`
`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.: IPR2021-008801
`
`
`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
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`
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`
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`PETITIONER’S OPPOSITION TO PATENT OWNER’S
`MOTION TO EXCLUDE EVIDENCE
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`1 IPR2022-00257 and IPR2022-00301 have been joined with this proceeding.
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`
`
`I.
`II.
`III.
`
`TABLE OF CONTENTS
`INTRODUCTION. .......................................................................................... 1
`LEGAL STANDARD. .................................................................................... 1
`PO’S MOTION IS PROCEDURALLY DEFICIENT. ................................... 1
`A.
`PO Has Not Made Timely Objections to Evidence. ............................. 1
`B.
`PO’s Motion Is an Unauthorized (and Previously-Denied)
`Motion To Strike. .................................................................................. 4
`IV. PETITIONER’S REPLY PROPERLY RESPONDS TO PO’S
`RESPONSE ARGUMENTS. .......................................................................... 6
`A. VEGF Trap-Eye Was Publicly Distributed. .......................................... 7
`B.
`Ground 4 Anticipation Argument. ........................................................ 8
`C.
`Ground 5 Obviousness Arguments. ...................................................... 9
`PO HAS NOT MADE A SUFFICIENT CASE FOR EXCLUSION
`OF UNCITED EXHIBITS AND EXPERT TESTIMONY. ......................... 12
`VI. CONCLUSION. ............................................................................................. 14
`
`
`
`V.
`
`i
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`
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`ABB Inc. v. Roy-G-Biv Corp.,
`IPR2013-00062 (P.T.A.B. Apr. 11, 2014) .................................................. 3, 5, 11
`Aisin Seiki Co. v. Intell. Ventures II LLC,
`IPR2017-01539 (P.T.A.B. Dec. 12, 2018) .........................................................6, 9
`Apple Inc. v. Achates Reference Publ’g, Inc.,
`IPR2013-00080 (P.T.A.B. June 2, 2014) ............................................................... 2
`Apple v. Andrea Elecs. Corp.,
`949 F.3d 697 (Fed. Cir. 2020) ................................................................................ 6
`Avaya Inc. v. Network-1 Sec. Sols., Inc.,
`IPR2013-00071 (P.T.A.B. Dec. 2, 2013) ........................................................ 2, 11
`Belden Inc. v. Berk-Tek LLC,
`805 F.3d 1064 (Fed. Circ. 2015) ................................................................... 5, 6, 7
`Ericsson Inc. v. Intellectual Ventures I LLC,
`901 F.3d 1374 (Fed. Cir. 2018) ....................................................................... 9, 12
`Google Inc. v. Visual Real Estate, Inc.,
`IPR2014-01340 (P.T.A.B. Feb. 25, 2016).............................................................. 5
`Idemitsu Kosan Co. v. SFC Co.,
`870 F.3d 1376 (Fed. Cir. 2017) ....................................................................... 7, 11
`Invue Sec. Prods., Inc. v. Merch. Techs., Inc.,
`IPR2013-00122 (P.T.A.B. Oct. 10, 2013) .............................................................. 6
`K-40 Elecs., LLC v. Escort, Inc.,
`IPR2013-00203 (P.T.A.B. Aug. 27, 2014) ............................................................. 2
`Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co.,
`CBM2012-00002 (P.T.A.B. Jan. 23, 2014) ........................................................... 1
`Peabody Coal Co. v. McCandless,
`255 F.3d 465 (7th Cir. 2001) ................................................................................ 13
`
`ii
`
`
`
`Puzhen Life USA, LLC, v. Esip Series 2, LLC,
`IPR2017-02197 (P.T.A.B. Feb. 27, 2019)..........................................................5, 6
`Samsung Elecs. Co. v. Affinity Labs of Texas, LLC,
`IPR2014-01181 (P.T.A.B. Jan. 28, 2016) ..........................................................8, 9
`Square Inc. v. 4361423 Canada Inc.,
`IPR2019-01649 (P.T.A.B. Apr. 22, 2021) ........................................................... 13
`Twitter, Inc. v. Vidstream, LLC,
`IPR2017-00829 (P.T.A.B. Jan. 28, 2019) .............................................................. 4
`Volkswagen Grp. of Am., Inc. v. Emerachem Holdings, LLC,
`IPR2014-01555 (P.T.A.B. Oct. 9, 2015) ......................................................... 8, 12
`Regulations
`37 C.F.R. § 42.20(c) ................................................................................................... 1
`37 C.F.R. § 42.23(b) .................................................................................................. 8
`37 C.F.R. § 42.62(a) ................................................................................................... 1
`37 C.F.R. § 42.64 .................................................................................... 1, 2, 3, 4, 11
`37 C.F.R. § 42.64(b) ................................................................................................ 11
`37 C.F.R. § 42.64(b)(1) .............................................................................................. 2
`37 C.F.R. § 42.64(b)(2) ..........................................................................................2, 3
`37 C.F.R. § 42.64(c) .......................................................................................... 11, 12
`
`
`
`iii
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`
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`
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`I.
