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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`Adam R. Brausa (Reg No. 60,287)
`Daralyn J. Durie (Pro Hac Vice)
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
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`
`
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`
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`Filed on behalf of Patent Owner Genentech, Inc. by:
`
`David L. Cavanaugh (Reg. No. 36,476)
`Lauren V. Blakely (Reg. No. 70,247)
`Robert J. Gunther, Jr. (Pro Hac Vice)
`Lisa J. Pirozzolo (Pro Hac Vice)
`
`Kevin S. Prussia (Pro Hac Vice)
`
`Andrew J. Danford (Pro Hac Vice)
`
`WILMER CUTLER PICKERING
`
` HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
`
`Washington, DC 20006
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________
`PFIZER, INC. AND
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioners,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________________________________________
`Case IPR2017-014881
`U.S. Patent No. 6,407,213
`____________________________________________
`PATENT OWNER’S OPPOSITION TO
`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE
`
`
`1 Case IPR2017-02139 has been joined with this proceeding.
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`

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`
`
`I. 
`
`II. 
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`
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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`TABLE OF CONTENTS
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`PETITIONERS’ MOTION IS PROCEDURALLY IMPROPER ................... 1 
`
`PATENT OWNER’S ANTEDATION EVIDENCE IS ADMISSIBLE. ........ 2 
`
`A. 
`
`Patent Owner’s Lab Notebooks (Exs. 2001-2009) Are
`Admissible Under Federal Rules Of Evidence 901, 902(11),
`and 803(6). ............................................................................................. 2 
`
`1. 
`
`2. 
`
`Petitioners do not provide an evidentiary basis for
`exclusion of Exhibits 2001-2009. ............................................... 2 
`
`The lab notebooks (Exs. 2001-2009) are accurate copies
`of Patent Owner’s official records. ............................................. 7 
`
`B. 
`
`C. 
`
`Exhibits 2010-2015 Are Admissible. .................................................. 10 
`
`Patent Owner’s Declarations Regarding Prior Invention Are
`Admissible. .......................................................................................... 11 
`
`III. 
`
`PATENT OWNER’S SECONDARY CONSIDERATIONS
`EVIDENCE IS ADMISSIBLE. ..................................................................... 12 
`
`IV.  DR. WILSON’S EXPERT OPINION IS ADMISSIBLE. ............................ 14 
`
`V.  DR. WILSON’S AND DR. CARTER’S ERRATA ARE PROPER............. 14 
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`i
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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`TABLE OF AUTHORITIES
`
`
`Cases
`Apator Miitors ApS v. Kamstrup A/S, 887 F.3d 1293 (Fed. Cir. 2018) ..................... 1
`Apple Inc. v. DSS Tech. Mgmt., Inc., IPR2015-00369, Paper 40 (June
`17, 2016) .......................................................................................................... 1
`Corning Inc. v. DSM IP Assets B.V., IPR2013-00049, Paper 88 (May
`9, 2014) .......................................................................................................... 14
`
`Page(s)
`
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule
`Patent Litig., 676 F.3d 1063 (Fed. Cir. 2012) ............................................... 13
`Knorr v. Pearson, 671 F.2d 1368 (C.C.P.A. 1982) ............................................. 6, 11
`Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157 (Fed. Cir. 2006) .............................. 2
`Microsoft Corp. v. Surfcast, Inc., IPR2013-00292, Paper 33
`(Oct. 14, 2014) ................................................................................................ 5
`Neste Oil Oyj v. REG Synthetic Fuels, LLC, IPR2013-00578, Paper 52
`(Mar. 12, 2015) ................................................................................................ 5
`NHK Seating of Am., Inc. v. Lear Corp., IPR2014-01200, Paper 29
`(Feb. 2, 2016) ................................................................................................. 12
`In re NTP, Inc., 654 F.3d 1279 (Fed. Cir. 2011) ................................................... 4, 5
`Pieters v. B-Right Trucking, Inc., 669 F. Supp. 1463 (N.D. Ind. 1987) .................... 9
`Shu-Hui Chen v. Bouchard, 347 F.3d 1299 (Fed. Cir. 2003) .................................... 5
`SMF Holding Co. v. BASF Corp., IPR2015-00600, Paper 41
`(Apr. 7, 2016) ................................................................................................ 15
`In re Steed, 802 F.3d 1311 (Fed. Cir. 2015) ............................................................ 12
`United States v. Franks, 939 F.2d 600 (8th Cir. 1991) .............................................. 4
`United States v. Komsa, 767 F.3d 151 (2d Cir. 2014) ............................................... 4
`
`
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`ii
