Ward, Trenton (External)
`Thursday, December 6, 2018 3:15 PM
`Precedential_Opinion_Panel_Request
`Tara Raghavan; Steven J. Birkos; EXT- wrakoczy@rmmslegal.com; Joseph T. Jaros; Rea,
`Terry (External); 'slentz@crowell.com'; 'TLiu@agpharm.com' (TLiu@agpharm.com);
`Livingstone, John; Yoshida, Naoki; 'toan.vo@bausch.com' (toan.vo@bausch.com);
`Hartmann, Anthony; Rudolph, Barbara; Ward, Trenton (External)
`IPR2017-00190: Authority Under 35 U.S.C. 315(d) to Stay a Reissue or Reexamination
`Proceeding
`IPR2017-00190_2018-07-27_Paper 84_Kaken Request for Rehearing and for Expanded
`Panel.pdf
`
`. F
`
`rom:
`Sent:
`To:
`Cc:
`
`Subject:
`
`Attachments:
`
`To the Honorable Board,
`
`Based on my professional judgment, I believe this case requires an answer to a precedent-setting
`question of exceptional importance:
`
`Whether the authority under 35 U.S.C. § 315(d) to stay a reissue or reexamination
`proceeding before the Office “during the pendency of an inter partes review” ends once
`a final written decision has been entered and all requests for rehearing have expired or
`concluded or, instead, ends after the exhaustion of an appeal?
`
`PTAB panels have inconsistently answered this important question.
`
`The “Director has an interest in creating binding norms for fair and efficient Board proceedings, and
`for establishing consistency across decision makers.” Patent Trial and Appeal Board (“PTAB”)
`Standard Operating Procedure 2 (Rev. 10) (“SOP2”), 2. To that end, Precedential Opinion Panel
`(“POP”) review “may be used to resolve conflicts between Board decisions.” SOP2, 4.
`
`POP review is necessary here because PTAB panels are currently answering the above question in
`directly contradictory ways. For instance, consistent with the plain language of § 315(d), Patent
`Owner is aware of at least eight cases where Board panels have lifted stays in concurrent reissue or
`reexamination proceedings after a final written decision but before exhaustion of an appeal. See
`Table 1 below. Patent Owner is unaware of any cases to the contrary. Nevertheless, the panel in
`this proceeding applied § 315(d) inconsistently and denied a request to lift a stay under
`analogous circumstances.
`
`This request also implicates issues related to transparency and clarity in agency decision-
`making. Although unclear from the records, other panels may have made similar denials. Because
`motions to lift a stay must be authorized by the panel, denials of such requests may occur only by
`email and, when they do, likely do not become part of the record. In fact, in this proceeding, were it
`not for Patent Owner’s efforts, the Board’s inconsistent and unexplained decision would not have
`become part of the transparent record.
`
`Accordingly, in the interests of consistency, clarity, and transparency, a precedential decision by the
`Board is necessary to establish whether a stay of a concurrent proceeding under 35 U.S.C. § 315(d)
`should be lifted after a final written decision but before exhaustion of an appeal. Pursuant to SOP2,
`IPR2017-00190
`Ex. 3001 p. 1 of 5
`
`1
`
`

