IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
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`QUALICAPS CO., LTD.,
`Patent Owner.
`
`
`
`Case No. IPR2017-00203
`Patent No. 6,649,180
`
`PATENT OWNER’S OPPOSITION TO PETITIONER MYLAN
`PHARMACEUTICALS INC.’S MOTION FOR ADDITIONAL
`DISCOVERY UNDER 37 C.F.R. § 42.51(b)(2)
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`DC: 6503304-6
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`
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`QUALICAPS CO., LTD.,
`Patent Owner.
`
`
`
`Case No. IPR2017-00203
`Patent No. 6,649,180
`
`PATENT OWNER’S OPPOSITION TO PETITIONER MYLAN
`PHARMACEUTICALS INC.’S MOTION FOR ADDITIONAL
`DISCOVERY UNDER 37 C.F.R. § 42.51(b)(2)
`
`
`
`
`
`
`
`
`
`
`
`
`DC: 6503304-6
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`
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`
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`IPR2017-00203
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`Petitioner requested authorization “to file a motion for additional discovery in
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`the form of Mr. Tanjoh’s deposition . . .” based on Mr. Tanjoh’s prosecution history
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`declaration. See Ex. 2061 (emphasis added). Petitioner’s motion, however, seeks
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`additional discovery not only in the form of the deposition of Mr. Masaru Tanjoh,
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`but also “production of all documents . . . supporting or refuting Patent Owner’s
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`assertion that the invention of the U.S. Patent No. 6,649,180 (“the ’180 [P]atent”)
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`yielded unexpected results.” Paper 31 at 1. Neither Petitioner’s request for additional
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`discovery, nor the Board’s authorization, addressed the production of documents.
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`See Ex. 2061. Petitioner tries to justify this expanded request by stating that the
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`documents in question go to Patent Owner’s showing of unexpected results. This
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`rationale is misplaced. Petitioner has already deposed Patent Owner’s expert, Dr.
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`McConville, the witness in this proceeding who actually opined on “unexpected
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`results.” Moreover, Patent Owner has already consented to filing the March 2017
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`transcript from Mr. Tanjoh’s litigation deposition in the present proceeding (Ex.
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`2062 at 3-5), which Petitioner concedes is a sufficient alternative to a second
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`deposition (Paper 31 at 1 & 7). Because Petitioner’s remaining request for litigation-
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`produced documents was unauthorized, there is effectively nothing left to decide.
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`I.
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`BACKGROUND
`The declaration that formed the basis of Petitioner’s request for additional
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`discovery is not one prepared for purposes of this proceeding. Rather, it is a short
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`1
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`
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`IPR2017-00203
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`declaration from an inventor, Mr. Tanjoh, submitted during the original prosecution
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`of the ’180 patent. (“Tanjoh Declaration”; Ex. 1010 at 105–108). The declaration
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`reports data and test results from Mr. Tanjoh’s experiments, the accuracy of which
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`Petitioner’s own expert does not contest. Ex. 2029 at 114:7–23. Mr. Tanjoh does not
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`opine on whether the reported data and test results would have been surprising or
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`unexpected to a POSA, and Petitioner cites to no testimony of Mr. Tanjoh to that
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`effect. Rather, it is Dr. McConville who opines on the unexpected and surprising
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`nature of Mr. Tanjoh’s test results. Compare Paper 31 at 2 (quoting Mr. Tanjoh’s
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`test results from Ex. 1010 at 107), id. at 4 (no citation to where “the inventor’s self-
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`serving testimony that the claim possesses surprising or unexpected import” appears,
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`much less a cite to the Tanjoh Declaration), and id. at 5 (no citation to where Mr.
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`Tanjoh “assert[ed] surprising or unexpected results”), with id. at 2 (“He [Dr.
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`McConville] concludes that ‘the POSA would have found this result surprising an[d]
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`unexpected’” (emphasis added), citing to McConville Declaration, Ex. 2028 at ¶¶
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`99–100). Petitioner deposed Dr. McConville on August 17, 2017.
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`As Petitioner acknowledges, in the related district court litigation (Civil
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`Action Nos. 2:15-cv-1471; 2:15-cv-1740 (E.D. Tex.)), Mr. Tanjoh was designated
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`to testify regarding, among other things, unexpected results as an objective indicia
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`of nonobviousness of the ‘180 Patent. Paper 31 at 4–5; see also Ex. 1024 at 6 (Topic
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`17 includes unexpected results); Ex. 1025 at 2 (confirming Topic 17 for testimony
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`2
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`IPR2017-00203
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`by Mr. Tanjoh). Petitioner’s back-up counsel in the present proceeding, Mr. Olinger,
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`conducted Mr. Tanjoh’s litigation deposition in March of this year, during which a
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`number of deposition exhibit documents were identified as “RESTRICTED—
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`ATTORNEYS’ EYES ONLY” (“the AEO Exhibits”).
