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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`PFIZER, INC., and
`SAMSUNG BIOEPIS CO., LTD.,1
`Petitioners,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`____________
`
`Case IPR2017-01489
`Patent 6,407,213
`____________
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`
`
`PETITIONERS’ OPPOSITION TO PATENT OWNER’S
`MOTION TO STRIKE PURSUANT TO PAPER NO. 572
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`
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`1 Samsung Bioepis Co. Ltd.’s IPR2017-02140 has been joined with this
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`proceeding. (IPR2017-02140, Paper 40.)
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`2 All emphases within are added.
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`IPR2017-01489: Petitioners’ Opposition to Patent Owner’s Motion to Strike
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`TABLE OF CONTENTS
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`Page
`INTRODUCTION ........................................................................................... 1
`I.
`FACTUAL BACKGROUND .......................................................................... 1
`II.
`III. ARGUMENT ................................................................................................... 4
`A.
`PO’s Objections To The Foote And Wilson Deposition
`Testimony, And Accompanying Foote 1989 Reference, Have
`Been Waived ......................................................................................... 4
`B. Much Of The Evidence And Argument PO Seeks To Strike
`Was Raised In The Petition And Supporting Foote Declaration .......... 6
`The Evidence And Argument PO Seeks To Strike
`Appropriately Replies To PO’s Own Evidence And Arguments
`In Its Response ...................................................................................... 7
`IV. CONCLUSION .............................................................................................. 10
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`
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`C.
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`i
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`IPR2017-01489: Petitioners’ Opposition to Patent Owner’s Motion to Strike
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`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Anacor Pharms., Inc. v. Iancu,
`889 F.3d 1372 (Fed. Cir. 2018) ...................................................................... 8, 10
`Apple, Inc. v. Smartflash LLC,
`CBM2014-00106, Paper 52 (Sept. 25, 2015) ....................................................... 5
`Cox Comms., Inc. v. AT&T Intellectual Prop. iI, L.P.,
`IPR2015-01187, Paper 59 (Nov. 15, 2016) ........................................................ 10
`eBay Inc. v. Global Equity Mgmt.,
`IPR2016-01829, Paper 63 (April 18, 2018) ......................................................... 7
`Emerson Elec. Co. v. Sipco, LLC,
`IPR2016-00984, Paper 43 (Oct. 25, 2017) ......................................................... 10
`Generico, LLC, v. Dr. Falk Pharma Gmbh,
`IPR2016-00297, Paper 55 (May 19, 2017) ........................................................... 5
`Genzyme Therapeutic Prods. Ltd. P’ship. v. Biomarin Pharm. Inc.,
`825 F.3d 1360 (Fed. Cir. 2016) ...................................................................... 8, 10
`Mylan Pharm. Inc. v. UCB Pharma GmbH,
`IPR2016-00517, Paper 37 (Jul. 19, 2017) .......................................................... 10
`Volkswagen Group v. Emerechem Holdings, LLC,
`IPR2014-01555, Paper 50 (Jan. 22, 2016) ............................................................ 6
`Other Authorities
`37 C.F.R. § 42.64(a) ........................................................................................... 1, 4, 5
`37 C.F.R. § 42.64(c) ................................................................................................... 4
`
`
`
`ii
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`
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`IPR2017-01489: Petitioners’ Opposition to Patent Owner’s Motion to Strike
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`I.
`
`INTRODUCTION
`PO asserts that Petitioners have changed the bases for their position that the
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`prior art disclosed use of a “consensus” sequence. That is incorrect. Petitioners did
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`not “pivot” to relying “for the first time in their Reply” on Foote 1989, Reichmann
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`1988, and Kurrle for this limitation. Much of the evidence PO seeks to exclude—
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`including evidence that Riechmann’s CAMPATH antibody was made using the
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`“consensus” approach, and that Kurrle teaches use of a “consensus” sequence in its
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`humanization method—was squarely raised in the Petition and/or supporting
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`declaration of Dr. Foote. In fact, PO deposed Dr. Foote about it before filing its POR.
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`The evidence and argument PO seeks to exclude also is legitimate reply, as it
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`responds directly to the inaccurate description of the state of the art, and flawed
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`secondary considerations arguments, PO and its expert presented in the Response.
