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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 MOTION TO EXCLUDE EVIDENCE
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`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`I.
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`Introduction
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`Pursuant to 37 C.F.R. § 42.64(c), the Board’s Scheduling Order (Paper 16),
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`and the Federal Rules of Evidence, Petitioner Celltrion, Inc. hereby moves to
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`exclude, in whole or in part, Exhibits 2001-2009, 2014-2018, 2021, 2029, 2041-
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`2044, 2053, 2055, and 2059-2062 submitted by Patent Owner Genentech, Inc.
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`Petitioner also moves to exclude the following paragraphs from the Declarations
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`submitted by Patent Owner: paragraphs 11-30, 32, 34-36, 38, 39, 41-50 of Exhibit
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`2016; paragraphs 12, 15, 20, 23-29, 35-39, 41, 43-50, 53, 54-56, 59-65, 68, 70, 73-
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`75, and 78 of Exhibit 2017; paragraphs 9, 10, 12-17, 19, and 21-23 of Exhibit
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`2018; and paragraphs 25, 36-37, 48, 65, 172, 180, 186, and 231 of Exhibit 2041.
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`II.
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` Identification of Original Objections
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`Petitioner timely raised objections to Patent Owner’s evidence on December
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`15, 2017, and March 15, 2018. (Papers 21and 40, respectively.) Patent Owner did
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`not address Petitioner’s objections with supplemental evidence or otherwise. Here,
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`Petitioner requests the Board to exclude additional evidence that was not objected
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`to in the prior papers because Petitioner was not aware of the circumstances that
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`give rise to the objections when the prior objections were submitted. Petitioner did
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`not appreciate the identity of Exhibits 2001-2009 until the depositions of Patent
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`Owners’ witnesses, at which time Petitioner promptly lodged its objections. (Ex.
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`1141, 7:10-8:7, 8:23-10:2.)
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`III. Exhibits 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, and 2009
`Should Be Excluded as Unauthenticated, Not the Best Evidence, and
`Hearsay
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`IV. Exhibits 2014 and 2015 Should Be Excluded
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`IV. Exhibits 2014 and 2015 Should Be Excluded
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`V.
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`Portions of Exhibits 2016, 2017, and 2018 Should Be Excluded to the
`Extent that they Rely on Otherwise Inadmissible Evidence
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`Portions of Exhibit 2016, the Declaration of Dr. Leonard G. Presta, should
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`be excluded to the extent that they rely on otherwise inadmissible evidence, as
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`described above regarding Exhibits 2001-2009. Specifically, paragraphs 11-30,
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`32, 34-36, 38, 39, and 41-48 of Exhibit 2016 rely on Exhibits 2001 and 2002, and
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`should be excluded for the same reasons as stated above for Exhibits 2001 and
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`2002.
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`Portions of Exhibit 2017, the Declaration of Dr. Paul Carter, should
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`similarly be excluded to the extent that they rely on otherwise inadmissible
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`evidence, as described above regarding Exhibits 2001-2009. Specifically,
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`paragraphs 12, 15, 20, 23-29, 35-39, 41, 43-50, 53, 54-56, 59-65, 68, 70, 73-75,
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`and 78 of Exhibit 2017 rely on Exhibits 2003, 2004, 2006, 2007, and 2008 and
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`should be excluded for the same reasons as stated above for Exhibits 2003 and
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`2004.
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`Portions of Exhibit 2018, the Declaration of John Ridgeway Brady, should
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`also be excluded to the extent that they rely on otherwise inadmissible evidence, as
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`described above regarding Exhibits 2001-2009. Specifically, paragraphs 9, 10, 12-
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`17, 19, and 21-23 of Exhibit 2018 rely on Exhibits 2005, 2006, and 2009 and
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`should be excluded for the same reasons as stated above for Exhibits 2005 and
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`2006.
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`6
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`VI. Portions of Exhibits 2016 and 2018 Should Be Excluded Because They
`Lack Foundation
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`Paragraphs 23, 49, and 50 of Exhibit 2016 should be excluded because they
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`lack foundation under Federal Rule of Evidence 602. There is no evidence in the
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`record that Dr. Presta had personal knowledge of Dr. Carter’s knowledge or
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`activities that is discussed in paragraphs 23, 49, and 50. Therefore, these
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`paragraphs should be excluded under Federal Rule of Evidence 602.
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`Similarly, Paragraphs 21 and 23 and Exhibit 2018 should be excluded under
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`Federal Rule of Evidence 602 because they lack foundation. There is no evidence
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`in the record that Mr. Brady had personal knowledge of the activities of Monique
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`Carver as discussed in paragraphs 21 and 23. Therefore, these paragraphs should
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`also be excluded under Federal Rule of Evidence 602.
