`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN PHARMACEUTICALS INC., CELLTRION, INC., and
`APOTEX, INC.,
`Petitioners,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`
`
`Inter Partes Review No.: IPR2021-008811
`
`
`U.S. Patent No. 9,254,338 B2
`Filed: July 12, 2013
`Issued: February 9, 2016
`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)
`
`
`
`1 IPR2022-00258 and IPR2022-00298 have been joined with this proceeding.
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`I.
`II.
`
`V.
`
`C.
`D.
`
`Introduction. ..................................................................................................... 1
`Exhibits Referenced in the Weber Declaration (Ex.2286). ............................. 1
`A.
`Ex.2059: PO Sample Analysis Report [CONFIDENTIAL]. ................ 3
`B.
`Ex.2060: VGFT-OD-0605 Analysis Summary
`[CONFIDENTIAL]. .............................................................................. 4
`Ex.2073: Zaltrap Non-Comparability Issue [CONFIDENTIAL]. ........ 6
`Ex.2128: VIEW Signature Page Compilation
`[CONFIDENTIAL]. .............................................................................. 7
`III. Ex.2096: Clinical Study Agreement [CONFIDENTIAL]. .............................. 8
`IV. Exs.2169-70, 2279-85, and Portions of Ex.2052 (¶¶11, 28-29, 50-55,
`60-61, 63-69, 72, 74-75, 108-09, 113-16 and Attachments C1-C12,
`D1-D4, D7, and X2): Financial Documents [CONFIDENTIAL]. .................. 9
`Exs.2136-40, 2163, 2190, 2197, 2208, 2277-78, and Portions of
`Ex.2052 (¶¶88-94): Marketing Materials [CONFIDENTIAL]. .................... 13
`VI. Ex.2052 (¶¶48-117): Lack of Nexus Evidence. ............................................ 14
`VII. Portions of Exs.2048-50, 2052: Corresponding Expert Opinions. ................ 15
`VIII. Conclusion. .................................................................................................... 15
`
`
`
`
`
`i
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`
`
`TABLE OF AUTHORITIES
`
`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) .............................................................................. 7
`Ingenico Inc. v. IOENGINE, LLC,
`IPR2019-00929, Paper 53 (P.T.A.B. Sept. 21, 2020) ............................... 4, 6, 8, 9
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 33 (P.T.A.B. Jan. 24, 2020) ............................................ 14
`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
`Peat, Inc. v. Vanguard Rsch., Inc.,
`378 F.3d 1154 (11th Cir. 2004) ............................................................................ 11
`Riverbed Tech., Inc v. Reatime Data LLC,
`IPR2016-00978, Paper 67 (P.T.A.B. Oct. 30, 2017)................................. 2, 5, 8, 9
`SK Innovation Co. v. Celgard, LLC,
`IPR2014-00679, Paper 58 (P.T.A.B. Sept. 25, 2015..................................... 4, 7, 8
`TRW Auto. U.S. LLC v. Magna Elecs.,
`IPR2014-01348, Paper 25 (P.T.A.B. Jan. 15, 2016) ................................. 2, 5, 8, 9
`United States v. Kim,
`595 F.2d 755 (D.C. Cir. 1979) ............................................................................. 11
`Wi-LAN Inc. v. Sharp Elecs. Corp.,
`992 F.3d 1366 (Fed. Cir. 2021) ............................................................................ 15
`
`
`
`
`ii
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`
`
`
`
`
`
`Federal Regulations
`
`37 C.F.R. § 42.62 ....................................................................................................... 1
`37 C.F.R. § 42.64 ....................................................................................................... 1
`
`
`
`
`
`
`iii
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`I.
`
`Introduction.
`
`
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`Mylan Pharmaceuticals Inc. (“Petitioner”), in accordance with 37 C.F.R. §§
`
`42.62 and 42.64(c), moves to exclude Patent Owner (“PO”) Exhibits 2059-60, 2073,
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`2096, 2128, 2133-40, 2163, 2169-70, 2176, 2190, 2197, 2200, 2205, 2208, 2218,
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`2229, 2272-85, 2243-44, 2250, 2259, and the below-identified portions of Exhibits
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`2048-50 and 2052 (collectively, the “Challenged Exhibits”). Petitioner timely
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`objected to these exhibits through written objections (Paper 43) 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 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. 31, 2016). The
`
`Federal Rules of Evidence (FRE) generally applies to IPR proceedings. 37 C.F.R. §
`
`42.62; LKQ Corp. v. Clearlamp, LLC, IPR2013-00020, Paper 17, 3 (P.T.A.B. Mar.