`

`Kaken Pharmaceutical, Inc. and Bausch Health Companies Inc. (collectively “Patent Owner”)
`therefore respectfully submits this Request for POP review. According to SOP2, § II(C), Patent
`Owner attaches herewith Patent Owner’s Request for Rehearing Under 37 C.F.R. § 42.71(d), and for
`an Expanded Panel, which was timely filed and is still pending before the Board. See No. IPR2017-
`00190, Paper 84 (PTAB July 27, 2018); see also infra § II.
`
`I.
`
`POP Review is Needed
`
`POP review is necessary here to address a “conflict between Board decisions,” to establish binding
`agency authority for a major procedural issue, and to promote consistency, clarity, and transparency
`in PTAB decisions. SOP2, 4. Without POP review, Board panels will continue to contradict each
`other, some lifting stays prior to exhaustion of all appeals and others waiting until appeals are
`exhausted. Given this panel-by-panel, inconsistent application of § 315(d), patent owners are left
`with uncertainty in making important business decisions related to their patent rights.
`
`For instance, among the cases in Table 1, the Board panel in Hewlett-Packard Company v. MCM
`Portfolio, LLC, IPR2013-00217, lifted a stay of a reissue application following the final written decision
`but before a subsequent notice of appeal. Paper 32, at 2 (PTAB Sept. 12, 2014). In Gnosis S.p.A. v.
`Merck & CIE, IPR2013-00117, the Board lifted the stay in a reexamination proceeding following both
`the final written decision and the notice of appeal, while the appeal was pending. Paper 74, at 3
`(PTAB Feb. 5, 2015). These cases are consistent with the statutorily-granted right to reissue
`(35 U.S.C. § 251), the special status afforded reissue applications (MPEP § 1442), the plain language
`of 35 U.S.C. § 315(d), and PTAB’s interpretation of the same. Specifically, Congress allowed for
`stays during the “pendency” of an inter partes review. 35 U.S.C. § 315(d) (emphasis
`added). Pendency before the Board is “normally no more than one year,” consistent with the 12-
`month statutory mandate for obtaining a final written decision following institution of an inter partes
`review and clearly inconsistent with including the time to exhaust all appeals. 37 C.F.R. § 42.100;
`see also 35 U.S.C. § 316(a)(11). Also consistent with that view, in Valeo, IPR2016-00502, Paper 44
`at 7 (PTAB July 20, 2017), the Board made clear that a pending reissue application is not
`“concurrent” with an inter partes review proceeding when the Board “already issued a Final Written
`Decision.” Notably, this interpretation is also entirely consistent with the Board’s practice of applying
`the estoppel provisions of 35 U.S.C. § 315(e)(1) upon final written decision and not upon exhaustion
`of any appeal therefrom. See, e.g., Apple Inc. v. Papst Licensing GmbH & Co., KG, IPR2016-01860,
`Paper 28 at 9 (PTAB Jan. 10, 2018) (rejecting argument that the Board should not apply estoppel
`provisions until exhaustion of appeals in other proceedings and, instead, terminating inter partes
`review under §315(e)(1) following final written decisions in those proceedings); see also Facebook,
`Inc. v. Uniloc USA, Inc., IPR2017-01427, Paper 30 at 2-3, 8 (PTAB May 29, 2018) (applying estoppel
`provisions within one week of final written decision in another proceeding and well before the
`exhaustion of all appeals).
`
`In the face of the plain language of the statute and PTAB’s prior interpretation thereof, the Board here
`denied Patent Owner’s request to lift the stay of a reissue application after entry of the final written
`decision. See IPR2017-00190, Ex. 2203, at 1, 3. The Board did not cite any precedent or controlling
`authority in its decision. Id. at 3. Patent Owner brought to the Board’s attention some of the
`contradictory decisions in Table 1 and sought clarification of the Board’s decision. Id. at 2. Only then
`did the Board state that the reissue application would remain stayed until “either the time for appeal
`has expired and no appeal has been filed, or upon the exhaustion of any appeal from this
`proceeding.” Id. at 1. But the Board again provided no reasoning, legal authority, or justification for
`its contradictory decision. See id. Notably, such limited explanation fails to provide a “satisfactory
`explanation” for the Board’s decision-making. See Paper 84, at 9-12; see also id. at 12-14 (citing
`Ultratec, Inc. v. CaptionCall, LLC, 872 F.3d. 1267, 1271-75 (Fed. Cir. 2017)).
`2
`
`