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`PO also waived its objection to the Foote and Wilson deposition testimony, and the
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`Foote 1989 reference discussed therein. PO’s counsel did not raise timely objections
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`during the depositions as 37 C.F.R. § 42.64(a) requires.
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`II.
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`FACTUAL BACKGROUND
`Challenged claims 4, 33, 62, 64 and 69 of the ’213 patent recite a “consensus”
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`sequence element. Pet. at 13, 15. The Petition cited either Queen 1990, or Queen
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`1989 in view of Kabat 1987, as disclosing or rendering obvious the “consensus”
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`sequence element in the recited invalidity grounds. Pet. at 31-38, 55-56, 60. The
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`1
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`IPR2017-01489: Petitioners’ Opposition to Patent Owner’s Motion to Strike
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`Petition and supporting expert declaration also showed use of “consensus”
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`sequences in humanizing antibodies was otherwise known. For example, the Petition
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`cited Dr. Foote’s testimony that the prior art CAMPATH antibody Riechmann 1988
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`described was made using “a ‘consensus’ sequence.” Ex. 1503, ¶ 103 (cited Pet. at
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`8) (describing use of a consensus sequence “in which relatively uncommon residues
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`in certain positions were substituted with more commonly found ones,” where
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`“[j]udgment of whether a residue type was common or uncommon at a particular
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`position was based on the Kabat database, 1983 edition”). Dr. Foote also explained
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`that, in Kurrle’s method, when humanizing an antibody with a given human
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`framework, one should “consider changing the chosen human framework residue
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`with the consensus human residue at that position.” Id., ¶ 123.
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`During Dr. Foote’s deposition before PO submitted its Response, PO’s
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`counsel questioned him extensively about both of these issues. Ex. 2039 at 77:18–
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`88:23; 293:16–304:25. Dr. Foote explained without objection that Riechmann’s
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`CAMPATH “consensus” sequence was derived from his own “anti-lysozyme”
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`construct described in Foote 1989. Id. at 79:12–80:7, 83:17–16. That reference was
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`subsequently submitted as an exhibit and discussed on redirect, again without
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`objection. Id. at 327-332. Indeed, PO’s counsel questioned Dr. Foote on Foote 1989
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`during re-cross. Id. at 349:22–350:20. PO’s counsel also questioned Dr. Foote
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`regarding Kurrle’s choice of a framework, and Dr. Foote testified (again without
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`2
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`IPR2017-01489: Petitioners’ Opposition to Patent Owner’s Motion to Strike
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`objection) to Kurrle’s use of a “consensus” sequence, with the result being that
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`“Kurrle is an example where both methods [consensus and best fit] arrive at the same
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`result.” Id. at 320:4–11; see also id. at 293:16–304:25, 313:7–320:3.
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`In its subsequent Response and supporting expert declaration, PO and its
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`expert Dr. Wilson simply ignored this evidence. They asserted that the ’213 patent’s
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`description of a “consensus” human framework was a “new approach to humanizing
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`antibodies” and a “novel strategy.” POR at 8, 23-24. And in arguing unexpected
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`results using the “consensus” approach, PO and Dr. Wilson suggested the
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`CAMPATH antibody was made using the “best fit” approach, and compared the
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`claimed invention to it, notwithstanding the CAMPATH antibody actually was made
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`using the same “consensus” approach. POR at 66.
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`The Reply and Dr. Foote responded to these incorrect contentions. Dr. Foote
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`corrected Dr. Wilson’s description of the state of the art, reiterating that the
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`CAMPATH antibody was actually made using the “consensus” sequence Foote
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`himself generated for his anti-lysozyme construct described in Foote 1989. Ex. 1702,
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`¶¶12, 40-43. Thus, PO’s comparison of the claimed invention with CAMPATH for
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`unexpected results purposes made no sense, since both used the so-called
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`“consensus” approach that allegedly led to the unexpected results. Id., ¶¶185-189;
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`Reply at 24-27. The Reply and Dr. Foote also responded to PO’s argument that the
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`“consensus” and “best fit” approaches are somehow fundamentally different by
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`3
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`IPR2017-01489: Petitioners’ Opposition to Patent Owner’s Motion to Strike
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`pointing out, as Dr. Foote did during his deposition, that both can lead to the same
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`antibody, exemplified by Kurrle’s combined best-fit/consensus approach. Id.
