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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PFIZER, INC., and
`SAMSUNG BIOEPIS CO., LTD.,1
`Petitioners,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01489
`Patent 6,407,213
`____________
`
`
`
`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE2
`
`
`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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`

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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`
`
`TABLE OF CONTENTS
`
`Page
`INTRODUCTION ........................................................................................... 1
`I.
`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 4
`II.
`III. ARGUMENT ................................................................................................... 4
`A.
`PO’s Unreliable “Secondary Considerations” Opinions ....................... 4
`B.
`PO’s Unreliable Notebooks and Internal Documents ........................... 7
`C.
`Dr. Wilson’s Unreliable Validity Opinions ........................................ 13
`D.
`Improper Errata ................................................................................... 14
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`i
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Am. Med. Sys. v. Laser Peripherals, LLC,
`712 F. Supp. 2d 885 (D. Minn. 2010) ................................................................. 14
`Apple, Inc. v. Achates Reference Publishing, Inc.,
`IPR2013-00080, Paper 61 (Jan. 21, 2014) .......................................................... 14
`Chen v. Bouchard,
`347 F.3d 1299 (Fed. Cir. 2003) ...................................................................... 7, 11
`Chen v. Bouchard,
`Inter. No. 103,675, Paper No. 336, 2002 Pat. App. LEXIS 201
`(B.P.A.I. Aug. 2, 2002) ....................................................................................... 11
`Gnosis SPA v. S. Ala. Med. Sci. Found’n,
`IPR2013-00116, Paper 68 (June 20, 2014) ........................................................... 6
`Herbert v. Lisle Corp.,
`99 F.3d 1109 (Fed. Cir. 1996) ............................................................................ 14
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) ........................................................................ 5, 6
`In re Kubin,
`561 F.3d 1351 (Fed. Cir. 2009) .......................................................................... 14
`Mahurkar v. C.R. Bard, Inc.,
`79 F.3d 1572 (Fed. Cir. 1996) .............................................................................. 7
`MaxLinear, Inc. v. Cresta Tech. Corp.,
`IPR2015-00594, Paper 90 (Aug. 15, 2016) ........................................................ 12
`Medichem S.A. v. Rolabo, S.L.,
`437 F.3d 1157 (Fed. Cir. 2006) .................................................................... 10, 11
`Microsoft v. Surfcast,
`IPR2013-00293, Paper 33 (Oct. 14, 2014) ......................................................... 11
`
`
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`ii
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
`
`Neste Oil Oyj v. REG Synthetic Fuels, LLC,
`IPR2013-00578, Paper 52 (Mar. 12, 2015) .................................................... 7, 10
`NHK Seating of Am., Inc. v. Lear Corp.,
`IPR2014-01200, Paper 29 (Feb. 2, 2016) ........................................................... 13
`In re NTP, Inc.,
`654 F.3d 1279 (Fed. Cir. 2011) ............................................................................ 7
`Procter & Gamble Co., v. Teva Pharm.,
`566 F.3d 979 (Fed. Cir. 2009) ............................................................................ 10
`Reese v. Hurst,
`661 F.2d 1222 (CCPA 1981) .......................................................................... 8, 10
`Riverbed Tech. v. Realtime Data LLC,
`IPR2016-00978, Paper 67 (Oct. 30, 2017) ......................................................... 12
`Shimano, Inc. v. Globeride, Inc.,
`IPR2015-00273, Paper 40 (June 16, 2016) ........................................................... 6
`Vicor Corp. v. SynQor, Inc.,
`603 Fed. Appx. 969 (Fed. Cir. 2015) .................................................................. 14
`XpertUniverse Inc. v. Cisco Systems Inc.,
`Civil No. 09-157-RGA slip. op. 608 (D. Del. Feb. 28, 2013) ............................ 12
`Rules
`FRE 401 ............................................................................................................. 12, 14
`FRE 402 ..................................................................................................... 6, 7, 12, 14
`FRE 403 ................................................................................................................... 12
`FRE 602 ................................................................................................................... 12
`FRE 702 ............................................................................................................... 6, 14
`FRE 801 ............................................................................................................. 11, 12
`FRE 802 ............................................................................................................. 11, 12
`FRE 803(6)(D) ................................................................................................... 11, 12
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`
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`iii
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`FRE 806 ................................................................................................................... 12
`FRE 901 ............................................................................................................. 10, 12
`FRE 902 ................................................................................................................... 10
`Other Authorities
`37 C.F.R. § 42.64(b)(1) .............................................................................................. 4
`37 C.F.R. § 42.64(c) ................................................................................................... 1
` (37 C.F.R. § 42.65) ................................................................................................... 6
`Office Trial Practice Guide, 77 Fed. Reg. 48,612, 48,642 ...................................... 14
`
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`iv
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`I.