`

`Patent Owner timely sought rehearing of the Board’s decision, and that request remains
`pending. See generally Paper 84. Together with Patent Owner’s request for rehearing, Patent
`Owner also included the email correspondence recording the Board’s denial of Patent Owner’s
`request to lift stay. See id. (citing Ex. 2203). But for Patent Owner’s rehearing request, the Board’s
`denial would not be in the record of this proceeding. See Ultratec, 872 F.3d at 1275. The Board has
`yet to respond to Patent Owner’s July 27th-request for rehearing, whether by entering an order or
`requesting additional briefing. Cf. Office Practice Trial Guide, 77 Fed. Reg. 48755, 48768 (Aug. 14,
`2012) (“The Board envisions that, absent a need for additional briefing by an opponent, requests for
`rehearing will be decided approximately one month after receipt of the request.”).
`
`At this time, Patent Owner has not identified any prior PTAB case law, order, or other decision
`consistent with this panel’s decision. And neither the Board nor Petitioners have pointed to any such
`cases. Accordingly, there is a clear conflict between this panel’s application of § 315(d) and prior
`Board decisions.
`
`This conflict thwarts consistent panel procedure and denies parties clarity and transparency with
`respect to their rights before the PTAB. See SOP2, at 2, 4 (POP review is used for “creating binding
`norms for fair and efficient Board proceedings,” and for promoting “certainty and
`consistency.”). Because stays in concurrent reissue and reexamination proceedings impact patent-
`owner property rights beyond the instant inter partes review proceeding, the unpredictability of the
`Board’s decision paralyzes a patent owner’s ability to pursue statutorily-granted reissue rights, make
`decisions with respect to ongoing or future litigation, and creates additional questions about liability
`for stakeholders by making intervening rights less than clear. These consequences are amplified, as
`in the present case, by unexplained decision-making and delays in Board action.
`
`The Board’s inconsistent application of § 315(d) merits POP review.
`
`II.
`
`Patent Owner’s Request for POP Review is Timely or Otherwise Permissible
`
`SOP2 requires that this “email be accompanied by a request for rehearing filed with the
`Board.” SOP2, 5 (emphasis added). Accordingly, Patent Owner provides its previously filed Request
`for Rehearing along with this email. Patent Owner’s request satisfied the requirements of 37 C.F.R.
`§ 42.71(d), including compliance with the due dates set forth therein. See id.; see also Paper 84
`(filed on July 27, 2018, within 14 days from the Board’s panel decision (Ex. 2203) on July 13, 2018).
`
`SOP2 does not state a deadline for requesting POP review. See SOP2, 5–6. To the extent,
`however, that the Screening Committee interprets the procedures in SOP2 to generally require
`submission of a POP-review request by the same deadline set for the request for rehearing under
`37 C.F.R. § 41.52(a) or 42.71(d), several factors nevertheless support consideration of Patent
`Owner’s request for POP review. When Patent Owner filed its Request for Rehearing, SOP2 had not
`yet been revised, and procedures for requesting POP review were not yet available.
`
`Further, the flexible nature of SOP2 in this instance is reasonable, providing parties in Patent Owner’s
`position with a fair procedure for POP requests to be considered. As noted above, Patent Owner’s
`Request for Rehearing, which forms the basis for this POP request, has not been decided and is still
`pending before the Board without any other mechanism for obtaining a decision. Patent Owner’s
`reissue application has been stayed for over fifteen months and each day Patent Owner’s Request for
`Rehearing remains unaddressed, the Board prevents Patent Owner from exercising its statutory right
`to pursue reissue claims pursuant to 35 U.S.C. § 251. See Paper 84, at 11. Accordingly, even if the
`Screening Committee generally requires that requests for POP review be submitted within the time
`3
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`

`

`limit set for corresponding requests for rehearing, the unique circumstances of this case should
`permit Patent Owner to avail itself of this new procedure.
`
`Alternatively, SOP2 provides that the Director may convene a POP review “sua sponte” and “in his
`or her sole discretion and without regard to the procedures set forth herein.” SOP2, 5 (emphasis
`added). Should the Screening Committee determine that Patent Owner’s request is untimely, sua
`sponte review is appropriate here to resolve the “conflict between Board decisions” described above,
`which arose before SOP2 was put in place. SOP2, 4; see also supra § 1.
`
`For each of the above-stated reasons, Patent Owner respectfully requests POP review of the PTAB
`panel decision.
`
`Thank you,
`
`/s/ Trenton A. Ward
`ATTORNEY OF RECORD FOR PATENT OWNER
`
`Case No.
`
`No.
`1.
`
`IPR2013-00071
`
`Paper No.
`103
`
`25
`
`74
`
`32
`
`38
`39
`121
`
`86
`
`4
`
`Table 1
`Orders Lifting Stays in Concurrent Reissue or Reexamination Proceedings
`PRIOR to Appeal Exhaustion
`Parties
`Avaya Inc., Dell Inc., Sony
`Corporation of America, and
`Hewlett-Packard Co. v. Network-1
`Security Solutions, Inc.
`Sony Corporation of America, Axis
`Communications AB, and Axis
`Communications Inc. v. Network-1
`Security Solutions, Inc.
`Gnosis S.p.A., Gnosis Bioresearch
`S.A., and Gnosis U.S.A., Inc. v.
`Merck & CIE
`Hewlett-Packard Company v.
`MCM Portfolio, LLC
`Google Inc. v. Grandeye Ltd.
`Google Inc. v. Grandeye Ltd.
`GEA Process Engineering, Inc. v.
`Steuben Foods, Inc.
`Argentum Pharmaceuticals LLC,
`Mylan Pharmaceuticals Inc.,
`
`2.
`
`3.
`
`4.
`
`5.
`6.
`7.
`
`8.
`
`IPR2013-00092
`
`IPR2013-00117
`
`IPR2013-00217
`
`IPR2013-00547
`IPR2013-00548
`
`IPR2014-00043
`
`IPR2016-00204
`
`

`

`Breckenridge Pharmaceutical, Inc.
`and Alembic Pharmaceuticals, Ltd.
`v. Research Corporation
`Technologies, Inc.
`
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`
`5
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`