`
`Introduction.
`Patent Owner (“PO”) has moved for the “extraordinary relief” that the Board
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`exclude Petitioner’s Reply arguments and evidence. (See Paper 77). But, PO has not
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`carried its burden to establish that any portion of Petitioner’s Reply, nor any of its
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`evidence, should be excluded. PO’s Motion should be denied.
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`II. Legal Standard.
`Exclusion “is an exceptional remedy that the Board expects will be granted
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`rarely.” (Consolidated Trial Practice Guide Update (Nov. 2019) (“TPG”), 80). The
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`party moving to exclude evidence bears the burden of proof to establish that it is
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`entitled to the relief requested—namely, that the objected-to material is inadmissible
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`under the Federal Rules of Evidence. 37 C.F.R. §§ 42.20(c), 42.62(a). The Board
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`has emphasized that “[t]here is a strong public policy for making all information
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`filed in a non-jury, quasi-judicial administrative proceeding available to the public,
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`especially in an [IPR] which determines the patentability of claim[s] in an issued
`
`patent.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012-00002, Paper
`
`66, 60 (P.T.A.B. Jan. 23, 2014).
`
`III. PO’s Motion Is Procedurally Deficient.
`A.
`PO Has Not Made Timely Objections to Evidence.
`PO’s Motion does not comply with the procedural requirements of 37 C.F.R.
`
`§ 42.64. As a threshold matter, PO seeks exclusion of Petitioner’s Reply, (Mot., 1-
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`8, 11), but Rule 42.64 pertains to evidence, not pleadings.
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`1
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`
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`
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`Additionally, PO failed to provide the required notice via objections to
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`evidence, contrary to the Rule, thus depriving Petitioner of any potential remedial
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`measures provided by 37 C.F.R. § 42.64(b)(2). “A party wishing to challenge the
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`admissibility of evidence other than deposition evidence, must file any objections
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`within five business days of service of evidence to which the objection is directed.”
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`(TPG, 78-79 (citing 37 C.F.R. § 42.64(b)(1))). PO’s failure to lodge such objections
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`in the record warrants denial. See K-40 Elecs., LLC v. Escort, Inc., IPR2013-00203,
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`Paper 46, 4-5 (P.T.A.B. Aug. 27, 2014) (denying motion to exclude “[i]n view of
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`[PO’s] failure to comport with the requirements of 37 C.F.R. § 42.64 [i.e., timely
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`object]”); Apple Inc. v. Achates Reference Publ’g, Inc., IPR2013-00080, Paper 90,
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`49, 52 (P.T.A.B. June 2, 2014) (denying a motion to exclude for failure to allege that
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`an objection was timely served).