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`VII. Exhibits 2021, 2053, 2059, and 2060 Should Be Excluded Because they
`Are Not Prior Art and Are Therefore Not Relevant
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`Exhibits 2021, 2053, 2059, and 2060 were not available until after the
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`relevant priority date. The Petition asserts invalidity positions based on
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`obviousness. In an obviousness inquiry, it is the available knowledge of a POSA
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`as of the priority date that is relevant. See Graham v. John Deere Co., 383 U.S. 1,
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`3 (“This is the test of obviousness, i.e., whether the subject matter sought to be
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`patented and the prior art are such that the subject matter as a whole would have
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`been obvious at the time the invention was made…”); id. at 14-15 (“Section
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`103…refers to the difference between the subject matter sought to be patented and
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`the prior art, meaning what was known before…”) (emphasis added). Patent
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`Owner has not demonstrated that Exhibits 2021, 2023, 2042, 2043, 2044, 2053,
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`2055, 2059, 2060, and 2061 were available to a POSA before the priority date, and
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`therefore, are irrelevant for the purpose of establishing the teachings of the prior
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`art. Since these documents are not prior art, having them in the record is
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`prejudicial, as Patent Owner is relying on them for improper purposes, as
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`explained below.
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`Exhibit 2021 is a purported copy of an article entitled “Humanization of an
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`Anti-Vascular Endothelial Growth Factor Monoclonal Antibody for the Therapy of
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`Solid Tumors and Other Disorders” that appears to bear a date of October 15,
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`1997, years after the relevant priority date. Patent Owner cites this article to
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`support its argument that residues disclosed by the inventors are relevant to other,
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`post-art, therapies. (Paper 7 at 35.) Patent Owner does not contend that this
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`knowledge was available in the prior art.
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`Exhibit 2053 is a purported copy of an article entitled “Therapeutic
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`Antibodies for Human Diseases at the Dawn of the Twenty-First Century” that
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`appears to bear a date of January 2003, years after the relevant priority date. Patent
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`Owner cites this article in its Response to show the purported skepticism regarding
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`the therapeutic potential of monoclonal antibodies. (Paper 37 at 33-34 n.6.)
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`However, Patent Owner does not contend that this knowledge was available in the
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`prior art.
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`Exhibit 2059 is a purported copy of an article entitled “Monoclonal
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`Antibodies in the Detection and Therapy of Micrometastatic Epithelial Cancers”
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`that appears to bear a date of 1992. Patent Owner relies, in part, on Exhibit 2059
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`to support its argument that a POSA would have known that there were difficulties
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`in developing antibody-based treatments at the time of the invention. However,
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`Patent Owner does not contend that this knowledge was available in the prior art.
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`Exhibit 2060 is a purported copy of an article entitled “Monoclonal
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`Antibodies in Cancer Therapy” that appears to bear a date of 1993. Patent Owner
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`relies, in part, on Exhibit 2060 to support its argument that a POSA would have
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`known that there were difficulties in developing antibody-based treatments at the
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`time of the invention. However, Patent Owner does not contend that this
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`knowledge was available in the prior art.
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`***
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`The probative value of each of these Exhibits is substantially outweighed by
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`the undue prejudice stemming from Patent Owner’s improper reliance on these
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`non-prior art documents to show purported prior art practices or the knowledge of
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`a person of ordinary skill in the art. The Board should therefore exclude Exhibits
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`2021, 2023, 2053, 2059, and 2060 under Federal Rule of Evidence 402 and 403.
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`VIII. Exhibits 2042, 2043, 2044, 2055, and 2061 Should Be Excluded Because
`they are Irrelevant
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`Exhibits 2042, 2043, 2044, 2055, and 2061 should be excluded because
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`Patent Owner did not rely on any of them in either its Patent Owner’s Preliminary
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`Response or its Patent Owner’s Response, and thus they are not relevant under
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`Federal Rule of Evidence 401 and inadmissible under Federal Rule of Evidence of
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`402. To the extent that they are relevant, the risk of unfair prejudice outweighs any
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`probative value, and should therefore be excluded under Federal of Evidence 403.
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`Furthermore, each of the Exhibits was published after the relevant priority date.
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`Exhibit 2042 is s a purported copy of United States Patent No. 7,375,193,
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`which issued to Manuel Baca, et al., on May 20, 2008, years after the relevant
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`priority date. Patent Owner did not rely on this Exhibit in either its Patent Owner’s
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`Preliminary Response or its Patent Owner’s Response.
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`Exhibit 2043 is a purported copy of United States Patent No. 7,560,111,
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`which issued to Yung-Hsiang Kao, et al., on July 14, 2009, years after the relevant
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`priority date. Patent Owner did not rely on this Exhibit in either its Patent Owner’s
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`Preliminary Response or its Patent Owner’s Response.