`
`5, 2013). The moving party bears the burden of proof to establish that it is entitled
`
`to the relief requested—namely, that the material to be excluded is inadmissible
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`under the FRE. See Microsoft Corp. v. FG SRC LLC, IPR2018-0605, Paper 72, 11
`
`(P.T.A.B. Apr. 9, 2020).
`
`II. Exhibits Referenced in the Weber Declaration (Ex.2286).
`
`In response to Petitioner’s objections (Paper 43), PO served the 7-page
`
`declaration of Doris Weber (Ex.2286), PO’s senior litigation support specialist,
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`1
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`
`
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`attempting to cure the authentication deficiencies of 40 exhibits. Ms. Weber offers
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`
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`the following exhibits as “true and correct” copies of what each purports to be:
`
`Exhibits 2059-60, 2073, 2128, 2133-40, 2163, 2169-70, 2176, 2197, 2200, 2205,
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`2208, 2218, 2229, 2272-85, 2243-44, 2250, 2259 (the “Weber Exhibits”).
`
`Yet, Ms. Weber is not a custodian of these exhibits, and has no personal
`
`knowledge of the creation, authorship, maintenance, or modification of any of the
`
`exhibits or the underlying documents from which they were prepared. Thus, Ms.
`
`Weber’s declaration does not (and cannot) “satisfy the requirement of authenticating
`
`or identifying an item of evidence.” FRE 901(a); id. (“[T]he proponent must produce
`
`evidence sufficient to support a finding that the item is what the proponent claims it
`
`is.”); Riverbed Tech., Inc v. Reatime Data LLC, IPR2016-00978, Paper 67, 39-41
`
`(P.T.A.B. Oct. 30, 2017) (excluding exhibit as unauthenticated under FRE 901, as
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`well as portions of evidence relying expressly on said exhibit); TRW Auto. U.S. LLC
`
`v. Magna Elecs., IPR2014-01348, Paper 25, 5-12 (P.T.A.B. Jan. 15, 2016).
`
`Ms. Weber’s deposition testimony confirmed the authentication deficiencies.
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`For example, Ms. Weber testified she has no personal knowledge regarding the
`
`documents in her declaration, and the only action she took to authenticate the
`
`exhibits was review them with counsel. (Ex.1150, 128:8-131:23). She was also
`
`unable to answer basic foundational questions, including where each exhibit came
`
`from, how it was prepared, who prepared it, or how it was stored and maintained
`
`2
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`
`
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`within PO’s files. (See id.). The Board cannot fairly or reliably consider any of the
`
`
`
`Weber Exhibits given the complete lack of authenticating evidence—from PO, its
`
`witnesses, and the documents themselves.
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`None of the Weber Exhibits are self-authenticating under FRE 902—
`
`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’
`
`admissibility. In addition, PO submitted Exs.2060, 2128, 2169-70, 2229, 2273, 2285
`
`as incomplete and/or excerpted versions of unproduced, supposedly confidential
`
`originals, casting further doubt on their authenticity and reliability. As such, the
`
`Weber Exhibits should be excluded as unauthenticated under FRE 901.
`
`Exhibits 2059-60, 2073, and 2128 also warrant exclusion for the following:
`
`A. Ex.2059: PO Sample Analysis Report [CONFIDENTIAL].
`Exhibit 2059, a confidential (filed under seal), non-public technical report,
`
`should be excluded under FRE 901 (discussed above), FRE 402, and FRE 802. PO’s
`
`experts, Drs. Klibanov and Del Priore, offer Exhibit 2059
`
`
`
`. (Ex.2049, ¶¶95, 97-102; Ex.2048, ¶¶98-
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`3
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`
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`104). Petitioner submitted written objections to this exhibit at Paper 43.
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`
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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
`
`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 10, 40, 73), demonstrating that it does not have a tendency to make any fact
`
`of consequence more or less probable and thus, it is inadmissible. FRE 401-402; SK
`
`Innovation Co. v. Celgard, LLC, IPR2014-00679, Paper 58, 49 (P.T.A.B. Sept. 25,
`
`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.”).
