`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`NEPTUNE GENERICS, LLC,
`APOTEX INC., APOTEX CORP., TEVA PHARMACEUTICALS,
`FRESENIUS KABI USA, LLC and WOCKHARDT BIO AG,
`Petitioners,
`
`v.
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`ELI LILLY & COMPANY,
`Patent Owner.
`__________________
`
`Case No: IPR2016-002401
`Patent No. 7,772,209
`__________________
`
`PATENT OWNER ELI LILLY’S OPPOSITION TO PETITIONERS’
`MOTION TO CROSS-EXAMINE DR. NIYIKIZA BY DEPOSITION2
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`1 Cases IPR2016-01191, IPR2016-01337, and IPR2016-01343 have been joined
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`with the instant proceeding.
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`2 Except for the cover page, identical copies of this Opposition have been filed in
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`Sandoz Inc. v. Eli Lilly & Company, IPR2016-00318, and Neptune Generics, LLC
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`v. Eli Lilly & Company, IPR2016-00237, IPR2016-00240.
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`In their Motion, Petitioners make a request for a deposition that is wholly
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`untethered from the Board’s rules regarding limited discovery. Patent Owner Eli
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`Lilly and Company (“Lilly”) submitted excerpts of the district court validity trial
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`testimony of inventor Dr. Clet Niyikiza relating principally to skepticism of the
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`invention. At Petitioners’ request, Lilly produced the rest of Dr. Niyikiza’s trial
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`testimony (including his trial cross-examination), his deposition on the same issues
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`by Joinder-Petitioners Teva and Fresenius (f/k/a APP), and all of the exhibits used
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`at the validity trial and at his deposition. Unsatisfied, Petitioners seek their own
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`additional deposition.
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`Contrary to Petitioners’ arguments, however, the deposition they seek is not
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`“routine” discovery nor proper “additional” discovery. It is not “routine” discovery
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`because Dr. Niyikiza has not submitted an affidavit “prepared for the proceeding.”
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`And because Petitioners have failed to articulate what new information a
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`deposition would provide, they also cannot show a need for “additional” discovery
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`under the standards the Board set forth in Garmin. Petitioners’ position amounts to
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`a per se rule that prior sworn testimony—even where the witness was already
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`subject to cross-examination—can only be submitted and given consideration if the
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`witness is deposed. That is not even the law in district courts, never mind in IPR
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`proceedings where discovery is limited.
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`1
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`I.
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`A Deposition of Dr. Niyikiza Is Not Routine Discovery
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`Petitioners first assert that they are entitled to a deposition of Dr. Niyikiza
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`because “there is no reason to treat sworn trial testimony” from another proceeding
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`“any differently” from the affidavit testimony for which cross-examination is
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`authorized under 37 C.F.R. § 42.51(b)(1)(ii). Mot. at 3. But there is a very good
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`reason: the controlling regulation expressly distinguishes them.
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`By the plain language of the regulation, “routine discovery” encompasses
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`only “[c]ross examination of affidavit testimony prepared for the proceeding.” 37
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`C.F.R. § 42.51(b)(1)(ii) (emphasis added). This language could not be clearer. Dr.
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`Niyikiza’s trial testimony constitutes sworn testimony from a different adversarial
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`proceeding—it was not “prepared for” these IPR proceedings. His deposition is
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`therefore not “routine” discovery and is not authorized under § 42.51(b)(1)(ii).3
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`3 It is also irrelevant, contrary to Petitioners’ arguments, how “extensive” Lilly’s
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`reliance on Dr. Niyikiza’s testimony is. Mot. at 1, 3. The extent to which Lilly has
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`relied on the testimony does not affect whether it is an “affidavit prepared for the
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`proceeding,” which plainly it is not. But Petitioners’ assertions are also grossly
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`overstated. The relevance of Dr. Niyikiza’s testimony is principally in support of
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`Lilly’s skepticism arguments, and even as to those arguments the story is well-
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`supported by documentary evidence that Dr. Niyikiza’s testimony serves to
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`2
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`That should end the matter as to Petitioners’ first argument. But the
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`conclusion is further supported by the history of the regulation. Until 2015, the
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`regulation provided that “[c]ross examination of affidavit testimony” was routine
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`discovery, without a provision specifying the proceeding for which it had to be
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`prepared. 37 C.F.R. § 42.51(b)(1)(ii) (2012). Panels of the Board were split as to
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`whether the regulation encompassed testimony from other proceedings. Compare,
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`e.g., GEA Process Eng’g, Inc. v. Steuben Foods, Inc., IPR2014-00041, Paper 41 at
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`2–3 (PTAB June 11, 2014) with, e.g., Ikaria, Inc. v. Geno LLC, IPR2013-00253,
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`Paper 20 (PTAB Apr. 1, 2014). The amended regulation resolved this
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`disagreement by “clarify[ing] that routine discovery includes only the cross-
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`examination of affidavit testimony prepared for the proceeding.” 80 Fed. Reg.
