`Patent Owner’s Motion to Strike
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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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`Filed on behalf of Patent Owner Genentech, Inc. by:
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`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)
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`Kevin S. Prussia (Pro Hac Vice)
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`Andrew J. Danford (Pro Hac Vice)
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`WILMER CUTLER PICKERING
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` HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
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`Washington, DC 20006
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________
`CELLTRION, INC.,
`Petitioner,
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`v.
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`GENENTECH, INC.,
`Patent Owner.
`____________________________________________
`Case IPR2017-01373
`U.S. Patent No. 6,407,213
`____________________________________________
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`PATENT OWNER’S MOTION TO STRIKE
`PURSUANT TO PAPER NO. 58
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`IPR2017-01373
`Patent Owner’s Motion to Strike
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`TABLE OF CONTENTS
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`I.
`II.
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`Page
`INTRODUCTION ........................................................................................... 1
`PETITIONER’S EVOLVING INVALIDITY ARGUMENTS ...................... 2
`A.
`The Petition Relies on Queen 1990 or Queen 1989 in
`Combination with Kabat 1987 for the “Consensus” Sequence
`Limitations of Claims 4, 33, 62, 64, and 69 .......................................... 2
`Petitioner’s Belated Attempt to Fill Gaps in Its Invalidity Case .......... 3
`B.
`III. PETITIONER’S NEW ARGUMENTS ARE FORECLOSED BY
`FEDERAL CIRCUIT PRECEDENT, STATUTE, AND THE
`BOARD’S REGULATIONS ........................................................................... 4
`A. Applicable Law ..................................................................................... 4
`B.
`Petitioner’s New Invalidity Theory is Improper ................................... 5
`C.
`Petitioner Should Have Been Aware of Foote 1989 at the Time
`the Petition Was Filed ........................................................................... 7
`IV. CONCLUSION .............................................................................................. 10
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`IPR2017-01373
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`TABLE OF AUTHORITIES
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`CASES
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`Page(s)
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`Apple Inc. v. e-Watch Inc.,
`IPR2015-00412, Paper 50 (PTAB May 6, 2016) ...................................... 4, 10
`Cox Comms., Inc. v. AT&T Intellectual Prop. II, L.P,
`IPR2015-01187, Paper 59 (PTAB Nov. 15, 2016) .......................................... 6
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`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule
`Patent Litigation,
`676 F.3d 1063 (Fed. Cir. 2012) ....................................................................... 7
`Dexcom, Inc. v. Waveform Techs, Inc.,
`IPR2016-01679, Paper 53 (PTAB Feb. 28, 2018) .......................................... 5
`Intelligent-BioSystems, Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ....................................................................... 5
`Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc.,
`853 F.3d 1272 (Fed. Cir. 2017) ....................................................................... 5
`FEDERAL STATUTES
`35 U.S.C. § 312(a) ..................................................................................................... 5
`35 U.S.C. § 325(d) ..................................................................................................... 8
`REGULATIONS
`37 C.F.R. § 42.23 (b) ................................................................................................. 4
`Patent Trial Practice Guide, 77 Fed. Reg. 48,612, 48,620 (Aug. 14,
`2012) ................................................................................................................ 4
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`ii
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`I.
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`IPR2017-01373
`Patent Owner’s Motion to Strike
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`INTRODUCTION
`Pursuant to the Board’s authorization in Paper No. 58, Patent Owner files
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`this motion to strike evidence and argument pertaining to Petitioner’s new
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`obviousness theory that a new exhibit, Foote 1989 (Ex. 1193) discloses using a
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`“consensus” sequence as described in the claims of the ’213 patent. Patent Owner
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`seeks to strike Exhibit 1193 and the associated arguments and testimony that rely
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`on this exhibit, including the first full paragraph of pages 15 and 21 of the Reply,
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`Ex. 1143 ¶30, and Ex. 1138 at 176:25 to 178:23.
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`Petitioner chose to file a copycat petition based on the petition filed by
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`Mylan Pharmaceuticals, Inc. in IPR2016-01694 (the “Mylan IPR”). (Compare
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`Paper 2 with Mylan Pharms. Inc. v. Genentech, Inc., IPR2016-01694 (Paper 1).)
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`In doing so, Petitioner’s experts submitted nearly word-for-word copies of the
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`analysis for the proposed grounds in the declarations from the Mylan IPR. (See
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`Ex. 2062 (redline comparing Dr. Riechmann’s declaration with Mylan’s expert’s
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`declaration); Ex. 1004 at ¶4 (Dr. Leonard stating he repeated the statements of
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`Mylan’s expert and “revised only as necessary.”).) Having made that strategic
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`choice, Petitioner should not now be permitted to deviate from the arguments made
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`in the Petition and shoehorn in a new reference to support its obviousness case and
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`better suit its experts here.