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`Regarding the Reply, PO fails to point to a single objection on the record to
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`support its Motion. Nor can it. PO did not object to the admissibility of Petitioner’s
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`Reply in its Objections (Paper 60), and certainly did not “identify the grounds for
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`the objection with sufficient particularity to allow correction in the form of
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`supplemental evidence.” 37 C.F.R. § 42.64(b)(1); see also Avaya Inc. v. Network-1
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`Sec. Sols., Inc., IPR2013-00071, Paper 75, 4 (P.T.A.B. Dec. 2, 2013) (exclusion
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`motions “must identify specifically each piece of evidence sought to be excluded,
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`identify where in the record the evidence was relied upon by the opposing party,
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`2
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`
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`identify where in the record the corresponding objection was made, and explain the
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`objection” (interpreting Rule 42.64)); ABB Inc. v. Roy-G-Biv Corp., IPR2013-
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`00062, Paper 84, 27 (P.T.A.B. Apr. 11, 2014) (dismissing motion to exclude; “[PO]
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`does not identify where in the record an objection originally was made”). By failing
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`to file objections, PO denied Petitioner the ten days provided by the Rules for curing
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`any alleged deficiencies in the evidence. 37 C.F.R. § 42.64(b)(2).
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`Also, despite PO’s suggestion otherwise, (Mot., 1), PO’s June 3, 2022
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`communication with the Board does not satisfy PO’s obligations under 37 C.F.R.
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`§ 42.64. Rule 42.64 is explicit in its instructions as to how a party must preserve
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`admissibility objections; it does not provide that a party may preserve its
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`admissibility objections via unfiled email correspondence to the Board. And, PO’s
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`claim that it “timely and specifically objected to each of Petitioner’s new arguments
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`in its June 3, 2022, communication with the Board” is belied by the factual record.
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`(Mot., 4). As to the pending IPR, PO’s June 3 communication does not even mention
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`Petitioner’s argument that VEGF Trap-Eye/aflibercept was publicly distributed prior
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`to 2011, let alone “timely and specifically object.” (See 6-3-22 D. Caine email). For
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`this reason alone, PO’s motion to exclude Petitioner’s public distribution argument
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`must fail.
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`Further, PO cannot credibly assert that its vague references in its June 3
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`communication regarding “Petitioner’s Ground 4 anticipation argument based on the
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`3
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`
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`VIEW and CLEAR-IT disclosures in Dixon” and “Petitioner’s Ground 5
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`obviousness arguments based on Dixon’s disclosure of CLEAR-IT-2 and/or
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`Mitchell’s disclosure of PrONTO for PRN dosing” satisfy the Rule’s requirement
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`that the objecting party “identify the grounds for the objection with sufficient
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`particularity to allow correction in the form of supplemental evidence.” Hence, PO’s
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`failure to comply with the plain requirements of 37 C.F.R. § 42.64 by, inter alia,
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`failing to provide the mandated notice via objections to evidence, warrants denial.
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`B.
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`PO’s Motion Is an Unauthorized (and Previously-Denied) Motion
`To Strike.
`PO’s motion to exclude portions of the Reply is premised entirely on PO’s
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`argument that the Reply raises “new” arguments. But, a motion to exclude is not the
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`proper vehicle for PO’s argument, per the Board’s rules. (TPG, 79 (“Nor should a
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`motion to exclude address arguments or evidence that a party believes exceeds the
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`proper scope of reply or sur-reply.”)). Indeed, the PTAB has repeatedly held that a
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`motion to exclude is not the appropriate vehicle for consideration of whether a party
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`has improperly raised new arguments.2 See Twitter, Inc. v. Vidstream, LLC,
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`IPR2017-00829, Paper 68, 47-48 (P.T.A.B. Jan. 28, 2019) (“timeliness arguments
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`are not properly the subject of a motion to exclude, which should seek to exclude
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`evidence as inadmissible, but rather should have been filed as a motion to strike
`
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`2 PO, as it must, acknowledges this fact. (Mot., 3 n.3)
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`4
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`
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`
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`because they seek to exclude belatedly presented evidence that [PO] contends
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`exceeds the proper scope of reply”); Puzhen Life USA, LLC, v. Esip Series 2, LLC,
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`IPR2017-02197, Paper 24, 48, 51 (P.T.A.B. Feb. 27, 2019) (denying PO’s motion
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`to exclude and noting that the proper procedure would have been to request
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`authorization to file a motion to strike); Google Inc. v. Visual Real Estate, Inc.,
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`IPR2014-01340, Paper 38, 39-40 (P.T.A.B. Feb. 25, 2016) (denying PO’s motion to
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`exclude because a “motion to exclude is not a proper vehicle for a party to raise the
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`issue of testimony in a rebuttal declaration exceeding the permissible scope of reply
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`testimony”); Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1082 (Fed. Circ. 2015);
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`ABB, IPR2013-00062, Paper 84, 27.
