Trial@uspto.gov
`571-272-7822
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`Paper No. 21
` Entered: August 29, 2014
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________
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`BIODELIVERY SCIENCES INTERNATIONAL, INC.,
`Petitioner,
`
`v.
`
`RB PHARMACEUTICALS LIMITED,
`Patent Owner.
`____________
`
`Case IPR2014-00325
`Patent 8,475,832
`____________
`
`Before TONI R. SCHEINER, JACQUELINE WRIGHT BONILLA, and
`ZHENYU YANG, Administrative Patent Judges.
`
`BONILLA, Administrative Patent Judge.
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`
`
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. § 42.5
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`

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`Case IPR2014-00325
`Patent 8,475,832
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`1.
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`Introduction
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`On August 26, 2014, an initial conference call was conducted between
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`respective counsel for the parties and Judges Scheiner, Bonilla, and Yang.
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`BioDelivery Sciences International, Inc. (“Petitioner”) was represented by counsel,
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`Danielle Herritt. RB Pharmaceuticals Limited (“Patent Owner”) was represented
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`by counsel, James Bollinger and Daniel Ladow. The purpose of the call was to
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`determine if the parties have any issues concerning the Scheduling Order (Paper
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`18) and to discuss any motions contemplated by the parties.
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`Prior to the call, both parties filed a list of proposed motions. Papers 19, 20.
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`Both lists indicated that the parties may file a motion to exclude and a motion for
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`observation on cross-examination. Id. Consistent with Patent Owner’s List of
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`Proposed Motions (Paper 20), Patent Owner confirmed during the conference call
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`that it would not file a motion to amend.
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`In its list, Petitioner indicated that it may file a motion for additional
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`discovery regarding “Facts Relevant to Determination” of whether MonoSol Rx,
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`LLC (“MonoSol”) is a real party-in-interest in relation to Patent Owner, and a
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`“Motion for Determination” that MonoSol is a real party-in-interest. Paper 19.
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`Petitioner also indicated that it may file a motion for additional discovery
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`regarding secondary considerations, a motion to request oral argument, and a
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`motion for supplemental information and evidence. Id.
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`2.
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`Scheduling Order
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`The parties stated during the call that they may wish to modify one or more
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`of DUE DATES 1-5 in the Scheduling Order (Paper 18). We reminded the parties
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`that, without obtaining prior authorization from the Board, they may stipulate to
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`different dates for DUE DATES 1-5 by filing an appropriate notice with the Board.
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`Case IPR2014-00325
`Patent 8,475,832
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`3. Motions to Exclude, Observations on Cross-Examination, and Requests for
`Oral Hearing
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`Both parties are authorized to file a motion to exclude evidence, a motion for
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`observation on cross-examination, as well as a request for oral argument, as
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`indicated in the Scheduling Order (Paper 18).
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`4.
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`Discovery
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`The parties are reminded of the discovery provisions of 37 C.F.R. §§ 42.51-
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`52 and Office Patent Trial Practice Guide. See Office Patent Trial Practice Guide,
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`77 Fed. Reg. 48,756, 48,761-62 (Aug. 14, 2012). Discovery requests and
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`objections are not to be filed with the Board without prior authorization. If the
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`parties are unable to resolve discovery issues between them, the parties may
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`request a conference with the Board. A motion to exclude, which does not require
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`Board authorization, must be filed to preserve any objection. See 37 C.F.R.
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`§ 37.64; Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,767.
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`Each party may depose experts and affiants supporting the opposing party.
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`The parties are reminded of the provisions for taking testimony found at 37 C.F.R.
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`§ 42.53 and the Office Patent Trial Practice Guide at 77 Fed. Reg. at 48,772,
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`App. D. The parties shall file entire transcripts of any depositions, rather than
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`portions or sections, when relying on such testimony in a paper.
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`In its motions list, Petitioner indicated that it may file two different motions
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`for additional discovery. Paper 19 at 2-3. During the conference call, counsel for
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`Petitioner requested that the Board authorize, at this time, the filing of Petitioner’s
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`proposed motion for additional discovery regarding “Facts Relevant to
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`Determination” of whether MonoSol is a real party-in-interest, particularly as it
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`relates to three agreement documents outlined in Petitioner’s motion list. Paper 19
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`at 2. We asked Petitioner to explain why obtaining such information would be
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`useful, i.e., how it would uncover information of substantive value to a contention
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`of Petitioner in this proceeding. See Garmin Int’l Inc. v. Cuozzo Speed Techs.
