McGuffin, Asher S.
`
`From:
`Sent:
`To:
`
`Cec:
`
`Subject:
`
`Counsel,
`
`McGuffin, Asher S.
`Friday, March 8, 2024 12:30 PM
`Philip.Segrest@huschblackwell.com; Sportel, Nathan; Howe,Steve; Mizerk, Don;
`Hitchens, A. Lauren
`WH Merck KGaA Mavenclad ANDA; Whelan, Emily; Geng, Deric; Bassett, David; Ferrera,
`Vinita; Kan, Cindy
`RE: TWi v. Merck Serono, IPR2023-00049 & -00050: Dr. Bodor
`
`TWi’s threat to move for non-routine discovery in response to Patent Owner’s requestto engagein a collaborative
`discussion about how to accommodateits witness’s healthis not well taken. TWi has notidentified anything in
`Patent Owner’s request that is unreasonable but has instead prematurely dismissed Patent Owner’s proposal
`withoutthe benefit of a good faith meet and confer.
`
`TWi has wholly mischaracterized Patent Owner’s proposal as refusing to produce Dr. Bodorfor cross-
`examination. That is not so. Patent Owner agreesthat cross-examination is routine discovery, and we are
`attempting to provide TWi the fullest opportunity possible, under the circumstances, to cross-examine Dr.
`Bodor. However, his health is not routine, and Patent Owner cannot override Dr. Bodor’s own medical decisions
`abouthis health and the risks he apparently takesin sitting for a deposition. We believe that a combination of
`reasonable accommodations, including offering to stipulate to the admissibility Dr. Bodor’s deposition transcript
`from IPR2023-00480 and -00481 and, as we havealready offered, potentially sitting for a short, remote deposition,
`would be more than adequateto allow TWitofully explore Dr. Bodor’s testimony. Indeed, Dr. Bodor’s testimonyis
`itself limited only to his knowledgeof the Ilvax/Serono partnership and the disclosuresin his patent and
`corresponding applications—none of which depends on any unique ground or arguments presented by TWior
`Hopewell. TWi has not explained how its examination of Dr. Bodor would elicit testimony that is not duplicative of
`the three hours Dr. Bodor has already been deposed on the issuesin his Declaration. Regardless, Patent Owner’s
`proposal that Dr. Bodor sit for an additional hour remotely should be morethan sufficient for any such
`examination.
`
`Moreover, Patent Owner doesnot agreethatuse of his prior testimony would be inadmissible hearsay or would
`violate TWi’s right of confrontation. As TWi knows, the right of confrontation does not extend to civil or
`administrative proceedings. And the sworn prior testimonyof an unavailable witness subject to prior cross-
`examination is admissible under Rule of Evidence 804(b)(1). Nonetheless, consistent with the Board’s procedural
`rules, 37 C.F.R. § 42.51(b)(1)(ii), Patent Owner is committed to offering TWi the fullest opportunity possible, under
`the circumstances, to depose Dr. Bodor, and we hope TWiwill engage with us in discussing reasonable
`accommodations.
`
`Turning to logistics, as noted in my previous email, the Board’s default protective order lays out a protocol for
`handling allegedly confidential information. Under that protocol, documents producedbutnotfiled, such as Dr.
`Bodor’s prior testimony, can be marked PROTECTIVE ORDER MATERIAL,in which caseit should be handled ina
`manner that preservesits confidentiality. Default Protective Order 8§ 2, 5(B). Patent Owner would identify what
`information in the transcript is confidential and why it should remain sealed sufficiently in advance of the due date
`for TWi’s reply to facilitate filing a motion to seal. 8 5(A). We noteatthis juncture, however, that Patent Owner is
`merely attempting to facilitate providing information to TWi so that TWi can fully consider Patent Owner’s
`proposal.
`If it is TWi’s position thatit is refusing to consider Patent Owner’s proposal without adequately meeting
`and conferring, we will note that for the Board.
`
`1
`
`Merck 2081
`TWi v Merck
`IPR2023-00049
`
`

