throbber
Paper No. 56
`Filed: February 14, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`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.
`
`ELI LILLY & COMPANY,
`
`PATENT OWNER.
`
`
`
`___________________
`
`Case IPR2016-002401
`Patent 7,772,209
`___________________
`
`
`
`PETITIONER’S MOTION TO EXCLUDE PATENT OWNER’S EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64(c)
`
`
`1 Cases IPR2016-01191, IPR2016-01337 and IPR2016-01343 have been joined
`with the instant proceeding.
`
`

`

`In accordance with 37 C.F.R. § 42.62 and the Federal Rules of Evidence,
`
`and for the reasons stated below, Petitioner respectfully requests that the Board
`
`exclude Patent Owner’s Exhibit Numbers 2120 and 2116.
`
`I.
`
`THE BOARD SHOULD EXCLUDE EXHIBIT 2120 AS UNRELIABLE
`UNDER FRE 702 AND 703.
`
`On October 7, 2016, Neptune timely objected to Exhibit 2120, which
`
`consists of the declaration testimony of Dr. Bruce Chabner. (Paper 35). Pursuant to
`
`FRE 702, “the trial judge must ensure that any and all scientific testimony or
`
`evidence admitted is not only relevant, but reliable.” Daubert v. Merrell Dow
`
`Pharms., Inc., 509 U.S. 579, 589 (U.S. 1993). “Expert testimony is not admissible
`
`if it includes unsubstantiated speculation and subjective beliefs.” Sport Dimension,
`
`Inc. v. Coleman Co., 820 F.3d 1316, 1323 (Fed. Cir. 2016) (quotation omitted).
`
`Expert opinions are also “inadmissible [if] they are based on incorrect legal
`
`standards.” Am. Med. Sys. v. Laser Peripherals, LLC, 712 F. Supp. 2d 885, 901 (D.
`
`Minn. 2010) (citing Hebert v. Lisle Corp., 99 F.3d 1109, 1117 (Fed. Cir. 1996)).
`
`Dr. Chabner’s opinions are all of the above—unsubstantiated, and based on
`
`subjective beliefs and incorrect legal standards.
`
`A. Dr. Chabner applies subjective beliefs and incorrect legal standards
`to reach his opinions.
`
`When Dr. Chabner, was asked what methodology he used to distinguish
`
`between his knowledge acquired over 50 years and a POSA’s knowledge in June
`
`
`
`1
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`

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`1999, he testified that he “really can’t answer that question,” and admitted he did
`
`not “employ methodologies” because he used “his own personal experience” and
`
`did not conduct his analysis based on a POSA “less informed than myself.” (Ex.
`
`1075- 233:15-234:12, 228:11-229:3.)
`
`When asked how he applied the reasonable expectation of success standard
`
`in his declaration, Dr. Chabner testified, “I looked at what I knew as of 1999, and
`
`what the literature said and what was publicly available, and I concluded that it
`
`was not obvious that – that using these vitamins would make a difference, would
`
`improve therapy.” (Id. at 88:25-89:8.) When asked what criteria he employed, he
`
`testified, “I think, you know, it’s like pornography. When it’s reasonable, you
`
`understand it when you see it. Scientifically, I was skeptical about it.” (Id. at 1075-
`
`89:20-25.)
`
`When pressed to explain how reasonably successful the claimed
`
`combination needed to be for obviousness, Dr. Chabner testified, “I think it would
`
`need to be something that I could endorse”— admitting “my standard for saying
`
`what’s obvious and reasonable is my personal standard. And that’s why I have 50
`
`years in the field.” (Id. at 90:19-94:3 (emphasis added).)
`
`Dr. Chabner’s failure to opine from a POSA’s perspective renders his
`
`opinions unreliable and inadmissible. See Amazon.com, Inc. v.
`
`Barnesandnoble.com, 239 F.3d 1343, 1364 (Fed. Cir. 2001) (what an expert “did
`
`
`
`2
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`

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`or did not personally realize at the time based on his actual knowledge is
`
`irrelevant”); Custom Accessories, Inc. v. Jeffrey-Allan Indus., 807 F.2d 955, 962
`
`(Fed. Cir. 1986) (inquiry is whether challenged claims are obvious to a POSA, “not
`
`to the judge, or to a layman . . . or to geniuses in the art.”); Ryko Mfg. Co. v. Nu-
`
`Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991) (noting the “importance of resolving
`
`the level of ordinary skill in the art lies in the necessity of maintaining objectivity
`
`in the obviousness inquiry. Instead of ascertaining what was subjectively obvious
`
`…, the court must ascertain what would have been objectively obvious...”).
`
`Separately, Dr. Chabner admitted that his personal standard for a reasonable
`
`expectation of success required “evidence that it worked in the clinical setting” and
`
`that “what was really needed was clinical evidence” of success. (Ex. 1075-214:9-
`
`215:4.) But “[c]onclusive proof of efficacy is not necessary to show obviousness.
`
`All that is required is a reasonable expectation of success.” Hoffman-LaRoche Inc.
`
`v. Apotex, Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014). Because Dr. Chabner did not
`
`use the proper standard for determining whether a POSA would have a reasonable
`
`expectation of success, his opinions should be excluded.
`
`Dr. Chabner further opines that rather than administering folic acid and B12
`
`to address pemetrexed’s known toxicity to patients with elevated homocysteine, a
`
`POSA would have instead attempted alternative interventions to address toxicity.
`
`(Ex. 1075-149:18-152:4.) Dr. Chabner testified that he would have been “very
`
`
`
`3
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`