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`LLC, IPR2012-00001, Paper 26 at 6-7.
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`Petitioner responded that a different pending patent application, allegedly
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`assigned to Monosol, addresses claims that Petitioner contends are not patentably
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`distinct from claims challenged in this proceeding. Petitioner referred to the
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`estoppel provision of 37 C.F.R. § 42.73(d)(3)(i), which states that a “patent
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`applicant or owner is precluded from taking action inconsistent with the adverse
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`judgment, including obtaining in any patent: (i) A claim that is not patentably
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`distinct from a finally refused or canceled claim.” Petitioner also cited 37 C.F.R.
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`§ 42.8(b)(1), which states that Patent Owner’s mandatory notice must “[i]dentify
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`each real party-in-interest for the party.”
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`As an initial matter, we note Patent Owner’s Second Amended Mandatory
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`(Paper 16) states that MonoSol was the original assignee of the ʼ832 patent and
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`that “named inventors were, and in some cases remain, MonoSol employees,” but
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`that MonoSol now has exclusive manufacturing rights under the patent and
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`“therefore is an implied, exclusive licensee.” Id. at 2. In that Notice, Patent
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`Owner also states “[t]o the extent these facts are sufficient to render MonoSol a
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`real party-in-interest, Patent Owner also identifies MonoSol under 37 CFR
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`§ 42.8(b)(1).” Id. We are satisfied that Patent Owner adequately meets the notice
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`requirement of § 42.8(b)(1).
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`In relation to Petitioner’s assertions regarding a pending patent application
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`assigned to Monosol, we note that the estoppel provision of § 42.73(d)(3)(ii) will
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`apply to Patent Owner only in the event that we enter an adverse judgment against
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`Patent Owner, i.e., an event that has yet to occur, if it ever will. 37 C.F.R.
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`Patent 8,475,832
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`§ 42.73(b), (d)(3). Moreover, Petitioner’s assertions assume that Monosol, as a
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`“patent applicant or patent owner” under § 42.73(d)(3), in the future, in a different
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`patent application, will pursue or obtain claims that are not patentably distinct from
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`claims disclaimed or cancelled in this proceeding. Such assertions are entirely
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`speculative, not only in view of where we stand in this proceeding, but also in view
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`of the fact that any pending application is still pending, i.e., an applicant can still
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`amend claims.
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`Moreover, Petitioner stated in its motions list, and during the call, that it
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`requests additional discovery in relation to whether Monosol is a real party-in-
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`interest (Paper 19 at 2), but then indicated on the call that it actually seeks
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`information as to whether Monosol is a “patent applicant or patent owner” for the
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`purposes of § 42.73(d)(3). A motion for additional discovery regarding a real
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`party-in-interest is not the proper avenue to seek information as to whether
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`Monosol, as a “patent applicant or patent owner,” is estopped from taking action in
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`an entirely different matter. Even assuming Patent Owner is subject to an adverse
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`judgment at a later date in this case, the time and place to address whether an
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`applicant or patent owner is subject to § 42.73(d)(3) is after an adverse judgment is
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`entered, and in a proceeding relevant to the pending application or patent
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`potentially impacted by the estoppel, i.e., not in this proceeding relating to claims
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`of the ’832 patent.
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`Thus, we do not authorize Petitioner to file its proposed motion for
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`additional discovery regarding “Facts Relevant to Determination” of whether
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`MonoSol is a real party-in-interest, or its proposed “Motion for Determination”
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`that MonoSol is a real party-in-interest. Paper 19 at 2.
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`We also do not authorize, at this time, Petitioner to file its proposed motion
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`for additional discovery regarding secondary considerations. Id. at 2-3. Patent
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`Owner has yet to file a Patent Owner Response in this case, and did not raise
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`secondary considerations in its Preliminary Response (Paper 15). To the extent
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`that Patent Owner raises such considerations in the future, as discussed in the
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`conference call, we encourage the parties to confer, and wherever possible agree,
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`in relation to additional discovery. If the parties cannot agree regarding additional
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`discovery between themselves, a party must seek authorization to file a motion for
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`additional discovery by initiating a conference call with the Board and the other
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`party. The Board applies a “necessary in the interest of justice” standard when
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`deciding whether to grant additional discovery in inter partes reviews. 35 U.S.C.
