UNITED STATES PATENT AND TRADEMARK OFFICE
`________________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________________________________
`
`TWI PHARMACEUTICALS, INC.,
`Petitioner,
`v.
`MERCK SERONO S.A.,
`Patent Owner.
`________________________________________________
`Case IPR2023-00050
`U.S. Patent 8,377,903
`
`________________________________________________
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`PATENT OWNER’S OPPOSITION TO PETITIONER’S
`MOTION FOR ADDITIONAL DISCOVERY
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`________________________________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________________________________
`
`TWI PHARMACEUTICALS, INC.,
`Petitioner,
`v.
`MERCK SERONO S.A.,
`Patent Owner.
`________________________________________________
`Case IPR2023-00050
`U.S. Patent 8,377,903
`
`________________________________________________
`
`PATENT OWNER’S OPPOSITION TO PETITIONER’S
`MOTION FOR ADDITIONAL DISCOVERY
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`IPR2023-00050
`U.S. Patent 8,377,903
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`TABLE OF CONTENTS
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`Statement of Material Facts ............................................................................. 1
`Petitioner’s Requests should be denied because the requested
`materials are both privileged and protected work product .............................. 5
`A.
`Communications with counsel are privileged ....................................... 5
`B.
`Dr. Bodor’s and Dr. Dandiker’s drafts and communications
`with counsel are protected work product .............................................. 7
`Petitioner fails to establish its requests are in the interests of justice ............. 8
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`I.
`II.
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`III.
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`i
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`TABLE OF AUTHORITIES
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`IPR2023-00050
`U.S. Patent 8,377,903
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`Page(s)
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`CASES
`ChemFree Corp. v. J. Walter, Inc., No. 04-3711, 2008 WL 5234252
`(N.D. Ga. June 11, 2008) ................................................................................. 5
`Clemmons v. Acad. for Educ. Dev., No. 10- 911, 2013 WL 5994487
`(D.D.C. Nov. 13, 2013) ............................................................................... 7, 9
`Garmin Int’l, Inc. et al. v. Cuozzo Speed Techs. LLC, IPR2012-00001,
`Paper No. 26 (March 5, 2013) ......................................................................... 8
`In re Regents of Univ. of California, 101 F.3d 1386 (Fed. Cir. 1996) ...................... 2
`In re Spalding Sports Worldwide, Inc., 1203 F.3d 800 (Fed. Cir. 2000) .................. 6
`Murphy v. Kmart Corp., 259 F.R.D. 421 (D.S.D. 2009) ....................................... 7–8
`Pevarello v. Lan, 85 U.S.P.Q.2d 1771 (B.P.A.I. 2007) ......................................... 6, 7
`Shearing v. Iolab Corp., 975 F.2d 1541 (Fed. Cir. 1992) ......................................... 6
`Siler v. EPA, 908 F.3d 1291 (Fed. Cir. 2018) ............................................................ 6
`Tennant Co. v. Oxygenator Water Techs. Inc., IPR2021-00625, Paper
`30 (P.T.A.B. 2021) ........................................................................................ 10
`Twitter, Inc. v. Palo Alto Rsch. Ctr. Inc., IPR2021-01398, Paper 33
`(P.T.A.B. Nov. 18, 2022) .................................................................... 6, 7, 8, 9
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`ii
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`Petitioner improperly requests privileged communications between Drs.
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`Bodor and Dandiker and their counsel, WilmerHale, including protected work
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`product. Petitioner’s request should be denied on this basis alone. Even if
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`Petitioner were permitted to pierce both the declarants’ privilege and related work
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`product protections, Petitioner makes no attempt to demonstrate how its requested
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`discovery would serve the interests of justice. On the contrary, Petitioner’s
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`requests should be denied as nothing more than a speculative fishing expedition.
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`I.
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`Statement of Material Facts
`Each of Petitioner’s grounds in these IPRs relies on a single passage of the
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`Bodor PCT. Pet. (Paper 1) 45-48. This passage of the Bodor PCT does not qualify
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`as prior art, however, because the dosing regimen disclosed therein was made by
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`the inventors of the challenged patents, not by Dr. Bodor or Dr. Dandiker.