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`Although presented under the guise of a “Motion to Exclude,” PO’s July 20,
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`2022 submission is an unauthorized de facto motion to strike. The Board has already
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`considered, and denied, PO’s earlier request for authorization to move to strike. (See
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`6-7-22 PTAB email order (“The Board also denies Patent Owner’s request to file a
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`motion to strike in either of the proceedings.”)).3 Thus, PO’s efforts to end-run the
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`3 In its June 7 Order, the Board directed PO to “file, with its Sur-Reply, a table
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`identifying any portion of the Reply that [PO] considers to have exceeded the scope
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`of the Reply. Alternatively, [PO] may simply address those contentions, or the merits
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`of any newly-raised arguments or evidence in its Sur-Reply.” (6-7-22 PTAB email).
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`5
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`
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`Board’s prior denial of its motion to strike request should not be tolerated, and its
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`unauthorized motion warrants expungement. See Invue Sec. Prods., Inc. v. Merch.
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`Techs., Inc., IPR2013-00122, Paper 27 (P.T.A.B. Oct. 10, 2013) (party’s filing of an
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`unauthorized motion warranted expungement of that motion); Puzhen, IPR2017-
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`02197, Paper 24, 49 (declining to treat a motion to exclude as a motion to strike
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`because PO did not request authorization).
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`IV. Petitioner’s Reply Properly Responds to PO’s Response Arguments.
`In its Reply, Petitioner “merely responded to [PO’s] arguments, as it was
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`entitled to do.” Aisin Seiki Co. v. Intell. Ventures II LLC, IPR2017-01539, Paper 43,
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`69-70 (P.T.A.B. Dec. 12, 2018) (denying PO’s motion to strike after determining
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`that the Reply was “directly responsive to [PO’s] arguments raised in its Response”);
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`Belden, 805 F.3d at 1082. As shown below, the Reply arguments and evidence are
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`not “impermissible new matter,” and refusal to consider them would be legal error.
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`Apple v. Andrea Elecs. Corp., 949 F.3d 697, 706 (Fed. Cir. 2020) (holding that the
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`Board erred in refusing to consider petitioner’s reply arguments and evidence where
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`the Board had “pars[ed] [Petitioner’s] arguments on reply with too fine of a filter”).
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`Notably, PO does not allege that it has been denied a meaningful opportunity
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`to respond to the purportedly “new” Reply arguments or evidence. Nor can it since,
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`Notwithstanding the Board’s offered suggestion, PO chose not to submit a table.
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`6
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`
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`by PO’s own admission, it “addressed these new arguments in its Sur-reply.” (Mot.,
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`5). The Federal Circuit has affirmed the Board in denying a motion to exclude where
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`the appellant had means to address the evidence substantively, as was the case here.
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`See Belden, 805 F.3d at 1082. As in Belden, PO has had sufficient opportunity
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`through cross-examination and sur-reply briefing to address the Reply arguments
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`and evidence; thus, PO’s Motion should be denied.
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`A. VEGF Trap-Eye Was Publicly Distributed.