`
`INTRODUCTION
`Pursuant to 37 C.F.R. § 42.64(c), Petitioner respectfully requests that the
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`Board exclude the following evidence relied upon by Patent Owner (PO).
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`First, the Board should exclude testimony of PO’s expert and inventors (and
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`supporting documents) regarding “secondary considerations” of non-obviousness.
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`Such secondary considerations must bear a nexus to the claimed invention. But PO’s
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`opinions and evidence fail to meet that basic threshold. PO relies on alleged
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`“commercial success” and “unexpectedly superior properties” of certain drugs—
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`Herceptin, Perjeta, Avastin, Lucentis and Xolair—that it contends were made using
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`“the ’213 patent invention.” But PO, its expert and inventors have failed to present
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`any evidence tying these drugs to the challenged claims, much less showing their
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`success and any properties are due to the claimed invention.
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`
`
`
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` But they do not even attempt to show the drugs meet the
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`specific requirements of any ’213 patent claim. PO’s “secondary considerations”
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`evidence and opinions are thus are unreliable and irrelevant, and should be excluded.
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`Second, the Board should exclude the notebooks and other internal documents
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`PO relies on in its attempt to antedate prior art, as well as testimony relying on them.
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`PO argues that certain prior art is antedated because the inventors, Drs. Carter and
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`Presta, allegedly conceived of and reduced to practice claimed subject matter before
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`
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`1
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`the prior art was published. But testimony from the named inventors is insufficient
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`for antedation; it must be independently corroborated. For that purpose, PO relies on
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`notebooks, including those of the inventors and other scientists, and other internal
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`documents. Because they are relied on to corroborate work allegedly performed on
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`certain dates, their authenticity and reliability is crucial. But PO’s evidence is
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`insufficient to demonstrate such authenticity and reliability; rather, the record
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`evidence raises serious questions that undermine any reliance on these documents.
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`As an initial matter, the notebook copies PO relies on were scanned from the
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`physical notebooks in late 2016.
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`
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` PO’s reliance on these recently-scanned copies is particularly curious
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` And even more so given that when PO’s counsel
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`
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`belatedly sought to produce a stack of documents purporting to be the microfilmed
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`versions immediately before its records manager’s deposition, he clawed them back
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`after Petitioner’s counsel identified differences from the filed, scanned versions.
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`These unexplained gaps in the chain of custody of the notebooks alone warrant
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`exclusion. But they are compounded by other unexplained discrepancies that further
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`call into question the notebooks’ reliability. For example, the most critical notebooks
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`2
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`for PO’s antedation argument—the notebooks assigned to its inventors Drs. Carter
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`and Presta (Exs. 2001–
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`
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`
`
`
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` the
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`notebook contents and dates remain uncorroborated by any independent source.
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`For other notebooks (Exs. 2007–09) and internal documents (Exs. 2010–15)
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`relied on for antedation, PO presented no testimony from any witness with relevant
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`knowledge. PO presented no testimony from their authors. And records manager Ms.
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`Loeffler
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`
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`For these reasons, PO’s notebooks and internal documents should be excluded
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`together with the testimony of PO’s witnesses relying on them.