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`Drs. Bodor and Dandiker are former employees of IVAX who partnered
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`with Patent Owner’s predecessor, Serono, to develop cladribine for treating MS.
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`Ex. 2054, ¶18; Ex. 2055, ¶¶14-18. Drs. Bodor and Dandiker developed an oral
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`formulation of cladribine. Id. Serono designed and ran clinical studies for treating
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`MS with cladribine, including developing the regimens which Serono later
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`patented. Ex. 2048, 2, 17-20; Ex. 2054, ¶13; Ex. 2055, ¶14. Even though “they
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`have no interest in the outcome of this matter whatsoever,”1 Mot. (Paper 52) 6-7,
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`Drs. Bodor and Dandiker each submitted a declaration confirming that they did not
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`invent the cited dosing regimen; the Serono inventors did. Ex. 2054, ¶¶27-28; Ex.
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`2055, ¶¶25-29.
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`Each declarant sought WilmerHale’s legal advice regarding both preparation
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`of their declarations, attesting that they did not invent any dosing regimen, and
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`preparation for and representation at their depositions in these proceedings and
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`related proceedings, Hopewell Pharma Ventures, Inc. v. Merck Serono S.A.,
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`IPR2023-00480, IPR2023-00481, Merck KGaA v. Hopewell Pharma Ventures,
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`Inc., No. 22-1365 (Consolidated) (D. Del.). Dr. Bodor established an attorney-
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`client relationship with WilmerHale as of October 18, 2023, and Dr. Dandiker
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`1 Although Petitioner does not request them, communications between IVAX’s and
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`Serono’s counsel regarding prosecution of the Bodor PCT, exchanged under a joint
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`research agreement including developing a patent portfolio protecting cladribine
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`for treating MS, Ex. 2048, are protected by common interest privilege. In re
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`Regents of Univ. of California, 101 F.3d 1386, 1389 (Fed. Cir. 1996).
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`established an attorney-client relationship with WilmerHale as of November 27,
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`2023.2
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`Petitioner has been on notice that WilmerHale represents at least Dr. Bodor
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`since February 29, 2024. At that time, Patent Owner preemptively reached out to
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`Petitioner to disclose Dr. Bodor, the anticipated subject matter of his declaration,
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`and his health concerns. Ex. 2081. Patent Owner requested (twice) to meet and
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`confer about reasonable accommodations to allow Petitioner to depose Dr. Bodor.
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`Id. Petitioner responded, on March 5, by threatening to bring multiple motions to
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`the Board. Id.
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`On March 13, Patent Owner submitted declarations from Dr. Bodor and Dr.
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`Dandiker in support of Patent Owner’s Response. Petitioner then waited over two
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`months before raising this dispute to the Board. Petitioner now belatedly requests
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`privileged communications between Dr. Bodor or Dr. Dandiker and WilmerHale,
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`including any drafts of their declarations and whether WilmerHale showed the
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`declarants any documents not cited in their declarations. Petitioner attempts to
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`justify its requests by claiming, for the first time and without any evidence, that
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`2 If the Board feels further evidence is required, Patent Owner requests
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`authorization to file another brief addressing that issue.
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`“additional materials providing relevant evidence underlying the declarations were
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`indeed provided to … the witnesses.” Mot. 10. That misrepresents the record.
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`Dr. Bodor did not recall or cite any specific communications between IVAX
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`and Serono. Ex. 2054, ¶¶28-30. Nonetheless, Petitioner cites Dr. Bodor’s
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`discussion of his personal files, which he testified were irrelevant and “had no
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`effect on the declaration.” Ex. 1044, 48:10-51:15. Petitioner does not seek those
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`files in its requests. Paper 54. Similarly, Dr. Dandiker testified that, while he
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`recalled other meetings with Serono, he did not believe there were written records
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`of them. Ex. 1043, 122:8-126:12 (“Q. Would those meetings have had meeting
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`minutes like the ones we saw in Exhibit 2050? A. Not necessarily. My
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`recollection is that more so the communication with Serono was over the phone….
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`Q. So it’s your belief that there’s other emails, meetings maybe with minutes,
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`communications between Serono and IVAX about the dosing regimen, right? A:
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`No, that’s not my belief.”) (emphasis added). In depositions in related
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`proceedings, both declarants have consistently denied knowing of other written
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`communications. Petitioner cites no evidence that any other written records exist,
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`let alone that declarants have them now. And, contrary to Petitioner’s argument, it
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`cannot presume adverse evidence because of privilege assertions.
