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UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`SANDOZ INC.,
`APOTEX INC., APOTEX CORP.,
`EMCURE PHARMACEUTICALS LTD.,
`HERITAGE PHARMA LABS INC.,
`HERITAGE PHARMACEUTICALS INC.,
`GLENMARK PHARMACEUTICALS, INC., USA,
`GLENMARK HOLDING SA,
`GLENMARK PHARMACEUTICALS, LTD.,
`MYLAN LABORATORIES LIMITED,
`TEVA PHARMACEUTICALS USA, INC.
`and FRESENIUS KABI USA, LLC,
`
`Petitioners
`
`v .
`ELI LILLY AND COMPANY,
`Patent Owner.
`
`Case IPR2016-003181
`U.S. Patent 7,772,209
`
`
`
`
`
`
`
`
`PETITIONERS’ MOTION TO CROSS-EXAMINE DR. NIYIKIZA BY
`DEPOSITION2
`
`
`1 Cases IPR2016-01340 and IPR2016-01429 have been joined with the instant
`
`proceeding.
`
`2 Identical copies of this motion have been filed in Sandoz Inc. v. Eli Lilly &
`
`Company, IPR2016-00318, and Neptune Generics, LLC v. Eli Lilly & Company,
`
`IPR2016-00237, IPR2016-00240.
`
`

`

`Petitioners Sandoz Inc. (“Sandoz”) and Neptune Generics, LLC
`
`(“Neptune”)3 hereby request the deposition of inventor Dr. Clet Niyikiza pursuant
`
`to either routine discovery under 37 C.F.R. § 42.51(b)(1)(ii), or alternatively,
`
`additional discovery under 37 C.F.R. § 42.51(b)(2). Should the Patent Trial and
`
`Appeal Board (the “Board”) not compel Dr. Niyikiza’s deposition, then according
`
`to prior Board decisions, Exhibit 2116, which is Dr. Niyikiza’s direct testimony at
`
`a prior district court trial, should be given no weight because Sandoz and Neptune
`
`would not have had the opportunity to cross-examine Dr. Niyikiza about that
`
`testimony in the present inter partes review (“IPR”) proceeding.
`
`I.
`
`Background
`
`Exhibit 2116 consists of 102 pages from the August 22, 2013 direct trial
`
`testimony of Dr. Clet Niyikiza, who is the sole inventor listed on the face of the
`
`patent at issue in these IPRs. This testimony was given in the litigation, to which
`
`neither Sandoz nor Neptune was a party, Eli Lilly & Co. v. Teva Parenteral Meds.,
`
`Inc., No. 1:10-CV-1376 (S.D. Ind.) (“Teva Litigation”). Patent Owner Eli Lilly
`
`and Company (“Lilly”) relies on 37 pages of Exhibit 2116 in its Patent Owner
`
`Responses, citing to the exhibit nine times in each response.
`
`
`3 The parties joined in IPR2016-00318, IPR2016-00237, and IPR2016-00240 join
`
`this motion.
`
`1
`
`

`

`On October 4 and 10, respectively, Neptune and Sandoz each requested the
`
`availability of Dr. Niyikiza to sit for his deposition. Lilly responded that it did not
`
`intend to make Dr. Niyikiza available. Subsequently, Lilly served supplemental
`
`evidence, which included the deposition transcript and the entire direct, cross,
`
`redirect, and re-cross trial testimony of Dr. Niyikiza in the Teva Litigation. The
`
`parties met and conferred on October 21 and 26, and then participated in a call
`
`with the Board on October 31. During that call, the Board authorized the parties to
`
`brief the issue of whether Dr. Niyikiza should be deposed. (Ex. 1062, Tr. at 4:18-
`
`5:4, 16:12-18.)
`
`II. Dr. Niyikiza Should Be Deposed Because His Deposition Is Routine
`Discovery Under 37 C.F.R. § 42.51(b)(1)(ii)
`
`In an IPR, “[u]ncompelled direct testimony must be submitted in the form of
`
`an affidavit,” 37 C.F.R. § 42.53(a), and a declarant or affiant must be made
`
`available for cross-examination, as the deposition is routine discovery, 37 C.F.R.
`
`§ 42.51(b)(1)(ii). A patentee cannot circumvent this requirement by relying on
`
`some other form of sworn testimony. For example, the Board has held that, if
`
`substantively relied on by the patent owner, a declaration from another proceeding,
`
`such as prosecution of a patent application, is also considered “affidavit
`
`testimony,” in which case the declarant’s deposition is routine discovery. See
`
`Altaire Pharm., Inc. v. Paragon Bioteck, Inc., PGR2015-00011, Paper 29 at 1-2
`
`(P.T.A.B. Apr. 1, 2016); see also Ikaria, Inc. v. Geno LLC, IPR2013-00253, Paper
`
`2
`
`

