`
`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
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`MYLAN PHARMACEUTICALS INC., CELLTRION, INC., and
`APOTEX, INC.,
`Petitioners,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
`
`Inter Partes Review No.: IPR2021-008801
`
`
`U.S. Patent No. 9,669,069 B2
`Filed: December 17, 2015
`Issued: June 6, 2017
`Inventor: George D. Yancopoulos
`
`Title: USE OF A VEGF ANTAGONIST TO TREAT
`ANGIOGENIC EYE DISORDERS
`
`
`
`
`
`PETITIONER’S MOTION TO EXCLUDE EVIDENCE
`37 C.F.R. § 42.64(c)
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`1 IPR2022-00257 and IPR2022-00301 have been joined with this proceeding.
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`I.
`II.
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`TABLE OF CONTENTS
`Introduction. ..................................................................................................... 1
`Exhibits Referenced in the Weber Declaration (Ex.2131). ............................. 2
`A.
`Ex.2059: PO Sample Analysis Report [CONFIDENTIAL]. ................ 4
`B.
`Ex.2060: VGFT-OD-0605 Analysis Summary
`[CONFIDENTIAL]. .............................................................................. 5
`Ex.2073: Zaltrap Non-Comparability Issue [CONFIDENTIAL]. ........ 7
`Ex.2128: VIEW Signature Page Compilation
`[CONFIDENTIAL]. .............................................................................. 8
`III. Ex.2096: Clinical Study Agreement [CONFIDENTIAL]. .............................. 9
`IV. Portions of Exs.2048-2050: Corresponding Expert Opinions. ...................... 10
`V.
`Conclusion. .................................................................................................... 11
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`
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`C.
`D.
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`i
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`TABLE OF AUTHORITIES
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`Cases
`
`Actifio, Inc. v. Delphix Corp.,
`IPR2015-00050, Paper 57 (P.T.A.B. Mar. 31, 2016) ............................................. 1
`Constant v. Advanced Micro-Devices, Inc.,
`848 F.2d 1560 (Fed. Cir. 1988) .............................................................................. 8
`Ingenico Inc. v. IOENGINE, LLC,
`IPR2019-00929, Paper 53 (P.T.A.B. Sept. 21, 2020) ............................. 5, 7, 9, 10
`LKQ Corp. v. Clearlamp, LLC,
`IPR2013-00020, Paper 17 (P.T.A.B. Mar. 5, 2013) ............................................... 1
`Microsoft Corp. v. FG SRC LLC,
`IPR2018-0605, Paper 72 (P.T.A.B. Apr. 9, 2020) ................................................. 1
`Riverbed Tech., Inc v. Reatime Data LLC,
`IPR2016-00978, Paper 67 (P.T.A.B. Oct. 30, 2017)..........................................3, 6
`SK Innovation Co. v. Celgard, LLC,
`IPR2014-00679, Paper 58 (P.T.A.B. Sept. 25, 2015..........................................4, 8
`TRW Auto. U.S. LLC v. Magna Elecs.,
`IPR2014-01348, Paper 25 (P.T.A.B. Jan. 15, 2016) ................................... 3, 9, 10
`Wi-LAN Inc. v. Sharp Elecs. Corp.,
`992 F.3d 1366 (Fed. Cir. 2021) ............................................................................ 10
`Regulations
`
`37 C.F.R. § 42.64 ....................................................................................................... 3
`37 C.F.R. § 42.62 ....................................................................................................... 3
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`ii
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`I.
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`Introduction.
`Mylan Pharmaceuticals Inc. (“Petitioner”) submits this motion pursuant to 37
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`C.F.R. §§ 42.62 and 42.64(c). Petitioner requests exclusion of the entirety of Patent
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`Owner (“PO”) Exhibits 2059-60, 2073, 2096, 2128, and the below-identified
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`portions of Exhibits 2048-50 (collectively, the “Challenged Exhibits”). Petitioner
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`timely objected to these exhibits through written objections (Paper 40) and/or during
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`deposition.
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`In IPRs, documents are admitted into evidence subject to an opposing party
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`asserting objections to the evidence and moving to exclude the evidence. 37 C.F.R.
`
`§ 42.64; Actifio, Inc. v. Delphix Corp., IPR2015-00050, Paper 57, 5 (P.T.A.B. Mar.
