Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper 35
`Entered: May 17, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BIOGEN MA INC.,
`Patent Owner.
`_______________
`
`Case IPR2018-01403
`Patent No. 8,399,514 B2
`_______________
`
`
`Before SHERIDAN K. SNEDDEN, JENNIFER MEYER CHAGNON, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`
`ORDER
`Patent Owner’s Motion for Additional Discovery
`37 C.F.R. §§ 42.5, 42.51
`
`
`
`
`
`Tel: 571-272-7822
`
`
`
`
`Paper 35
`Entered: May 17, 2019
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BIOGEN MA INC.,
`Patent Owner.
`_______________
`
`Case IPR2018-01403
`Patent No. 8,399,514 B2
`_______________
`
`
`Before SHERIDAN K. SNEDDEN, JENNIFER MEYER CHAGNON, and
`JACQUELINE T. HARLOW, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`
`ORDER
`Patent Owner’s Motion for Additional Discovery
`37 C.F.R. §§ 42.5, 42.51
`
`
`
`
`
`
`IPR2018-01403
`Patent No. 8,399,514 B2
`
`I. INTRODUCTION
`With our authorization, Patent Owner filed a Motion for Additional
`Discovery (Paper 24, “Motion” or “Mot.”) in the instant proceedings, and
`Petitioner filed an Opposition (Paper 28, “Opp.”). For the reasons stated
`below, Patent Owner’s Motion is denied.
`
`II. DISCUSSION
`A. The Parties’ Dispute
`The dispute between the parties concerns the admissibility of the
`originally filed ClinicalTrials.gov exhibit, Exhibit 1010. With its Petition,
`Petitioner submitted a declaration of Robert Mihail. Ex. 1054 (“Mihail
`Declaration”). The Mihail Declaration is an identical copy of the declaration
`previously submitted in IPR2015-01993. Opp. 1–2. The Mihail Declaration
`describes the process in which the content of the ClinicalTrials.gov exhibit
`(Ex. 1010) was obtained. Id. Petitioner submitted the same Mihail
`Declaration into this proceeding for the purposes of describing how the same
`ClinicalTrials.gov information was collected. Id.
`In response to Patent Owner’s objections related to the authenticity of
`Exhibit 1010 (Paper 14, 1), Petitioner served supplemental evidence in the
`form of a “Declaration of Emily J. Greb” (“Greb Declaration”)1 and a
`“Replacement Exhibit 1010” (Ex. 1057).2 Mot. 2–3; Ex. 2049.
`
`
`1 The Greb Declaration is currently not of record.
`2 Service of supplemental evidence is permitted under 37 C.F.R.
`§ 42.64(b)(2), which provides as follows: “The party relying on evidence to
`which an objection is timely served may respond to the objection by serving
`supplemental evidence within ten business days of service of the objection.”
`
`2
`
`
`
`IPR2018-01403
`Patent No. 8,399,514 B2
`
`
`Patent Owner contends that Replacement Exhibit 1010 “is not the
`same document as Ex. 1010 and bears dates after the relevant time period.”3
`Mot. 3. Petitioner, however, contends that the Replacement Exhibit 1010
`“shows the same substance of originally submitted Exhibit 1010
`(authenticated by Mr. Mihail) as retrieved from the public website
`ClinicalTrials.gov on February 26, 2019.” Opp. 2.
`
`B. Analysis
`In its Motion, Patent Owner requests additional discovery in the form
`of cross-examination of Mr. Mihail and Ms. Greb. See Mot. 3–4.
`With respect to the cross-examination of Mr. Mihail, Patent Owner
`contends that Mr. Mihail’s testimony is “[t]he only support for [Ex. 1010’s]
`alleged authenticity and public accessibility.” Id. at 2. Patent Owner further
`contends that “there is already evidence that the Mihail Declaration’s
`accuracy is more than merely suspect,” namely that the URL, provided by
`Mr. Mihail as the source of Ex. 1010, results in an error message. Id. at 4;
`Ex. 2050. Pursuant to our rules, a party wishing to challenge the
`admissibility of evidence, such as Ex. 1010 here, must object timely to the
`evidence at the point it is offered and then preserve the objection by filing a
`motion to exclude the evidence. 37 C.F.R. § 42.64(a), (b)(1), and (c). Here,
`
`
`3 Patent Owner does not provide an explanation of any identified differences
`between Ex. 1010 and Replacement Exhibit 1010 or how any such
`differences would impact the merits of Petitioner’s patentability challenges
`that rely on Ex. 1010. Petitioner, however, suggests that one such difference
`may be “allegedly inconsistent dates in the ClinicalTrials.gov exhibits
`(Sept. 14, 2005 for Exhibit 1010, and an estimate of Sept. 15, 2005 for
`Exhibit 1057).” Opp. 3.