`

`20 at 2 (P.T.A.B. Apr. 1, 2014) (noting deposition required notwithstanding the
`
`argument that the declaration was submitted during prosecution and thus “was not
`
`prepared for the purposes of this proceeding”). There is no reason to treat sworn
`
`trial testimony, submitted in place of an affidavit, any differently. In both cases,
`
`an individual makes arguments regarding validity, and the Board can only properly
`
`weigh those arguments after he or she has been cross-examined in the IPR.
`
`Lilly’s Patent Owner Responses repeatedly rely on Dr. Niyikiza’s trial
`
`testimony to support substantive allegations including alleged skepticism about the
`
`claimed invention, alleged industry praise, and Lilly’s own version of the invention
`
`story. (IPR2016-00318, Paper 36 at 10-12, 57, 59; IPR2016-00237, Paper 33 at
`
`11-12, 55-56; IPR2016-00240, Paper 32 at 11-13, 55-56.) Dr. Niyikiza’s
`
`testimony and Lilly’s extensive reliance on this testimony is equivalent to a party
`
`relying on “affidavit testimony” in an IPR. Lilly’s reliance on this testimony in
`
`this IPR mandates the cross-examination of Dr. Niyikiza as routine discovery. See
`
`Altaire, PGR2015-00011, Paper 29 at 1-2.
`
`Additionally, Lilly’s reliance on Dr. Niyikiza’s trial testimony, from a matter
`
`to which Sandoz and Neptune were not parties, is an improper attempt to
`
`circumvent the Board’s rules, which make clear that cross-examination of a
`
`declarant is an essential component to IPR proceedings. See 37 C.F.R.
`
`§§ 42.51(b)(1)(ii), (b)(2). Lilly cannot avoid cross-examination by using testimony
`
`3
`
`

`

`from a prior proceeding. Moreover, Lilly’s production of Dr. Niyikiza’s cross-
`
`examination trial testimony does not excuse Lilly’s failure to make Dr. Niyikiza
`
`available for a deposition in these proceedings, particularly here where lead
`
`petitioners never had the opportunity to examine Dr. Niyikiza at trial. By heavily
`
`relying on Dr. Niyikiza’s trial testimony as if it were an affidavit, Lilly injected Dr.
`
`Niyikiza into these IPRs and must make him available for deposition under both
`
`the letter and spirit of 37 C.F.R. § 42.51(b)(1)(ii), or suffer the consequences for
`
`failing to do so. See Section IV, infra, at 9.
`
`III. Alternatively, Dr. Niyikiza’s Deposition Should Be Ordered As
`Additional Discovery Under 37 C.F.R. § 42.51(b)(2)
`
`If the Board finds that the deposition of Dr. Niyikiza is not routine
`
`discovery, then Sandoz and Neptune move for his deposition as additional
`
`discovery that is “necessary in the interest of justice” under the Garmin factors.
`
`See 35 U.S.C. § 316(a)(5); Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
`
`IPR2012-00001, Paper 26 at 6-7 (P.T.A.B. Mar. 5, 2013). All five Garmin factors
`
`support granting petitioners an opportunity to depose Dr. Niyikiza.
`
`A. Garmin Factor 1: There is more than a mere possibility that
`Dr. Niyikiza’s deposition will uncover useful information
`
`Sandoz and Neptune are already in possession of a threshold amount of
`
`evidence showing that information useful to petitioners will be uncovered by Dr.
`
`Niyikiza’s deposition. Lilly’s Patent Owner Responses rely on Dr. Niyikiza’s trial
`
`4
`
`