`
`
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`FRE 801-802. Exhibit 2059 should be excluded as inadmissible hearsay
`
`because it includes out-of-court statements of PO in-house personnel, offered for the
`
`truth of the matters asserted therein, i.e.,
`
`
`
` (See Ex.2049, ¶¶95, 97-102; Ex.2048, ¶¶98-104); FRE 801-03;
`
`see also Ingenico Inc. v. IOENGINE, LLC, IPR2019-00929, Paper 53, 99-101
`
`(P.T.A.B. Sept. 21, 2020) (excluding exhibit as inadmissible hearsay).
`
`B.
`Ex.2060: VGFT-OD-0605 Analysis Summary [CONFIDENTIAL].
`Exhibit 2060, a confidential (filed under seal), non-public excerpt, should be
`
`excluded under FRE 901, FRE 402, FRE 403, and FRE 802. PO and its expert (Dr.
`
`Del Priore) offer Exhibit 2060
`
`
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`4
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`. (See POR, 45; Ex.2048, ¶107).
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`Petitioner timely submitted written objections at Paper 43.
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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,
`
`175:15-176:5), and that he “[did not] know the source of the document,” (id.,
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`175:13-14; see also id., 174:8-190:2 (refusing to answer questions relating to
`
`Ex.2060 due to lack of personal knowledge)). Since PO failed to submit proper
`
`evidence to authenticate this document, Exhibit 2060 must be excluded. FRE 901(a);
`
`Riverbed, IPR2016-00978, Paper 67, 39-41; TRW, IPR2014-01348, Paper 25, 5-12.
`
`FRE 402-403. Exhibit 2060, an excerpted portion of a confidential, non-
`
`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’s
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`sealed filing of Exhibit 2060 confirms it was not publicly available and thus does
`
`not demonstrate the POSA’s knowledge or a prior art teaching. Any probative value
`
`is substantially outweighed by the dangers of unfair prejudice, confusion, and
`
`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.
`
`FRE 802. PO and its expert (Del Priore) cite Exhibit 2060 to assert as true the
`
`
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`5
`
`
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`
`
`
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`. Hence, Exhibit 2060 satisfies
`
`the “hearsay” definition under FRE 801(c), (d), thus warranting exclusion. FRE 802;
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`Ingenico, IPR2019-00929, Paper 53, 99-101.
`
`C. Ex.2073: Zaltrap Non-Comparability Issue [CONFIDENTIAL].
`
`Exhibit 2073 is a confidential (filed under seal), non-public document
`
`purporting to be a
`
` that should be excluded under FRE
`
`901 and FRE 402. PO’s expert (Dr. Klibanov) offers Exhibit 2073
`
`
`
`.
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`(Ex.2049, ¶94). Petitioner timely objected to Exhibit 2073 at Paper 43.
`
`FRE 901. PO’s declarant, Ms. Weber, could not authenticate Exhibit 2073.
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`Nor could PO’s expert, Dr. Klibanov, who at deposition lacked knowledge on
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`critical foundational questions about Exhibit 2073, e.g.,
`
`. Dr. Klibanov admitted
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`6
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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
`
`is—i.e.,
`
`
`
`. (Ex.2049, ¶94).
`
`FRE 402. PO does not cite Exhibit 2073 in its POPR, POR, or Sur-Reply;
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`thus, it is not relevant to any contested issue in this proceeding. FRE 402; SK
`
`Innovation, IPR2014-00679, Paper 58, 49. Plus, Exhibit 2073 is dated March 14,
`
`2014, and PO filed it under seal—as such, Exhibit 2073 was not publicly available
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`prior art. See Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1568-69
`
`(Fed. Cir. 1988). Thus, Exhibit 2073 lacks any probative value or relevance.
`
`D. Ex.2128: VIEW Signature Page Compilation [CONFIDENTIAL].
`Exhibit 2128, a confidential (filed under seal), non-public compilation of the
`
`VIEW protocol signature pages, should be excluded under FRE 901, FRE 402, FRE
`
`403, and FRE 802. PO’s expert, Dr. Brown, cites Exhibit 2128 to allege information
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`regarding VEGF Trap-Eye was not in the public domain. (Ex.2050, ¶71). Petitioner
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`timely objected at Paper 43.
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`FRE 901. Exhibit 2128 warrants exclusion because no witness with personal
`
`knowledge has authenticated it. Nor is there evidence that it is an accurate
`
`compilation of excerpts as they existed at the time of creation or regarding the
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`maintenance of the documents in the 13-15 years since their alleged creation. FRE
`
`7
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`
`
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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
`
`documents under FRE 902.