`

`encouraged to undertake further investigation [of these alternatives].” (Ex. 1075-
`
`136:2-6.) When asked, with respect to these alternatives, “[d]oes being encouraged
`
`to undertake further investigation satisfy your understanding and application of a
`
`reasonable expectation of success?”—Dr. Chabner answered “Yes.” (Id., 136:7-
`
`13.) Dr. Chabner’s use of a lower standard (encouraged to undertake investigation)
`
`for a reasonable expectation of success for his alternatives—and a heightened
`
`standard (proof from clinical data) when evaluating reasonable expectation of
`
`success for the claimed folic acid/B12 pretreatment—should result in the exclusion
`
`of his opinions.
`
`B. Dr. Chabner’s Opinions are Unsubstantiated.
`The Supreme Court has held that courts should not admit expert testimony
`
`that “is connected to existing data only by the ipse dixit of the expert.” Gen. Elec.
`
`v. Joiner, 522 US 136, 146 (1997). That is what Dr. Chabner’s opinions entail.
`
`Three documents demonstrate that Dr. Chabner’s opinions are unsubstantiated and
`
`so inadmissible, or at a minimum entitled to no weight. Lilly has produced two
`
`documents it submitted to the FDA prior to the earliest effective filing date of the
`
`’209 Patent. (Exs. 2103 and 2017.) These documents constitute party admissions
`
`concerning the content of the prior art from a POSA’s perspective. Fed. R. Evid.
`
`801(d)(2); In re Copaxone Consol. Cases, 2017 U.S. Dist. LEXIS 12168 at *78 (D.
`
`Del. Jan. 30, 2017) (holding that non-prior art “statements that [Patent Owner]
`
`
`
`4
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`

`

`made to the FDA” “can properly be considered as an admission of a party
`
`opponent,” and can inform the court’s “analysis of the motivations of those having
`
`ordinary skill in the art at the time of the invention.”)
`
`Lilly submitted a third document (Ex. 1047) to The Oncologist, of which Dr.
`
`Chabner has always been Editor-in-Chief. (Ex. 1075 at 34:13-20). Although
`
`Exhibit 1047 was submitted six months after the effective filing date, it is also
`
`relevant to obviousness. See e.g., Ex Parte Raychem, 1992 Pat. App. LEXIS 21,
`
`*10-11 & n. 4 (Bd. Pat. App. & Interferences June 30, 1992) (later-published
`
`reference “relevant evidence” concerning a POSA’s knowledge about the prior art
`
`reference’s teaching); Ex Parte Erlich, 1992 Pat. App. Lexis 2, *6 (Bd. Pat. App.
`
`& Interferences Jan. 16 1992) (later-published reference citing many prior art
`
`references relevant to POSAs knowledge about the prior art references on patent
`
`filing date); In re Hogan, 559 F.2d 595, 605 & n. 17 (C.C.P.A. 1977) (later-
`
`published reference permissible evidence of art-related facts existing on the filing
`
`date).
`
`These documents cite the teachings of several prior art references at issue,
`
`and uniformly contradict Dr. Chabner’s opinions of this prior art. During his
`
`deposition, Dr. Chabner was shown Lilly’s admissions regarding the relevant prior
`
`art cited in these three documents. Although Lilly’s admissions are consistent with
`
`the references themselves, Dr. Chabner repeatedly rejected them.
`
`
`
`5
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`