`

`testimony as evidence of alleged secondary considerations and also to tell the
`
`alleged invention story. Dr. Niyikiza thus has knowledge pertinent to these issues
`
`and there is more than a “mere possibility” that his deposition will uncover
`
`information useful to petitioners. See Garmin, IPR2012-00001, Paper 26 at 6.
`
`B. Garmin Factor 2: Sandoz and Neptune will not be asking
`for Lilly’s litigation positions via Dr. Niyikiza’s deposition
`
`Sandoz and Neptune do not seek Lilly’s litigation positions and their
`
`underlying bases, which Lilly has already disclosed in its Patent Owner Responses.
`
`C. Garmin Factor 3: A deposition is the only way for
`Petitioners to obtain the information sought
`
`Sandoz and Neptune lack an “ability to generate equivalent information by
`
`other means” besides the deposition of Dr. Niyikiza. See Garmin, IPR2012-00001,
`
`Paper 26 at 6. Sandoz and Neptune were not parties to the litigation where Dr.
`
`Niyikiza gave the testimony in Exhibit 2116. Sandoz and Neptune are competitors
`
`of the parties to the Teva Litigation and had no role in that litigation. Thus, neither
`
`Sandoz nor Neptune had an opportunity to cross-examine Dr. Niyikiza previously.
`
`The fact that Teva and Fresenius are joined in these IPRs does not change these
`
`facts, particularly here where Teva and Fresenius are simply silent understudies.
`
`(IPR2016-00318, Paper 33, ¶ 3; IPR2016-00237 & -00240, Paper 29, ¶ 3.)
`
`
`
`Introducing the transcript of Dr. Niyikiza’s prior cross-examination cannot
`
`cure the lack of a deposition for several reasons. First, it does not fill the gaps
`
`5
`
`

`

`Sandoz and Neptune would seek to fill by taking Dr. Niyikiza’s deposition.
`
`Although Teva and Fresenius certainly obtained useful admissions from Dr.
`
`Niyikiza on cross-examination, their questioning did not cover all the topics
`
`covered in the 37 pages of testimony cited by Eli Lilly. By way of example,
`
`Lilly’s Patent Owner Response quotes a statement that was purportedly made by a
`
`principal investigator “prais[ing] Dr. Niyikiza’s contribution to pemetrexed’s
`
`development [and] stating that ‘[i]f you didn’t do it, the drug would probably be
`
`dead.’” (IPR2016-00318, Paper 36 at 59; IPR2016-00237, Paper 33 at 56;
`
`IPR2016-00240, Paper 32 at 56.) The questioning on cross-examination in the
`
`Teva Litigation does not touch on this statement, which is the primary allegation
`
`on which Lilly's assertion of skepticism is based in these IPRs.4 Likewise, the
`
`recently produced Teva Litigation exhibits and deposition transcripts – taken
`
`before trial – leave this issue, and others, unaddressed and are not substitutes for
`
`cross-examination on the specific topics raised in Dr. Niyikiza’s direct testimony.
`
`
`
`Second, during the parties’ meet-and-confers, Lilly attempted to justify its
`
`reliance on Dr. Niyikiza’s testimony by characterizing it as narrowly limited to
`
`issues related to skepticism that were already covered in the Teva Litigation. This
`
`claim is belied by Lilly’s extensive citations to Dr. Niyikiza’s transcript and the
`
`4 This issue is exemplary. Petitioners are not obligated to explain in advance every
`
`issue in Exhibit 2116’s 102 pages on which they may question Dr. Niyikiza.
`
`6
`
`