`

`Please let us know whether you are willing to confer about potential accommodations, as requested, before we
`seek relief from the Board.
`
`Thanks,
`
`Asher S. McGuffin | WilmerHale
`60 State Street
`
`Boston, MA 02109 USA
`+1 617 526 6201 (t)
`+1 617 526 5000(f)
`asher.mcguffin@wilmerhale.com
`
`Please consider the environmentbeforeprinting this email.
`
`This email message and any attachmentsare being sent by Wilmer Cutler Pickering Hale and Dorr LLP, are confidential, and may beprivileged. If you
`are not the intendedrecipient, please notify us immediately—byreplying to this messageor by sending an email to postmaster@wilmerhale.com—
`and destroy all copies of this message and any attachments.Thank you.
`
`For more information about WilmerHale, pleasevisit us at http://www.wilmerhale.com.
`
`From: Segrest, Philip <Philip.Segrest@huschblackwell.com>
`Sent: Tuesday, March 5, 2024 3:27 PM
`To: McGuffin, Asher S. <Asher.McGuffin@wilmerhale.com>; Sportel, Nathan <Nathan.Sportel@huschblackwell.com>;
`Howe, Steve <Steve.Howe@huschblackwell.com>; Mizerk, Don <Don.Mizerk@huschblackwell.com>; Hitchens, A. Lauren
`<Lauren.Hitchens@huschblackwell.com>
`Cc: WH Merck KGaA Mavenclad ANDA <WHMerckKGaAMavencladANDA@wilmerhale.com>; Whelan, Emily
`<Emily.Whelan@wilmerhale.com>; Geng, Deric <Deric.Geng@wilmerhale.com>; Bassett, David
`<David.Bassett@wilmerhale.com>; Ferrera, Vinita <Vinita.Ferrera@wilmerhale.com>; Kan, Cindy
`<Cindy.Kan@wilmerhale.com>
`Subject: RE: TWi v. Merck Serono, IPR2023-00049 & -00050: Dr. Bodor
`
`[EXTERNALSENDER
`
`Counsel,
`
`Petitioner TWi does not consider the proposal regarding cross-examination of Dr. Bodoras a fact witness reasonable and
`does not agree. Cross-examination of the other side’s declarants is routine discovery, and Dr. Bodor’s deposition in
`another IPR by different party represented by different counsel asserting its own groundsofinvalidity for obviousnessis
`hearsay and does not adequately protect Petitioner’s TWi’s right to confront and cross-examine witnesseson its own
`behalf. Consolidated Trial Practice Guide at 23; 37 C.F.R. § 42.51(b)(1)(ii); 35 U.S.C. § 315(a)(5)(A); Samsung Elecs. Co.,
`Ltd. v. Nucurrent, Inc., No. |PR2019-00860, Paper 27 at 2, 2020 WL 3965912, at *1 (P.T.A.B. July 13, 2020) (“Cross
`examination is ordinarily allowed in each separate proceeding as a matter of routine discovery.”). In Samsung, the Board
`denied patent owner’s request to prevent Petitioner Samsung from deposing Patent Owner's declarants where Patent
`Owner argued that “that these proceedings have been consolidated (or effectively consolidated with the alignment of
`due dates).” /d. Here there has been no such consolidation or alignment. If Dr. Bodor is unable or unwilling to sit for
`cross-examination in the United States the Patent Owner should not submit or rely on direct testimony from him in
`these proceedings.
`
`Evenif the cross-examination of declarant Dr. Bodor were not “routine discovery”for these proceedings, cross-
`examination of the declarant would be required as “additional discovery” herein the interests of justice. 37 C.F.R.
`§ 42.51(b)(2)(i); 35 U.S.C. § 315(a)(5)(A); Arkema Inc. v. Honeywell Int'l Inc., No. PATENT 9,157,017 B2, 2020 WL 439969,
`at *2 (P.T.A.B. Jan. 27, 2020) (“After considering the parties' respective arguments, wefind that the cross-examination of
`2
`
`