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`FRE 402-403. PO’s sealed filing of Exhibit 2128 confirms it was not publicly
`
`available. Accordingly, Exhibit 2128 does not represent the POSA’s knowledge or
`
`a prior art teaching. PO also fails to cite Exhibit 2128 in its POPR, POR, or Sur-
`
`Reply—i.e., Exhibit 2128 does not have a tendency to make any fact or consequence
`
`more or less probable. FRE 402; SK Innovation, IPR2014-00679, Paper 58, 49. Any
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`probative value is substantially outweighed by the dangers of unfair prejudice,
`
`confusion, and misleading the factfinder. Allowing PO to introduce and rely upon
`
`hand-picked excerpts of the non-public, unproduced VIEW protocols denies the
`
`factfinder here a complete set of materials to judge the accuracy of its claim.
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`FRE 802. Exhibit 2128 is inadmissible hearsay. FRE 802; Ingenico, IPR2019-
`
`00929, Paper 53, 99-101. The papers are out-of-court statements offered for the truth
`
`of matter asserted, i.e., the alleged confidentiality restrictions in place as of July 2007
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`regarding VEGF Trap-Eye.
`
`III. Ex.2096: Clinical Study Agreement [CONFIDENTIAL].
`Exhibit 2096, a confidential (filed under seal), non-public document purported
`
`to be a clinical study agreement between Vitreoretinal Consultants and Regeneron
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`Pharmaceuticals, Inc., should be excluded under FRE 901 and 802. PO and its expert
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`8
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`
`
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`(Dr. Brown) use Exhibit 2096 to show VEGF Trap was not in the public domain.
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`
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`(Sur-Reply, 18-19; Ex.2050, ¶71). Petitioner timely objected. (Paper 43).
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`FRE 901. Dr. Brown, at deposition, conceded he did not sign the Exhibit 2096
`
`agreement, nor could he answer foundational questions about it. (See Ex.1110,
`
`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. PO relies on Exhibit 2096 to allege the truth of the matter asserted
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`therein—i.e., the purported restricted disclosure of information regarding VEGF
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`Trap-Eye. (Sur-Reply, 18-19). Exhibit 2096 thus qualifies as “hearsay” under FRE
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`801, and should be excluded. See Ingenico, IPR2019-00929, Paper 53, 99-101.
`
`IV. Exs.2169-70, 2279-85, and Portions of Ex.2052 (¶¶11, 28-29, 50-55, 60-61,
`63-69, 72, 74-75, 108-09, 113-16 and Attachments C1-C12, D1-D4, D7,
`and X2): Financial Documents [CONFIDENTIAL].
`PO’s commercial success contentions rely on its expert, Dr. Manning. (POR,
`
`54, 61-62; Sur-Reply, 36-37). Dr. Manning in turn relies on various documents
`
`purporting to reflect profit and loss statements for PO’s product: Exs.2169-70, 2279-
`
`85, and Ex.2052 at Attachments C1-C12, D1-D4, D7, and X2 (collectively, the
`
`“Financial Exhibits”). The challenged Financial Exhibits constitute unauthenticated
`
`hearsay evidence not subject to any exception, and thus should be excluded. FRE
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`801-03, 901, 1006. Relatedly, exclusion is also warranted for the portions of Dr.
`
`Manning’s declaration relying on this evidence, i.e., Ex.2052, ¶¶11, 28-29, 50-55,
`
`9
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`
`
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`60-61, 63-69, 72, 74-75, 108-09, 113-16). Petitioner timely objected to the
`
`
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`challenged Financial Exhibits. (Paper 43; see also Ex.1151, 285:9-286:4).
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`FRE 1006. PO refused to produce the underlying business records from
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`whence Manning’s numbers allegedly came. (See Ex.1116, 35:16-41:18); see also
`
`FRE 1006 (if a proponent seeks to use summaries to prove a point, the
`
`proponent “must make the originals or duplicates available for examination or
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`copying” to the other party). That alone warrants exclusion.