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`Specifically, Lilly admits in these references that Hammond taught a POSA
`
`that the addition of folic acid supplementation permits pemetrexed dose escalation
`
`and ameliorates toxicity. (Ex. 1077 ¶69.) Dr. Chabner’s declaration, in contrast,
`
`states that Hammond teaches that folic acid undermines pemetrexed’s efficacy (Ex.
`
`2120 ¶ 96), and he also disagreed with Lilly’s representations that Hammond
`
`encouraged the use of folic acid for pemetrexed patients. (Ex. 1075-141:25-142:19,
`
`146:11-148:14, 167:14-168:21, 180:13-184:15.) Dr. Chabner testified that he
`
`“disagree[s] with everyone,” including Lilly scientists, who interpreted Hammond
`
`as supporting the use of folic acid pretreatment with pemetrexed. (Ex. 1075-160:5-
`
`20.) Not surprisingly, Dr. Chabner could not identify a single reference interpreting
`
`Hammond the way he does. (Id., 160:22-161:12.)
`
`Likewise, Lilly admitted Worzalla teaches that folic acid supplementation
`
`reduced pemetrexed’s toxicities while maintaining antitumor efficacy. (Ex. 1077
`
`¶70.) Dr. Chabner, in contrast, said Worzalla teaches that folic acid compromises
`
`pemetrexed’s efficacy. (Ex. 2120 ¶ 157.) Dr. Chabner also disagreed with Lilly’s
`
`interpretation of Worzalla evidencing that folic acid can ameliorate pemetrexed
`
`toxicities without a reduction in antitumor efficacy. (Ex. 1075-157:5-159:20,
`
`165:5-167:13, 219:23-221:5, 249:12-250:20, 269:3-277:2.) When asked “are you
`
`aware of any publication that sides with your interpretation of Worzalla and not the
`
`
`
`6
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`

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`one that is disclosed in The Oncologist article – or these reports?” He responded:
`
`“No.” (Ex. 1075-251:19-24.) Again, Dr. Chabner’s opinions are unsubstantiated.
`
`Lilly also admitted that Laohavinij teaches “it is possible to decrease the
`
`toxicity [of lometrexol] to healthy tissue while maintaining antitumor effect
`
`through careful adjustment of folic acid intake.” (Ex. 2107-10.) Dr. Chabner says
`
`the opposite (Ex. 2120 ¶ 157) and disagrees with Lilly’s contemporaneous
`
`understanding. (Ex. 1075-254:3-258:20.)
`
`Dr. Chabner’s opinions regarding Hammond, Worzalla, and Laohavinij are
`
`unsupported by any other reference and are inconsistent with contemporaneous
`
`admissions made by Lilly to the FDA and a peer-reviewed journal. Because Dr.
`
`Chabner’s opinions are unsubstantiated, they should not be admitted into evidence,
`
`or at a minimum should be given no weight. See, e.g., Pharmastem Therapeutics,
`
`Inc. v. Viacell, Inc., 491 F.3d 1342, 1361-63 (Fed. Cir. 2007); Ortho-McNeil
`
`Pharm., Inc. v. Teva Pharms. Indus., Ltd., 344 F. App’x 595, 603 (Fed. Cir. 2009)
`
`(expert opinions given little weight when they fly in the face of explicit prior art
`
`disclosures).
`
`II. EXHIBIT 2116 (DR. NIYIKIZA’S TESTIMONY IN A PRIOR
`PROCEEDING) SHOULD BE EXCLUDED.
`
`On October 7, 2016, Neptune timely objected to Exhibit 2116, which
`
`consists of 102 pages from the August 22, 2013 direct trial testimony of Dr. Clet
`
`Niyikiza, the sole inventor listed on the face of the patent at issue in this IPR.
`
`
`
`7
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`(Paper 36). This testimony was given in litigation, to which Neptune was not a
`
`party, Eli Lilly & Co. v. Teva Parenteral Meds., Inc., No. 1:10-CV-1376 (S.D.
`
`Ind.) (“Teva Litigation”). Lilly relies on 37 pages of Exhibit 2116 in its Patent
`
`Owner Response, citing to the exhibit nine times. See Paper No. 32 at 11-13, 55-
`
`56. As explained below, the testimony in Exhibit 2116 should be excluded as (1)
`
`hearsay under Fed. R. Evid. 802; (2) improper expert testimony under Fed. R.
`
`Evid. 602 and 702; (3) an improper attempt to circumvent the right to cross-
`
`examination in violation of the Board’s rules under 37 C.F.R. § 42.51(b)(i); and (4)
`
`incomplete under Fed. R. Evid. 106.
`
`A. Exhibit 2116 constitutes hearsay (and double hearsay) because the
`testimony was not given in this proceeding.
`
`The testimony from Dr. Niyikiza (Ex. 2116) relied upon by Lilly is
`
`impermissible hearsay. Dr. Niyikiza’s testimony falls squarely into the definition
`
`of hearsay because he gave the testimony during the Teva Litigation, not “while
`
`testifying at the current trial or hearing,” i.e., this IPR. See Fed. R. Evid. 801(c)(1).
`
`In addition, much of Dr. Niyikiza’s trial testimony constitutes double
`
`hearsay because the testimony as given in the district court was itself hearsay. For
`
`example, Dr. Niyikiza testified about statements made by FDA officials during a
`
`meeting in 1998. (Ex. 2116 at 787-88.) These alleged statements were made by
`
`individuals other than Dr. Niyikiza. The same applies to Dr. Niyikiza testifying
`
`about comments made by certain advisory panels (Ex. 2116 at 750-58, 760-65,
`8
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`
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`