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`For the reasons discussed below, the Board should deny Petitioner’s
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`requests.
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`II.
`Petitioner’s Requests should be denied because the requested materials
`are both privileged and protected work product.
`Petitioner requests drafts and correspondence between Drs. Bodor and
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`Dandiker and their attorneys related to the preparation of their declarations. Paper
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`54. Such materials are textbook privileged communications and protected work
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`product. Petitioner concedes that WilmerHale represents both Drs. Bodor and
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`Dandiker in these proceedings. Mot. 4. In fact, WilmerHale has represented both
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`since October and November 2023, respectively. Section I, supra. Nevertheless,
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`Petitioner argues it should be allowed to discover their communications with
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`WilmerHale because WilmerHale also represents Patent Owner. That is wrong.
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`Drs. Bodor and Dandiker are independently entitled to privilege. And the
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`requested communications are protected work product.
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`A. Communications with counsel are privileged.
`It is undisputed that WilmerHale represents Drs. Bodor and Dandiker in
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`these proceedings. Mot. 4. Petitioner disputes the declarants’ assertion of
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`privilege because they are non-parties so, according to Petitioner, WilmerHale’s
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`advice was for the sole benefit of Patent Owner. Petitioner cites no case in support
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`of that position. On the contrary, courts, the Board, and its predecessor, routinely
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`recognize that non-parties are entitled to privilege with their own counsel, even if
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`that counsel also represents one of the parties. ChemFree Corp. v. J. Walter, Inc.,
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`No. 04-3711, 2008 WL 5234252, at *2 (N.D. Ga. June 11, 2008) (“[T]here
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`typically would be no reason why the defending attorney could not also represent a
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`nonparty witness for purposes of that witness’s deposition. That representation
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`should prevent the adverse party from inquiring into the substance of the
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`conversation between the witness and the defending lawyer…”); Pevarello v. Lan,
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`85 U.S.P.Q.2d 1771, at *11 (B.P.A.I. 2007); Twitter, Inc. v. Palo Alto Rsch. Ctr.
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`Inc., IPR2021-01398, Paper 33 at 3-13 (P.T.A.B. Nov. 18, 2022). Because it is
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`undisputed that WilmerHale represents Drs. Bodor and Dandiker, the inquiry
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`should end there.
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`Nevertheless, Petitioner argues that the Board should dissect Dr. Bodor’s
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`and Dr. Dandiker’s communications with counsel to assess whether WilmerHale
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`provided “legal advice” to them. Petitioner’s own citation holds the Board should
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`not. In In re Spalding Sports Worldwide, Inc., the lower court held that a largely
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`factual disclosure provided by inventors to in-house lawyers was not privileged
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`because it was not clear the inventors had requested or received legal advice. 203
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`F.3d 800, 802-03, 805-06 (Fed. Cir. 2000). The Federal Circuit issued a writ of
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`mandamus to protect the privilege. Id. at 808. The Federal Circuit held courts
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`should not “dissect the document to separately evaluate” whether each
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`communication related to legal advice. Id. at 806. “It is not necessary to expressly
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`request confidential legal assistance” because “the overall tenor of the document”
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`and the fact that it was “a communication to an attorney” is enough to establish
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`privilege. Id.
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`Petitioner’s other cases are inapposite. Siler v. EPA, 908 F.3d 1291, 1298
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`(Fed. Cir. 2018), did not involve communication with an attorney. And Shearing
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`v. Iolab Corp., 975 F.2d 1541, 1546 (Fed. Cir. 1992), involved a strictly non-client
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`relationship. Unlike those cases, Petitioner concedes WilmerHale represents Drs.
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`Bodor and Dandiker in these proceedings. Mot. 4. The Board has recognized that
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`helping a witness prepare a declaration for an IPR is inherently legal advice, and
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`therefore privileged. Twitter, IPR2021-01398, Paper 33 at 11-13. The Board
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`should uphold Dr. Bodor’s and Dr. Dandiker’s privilege here.
