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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Celltrion, Inc.
`Petitioner,
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`v.
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`Genentech, Inc.
`Patent Owner
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`Patent No. 6,407,213
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`Inter Partes Review No. IPR2017-01373
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`PETITIONER CELLTRION’S OPPOSITION TO
`PATENT OWNER’S MOTION TO STRIKE
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`I.
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`Introduction
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`IPR2017-01373
`Petitioner’s Opposition to Motion to Strike
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`Patent Owner is seeking to strike Exhibit 1193 and the arguments and
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`testimony that rely on this Exhibit1 from the record because they show that Patent
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`Owner has mischaracterized the prior art relevant to this proceeding. Patent Owner
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`incorrectly proclaims in its Response that the subject matter claimed in the
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`’213 patent is different from the prior art because it includes a human consensus
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`sequence as a framework for humanized antibodies. This is simply incorrect. As
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`noted throughout Petitioner’s papers, the prior art shows that others had
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`successfully used a human consensus sequence to humanize antibodies.
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`Petitioner’s entry of Exhibit 1193 into the record as additional evidence to show
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`that Patent Owner’s position is wrong is not only proper, but is precisely the
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`purpose of reply papers. Patent Owner should not be permitted to mischaracterize
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`the prior art and then seek to strike any evidence that does not fit its narrative.
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`Exhibit 1193 is a 1989 publication by Dr. Jefferson Foote, a scientist
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`working in the field of antibody humanization prior to, and concurrently with, the
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`alleged development of the subject matter of the challenged claims of the
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`1 Patent Owner seeks to strike Exhibit 1193, the first full paragraphs on pages 15
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`and 21 of Petitioner’s Reply, paragraph 30 of Exhibit 1143, and Exhibit 1138 at
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`176:25-178:23.
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`1
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`’213 patent. Exhibit 1193 describes Dr. Foote’s development of a humanized anti-
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`IPR2017-01373
`Petitioner’s Opposition to Motion to Strike
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`lysozyme antibody in which he created a light chain framework using a human
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`consensus sequence. (Ex. 1193, 106.) As explained in Dr. Riechmann’s
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`deposition, in his humanization of the CAMPATH antibody, Dr. Riechmann used
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`the same light chain framework that Dr. Foote created and used in the anti-
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`lysozyme antibody. (Ex. 2039 at 118:1-18 .) Dr. Wilson, Patent Owner’s expert,
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`also testified at deposition about Exhibit 1193—testimony that Patent Owner now
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`seeks to strike—in response to questions regarding his opinions about whether
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`consensus sequences were known in the prior art. (Ex. 1138 at 176:15-178:23.)
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`As discussed in more detail below, Petitioner’s Reply properly relies on
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`Exhibit 1193 for two arguments in response to Patent Owner’s positions: (1)
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`contrary to Patent Owner’s argument that the ’213 patent’s consensus sequence
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`differentiated the claimed antibodies from prior art humanized antibodies, a person
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`of ordinary skill in the art would have known that others in the field had
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`successfully used a human consensus sequence in a humanized antibody, and (2) it
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`would not have been unexpected for a person of ordinary skill in the art to use the
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`same consensus sequence to humanize multiple antibodies.
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`II.
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`Petitioner’s Reply Arguments are Proper
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` “There is no blanket prohibition against the introduction of new evidence
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`during an inter partes review proceeding.” Anacor Pharm., Inc. v. Iancu, 889 F.3d
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`2
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`1372, 1380 (Fed. Cir. 2018). New evidence is “perfectly permissible” if the
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`IPR2017-01373
`Petitioner’s Opposition to Motion to Strike
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`opposing party has notice of the evidence and an opportunity to respond. Id. But
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`the Federal Circuit recently confirmed that this is not the only permissible use of
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`new evidence after the petition:
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`In addition, the petitioner in an inter partes review
`proceeding may introduce new evidence after the petition
`stage if the evidence is a legitimate reply to evidence
`introduced by the patent owner, or if it is used ‘to
`document the knowledge that a skilled artisan would
`bring to bear in reading the prior art identified as
`producing obviousness.’
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`Id. at 1380-81(citing Genzyme Therapeutic Prod. Ltd. P’ship v. Biomarin Pharm.