`PO argues that Petitioner’s Reply argument that “VEGF Trap-Eye was
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`publicly distributed” is improper because “Petitioner could have presented [it]
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`earlier.” (Mot., 5; see also id., 1, 6). But, Petitioner could not, in fact, have made this
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`argument earlier because this argument was not relevant until PO injected the issue
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`of VEGF Trap-Eye’s public availability into the case via its POR and its reliance on
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`a non-public confidential research agreement (Ex.2096). (See Paper 39, 9-10 & n.6;
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`Ex.2050, ¶¶70-72; Paper 68, 10 (citing POR to support the notion that “there is no
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`evidence that VEGF Trap-Eye was in the public domain”)). Indeed, Petitioner could
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`not have predicted at the time of the Petition the existence of the non-public
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`confidentiality agreement relied upon by PO to try to distinguish the claims from the
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`prior art. Petitioner is thus entitled to counter. See Idemitsu Kosan Co. v. SFC Co.,
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`870 F.3d 1376, 1380-81 (Fed. Cir. 2017) (rejecting PO’s “new argument” argument
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`since “[Petitioner] simply countered, as it was entitled to do”).
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`7
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`
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`B. Ground 4 Anticipation Argument.
`PO argues that Petitioner’s Ground 4 Anticipation argument that Dixon
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`discloses the VIEW Year-2 PRN dosing regimen is improper Reply material. (Mot.,
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`2, 6-7, 11). This is not a “new” argument as PO contends. Rather, this argument is
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`directly responsive to PO’s recharacterization of its prosecution history arguments
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`as pertaining to the second year PRN phase of VIEW, (Paper 39, 24), and is therefore
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`proper. As PO acknowledges
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`in
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`its Motion,
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`the parties had different
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`“interpretation[s] of [PO’s] statements in the prosecution history.” (Mot., 6 n.5).
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`And, as
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`the Board has previously held, “Petitioner cannot anticipate
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`every…argument that [PO] may make in its response and is entitled to provide
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`argument and evidence in its Reply to refute arguments and evidence in [PO’s]
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`Response.” Samsung Elecs. Co. v. Affinity Labs of Texas, LLC, IPR2014-01181,
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`Paper 36, 62 (P.T.A.B. Jan. 28, 2016) (citing 37 C.F.R. § 42.23(b)); see also
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`Volkswagen Grp. of Am., Inc. v. Emerachem Holdings, LLC, IPR2014-01555, Paper
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`36, 5 (P.T.A.B. Oct. 9, 2015) (“[P]atent owners have too often cried foul when
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`evidence is properly relied upon in a reply. In a reply, a petitioner legitimately may
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`respond to arguments made in an opposition.”). Here, Petitioner could not (and need
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`not) anticipate all possible interpretations of the prosecution history arguments, and
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`Petitioner was well within its right to respond to PO’s interpretation as presented in
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`the POR.
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`8
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`
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`C. Ground 5 Obviousness Arguments.
`PO contends that the Reply raises for the first time “several new theories,”
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`(Mot., 7), and thus seeks the “exceptional remedy” of excluding various portions of
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`the Reply and related Albini Declaration concerning Petitioner’s Ground 5
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`obviousness arguments, (id., 2, 7-8, 11 (seeking exclusion of portions of Paper 56
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`(on pages 24-25, 27-28, 30-31, 34) and Ex.1114, ¶39)). Under PO’s interpretation
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`of the Rules, however, a petitioner would never have an opportunity to respond to
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`issues raised after the petition was filed. This is not the law. See Ericsson Inc. v.
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`Intellectual Ventures I LLC, 901 F.3d 1374, 1380 (Fed. Cir. 2018). Petitioner, as it
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`is entitled to do, provided argument and evidence in its Reply to refute arguments
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`and evidence in PO’s response. See Samsung, IPR2014-01181, Paper 36, 62. As
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`shown below, each of the objected-to Reply arguments is unequivocally presented
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`in the original Petition and/or properly in rebuttal to PO’s arguments, which is
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`exactly the kind of Reply arguments and testimony that is permitted. See Aisin Seiki,
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`IPR2017-01539, Paper 43, 69-70.