`
`3
`
`
`
`IPR2018-01403
`Patent No. 8,399,514 B2
`
`Patent Owner has done so, and is already in possession of supplemental
`evidence that Petitioner has served to address Patent Owner’s objections—
`that is, the Greb Declaration and Replacement Exhibit 1010. That
`information was served to Patent Owner as supplemental evidence under
`37 C.F.R. § 42.64(b)(2), which is the proper procedure for responding to
`admissibility objections.
`We note, however, that Rule 42.64(b)(1) provides for objection to
`evidence, not for objection to supplemental evidence. If Patent Owner, now
`in possession of supplemental evidence, is still of the opinion that the
`originally objected to evidence is inadmissible (i.e., Ex. 1010), Patent Owner
`may file a motion to exclude the evidence. 37 C.F.R. § 42.64(c); see
`Paper 13, 8 (setting forth the DUE DATE 4 for filing a motion to exclude).
`Petitioner may file the previously served supplemental evidence with any
`opposition to the motion to exclude, and Patent Owner may respond to the
`supplemental evidence in its reply to the opposition. Patent Owner also may
`address the sufficiency of and the proper weight the Board should give to
`Mr. Mihail’s testimony and Ex. 1010, in its Patent Owner Response. We are
`not persuaded that Patent Owner has shown that the cross-examination of
`Mr. Mihail, whose testimony was not prepared for this proceeding, is in the
`interests of justice based on the facts and circumstances present here.
`Turning to the cross-examination of Ms. Greb, our Rule 42.51
`provides that routine discovery includes, “[e]xcept as the Board may
`otherwise order: . . . (ii) Cross examination of affidavit testimony prepared
`for the proceeding is authorized within such time period as the Board may
`set.” 37 C.F.R. § 42.51(b)(1). As noted by Patent Owner, the declaration
`from Ms. Greb, purportedly relating to the authenticity of Replacement
`
`4
`
`
`
`IPR2018-01403
`Patent No. 8,399,514 B2
`
`Exhibit 1010, was prepared for this proceeding. Mot. 3. Accordingly, if that
`declaration is filed with an opposition to a motion to exclude, it will be
`subject to routine discovery. In its Motion, Patent Owner requests
`cross-examination of Ms. Greb prior to the filing of the Greb Declaration.
`We recognize Petitioner’s concern that the possibility that the Greb
`Declaration may never be of record makes “taking the deposition now [] an
`inappropriate use of time and resources.” Opp. 7. We determine, however,
`that this concern is outweighed by the timing considerations implicated by
`waiting to see if the Greb Declaration is filed in response to any motion to
`exclude filed by Patent Owner. See Mot. 7.
`We, thus, authorize cross-examination of Ms. Greb at this time,
`limited to the factual issue of “how publicly available information from
`[the ClinicalTrials.gov website] . . . was collected” (Opp. 1).4 The parties
`are instructed to confer to determine a date for and an appropriate length of
`time for Ms. Greb’s deposition. Alternatively, Petitioner may withdraw the
`Greb Declaration as supplemental evidence, and provide assurance that it
`will not rely on that declaration in this proceeding. In addition, in the event
`Patent Owner elects to depose Ms. Greb, the transcript of that deposition is
`not to be made of record in this proceeding unless and until Petitioner files
`the Greb Declaration as an exhibit to its opposition to Patent Owner’s
`motion to exclude.
`
`4 Petitioner requests that if the deposition of Ms. Greb is granted “it should
`be limited to the ClinicalTrials.gov portion of the declaration.” Opp. 4 n.1.
`Because the Greb Declaration is not of record, the panel has not reviewed
`the contents thereof. We recognize, however, that Ms. Greb is counsel for
`Petitioner in this proceeding, and caution Patent Owner’s counsel to limit its
`questions to the factual issue at hand.
`
`5
`
`
`
`IPR2018-01403
`Patent No. 8,399,514 B2
`
`III. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that Patent Owner’s Motion for Additional Discovery is
`denied as to the requested cross-examination of Mr. Mihail; and
`FURTHER ORDERED that Patent Owner is authorized to conduct
`cross-examination of Ms. Greb, subject to the conditions set forth above.
`
`
`PETITIONER:
`
`Brandon M. White
`Emily J. Greb
`PERKINS COIE LLP
`bmwhite@perkinscoie.com
`egreb@perkinscoie.com
`
`PATENT OWNER:
`
`Barbara C. McCurdy
`Mark J. Feldstein
`Erin M. Sommers
`Pier D. DeRoo
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`barbara.mccurdy@finnegan.com
`mark.feldstein@finnegan.com
`erin.sommers@finnegan.com
`pier.deroo@finnegan.com
`
`
`
`6
`
`
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