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`§ 316(a)(5); 37 C.F.R. § 42.51(b)(2). In relation to a motion for additional
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`discovery, we point the parties to guidance in the following cases: Garmin,
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`IPR2012-00001, Papers 26 and 20; RPX Corp. v. VirnetX Inc., IPR2014-00171,
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`Paper 25; Corning Inc. v. DSM IP Assets B.V., IPR2013-00043, Paper 27; Apple
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`Inc. v. Achates Reference Publ’g, Inc., IPR2013-00080, Paper 66; and Microsoft
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`Corp. v. Proxyconn, Inc., IPR2012-00026, Paper 32.
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`5.
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`Proposed Motion to Submit Supplemental Information or Evidence
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`Petitioner also indicated that it may request to file a motion to file
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`supplemental information and evidence. Paper 19 at 3. As discussed during the
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`conference call, “supplemental information” under 37 C.F.R. § 42.123 differs from
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`“supplemental evidence” under § 42.64. For instance, § 42.64 addresses objections
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`to evidence, as well as service of supplemental evidence to respond to objections.
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`Any objection to evidence must be served, but not filed. 37 C.F.R. § 42.64(b)(1).
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`A party seeking to file supplemental evidence under § 42.64(b)(2) must receive
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`Patent 8,475,832
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`Board authorization to file such evidence, because the rule contemplates serving
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`such evidence, not filing it. Id. at § 42.64(b)(2).
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`Under § 42.123(a), on the other hand, a party may file a motion to submit
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`supplemental information if the following requirements are met: (1) a request for
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`authorization to file such motion is made within one month of the date the trial is
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`instituted; and (2) the supplemental information is relevant to a claim for which
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`trial has been instituted. To the extent that either party wishes to seek late
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`submission of supplemental information under § 42.123(b), i.e., more than one
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`month after the date the trial was instituted, that party must seek authorization to
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`file such a motion by initiating a conference call with the Board and the other
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`party, when it becomes relevant. During such a call, the requesting party should be
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`prepared to discuss why the supplemental information reasonably could not have
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`been obtained earlier, and why consideration of the supplemental information
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`would be in the interests-of-justice. 37 C.F.R. § 42.123(b).
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`6. Motions
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`The parties are reminded that, except as otherwise provided in the Rules,
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`Board authorization is required before filing a motion. 37 C.F.R. § 42.20(b). A
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`party seeking to file a motion should request a conference to obtain authorization
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`to file the motion. No other motions are authorized in this proceeding at this time.
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`7.
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`Protective Order
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`The parties have not discussed a protective order at this time. No protective
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`order has been entered. Should circumstances change, the parties are reminded of
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`the requirement for a protective order when filing a Motion to Seal. 37 C.F.R.
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`§ 42.54. If the parties choose to propose a protective order other than or departing
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`from the default Standing Protective Order, Office Trial Practice Guide, 77 Fed.
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`Patent 8,475,832
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`Reg. 48,756, App. B (Aug. 14, 2012), they must submit a joint, proposed
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`protective order, accompanied by a red-lined version based on the default
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`protective order in Appendix B to the Board’s Office Patent Trial Practice Guide.
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`See id. at 48,769.
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`Accordingly, it is
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`ORDERED that no other motions are authorized at this time, other than
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`those already authorized by rule, the Notice of Filing Date Accorded to Petitioner,
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`the Scheduling Order; and
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`FURTHER ORDERED that due dates specified in the Scheduling Order
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`dated July 29, 2014, remain unchanged.
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`Case IPR2014-00325
`Patent 8,475,832
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`PETITIONER:
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`Danielle L. Herritt
`Kia L. Freeman
`McCarter & English, LLP
`dherritt@mccarter.com
`kfreeman@mccarter.com
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`PATENT OWNER:
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`James M. Bollinger
`Daniel A. Ladow
`Troutman Sanders LLP
`james.bollinger@troutmansanders.com
`daniel.ladow@troutmansanders.com
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