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`Third, the Board should exclude the validity opinions of PO’s expert Dr.
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`Wilson, who admitted that he applied an incorrect legal standard. It is axiomatic that
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`anticipation or obviousness are established by showing any single embodiment is
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`3
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`disclosed in, or obvious in light of, the prior art. Yet Dr. Wilson testified he applied
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`a standard requiring disclosure or obviousness of every claimed embodiment.. Dr.
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`Wilson’s validity analysis is thus fatally flawed, and should be excluded.
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`Fourth, the Board should exclude certain portions of the deposition errata
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`submitted by PO’s expert Dr. Wilson and inventor Dr. Carter, who attempt to
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`improperly change testimony that is unhelpful to PO.
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`II.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED
`Petitioner respectfully requests that the Board exclude:
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`• Unreliable “secondary considerations” evidence (Exs. 2016 (Presta), ¶¶ 5, 51–
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`53; 2017 (Carter), ¶¶ 4, 77–79; 2041 (Wilson), ¶¶ 83–87, 263–68; 2029);
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`• Unreliable notebooks and internal documents (Exs. 2001–15), and testimony
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`relying on them (Exs. 2016 (Presta), ¶¶11-12, 27-30, 32-36, 38-39, 42-49;
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`2017 (Carter), ¶¶12-14, 20, 23- 29, 32-66, 68-79; 2018 (Brady), ¶¶9-10, 12-
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`17, 19-24; 2019 (Loeffler); 2041 (Wilson), ¶86);
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`• Dr. Wilson’s flawed validity opinions (Ex. 2041, ¶¶ 163-262);
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`• Improper errata (Ex. 1697 (Wilson Tr.) at 137; Ex. 1698 (Carter Tr.) at 100).
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`Petitioners timely objected to these exhibits. Paper 32 at 2–26; Paper 44 at 2–
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`4; Paper 52 at 1; 37 C.F.R. § 42.64(b)(1).
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`III. ARGUMENT
`A.
`PO’s Unreliable “Secondary Considerations” Opinions
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`4
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`In support of its non-obviousness contentions, PO relies on certain “secondary
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`considerations,” i.e., commercial success and unexpected results. To be relevant,
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`however, “secondary considerations” evidence must bear a nexus to the claimed
`
`invention. In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011).
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`PO and its witnesses have presented no evidence to establish this requisite
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`nexus. PO rests its arguments on testimony from its expert and inventors purporting
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`to show that certain FDA-approved drugs—Herceptin, Perjeta, Avastin, Lucentis,
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`and Xolair—have been commercially successful and have “unexpectedly superior
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`properties.” POR 64–68; Exs. 2041 (Wilson) at ¶¶ 86, 130, 266; 2017 (Carter) at ¶¶
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`4, 77–79; 2016 (Presta) at ¶¶ 5, 51–53. But PO’s witnesses fail to tie any such
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`success or properties to the claimed invention.
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`The named inventors at most state that these drugs “use the humanization
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`techniques of the ’213 patent.” Exs. 2017 (Carter) at ¶¶ 4, 77–79; 2016 (Presta) at
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`¶¶5, 51–53. But they made no attempt to compare the drugs with the ’213 patent
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`claim elements. Exs.1698 (Carter) 32:25–39:15;1699 (Presta) 41:10–44:4. Dr.
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`Wilson goes somewhat further, pointing out the drugs used the so-called “consensus
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`approach” to choose the human framework, and include some common framework
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`substitutions with the claims. Ex. 2041 at ¶¶82–86. But the ’213 patent does not
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`claim a “consensus approach” or merely require a few framework substitutions in
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`common. Rather, they recite specific humanized antibodies with requirements that
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`5
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`Dr. Wilson admittedly did not even attempt to establish were embodied by any of
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`identified drug. Ex. 1697 (Wilson) 246–248, 252:12–254:21. Relatedly, Dr. Wilson
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`also seeks to rely on a prosecution declaration from PO scientist Dr. Shak purporting
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`to identify properties of certain humanized antibodies described in publications after
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`the ’213 patent invention. Ex. 2041 at ¶85. But Dr. Shak’s declaration also cannot
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`support Dr. Wilson’s secondary considerations opinions, because neither Dr. Shak
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`nor Dr. Wilson made any attempt to show that the antibodies described in these
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`publications embody the claims either. Id.; Ex. 1502 at 7–3439 ¶¶2–9 (Shak Decl.).
