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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`____________
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`MYLAN PHARMACEUTICALS INC.,
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`Petitioners,
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`v.
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`BIOGEN MA INC.,
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`Patent Owner.
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`____________
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`Case IPR2018-01403
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`Patent 8,399,514
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`____________
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`Motion for Additional Discovery
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`Ground 4 in Mylan’s Petition is based on Exhibit 1010 (“Clinical Trials”),
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`Case IPR2018-01403
`Motion for Additional Discovery
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`the alleged public availability and authenticity of which rest solely on a declaration
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`from Robert Mihail, Esq. (Exhibit 1054) originally filed in a prior IPR. In
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`response to evidentiary objections to Exhibit 1010, Mylan served alternative
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`“Replacement Exhibit 1010,” supported solely by the declaration of Mylan’s
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`counsel Emily Greb, Esq, which was served but not filed. Mylan refused to provide
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`either witness for deposition. It is not clear that Mylan even attempted to secure
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`Mr. Mihail. Ms. Greb is, of course, under Mylan’s control and could readily be
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`produced. Ex. 2041 at 17:15-17. Depositions of these witnesses would serve the
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`interests of justice because: (1) the declarations provide the only support for
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`Mylan’s assertion that Clinical Trials and its “Replacement” are prior art;
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`(2) inconsistencies between the declarations and the evidence call into question
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`their reliability and credibility; and (3) the declarations should be entitled to no
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`weight without depositions such that Ground 4 would necessarily fail. Mexichem
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`Amanco Holdings S.A. de C.V. v. Honeywell Int’l, Inc., IPR2013-00576, Paper 29
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`at 3 (PTAB Aug. 15, 2014); Borror v. Herz, 666 F.2d 569, 573 (C.C.P.A. 1981) (in
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`the interference context); see also IBG LLC v Trading Techs., CBM2015-00179,
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`Paper 39 at 3 (PTAB Apr. 15, 2016) (burden is on proponent of testimony to
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`secure witnesses’ availability). Biogen is entitled to cross-examine the witnesses
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`presented against it.
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`1
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`Case IPR2018-01403
`Motion for Additional Discovery
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`Statement of Facts
`Mylan’s Ground 4 rests on “Clinical Trials” (Ex. 1010). Pet. 5, 23. The only
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`I.
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`support for its alleged authenticity and public accessibility at the relevant time is
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`the declaration of Robert Mihail (Ex. 1054). Pet. 23 (“It is a document publicly
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`available from ClinicalTrials.gov as of September 14, 2005.”). Rather than having
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`personal knowledge of ClinicalTrials.gov from 2005, Mr. Mihail was counsel
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`advocating for a different petitioner in an earlier IPR. IPR2015-01993, Paper 29.
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`Mr. Mihail does not state that he accessed the document at the relevant time,
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`instead describing a process he allegedly followed to obtain Ex. 1010 in 2015. Ex.
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`1054, ¶ 8. However, the Mihail process for obtaining Ex. 1010 leads to an error
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`message:
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`Ex. 2050 (clinicaltrials.gov/archive/NCT00168701/2005_09_14).
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`In response to Biogen’s objections to Exs. 1010 and 1054 (Paper 14, 1, 11),
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`Mylan served as supplemental evidence the “Declaration of Emily J. Greb” (“Greb
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`Declaration”) addressing both prior exhibits as well as a “Replacement Exhibit
`2
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`1010.” Ex. 2049. While the Greb Declaration was specifically prepared for this
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`Case IPR2018-01403
`Motion for Additional Discovery
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`IPR, it lacks the required attestation to be a proper declaration. See 37 C.F.R.
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`§§ 1.68, 42.2; see also 28 U.S.C. § 1746; Ex. 2049. Mylan’s assertion of the public
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`availability of Ex. 1010 at the relevant time period is based solely on the Mihail
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`declaration. Pet. 23 (citing Ex. 1054). Although plainly inconsistent with Mylan’s
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`public availability assertion, the Greb Declaration fails to disclose that Ex. 1010 is
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`not available as described in the Mihail declaration (Ex. 1054). Instead, the Greb
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`Declaration refers to an allegedly “substantially identical” Replacement Exhibit
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`1010, which is not the same document as Ex. 1010 and bears dates after the
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`relevant time period.