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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`United States v. Reyes, 157 F.3d 949 (2d Cir. 1998) ................................................. 4
`Statutes, Rules, and Regulations
`37 C.F.R. § 42.7(a) .................................................................................................... 1
`37 C.F.R. § 42.53(f)(5) ............................................................................................ 14
`37 C.F.R. § 42.64(c) ................................................................................................... 2
`Fed. R. Evid. 401 ..................................................................................................... 13
`Fed. R. Evid. 803(6) ..........................................................................................passim
`Fed. R. Evid. 901 ..............................................................................................passim
`Fed. R. Evid. 902(11) ......................................................................................... 2, 3, 6
`Fed. R. Evid. 1003 ..................................................................................................... 7
`Patent Trial Practice Guide, 77 Fed. Reg. 48,756 (Aug. 14, 2012) ..................... 1, 2
`Treatises
`30B Fed. Prac. & Proc. Evid. § 6862 (2018 ed.) ....................................................... 3
`1 Weinstein’s Evidence Manual § 16.07 (2018) ....................................................... 4
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`
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`iii
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`I.
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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`PETITIONERS’ MOTION IS PROCEDURALLY IMPROPER.
`The Board should reject Petitioners’ motion to exclude as procedurally
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`improper because it challenges the sufficiency of Patent Owner’s evidence but fails
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`to present an evidentiary basis to exclude it. Patent Trial Practice Guide, 77 Fed.
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`Reg. 48,756, 48,767 (Aug. 14, 2012) (“A motion to exclude must explain why the
`
`evidence is not admissible … but may not be used to challenge the sufficiency of
`
`the evidence to prove a particular fact.”); 37 C.F.R. § 42.7(a) (the Board may
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`expunge an improper filing); see also Apple Inc. v. DSS Tech. Mgmt., Inc.,
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`IPR2015-00369, Paper 40, at 36-37 (June 17, 2016).
`
`Petitioners’ challenge to Patent Owner’s antedation evidence (Ex. 2001-
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`2015) is particularly problematic in this regard. Petitioners focus on whether the
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`inventors’ antedation testimony is sufficiently corroborated. (Paper 67 at 1-3, 7-
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`13.) Corroboration, however, is not a binary rule of evidence or an independent
`
`basis for excluding evidence. Rather, it is evaluated under a “rule of reason”
`
`analysis that examines all pertinent evidence to determine the credibility of an
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`inventor’s testimony. Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1170 (Fed.
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`Cir. 2006). Importantly, “‘the fact that a notebook entry’ or other writing ‘has not
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`been promptly witnessed does not necessarily disqualify it in serving as
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`corroboration of conception.’” Apator Miitors ApS v. Kamstrup A/S, 887 F.3d
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`1293, 1297 (Fed. Cir. 2018). Petitioners’ corroboration arguments are thus
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`1
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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`fundamentally a challenge to the merits of Patent Owner’s antedation defense, not
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`the admissibility of that evidence.
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`To the extent that Petitioners’ corroboration argument is even a cognizable
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`evidentiary objection (it is not), Petitioners failed to preserve it. (See Paper 33;
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`Paper 55.) Indeed, Petitioners fail to identify where in the record their objection
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`was originally made, which is an independent basis for denying their challenge to
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`Patent Owner’s antedation evidence. See 37 C.F.R. § 42.64(c); Patent Trial
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`Practice Guide, 77 Fed. Reg. at 48,767 (motion must “[i]dentify where in the
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`record the objection originally was made”).
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`II.
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`PATENT OWNER’S ANTEDATION EVIDENCE IS ADMISSIBLE.