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`28563. Petitioners’ argument thus not only flies in the face of the regulation’s
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`plain language, but it ignores the history that gave rise to that language.
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`The cases Petitioners cite to the contrary are inapposite. Petitioners rely
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`upon Ikaria, Inc. v. Geno LLC, IPR2013-00253, Paper 20 (PTAB Apr. 1, 2014),
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`authenticate and contextualize. Dr. Niyikiza’s additional testimony as to the
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`background of the invention story further explains the context in which the
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`skepticism arose. Lilly does not rely on that invention story for the teachings of
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`the references at issue or the motivations of the person of ordinary skill.
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`3
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`
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`but that case was decided before the PTO amended § 42.51(b)(1)(ii) in 2015 to
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`clarify that cross-examination of testimony from other proceedings as routine
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`discovery is not authorized. Ikaria also involved a written declaration rather than
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`oral testimony that was subjected to cross-examination. Id. Similarly, although
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`the panel in Altaire Pharm., Inc. v. Paragon Bioteck, Inc., PGR2015-00011, Paper
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`29 (PTAB Apr. 1, 2016), indicated that the Patent Owner must make available for
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`deposition a witness who had submitted affidavit testimony during patent
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`prosecution, id. at 1–2, the Patent Owner never raised, and the Altaire panel did not
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`discuss or analyze, the “prepared for the proceeding” language of
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`§ 42.51(b)(1)(ii). Where the PTAB has addressed the relevant question here, as in
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`Maxliner, Inc. v. Cresta Tech. Corp., IPR2015-00594, Paper 32 at 2 (Jan. 15,
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`2016), it has followed the clear text of § 42.51(b)(1)(ii) and held that cross-
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`examination of testimony prepared for another proceeding is not authorized.
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`For these reasons, Petitioners’ assertion that the submission of prior
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`testimony is somehow a way to “avoid cross-examination” or “circumvent the
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`Board’s rules,” Mot. at 4, is meritless. Under the rules, witnesses who prepare
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`affidavits “for the proceeding” are automatically subject to cross-examination.
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`Witnesses who testified previously—and, as here, were subject to cross-
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`examination previously—are not.
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`4
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`II.
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`Petitioners Have Not Demonstrated That the Additional Discovery of a
`Deposition of Dr. Niyikiza Is Necessary In the Interest of Justice
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`Petitioners next resort to the rules on “additional” discovery under 37 C.F.R.
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`§ 42.51(b)(2)(i). Because discovery in IPR proceedings is “limited” and “less than
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`what is normally available in district court patent litigation,” Google Inc. v.
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`Jongerius Panoramic Techs., LLC, IPR2013-00191, Paper 27 at 3 (PTAB Sept. 30,
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`2013), Petitioners can only obtain such additional discovery if they show that such
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`additional discovery is “necessary in the interest of justice.” 35 U.S.C. §
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`316(a)(5). Under the well-known Garmin factors that the Board uses to analyze
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`this question, Petitioners cannot come close to meeting their burden.
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`A. Petitioners argue that there is more than a mere possibility that Dr.
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`Niyikiza’s deposition will uncover information useful to Petitioners regarding
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`skepticism and the invention story of the claimed invention, Mot. at 5 (Garmin
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`factor 1), and that there is no other way to obtain this information other than Dr.
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`Niyikiza’s deposition, Mot. at 6‒9 (Garmin factor 3). Petitioners are mistaken.
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`To begin with, Dr. Niyikiza was examined extensively in Eli Lilly & Co. v.