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`FRE 901. The challenged Financial Exhibits warrant exclusion because no
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`witness with personal knowledge has properly authenticated them. PO has not shown
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`the Exhibits’ presented numbers, whether a sales figure, profit figure, loss figure,
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`expense, etc., match to the original record. Nor would PO identify the people
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`involved in compiling the Exhibits’ numbers—to the contrary, PO and its expert
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`went out of their way to hide the names of their in-house individuals involved. (See
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`Ex.2052, ¶¶11, 28, 53, 55, 60-61, 68, 108, 113-14). That warrants exclusion. FRE
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`901(b)(8) (a data compilation must be in a condition “that creates no suspicion about
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`its authenticity”). The authenticity of the numbers is also undermined because
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`known expenses are not properly accounted for, as seen below.
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`FRE 801, 803. Dr. Manning’s commercial success opinions hinge on the truth
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`of the financial numbers. Thus, the exhibits containing them are hearsay. To render
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`them admissible, they must qualify as a FRE 803(6) “business record.” See FRE
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`10
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`
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`803(6) (business record exception requires that “the record was kept in the course of
`
`
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`a regularly conducted activity of a business”). At least Exhibits 2169-70, 2285, and
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`Manning Attachments D1-D4 and D7 (Ex.2052, pages 171-76, 179) are not original,
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`but prepared for these proceedings. (See, e.g., Ex.1151, 15:18-17:11).2 An exhibit is
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`not admissible using the FRE 803(6) business records exception if it was “prepared
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`during, and for use in, litigation.” Peat, Inc. v. Vanguard Rsch., Inc., 378 F.3d 1154,
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`1161 (11th Cir. 2004).
`
`Further, the rationale for exempting business records from the hearsay
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`prohibition is that “[b]usiness records are presumed to be trustworthy because they
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`are made in the ordinary course of business, and because a business that relies on its
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`records will ensure that those records are accurate. United States v. Kim, 595 F.2d
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`755, 765 (D.C. Cir. 1979). Dr. Manning’s deposition testimony confirmed the
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`numbers presented are not trustworthy. To illustrate, Dr. Manning could not identify
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`whether kickback or rebate dollars described in USDOJ proceedings against PO for
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`this product properly were accounted for in a cost of goods sold line item, in a rebate
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`line item, or, indeed, anywhere at all in the challenged Financial Exhibits’ presented
`
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`2 Petitioner has not been able to determine whether the other challenged Financial
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`Documents (i.e., Exs.2279-84 and Manning Attachments C1-C12 and X2) were
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`created in the ordinary course of business.
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`11
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`
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`profits/loss numbers. (Ex.1151, 173:5-13 (could not say whether any Good Days
`
`
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`organization payments “would end up on the P&L”); 178:22-183:7; 183:14-184:11
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`(Q: “[D]o you have any idea where that – whether that 35 million, if true, would be
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`captured in the Eylea profit and loss data?” A: “…I do not know how that would be
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`characterized in their accounts and I do not know where it would be, if it was there.
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`I don’t even know that.”); 199:4-200:19). For this reason, Exhibits 2169-70, 2285,
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`and Attachments D1-D4 and D7 to Exhibit 2052 should be excluded.
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`FRE 702. In support of his commercial success opinions, Dr. Manning
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`declared that “[he was] informed by interviews with” unnamed PO directors.
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`(Ex.2052, ¶11; id. ¶¶28, 53, 55, 60-61, 68, 108, 113-14). At deposition, however, he
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`testified he had no notes or recordings from those interviews, could not identify their
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`names nor recall any specifics from those conversations, was unable to confirm the
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`accuracy of the information he received, and did not cite any of these individuals as
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`sources of information in his declaration. (Ex.1151, 17:20-30:6, 175:17-19, 177:25-
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`178:3, 241:14-18). He also admitted that he took no efforts to validate the accuracy
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`of the information he received. (Id., 19:19-20:17, 28:16-29:1). Thus, Dr. Manning’s
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`opinions are unreliable under FRE 702, and the portions of his declaration citing to
`
`those undisclosed interviews (i.e., Ex.2052, ¶¶11, 28, 53, 55, 60-61, 68, 108, 113-
`
`14) should be excluded under FRE 702.
`
`
`
`12
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`
`
`V. Exs.2136-40, 2163, 2190, 2197, 2208, 2277-78, and Portions of Ex.2052
`(¶¶88-94): Marketing Materials [CONFIDENTIAL].