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`Inc., 825 F.3d 1360, 1369 (Fed. Cir. 2016)).
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`In Anacor, the petitioner used one of the supposedly untimely references
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`during the deposition of the patent owner’s expert, in response to statements made
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`by the expert witness. Anacor, 889 F.3d at 1381. The Federal Circuit held that
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`introducing a responsive reference into the record in this manner did not deny
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`Anacor its procedural rights, because the Board did not materially deviate from the
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`obviousness theory set forth in the petition and Anacor had ample notice of the
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`reference. Id. at 1382. As in Anacor, the Foote reference was used in at the
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`deposition of Dr. Ian Wilson, Patent Owner’s expert, in direct response to
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`testimony that the use of consensus sequences was not known in the prior art. (Ex.
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`3
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`1138 at 176:15-178:23.) Patent Owner now seeks to strike this testimony of its
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`IPR2017-01373
`Petitioner’s Opposition to Motion to Strike
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`own expert.
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`Here, Petitioner’s citation of Exhibit 1193 in its reply was proper not only
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`because Patent Owner had notice of the subject matter of the disputed material, but
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`also because it directly contradicts Patent Owner’s arguments in its Response.
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`A.
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`Petitioner’s Reply Does Not Alter the Instituted Grounds of Invalidity
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`Patent Owner’s arguments that Petitioner’s invalidity arguments are “new”
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`or “evolving” are wrong. As stated in both the Petition and Reply, the challenged
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`claims of the ’213 patent are invalid as obvious in light of the prior art identified in
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`the instituted grounds. (Paper 2 (Petition) at 26-57; Paper 53 (Reply) at 4-18.) As
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`Patent Owner acknowledges, a subset of the challenged claims require the use of a
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`“consensus” sequence, as defined in the ’213 patent. (Paper 59 (Motion to Strike)
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`at 2.) The Petition explains that the prior art disclosed, or would have taught a
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`person of ordinary skill in the art to make, a consensus sequence for use in a
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`humanized antibody. Specifically, as of the priority date, Queen 1990 (Ex. 1050)
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`or Queen 1989 (Ex. 1034) in combination with Kabat 1987 (Ex. 1052) and/or the
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`PDB database would have taught a person of ordinary skill in the art to use a
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`human consensus sequence or make substitutions to move towards a more human
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`sequence.
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`4
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`IPR2017-01373
`Petitioner’s Opposition to Motion to Strike
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`Petitioner maintains that the grounds set forth in the Petition, and on which
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`the Board instituted this proceeding, show the invalidity of the challenged claims.
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`The paragraph that Patent Owner argues is asserting a “new invalidity theory” does
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`no such thing. Contrary to Patent Owner’s arguments, Petitioner does not offer
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`Exhibit 1193 as a substitute for the disclosure of a consensus sequence in either
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`Queen 1990 or Queen 1989 in combination with other prior art. Petitioner relies
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`on Exhibit 1193 in its Reply at page 15 as rebuttal evidence showing that Patent
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`Owner had misconstrued the prior art in its Response, in particular regarding what
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`a person of ordinary skill in the art would have understood about the use of human
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`consensus sequences. Petitioner did not modify the instituted grounds of invalidity
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`in this proceeding. (Paper 53 (Reply) at 12-15.) Patent Owner’s claim that it is
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`prejudiced by new disclosures of elements in the claims is baseless.
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`B.
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`The Disputed Material was Raised in Reply to Evidence Introduced
`by the Patent Owner and Reflects the Knowledge of a POSA
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`1.