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`B. Dr. Bodor’s and Dr. Dandiker’s drafts and communications with
`counsel are protected work product.
`Petitioner seeks drafts of declarations and related communications, which
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`are protected by the work product doctrine. Unlike the final declarations
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`themselves, such drafts and related communications would “expose[] [a] lawyer’s
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`mental processes.” Twitter, IPR2021-01398, Paper 33 at 11 (quoting Clemmons v.
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`Acad. for Educ. Dev., No. 10- 911, 2013 WL 5994487, at *2 (D.D.C. Nov. 13,
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`2013)). The Board and courts have routinely recognized that drafts and
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`communications about preparation, like those requested here, are protected work
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`product. Id.; Pevarello v. Lan, 85 U.S.P.Q.2d 1771, at *11 (B.P.A.I. 2007).
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`Again, Petitioner’s citation squarely contradicts its argument. Murphy v. Kmart
`7
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`Corp. held that, while signed affidavits were not work product, prior drafts and
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`communications about their preparation were. 259 F.R.D. 421, 424-25, 428-31
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`(D.S.D. 2009). Therefore, the preparatory communications Petitioner seeks here
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`are protected work product.
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`III. Petitioner fails to establish its requests are in the interests of justice.
`Even if Dr. Bodor’s and Dr. Dandiker’s communications were not
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`privileged, Petitioner has not shown its requests are in the interests of justice.
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`What Petitioner seeks is district-court style discovery—it requests a fishing
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`expedition in the hopes of finding inconsistent information. The Board’s rules do
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`not allow such speculative discovery. E.g., Twitter, IPR2021-01398, Paper 33 at
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`13-19 (denying requests for drafts under Garmin factors); Garmin Int’l, Inc. et al.
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`v. Cuozzo Speed Techs. LLC, IPR2012-00001, Paper No. 26 at 5 (March 5, 2013).
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`The Garmin factors, on balance, weigh against granting Petitioner’s discovery
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`requests.
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`Factor 1: Petitioner’s requests are plainly speculative. The declarants did
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`not agree that additional written communications existed. Section I, supra. Even
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`if other written records of meetings do exist, Drs. Bodor and Dandiker each
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`testified that they believe all other communications between IVAX and Serono
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`confirm the Serono inventors made the regimen in the Bodor PCT, just as the filed
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`exhibits do. See Ex. 2054, ¶¶28-30; Ex. 2055, ¶¶25-29. There is no evidence that
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`Petitioner’s requests would find any documents, let alone any that are contrary to
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`the existing record.
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`Similarly, Petitioner asserts that it also requests communications with Patent
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`Owner without counsel involved. Mot. 5 n.3. But there is no evidence that such
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`communications exist. Further, because of Petitioner’s two-and-a-half-month
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`delay in bringing this to the Board, it is now too late for Petitioner to use any
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`evidence obtained or for Patent Owner to have an opportunity to respond. For all
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`these reasons, this factor weighs strongly against Petitioner.
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`Factor 2: Petitioner seeks drafts of declarations and related communications. “[A]
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`draft of a declaration…exposes [a] lawyer’s mental processes,” which reveals their
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`litigation positions. Twitter, IPR2021-01398, Paper 33 at 11 (quoting Clemmons v.
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`Acad. for Educ. Dev., No. 10- 911, 2013 WL 5994487, at *2 (D.D.C. Nov. 13,
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`2013)). Thus, in similar scenarios, the Board has held Factor 2 weighs strongly
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`against such requests. Id. at 14. This factor weighs against Petitioner.
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`Factor 3: Petitioner had adequate opportunity to explore Dr. Bodor’s and
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`Dr. Dandiker’s knowledge of the facts through their depositions. E.g., Ex. 1043,
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`63:6-65:3, 128:7-130:17. Petitioner has no genuine need for the privileged
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`material it requests. Rather, Petitioner demands privileged communications simply
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`because it is unhappy that the facts show Drs. Bodor and Dandiker did not invent
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`IPR2023-00050 (Patent 8,377,903)
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`the regimen it relies on. Therefore, this factor weighs against Petitioner. Twitter,
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`IPR2021-01398, Paper 33 at 14-16.
