UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
`
`BIOGEN MA INC.
`
`Patent Owner
`____________________________
`
`Case No. IPR2018-01403
`U.S. Patent No. 8,399,514
`____________________________
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION FOR
`ADDITIONAL DISCOVERY
`
`
`
`
`
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
`
`MYLAN PHARMACEUTICALS INC.
`
`Petitioner
`
`v.
`
`BIOGEN MA INC.
`
`Patent Owner
`____________________________
`
`Case No. IPR2018-01403
`U.S. Patent No. 8,399,514
`____________________________
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION FOR
`ADDITIONAL DISCOVERY
`
`
`
`
`
`Biogen MA Inc. (“Patent Owner”) failed to carry its burden of proving that its
`
`request for additional discovery is “in the interests of justice.” 37 C.F.R.
`
`§ 42.51(b)(2)(i). Patent Owner seeks unnecessary depositions of two attorneys, one
`
`of which is not within Mylan Pharmaceuticals Inc.’s (“Petitioner”) control, who
`
`merely described how publicly available information from ClinicalTrials.gov, a
`
`website equally available to Patent Owner, was collected. Patent Owner failed to
`
`satisfy the Garmin factors in its motion. Patent Owner’s request for additional
`
`discovery should be denied.
`
`I.
`
`BACKGROUND
`Patent Owner’s motion relates to a single prior art reference. This publicly
`
`available reference from ClinicalTrials.gov (Ex. 1010) is not before the Board for
`
`the first time. In IPR2015-01993, the Mihail Declaration (Ex. 1054) described the
`
`process in which the content of the ClinicalTrials.gov exhibit was accessed. In that
`
`earlier IPR, Patent Owner did not object to the Mihail Declaration, did not depose
`
`Mr. Mihail, and did not move to exclude ClinicalTrials.gov. Biogen’s Objections to
`
`Petitioner’s Exhibits, Coalition for Affordable Drugs V LLC v. Biogen MA Inc.,
`
`IPR2015-01993, Paper 25 (PTAB Apr. 5, 2016).
`
`Now, in this IPR, Petitioner submitted the same Mihail Declaration describing
`
`how the same ClinicalTrials.gov information, Exhibit 1010, was collected. Ex.
`
`1054. Patent Owner now objects to Exhibit 1010 as, among other things, not
`
`- 1 -
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`
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`properly authenticated. Paper 14 at 1. In response, Petitioner served as supplemental
`
`evidence in accordance with 37 C.F.R. § 42.64(b)(2) a replacement Exhibit 1010
`
`authenticated by the Greb Declaration. See Ex. 2049. The replacement Exhibit 1010
`
`(filed with this motion as Exhibit 1057) 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.
`
`Patent Owner now seeks depositions of Mr. Mihail (who is not under
`
`Petitioner’s control) and Ms. Greb, counsel for Petitioner.
`
`II. ARGUMENT
`Patent Owner’s motion fails to meet the standard for additional discovery.
`
`Instead it appears an attempt to circumvent the rules for excluding evidence. Its
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`three-listed justifications for seeking the depositions is to attack Exhibit 1010’s
`
`(1) prior art status, (2) reliability and credibility, and (3) weight of such evidence.
`
`Paper 24 at 1. But, “[a]s explained by the Board, parties may raise issues related to
`
`admissibility of evidence (e.g., authenticity or hearsay) in a motion to exclude” and
`
`“issues related to credibility and the weight of the evidence should be raised in
`
`responses and replies.” Bloomberg Inc. v. Markets-Alert Pty Ltd., CBM2013-
`
`00005, Paper 56 at 5 (PTAB Nov. 15, 2013) (emphasis added) (citing 37 C.F.R.
`
`§§ 42.64, 42.62). Moreover, each of the five Garmin factors, which frame the
`
`analysis for determining whether additional discovery is in the interests of justice,
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`- 2 -
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`
`
`fails to support the requested depositions. See Garmin Int’l Inc. v. Cuozzo Speed
`
`Techs. LLC, IPR2012-00001, 2013 WL 11311697, at *3 (PTAB Mar. 5, 2013).
`
`A. Garmin Factor #1: Patent Owner failed to show that there is more
`than a possibility or mere allegation that something useful will be
`uncovered by deposing Mr. Mihail and Ms. Greb.