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`31, 2016).The Federal Rules of Evidence (FRE) govern the admissibility of evidence
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`in IPR proceedings. 37 C.F.R. § 42.62; LKQ Corp. v. Clearlamp, LLC, IPR2013-
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`00020, Paper 17, 3 (P.T.A.B. Mar. 5, 2013). The party moving to exclude evidence
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`bears the burden of proof to establish that it is entitled to the relief requested—
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`namely, that the material to be excluded is inadmissible under the FRE. See
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`Microsoft Corp. v. FG SRC LLC, IPR2018-0605, Paper 72, 11 (P.T.A.B. Apr. 9,
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`2020). As shown herein, the Challenged Exhibits should be excluded as not being
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`relevant to any issue on which trial has been instituted, lacking authentication,
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`containing hearsay, and/or causing undue prejudice.
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`The Board should not dismiss this Motion as moot even if the Board does not
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`1
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`rely on the inadmissible evidence in reaching its Final Written Decision. Instead,
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`Petitioner respectfully requests that the Board grant the motion so that PO cannot
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`continue to rely upon the exhibits and paragraphs identified herein on appeal. Not
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`excluding the exhibits would force Petitioner to address them again, e.g., on appeal,
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`thereby wasting judicial and party resources. To the extent that any exhibit or portion
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`of an exhibit is not excluded, use of the exhibit should be restricted to the use for
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`which it was originally submitted. FRE 105.
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`II. Exhibits Referenced in the Weber Declaration (Ex.2131).
`In response to Petitioner’s objections (Paper 40), PO served the declaration of
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`Doris Weber (Ex.2131), PO’s in-house, senior litigation support specialist,
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`attempting to cure the authentication deficiencies with Exhibits 2059-60, 2073, and
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`2128. Ms. Weber offers the following exhibits are “true and correct” copies of what
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`each purports to be: Exhibits 2059-60, 2073, and 2128.
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`Yet, Ms. Weber is not a custodian of these exhibits, and has no personal
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`knowledge of the creation, authorship, maintenance, or modification of any of the
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`exhibits or the underlying documents from which they were prepared. Thus, Ms.
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`Weber’s declaration does not (and cannot) “satisfy the requirement of authenticating
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`or identifying an item of evidence.” FRE 901(a); id. (“[T]he proponent must produce
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`evidence sufficient to support a finding that the item is what the proponent claims it
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`is.”); see also Riverbed Tech., Inc v. Reatime Data LLC, IPR2016-00978, Paper 67,
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`2
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`39-41 (P.T.A.B. Oct. 30, 2017) (granting motion to exclude exhibit as
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`unauthenticated under FRE 901, as well as portions of evidence relying expressly on
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`said exhibit); TRW Auto. U.S. LLC v. Magna Elecs., IPR2014-01348, Paper 25, 5-
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`12 (P.T.A.B. Jan. 15, 2016).
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`In view of the foregoing, the Board cannot fairly or reliably consider any of
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`the exhibits referenced in the Weber Declaration given the complete lack of
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`authenticating evidence—from PO, its witnesses, or the documents themselves—
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`needed to establish that the documents are what PO claims they are. PO also cannot
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`establish that any of these exhibits are self-authenticating under FRE 902.
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`None of the Weber Exhibits are self-authenticating under FRE 902—
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`specifically, [a] none are certified, signed, or sealed (FRE 902(1)-(4), (11)-(12)); [b]
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`none are an “official publication” (FRE 902(5)); [c] none are newspapers,
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`periodicals, trade inscriptions, notarized, or a commercial paper (FRE 902(6)-(9));
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`and [d] none are presumed authentic by federal statute (FRE 902(10)). Since the
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`Weber Exhibits do not satisfy any self-authenticating document category, PO’s
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`failure to provide “extrinsic evidence of authenticity” is fatal to the exhibits’
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`admissibility. In addition, PO submitted Exhibit 2060 and Exhibit 2128 as
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`incomplete and/or excerpted versions of un-produced, supposedly confidential
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`originals, casting further doubt on their authenticity and reliability.
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`As such, the exhibits referenced in the Weber Declaration—i.e., Exhibits
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`3
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`2059-60, 2073, and 2128—should be excluded as unauthenticated under FRE 901.
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`Exhibits 2059-60, 2073, and 2128 also warrant exclusion for the following reasons.
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`A. Ex.2059: PO Sample Analysis Report [CONFIDENTIAL].