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`III. ARGUMENT
`A.
`PO’s Objections To The Foote And Wilson Deposition Testimony,
`And Accompanying Foote 1989 Reference, Have Been Waived
`PO seeks to exclude deposition testimony from the parties’ experts, and the
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`Foote 1989 reference submitted and discussed therein. But “[a]n objection to the
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`admissibility of deposition evidence must be made during the deposition.” 37 CFR
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`§ 42.64(a). And, any motion to exclude evidence “must identify the objections in the
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`record in order and must explain the objections.” 37 C.F.R. § 42.64(c). PO’s motion
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`fails on both counts.
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`With respect to use of Dr. Foote’s “consensus” sequence described in Foote
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`1989 in development of the prior art anti-lysozyme and CAMPATH antibodies, PO
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`seeks to strike four pages of Dr. Foote’s deposition testimony (Ex. 2039 at 327:12–
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`331:11), two pages of Dr. Wilson’s testimony (Ex. 1697 at 176:25–178:23), and
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`Foote 1989 itself (Ex. 1693). And with respect to Kurrle’s use of a “consensus”
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`sequence, PO seeks to strike seven pages of Dr. Foote’s testimony (Ex. 2039 at
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`313:77–320:11) and eleven pages of Dr. Wilson’s testimony (Ex. 1697 at 258:3–
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`263:21, 264:9–267:18, 267:24–268:12). Yet, PO’s motion does not identify a single
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`objection its counsel “made during the deposition(s)” on these bases.
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`Indeed, during the entirety of Dr. Foote’s testimony PO seeks to strike, PO’s
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`4
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`IPR2017-01489: Petitioners’ Opposition to Patent Owner’s Motion to Strike
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`counsel objected to the “form” of some of the questions (Ex. 2039 at 315:8, 19,
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`317:7, 15, 318:10, 319:2, 15, 320:6) and once as calling for a “legal conclusion” (id.
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`at 319:2-3), but never as being outside the scope of the Petition as PO’s motion to
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`strike alleges. PO’s objection to Dr. Foote’s testimony on that basis is thus waived.
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`See Apple, Inc. v. Smartflash LLC, CBM2014-00106, Paper 52 at 40 (Sept. 25, 2015)
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`(“Moreover, as Petitioner correctly points out, many of the questions and answers
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`that Patent Owner now seeks to exclude were not objected to during the deposition,
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`even giving the transcript the ‘fair reading’ that Patent Owner suggests. ‘An
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`objection to the admissibility of deposition evidence must be made during the
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`deposition.’”) (quoting 37 C.F.R. § 42.64(a)). Further, Foote 1989 was submitted as
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`an exhibit and addressed during Dr. Foote’s deposition without objection. Ex. 2039
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`at 327:12–331:11. PO’s counsel had the opportunity to, and indeed did, question on
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`Foote 1989. Id. at 350:15-20; 361:9-362:7. PO’s objection to Foote 1989 thus also
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`is waived. See Generico, LLC, v. Dr. Falk Pharma Gmbh, IPR2016-00297, Paper
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`55 at 51 (May 19, 2017) (denying motion to exclude exhibit because it was marked
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`at expert’s deposition without objection, and party seeking exclusion should have
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`been aware of it because it was cited during prosecution)3; Volkswagen Group v.
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`3 Sure enough, during prosecution of the ’213 patent, PO cited Foote 1989. PO
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`represented that it had “learnt that the humanized light chain gene of the
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`5
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`IPR2017-01489: Petitioners’ Opposition to Patent Owner’s Motion to Strike
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`Emerechem Holdings, LLC, IPR2014-01555, Paper 50 at 73-75 (Jan. 22, 2016)
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`(denying motion to exclude exhibit filed with reply, where no objection was made
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`to its admissibility during deposition, and PO addressed it on redirect).
