, 91:3-13, 92:3-14, 93:4-12. Nor does PO dispute this analysis is
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`legally flawed. Mot. at 14. That Dr. Wilson’s declaration lays out the same invalidity
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`standards offered by Petitioners (Opp. at 14) is irrelevant as his testimony confirms
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`he applied them incorrectly. And whether or not the limitation is “determinative” of
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`obviousness (id.), at the very least his opinions on that limitation should be excluded.
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`V.
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`IMPROPER ERRATA
`PO’s opposition confirms its errata are improper. That Dr. Carter “did not
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`know exactly how Kabat was compiled” (Opp. at 15) further explains why he should
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`not be permitted to change his testimony to suggest that Kabat included all known
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`sequences. And the fact that Dr. Wilson provided contradictory testimony (id.) also
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`does not justify withdrawal of his admission that he was aware that Riechmann’s
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`CAMPATH antibody was made using a “consensus” sequence. At the very least, the
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`Board should “ultimately give little or no weight” to the changed testimony. SMF
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`Holding Co. v. BASF, IPR2015-00600, Paper 41 at 3 (Apr. 7, 2016).
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`Date: July 10, 2018
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`
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`Respectfully submitted,
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`/Amanda Hollis/
`Attorney For Petitioner Pfizer, Inc.
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`5
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`IPR2017-01489: Petitioners’ Reply in Support of Motion to Exclude Evidence
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that a copy of the foregoing Reply in Support
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`of Motion to Exclude Evidence was served on July 10, 2018, via electronic service
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`on lead and back-up counsel:
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`For Genentech:
`david.cavanaugh@wilmerhale.com
`lauren.blakely@wilmerhale.com
`robert.gunther@wilmerhale.com
`abrausa@durietangri.com
`ddurie@durietangri.com
`andrew.danford@wilmerhale.com
`kevin.prussia@wilmerhale.com
`lisa.pirozzolo@wilmerhale.com
`
`For Samsung Bioepis Co., Ltd.:
`ddrivas@whitecase.com
`sweingaertner@whitecase.com
`eric.majchrzak@whitecase.com
`athakore@whitecase.com
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` /Amanda Hollis/
`Amanda Hollis
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`6
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