`Exhibit 2059 is a confidential (filed under seal), non-public, technical report
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`regarding
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`. PO’s experts, Drs. Del
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`Priore and Klibanov, offer Exhibit 2059
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`. (Ex.2048, ¶¶98-104; Ex.2049, ¶¶95, 97-102). Exhibit 2059 should
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`be excluded under FRE 901 (discussed above), FRE 402, and FRE 802. Petitioner
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`submitted written objections to this exhibit at Paper 40.
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`FRE 402. Exhibit 2059, a non-public, internal, technical report, does not
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`demonstrate the POSA’s knowledge or a prior art teaching, and thus should be
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`excluded as irrelevant non-prior art under FRE 402. PO also fails to cite Exhibit
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`2059 in its Preliminary Response (POPR), Response (POR), or Sur-Reply (Papers
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`10, 39, 68), demonstrating that it does not have a tendency to make any fact of
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`consequence more or less probable and thus, it is inadmissible. FRE 401-402; SK
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`Innovation Co. v. Celgard, LLC, IPR2014-00679, Paper 58, 49 (P.T.A.B. Sept. 25,
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`2015) (“Because [PO] did not cite Exhibits 2013 and 2016 in this proceeding, we
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`grant Petitioner’s Motion to Exclude Exhibits 2013 and 2016.”). Additionally, PO’s
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`expert (Dr. Klibanov)
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` (Ex.2049, ¶¶95, 97-102), which has no
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`4
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`relevance to any contested issue in this proceeding.
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` FRE 801-802. Exhibit 2059 should be excluded as inadmissible hearsay
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`because it includes out-of-court statements of PO in-house personnel, offered for the
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`truth of the matters asserted therein, i.e.,
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` (See Ex.2048, ¶¶98-104; Ex.2049, ¶¶95, 97-102). If an exception
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`does not apply, the rule against hearsay prohibits out-of-court statements from being
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`offered to prove the truth of the matter asserted. FRE 801-03; see also Ingenico Inc.
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`v. IOENGINE, LLC, IPR2019-00929, Paper 53, 99-101 (P.T.A.B. Sept. 21, 2020)
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`(granting motion to exclude exhibit as inadmissible hearsay).
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`B.
`Ex.2060: VGFT-OD-0605 Analysis Summary [CONFIDENTIAL].
`Exhibit 2060, a confidential (filed under seal), non-public excerpt, should be
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`excluded under FRE 901, FRE 402, FRE 403, and FRE 802. PO’s expert (Dr. Del
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`Priore) offers Exhibit 2060
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`. (Ex.2048, ¶107). Petitioner timely
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`submitted written objections to Exhibit 2060 at Paper 40.
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`FRE 901. PO’s declarant, Ms. Weber, could not authenticate Exhibit 2060.
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`PO’s expert, Dr. Del Priore, confirmed the lack of authenticity, testifying that
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`Exhibit 2060 fails to identify which clinical trial the data come from. (Ex.1111,
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`175:15-176:5). Dr. Del Priore also testified that he “[did not] know the source of
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`the document” and refused to answer questions relating to Exhibit 2060 due to his
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`5
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`lack of personal knowledge. (Id., 175:13-14; see also id., 174:8-190:2). Since PO
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`failed to submit proper evidence to authenticate this document, Exhibit 2060 must
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`be excluded. FRE 901(a); Riverbed, IPR2016-00978, Paper 67, 39-41; TRW,
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`IPR2014-01348, Paper 25, 5-12.
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`FRE 402-403. Exhibit 2060, an excerpted portion of a confidential, non-
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`public VIEW clinical trial protocol that PO never produced, should be excluded as
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`irrelevant non-prior art under FRE 402 and unfairly prejudicial under FRE 403. PO
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`does not cite Exhibit 2060 in its POPR, POR, or Sur-Reply, and thus it lacks
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`relevance and should be excluded. See Papers 10, 39, 68. PO’s failure to cite Exhibit
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`2060 demonstrates that this exhibit does not have a tendency to make any fact of
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`consequence more or less probable; thus, this evidence is inadmissible as irrelevant.
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`See FRE 402 (“Irrelevant evidence is not admissible.”). PO’s sealed filing of Exhibit
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`2060 confirms it was not publicly available and thus does not demonstrate the
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`POSA’s knowledge or a prior art teaching. In addition, any probative value is
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`substantially outweighed by the dangers of unfair prejudice, confusion, and
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`misleading the factfinder. Allowing PO to cherry-pick a portion of a document
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`denies the factfinder a complete set of materials to judge the accuracy of its claim.