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`Biogen requested dates for the cross-examination of both Mr. Mihail and
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`Ms. Greb. Nearly three weeks after repeated follow-up correspondence that went
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`unanswered regarding these witnesses, Mylan refused to make them available.
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`Biogen requested a call with the Board the next day. The call transcript was filed
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`as Ex. 2041, and the Board issued an order (Paper 22) authorizing this motion.
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`II.
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`If the Declarations Are to be Given Any Weight, Cross-Examination Is
`in the Interest of Justice
`Discovery in IPRs is governed by 35 U.S.C. § 316(a)(5), which provides for
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`the “deposition of witnesses submitting affidavits or declarations” and discovery
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`“otherwise necessary in the interest of justice.” Id. Cross-examination of Mr.
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`3
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`Mihail and Ms. Greb should be authorized because Mylan’s Ground 4 necessarily
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`Case IPR2018-01403
`Motion for Additional Discovery
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`rests on their credibility and veracity, making their declarations and depositions
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`significant issues in this IPR. Each of the five factors in Garmin Int’l, Inc. v.
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`Cuozzo Speed Techs. LLC confirm that this discovery is “necessary in the interest
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`of justice.” IPR2012-00001, Paper 26 at 6-7 (PTAB Mar. 5, 2013) (precedential).
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`Factor 1 - “More Than A Possibility And Mere Allegation”: The first factor
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`focuses on whether a “party requesting discovery … already [is] in possession of
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`evidence tending to show beyond speculation that in fact something useful will be
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`uncovered.” Garmin, IPR2012-00001, Paper 26 at 6. Here, Biogen has precisely
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`such evidence for both declarants.
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`First, there is already evidence that the Mihail Declaration’s accuracy is
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`more than merely suspect. As explained above, entering the URL provided by Mr.
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`Mihail as the source of Ex. 1010 results in an error message. Supra at I. Second,
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`both the lack of the required 37 CFR § 1.68 attestation and objective evidence—
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`the omission of inconsistent facts regarding the availability of Ex. 1010—call into
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`question the reliability of the Greb Declaration, which, in turn, undermines the
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`Mihail Declaration and the Petition. Supra at I.
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`Factor 2 - “Litigation Positions And Underlying Basis”: This factor focuses
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`on whether the discovery is seeking “the other party’s litigation positions and the
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`underlying basis for those positions.” Garmin, IPR2012-00001, Paper 26 at 6, 13.
`4
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`Biogen is not seeking discovery to prematurely ascertain Mylan’s litigation
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`Case IPR2018-01403
`Motion for Additional Discovery
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`positions. Instead, Biogen seeks to cross-examine witnesses whose declarations
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`Mylan submitted and affirmatively put at issue in the IPR. Mylan cannot use the
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`status of Mr. Mihail and Ms. Greb as counsel to shield cross-examination of
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`testimony intentionally provided in their declarations. Fed. R. Evid. 502(a).
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`Factor 3 - “Ability To Generate Equivalent Information By Other Means”:
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`The third factor, which focuses on whether a party can reasonably figure out or
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`assemble the requested information without a discovery request (Garmin,
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`IPR2012-00001, Paper 26 at 6, 13-14), strongly favors cross-examination because
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`an equivalent test of credibility and reliability cannot be provided through other
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`means, id. As noted by the Federal Circuit, the purpose of cross-examination is to
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`“test the credibility and reliability of proferred [sic] testimony.” Borror, 666 F.2d
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`at 573. Cross-examination is critical here because Biogen has identified facts that
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`call into question both the credibility and the reliability of the proffered testimony
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`and the exhibits they address. Supra at I.
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`Factor 4 - “Easily Understandable Instructions”: The instructions could not
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`be clearer. Cross-examination will be conducted under the Board’s normal rules.
