Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper 16
`Entered: January 14, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`AMNEAL PHARMACEUTICALS, LLC
`Petitioner
`
`v.
`
`SUPERNUS PHARMACEUTICALS, INC.
`Patent Owner
`_______________
`
`Case IPR2013-00372
`Patent 8,394,406
`_______________
`
`
`Before LORA M. GREEN and SCOTT E. KAMHOLZ,
`Administrative Patent Judges.
`
`
`KAMHOLZ, Administrative Patent Judge.
`
`
`
`INITIAL CONFERENCE SUMMARY
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`
`
`
`
`Tel: 571-272-7822
`
`
`
`
`Paper 16
`Entered: January 14, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`AMNEAL PHARMACEUTICALS, LLC
`Petitioner
`
`v.
`
`SUPERNUS PHARMACEUTICALS, INC.
`Patent Owner
`_______________
`
`Case IPR2013-00372
`Patent 8,394,406
`_______________
`
`
`Before LORA M. GREEN and SCOTT E. KAMHOLZ,
`Administrative Patent Judges.
`
`
`KAMHOLZ, Administrative Patent Judge.
`
`
`
`INITIAL CONFERENCE SUMMARY
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`
`
`
`
`
`Case IPR2013-00372
`Patent 8,394,406
`
`
`The initial conference call for this proceeding was held on January 10, 2014.
`
`Amneal provided a Court Reporter for the call. For a complete record of the call,
`
`of which this paper is only a summary, see the transcript to be filed by Amneal as
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`an exhibit.
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`Both parties filed lists of proposed motions before the call. The following
`
`proposed motions and other matters were discussed during the call.
`
`A. Patent Owner’s Matters
`
`1. Joint motion for a proposed protective order
`
`We reminded the parties that a protective order does not exist in a case until
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`one is filed in the case and is approved by the Board. If a motion to seal is filed by
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`either party, the proposed protective order should be presented as an exhibit to the
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`motion. We encourage the parties to operate under the Board’s default protective
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`order, should that become necessary. See Default Protective Order, Office Patent
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`Trial Practice Guide, 77 Fed. Reg. 48,756, App. B (Aug. 14, 2012). If the parties
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`choose to propose a protective order deviating from the default protective order,
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`they must submit the proposed protective order jointly. We would appreciate the
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`inclusion of a marked-up comparison of the proposed and default protective orders
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`so that we can readily understand the differences.
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`We emphasized that redactions should be limited strictly to isolated passages
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`consisting entirely of confidential information and that the thrust of the underlying
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`argument or evidence must be clearly discernible from the redacted versions. We
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`also reminded the parties that information subject to a protective order will become
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`public if identified in a final written decision in this proceeding and that a motion
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`to expunge the information will not necessarily prevail over the public interest in
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`Case IPR2013-00372
`Patent 8,394,406
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`maintaining a complete and understandable file history. See Office Patent Trial
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`Practice Guide, 77 Fed. Reg. at 48,761.
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`2. Motion to submit a substitute version of Exhibit 2011
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`Amneal objected to Exhibit 2011 on the basis of illegibility. Supernus
`
`proposed to resubmit the exhibit as a series of enlarged pages and to expunge the
`
`original version. Amneal indicated that this would be acceptable. We authorized
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`Supernus to proceed as proposed.
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`3. Additional Discovery
`
`Supernus represented that it was in discussions with Amneal concerning
`
`production of evidence relating to Amneal’s alleged copying and that it has no
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`present intention to request authorization to file a motion for additional discovery.
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`We encouraged the parties to reach agreement on discovery. The parties may
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`request a conference call with the Board only if they cannot reach agreement.
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`4. Motion to compel testimony of USPTO official
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`Supernus seeks authorization to move to compel testimony of a USPTO
`
`official concerning the date of public availability of provisional application serial
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`No. 60/281,854, insofar as it was not identified by serial number when
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`incorporated by reference in International application publication
`
`No. WO 02/080932 (“Ashley ’932”). We did not authorize this motion, because
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`the public availability of unpublished applications is governed by regulation, and
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`does not require compelled testimony of a USPTO official for ascertainment.
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`5. Motion to file evidence of prior invention
`
`Supernus proposed a motion to file evidence of prior invention, under
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`Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572 (Fed. Cir. 1996) and/or 37 C.F.R.