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`Petitioner’s new evidence and argument principally relies on Exhibit 1193
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`(“Foote 1989”)—a publication titled “Humanized Antibodies” authored by Jefferson
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`Foote, the petitioners’ expert in the companion cases brought by Pfizer. As set forth
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`in more detail below, Foote 1989 was submitted by Petitioner in reply to backdoor
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`in a new ground for unpatentability and fill in the gaps in its prima facie case.
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`Petitioner has no excuse for failing to identify Foote 1989 in the Petition because its
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`own expert, Dr. Riechmann, now claims that Foote 1989 discloses a consensus
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`sequence that Dr. Riechmann himself used in his own work.
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`II.
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`PETITIONER’S EVOLVING INVALIDITY ARGUMENTS
`A. The Petition Relies on Queen 1990 or Queen 1989 in Combination
`with Kabat 1987 for the “Consensus” Sequence Limitations of
`Claims 4, 33, 62, 64, and 69.
`Claims 4, 33, 62, 64, and 69 require the use of a “consensus” sequence. The
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`’213 patent provides a specific definition of the claimed human “consensus”
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`sequence, “which comprises the most frequently occurring amino acid residues at
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`each location in all human immunoglobulins of any particular subclass or subunit
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`structure.” (Ex. 1001, 11:32-38; Paper 16 at 10-11.) The Petition argued that the
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`“consensus” limitation was met by either by Queen 1990’s (Ex. 1050) disclosure of
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`“a consensus framework from many human antibodies,” or by Queen 1989’s (Ex.
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`1034) supposed teaching “moving towards a consensus framework region” in
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`combination with Kabat 1987 (Ex. 1052) and/or the PDB database. (Paper 2 at 36-
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`37, 38-39, 51-52.) Although Dr. Riechmann’s original declaration filed with the
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`Petition describes his work on humanizing an antibody called CAMPATH-1, that
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`discussion (i) is not mentioned in the Petition; and (ii) does not mention a
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`consensus sequence, Dr. Foote, or the Foote 1989 reference. (See Ex. 1003 at
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`¶¶31, 94-98, 340.) As explained in Patent Owner’s Response, the references relied
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`upon in the Petition are insufficient to carry Petitioner’s burden of demonstrating
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`the unpatentability of the challenged claims reciting a “consensus” sequence.
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`(Paper 38 at 52-56.)
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`B.
`Petitioner’s Belated Attempt to Fill Gaps in Its Invalidity Case.
`In Reply, Petitioner pivots from relying on the prior art in the instituted
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`grounds, and instead invites to Board to rely on Foote 1989—a reference not found
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`in the Petition or in the institution decision—to cure the deficiencies in its proof
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`with respect to the “consensus” limitations. Petitioner argues that Foote 1989
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`shows that “scientists had already created humanized antibodies using consensus
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`sequences” both as part of its prima facie case (Paper 54 at 15) and to argue that
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`because the prior art taught “using Foote’s consensus sequence” to humanize an
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`antibody, “there was nothing unexpected about the broad applicability of a
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`consensus,” (id. at 21).
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`Petitioner attempts to support this new theory with Dr. Riechmann’s reply
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`declaration. Dr. Riechmann states that his work during the late 1980s humanizing
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`the CAMPATH-1 antibody apparently used a consensus sequence he received
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`from his “colleague,” Dr. Foote. (Ex. 1143, ¶30 (citing Ex. 1193 at 106).)
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`Although Dr. Riechmann’s original declaration addressed his work on
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`CAMPATH-1 (Ex. 1003, ¶¶31, 94-98, 340), he never mentioned in his original
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`declaration that this work supposedly involved a “consensus” sequence.
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`Moreover, the Petition never describes how Dr. Riechmann’s work might relate to
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`the “consensus” limitations in the challenged claims.
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`III. PETITIONER’S NEW ARGUMENTS ARE FORECLOSED BY
`FEDERAL CIRCUIT PRECEDENT, STATUTE, AND THE BOARD’S
`REGULATIONS.
`A. Applicable Law
`Evidence introduced in a reply “must be responsive and not merely new
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`evidence that could have been presented earlier” to support the petition. Patent
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`Trial Practice Guide, 77 Fed. Reg. 48,612, 48,620 (Aug. 14, 2012); see also 37
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`C.F.R. § 42.23 (b) (“A reply may only respond to arguments raised in the … patent
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`owner response.”). But “‘[r]espond,’ in the context of 37 C.F.R. § 42.23(b), does
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`not mean embark in a new direction with a new approach as compared to the
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`position originally taken in the Petition.” Apple Inc. v. e-Watch Inc., IPR2015-
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`00412, Paper 50 at 44 (PTAB May 6, 2016).