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`Under these circumstances, in the absence of any evidence or analysis
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`establishing that any of these drugs or other humanized antibodies embodies any
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`claim, PO and its witnesses cannot rely on them for commercial success or
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`unexpected results. Kao, 639 F.3d at 1068; Gnosis SPA v. S. Ala. Med. Sci. Found’n,
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`IPR2013-00116, Paper 68, at 38 (June 20, 2014) (“All types of objective evidence
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`of nonobviousness must be shown to have nexus….A nexus is required in order to
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`establish that the evidence relied upon traces its basis to a novel element in the claim,
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`not to something in the prior art.”) (internal cites omitted). The opinions and
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`evidence thus should be excluded as irrelevant (FRE 402), lacking sufficient
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`reliability for expert testimony (FRE 702), and for failing to show supporting facts
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`and/or data (37 C.F.R. § 42.65). See Shimano, Inc. v. Globeride, Inc., IPR2015-
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`00273, Paper 40, at 26-28 (June 16, 2016) (excluding exhibits under FRE 402 based
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`6
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`in part on PO’s failure to establish nexus with claimed invention).
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`B.
`PO’s Unreliable Notebooks and Internal Documents
`PO asserts that certain references in the Petition are not prior art because “the
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`’213 inventors conceived and actually reduced to practice [the claimed invention]
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`before the publication of [the references].” POR at 23–44. In support, PO relies
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`primarily on declarations from the named inventors. Id.; Exs. 2016, 2017. To
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`antedate, however, any inventor testimony must be independently corroborated.
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`Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577 (Fed. Cir. 1996).
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`To that end, PO relies on certain notebooks from the inventors and other
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`scientists (Exs. 2016–2019), and certain other internal PO documents (Exs. 2010–
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`2015). Because these documents provide the only alleged independent corroboration
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`of the work on the claimed inventions, and the dates on which it was performed, it
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`is particularly critical that they be properly authenticated and established as reliable.
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`See Neste Oil Oyj v. REG Synthetic Fuels, LLC, IPR2013-00578, Paper 52 at 4 (Mar.
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`12, 2015). And, as the Board held in Neste Oil, such authenticity must be established
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`by a witness other than the inventors, to avoid the “circular” situation where a
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`document relied on to corroborate a witness’s testimony is being authenticated only
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`by that same witness. See id.; In re NTP, Inc., 654 F.3d 1279, 1291 (Fed. Cir. 2011);
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`Chen v. Bouchard, 347 F.3d 1299, 1308 (Fed. Cir. 2003) (rejecting authentication
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`established by only inventors testimony). Furthermore, corroboration evidence
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`7
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`bearing hallmarks of unreliability, such as unwitnessed notebooks, should be
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`accorded no weight. Reese v. Hurst, 661 F.2d 1222, 1231 (CCPA 1981) (“inventors’
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`notebooks are accorded no more weight than the inventors’ testimony in this
`
`instance, since they were not witnessed or signed and were unseen by any witness”).
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`In this case, PO has failed to produce evidence sufficient to authenticate its
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`inventor notebooks and other internal documents. First, the notebook copies it has
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`produced were scanned from physical notebooks in late 2016. Exs. 1700 (Loeffler)
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`15:1-12; 2019 at ¶7.
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`
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`
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`174–175. For other notebooks (Exs. 2007–2009), PO presented no testimony from
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`. Exs. 1698 at 133–135; 1699 at
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`their authors whatsoever. Ex. 1700 (Loeffler) 38:1-39:2.