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`FRE 802. PO’s expert (Dr. Del Priore) cites Exhibit 2060 to prove the truth
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`6
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`. (Ex.2048, ¶107). Hence, Exhibit 2060 satisfies the “hearsay”
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`definition under FRE 801(c), (d), thus warranting exclusion. FRE 802; Ingenico,
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`IPR2019-00929, Paper 53, 99-101.
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`C. Ex.2073: Zaltrap Non-Comparability Issue [CONFIDENTIAL].
`Exhibit 2073 is a confidential (filed under seal), non-public document
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`purporting to be a
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` that should be excluded under FRE
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`901 and FRE 402. PO’s expert (Dr. Klibanov) offers Exhibit 2073
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`.
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`(Ex.2049, ¶94). Petitioner timely objected to Exhibit 2073 at Paper 40.
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`FRE 901. Ms. Weber’s declaration fails to authenticate Exhibit 2073. PO’s
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`expert, Dr. Klibanov, was also unable to authenticate Exhibit 2073. At deposition,
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`Dr. Klibanov could not answer foundational questions about Exhibit 2073, e.g.,
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` Dr. Klibanov
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`admitted
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`7
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`. PO has produced no credible
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`evidence to support a finding that Exhibit 2073 is in fact what its expert claims it
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`is—i.e.,
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`. (Ex.2049, ¶94).
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`FRE 402. PO does not cite Exhibit 2073 in its POPR, POR, or Sur-Reply
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`(Papers 10, 39, 68); thus, it is not relevant to any contested issue in this proceeding.
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`FRE 402; SK Innovation, IPR2014-00679, Paper 58, 49. Plus, Exhibit 2073 is dated
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`March 14, 2014, and PO filed it under seal—as such, Exhibit 2073 was not publicly
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`available prior art. See Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560,
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`1568-69 (Fed. Cir. 1988). Thus, Exhibit 2073 lacks any probative value or relevance.
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`D. Ex.2128: VIEW Signature Page Compilation [CONFIDENTIAL].
`Exhibit 2128, a confidential (filed under seal), non-public compilation of the
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`VIEW protocol signature pages, should be excluded under FRE 901, FRE 402, FRE
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`403, and FRE 802. PO and its expert, Dr. Brown, cite Exhibit 2128 to allege
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`information regarding VEGF Trap-Eye was not in the public domain. (Paper 39,
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`POR, 10 n.6, Ex.2050, ¶71). Petitioner timely objected to this exhibit. (Paper 40).
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`FRE 901. Exhibit 2128 warrants exclusion because no witness with personal
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`knowledge has authenticated it. Nor is there evidence that it is an accurate
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`compilation of excerpts as they existed at the time of creation or regarding the
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`8
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`maintenance of the documents in the 13-15 years since their alleged creation. FRE
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`901(a); Riverbed, IPR2016-00978, Paper 67, 39-41; TRW, IPR2014-01348, Paper
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`25, 5-12. Nor does Exhibit 2128 satisfy any of the categories of self-authenticating
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`documents under FRE 902.
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`FRE 402-403. PO’s sealed filing of Exhibit 2128 confirms it was not publicly
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`available. Accordingly, Exhibit 2128 does not (and cannot) represent the POSA’s
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`knowledge or a prior art teaching. Any probative value is substantially outweighed
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`by the dangers of unfair prejudice, confusion, and misleading the factfinder.
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`Allowing PO to introduce and rely upon hand-picked excerpts of the non-public,
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`unproduced VIEW protocols denies the factfinder here a complete set of materials
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`to judge the accuracy of its claim.
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`FRE 802. Exhibit 2128 is inadmissible hearsay. FRE 802; Ingenico, IPR2019-
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`00929, Paper 53, 99-101. The papers are out-of-court statements offered for the truth
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`of matter asserted, i.e., the alleged confidentiality restrictions in place as of July 2007
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`regarding VEGF Trap-Eye.
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`III. Ex.2096: Clinical Study Agreement [CONFIDENTIAL].
`Exhibit 2096, a confidential (filed under seal), non-public document purported
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`to be a clinical study agreement between Vitreoretinal Consultants and Regeneron
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`Pharmaceuticals, Inc., should be excluded under FRE 901 and FRE 802. PO and its
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`expert (Dr. Brown) rely on Exhibit 2096 at Paper 39, POR (page 10, footnote 6);
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`9
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`
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`Paper 68, Sur-Reply (page 10); and Ex.2050 (¶71) to show that VEGF Trap-Eye was
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`not in the public domain. Petitioner timely objected to this exhibit at Paper 40.