`

`Mr. Posillico in this case is in the interest of justice.”). Moreover, if Dr. Bodor submits such a declaration, it would here
`be appropriate (and the interest of justice would also require) as additional discovery the production of documents
`including, for example, all communications between Dr. Bodor and Patent Owner or counsel for Patent Owner. From
`Patent Owner’s description and from declaration previously filed in Hopewell Pharma Ventures, Inc. v. Merck Serono SA,
`IPR2023-00480 and -00481, Dr. Bodoris being offered as a fact witness, not an expert, and his communications with
`counsel for Patent Owner are notprivileged.
`
`Also , our understandingis that no provision in IPR practice (unlike district court litigation) supports Patent Owner’s
`suggestion that an entire cross-examination deposition may be “designated PROTECTIVE ORDER MATERIALS.” See
`Argentum Pharms. LLC v. Alcon Rsch., Ltd., No. |PR2017-01053, 2018 WL 495204,at *1 (P.T.A.B. Jan. 19, 2018) (“We are
`mindful that, in district court, a party routinely will determine (by marking or stamping a document‘confidential’)
`whether a documentis produced under the termsof a district court protective order. By contrast, in an inter partes
`review,‘the default rule is that all papers ... are open and available for access by the public.’”) (quoting Garmin Int’I v.
`Cuozzo SpeedTechs., LLC, Case IPR2012—00001, Paper 34 at 2, 2013 WL 8696523 (PTAB Mar. 14, 2013)); Corning Optical
`CommunicationsRF, LLC, v. PPC Broadband, Inc., Case IPR2014—00440, Paper 46 at 3, 2015 WL 1523712 (PTAB April 6,
`2015) (“With respect to Exhibits 2106, 2107, and 2108, the Motion to Seal states merely that Patent Owner has
`identified the information as subject to a protective order in either a Civil Action before a U.S. District Court or an
`Investigation before the U.S. International Trade Commission(ITC)....That is insufficient. The parties do not represent
`that the District Court or the ITC has ruled that any such information would be presentedfor trial in a “sealed” status.
`Wealready areattrial.”). Our understanding regarding confidential materials is discussed more extensively in our other
`email today concerning motionsto seal and protective orders in IPR practice.
`If Patent Owner contends that some
`information in Dr. Bodor’s cross-examination is confidential to Patent Owner (even though Dr. Bodoris not an employee
`of Patent Owner and even thoughhis declaration in that proceeding was not considered confidential), then Patent
`Owner should proposeredactionsofthe allegedly confidential information, not seek to file the entire routine discovery
`cross-examination deposition under seal.
`
`If Patent Ownerintends to approach the Boardfor relief or to request a conferencecall concerning the cross-
`examination of Dr. Bodor then TWiwill also ask for a conference with the Board to discuss its request additional
`discovery including the production of documents discussed above. Please send us a copy of what Patent Owner will
`submit to the Board, and wewill add a brief statement of what Petitioner also wants to discuss in that conference.
`
`Philip D. Segrest, Jr.
`(he/him/his)
`Partner
`Direct: 312-526-1548
`Mobile: (312) 805-0314
`Philip. Segrest@huschblackwell.com
`
`From: McGuffin, Asher S. <Asher.McGuffin@wilmerhale.com>
`Sent: Thursday, February 29, 2024 2:31 PM
`To: Segrest, Philip <Philip.Segrest@huschblackwell.com>; Sportel, Nathan <Nathan.Sportel@huschblackwell.com>;
`Howe,Steve <Steve. Howe@huschblackwell.com>; Mizerk, Don <Don.Mizerk@huschblackwell.com>; Hitchens, A. Lauren
`<Lauren.Hitchens@huschblackwell.com>
`Cc: WH Merck KGaA Mavenclad ANDA <WHMerckKGaAMavencladANDA@wilmerhale.com>; Whelan, Emily
`<Emily.Whelan@wilmerhale.com>; Geng, Deric <Deric.Geng@wilmerhale.com>; Bassett, David
`<David.Bassett@wilmerhale.com>; Ferrera, Vinita <Vinita.Ferrera@wilmerhale.com>; Kan, Cindy
`<Cindy.Kan@wilmerhale.com>
`Subject: TWi v. Merck Serono, IPR2023-00049 & -00050: Dr. Bodor
`
`[EXTERNAL EMAIL]
`
`Counsel,
`
`

`

`Weanticipate submitting a declaration from Dr. Nicholas Bodor in connection with our Patent Owner
`Response in IPR2023-00049 and -00050. Dr. Bodor’s declaration will be substantively the same as his
`declaration previously filed in Hopewell Pharma Ventures,Inc. v. Merck Serono SA, IPR2023-00480 and -
`00481.
`
`Dr. Bodor, who is 85 years old and suffers from chronic health conditions, has expressed serious
`concerns abouthis health following his deposition in IPR2023-00480 and -00481. To addresshis health
`concerns, weare reaching out in advanceoffiling our Patent Owner Response to discuss options to
`minimize the burden on Dr. Bodor that would be agreeable to both parties if TWi intends to depose Dr.
`Bodor.
`
`To that end, provided TWi consentsto entry of the PTAB’s default protective order, Patent Owner is
`willing to produce a copy of Dr. Bodor’s deposition transcript from IPR2023-00480 and -00481, which is
`designated PROTECTIVE ORDER MATERIALin those matters, in IPR2023-00049 and -00050. Once TWi
`has had achanceto review the transcript, we would like to meet and confer about whether TWi intends
`to depose Dr. Bodor again and, if it does, what reasonable accommodations the parties can agree to that
`would protect Dr. Bodor’s health in view of his recent deposition on substantially the same declaration.
`
`If TWi does not agree to reasonable accommodations, such as submitting Dr. Bodor’s prior transcript
`here and either forgoing a second deposition or limiting any deposition to no more than one more hour
`fully remote, then we will need to approach the Boardfor relief.
`
`Please let us know if you are open to this proposal.
`
`Thanks,
`
`Asher S. McGuffin | WilmerHale
`60 State Street
`
`Boston, MA 02109 USA
`+1 617 526 6201(t)
`+1 617 526 5000(f)
`asher.mcguffin@wilmerhale.com
`
`Please consider the environmentbefore printing this email.
`
`This email message and any attachmentsare being sent by Wilmer Cutler Pickering Hale and Dorr LLP, are confidential, and may beprivileged. If you are not
`the intended recipient, please notify us immediately—byreplying to this message or by sending an email to postmaster@wilmerhale.com—anddestroyall
`copies of this message and any attachments. Thank you.
`
`For more information about WilmerHale, please visit us at http://www.wilmerhale.com.
`
`