`A.
`Patent Owner’s Lab Notebooks (Exs. 2001-2009) Are Admissible
`Under Federal Rules Of Evidence 901, 902(11), and 803(6).
`1.
`Petitioners do not provide an evidentiary basis for exclusion of
`Exhibits 2001-2009.
`Exhibits 2001-2009 are properly admitted under Federal Rules of Evidence
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`901, 902(11), and 803(b). With respect to Exhibits 2001-2006, the individuals
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`who created the documents testified that they have personal knowledge of their
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`respective lab notebooks, and that Exhibits 2001-2006 are true and accurate copies
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`of those notebooks. (Exs. 2016, ¶¶10-11; Ex. 2017 ¶¶11-16, Ex. 2018, ¶¶8-9.)
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`That is all that is required to authenticate the exhibits. See Fed. R. Evid. 901(b)(1)
`
`(authenticity established by “Testimony of a Witness with Knowledge … that an
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`2
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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`item is what it is claimed to be”). Indeed, Petitioners make no attempt to argue
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`that Mr. Brady’s lab notebooks were not properly authenticated, and he offered the
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`same authenticating testimony as Drs. Carter and Presta. (See Ex. 2018, ¶¶8-9.)
`
`Moreover, Patent Owner’s records custodian, Ms. Loeffler, testified that
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`Exhibits 2001-2009 are “true and authentic copies … of Genentech laboratory
`
`notebooks” that came from Patent Owner’s files. (Ex. 2019, ¶4.) She also testified
`
`that (1) it was the regular practice of Genentech’s personnel to create lab
`
`notebooks “at or near the time of the recorded act, event, condition, or opinion
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`occurred”; (2) “[s]uch records would only be made by someone with knowledge or
`
`from information transmitted by someone with knowledge”; (3) “[i]t was the
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`general practice of Genentech’s personnel to date such documents as of the date
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`the record was created or modified”; and (4) the lab notebooks were generated
`
`during the regular course of Genentech’s business. (Id. at ¶6; Ex. 1200 at 39:9-
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`40:21, 43:15-44:4.) That is all that is required to authenticate the documents and
`
`establish their admissibility as business records. See Fed. R. Evid. 902(11); Fed.
`
`R. Evid. 803(6); 30B Fed. Prac. & Proc. Evid. § 6862 (2018 ed.).
`
`Petitioners’ arguments with respect to introduction of the lab notebooks
`
`under Rule 803(6) are focused on Ms. Loeffler’s purported lack of personal
`
`knowledge regarding these specific lab notebooks. (Paper 67 at 8, 10-11.) But
`
`Ms. Loeffler, as a record custodian, need not have personal knowledge of how
`3
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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`each lab notebook was created or maintained in order to satisfy Rule 803(6). See,
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`e.g., U.S. v. Reyes, 157 F.3d 949, 952 (2d Cir. 1998) (custodian who testifies as to
`
`the authenticity of a record need not have firsthand knowledge of the creation of
`
`the record to satisfy Rule 803(6)); 1 Weinstein’s Evidence Manual § 16.07 (2018).
`
`All the rules require is that she is familiar with the record-keeping system of
`
`Genentech and knows how Genentech’s records were created and maintained. See
`
`U.S. v. Komsa, 767 F.3d 151, 156 (2d Cir. 2014); Reyes, 157 F.3d at 952. She
`
`testified as such here. (Ex. 2019, ¶¶3-7; Ex. 1200 at 11:11-12:3, 16:20-17:19.)
`
`Petitioners’ contrary rule requiring the testimony of the person with personal
`
`knowledge of the preparation and maintenance of the particular records introduced
`
`“would eviscerate the business records exception.” U.S. v. Franks, 939 F.2d 600,
`
`602 (8th Cir. 1991). Ms. Loeffler’s alleged “lack of personal knowledge” of the
`
`particular notebooks here is not a basis to exclude her testimony, or the lab
`
`notebooks she testified about.2
`
`The cases cited by Petitioners regarding authentication by inventors (Paper
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`67 at 7-8) are inapposite. In re NTP held that inventor testimony alone was
`
`insufficient to prove that certain parts of a document dated after the purported
`
`
`2 Because the requirements of Rule 803(6) are met, Petitioners are incorrect that
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`Exhibits 2007-2009 are hearsay.