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`Factor 4: Petitioner’s requests include 3 pages of instructions and appear to
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`potentially cover communications with other attorneys and parties about different
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`patents. Paper 54 (e.g., “Patent Owner” is defined to include prosecution counsel
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`for a “Family” of more than 20 patents). This factor is, at best, neutral.
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`Factor 5: The Board has held that requests invading privilege create an
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`enormous burden for the responding party. Tennant Co. v. Oxygenator Water
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`Techs. Inc., IPR2021-00625, Paper 30 at 10 (P.T.A.B. 2021). Moreover, the
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`burden should be weighed in view of the fact that Petitioner’s requests are directed
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`to documents (allegedly) in the possession of non-parties Drs. Dandiker and Bodor,
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`not Patent Owner. Because these requests would require non-parties to navigate
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`overlapping privilege and work product, this factor should weigh strongly against
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`Petitioner.
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`Garmin Factors 1-3 and 5, and the balance of the factors, all weigh against
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`granting Petitioner’s requests. Therefore, Petitioner’s requests should be denied.
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`Respectfully submitted,
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`By: /Emily R. Whelan/
`Emily R. Whelan (Reg. No. 50,391)
`Counsel for Patent Owner Merck
`Serono S.A.
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`IPR2023-00050 (Patent 8,377,903)
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`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`Description
`
`Exhibit
`No.
`2001 Declaration of David B. Bassett in Support of Motion for Admission
`Pro Hac Vice
`2002 Declaration of Vinita Ferrera in Support of Motion for Admission Pro
`Hac Vice
`2003 Declaration of Mary Pheng in Support of Motion for Admission Pro
`Hac Vice
`
`2004
`
`J. C. Sipe et al., Cladribine in Treatment of Chronic Progressive
`Multiple Sclerosis, 344 THE LANCET 9 (1994)
`
`2005
`
`2006
`
`B. M. Greenberg et al., Multiple Sclerosis, in PHARMACOLOGY AND
`THERAPEUTICS: PRINCIPLES TO PRACTICE 685 (S. A. Waldman & A.
`Terzic eds., 2009)
`
`C. Krishnan et al., Reduction of Disease Activity and Disability With
`High-Dose Cyclophosphamide in Patients With Aggressive Multiple
`Sclerosis, 65 ARCHIVES OF NEUROLOGY 1044 (2008)
`
`2007
`
`B. Greenberg & E. M. Frohman, Defining Success in Multiple
`Sclerosis: Treatment Failures and Nonresponders, 8 PROCEEDINGS,
`JOHNS HOPKINS ADVANCED STUDIES IN MEDICINE 274 (2008)
`2008 B. M. Greenberg et al., Current and Emerging Multiple Sclerosis
`Therapeutics, 16 CONTINUUM 58 (2010)
`
`2009 Transcript of Deposition of Benjamin Greenberg (Feb. 26, 2024)
`
`2010
`
`A. E. Miller & R. M. Herndon, Treatment Issues, in MULTIPLE
`SCLEROSIS: THE QUESTIONS YOU HAVE—THE ANSWERS YOU NEED 43
`(R. C. Kalb ed., 2nd Ed. 2000)
`
`11
`
`
`
`
`
`
`
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`IPR2023-00050 (Patent 8,377,903)
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`Description
`
`J. Noseworthy et al., Disease-Modifying Treatments in Multiple
`Sclerosis, in MCALPINE’S MULTIPLE SCLEROSIS 729 (A. Compston et
`al. eds., 4th ed. 2005)
`
`Exhibit
`No.