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`
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`
`
`
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` Ex. 1700 at 18:2-20:6, 21:1-22:7,
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`23:18-27:24, 28:2-38:11, 41:18-42:4, 46:14-50:3.
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`Notably, PO admittedly has copies of the notebooks that were microfilmed
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` (Exs. 2017 at ¶12, 2019 at ¶7,
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`
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`8
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`2018), but those versions inexplicably were not produced with PO’s Response. And
`
`when PO’s counsel sought to belatedly produce them immediately before Ms.
`
`Loeffler’s deposition he subsequently clawed them back after Petitioner’s counsel
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`identified differences between them and the scanned versions submitted in these
`
`proceedings. Ex. 1700 (Loeffler) at 7–9, 44–45. As a result, the contemporaneous
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`notebook copies are not in evidence. The unfairness to Petitioners in admitting the
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`later-scanned versions itself warrants exclusion.
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`This reliability and authenticity concern is very real, particularly as it is
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`compounded by other discrepancies in the evidence that remain unexplained.
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`
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` Exs. 2001 at 4, 13-90; 2002 at 4, 13-68; 2003 at 4, 13-110; 2004 at 4,
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`13-109; 1698 (Carter) 169:14-173:14, 174:9-175:10; 1699 (Presta) 63:12-64:10,
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`65:1-67:5, 180:16-181:24.
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`9
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`1699 at 179:14–180:15; 2001 at 4; 1700 at 41. At base, in
`
`
`
`
`
`
`
`
`
`. Exs.
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`
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`there is no independent authentication for the notes and contents of the inventor
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`notebooks, and they are thus entitled to no weight. See Reese, 661 F.2d at 1231; see
`
`also Procter & Gamble Co., v. Teva Pharm., 566 F.3d 979, 998-99, (Fed. Cir. 2009)
`
`(unwitnessed notebook alone insufficient to support reduction to practice);
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`Medichem S.A. v. Rolabo, S.L., 437 F.3d 1157, 1170 (Fed. Cir. 2006) (same). In that
`
`way, this case is relevantly indistinguishable from the Neste Oil decision, where the
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`PTAB excluded as unauthenticated under FRE 901 unwitnessed pages of an
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`inventor’s notebook, where only testimony from the inventor was presented to
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`authenticate it. Neste Oil, IPR2013-00578, Paper 52 at 4–5.
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`PO also seeks to rely on notebooks (Exs. 2007–09) from assignees who have
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`provided no authenticating declaration in these proceedings. These notebooks should
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`be excluded for the same reasons above, including that they are recently-scanned
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`versions rather than the contemporaneous microfilmed versions. They also should
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`be excluded under FRE 902 for the additional reason that they have not been
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`10
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`authenticated by any witness with personal knowledge of their contents, or the
`
`process by which they were produced, copied, or stored—Ms. Loeffler had no
`
`personal knowledge in that regard. Ex. 1700 (Loeffler) 38:1-39:2. Additionally, such
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`lab notebooks from non-testifying assignees should be excluded as inadmissible
`
`hearsay because they are out of court statements offered to prove the truth of the
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`matter asserted—namely, to corroborate an inventor’s alleged prior invention. FRE
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`801–802. See Chen v. Bouchard, Inter. No. 103,675, Paper No. 336, 2002 Pat. App.
`
`LEXIS 201, at *61-63 (B.P.A.I. Aug. 2, 2002) (excluding notebooks and data of
`
`inventor’s assistant offered to prove inventor’s reduction to practice as inadmissible
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`hearsay where the assistant did not testify), aff’d, 347 F.3d 1299 (Fed. Cir. 2003);
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`Medichem, 437 F.3d at 1172 n.10 (lab notebooks of non-testifying witness offered
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`to corroborate inventor’s testimony entitled to no evidentiary weight).