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`Teva Parenteral Meds., Inc., No. 1:10-CV-1376 (S.D. Ind.) (the “Teva Litigation”)
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`on two separate occasions—once during his day-long deposition, and again at the
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`trial on validity. The issues to which Petitioners allege Dr. Niyikiza’s testimony
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`relates were the subject of questioning by Joinder-Petitioners Teva and Fresenius
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`on both occasions. In response to Petitioners’ requests, Lilly has provided all of
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`5
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`this testimony, as well as a wealth of additional discovery from the Teva
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`Litigation, including all the exhibits from Dr. Niyikiza’s deposition and every
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`exhibit used at the validity trial.
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`Yet still Petitioners are not satisfied. However, Petitioners do not even
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`attempt to identify what information they are missing that could possibly be
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`gleaned from a deposition of Dr. Niyikiza in this proceeding. Petitioners assert
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`that “[a]lthough Teva and Fresenius certainly obtained useful admissions from Dr.
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`Niyikiza on cross-examination, their questioning did not cover all the topics
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`covered in the 37 pages of testimony cited by Eli Lilly.” Mot. at 6. However,
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`Petitioners only identify one issue that was allegedly not addressed by Joinder-
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`Petitioners in Dr. Niyikiza’s prior cross-examinations: a phase III pemetrexed trial
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`investigator’s praise of Dr. Niyikiza’s invention where he stated that “[i]f you
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`didn’t do it, the drug would probably be dead.” See Mot. at 6‒7. Petitioners
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`indicate that Joinder-Petitioners Teva and Fresenius’ cross-examinations did “not
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`touch on this statement.” Mot. at 7. But Petitioners fail to indicate what additional
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`information they expect to elicit in a second deposition or why Joinder-Petitioners
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`could not or did not obtain that information. Petitioners’ cursory identification of
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`this single topic for questioning falls far short of the first Garmin factor’s
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`requirement of “evidence tending to show beyond speculation that in fact
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`something useful will be uncovered” instead of offering “[t]he mere possibility of
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`6
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`finding something useful.” Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
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`IPR2012-00001, Paper 26 at 6 (PTAB Mar. 5, 2013).
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`Petitioners further argue that the Board should permit Petitioners to take the
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`deposition testimony of Dr. Niyikiza because the Joinder-Petitioners who
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`previously examined him are “simply silent understudies” here and “neither
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`Sandoz nor Neptune had an opportunity to cross-examine Dr. Niyikiza
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`previously.” Mot. at 6. While that is literally true, it is completely irrelevant. The
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`Joinder-Petitioners who examined Dr. Niyikiza previously are generic
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`pharmaceutical companies with exactly the same interests in invalidating the ’209
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`patent as Petitioners and were represented by competent counsel in the prior
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`proceeding. There is no basis to believe that Petitioners would glean any new
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`information if they get their own additional “bite at the apple,” and Petitioners do
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`not even try to articulate one, much less articulate what that information might be.
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`Anticipating Lilly’s response, Petitioners further argue that the invalidity
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`grounds in these IPRs are not the same as the arguments at issue in the Teva
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`Litigation, and thus, Petitioners should be able to question Dr. Niyikiza “in light of
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`the particular art and the allegations raised in his testimony.” Mot. at 8‒9. That
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`misses the point. The issues about which Dr. Niyikiza testified are the same in
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`both the IPRs and in the Teva Litigation; whether the claimed invention was the
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`subject of skepticism or praise does not depend on what particular prior art is
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`7
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`alleged to render it obvious. Petitioners’ assertion, rather, suggests their true
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`motivation for seeking to depose Dr. Niyikiza: he is the author of a prior art
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`reference relied on by Petitioners in these IPRs, and which forms part of the
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`Grounds in two of the three proceedings. Tellingly, Petitioners have indicated to
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`counsel for Lilly that they are unwilling to limit the scope of Dr. Niyikiza’s
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`potential deposition. Petitioners’ desire to fish for admissions that may be relevant
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`to their prima facie obviousness case has no place in the Garmin framework, and
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`the Board should not indulge it.
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`In sum, Petitioners have failed to demonstrate that there is more than a mere
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`possibility that Dr. Niyikiza’s deposition will uncover useful information (Garmin
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`factor 1) or that a deposition of Dr. Niyikiza is the only way for Petitioners to
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`obtain the information sought (Garmin factor 3).