`
`2011
`
`2012
`
`H. El-Moslimany & A. E. Miller, Escape Therapies and Management
`of Multiple Sclerosis, in MULTIPLE SCLEROSIS: A COMPREHENSIVE
`TEXT 333 (C. S. Raine et al. eds., 2008)
`2013 F. Lublin, History of Modern Multiple Sclerosis Therapy, 252 JOURNAL
`OF NEUROLOGY III/3 (2005)
`2014 D. S. Goodin et al., Disease Modifying Therapies in Multiple Sclerosis,
`58 NEUROLOGY 169 (2002)
`
`2015
`
`2016
`
`G. Giovannoni et al., Long-Term Follow-Up of Patients with Relapsing
`Multiple Sclerosis From the CLARITY/CLARITY Extension Cohort of
`CLASSIC-MS: An Ambispective Study, 29 MULTIPLE SCLEROSIS
`JOURNAL 719 (2023)
`
`M. Filippi et al., The Effect of Cladribine on T1 ‘Black Hole’ Changes
`in Progressive MS, 176 JOURNAL OF THE NEUROLOGICAL SCIENCES 42
`(2000)
`
`2017
`
`J. E. Joy & R. B. Johnston, Jr., MULTIPLE SCLEROSIS: CURRENT STATUS
`AND STRATEGIES FOR THE FUTURE 17 (2001)
`
`2018
`
`O. Neuhaus et al., Immunomodulation in Multiple Sclerosis: From
`Immunosuppression to Neuroprotection, 24 TRENDS IN
`PHARMACOLOGICAL SCIENCES 131 (2003)
`
`2019 Declaration of Fred Lublin, M.D.
`2020 L. Durelli, Dose and Frequency of Interferon Treatment Matter, 250
`JOURNAL OF NEUROLOGY IV/9 (2003)
`
`12
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`IPR2023-00050 (Patent 8,377,903)
`
`Exhibit
`No.
`
`Description
`
`2021
`
`R. Rudick & A. Sandrock, Natalizumab: 4-Integrin Antagonist
`Selective Adhesion Molecule Inhibitors for MS, 4 EXPERT REVIEW OF
`NEUROTHERAPEUTICS 571 (2004)
`2022 D. S. Alberts et al., Disposition of Mitoxantrone in Cancer Patients, 45
`CANCER RESEARCH 1879 (1985)
`
`2023
`
`K. Rammohan et al., The Development of Cladribine Tablets for the
`Treatment of Multiple Sclerosis: A Comprehensive Review, 80 DRUGS
`1901 (2020)
`
`2024
`
`J. F. Kurtzke, Rating Neurologic Impairment in Multiple Sclerosis: An
`Expanded Disability Status Scale (EDSS), 33 NEUROLOGY 1444 (1983)
`
`2025
`
`2026
`
`2027
`
`2028
`
`M. J. Tullman et al., Immunotherapy of Multiple Sclerosis—Current
`Practice and Future Directions, 39 JOURNAL OF REHABILITATION
`RESEARCH AND DEVELOPMENT 273 (2002)
`
`G. Giovannoni et al., A Placebo-Controlled Trial of Oral Cladribine
`for Relapsing Multiple Sclerosis, 362 NEW ENGLAND JOURNAL OF
`MEDICINE 416 (2010)
`
`Supplementary Appendix to G. Giovannoni et al., A Placebo-
`Controlled Trial of Oral Cladribine for Relapsing Multiple Sclerosis,
`362 NEW ENGLAND JOURNAL OF MEDICINE 416 (2010) (Exhibit 2026)
`
`G. Giovannoni et al., Safety and Efficacy of Cladribine Tablets in
`Patients with Relapsing–Remitting Multiple Sclerosis: Results from the
`Randomized Extension Trial of the CLARITY Study, 24 MULTIPLE
`SCLEROSIS JOURNAL 1594 (2018)
`
`2029 US Patent No. 8,785,415
`2030 Serono Press Release, Serono and Ivax to Develop Oral Therapy for
`Multiple Sclerosis (Oct. 30, 2002)
`
`13
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`IPR2023-00050 (Patent 8,377,903)
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`Exhibit
`No.
`
`Description
`
`2031 Serono Form 20-F (2003)
`
`2032
`
`C. Sargent, Serono Purchases Rights to Experimental MS Drug, WALL
`STREET JOURNAL (Oct. 31, 2002),
`https://www.wsj.com/articles/SB1035995148253461151 (accessed
`Dec. 14, 2023)
`
`2033 Reserved
`
`2034
`
`P. S. Rommer et al., Requirement for Safety Monitoring for Approved
`Multiple Sclerosis Therapies: An Overview, 175 CLINICAL AND
`EXPERIMENTAL IMMUNOLOGY 397 (2013)
`
`2035 Reserved
`
`2036 LEUSTATIN® (cladribine) Package Insert (2002)
`
`2037
`
`Merck Receives Complete Response Letter from FDA on Cladribine
`Tablets New Drug Application, FIERCEBIOTECH.COM (Mar. 2, 2011),
`https://www.fiercebiotech.com/biotech/merck-receives-complete-
`response-letter-from-fda-on-cladribine-tablets-new-drug-application
`(accessed Mar. 12, 2024)
`
`2038
`
`M. Hoffman, Interview of K. Rammohan: Short-Term Dosing Regimen
`Gives Cladribine an Advantage in MS, NEUROLOGYLIVE.COM (Jul. 1,
`2020), https://www.neurologylive.com/view/short-commitment-
`dosing-regimen-gives-cladribine-an-advantage-in-ms (accessed Nov.