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`II.
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`ARGUMENT
`Each of the five Garmin factors, which frame the analysis for determining
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`whether additional discovery is in the interests of justice and should thus be allowed,
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`fails to support either the cross-examination of Mr. Tanjoh, or the requested
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`production of documents. See Garmin Int’l Inc. v. Cuozzo Speed Techs. LLC, Case
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`IPR2012-00001, Paper 26 (PTAB March 5, 2013).
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`A. Garmin factor #1: Petitioner has failed to show that there is more
`than a possibility or mere allegation that something useful will be
`uncovered by deposing Mr. Tanjoh for a second time.
`Contrary to Petitioner’s assertion, the Tanjoh Declaration does not opine on
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`whether the data and results reported therein would be surprising or unexpected to a
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`POSA. See Ex. 1010 at 105–108. Petitioner’s motion cites to no testimony of Mr.
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`Tanjoh to that effect. See Paper 31 at 2, 4, & 5. Therefore, Petitioner has not shown
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`that something “useful” will be obtained from the cross-examination. In addition,
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`Petitioner specifically required Mr. Tanjoh to be prepared to discuss any knowledge
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`he had bearing on “unexpected results” during the March 2017 litigation deposition
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`(Ex. 1024 at 6), by which time Petitioner was in possession of the Patent Owner
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`3
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`IPR2017-00203
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`Preliminary Response (“POPR”; Paper 9, February 17, 2017) that laid out the
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`unexpected results arguments from the present proceeding (Paper 9 at 1, 4–11, 13–
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`14, 17).
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`Patent Owner has already consented to filing in the present proceeding Mr.
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`Tanjoh’s complete sworn testimony from the March 2017 litigation deposition. Ex.
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`2062 at 3-5. Thus, any testimony from Mr. Tanjoh regarding unexpected results, and
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`the AEO Exhibits, would be included in the deposition transcript, and the record of
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`Mr. Tanjoh’s testimony would be complete. Petitioner’s “extremely unburdensome
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`request” (Paper 31 at 1) for consent to file the AEO Exhibits from Mr. Tanjoh’s
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`March deposition, along with the complete sworn testimony and the non-AEO
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`deposition exhibits, is nothing more than a back-door attempt to obtain documents
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`through additional discovery that were not requested, much less authorized by the
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`Board. See Ex. 2061.
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`Significantly, Petitioner has not asserted or alleged that any of the AEO
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`Exhibits is directed to the data and experiments contained in the Tanjoh Declaration,
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`much less directed to why such results are surprising or unexpected, as opposed to
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`any of the other numerous topics on which Mr. Tanjoh was deposed. See Exs. 1024,
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`1025. Petitioner’s rationale that a protective order would solve confidentiality
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`concerns about the AEO Exhibits misses the point. Petitioner has not, and cannot,
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`establish that they are independently entitled to production of the AEO Exhibits
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`4
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`IPR2017-00203
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`under the rules of additional discovery in IPR proceedings.
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`B. Garmin factor #2: Petitioner is seeking Patent Owner’s litigation
`positions and the underlying basis for those positions.
`The fact that Petitioner finds the complete sworn testimony of Mr. Tanjoh
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`inadequate to meet their needs is telling—Petitioner seeks a “do-over” of the first
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`Tanjoh deposition to gain more favorable testimony for use in the related litigation.1
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`Thus, Petitioner’s request violates the Board’s “established rules for the presentation
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`of arguments and evidence” and is thus not in the interest of justice. Garmin, Case
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`IPR2012-00001, Paper 26 at 6.
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`C. Garmin factor #3: Petitioner has the ability to generate equivalent,
`and more relevant, information by other means.
`Petitioner seeks additional discovery regarding the unexpected and surprising
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`results of the claimed invention in the ’180 patent. Paper 31 at 1, 7. However, as the
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`motion acknowledges, it is Dr. McConville who opines that the results reported in
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`the Tanjoh Declaration were surprising and unexpected to a POSA. Paper 31 at 2,
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`citing Ex. 2028 at ¶¶ 99–100. Patent Owner relies not on the AEO Exhibits, but on
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`1 The Protective Order in the litigation precludes use of the litigation deposition in
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`the IPR absent consent, which Patent Owner provided, agreeing to work with
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`Petitioner on a Protective Order for the IPR with respect to the filing of the March
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`2017 deposition transcript. Ex. 2062 at 4-5.
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`5
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`
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`IPR2017-00203
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`the declaration of Dr. McConville (Ex. 2028) and the documents cited therein, to
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`support its position regarding unexpected results. Petitioner deposed Dr. McConville
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`on August 17, 2017, completing the deposition in less than the allotted seven hours.