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`Garmin, IPR2012-00001, Paper 26 at 6, 14.
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`Factor 5 - “Requests Not Overly Burdensome To Answer”: Consideration of
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`burden, e.g., financial, human resources, and time schedule, is the final factor and
`5
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`also favors cross-examination. See id. at 7. Any potential burden—Mylan has
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`Case IPR2018-01403
`Motion for Additional Discovery
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`identified none—is outweighed by the genuine need for the cross-examination of
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`Mr. Mihail and Ms. Greb. Such discovery is simply not burdensome and should
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`have been anticipated by Mylan who affirmatively sought to rely on the testimony
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`of Mr. Mihail and Ms. Greb.
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`Mylan could have saved the resources of the Board and all parties by filing
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`with its Petition a declaration addressing Ex. 1010 by someone under its control. It
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`did not. Instead, Mylan chose to adopt the Mihail Declaration without disclosing
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`the inconsistent fact that Ex. 1010 is not available as described therein. Mylan also
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`chose to serve the Greb Declaration when Exs. 1010 and 1054 were challenged.
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`Any burden to Mylan is a direct consequence of its own strategy.
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`There is a genuine need to cross-examine Mr. Mihail and Ms. Greb given the
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`noted inconsistencies between the testimony and the underlying exhibits it
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`supports, as well as between the two declarations themselves. Supra at I. The need
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`is amplified by the fact that the Mihail Declaration is the only evidence of record
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`relied upon by Mylan to establish that Clinical Trials is a prior art printed
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`publication. Pet. 23; IBG, CBM2015-00179, Paper 39 at 3 (Board holding
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`petitioner is responsible to produce for cross-examination a witness whose
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`testimonial evidence petitioner relies upon “to show that [a reference] was publicly
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`available, and thus constitutes prior art.”).
`6
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`Mylan should not be permitted to prevent cross examination of Ms. Greb—
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`Case IPR2018-01403
`Motion for Additional Discovery
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`her deposition otherwise being routine discovery—by having served-but-not-filed
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`her declaration. Ex. 2041 at 17:21-25. Endorsing such a strategy would incentivize
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`parties to hold back critical evidentiary testimony to avoid cross-examination and
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`delay an otherwise routine deposition. Waiting to see if Mylan files the Greb
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`declaration in its response to a motion to exclude (i.e., after Due Date 5) before
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`authorizing her cross-examination would prejudice Biogen. By then, the IPR
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`discovery period and substantive briefing will already be complete. It would also
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`be difficult to conduct her deposition and prepare briefing during the six calendar
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`days between Due Dates 5 and 6. See 37 CFR § 42.53(d)(2) (“Cross-examination
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`should ordinarily take place after any supplemental evidence relating to the direct
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`testimony has been filed and more than a week before the filing date for any paper
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`in which the cross-examination testimony is expected to be used.”), (4) (“a notice
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`of the deposition [must be filed] at least ten business days before a deposition.”).
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`III. Conclusion
`For all of these reasons, Mylan respectfully requests that the Board authorize
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`the cross-examination of the witnesses Mylan chose to rely upon.
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`Dated: April 22, 2019
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`Respectfully submitted,
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`By: /Barbara C. McCurdy/
` Barbara C. McCurdy,
` Reg. No. 32,120
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`7
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the foregoing Motion for Additional
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`Discovery was served electronically via e-mail on April 22, 2019, in its entirety on
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`the following:
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`Brandon M. White
`Perkins Coie LLP
`700 13th St., NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6206
`E-mail: bmwhite@perkinscoie.com
`David L. Anstaett
`Emily Greb
`Perkins Coie LLP
`One East Main St., Suite 201
`Madison, WI 53703
`Telephone: (608) 663-7494
`Email: danstaett@perkinscoie.com
`E-mail: egreb@perkinscoie.com
`Petitioner has agreed to electronic service.
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`Dated: April 22, 2019
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`
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`By: / Catherine A. Sadler /
`Catherine A. Sadler
`Case Manager
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`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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