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`Furthermore, even if lab notebooks could constitute records of a “regularly
`
`conducted” business activity, these exhibits do not qualify because no witness with
`
`knowledge has testified as to how they were made or kept in the ordinary course of
`
`business. FRE 803(6)(D). The same is true of the other internal documents relied
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`upon by PO (Exs. 2010–15) which were not identified or established as business
`
`records by any non-inventor— Ms. Loeffler did not address these documents in her
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`declaration (Ex. 2019). Ex. 1700 (Loeffler) 38:1–39:2; Chen, 347 F.3d at 1308
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`(rejecting authentication support only by inventor testimony); Microsoft v. Surfcast,
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`
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`11
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`IPR2013-00293, Paper 33 (Oct. 14, 2014) (excluding conception, reduction-to-
`
`practice exhibits under FRE 901 as PO failed to authenticate with any independent
`
`evidence); see also FRE 803(6)(D); XpertUniverse Inc. v. Cisco Systems Inc., Civil
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`No. 09-157-RGA slip. op. 608 at fn. 3 (D. Del. Feb. 28, 2013) (excluding under FRE
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`806 based on failure to present testimony from a custodian for the impugned exhibit).
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`Once these documents are excluded, the Board also should exclude the
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`testimony of PO’s declarants relying on them (Exs. 2016 (Presta), ¶¶11-12, 27-30,
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`32-36, 38-39, 42-49; 2017 (Carter), ¶¶12-14, 20, 23- 29, 32-66, 68-79; 2018 (Brady),
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`¶¶9-10, 12-17, 19-24; 2019 (Loeffler); 2041 (Wilson), ¶86) under FRE 401–03, 801–
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`02 and 901 for the same reasons. See, e.g., Riverbed Tech. v. Realtime Data LLC,
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`IPR2016-00978, Paper 67 at 41 (Oct. 30, 2017) (excluding unauthenticated exhibit
`
`under FRE 901 and parts of declaration expressly relying on that exhibit). The
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`declaration of PO’s records manager Ms. Loeffler (Ex. 2019)
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`
`
`
`
`
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` Ex. 1700 (Loeffler) at 18:2-20:6, 21:1-22:7, 23:18-27:24, 28:2-38:11,
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`41:18-42:4, 46:14-50:3; MaxLinear, Inc. v. Cresta Tech. Corp., IPR2015-00594,
`
`Paper 90 at 8-9 (Aug. 15, 2016) (excluding exhibit portions under FRE 602 for lack
`
`of personal knowledge).
`
`Finally, the Board also should exclude the portions of the declarations of PO’s
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`12
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`inventors concluding that they “possessed the invention recited in claims 1–2, 4, 12,
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`25, 29–31, 33, 42, 60, 62–67, 69, and 71-81 before July 26, 1990.” (Exs. 2016 at
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`¶53; 2017 at ¶79.) In fact, both inventors admitted that they never attempted to show
`
`any correlation between the disclosures in the cited notebooks and other internal
`
`documents they rely on and the elements of the Challenged Claims. Exs. 1698
`
`(Carter) 37:19-39:15;1699 (Presta) 84:3-85:2. Nor does Dr. Wilson do so. Ex. 2041
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`(Wilson) at 256:20–257:3. And the inventors could not even agree on key aspects of
`
`the alleged invention story, such as who first suggested the “consensus” approach.
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`Exs. 1699 (Presta) at 26:7-27:13; 1698 (Carter) 50:17-51:11; 2016 at ¶9 (“I…
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`proposed a human consensus sequence”); 23–24; 2017 at ¶18 (“I proposed to Dr.
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`Presta that we attempt… creating broadly-applicable consensus” variable domain
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`sequences.”). The declarations therefore cannot reliably show invention of the
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`subject matter of any claim of the ’213 patent. See NHK Seating of Am., Inc. v. Lear
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`Corp., IPR2014-01200, Paper 29 (Feb. 2, 2016).