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`Finally, although PO’s counsel did object to Foote 1989 during Dr. Wilson’s
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`deposition (Ex. 1697 at 177:4–6), that objection already had been waived during Dr.
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`Foote’s deposition. And with respect to Kurrle, PO’s counsel stated only a
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`“foundation” objection that “I don’t believe anyone’s pointed to Kurrle using a
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`consensus sequence in this case” (id. at 257:9–258:1), which is different from the
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`objection PO presents here, and in any event was incorrect, as Kurrle’s use of a
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`“consensus” sequence was discussed in Dr. Foote’s declaration and at his deposition.
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`Thus, Dr. Wilson’s testimony should not be stricken either.
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`B. Much Of The Evidence And Argument PO Seeks To Strike Was
`Raised In The Petition And/Or Supporting Foote Declaration
`PO’s motion seeks to strike evidence and argument that were clearly presented
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`with the Petition. For example, PO seeks to strike part of Reply page 27 and ¶¶ 12,
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`CAMPATH-1 antibody in Riechmann et al. was converted from an anti-
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`lysozyme construct” and that “Foote’s anti-lysozyme construct was prepared by
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`combining CDR sequences from the kappa light chain of the anti-lysozyme
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`antibody with consensus human kappa frameworks.” Ex. 1502_5:2500 (citing
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`Foote 1989).
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`6
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`IPR2017-01489: Petitioners’ Opposition to Patent Owner’s Motion to Strike
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`41–43, 61, 79, 82, 119, 162, and 187 of Dr. Foote’s reply declaration regarding use
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`of a “consensus” sequence in the humanization of Riechmann’s CAMPATH
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`antibody. Mot. at 1. But Dr. Foote discussed the use of “consensus” approach in
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`CAMPATH in his first declaration, and this discussion was cited in the Petition. Ex.
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`1503, ¶103; Pet. at 11. Similarly, PO seeks to part of Reply page 18, and ¶¶ 7, 44,
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`104-106, and 160-162 of Dr. Foote’s reply declaration regarding use of a
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`“consensus” sequence in Kurrle’s humanization method. Mot. at 1. Yet, again, Dr.
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`Foote described Kurrle’s instruction to use a human “consensus” sequence in his
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`first declaration. Ex. 1503 at ¶123. PO’s motion should be denied for this additional
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`reason. See eBay Inc. v. Global Equity Mgmt., IPR2016-01829, Paper 63 at 2-4
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`(April 18, 2018) (motion to strike reply evidence denied where petitioner “point[ed]
`
`out where it had first raised the issue in the Petition”).
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`C. The Evidence And Argument PO Seeks To Strike Appropriately
`Replies To PO’s Own Evidence And Arguments In Its Response
`PO’s motion also should be denied because the evidence and argument it seeks
`
`to strike appropriately responds to arguments PO raised in the Response. “The
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`development of evidence in the course of the trial is in keeping with the oppositional
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`nature of an [IPR] proceeding.” Genzyme Therapeutic Prods. Ltd. P’ship. v.
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`Biomarin Pharm. Inc., 825 F.3d 1360, 1366-67 (Fed. Cir. 2016). Thus, “the Board
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`may consider a prior art reference to show the state of the art at the time of the
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`invention, regardless of whether that reference was cited in the Board’s institution
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`7
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`IPR2017-01489: Petitioners’ Opposition to Patent Owner’s Motion to Strike
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`decision.” Id. at 1369; Anacor Pharms., Inc. v. Iancu, 889 F.3d 1372, 1380–81 (Fed.
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`Cir. 2018) (“the petitioner in an inter partes review proceeding may introduce new
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`evidence after the petition stage if the evidence is a legitimate reply to evidence
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`introduced by the patent owner, or if it is used ‘to document the knowledge that
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`skilled artisans would bring to bear in reading the prior art identified as producing
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`obviousness.’”). The evidence and argument at issue here meets these standards.
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`For example, PO’s Response made an “unexpected results” argument
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`contrasting the ’213 patent antibodies against CAMPATH and implying that use of
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`the “best-fit” approach (rather than the “consensus” approach) was responsible for
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`its allegedly inferior immunogenicity. POR at 66; Ex. 2041, ¶267. Petitioners’
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`evidence and argument regarding use of the “consensus” sequence from Foote 1989
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`to generate CAMPATH responds directly to this.