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`First, contrary to PO’s assertions, Petitioner’s Ground 5 did not “rel[y] solely
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`on Heier-2009 (and its disclosure of CLEAR-IT-2’s PRN dosing regimen) to supply
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`PRN dosing.” (Mot., 7). Ground 5 in the Petition unambiguously relies on “Heier-
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`2009 in combination with either Mitchell or Dixon—and, optionally, either the ’758
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`patent or Dix.” (Paper 1, 60). The Petition itself clearly contradicts PO’s allegation
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`9
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`
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`regarding Petitioner’s “new use” of Dixon and/or Mitchell to supply disclosure of
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`PRN dosing in Ground 5. (See id., 60-69). For example, the Petition states that
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`“[b]oth Mitchell and Dixon teach anti-VEGF regimens for AMD employing…a total
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`of three loading doses, and tertiary PRN dosing. (Paper 1, 65 (emphasis added); id.,
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`39-40 (“Mitchell expressly discusses the viability of less-frequent dosing, wherein
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`monthly monitoring is coupled with flexible retreatment—in other words, PRN
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`dosing.” (emphasis added)); id., 63 (relying on Mitchell’s PrONTO disclosure of
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`“‘three consecutive monthly injections’…followed by PRN dosing” (emphasis
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`added)); id., 64 (“Dixon discloses…monthly loading doses followed by PRN”
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`(emphasis added)); id., 65 (relying on Mitchell’s/Dixon’s disclosures of “assessed
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`by a physician” as relevant to PRN dosing)).
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`Second, PO concludes without elaboration that Petitioner could have raised in
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`its Petition the argument that dropping from 4 to 3 loading doses is inconsequential
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`in the context of PRN dosing, and thus portions of the Reply should be excluded.
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`(Mot., 8, 11 (seeking exclusion of Paper 56, 25, 34)). The complained-of argument
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`is directly and plainly responsive to issues posed in PO’s Response, i.e., PO’s (and
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`its expert’s) argument that a POSA would have been discouraged, not motivated, to
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`reduce the number of monthly loading doses from 4 to 3. (See, e.g., Paper 39, 30-41;
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`Ex.2050, ¶¶141-46). Contrary to PO’s assertions, (Mot., 8), PO’s argument
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`regarding the criticality of the fourth loading dose was not foreseeable such that
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`10
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`
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`Petitioner had an obligation to address that argument in its Petition, and would be
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`precluded from addressing it in its Reply. Rather, because PO raised a lack-of-
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`motivation argument in its POR, Petitioner “simply countered, as it was entitled to
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`do.” Idemitsu, 870 F.3d at 1380-81.
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`Third, PO argues that Petitioner’s citation of Exhibit 1068 in its Reply was
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`improper because “Exhibit 1068 was never cited in the original Petition, and neither
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`Petitioner nor its experts relied upon Ex. 1068’s disclosure of the DME trial at any
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`time prior to Petitioner’s Reply.” (Mot., 8). Notably, PO does not seek exclusion of
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`Exhibit 1068—nor could it since PO failed to file any objection to this exhibit, in
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`violation of 37 C.F.R. § 42.64(b), (c). (See Papers 30, 60). Instead, PO improperly
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`seeks exclusion of “Petitioner’s Reply arguments on Exhibit 1068.”4 (Mot., 8, 11).
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`PO’s argument on Exhibit 1068 should therefore be denied since a proper motion to
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`exclude must be keyed to an earlier-made evidentiary objection. 37 C.F.R.
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`§ 42.64(c); Avaya, IPR2013-00071, Paper 75, 4; ABB, IPR2013-00062, Paper 84,
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`27. Additionally, PO’s only argument for exclusion—that Petitioner and its experts
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`never cited or relied upon Exhibit 1068 in the original Petition—is insufficient to
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`warrant exclusion. Indeed, the PTAB has previously recognized that a “petitioner
`
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`4 As noted above, 37 C.F.R. § 42.64, pertains to evidence, not pleadings, and is thus
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`inapplicable to PO’s argument regarding the Reply.