`
`C. Dr. Wilson’s Unreliable Validity Opinions
`PO relies solely on Dr. Wilson’s opinions for its contention that the challenged
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`claims are not anticipated by, or obvious over, the prior art. Ex. 2041 at ¶¶163-262.
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`Central to Dr. Wilson’s opinions is his contention that the framework region
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`substitutions recited in the claims were not disclosed by or obvious in light of the
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`prior art. Id. at ¶¶108, 125, 138, 141, 144. However, at his deposition, Dr. Wilson
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`admitted that in conducting his validity analysis he applied a standard requiring
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`every framework region substitution recited in a claim to be disclosed or obvious.
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`Ex. 1697 (Wilson) 84:11-15, 91:3-13 (“Q: []If there is one embodiment with only
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`one of those substitutions…, is it your opinion in your obviousness analysis that the
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`entire claim is therefore obvious? A: No.”), 92:3-14, 93:4-12. The standard applied
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`by Dr. Wilson directly conflicts with Federal Circuit precedent, which provides that
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`a single embodiment falling within the scope of the claims is all that is required for
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`anticipation or obviousness. See In re Kubin, 561 F.3d 1351, 1361 (Fed. Cir. 2009);
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`Vicor Corp. v. SynQor, Inc., 603 Fed. App’x 969, 975 (Fed. Cir. 2015). Dr. Wilson’s
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`validity opinions are therefore inadmissible under FRE 702, as they are based on
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`incorrect legal standards. Am. Med. Sys. v. Laser Peripherals, LLC, 712 F. Supp. 2d
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`885, 901 (D. Minn. 2010) (excluding expert’s opinions, finding them “inadmissible
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`because they [were] based on incorrect legal standards,” citing Herbert v. Lisle
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`Corp., 99 F.3d 1109, 1117 (Fed. Cir. 1996) (“Incorrect statements of law are no more
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`admissible through ‘experts' than are falsifiable scientific theories.”)) His opinions
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`are also irrelevant under FRE 401-02 for the same reason.
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`D.
`Improper Errata
`The Board has held that errata “cannot be used as a substitute for [] redirect
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`examination, particularly where the opposing party would have no meaningful
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`opportunity to respond to the altered testimony,” and thus substantive changes are
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`not permitted. Apple, Inc. v. Achates Reference Publishing, Inc., IPR2013-00080,
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`Paper 61 at 3-5 (Jan. 21, 2014) (expunging errata); Office Trial Practice Guide, 77
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`Fed. Reg. 48,612, 48,642. Here, PO’s witnesses seek to do just that.
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`Specifically, when asked whether he was aware that light chain of the
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`Campath humanized antibody was created using a consensus sequence, Dr. Wilson
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`first stated “I’m not aware of them using consensus sequences,” but then corrected
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`himself, stating “I know it, but I would like to see the document, please.” Ex. 1697,
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`50:5-19. In his errata, Dr. Wilson seeks to reverse his correction by deleting the
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`words “I know it, but” to “clarify meaning.” Id. at 137. Such a substantive change
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`to reverse the meaning of testimony is impermissible. Similarly, when asked whether
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`Kabat 1987 “profess[es] to include all sequences that were even known at the time,”
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`Dr. Carter testified, in part, “I think they tried very hard to include certain known
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`sequences.” Ex. 1698, 60:3-12. In his errata, he seeks to change that testimony by
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`deleting “certain” to “remove unintended qualifier.” Id. at 100.
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`On the face of these changes, it is clear that the witnesses do not dispute using
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`these words, but instead seek to make substantive changes to their testimony. That
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`is improper and these errata should be expunged from the record.
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` Date: June 22, 2018
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`Respectfully submitted,
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`/Amanda Hollis/
`Attorney For Petitioner Pfizer, Inc.
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`IPR2017-01489: Petitioners’ Motion to Exclude Evidence
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that a copy of the foregoing Motion to
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`Exclude Evidence was served on June 22, 2018, via electronic service on lead and
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`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
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`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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