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` Paper No. 12
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` Entered: April 5, 2017
`
`Trials@uspto.gov
`571-272-7822
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ALKERMES PHARMA IRELAND LTD.
`and ALKERMES, INC.,
`Petitioners,
`
`v.
`
`OTSUKA PHARMACEUTICAL CO., LTD.,
`Patent Owner.
`____________
`
`Case IPR2017-00287
`Patent 9,125,939 B2
`____________
`
`
`
`Before SUSAN L. C. MITCHELL and JACQUELINE T. HARLOW,
`Administrative Patent Judges.
`
`HARLOW, Administrative Patent Judge.
`
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`
`
`
`
`
`IPR2017-00287
`Patent 9,125,939 B2
`
`
`
`On April 3, 2017, a conference call was conducted among counsel for
`Petitioners, Alkermes Pharma Ireland Ltd. and Alkermes, Inc. (collectively,
`“Alkermes”), counsel for Patent Owner, Otsuka Pharmaceutical Co., Ltd.
`(“Otsuka”), and Judges Mitchell and Harlow. The purpose of the call was to
`address Alkermes’ request for authorization to file two motions: a motion
`for pre-institution discovery, and a motion to file a reply to Patent Owner’s
`Preliminary Response (Paper 10).
`During the call, Alkermes explained that its motion for pre-institution
`discovery would seek the production of information concerning the public
`accessibility of three documents that Alkermes asserts as prior art against
`U.S. Patent No. 9,125,939 B2 (“the ’939 patent): Keck (Ex. 1007),1 Citrome
`(Ex. 1008),2 and the BMS/Otsuka Press Release (Ex. 1028).3 Alkermes
`contends that Keck, Citrome, and the BMS/Otsuka Press Release were
`authored or issued by employees of Otsuka or Otsuka itself. Alkermes,
`therefore, requests authorization to file a motion seeking pre-institution
`discovery directed to obtaining information regarding the date of release for
`
`
`1 Keck et al., Aripiprazole versus placebo in acute mania, Abstracts of the
`2002 Annual Meeting of the American Psychiatric Association (2002).
`
` 2
`
` Citrome et al., Pharmacokinetics and safety of aripiprazole and
`concomitant mood stabilizers, Abstracts of the 2002 Annual Meeting of the
`American Psychiatric Association (2002).
`
` 3
`
` Data Demonstrate Aripiprazole Significantly Improved Symptoms of Acute
`Mania in Patients With Bipolar Disorder; New Data Presented Today at
`American Psychiatric Association Annual Meeting, PR Newswire (2002).
`2
`
`
`
`IPR2017-00287
`Patent 9,125,939 B2
`
`
`each of the above-referenced exhibits. Alkermes additionally requests
`authorization to file a motion to file a reply to Patent Owner’s Preliminary
`Response, in order to address to the public accessibility arguments made by
`Otsuka in its Preliminary Response.
`Otsuka opposes Alkermes’ requests. In this regard, Otsuka points out
`that irrespective of Otsuka’s contribution to the content of the documents,
`each of the references for which Alkermes seeks discovery is a third party
`document, and is not published by Otsuka itself. Otsuka argues also that
`pre-institution discovery is an extraordinary remedy, and one not appropriate
`here, because Alkermes was required to make a threshold showing of public
`accessibility in its Petition. Otsuka further asserts that Alkermes’ request for
`authorization to file a motion to file a reply is premature, because it
`presumes that the sought-after discovery would yield information that
`supports Alkermes’ position.
`We recognize, and are sympathetic to, Alkermes’ concerns regarding
`Otsuka’s efforts to distance itself from references Otsuka itself had a hand in
`creating by challenging not the fact of publication and dissemination of
`those references, but rather, the sufficiency of Alkermes’ evidentiary
`showing with regard to public accessibility.
`We nevertheless deny Alkermes’ requests for authorization. As an
`initial matter, we note that Alkermes’ discovery requests are premised on
`Alkermes’ speculation that Otsuka maintains particular types of records
`regarding scientific meeting abstract and press release submissions. See
`Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC, Case IPR2012-00001, slip
`
`3
`
`
`
`IPR2017-00287
`Patent 9,125,939 B2
`
`
`op. at 7 (PTAB Mar. 5, 2013) (Paper 26) (precedential) (“[T]he requester of
`information should already be in possession of a threshold amount of
`evidence or reasoning tending to show beyond speculation that something
`useful will be uncovered.”).
`Furthermore, even if such records exist, it is unclear how they would
`be useful in establishing the public accessibility of Keck, Citrome, and the
`BMS/Otsuka Press Release, as those documents were published by third
`parties, not Otsuka itself. For example, the public accessibility of Keck and
`Citrome depends upon the date on which the American Psychiatric
`Association made the New Research Abstracts for its 2002 Annual Meeting
`available to the interested public, not the date on which Otsuka or its
`employees submitted abstracts to the meeting organizers. Similarly, the
`public accessibility of the BMS/Otsuka Press Release turns on the date PR
`Newswire published that release, not the date on which Otsuka authorized
`publication. See id. (“‘[U]seful’ means favorable in substantive value to a
`contention of the party moving for discovery.”).
`Lastly, the fact that Keck, Citrome, and the BMS/Otsuka Press
`Release were published by––and disseminated to––third parties underscores
`that the information sought could, and should, have been obtained by other
`means. See id. at 6 (“Information a party can reasonably figure out or
`assemble without a discovery request would not be in the interest of justice
`to have produced by the other party.”).
`
`4
`
`
`
`IPR2017-00287
`Patent 9,125,939 B2
`
`
`
`Accordingly, we deny Alkermes’ request for authorization to file a
`motion for pre-institution discovery, and Alkermes’ request for authorization
`to file a motion to file a reply to Patent Owner’s Preliminary Response.
`
`ORDER
`
`It is hereby:
`ORDERED that Petitioners’ request for authorization to file a motion
`for pre-institution discovery is denied;
`FURTHER ORDERED that Petitioners’ request for authorization to
`file a motion to file a reply to Patent Owner’s Preliminary Response is
`denied.
`
`
`5
`
`
`
`IPR2017-00287
`Patent 9,125,939 B2
`
`
`PETITIONERS:
`Theresa C. Kavanaugh
`Nicholas K. Mitrokostas
`GOODWIN PROCTER LLP
`tkavanaugh@goodwinlaw.com
`nmitrokostas@goodwinlaw.com
`
`Carolyn S. Elmore
`ELMORE PATENT LAW GROUP, P.C.
`docketing@elmorepatents.com
`
`PATENT OWNER:
`Erin M. Sommers
`James B. Monroe
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, L.L.P.
`erin.sommers@finnegan.com
`james.monroe@finnegan.com
`
`
`
`6
`
`
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