Trials@uspto.gov
`571-272-7822
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`
`
`
`
`
`Paper 21
`Date: May 27, 2016
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner,
`
`v.
`
`INDIVIOR UK LIMITED,
`Patent Owner.
`____________
`
`Case IPR2016-00280
`Patent 8,475,832 B2
`____________
`
`
`
`Before TONI R. SCHEINER, JACQUELINE WRIGHT BONILLA, and
`ZHENYU YANG, Administrative Patent Judges.
`
`BONILLA, Administrative Patent Judge.
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`571-272-7822
`
`
`
`
`
`
`
`Paper 21
`Date: May 27, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner,
`
`v.
`
`INDIVIOR UK LIMITED,
`Patent Owner.
`____________
`
`Case IPR2016-00280
`Patent 8,475,832 B2
`____________
`
`
`
`Before TONI R. SCHEINER, JACQUELINE WRIGHT BONILLA, and
`ZHENYU YANG, Administrative Patent Judges.
`
`BONILLA, Administrative Patent Judge.
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`
`IPR2016-00280
`Patent 8,475,832 B2
`
`
`On May 16, 2016, we conducted a conference call between respective
`counsel for the parties and the panel judges. A court reporter also was
`present on the call.1 Petitioner requested the conference to address its
`request to file a motion to compel discovery of information that Petitioner
`contended is in Patent Owner’s possession and is inconsistent with a
`position advanced by Patent Owner in its Preliminary Response (Paper 16,
`“Prelim. Resp.”). The information purportedly relates to two documents,
`i.e., “Suboxone® Label” (Ex. 1008) and “Suboxone® Tablet Summary
`Basis of Approval” or “SBOA” (Ex. 1009), relied upon in challenges raised
`in the Petition (Paper 1 at 20, 35, 37, 45). Petitioner also requested the
`conference to address its request to file a reply to the Preliminary Response
`under § 42.108(c). See 37 C.F.R. § 42.108(c) (revised April 1, 2016, stating
`that a petitioner may seek leave to file a reply to the preliminary response,
`but “must make a showing of good cause”).
`In the Petition as filed, Petitioner contends that “Patent Owner
`stipulated in a co-pending litigation that the Suboxone® 2002 Label and
`SBOA are prior art to the ’832 patent,” citing footnote 12. Pet. 18–19.
`Footnote 12 in the Petition reads in full:
`12 Reckitt Benckiser Pharmaceuticals, Inc. v. Watson
`Laboratories, Inc., No. 13-cv-0167-RGA P.I. 347, Ex. 1, at
`¶¶ 123–24. The Suboxone® Label and SBOA qualify as 102(b)
`prior art as both were publicly available printed publications at
`least as early as 2002.
`Id. at 18–19 n.12.
`
`
`1 Petitioner has filed a copy of the transcript of the call as Exhibit 1034.
`This Order summarizes statements made during the conference call. A more
`detailed record may be found in the transcript.
`2
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`
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`
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`IPR2016-00280
`Patent 8,475,832 B2
`
`
`In its Preliminary Response, Patent Owner asserts, inter alia, that
`Petitioner fails to show that either the Suboxone® Label or SBOA
`constitutes a “printed publication” and qualifies as prior art under 35 U.S.C.
`§ 102. Prelim. Resp. 17–24. For example, Patent Owner points out that the
`above-quoted contentions and footnote 12 in the Petition constitute
`Petitioner’s entire argument that Exhibits 1008 and 1009 qualify as prior art.
`Id. at 20.
`During the conference call, Petitioner requested leave to file: (1) the
`“pretrial stipulation” mentioned in the Petition (Pet. 18); (2) “further
`evidence” from a trial in the district court litigation that took place on
`December 17–19, 2016, after Petitioner filed its Petition on December 3,
`2016; and (3) a reply “so that [Petitioner] could pull everything together” for
`the panel. Ex. 1034, 5:12–12:6, 23:9–24:3. In relation to the “further
`evidence” from the district court trial, Petitioner asserted that Patent Owner
`admitted there that, for example, the Food and Drug Administration
`published SBOA in 2002, before the priority date for the ’832 patent. Id. at
`7:11–8:9. Petitioner also requested leave to “serve limited requests for
`admission[s]” from Patent Owner “so that [Petitioner] could submit them as
`evidence here.” Id. at 11:17–12:6.