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`4
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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`invention date were also included in a version of the document that predated the
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`prior art. In re NTP, Inc., 654 F.3d 1279, 1291-92 (Fed. Cir. 2011). And Shu-Hui
`
`Chen held that the Board did not abuse its discretion in excluding lab notebooks
`
`where there was no evidence of a company’s policies regarding maintenance of lab
`
`notebooks and the inventor attempted to authenticate the lab notebooks of a third
`
`party to corroborate his invention story. Shu-Hui Chen v. Bouchard, 347 F.3d
`
`1299, 1308 (Fed. Cir. 2003). Similarly, Neste Oil does not stand for the
`
`proposition that an inventor can never authenticate his own document within the
`
`meaning of Federal Rule of Evidence 901. Rather, consistent with NTP and Shu-
`
`Hui Chen, the Board held that inventor testimony alone cannot fill in critical gaps
`
`missing in the corroborating evidence such as the date or author where the
`
`circumstances of the document’s creation are unknown. Neste Oil Oyj v. REG
`
`Synthetic Fuels, LLC, IPR2013-00578, Paper 52 at 3-4 (Mar. 12, 2015).3
`
`
`3 To the extent that Petitioners seek to extend Neste Oil to preclude an inventor
`
`from authenticating a document under Rule 901 where the document is dated and
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`clearly “bears [] indication that they were created” by the offering witness, that
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`would be inconsistent with fundamental evidentiary principles. Cf. Neste Oil,
`
`Paper 52 at 3-4; Microsoft Corp. v. Surfcast, Inc., IPR2013-00292, Paper 33 at 51-
`
`52 (Oct. 14, 2014). Indeed, it is hard to imagine who would be better to
`
`
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`5
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`

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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`None of those unique circumstances are applicable in this case. Here, the
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`
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`inventors’ lab notebooks (Exs. 2001-2004) bear indicia of reliability not present
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`the cases where inventor testimony was insufficient to “authenticate” the
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`documents. For example, the authors of the notebooks are readily identifiable, the
`
`notebooks are dated before the critical date, and Patent Owner separately showed
`
`through the testimony of its records custodian that the lab notebooks were kept in
`
`the ordinary course of business and therefore admissible under Rules 902(11) and
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`803(6). This is thus not a case where the inventor’s testimony is filling in any
`
`gaps. All necessary information is in the documents being authenticated, which
`
`would be admissible even without the inventors’ testimony given Ms. Loeffler’s
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`records-custodian declaration. Patent Owner’s lab notebooks are thus admissible
`
`under Rules 901, 902(11), and 803(6).
`
`Moreover, irrespective of their status as business records, the lab notebooks
`
`are, at a minimum, admissible for what they describe and are relevant for their
`
`corroborative evidentiary value, independent of their truth. See Knorr v. Pearson,
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`671 F.2d 1368, 1372-73 (C.C.P.A. 1982) (act of communicating ideas supporting
`
`conception has independent legal significance beyond the truth of statements).
`
`Their relevance as corroborating evidence is independent of any hearsay purpose.
`
`
`authenticate the document under Rule 901 than the author of the document himself.
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`6
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`

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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`2.
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`The lab notebooks (Exs. 2001-2009) are accurate copies of
`Patent Owner’s official records.
`Exhibits 2001-2009 are true and accurate copies Genentech’s lab notebooks.
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`(Ex. 2016, ¶11; Ex. 2017, ¶12; Ex. 2018, ¶¶9-10; Ex. 2019, ¶4.) The fact that
`
`Exhibits 2001-2009 are high resolution color scans created in 2016 does not affect
`
`their admissibility. See Fed. R. Evid. 1003.