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`Thus, Petitioner has had a full opportunity to test with cross-examination Patent
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`Owner’s evidence of unexpected results. In addition, Petitioner had a full
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`opportunity to question Mr. Tanjoh on the issue of “unexpected results” in the March
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`2017 deposition (Exs. 1024, 1025), and Patent Owner has consented to filing of his
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`complete sworn testimony from that deposition in the present proceeding.
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`D. Garmin factor #4: Petitioner’s additional request for all
`documents relating to unexpected results is not easily
`understandable.
`Not only is the request for “all documents” relating to unexpected results
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`unauthorized by the Board (Ex. 2061), it is unduly broad (requesting “all
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`documents”), vague (requesting any documents that “support or refute [Patent
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`Owner’s] assertion of unexpected results”), and, by Petitioner’s own admission, a
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`“litigation” document request (Paper 31 at 7 referencing “similar requests in the
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`underlying district court litigation”) inappropriate for an IPR proceeding.
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`E. Garmin factor #5: Petitioner’s request is overly burdensome and
`not in the interest of justice.
`It cannot be in the interest of justice, and is certainly unduly burdensome, to
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`require a second deposition of Mr. Tanjoh with respect to a declaration from the
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`original prosecution, and any “unexpected results” as an objective indicia of
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`6
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`IPR2017-00203
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`nonobviousness, of the ‘180 Patent, when Petitioner had the opportunity to question
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`Mr. Tanjoh on these very topics, and Patent Owner has consented to the filing of the
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`complete testimony from that two-day deposition in the present proceeding. Mr.
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`Tanjoh is approximately 70 years old and resides in Japan, and requires an interpreter
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`in order to be deposed. Petitioner’s request to produce all documents that “support
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`or refute the assertion of unexpected results,” (Paper 31 at 7) is unduly burdensome
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`because it is not “sensible and responsibly tailored according to a genuine need.”
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`Garmin, Case IPR2012-00001, Paper 26 at 7.
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`Given that Patent Owner has consented to the filing of the complete transcript
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`of Mr. Tanjoh’s testimony from the March 2017 deposition, Petitioner has not
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`established a genuine need for a second deposition, particularly since Petitioner has
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`already deposed Dr. McConville, the witness in this proceeding who actually opined
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`on “unexpected results.” In addition, Petitioner has not established a genuine need
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`for the AEO Exhibits given that (i) the record of Mr. Tanjoh’s testimony would be
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`complete, (ii) Patent Owner does not rely on the AEO Exhibits as evidence of
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`unexpected results, (iii) Petitioner has not asserted that any of the AEO Exhibits is
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`directed to the Tanjoh Declaration data and experiments, and (iv) Petitioner has
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`tested with the cross-examination of Dr. McConville the evidence on which Patent
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`Owner relies for “unexpected results.” Petitioner’s request for the cross-examination
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`of Mr. Tanjoh and for production of the AEO Exhibits should be denied.
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`7
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`
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`Date: August 18, 201.7
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`Respectfully submitted,
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`lPR2017—00203
`
`By
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`
`
`
`
`
`
`6)
`No.86“,
`Jessica L.
`'glrezéfu (Reg
`Andrea G. l eister (Reg. No. 36,253)
`Scott E. Kamholz (Reg. No. 48,543)
`Michael N. Kennedy (pro hac vice)
`Megan P. Keane (pro hac vice)
`COVINGTON & BURLENG LLP
`
`”
`
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
`(202) 662-6000
`
`MaryAnne Armstrong (Reg. No. 40,069)
`Lynde F. Herzbach (Reg. No. 74,886)
`BIRCH, STEWART, KOLASCH & BIRCH, LLP
`8110 Gatehouse Road, Suite- 100 East
`
`Falls Church, VA 22042
`
`(703) 205-8000
`
`Attorneys for Patent Owner
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`
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 CPR. § 42.6, I hereby certify that on this 18th day of August
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`2017,
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`the
`
`foregoing Patent Owner’s Opposition To Petitioner Mylan
`
`Pharmaceuticals Inc.’s Motion For Additional Discovery Under 37 C.F.R.
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`§42.51(b)(2) was served via electronic mail, by agreement of the parties, on the
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`following counsel ofrecord for Petitioner.
`
`Mitchell G. Stockwell
`
`David C. Holloway
`Jonathan D. Olinger
`Miranda C. Rogers
`Mylan—WC—IPR@kilpatricktownsendeom
`Kilpatrick Townsend & Stockton LLP
`1 100 Peachtree Street, Suite 2800
`
`Atlanta, GA 30309
`
`Dated: August ES, 2017
`
`Rebistration No.: 50,286
`
`
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