`Patent Owner responded in the call that its Preliminary Response
`challenged only the sufficiency of evidence cited by Petitioner in its Petition,
`required to meet Petitioner’s burden to provide a threshold showing that
`Exhibits 1008 and 1009 qualify as a printed publication. Ex. 1034, 13:10–
`14:3. Patent Owner argued that its challenge to the sufficiency of the
`evidence “does not impose an obligation on our part to provide evidence to
`supplement the petitioner’s case.” Id. at 15:4–9. Patent Owner argued,
`
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`3
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`IPR2016-00280
`Patent 8,475,832 B2
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`citing similar arguments in its Preliminary Response, that the pretrial
`stipulation took place in a district court case that did not involve Petitioner,
`and the stipulation “is not binding on the patent owner in other proceedings.”
`Id. at 16:8–19, 21:13–17 (citing Prelim. Resp. 23–24). Patent Owner further
`argued that Petitioner had an opportunity to present the pretrial stipulation,
`and make it an exhibit of record, when filing the Petition, but they “chose to
`do what they did.” Id. at 17:7–12, 19:19–20:8.
`Upon considering both parties’ positions, Petitioner does not persuade
`us that sufficient good cause exists to grant its request to file a reply to the
`Preliminary Response or to file new evidence regarding the public
`accessibility of Exhibits 1008 and 1009. First, as Patent Owner notes, in
`relation to the pretrial stipulation, Petitioner could have, but did not, file that
`document when it filed its Petition. Petitioner has not established good
`cause as to why we should allow Petitioner to file that document as an
`exhibit now.
`In addition, neither party disputes that a statutory bar to institution
`under 35 U.S.C. § 315(b) exists in relation to a petition filed by Petitioner as
`of December 4, 2015. Although it may be that good cause could exist in
`certain situations where new evidence comes to light after the filing of a
`petition, we are not persuaded that sufficient good cause exists in this case.
`Here, Petitioner essentially asks to significantly bolster its Petition with new
`substantive argument and evidence, well after a statutory bar date, in relation
`to an issue where it has the burden to make a threshold showing. See Apple
`Inc. v. DSS Tech. Mgmt., Inc., Case IPR2015-00369, slip op. at 5 (PTAB
`Aug. 12, 2015) (Paper 14) (noting that Petitioner has the burden to establish
`
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`4
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`IPR2016-00280
`Patent 8,475,832 B2
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`a threshold showing that a reference is “printed publication” prior art under
`35 U.S.C. §§ 102 and 311(b)).
`To the extent a reply and newly filed evidence by Petitioner would be
`necessary to show a reasonable likelihood that it would prevail with respect
`to at least one challenged claim, we are not persuaded to allow Petitioner to
`“fix” its Petition in this fashion. Petitioner had the opportunity to file
`additional evidence along with its Petition, if it so wished. For example,
`rather than rely on “stipulations” or “admissions” by Patent Owner in
`another proceeding, Petitioner could have obtained, provided, and cited in its
`Petition evidence relevant to whether Exhibits 1008 and 1009 actually were
`publicly accessible, how one could have obtained a copy of those
`documents, and/or whether documents were reasonably accessible through
`generally available means, in the relevant time frame.
`In relation to Petitioner’s request to serve requests for “admissions”
`from Patent Owner, i.e., purported routine discovery under 37 C.F.R.
`§ 42.51(b)(1)(iii), we agree with Patent Owner that its own arguments in the
`Preliminary Response that Petitioner fails to provide a threshold showing in
`the Petition (Prelim. Resp. 17–24) do not impose an obligation on Patent
`Owner to answer requests for “admissions” that support Petitioner’s
`position. See Hughes Network Sys., LLC v. Cal. Inst. of Tech., Case
`IPR2015-00059, slip op. at 7 (PTAB Dec. 30, 2015) (Paper 34) (“Arguments
`pointing to a deficiency in petitioner’s case do not impose an obligation on
`the part of [Patent Owner] to provide evidence supplementing that provided
`by [Petitioner].”).
`
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`5
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`IPR2016-00280
`Patent 8,475,832 B2
`
`
`In consideration of the foregoing, it is:
`ORDERED that Petitioner is not authorized to file the pretrial
`stipulation mentioned in the Petition (Pet. 18) or other requested information
`from a related district court proceeding, or to file a reply as a means to
`present that information; and
`FURTHER ORDERED that Petitioner is not authorized to serve
`requests for admission from Patent Owner as it pertains to the requested
`information from the related district court proceeding.
`
`
`
`6
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`
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`IPR2016-00280
`Patent 8,475,832 B2
`
`PETITIONER:
`Elizabeth Holland
`Eleanor Yost
`John Stull
`Jennifer Albert
`eholland@goodwinprocter.com
`eyost@goodwinprocter.com
`jstull@goodwinprocter.com
`jalbert@goodwinprocter.com
`
`PATENT OWNER:
`Andrea Reister
`Enrique Longton
`Dustin Weeks
`areister@cov.com
`rlongton@cov.com
`dustin.weeks@troutmansanders.com
`
`
`
`
`
`7
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