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`11
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`
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`
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`legitimately may respond to arguments made in an opposition,” and “[t]o do so, often
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`it is necessary to rely on…new evidence.” Volkswagen, IPR2014-01555, Paper 36,
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`5; see also Ericsson, 901 F.3d at 1380 (finding legal error arising from the Board’s
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`failure to consider portions of reply that did “not identify a previously unidentified
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`piece of prior art to make a meaningfully distinct contention, but instead expand[ed]
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`the same argument made in its Petition”). Here, the use of Exhibit 1068 was in direct
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`response to PO’s (meritless) arguments regarding concerns with PRN dosing and the
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`use of 3 monthly loading doses. (Paper 56, 22, 24).
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`V.
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`PO Has Not Made a Sufficient Case for Exclusion of Uncited Exhibits and
`Expert Testimony.
`PO moves for exclusion of Petitioner’s Exhibits 1118, 1121, and 1124, as well
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`as certain passages of Petitioner’s expert declaration testimony, on the basis that they
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`are “not cited in the pleadings,” and thus “irrelevant.” (Mot., 9-12).5 Consistent with
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`the PTAB’s general preference for inclusion, and because PO has failed to meet its
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`burden of proving this evidence is in any way prejudicial,6 PO’s Motion must be
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`5 PO’s conclusory assertion in footnote 7 regarding the admissibility of Exhibits
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`1118, 1121, and 1124 under FRE 802, 901, and/or 1006, fails to “explain the
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`objections” as required by 37 C.F.R. § 42.64(c), thus warranting denial.
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`6 By contrast, Petitioner explained in its Motion to Exclude that PO’s uncited
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`exhibits are unfairly prejudicial, in addition to being irrelevant. (Paper 76, 6).
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`12
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`denied. Where necessary, administrative agencies further relax the rules of evidence
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`to account for the skill possessed by administrative judges to handle evidence that
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`may otherwise mislead a jury. See Peabody Coal Co. v. McCandless, 255 F.3d 465,
`
`469 (7th Cir. 2001).
`
`As an initial matter, PO’s contention that paragraph 160 of the Albini
`
`Declaration (Ex.1002) is “[u]ncited expert declaration testimony,” (Mot., 11), is
`
`inaccurate. Petitioner’s Reply does in fact rely upon the objected-to passage of
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`Exhibit 1002 to show that the prior art’s (Dixon’s) disclosure of the VIEW 8-week
`
`dosing regimen anticipates the challenged claims. (See Paper 56, 21; Ex.1114, ¶19).
`
`Specifically, the Reply, (Paper 56, 21), cites to the Albini Reply Declaration,
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`(Ex.1114, ¶19), which in turn cites to paragraph 160 of the Albini Declaration
`
`(Ex.1002).
`
`Furthermore, the identified exhibits and expert testimony are a matter of
`
`public record, and the Board may have its own reasons for wanting to consult any of
`
`these exhibits or take public notice of them. PO has provided no legitimate
`
`justification for excluding this evidence altogether at this time. Thus, rather than the
`
`exceptional remedy of complete exclusion, the Board can, in its discretion, assign
`
`weight to the evidence as appropriate, as it has done in prior IPRs. See, e.g., Square
`
`Inc. v. 4361423 Canada Inc., IPR2019-01649, Paper 43, 33 (P.T.A.B. Apr. 22,
`
`2021).
`
`13
`
`
`
`
`
`
`
`VI. Conclusion.
`PO merely repackages its rejected motion to strike and fails to justify why it
`
`is entitled to “an exceptional remedy.” PO’s Motion must be denied.
`
`
`
`
`
`
`Dated: July 27, 2022
`
`
`
`
`
`
`
`
`
`
`Respectfully Submitted,
`
`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
`
`14
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`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a true and correct copy of the foregoing
`
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude Evidence was served
`
`on July 27, 2022, via electronic mail by agreement of the parties, to the following
`
`counsel for record of Patent 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
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/Paul J. Molino/
` Paul J. Molino (Reg. No. 45,350)
`
`
`
`
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