`10, 2023)
`2039 Transcript of Deposition of Nicholas Bodor in IPR2023-00480 &
`IPR2023-00481 (PROTECTIVE ORDER MATERIAL)
`
`2040
`
`J. C. Sipe et al., Development of Cladribine Treatment in Multiple
`Sclerosis, 1 MULTIPLE SCLEROSIS 343 (1996)
`
`14
`
`
`
`
`
`
`
`
`IPR2023-00050 (Patent 8,377,903)
`
`Exhibit
`No.
`2041 Transcript of Deposition of Nicholas Bodor in IPR2023-00480 &
`IPR2023-00481 [Public, Redacted]
`
`Description
`
`2042 Reserved
`
`2043
`
`FDA News Release: FDA Approves New Oral Treatment for Multiple
`Sclerosis (Mar. 29, 2019), https://www.fda.gov/news-events/press-
`announcements/fda-approves-new-oral-treatment-multiple-sclerosis
`(accessed on Nov. 25, 2023)
`
`2044 U.S. Provisional Patent Application No. 60/458,922
`
`2045 U.S. Provisional Patent Application No. 60/484,756
`
`2046 U.S. Provisional Patent Application No. 60/541,247
`2047 Amendment and Reply to Rule 312 Communication (Jun. 12, 2014), in
`File History for U.S. Patent No. 8,785,415
`
`2048
`
`The 2002 Product Development and License Agreement between
`IVAX International GMBH and Ares Trading S. A. (PROTECTIVE
`ORDER MATERIAL)
`2049 December 17, 2003 Email and Cladribine Briefing Document
`(PROTECTIVE ORDER MATERIAL)
`2050 August 27, 2003 Minutes for the Oral Cladribine for MS Project Joint
`Meeting (PROTECTIVE ORDER MATERIAL)
`
`2051
`
`Video: A. E. Miller, What You Need to Know About Mavenclad®
`(https://www.nationalmssociety.org/Treating-
`MS/Medications/Mavenclad) (2019)
`2052 Transcript of Video: A. E. Miller, What You Need to Know About
`Mavenclad® (2019)
`
`15
`
`
`
`
`
`
`
`
`IPR2023-00050 (Patent 8,377,903)
`
`Exhibit
`No.
`
`Description
`
`2053 Declaration of Alain Munafo, Ph.D.
`
`2054 Declaration of Nicholas Bodor, Ph.D., D.Sc., d.h.c.
`
`2055 Declaration of Yogesh Dandiker, Ph.D.
`
`2056
`
`J. H. Noseworthy et al., Multiple Sclerosis, 343 THE NEW ENGLAND
`JOURNAL OF MEDICINE 938 (2000)
`2057 R. A. Rudick et al., Management of Multiple Sclerosis, 337 THE NEW
`ENGLAND JOURNAL OF MEDICINE 1604 (A. J. J. Wood ed., 1997)
`
`2058
`
`R. A. Rudick et al., Natalizumab plus Interferon Beta-1a for Relapsing
`Multiple Sclerosis, 354 THE NEW ENGLAND JOURNAL OF MEDICINE 911
`(2006)
`
`2059
`
`M. Caporro et al., Two Decades of Subcutaneous Glatiramer Acetate
`Injection: Current Role of the Standard Dose, and New High-Dose
`Low-Frequency Glatiramer Acetate in Relapsing–Remitting Multiple
`Sclerosis Treatment, 8 PATIENT PREFERENCE AND ADHERENCE 1123
`(2014)
`
`2060 COPAXONE® (glatiramer acetate) Package Insert (2014)
`
`2061 Reserved
`
`2062
`
`A. Liu, Better 8 Years Late than Never: Merck KGaA Nabs FDA Nod
`for MS Drug Mavenclad, FIERCEBIOTECH.COM (Apr. 1, 2019),
`https://www.fiercepharma.com/pharma/better-8-years-late-than-never-
`merck-kgaa-nabs-fda-nod-for-ms-drug-mavenclad (accessed Dec. 18,
`2023)
`
`16
`
`
`
`
`
`
`
`
`Exhibit
`No.