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`FRE 901. Dr. Brown, at deposition, conceded he did not sign the Exhibit 2096
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`agreement, nor could he answer foundational questions about it. (See Ex.1110,
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`59:23-62:17). Exhibit 2096 must be excluded as unauthenticated. FRE 901(a);
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`Riverbed, IPR2016-00978, Paper 67, 39-41; TRW, IPR2014-01348, Paper 25, 5-12.
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`FRE 802. Exhibit 2096 should also be excluded as inadmissible hearsay. PO
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`relies on Exhibit 2096 to allege the truth of the matter asserted therein—i.e., the
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`purported restricted disclosure of information regarding VEGF Trap-Eye. See Paper
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`39, POR, 9-10 & n.6; Paper 68, Sur-Reply, 10; Ex.2050, ¶71. Exhibit 2096 thus
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`qualifies as “hearsay” under FRE 801(c), (d), and should be excluded. See FRE 801-
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`03; see also Ingenico, IPR2019-00929, Paper 53, 99-101.
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`IV. Portions of Exs.2048-2050: Corresponding Expert Opinions.
`PO’s expert declaration testimony corresponding to the Challenged Exhibits
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`should also be excluded. “Rule 703 does not authorize admitting inadmissible
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`evidence ‘on the pretense that it is the basis for expert opinion when, in fact, the
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`expert adds nothing to the [inadmissible evidence] other than transmitting [it] to the
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`[fact finder].’” Wi-LAN Inc. v. Sharp Elecs. Corp., 992 F.3d 1366, 1374 (Fed. Cir.
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`2021) (first and second alterations in original). Here, PO has put forth no evidence
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`that any of the Challenged Exhibits are documents upon which a POSA would
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`10
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`“reasonably rely” in forming an opinion on the subject matter at issue, thus
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`warranting exclusion of the declarations of Drs. Del Priore (Ex.2048, ¶¶98-104,
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`107), Klibanov (Ex.2049, ¶¶94-95, 97-105), and Brown (Ex.2050, ¶71).
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`V. Conclusion.
`For the reasons stated above, Petitioner respectfully requests that the Board
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`exclude Exhibits 2059-60, 2073, 2096, and 2128 in their entirety, as well as portions
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`of Exhibit 2048 (¶¶98-104, 107), Exhibit 2049 (¶¶94-95, 97-105), and Exhibit 2050
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`(¶71).
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`Dated: July 20, 2022
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`Respectfully Submitted,
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`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`
`/Paul J. Molino/
`Paul J. Molino
`Registration No. 45,350
`6 West Hubbard Street
`Chicago, IL 60654
`Telephone:
`(312) 222-6300
`Facsimile:
`(312) 843-6260
`paul@rmmslegal.com
`
`
`Counsel for Petitioner
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`11
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a true and correct copy of the foregoing
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`Petitioner’s Motion to Exclude Evidence was served on July 20, 2022, via electronic
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`mail by agreement of the parties, to the following counsel for record of Patent
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`Owners:
`
`Alice S. Ho (Lim. Rec. No. L1162)
`Victoria Reines
`Jeremy Cobb
`Arnold & Porter Kaye Scholer LLP
`601 Massachusetts Ave., N.W.
`Washington D.C. 20001
`Tel: 202.942.5000
`Fax: 202.942.5999
`Alice.Ho@arnoldporter.com
`Victoria.Reines@arnoldporter.com
`Jeremy.Cobb@arnoldporter.com
`
`
`Deborah E. Fishman (Reg. No. 48,621)
`David A. Caine (Reg. No. 52,683)
`Arnold & Porter Kaye Scholer LLP
`3000 El Camino Real
`Five Palo Alto Square, Suite 500
`Palo Alto, California 94306-3807
`Telephone: 650.319.4519
`Telephone: 650.319.4710
`Facsimile: 650.319.4573
`Deborah.Fishman@arnoldporter.com
`David.Caine@arnoldporter.com
`RegeneronEyleaIPRs@arnoldporter.com
`
`Daniel Reisner
`Matthew M. Wilk
`Arnold & Porter Kaye Scholer LLP
`250 West 55th Street
`New York, New York 10019-9710
`Telephone: 212.836.8000
`Fax: 212.836.8689
`Daniel.Reisner@arnoldporter.com
`Matthew.Wilk@arnoldporter.com
`
`
`
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`
`
`/Paul J. Molino/
` Paul J. Molino (Reg. No. 45,350)
`
`
`
`
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