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`When a reply strays from “explaining how [the] original petition was
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`correct” and begins arguing new theories of unpatentability or relying on
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`references not disclosed in the petition, this amounts to a shifting of arguments that
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`IPR2017-01373
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`is “foreclosed by statute, our precedent, and Board Guidelines.” Wasica Fin.
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`GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1286–87 (Fed. Cir. 2017); see also
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`Dexcom, Inc. v. Waveform Techs, Inc., IPR2016-01679, Paper 53 at 50 (PTAB
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`Feb. 28, 2018) (evidence necessary to make out a prima facie case of
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`unpatentability may not be introduced for the first time in the reply brief); 35
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`U.S.C. § 312(a) (petition must identify “with particularity” the evidence supporting
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`the grounds). Thus, “[i]t is of the utmost importance that petitioners in the IPR
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`proceedings adhere to the requirement that the initial petition identify with
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`particularity the evidence that supports the grounds for the challenge to each claim
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`….” Intelligent-BioSystems, Inc. v. Illumina Cambridge, Ltd., 821 F.3d 1359,
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`1369-70 (Fed. Cir. 2016); id. at 1370 (“[T]he expedited nature of IPRs bring with it
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`an obligation for petitioners to make their case in their petition to institute.”).
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`B.
`Petitioner’s New Invalidity Theory is Improper.
`Petitioner for the first time in its Reply identified the Foote 1989 reference
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`and argued that it teaches the “consensus” sequence limitations of claims 4, 33, 62,
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`64, and 69. Indeed, although Petitioner denied during the June 18, 2018
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`teleconference with the Board that it was relying on Foote 1989 to support its
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`prima facie case of obviousness, that is plainly what Petitioner’s Reply seeks to do:
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`Finally, PO ignores that prior to the earliest possible priority date of
`the alleged invention, scientists had already created humanized
`antibodies using consensus sequences. (Ex. 1193, 106; Ex. 1138,
`196:5-197:6 (discussing Genentech’s admission during EU patent
`proceedings that Dr. Riechmann used Foote’s consensus sequence in
`humanizing CAMPATH).) This is compelling evidence that it would
`have been obvious to use human consensus sequences in the human
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`(Paper 54 at 15.) Petitioner’s reliance on an entirely new reference in its Reply to
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`advance a new theory for why the claim limitations are supposedly found in the
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`prior art is improper. See Cox Comms., Inc. v. AT&T Intellectual Prop. II, L.P,
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`Case No. IPR2015-01187, Paper 59 at 16-17 (PTAB Nov. 15, 2016) (declining to
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`consider obviousness combination where a “background reference” would be
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`substituted for part of instituted reference, finding the assertion comprised a “new
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`argument of unpatentability,” and “trial was not instituted on this ground”).
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`Petitioner’s attempt to use Foote 1989 to rebut unexpected results does not
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`remove the prejudice to Patent Owner caused by Petitioner’s shifting obviousness
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`theory. Using Foote 1989 to rebut unexpected results makes little practical sense.
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`If Petitioner is correct that Queen 1990 and Queen 1989 disclose using a consensus
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`sequence (they do not), then the addition of another reference showing that the
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`prior art disclosed the same thing adds nothing to Petitioner’s response to
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`“unexpected results;” Petitioner could simply rely on Queen 1990 or Queen 1989.
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`And, in any event, Petitioner raised unexpected results in its Petition (see, e.g.,
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`Paper 2 at 58) and its expert argued in the context of unexpected results that the
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`consensuses sequences of the ’213 patent are similar to sequences found in prior
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`art humanized antibodies—but he does not argue that those antibodies embody the
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`consensus sequence limitation. (E.g., Ex. 1003, ¶340.)
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`The substantial prejudice caused by Petitioner’s reliance on a new piece of
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`evidence to teach missing claim elements—even if in the context of secondary
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`considerations—greatly outweighs the relevance of Foote 1989 to the secondary
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`considerations debate. The Federal Circuit has required that all evidence—
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`including objective indicia of non-obviousness—must be considered together
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`before finding a patent invalid as obviousness. In re Cyclobenzaprine
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`Hydrochloride Extended-Release Capsule Patent Litigation, 676 F.3d 1063, 1079-
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`80 (Fed. Cir. 2012). Here, it is clear that Petitioner is attempting to use Foote 1989
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`to fill the gaps in Petitioner’s prima facie case.
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`C.
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`Petitioner Should Have Been Aware of Foote 1989 at the Time the
`Petition Was Filed.