`Patent Owner failed to identify anything it may discover besides a verbatim
`
`recitation of what is already in the two declarations—the steps Mr. Mihail and Ms.
`
`Greb took to access the publicly available ClinicalTrials.gov website. Patent Owner
`
`asserts that it “has . . . evidence” that the two declarations are purportedly
`
`“inconsistent.” Paper 24 at 4. To satisfy this Garmin test, Patent Owner needs to
`
`show that there is more than a possibility and mere allegation that something useful
`
`will be uncovered. Garmin, 2013 WL 11311697, at *3. “Useful” in this context
`
`“does not mean merely ‘relevant.’” Id.
`
`Patent Owner fails to even make a “mere allegation” as to what could be
`
`uncovered in the requested depositions, useful or not. Id. at *4 (“Yet, conspicuously
`
`absent from Cuozzo’s motion is a threshold amount of evidence or reasoning tending
`
`to show beyond speculation that the information to be discovered will be ‘useful’ to
`
`Cuozzo.”). Assuming Patent Owner will attempt to uncover facts relating to the
`
`allegedly inconsistent dates in the ClinicalTrials.gov exhibits (Sept. 14, 2005 for
`
`Exhibit 1010, and an estimate of Sept. 15, 2005 for Exhibit 1057), both dates
`
`irrefutably establish the exhibits as prior art. All Patent Owner can obtain from the
`
`- 3 -
`
`
`
`depositions is the fact that the Sept. 14, 2005 version is no longer available in the
`
`ClinicalTrials.gov archive (see Ex. 2050). But the version containing the same
`
`relevant information is still available, thus there is nothing to be gained from the
`
`requested depositions. And, importantly, Biogen’s admission that it already has the
`
`evidence of an alleged inconsistency alone demonstrates why its motion fails. See
`
`Shelton v. Am. Motors Corp., 805 F.2d 1323, 1327 (8th Cir. 1986) (depositions of
`
`counsel are limited “to where the party seeking to take the deposition has shown that
`
`(1) no other means exist to obtain the information than to depose opposing counsel;
`
`(2) the information sought is relevant and nonprivileged; and (3) the information is
`
`crucial to the preparation of the case” (citation omitted)). There is no further need
`
`for additional discovery when Patent Owner admits it already has the evidence it
`
`needs.
`
`B. Garmin Factor #2: Patent Owner is seeking Petitioner’s litigation
`positions and the underlying basis for those positions.
`Patent Owner argues that Petitioner “cannot use the status of Mr. Mihail and
`
`Ms. Greb as counsel to shield cross-examination.” Paper 24 at 5. Anything beyond
`
`the express statements in the declarations is likely privileged.1 See Garmin, 2013
`
`
`1 If the Board grants the deposition of Ms. Greb, it should be limited to the
`
`ClinicalTrials.gov portion of the declaration.
`
`- 4 -
`
`
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`WL 11311697, at *3 (discovery as to litigation positions not necessary in the interest
`
`of justice). As such, there is nothing further to be gained from either deposition.
`
`C. Garmin Factor #3: Patent Owner could generate equivalent
`information by other means.
`Patent Owner’s argument that the depositions are required to assess reliability
`
`and credibility likewise fail to meet the standard for granting discovery.
`
`“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.
`
`In that connection, the Board would want to know the ability of the requesting party
`
`to generate the requested information without need of discovery.” Id.; see also
`
`Shelton, 805 F.2d at 1327 (8th Cir. 1986) (limiting depositions of counsel).
`
`ClinicalTrials.gov, the subject of Exhibit 1010 and the Mihail and Greb
`
`Declarations, is a public website available to Patent Owner the same as to Mr. Mihail
`
`and Ms. Greb. Indeed, Patent Owner has already accessed that website and provided
`
`its own exhibit attempting to undermine the credibility or prior art status of Exhibit
`
`1010. See Exhibit 2050.
`
`D. Garmin Factor #4: Patent Owner’s request for depositions is not
`easily understandable.
`Although the fact that Patent Owner is requesting depositions of Mr. Mihail
`
`and Ms. Greb is clear, it is unclear what additional information not already available
`
`to Patent Owner it is seeking.
`
`- 5 -
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`
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`E. Garmin Factor #5: Patent Owner’s request is overly burdensome
`and not in the interest of justice.