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`The Disputed Material Responds to Patent Owner’s
`Mischaracterizations of the Prior Art and the Knowledge of a
`POSA
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`Patent Owner misrepresented the prior art in this proceeding by stating in its
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`Response that the ’213 patent was “[u]nlike prior art humanized antibodies”
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`because the claimed antibodies were constructed with a human consensus
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`sequence. (Paper 37 (POR) at 1.) Patent Owner made similar statements when
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`5
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`describing the inventors’ development of the claimed subject matter, stating that
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`IPR2017-01373
`Petitioner’s Opposition to Motion to Strike
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`the inventors “developed a new approach to humanizing antibodies . . . . Rather
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`than [using] an actual antibody, the inventors developed an artificial ‘consensus
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`human sequence.’” (Paper 37 (POR) at 8.) Patent Owner went on to tout that
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`“[a]ntibodies containing the ’213 patent’s consensus sequence were a significant
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`advance over the prior art.” (Paper 37 (POR) at 9-10.) Additionally, Patent
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`Owner’s expert, Dr. Wilson, stated in his declaration that it was his opinion that a
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`person of ordinary skill in the art would not have had a reasonable expectation of
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`success in using a human consensus sequence for a humanized antibody because
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`there was insufficient information in the prior art. (See, e.g., Ex. 2041 at ¶¶ 219-
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`225.)
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`Petitioner relied on Exhibit 1193 to respond to these arguments and correct
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`the record. The paragraph Patent Owner points to on page 15 of Petitioner’s Reply
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`merely explains that, contrary to Patent Owner’s arguments, a person of ordinary
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`skill in the art would have known that others in the field had successfully used a
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`consensus sequence in humanization projects. Thus, Petitioner was properly
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`responding to Patent Owner’s arguments and should not be prevented from
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`correcting Patent Owner’s mischaracterizations of the prior art or the knowledge of
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`a person of ordinary skill in the art.
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`6
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`IPR2017-01373
`Petitioner’s Opposition to Motion to Strike
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`2.
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`The Disputed Material Also Responds to Patent Owner’s
`Assertions of Unexpected Results
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`In its Response, Patent Owner argued that unexpected results showed that
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`the challenged claims were not obvious in light of the prior art. Specifically,
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`Patent Owner argued that it would not have been expected that a consensus
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`sequence could be used to humanize multiple antibodies. (Paper 37 (POR) at 63-
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`65.) Relying on Dr. Wilson’s declaration, Patent Owner argued: “Before the ’213
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`invention, scientists believed that it was necessary to identify an existing human
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`antibody framework sequence . . . as a starting point. . . . The ’213 patent’s
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`consensus sequence approach unexpectedly allowed numerous different antibodies
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`to be humanized from a single consensus sequence. . . .” (POR at 64, citing Ex.
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`2041 at ¶¶ 261-62.)
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`To contradict Patent Owner’s unexpected results argument, Petitioner
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`properly pointed to Dr. Riechmann’s use of Dr. Foote’s consensus sequence to
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`show that the use of a single sequence in multiple humanization projects would not
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`have been unexpected. (See Paper 53 (Reply) at 21.) Patent Owner’s argument
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`that Petitioner could rely on Queen 1990 and Queen 1989 to make the same
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`argument is incorrect. Petitioner relies on Queen 1990 and Queen 1989 to show
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`that the prior art disclosed and/or taught the use of a consensus sequence in a
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`humanized antibody. Petitioner relies on Foote (Ex. 1193) to show that, contrary
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`7
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`to Patent Owner’s unexpected results arguments, a human consensus sequence was
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`IPR2017-01373
`Petitioner’s Opposition to Motion to Strike
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`successfully used in multiple antibody humanization projects in the prior art.
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`These are distinct arguments, and Petitioner cannot “simply rely on Queen 1990 or
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`Queen 1989” because Foote does not disclose “the same thing,” as Patent Owner
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`suggests. (Paper 59 (Motion to Strike) at 6.) Thus, Patent Owner’s assessment
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`that Petitioner’s use of Foote to rebut the alleged unexpected results “make little
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`practical sense” misconstrues Petitioner’s argument and is incorrect.
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`Further, the relevance of this evidence to Patent Owner’s arguments of
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`unexpected results significantly outweighs any alleged prejudice to Patent Owner,
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`particularly when Patent Owner was aware of these facts and ignored them. Patent
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`Owner cannot dispute that it was aware of Exhibit 1193, its contents, and its
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`relationship to Dr. Reichmann’s work prior to this proceeding. In an amendment
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`to the claims during prosecution of the ’213 patent, Patent Owner stated to the
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`examiner that “[a]pplicants have now learnt that the humanized light chain gene of
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`the CAMPATH-1 antibody in Riechmann et al. [Ex. 1069] was converted from an
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`anti-lysozyme construct (see page 108 of Foote [Ex. 1193]). Foot’s anti-lysozyme
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`construct was prepared . . . with consensus human kappa frameworks.” (See Ex.