`Petitioner should have been aware of the Foote 1989 reference before filing
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`the Petition for at least two reasons. First, Foote 1989 is substantively discussed in
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`the prosecution history. (See, e.g., Ex. 1002 at 340.)1 Further, had Foote 1989
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`been raised in the Petition, Patent Owner would have responded differently,
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`including, for example, presenting argument that the proposed grounds should be
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`barred by 35 U.S.C. § 325(d) because the challenged claims were allowed over
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`Foote 1989. (See, e.g., Ex. 1002 at 340 (discussing Foote 1989); id. at 743-53
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`(Notice of Allowability); Ex. 1001 at 4 (listing Foote 1989).)
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`Second, the reply declaration of Dr. Riechmann confirms that Petitioner
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`should have been aware of Foote 1989 well prior to the filing of the Petition.
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`Dr. Riechmann explains that at the time he was purportedly developing a
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`humanized antibody called CAMPATH-1, Dr. Foote was a “colleague” who gave
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`him a “light chain” he claims was designed to match a consensus light chain. (Ex.
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`1143 ¶30.) Dr. Riechmann claims he used this to build a humanized antibody,
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`CAMPATH-1. (See id.) But in his initial declaration describing his work on
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`CAMPATH-1—a description that spans 7 paragraphs (Ex. 1003 at ¶¶31, 94-98,
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`340)—Dr. Riechmann fails to mention Dr. Foote, the Foote 1989 reference, or that
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`1 Whether Patent Owner was on notice of the existence of the Foote 1989 reference
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`is a different question from whether Patent Owner was on notice of Petitioner’s
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`reliance on Foote 1989 to teach the “consensus” sequence limitations of the ’213
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`patent.
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`a critical claim limitation was purportedly met by an amino acid sequence received
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`IPR2017-01373
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`from his colleague. Further, in his deposition, Dr. Riechmann stated that when he
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`worked in Dr. Winter’s lab, he had “a lot of discussions” with Dr. Foote about
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`humanizing an antibody, (Ex. 2039 at 76:18-77:2), and that he received a “light
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`chain” from Dr. Foote for use in his work (Id. at 144:10-18). But again, Dr.
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`Riechmann does not mention that he received a light chain purportedly embodying
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`a critical element of the claims until after Patent Owner submitted its Response.
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`As a colleague of Dr. Foote, and one with whom he had “a lot of
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`discussions” regarding humanizing antibodies, Dr. Riechmann should have known
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`about Dr. Foote’s work, including Ex. 1193, at the time he was drafting his original
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`declaration and should have raised it to Petitioner then.
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`*
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`*
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`In sum, allowing Petitioner to pivot from its reliance on Queen 1990 or
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`Queen 1989 in combination with Kabat 1987 to Foote 1989 would be “unjust to
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`the Patent Owner,” Apple Inc., IPR2015-00412, Paper 50 at 44. Exhibit 1193, the
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`arguments and testimony relying on it, and the testimony elicited from questioning
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`pertaining to it should be stricken because it is a new exhibit not included in the
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`instituted grounds used by Petitioner to argue that substantive elements of the ’213
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`claims were disclosed in the prior art.
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`IV. CONCLUSION
`The Board should strike Exhibit 1193 and the arguments and testimony that
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`IPR2017-01373
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`rely on this exhibit, including the first full paragraph of pages 15 and 21 of the
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`Reply brief, Ex. 1143 ¶30, and Ex. 1138 at 176:25 to 178:23.
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`Date: June 22, 2018
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`Respectfully submitted,
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`/David L. Cavanaugh/
`By:
`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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`IPR2017-01373
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`CERTIFICATE OF SERVICE
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`I hereby certify that, on June 22, 2018, I caused a true and correct
`copy of the following materials:
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` Patent Owner’s Motion to Strike
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`to be served via electronic mail on the following attorneys of record:
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`Cynthia Lambert Hardman
`GOODWIN PROCTER LLP
`chardman@goodwinlaw.com
`620 Eighth Avenue, New York, NY 10018
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`Robert V. Cerwinski
`GOODWIN PROCTER LLP
`rcerwinski@goodwinlaw.com
`620 Eighth Avenue, New York, NY 10018
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`Elizabeth Holland
`GOODWIN PROCTER LLP
`eholland@goodwinlaw.com
`620 Eighth Avenue, New York, NY 10018
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`Linnea P. Cipriano
`GOODWIN PROCTER LLP
`lcipriano@goodwinlaw.com
`620 Eighth Avenue, New York, NY 10018
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`Sarah J. Fischer
`GOODWIN PROCTER LLP
`sfischer@goodwinlaw.com
`100 Northern Avenue, Boston, MA 02110
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`IPR2017-01373
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`/Lauren V. Blakely/
`Lauren V. Blakely
`Reg. No. 70,247
`Wilmer Cutler Pickering Hale and Dorr LLP
`950 Page Mill Road
`Palo Alto, CA 94304
`(650) 600-5039
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