`
`The fact that Genentech also has low resolution microfilm copies of these
`
`notebooks is irrelevant to the admissibility of Exhibits 2001-2009. As
`
`Ms. Loeffler testified, the original lab notebooks are Genentech’s official record of
`
`the research (Ex. 1200 at 42:22-25), and Exhibits 2001-2009 are copies of the
`
`original notebooks (Ex. 2019, ¶4). The microfilms are also copies of the original
`
`notebooks and exist for “disaster recovery” purposes. (Ex. 1200 at 42:13-21.) But
`
`that does not make a high-resolution, color scan of the same notebook
`
`inadmissible; indeed Ms. Loeffler testified that Genentech uses the scans for the
`
`same purpose as the microfilms. (Id. at 42:16-43:14.) The microfilms and color
`
`scans are equally admissible as duplicates of the original. Fed. R. Evid. 1003.
`
`Petitioners’ assertion that Patent Owner presented the copies of microfilm
`
`documents only to “claw[] them back” after discrepancies with the color scans
`
`were identified (Paper 67 at 8-9) fundamentally misstates what occurred. Patent
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`Owner made the microfilms available to Petitioners at Ms. Loeffler’s deposition
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`
`
`7
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`

`

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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`because Petitioners had asked questions about the microfilms during prior
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`depositions. (E.g., Ex. 1198 at 130:23-132:20, 136:5-138:7, 173:15-173:20; Ex.
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`1201 at 17:17-18:5). At the outset of Ms. Loeffler’s deposition, Petitioners
`
`objected that they had inadequate time to review the microfilms and stated that
`
`they had identified three purported discrepancies between the microfilms and the
`
`color scans (without identifying what those alleged discrepancies were). (Ex. 1200
`
`at 7:10-8:7, 8:23-9:18.) Patent Owner offered to give Petitioners more time to
`
`review the microfilms and disputed that the content of the microfilms was any
`
`different from the color scans. (Id. at 8:8-22.) But if there were differences, Patent
`
`Owner noted that the microfilms were available to Petitioners if they wished to
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`cross-examine Ms. Loeffler concerning them. (Id.)
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`Petitioners then proceeded to take Ms. Loeffler’s deposition and did not ask
`
`about the microfilms, let alone any purported discrepancies between the microfilms
`
`and the color scans. At the end of Ms. Loeffler’s deposition, counsel for Patent
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`Owner retained custody of the microfilms, since (i) they were not used at the
`
`deposition; (ii) Petitioners objected to their use in these proceedings; and (iii) they
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`are confidential Genentech documents that were not branded as such. (Id. at
`
`44:12-46:6.) And Petitioners have made no request that Patent Owner provide the
`
`microfilms. To the extent Petitioners’ believed there were differences (there is no
`
`evidence of anything of the sort), Petitioners had the opportunity to ask Ms.
`8
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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`Loeffler about them, or introduce the microfilms into evidence. (Id. at 7:10-9:18
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`(asserting, before Ms. Loeffler’s deposition, that there were differences), 44:12-
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`46:6.) Petitioners may not now capitalize on their strategic decision not to identify
`
`or address the alleged differences or cross-examine Ms. Loeffler about them. If
`
`anything, the fact that they chose not to ask Ms. Loeffler about the microfilms or
`
`later seek to obtain copies from Patent Owner confirms that there are, in fact, no
`
`differences. But if Petitioners want the microfilms, Patent Owner is happy to file
`
`them as exhibits in this proceeding.
`
`Petitioners’ baseless speculation that these lab notebooks may have been
`
`altered after their creation is also not a reason to exclude this evidence. Patent
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`Owner’s records custodian testified that lab notebooks ordinarily remain in their
`
`author’s possession until that author leaves the company, at which point the
`
`notebooks are stored by Genentech’s corporate records department. (See Ex. 2019,
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`¶5, Ex. 1200 at 34:13-21; see also e.g., id. 30:14-31:3, 31:25-32:8.) And that is
`
`what happened with these notebooks here. (Ex. 2016, ¶11; Ex. 2017, ¶12.) There
`
`is no requirement that the authors of a record must account for the whereabouts of
`
`the documents they created since its creation. Pieters v. B-Right Trucking, Inc.,
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`669 F. Supp. 1463, 1465 (N.D. Ind. 1987) (“Federal Rule of Evidence 803(6) does
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`not require a showing of chain of custody.”).