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`B. The remaining Garmin factors are either inapposite or do nothing to
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`advance Petitioners’ case. As to the second Garmin factor, the discovery in
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`question is not a request for litigation positions. As to the fourth, while Petitioners
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`say there is “nothing complex” about their request, they also have failed to specify
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`the desired subject of the testimony; this factor thus weighs in Lilly’s favor,
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`because a deposition of uncertain scope is not a targeted and comprehensible
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`request for information.
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`Finally, Petitioners’ request to depose Dr. Niyikiza is overly burdensome
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`8
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`
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`and not tailored to a genuine need under the fifth Garmin factor. See Garmin,
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`IPR2012-00001, Paper 26 at 7. Dr. Niyikiza is not a Lilly employee—he is a third
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`party. He is the founder and CEO of an unrelated company, L.E.A.F.
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`Pharmaceuticals. Requiring Dr. Niyikiza to take time away from his work for the
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`deposition would be a burden both to him and to his company. Petitioners’
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`arguments concerning whether Dr. Niyikiza has a contractual obligation to help
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`Lilly or whether a subpoena may be necessary to secure his testimony are not
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`relevant to the question of the burden to him or his company.
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`III. Dr. Niyikiza’s Trial Testimony Should Be Accorded Full Weight
`In the event Petitioners’ request for a deposition is denied, they argue that
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`Dr. Niyikiza’s testimony should be given “no weight.” Mot. at 9. This draconian
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`suggestion is improper and should also be rejected, as it would turn the rules for
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`IPR proceedings on their head. As discussed, 37 C.F.R. § 42.51(b)(1)(ii)
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`authorizes as routine discovery only “[c]ross examination of affidavit testimony
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`prepared for the proceeding” (emphasis added). See supra p. 2–4. By limiting
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`routine cross-examination to such affidavits, the rules plainly contemplate that
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`testimony that is not “prepared for the proceeding” may be at issue. Petitioners’
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`suggestion would present parties like Lilly with a Hobson’s Choice: either make
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`any witnesses who offered such testimony available for deposition,
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`notwithstanding the language of the rule and the limited scope of IPR discovery, or
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`9
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`do not bother submitting their testimony because it is not afforded any weight.
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`Moreover, there is no reason why Dr. Niyikiza’s testimony is rendered any
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`less reliable just because he is not deposed again. Unlike in the one case
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`Petitioners cite on this point, Organik Kimya AS v. Rohm & Haas Co., IPR2014-
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`00185, Paper 42 at 2 (PTAB Dec. 18, 2014), Dr. Niyikiza has already been
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`examined on the subject matter at issue here. Petitioners do not and cannot
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`articulate why his prior cross-examinations were inadequate to test Dr. Niyikiza’s
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`testimony or why Petitioners’ interests were inadequately represented by Joinder-
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`Petitioners’ capable counsel when they performed those examinations. See supra
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`p. 6–8. Moreover, there is a wealth of documentary evidence before the Board that
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`corroborates Dr. Niyikiza’s testimony, but which the testimony will be helpful to
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`the Board in understanding. Dr. Niyikiza’s testimony should be accorded full
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`weight.
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`IV. Conclusion
`For the foregoing reasons, Petitioners’ Motion to Cross-Examine Dr.
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`Niyikiza By Deposition should be denied. Alternatively, if the Board orders Dr.
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`Niyikiza’s deposition, the Board should limit the scope of that deposition to Dr.
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`Niyikiza’s direct testimony regarding skepticism and praise for the invention.
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`Dated: November 18, 2016
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` Respectfully submitted,
`/Dov P. Grossman/
`Dov P. Grossman
`Reg. No. 72,525
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`10
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`Williams & Connolly, LLP
`725 12th St., NW
`Washington, DC 20005
`Telephone: 202-434-5812
`Facsimile: 202-434-5029
`Email: dgrossman@wc.com
`Lead Counsel for Patent Owner
`
`
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`11
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`CERTIFICATE OF SERVICE
`(37 C.F.R. §§ 42.6(e))
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`The undersigned hereby certifies that the foregoing document was served on
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`
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`November 18, 2016 by delivering a copy via electronic mail on the following
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`attorneys of record for the Petitioners in IPR2016-00237, IPR2016-00240, and
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`IPR2016-00318:
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`Sarah E. Spires
`Reg. No. 61,501
`237Neptune@skiermontderby.com
`240Neptune@skiermontderby.com
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`Skiermont Derby LLP
`2200 Ross Ave., Ste. 4800W
`Dallas, TX 75201
`P: 214-978-6600/F: 214-978-6601
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`Attorneys for Neptune Generics, LLC
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`Ralph J. Gabric
`Reg. No. 34,167
`rgabric@brinksgilson.com
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`Joshua H. James
`Reg. No. 72,568
`jjames@brinksgilson.com
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`Brinks Gilson & Lione
`455 Cityfront Plaza Drive
`Suite 3600 NBC Tower
`Chicago, IL 60611-5599
`T: 312-321-4200; F: 312-321-4299
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`Bryan T. Richardson, Ph.D.