`
`§ 1.131, to antedate Ashley ’932. We explained that Supernus should file any such
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`Case IPR2013-00372
`Patent 8,394,406
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`evidence with its Patent Owner Response, and not in a separate motion. We
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`reminded Supernus that Rule 1.131 is not applicable to this proceeding, and that an
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`inventor’s testimony concerning conception must be corroborated. See Mahurkar,
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`79 F.3d at 1577. A rule of reason applies to determine whether the inventor’s
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`testimony has been corroborated. Price v. Symsek, 988 F.2d 1187, 1194
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`(Fed. Cir. 1993). Supernus requested an enlarged page limit for its Response. We
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`declined to authorize enlargement at this stage, but noted that Supernus may seek
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`authorization at a later time if it can show good cause why it is unable to comply
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`with the 60-page limit.
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`6. Invocation of CREATE Act
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`Supernus proposed motions to perfect a claim under the CREATE Act
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`(35 U.S.C. § 103(c)(2) (2004)) disqualifying Ashley ’932 as prior art under
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`35 U.S.C. § 102(e). In particular, Supernus proposed filing a statement under 37
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`C.F.R. § 1.104(c)(4)(iii) (2011) (superseded by 37 C.F.R. § 1.104(c)(4)(ii) (2013))
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`and a request for certificate of correction under 37 C.F.R. §§ 1.71(g)(3) and 1.323.
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`Supernus also proposed a motion to extend the duration of this proceeding by up to
`
`six months in order to secure the certificate of correction.
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`We did not authorize these requests. Supernus may submit evidence in
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`support of its claim under the CREATE Act as part of its Patent Owner Response,
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`and not in a separate motion. We remind Supernus that Rule 1.104 is not
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`applicable to this proceeding, and that Supernus must file evidence substantiating
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`its claim under the CREATE Act, not merely a statement. Supernus also should
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`address Amneal’s contention that Ashley ’932 is available as prior art under
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`35 U.S.C. § 102(a), as well as under § 102(e). See 35 U.S.C. §103(c)(1) (2004)
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`(limiting its applicability to “[s]ubject matter developed by another person, which
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`Case IPR2013-00372
`Patent 8,394,406
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`qualifies as prior art only under one or more of subsections (e), (f), and (g) of
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`section 102”). The pendency of this proceeding will not be extended except for
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`good cause. See 37 C.F.R. § 42.100(c).
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`B. Petitioner’s Matters
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`Amneal indicated that it has no present intention to file any of its proposed
`
`motions except a motion for pro hac vice recognition of litigation counsel. That
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`motion is already authorized. We suggested that a party moving pro hac vice
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`recognition of counsel first confer with the opposing party and indicate in its
`
`motion whether the motion will be opposed.
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`C. Other Matters
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`1. Scheduling Order
`
`The parties indicated no concerns with, or proposed changes to, the
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`Scheduling Order, aside from that addressed above at I.A.6.
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`2. Challenging Admissibility
`
`We asked the parties to refrain from filing objections to evidence. If the
`
`parties cannot resolve an evidentiary objection, the objection and its proof of
`
`service may be filed as exhibits to a motion to exclude evidence, to demonstrate
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`timely service of the objection. See 37 C.F.R. § 42.64.
`
`3. Petitioner’s Request to Respond to Patent Owner’s Request for
`Rehearing
`
`We denied Amneal’s request to file a response to Supernus’s request for
`
`rehearing. See Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768.
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`Case IPR2013-00372
`Patent 8,394,406
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`D. Order
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`Accordingly, it is hereby
`
`ORDERED that Supernus is authorized to a file a corrected version of
`
`Exhibit 2011; and
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`FURTHER ORDERED that the original version of Exhibit 2011 shall be
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`expunged upon submission of the corrected Exhibit 2011.
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`Case IPR2013-00372
`Patent 8,394,406
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`FOR PETITIONER:
`
`Eldora L. Ellison
`Jonathan Tuminaro
`Sterne, Kessler, Goldstein & Fox P.L.L.C.
`
`FOR PATENT OWNER:
`
`Stephen B. Maebius
`Sunit Talapatra
`Andrew S. Baluch
`Foley & Lardner LLP
`
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