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`9
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`In any case, Patent Owner witnesses testified that nothing would lead them
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`
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`to believe that the lab notebooks were altered since they were completed. (See,
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`e.g., Ex 1119, 188:8-190:11; Ex. 1200 at 21:18-22:1.) The only instance of an
`
`alteration identified by Petitioners is where Dr. Presta contemporaneously fixed an
`
`incorrect date where the error was clear from the surrounding dates in the
`
`notebook. (Ex. 1119 at 179:14-180:15; Ex. 2016, ¶28 n.1 (“Although I wrote the
`
`date as December 15, 1988, Notebook 10098 was issued to me on December 5,
`
`1989. This entry should state December 15, 1989.”).) Petitioners can hardly
`
`complain about a correction that Dr. Presta made contemporaneously and that
`
`moved a date forward in time. Petitioners’ unsupported argument that nine lab
`
`notebooks were systematically altered is frivolous and provides no reason to
`
`exclude Exhibits 2001-2009 as an evidentiary matter. However, to the extent
`
`Petitioners wish to place the inventors’ credibility at issue, Patent Owner is happy
`
`to make Dr. Carter available to testify live at the July 16, 2018 hearing.
`
`B.
`Exhibits 2010-2015 Are Admissible.
`Exhibits 2010-2015 are printouts of emails, synthetic DNA request forms,
`
`project status reports, and meeting minutes that support the inventors’ testimony
`
`that they conceived of and reduced the claimed invention to practice. As
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`individuals with knowledge of the documents, Dr. Presta and Dr. Carter properly
`
`authenticated these documents under Rule 901 for the reasons discussed above.
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`10
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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`(See Ex. 2017, ¶¶13, 32-34 (Ex. 2010); Ex. 2017, ¶¶13, 52 and Ex.2016, ¶¶12, 49
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`(Ex. 2011); Ex. 2017, ¶72 (Ex. 2012); Ex. 2017, ¶40 (Ex. 2013); Ex. 2017, ¶¶14,
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`56 (Ex. 2014); Ex. 2017, ¶78 (Ex. 2015).) Further, these exhibits are all dated on
`
`the face of the document, and the inventors’ testimony does not fill any gaps in the
`
`antedation proof. These documents therefore avoid the “circular” situations in the
`
`cases cited by Petitioners where the inventors were attempting to establish the date
`
`of an undated or unattested third-party document through testimony alone.
`
`Exhibits 2010-2015 are also not hearsay; they are business records under
`
`Rule 803(6). (See, e.g., Ex. 2017, ¶¶11-16, 32-34, 40, 49, 52, 78; Ex. 2016, ¶¶12,
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`49.) Moreover, the mere fact the communications reflected in Exhibits 2010-2015
`
`were made has legal significance to establishing prior invention that is independent
`
`of any alleged hearsay purpose. See Knorr, 671 F.2d at 1372-73.
`
`C.
`
`Patent Owner’s Declarations Regarding Prior Invention Are
`Admissible.
`Petitioners assert that the inventors’ testimony stating they possessed the
`
`claimed invention should be precluded because they failed to correlate their work
`
`with the claimed invention. (Paper 67 at 12-13.) But Petitioners fail to identify
`
`any evidentiary requirement that an inventor must provide a claim-by-claim
`
`analysis of his prior invention. To be sure, the inventors must show that they
`
`possessed the claimed invention. See, e.g., In re Steed, 802 F.3d 1311, 1316 (Fed.
`
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`11
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`Cir. 2015). And that is exactly what the declarations from Drs. Carter and Presta
`
`show. (Ex. 2016, ¶53; Ex. 2017, ¶79.)