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`1002 at 340.) This is precisely the information that Petitioner included in its Reply
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`and Patent Owner seeks to strike.
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`8
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`IPR2017-01373
`Petitioner’s Opposition to Motion to Strike
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`Patent Owner should not now be allowed to suppress this evidence—which
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`corrects its mischaracterizations of the prior art—simply because it was not
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`explicitly addressed in the Petition. Patent Owner acknowledged during
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`prosecution that another scientist had used a consensus sequence to humanize an
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`antibody, and that the same consensus sequence was used in yet another
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`humanized antibody; and yet, Patent Owner still made representations in this
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`proceeding that use of a consensus sequence differentiated the challenged claims
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`from the prior art and the use of a single consensus sequence in multiple antibodies
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`would have been unexpected. (Paper 37 (POR) at 1, 8, 64.) Petitioner should not
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`be precluded from relying on evidence that Patent Owner knew about, but chose to
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`ignore because it contradicts Patent Owner’s narrative.2
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`2 Patent Owner also had knowledge of Dr. Foote’s and Dr. Riechmann’s use of a
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`human consensus sequence from Dr. Foote’s declaration that was submitted as
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`Exhibit 1003 in the co-pending, related IPR2017-01488 and -01489. (IPR2017-
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`01488, -01489, Ex. 1003 at ¶ 103.) Patent Owner deposed Dr. Foote regarding his
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`involvement in Dr. Riechmann’s humanization of the CAMPATH-1 antibody and
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`did not object when counsel for Pfizer introduced Exhibit 1193 and questioned Dr.
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`Foote about it. (IPR2017-01488, -01489, Ex. 2039 at 328:6-330:11.)
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`9
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`IPR2017-01373
`Petitioner’s Opposition to Motion to Strike
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`C.
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`That Petitioner Knew About the Disputed Material Is Irrelevant
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`There is no requirement that a Petitioner must put all relevant knowledge
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`into the Petition. That Petitioner knew or should have known about Exhibit 1193
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`when drafting the Petition does not preclude its use in Petitioner’s Reply,
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`particularly because, as described above, it was properly raised to rebut Patent
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`Owner’s arguments and correct its mischaracterizations.
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`Thus, Patent Owner’s motion to strike should be denied.
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`Dated: July 6, 2018
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`Respectfully submitted,
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`/Cynthia Lambert Hardman/
`Cynthia Lambert Hardman (Reg. No. 53,179)
`Elizabeth J. Holland (Reg. No. 47,657)
`Robert V. Cerwinski (admitted pro hac vice)
`Linnea P. Cipriano (Reg. No. 67,729)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`(212) 813-8800 (telephone)
`(212) 355-3333 (facsimile)
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`Sarah J. Fischer (Reg. No. 74,104)
`GOODWIN PROCTER LLP
`100 Northern Avenue
`Boston, MA, 02210
`(617) 570-3908 (telephone)
`(617) 801-8991 (facsimile)
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`Counsel for Petitioner
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`10
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 6th of July, 2018, I
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`caused a copy of this PETITIONER CELLTRION’S OPPOSITION TO PATENT
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`OWNER’S MOTION TO STRIKE by email on the lead and back up counsel for
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`Patent Owners at:
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`David Cavanaugh (David.Cavanaugh@wilmerhale.com)
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`Lauren V. Blakely (lauren.blakely@wilmerhale.com)
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`Robert Gunther (Robert.Gunther@wilmerhale.com)
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`Adam Brausa (abrausa@durietangri.com)
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`Daralyn Durie (ddurie@durietangri.com)
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`Andrew Danford (Andrew.Danford@wilmerhale.com)
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`Lisa Pirozzolo (Lisa.Pirozzolo@wilmerhale.com)
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`Kevin Prussia (Kevin.Prussia@wilmerhale.com)
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`By: /Cynthia Lambert Hardman/
`Cynthia Lambert Hardman (Reg. No. 53,179)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`(212) 813-8800 (telephone)
`(212) 355-3333 (facsimile)
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