`

`content of Exhibit 2116 itself. Lilly explicitly relies on 37 pages of Dr. Niyikiza’s
`
`trial testimony in its Patent Owner Responses to tell the alleged invention story and
`
`provide his own purported reasons for not adding vitamin B12 to the pemetrexed
`
`treatment – topics that are not related to its allegations of skepticism by experts in
`
`the relevant field. (IPR2016-00318, Paper 36 at 10-12, 57, 59; IPR2016-00237,
`
`Paper 33 at 11-12, 55-56; IPR2016-00240, Paper 32 at 11-13, 55-56.) For
`
`example, Lilly relies on Dr. Niyikiza to suggest that Dr. Niyikiza’s published data
`
`did not support the addition of vitamin B12 – not skepticism by others. (IPR2016-
`
`00318, Paper 36, at 10.) Further, Dr. Niyikiza’s tale of how he got the idea for the
`
`claimed invention at a Kroger pharmacy has no bearing on whether the claimed
`
`invention was met with any skepticism of experts. (Ex. 2116, Niyikiza at 744-45.)
`
`Yet, Exhibit 2116 includes a large amount of content like this that has nothing to
`
`do with skepticism.
`
`
`
`
`
`In addition, the invalidity positions in these IPRs are not the same as the
`
`Teva Litigation. Among the differences are: (i) all instituted grounds in both the
`
`Sandoz and Neptune IPRs include European Patent Application No. 0 595 005,
`
`which was not even a trial exhibit in the Teva Litigation; (ii) the instituted grounds
`
`for Neptune’s IPR2016-00240 rely on an article by Rusthoven, which was not
`
`relied on by Teva and Fresenius for their obviousness positions; and (iii)
`
`Petitioners rely on expert testimony as well as a number of secondary references
`
`7
`
`

`

`not raised in the Teva Litigation. Given the breadth of Niyikiza’s testimony and
`
`the differences between the grounds in these IPRs and the Teva litigation,
`
`Petitioners should have an opportunity to question Dr. Niyikiza’s testimony in light
`
`of the particular art and the allegations raised in his testimony.
`
`D. Garmin Factor 4: Sandoz and Neptune’s deposition request
`is easily understandable
`
`There is nothing complex about Sandoz and Neptune simple deposition
`
`request per 37 C.F.R. § 42.51(b)(1)(ii), or alternatively, 37 C.F.R. § 42.51(b)(2).
`
`E. Garmin Factor 5: Sandoz and Neptune’s deposition request
`is not overly burdensome
`
`There is nothing overly burdensome regarding the requested deposition. The
`
`Board’s rules contemplate depositions will be taken on request for any affiant
`
`under 37 C.F.R. § 42.51(b)(1)(ii). While the parties have conducted separate
`
`depositions in these two sets of related IPRs, Petitioners are willing to agree to a
`
`single 1-day deposition for Dr. Niyikiza to further reduce any burden.
`
`Although Dr. Niyikiza is no longer a Lilly employee, it should not be overly
`
`burdensome for him to sit for his deposition in this matter. Dr. Niyikiza was a
`
`Vice President at Merrimack Pharmaceuticals in Boston at the time he voluntarily
`
`traveled to DC and Indianapolis to testify at deposition and trial in the Teva
`
`Litigation and may be contractually obligated to assist Lilly in future matters
`
`involving the ‘209 patent – a common practice in the pharmaceutical industry.
`
`8
`
`

`

`(Dkt. 2116, Niyikiza at 712.) Lilly has identified no reason why Dr. Niyikiza
`
`could not be available to sit for his deposition in these proceedings at a location
`
`convenient to him. Further, to Sandoz and Neptune’s knowledge, Lilly has not
`
`even tried to arrange for Dr. Niyikiza’s deposition.5
`
`IV. The Board Should Give No Weight To Dr. Niyikiza’s Testimony If He
`Cannot Be Cross-Examined
`
`If Lilly does not make Dr. Niyikiza available for a deposition, then Dr.
`
`Niyikiza’s testimony should be given no weight. See Coalition for Affordable
`
`Drugs V LLC v. Biogen MA Inc., IPR 2015-01993, Paper 34 at 3 (P.T.A.B. Apr.
`
`19, 2016) (explaining that in order for a declaration submitted during patent
`
`prosecution to “be given any weight” in an IPR, the declarant/affiant must be made
`
`available for cross-examination in the manner specified in 37 C.F.R.
`
`§ 42.51(b)(1)(ii)). In Organik Kimya AS v. Rohm & Haas Co., the petitioner
`
`submitted a declaration in the IPR that had been originally submitted in a prior
`
`International Trade Commission (“ITC”) proceeding. IPR2014-00185, Paper 42 at
`
`2 (P.T.A.B. Dec. 18, 2014). The patent owner had deposed the declarant in the
`
`ITC proceeding but still sought a deposition in the IPR. Id. Even though the
`
`
`5 Given Dr. Niyikiza’s past cooperation with Lilly, Sandoz expects that it will not
`
`be necessary to subpoena Dr. Niyikiza under 35 U.S.C. § 24 should the Board
`
`order Lilly to make Dr. Niyikiza available.
`
`9
`
`