`
`2063
`
`IPR2023-00050 (Patent 8,377,903)
`
`Description
`
`ClinicalTrials.gov Publication and Record History, NCT00213135, A
`Safety and Efficacy Study of Oral Cladribine in Subjects With
`Relapsing-Remitting Multiple Sclerosis (RRMS) (CLARITY) (2014),
`https://clinicaltrials.gov/study/NCT00213135;
`https://clinicaltrials.gov/study/NCT00213135?tab=history&a=13,
`(accessed Nov. 25, 2023)
`
`2064
`
`Safety & Side Effects: Learn About the Possible Risks of
`MAVENCLAD,
`https://web.archive.org/web/20231004232146/https://www.mavenclad.
`com/en/home/why-mavenclad/safety-and-side-effects.html (last
`updated Nov. 2022) (accessed Dec. 19, 2023)
`2065 M. Filippi et al., Whole Brain Volume Changes in Patients with
`Progressive MS Treated with Cladribine, 55 NEUROLOGY 1714 (2000)
`
`2066 Declaration of Asher S. McGuffin
`
`2067 Declaration of Willem de Weerd
`
`2068 Declaration of Cindy Kan
`
`2069 Reserved
`
`2070 Reserved
`
`2071 Reserved
`2072 Reply and Amendment (Oct. 3, 2008), in File History for U.S. Patent
`No. 7,888,328
`2073 Declaration of Gillian Farrell in Support of Motion for Admission Pro
`Hac Vice
`
`2074 Supplemental Declaration of Cindy Kan (service only)
`
`17
`
`
`
`
`
`
`
`
`IPR2023-00050 (Patent 8,377,903)
`
`Exhibit
`No.
`
`Description
`
`2075
`
`J. C. Sipe et al., Cladribine in Treatment of Chronic Progressive
`Multiple Sclerosis, 344 THE LANCET 9 (1994) (service only)
`
`2076
`
`The 2002 Product Development and License Agreement between
`IVAX International GMBH and Ares Trading S.A. (PROTECTIVE
`ORDER MATERIAL) (service only)
`
`2077
`
`The 2002 Product Development and License Agreement between
`IVAX International GMBH and Ares Trading S. A. (REDACTED -
`PUBLIC)
`2078 December 17, 2003 Email and Cladribine Briefing Document
`(REDACTED - PUBLIC)
`2079 August 27, 2003 Minutes for the Oral Cladribine for MS Project Joint
`Meeting (REDACTED - PUBLIC)
`2080 Declaration of H. Rachael Million-Perez in Support of Motion for
`Admission Pro Hac Vice
`
`2081
`
`E-mail correspondence between counsel for Patent Owner and counsel
`for Petitioner (March 8, 2024, 12:30 pm EST; March 5, 2024, 3:27 pm
`EST; Feb. 29, 2024, 2:31 pm EST)
`
`
`
`18
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2023-00050 (Patent 8,377,903)
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on June 26, 2024 I caused a true and correct copy of the
`
`foregoing materials:
`
` Patent Owner’s Opposition to Petitioner’s Motion for Additional
`
`Discovery
`
` Patent Owner’s Updated Exhibit List
`
` Exhibit 2081
`
`to be served via e-mail, as consented to by Petitioner, on the following attorneys of
`
`record:
`
`Philip.Segrest@huschblackwell.com
`Nathan.Sportel@huschblackwell.com
`Steve.Howe@huschblackwell.com
`Don.Mizerk@huschblackwell.com
`
`
`
`By: /Cindy Kan/
`Cindy Kan (Reg. No. 76,385)
`Wilmer Cutler Pickering Hale and Dorr LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`Tel: 212-295-6470
`Email: cindy.kan@wilmerhale.com
`
`19
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`
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