`PO asserts that Eylea’s patented dosing regimen is one of the main drivers of
`
`
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`its commercial success, as evidenced by its marketing messages. (POR, 61-62; Sur-
`
`Reply, 35; Exs.2136-40, 2163, 2190, 2197, 2208, 2277-78). Exhibits 2136-40, 2163,
`
`2190, 2197, 2208, and 2277-78 (collectively, the “Marketing Exhibits”) are
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`documents purporting to be PO’s supportive internal marketing materials and ATU
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`survey data. Petitioner timely objected to these exhibits. (Paper 43; see also Ex.1151,
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`285:9-286:4).
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`The Board should exclude the challenged Marketing Exhibits (and Dr.
`
`Manning’s corresponding opinions, see Ex.2052, ¶¶88-94) under FRE 403 because
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`their probative value is substantially outweighed by the dangers of unfair prejudice,
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`confusion, and misleading the factfinder. PO insists its multi-billion-dollar market
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`spend did not influence sales independent of the patent since its marketing messages
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`involved the patented indication. (Sur-Reply, 35). Dr. Manning parrots this theory
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`by citing to a few cherry-picked marketing pieces. (Ex.2052, ¶94). But Dr. Manning
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`testified that PO sent him an electronic file of many more marketing materials.
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`(Ex.1151, 35:18-37:19; see Ex.1116, 30:15-19 (“those materials were a subset of
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`information that was provided” to Dr. Manning)). PO refused to produce the entire
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`marketing file. (Ex.1116, 30:5-23, 35:17:39:4). Petitioner confirmed that PO’s
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`marketing messages did not all involve the patented indication. (Ex.2289, 345:16-
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`13
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`347:11). Since PO has denied the factfinder a complete set of marketing materials to
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`judge the accuracy of its claim, the challenged Marketing Exhibits, and the
`
`corresponding expert opinions (Ex.2052, ¶¶88-94), should be excluded.
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`VI. Ex.2052 (¶¶48-117): Lack of Nexus Evidence.
`PO relies on Dr. Manning’s opinions to argue “EYLEA has enjoyed
`
`tremendous commercial success since launch” and “Regeneron’s U.S. sales of
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`EYLEA, as well as EYLEA’s share of sales relative to other anti-VEGF treatments,
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`have grown significantly since launch.” (POR, 61-62 (citing Ex.2052, ¶¶48-132)).
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`To be relevant, PO must establish a nexus between the alleged secondary
`
`considerations and the merits of the claimed invention. Lectrosonics, Inc. v. Zaxcom,
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`Inc., IPR2018-01129, Paper 33, 32 (P.T.A.B. Jan. 24, 2020) (precedential). PO’s
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`failure to do so here warrants exclusion under FRE 401-402.
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`The nexus-related deficiencies are confirmed by Dr. Manning’s deposition
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`testimony, where he acknowledged that his opinions were based on Eylea generally,
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`rather than the claimed regimen. (Ex.1151, 128:3-13 (“My analysis was of the entire
`
`sales of the product…I did not apportion the sales…”)). Dr. Manning conceded he
`
`did not apportion sales numbers so they properly reflected the data for the claimed
`
`dosing regimen. (Id., 35:1-17, 39:11-43:23, 47:9-24, 77:17-78:2, 89:7-16, 98:5-16,
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`126:15-128:13). Nor did he differentiate between any sales growth or market share
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`driven by properties of the molecule (e.g., efficacy or half-life), as opposed to dosing
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`14
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`
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`schedule. (Id., 103:3-107:16, 125:8-126:4, 238:14-24). As such, the commercial
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`
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`success opinions set forth in Exhibit 2052 (¶¶48-117) should be excluded.
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`VII. Portions of Exs.2048-50, 2052: 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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`“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), Brown (Ex.2050, ¶71), and Manning
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`(Ex.2052, ¶¶11, 28-29, 48-117).
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`VIII. Conclusion.
`Petitioner requests that the Board exclude Exhibits 2052, 2059-60, 2073,
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`2096, 2128, 2133-40, 2163, 2169-70, 2176, 2197, 2200, 2205, 2208, 2218, 2229,
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`2272-85, 2243-44, 2250, 2259 in their entirety, as well as portions of Exhibit 2048
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`(¶¶98-104, 107), Exhibit 2049 (¶¶94-95, 97-105), Exhibit 2050 (¶71), and Exhibit
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`2052 (¶¶11, 28-29, 48-117; Attachments C1-C12, D1-D4, D7, and X2).
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`15
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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
`
`16
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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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`Owner:
`
`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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