`Reg. No. 70,572
`brichardson@brinksgilson.com
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`
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`Dr. Parvathi Kota
`Reg. No. 65,122
`237Neptune@skiermontderby.com
`240Neptune@skiermontderby.com
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`
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`Laura Lydigsen
`Pro hac vice
`llydigsen@brinksgilson.com
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`
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`Brinks Gilson & Lione
`4721 Emperor Blvd.
`Suite 220
`Durham, NC 27703-8580
`T: 919-998-5700; F: 919-998-5701
`
`Counsel for Sandoz Inc.
`
`John D. Polivick
`Reg. No. 57,926
`jpolivick@rmmslegal.com
`
`William A. Rakoczy
`Pro hac vice to be filed
`wrakoczy@rmmslegal.com
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`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street, Suite 500
`Chicago, IL
`P: 312-527-2157/F: 312-527-4205
`
`Attorneys for Apotex Inc. and Apotex
`Corp.
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`Thomas J. Parker
`Reg. No. 42,062
`thomas.parker@alston.com
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`Alston & Bird LLP
`90 Park Avenue, 15th Floor
`New York, NY 10016
`P: 212-210-9529/F: 212-210-9444
`
`Counsel for Mylan Laboratories
`Limited
`
`Gerard A. Haddad
`Reg. No. 41,811
`GHaddad@BlankRome.com
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`Deanne M. Mazzochi
`Reg. No. 50,158
`dmazzochi@rmmslegal.com
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`Patrick C. Kilgore
`Reg. No. 69,131
`pkilgore@rmmslegal.com
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`Blank Rome LLP
`The Chrysler Building
`405 Lexington Ave.
`New York, NY 10174
`P: 212-885-5135/F: 917-591-6921
`
`Counsel for Glenmark
`Pharmaceuticals Inc., USA, Glenmark
`Holding SA, and Glenmark
`Pharmaceuticals Ltd.
`
`Paul M. Zagar
`Reg. No. 52,392
`PZagar@BlankRome.com
`
`Blank Rome LLP
`The Chrysler Building
`405 Lexington Ave.
`New York, NY 10174
`P: 212-885-5290/F: 917-332-3063
`
`Counsel for Emcure Pharmaceuticals
`Ltd., Heritage Pharma Labs Inc., and
`Heritage Pharmaceuticals Inc.
`
`Gary J. Speier
`Reg. No. 45,458
`gspeier@carlsoncaspers.com
`
`Carlson, Caspers, Vandenburgh,
`Lindquist & Schuman
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`P: 612-436-9600
`F: 612-436-9605
`
`Cynthia Lambert Hardman
`Reg. No. 53,179
`chardman@goodwinprocter.com
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`Mark D. Schuman
`Reg. No. 31,197
`mschuman@carlsoncaspers.com
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`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`P: 212-813-8800
`F: 212-355-3333
`
`Attorneys for Teva Pharmaceuticals
`USA, Inc. and Kabi Fresenius USA,
`LLC
`
`Patrick A. Doody
`Reg. No. 35,022
`patrick.doody@pillsburylaw.com
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`Pillsbury Winthrop Shaw Pittman LLP
`1650 Tysons Boulevard
`McLean, VA 22102
`P: 703-770-7755/F: 703-770-7901
`
`Counsel for Wockhardt Bio AG
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`
`
`Date: November 18, 2016
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`
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`Bryan P. Collins
`Reg. No. 43,560
`bryan.collins@pillsburylaw.com
`
`
`
`/Dov P. Grossman/
`Dov P. Grossman
`Reg. No. 72,525
`Lead Counsel for Patent Owner