`

`Board did not grant a deposition in the IPR as routine discovery, the Board held
`
`that the declaration would be “entitled to little or no weight, as it has not been
`
`subject to cross-examination as it pertains to the instant proceeding.” Id. at 3.
`
`Similarly, if Dr. Niyikiza is not deposed in the present IPRs, his trial testimony
`
`should be given no weight, especially because Sandoz and Neptune never had the
`
`opportunity to cross-examine him.
`
`The Board has also held that a declaration should be given no weight when it
`
`was originally submitted in a re-examination proceeding, Mexichem Amanco
`
`Holdings S.A. de C.V. v. Honeywell Int’l, Inc., IPR2013-00576, Paper 36 at 2-3
`
`(P.T.A.B. Sept. 5, 2014) (Bonilla, J.), or during prosecution of a related patent,
`
`Amneal Pharm., LLC v. Endo Pharm. Inc., IPR2014-00360, Paper 39 at 3-4
`
`(P.T.A.B. Dec. 3, 2014) (Bonilla, J.). The Board’s decisions are clear: if a witness
`
`is not cross-examined in the IPR, then it is given no weight.
`
`V. CONCLUSION
`For the foregoing reasons, petitioners respectfully request that the Board
`
`order Lilly to provide Dr. Niyikiza to sit for his deposition. In the event that Dr.
`
`Niyikiza is not produced for a deposition, petitioners request that his testimony be
`
`given no weight.
`
`Dated: November 9, 2016
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`/s/ Ralph J. Gabric
`Ralph J. Gabric (Reg. No. 34,167)
`
`10
`
`

`

`Laura L. Lydigsen
`Bryan T. Richardson, Ph.D. (Reg. No.
`70,572)
`Joshua H. James (Reg. No. 72,568)
`Brinks Gilson & Lione
`NBC Tower – Suite 3600
`455 N. Cityfront Plaza Dr.
`Chicago, Illinois 60611
`
`
`
`11
`
`

`

`CERTIFICATE OF SERVICE
`
`I hereby certify that true and correct copies of the foregoing document
`were served on November 9, 2016 via email to the following individuals at the
`email addresses below.
`
`Dov P. Grossman (Reg. No. 72,525)
`Williams & Connolly LLP
`725 Twelfth St. NW
`Washington DC 20005
`Direct Phone: 202-434-5812
`Facsimile: 202-434-5029
`dgrossman@wc.com
`
`David M. Krinsky (Reg. No. 72,339)
`Williams & Connolly LLP
`725 Twelfth St. NW
`Washington DC 20005
`Direct Phone: 202-434-5338
`Facsimile: 202-480-8302
`dkrinsky@wc.com
`
`Adam L. Perlman
`Williams & Connolly LLP
`725 Twelfth St. NW
`Washington DC 20005
`Direct Phone: 202-434-5244
`aperlman@wc.com
`
`James P. Leeds (Reg. No. 35,241)
`Eli Lilly and Company
`Lilly Corporate Center
`Indianapolis, IN 46285
`Direct Phone: 317-276-1667
`Facsimile: 317-277-6534
`leeds_james@lilly.com
`
`John C. Demeter (Reg. No. 30,167)
`Eli Lilly and Company
`
`
`
`

`

`
`
`Dated: November 9, 2016
`
`
`
`
`
`
`
`
`
`
`Lilly Corporate Center
`Indianapolis, IN 46285
`Direct Phone: 317-276-3785
`Facsimile: 317-276-3861
`demeter_john_c@lilly.com
`
`
`
`
`
`/s/ Ralph J. Gabric
`Ralph J. Gabric (Reg. No. 34,167)
`Laura L. Lydigsen
`Bryan T. Richardson, Ph.D. (Reg. No.
`70,572)
`Joshua H. James (Reg. No. 72,568)
`Brinks Gilson & Lione
`NBC Tower – Suite 3600
`455 N. Cityfront Plaza Dr.
`Chicago, Illinois 60611
`
`
`
`

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