`
`Petitioners’ only cited case, NHK Seating, stands for the unremarkable
`
`proposition that a document purporting to show prior invention must, in fact,
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`disclose the elements of the prior invention. NHK Seating of Am., Inc. v. Lear
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`Corp., IPR2014-01200, Paper 29 at 15-16 (Feb. 2, 2016). NHK Seating does not
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`require an element-by-element comparison by the inventors. See id. Petitioners’
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`disagreement with the inventors’ conclusion that they possessed the claimed
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`invention prior to July 26, 1990 is not a basis to exclude their testimony,
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`particularly where the element-by-element analysis demanded by Petitioners is in
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`Patent Owner’s Response. (See Paper 44 at 23-24, 36-39, 40-44.)
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`III. PATENT OWNER’S SECONDARY CONSIDERATIONS EVIDENCE
`IS ADMISSIBLE.
`With respect to Patent Owner’s evidence of secondary considerations,
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`Petitioners again argue the merits of their invalidity case, rather than any
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`evidentiary objection. Petitioners argue that there must be a nexus between the
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`claimed invention and secondary considerations. In other words, the secondary
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`considerations must be “attributable to the inventive characteristics of the
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`discovery as claimed in the patent.” In re Cyclobenzaprine Hydrochloride
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`Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1079 n.6 (Fed. Cir. 2012).
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`Here, Patent Owner’s evidence and testimony at least makes it “more or less
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`
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`probable” (Fed. R. Evid. 401) that the unexpected results and commercial success
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`of Herceptin® and other drugs were attributable to the characteristics of the
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`invention claimed in the ’213 patent. With respect to the commercial success,
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`Patent Owner’s witnesses testified that Herceptin®, Perjeta®, Avastin®, Lucentis®,
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`and Xolair® use the humanization techniques of the ’213 patent, such as, for
`
`example, the “consensus approach.” (Ex. 2016 at ¶¶5, 51-53; Ex. 2017 at ¶4, 77-
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`79; Ex. 2015 at 1; Ex. 2041 at ¶¶86, 130, 266; see also Paper 44 at 67-68.)
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`Petitioners argue that there is no evidence that that any of those drugs—including
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`Herceptin®—is an embodiment of the claims. But that is not true. The record
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`shows that those drugs include the ’213 patent’s consensus sequence and the
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`claimed framework substitutions. (Ex. 2016, ¶¶51-52; Ex. 2041, ¶266.) That is
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`sufficient for the Board to evaluate whether they embody the challenged claims.
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`Similarly, with respect to “unexpected results,” Patent Owner presented
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`evidence and testimony that claimed humanizations techniques yielded antibodies
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`that (1) unexpectedly allowed numerous different antibodies to be humanized from
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`a single consensus sequence (Paper 44 at 65-66; Ex. 2041, ¶265; Ex. 1002 at 3439-
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`41); and (2) unexpectedly lacked immunogenicity and demonstrated superior
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`binding affinity (Paper 44 at 65-66 (“unexpected results flow directly from the
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`consensus limitation of the ’213 patent”); Ex. 2017, ¶¶75-79; Ex. 2041, ¶267).
`13
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`IV. DR. WILSON’S EXPERT OPINION IS ADMISSIBLE.
`Petitioners’ arguments that Dr. Wilson applied an incorrect legal standard
`
`are without merit. Dr. Wilson’s declaration clearly lays out the standard he
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`applied. (Ex. 2041 at ¶¶14, 15.) This is the same standard offered by Petitioners.
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`(Paper 67 at 14.) Petitioners have not identified any of Dr. Wilson’s opinions that
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`supposedly rests on an incorrect legal standard.
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`Petitioners challenge rests on a portion of Dr. Wilson’s deposition
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`testimony. (Paper 67 at 14.) But Dr. Wilson’s testimony correctly reflected that
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`certain challenged claims encompass antibodies with any one of the recited
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`framework substitutions. (E.g., Ex. 1197 at 84:11-15.) And Petitioners’ cited
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`testimony focuses on a single limitation (i.e., the framework substitutions), which
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`is insufficient to demonstrate obviousness of the claims which contain other
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`limitations (e.g., the ability to bind an antigen). (Id. at 91:3-13.) Moreover, even
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`under Petitioners’ flawed analysis, this isolated statement is not “determinative of
`
`the issue” of whether Dr. Wilson applied the correct legal standard. Corning Inc.