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`Exhibit 2044 is a purported copy of an article entitled “Humanization of an
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`Antibody Directed Again IgE” that appears to bear a date of September 1, 1993,
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`more than a year after the priority date. Patent Owner did not rely on this Exhibit
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`in either its Patent Owner’s Preliminary Response or its Patent Owner’s Response.
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`Exhibit 2055 is a purported copy of an article entitled “Antibody-Based
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`Therapy” that appears to bear a date of May 1993, more than a year after the
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`relevant priority date. Patent Owner did not rely on this Exhibit in either its Patent
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`Owner’s Preliminary Response or its Patent Owner’s Response.
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`Exhibit 2061 is a purported copy of an article entitled “Phase II Study of
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`Receptor-Enhanced Chemosensitivity Using Recombinant Humanized Anti-
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`pl85HER2/neu Monoclonal Antibody Plus Cisplatin in Patients With HER2/neu-
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`Overexpressing Metastatic Breast Cancer Refractory to Chemotherapy Treatment”
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`that appears to bear a date of August, 1998, years after the relevant priority date.
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`Patent Owner did not rely on this Exhibit in either its Patent Owner’s Preliminary
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`Response or its Patent Owner’s Response.
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`IX. Exhibits 2029 Should Be Excluded Because they Are Not Authenticated
`and Are Inadmissible Hearsay
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`Exhibit 2029 purports to be a copy of a portion of a 2016 Finance Report
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`from Roche, which appears to contain only the cover page and pages 10 and 11 of
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`the document. Patent Owner relies on this document in an attempt to support its
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`argument that products that embody the claims have experienced commercial
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`success. (Paper 7 at 65; Paper 37 at 66.) Patent Owner has provided no
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`information to establish the authenticity of Exhibit 2029, as is required by Federal
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`Rule of Evidence 901. Further, Patent Owner relies on Exhibit 2029 for the truth
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`of the matter asserted, namely that the products listed in the document have
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`generated the purported number of sales (POR at 66), but has not established that
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`Exhibit 2029 falls within any exception to the rule against hearsay. Therefore,
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`Exhibit 2029 should be excluded as not authenticated under Federal Rule of
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`Evidence 901 and inadmissible hearsay under Federal Rule of Evidence 802.
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`X. Exhibit 2062 Should Be Excluded Because it Is an Irrelevant, Attorney-
`Created Exhibit
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`Exhibit 2062 purports to be a comparison between the declarations
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`submitted by Dr. Lutz Riechmann in this this matter and the declaration submitted
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`by Dr. Eduardo A. Padlan, submitted in Case Nos. IPR2016-01693 and IPR2016-
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`01694, which counsel for Patent Owner created. (Ex. 2039, 226:9-227:13.) Patent
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`Owner did not rely on Exhibit 2062 in either its Preliminary Response or its
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`Response. This attorney-created document does not make any issue in this
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`proceeding more or less probable. As such, it is not relevant under Federal Rule of
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`Evidence 401, and is therefore inadmissible under Federal Rule of Evidence 402.
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`To the extent that Exhibit 2062 is relevant, any probative value is outweighed by
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`danger of unfair prejudice, confusing the issues, wasting time, or needlessly
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`presenting cumulative evidence. The record shows that regardless of any
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`similarity between Dr. Padlan’s declaration submitted in IPR2016-01693 and
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`IPR2016-01694 and Dr. Riechmann’s declaration submitted in this proceeding, Dr.
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`Reichmann performed his own independent analysis and the opinions in his
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`declarations are his own. (See Ex. 1003, ¶ 10; Ex. 1142, ¶ 36.) Therefore, Exhibit
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`2062 should be excluded under Federal Rule of Evidence 403.
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`XI. Exhibit 2041 Should Be Excluded to the Extent that it Lacks
`Foundation or Relies on Evidence that Is Irrelevant
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`Portions of Exhibit 2041, the Expert Declaration of Dr. Ian Wilson, should
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`be excluded to the extent that they lack foundation or rely on improper evidence.
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`Specifically, Dr. Wilson does not provide any citations or support for the
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`statements made in paragraphs 25, 36-37, 48, 65, 172, 180, 186, and 231 of Exhibit
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`2041. Therefore, he has not provided suitable foundation for these opinions, and
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`the Board should exclude them under Federal Rule of Evidence 602. Further,
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`because they are unsupported, any probative value of paragraphs 25, 36-37, 48, 65,
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`172, 180, 186, and 231 of Exhibit 2041 is substantially outweighed by the danger
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`of unfair prejudice, confusing the issues, wasting time, or needlessly presenting
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`cumulative evidence for the reasons stated above, and therefore these paragraphs
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`should be excluded under Federal of Evidence 403.
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`Dated: June 22, 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
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`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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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 22nd of June, 2018, I
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`caused a copy of this PETITIONER CELLTRION’S MOTION TO EXCLUDE
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`EVIDENCE by email on the lead and back up counsel for 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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