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`The evidence and argument regarding Kurrle’s use of a “consensus” sequence
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`similarly responds to PO’s assertion that the ’213 patent’s “consensus” approach is
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`somehow superior to other approaches, e.g., “best-fit.” POR at 64–67; Ex. 2041,
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`¶¶ 264–68. Specifically, it demonstrates that there is no relevant difference between
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`antibodies generated using the “best-fit” and “consensus” approaches, which can
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`lead to the same result, as Kurrle exemplifies. Reply at 16–19.
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`Furthermore, all of this evidence is also relevant to PO’s contentions as to the
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`state of the art and the “knowledge that skilled artisans would bring to bear” in
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`8
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`IPR2017-01489: Petitioners’ Opposition to Patent Owner’s Motion to Strike
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`reviewing the prior art. Specifically, in describing the state of the art, PO and its
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`expert allege that the ’213 patent inventors’ use of a “consensus” sequence was
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`“novel” in contrast to humanization efforts in the prior art, which they contend only
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`used an individual human antibody for the framework, such as one identified as the
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`“best-fit” by homology matching to the donor mouse antibody. POR at 6-7, 9-10;
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`Ex. 2041, ¶¶ 55–72. The evidence sought to be stricken corrects the record regarding
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`the state of the art, and thus provides appropriate context for the prior art’s teaching
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`to use a “consensus sequence” as the starting point for the framework of a humanized
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`antibody, in response to PO’s contentions. See, e.g., Reply at 16-17, 26-27; Ex. 1702,
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`¶¶ 12, 41–43 (“It is here that Dr. Wilson’s description of the state of the art diverges
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`from a current summary of the history of antibody generation.”), 79, 82, 104–106,
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`119. The evidence and argument at issue in PO’s motion thus should not be stricken
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`for this additional reason. See Anacor, 889 F.3d at 1380–81; Genzyme, 825 F.3d at
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`1369; Emerson Elec. Co. v. Sipco, LLC, IPR2016-00984, Paper 43 at 46–50 (Oct.
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`25, 2017) (considering evidence regarding state of the art in reply to patent owner
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`arguments does not violate APA).4
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`4 PO’s cited cases are inapposite. Cox Comms., Inc. v. AT&T Intellectual Prop. II,
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`L.P., IPR2015-01187, Paper 59 at 16-17 (Nov. 15, 2016) (petitioner sought to
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`“replace” prior art reference in instituted ground for the first time at oral hearing);
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`
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`9
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`IPR2017-01489: Petitioners’ Opposition to Patent Owner’s Motion to Strike
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`IV. CONCLUSION
`PO’s motion should be denied.
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`
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` Date: July 6, 2018
`
`Respectfully submitted,
`
`/Amanda Hollis/
`Attorney For Petitioner Pfizer, Inc.
`
`
`Mylan Pharm. Inc. v. UCB Pharma GmbH, IPR2016-00517, Paper 37 (Jul. 19,
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`2017) (petitioner sought to “shift” argument from footnote in the Petition to
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`support prima facie case on a different claim element).
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`10
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`IPR2017-01489: Petitioners’ Opposition to Patent Owner’s Motion to Strike
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that a copy of the foregoing Opposition
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`Motion to Strike was served on July 6, 2018, via electronic service on lead and back-
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`up counsel:
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`For Genentech:
`david.cavanaugh@wilmerhale.com
`lauren.blakely@wilmerhale.com
`robert.gunther@wilmerhale.com
`abrausa@durietangri.com
`ddurie@durietangri.com
`andrew.danford@wilmerhale.com
`kevin.prussia@wilmerhale.com
`lisa.pirozzolo@wilmerhale.com
`
`For Samsung Bioepis Co., Ltd.:
`ddrivas@whitecase.com
`sweingaertner@whitecase.com
`eric.majchrzak@whitecase.com
`athakore@whitecase.com
`
`
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`11
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` /Amanda Hollis/
`Amanda Hollis
`
`
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