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`v. DSM IP Assets B.V., IPR2013-00049, Paper 88 at 13 (May 9, 2014).
`
`V. DR. WILSON’S AND DR. CARTER’S ERRATA ARE PROPER.
`A witness “shall read and sign” his deposition transcript. 37 C.F.R.
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`§ 42.53(f)(5). Dr. Wilson (Ex. 1197) and Dr. Carter (Ex. 1198) signed their
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`transcripts subject to errata. Neither change addressed by Petitioners is substantive.
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`14
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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`Dr. Wilson’s deletion of “I know it, but” does not change the meaning of his
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`
`
`testimony. That change aligns his testimony with the preceding sentence: “I’m
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`not aware of them using consensus sequences.” (Ex. 1197 at 50:17-18.)
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`Dr. Carter’s errata also did not substantively change his testimony. Dr.
`
`Carter testified that “I don’t know the – you know, exactly how, you know, Kabat
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`was, you know, compiled and whether they included every sequence that was
`
`available.” (Ex. 1198 at 60:7-9.) It does not alter the substance of Dr. Carter’s
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`testimony to omit “certain” from the following sentence: “Certainly, it’s a very
`
`scholarly work with extensive references, so I think that they tried very hard to
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`include certain known sequences.” (Id. at 60:9-12.) Indeed, omitting “certain”
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`from that sentence cannot be a substantive change when Dr. Carter’s testimony
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`was that he did not know exactly how Kabat was compiled and whether they
`
`included every sequence that was available. (Id. at 60:3-12.)
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`Moreover, even under Petitioners’ view that those changes were substantive,
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`it would be appropriate to include those errata here “where Patent Owner will not
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`otherwise have an opportunity to correct misstatements of a declarant during
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`subsequent deposition testimony or at trial.” SMF Holding Co. v. BASF Corp.,
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`IPR2015-00600, Paper 41 at 3 (Apr. 7, 2016).
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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`
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`Date: July 3, 2018
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`
`
`Respectfully submitted,
`
`By:
`
`/David L. Cavanaugh/
`David L. Cavanaugh
`Reg. No. 36,476
`Wilmer Cutler Pickering Hale and Dorr LLP
`1875 Pennsylvania Avenue NW
`Washington, DC 20006
`202-663-6025
`
`
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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`CERTIFICATE OF SERVICE
`
`
`
`
`
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`I hereby certify that, on July 3, 2018, I caused a true and correct copy of the
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`following materials:
`
` Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`
`
`
`
`
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`
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`to be served via electronic mail on the following attorneys of record:
`
`Amanda Hollis
`KIRKLAND & ELLIS LLP
`amanda.hollis@kirkland.com
`300 North LaSalle, Chicago, IL 60654
`
`Stefan M. Miller, Ph.D.
`stefan.miller@kirkland.com
` 601 Lexington Avenue, New York, NY 10022
`
`Benjamin A. Lasky
`benjamin.lasky@kirkland.com
`601 Lexington Avenue, New York, NY 10022
`
`Sarah K. Tsou
`sarah.tsou@kirkland.com
`601 Lexington Avenue, New York, NY 10022
`
`Mark C. McLennan
`mark.mclennan@kirkland.com
`601 Lexington Avenue, New York, NY 10022
`
`Christopher J. Citro
`christopher.citro@kirland.com
`601 Lexington Avenue, New York, NY 10022
`
`Pfizer_Genentech_IPRs@kirkland.com
`
`1
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`IPR2017-01488
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`Patent Owner’s Opposition to Petitioners’ Motion to Exclude
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`Dimitrios T. Drivas
`White & Case LLP
`ddrivas@whitecase.com
`1221 Avenues of the Americas, New York, NY 10020
`
`Scott T. Weingaertner
`White & Case LLP
`scott.weingaertner@whitecase.com
`1221 Avenues of the Americas, New York, NY 10020
`
`Amit H. Thakore
`White & Case LLP
`athakore@whitecase.com
`1221 Avenue of the Americas, New York, NY 10020
`
`Eric Majch