`Patent Owner’s argument with respect to factor five also fails to support its
`
`request. This factor considers “whether the requests are overly burdensome,”
`
`including financial burden, burden on human resources, and burden on meeting the
`
`time schedule of this review. “Requests should be sensible and responsibly tailored
`
`according to a genuine need.” Garmin, 2013 WL 11311697, at *7.
`
`Patent Owner asserts
`
`that
`
`the requested discovery “is simply not
`
`burdensome.” Paper 24 at 6. But Patent Owner fails to acknowledge a very real
`
`burden its request for additional discovery will impose—additional costs and time
`
`for preparation of Mr. Mihail and Ms. Greb for their deposition. Dynamic Air Inc.
`
`v. M-I Drilling Fluids UK Ltd., IPR2016-00256, Paper 39, at 7 (PTAB Nov. 30,
`
`2016) (fifth Garmin factor favors Patent Owner who argued “significant burden on
`
`the parties and witnesses in preparing for depositions”); Shelton, 805 F.2d at 1327
`
`(“Taking the deposition of opposing counsel not only disrupts the adversarial system
`
`and lowers the standards of the profession, but it also adds to the already burdensome
`
`time and costs of litigation.”). Further, Petitioner does not control Mr. Mihail; the
`
`logistics involved in securing his deposition would impose a further undue burden.
`
`Next, Patent Owner asserts that if there is a potential burden, it is outweighed
`
`by a genuine need for the requested depositions. Paper 24 at 6. However, as above
`
`there is no information beyond what is already included in in the declarations and
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`- 6 -
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`
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`exhibits, and a public website, for Patent Owner to gain. And Patent Owner has
`
`already conceded it has the information it believes necessary to undermine the
`
`challenged declarations. The request for additional discovery therefore is not
`
`sensible nor responsibly tailored according to a genuine need.
`
`Moreover, Patent Owner fails to tell the Board that the exact same Mihail
`
`Declaration here was submitted in a prior IPR, to which Patent Owner did not object
`
`nor was it excluded. Why Patent Owner now objects is unclear.
`
`Finally, Patent Owner’s argument that it is proper to take Ms. Greb’s
`
`deposition fails. Ms. Greb’s declaration is not of record in this case, and only may
`
`be if Patent Owner files a motion to exclude. Palo Alto Networks, Inc. v. Finjan,
`
`Inc., IPR2015-01979, 2016 WL 8969285, at *1 (PTAB Aug. 11, 2016)
`
`(supplemental evidence is not of record unless a motion to exclude is filed). Even if
`
`Ms. Greb’s deposition is proper, it should not be taken until after the declaration is
`
`of record. If Patent Owner fails to file a motion to exclude, as it failed to do in the
`
`prior IPR for the same evidence, Ms. Greb’s declaration will never be of record;
`
`taking the deposition now is an inappropriate use of time and resources.
`
`III. CONCLUSION
`Petitioner respectfully requests that the Board deny Patent Owner’s Motion.
`
`- 7 -
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`
`
`April 30, 2019
`
`
`
`
`
`Respectfully submitted,
`
`/s/ Brandon M. White
`Brandon M. White
`Reg. No. 52,354
`Perkins Coie LLP
`700 Thirteenth Street, N.W.
`Suite 600
`Washington, DC 20005-3960
`bmwhite@perkinscoie.com
`Tel: 202-654-6206
`Fax: 202-654-9681
`Counsel for Petitioner
`Mylan Pharmaceuticals Inc.
`
`- 8 -
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served a true and
`
`correct copy of the foregoing: PETITIONER’S OPPOSITION TO PATENT
`
`OWNER’S MOTION FOR ADDITIONAL DISCOVERY by email to the electronic
`
`service addresses for Patent Owner:
`
`Barbara C. McCurdy
`Erin M. Sommers
`Pier D. DeRoo
`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
`barbara.mccurdy@finnegan.com
`erin.sommers@finnegan.com
`pier.deroo@finnegan.com
`
`Dated: April 30, 2019
`
`
`
`/s/ Brandon M. White
`Brandon M. White
`Reg. No. 52,354
`Counsel for Petitioner Mylan Pharmaceuticals Inc.
`
`
`
`
`
`
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