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`771-75, 798-99), FDA employee responses at a meeting with Lilly (id. at 821-22),
`
`and comments made by an investigator at a conference (id. at 845).
`
`Further, Lilly is offering Dr. Niyikiza’s testimony for the truth of the matters
`
`asserted in the testimony. See Fed. R. Evid. 801(c)(2); Paper 32 at 11-13, 55-56
`
`(citing Ex. 2116 at 733-34, 742-48, 750-58, 760-65, 771-75, 787-88, 798-99, 821-
`
`22, 824).
`
`No hearsay exception applies and thus Dr. Niyikiza’s testimony should be
`
`excluded in its entirety. See Fed. R. Evid. 803, 804, 807. Lilly cannot rely on Fed.
`
`R. Evid. 804(b)’s exception for former testimony because there is no indication
`
`that Dr. Niyikiza “is unavailable as a witness” to testify in this proceeding. In
`
`addition, even if Lilly could establish that a hearsay exception exists for Dr.
`
`Niyikiza’s testimony generally, at least his double hearsay testimony about
`
`statements made by other scientists and third parties over a decade earlier, as
`
`discussed above, must be excluded under Fed. R. Evid. 802 and 805.
`
`B. Dr. Niyikiza is not an expert and Exhibit 2116 includes content
`over which he had no personal knowledge.
`
`Dr. Niyikiza’s trial testimony (Ex. 2116) also should be excluded because it
`
`includes extensive content over which he had no personal knowledge under Fed. R.
`
`Evid. 602, and for which he is not qualified to testify as an expert witness under
`
`Fed. R. Evid. 702. Dr. Niyikiza is not offered as an expert in this IPR and has
`
`admitted he has no background in oncology, nutrition, or vitamins. (Ex. 2116 at
`9
`
`
`
`

`

`717:15-20.) However, Dr. Niyikiza’s trial testimony includes repeated discussion
`
`of these areas – topics over which he had no personal knowledge or expertise. For
`
`example, Dr. Niyikiza testified regarding failures in programs that he did not
`
`participate in, the interactions of folic acid and pemetrexed, cancer therapy
`
`protocols, the folate pathway, and pemetrexed toxicity. (See id. at 733-34, 742-48,
`
`824.) Dr. Niyikiza also provided, in effect, expert testimony regarding statistical
`
`principles such as collinearity, but Dr. Niyikiza is not offered as an expert and was
`
`not deposed in this IPR. (See id. at 733-37.) Accordingly, Exhibit 2116 should be
`
`excluded under Fed. R. Evid. 602 and 702.
`
`C. Dr. Niyikiza was never made available for deposition, and
`therefore his prior testimony violates the Board’s rules.
`
`Dr. Niyikiza’s trial testimony also should be excluded, or, at a minimum, be
`
`entitled to no weight, because it violates the applicable regulations governing this
`
`proceeding, which require that “[u]ncompelled direct testimony must be submitted
`
`in the form of an affidavit” and that affidavit testimony be subject to cross
`
`examination under 37 C.F.R. § 42.51(b)(1)(ii). See 37 C.F.R. § 42.53(a).
`
`1.
`
`Lilly’s violation of 37 C.F.R. § 42.53 has deprived
`Neptune of Cross-Examination of Dr. Niyikiza.
`
`Lilly has refused to provide Dr. Niyikiza for deposition and thus Lilly’s
`
`violation of the 37 C.F.R. § 42.51(b)(1)(ii) cannot be cured. With the Board’s
`
`authorization (Ex. 1042, Tr. at 4:18-5:4, 16:12-18), Neptune filed a Motion to
`
`
`
`10
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`

`

`Cross-Examine Dr. Niyikiza on November 9 (Paper 43), which Lilly opposed
`
`(Paper 45). The Board has not ruled on Neptune’s motion and Lilly has not
`
`provided Dr. Niyikiza for deposition. Thus, Neptune has had no opportunity to
`
`depose Dr. Niyikiza in this IPR.
`
`Dr. Niyikiza’s prior cross-examination in the Teva Litigation does not
`
`excuse Lilly from complying with the Board’s rules or cure the prejudice to
`
`Neptune. By not making Dr. Niyijiza available for cross examination, Lilly has
`
`denied Neptune the opportunity to explore other topics with him such as, for
`
`example, the possibility that his allegation of “skepticism” was premised on
`
`matters unrelated to the claimed invention, such as Dr. Niyikiza’s alleged ability to
`
`design a study with sufficient statistical power to ensure FDA approval – not
`
`skepticism that the claimed vitamin pretreatment regimen would reduce
`
`pemetrexed related toxicities.
`
` Lilly has also prevented Neptune from probing Lilly’s reliance on Dr.
`
`Niyikiza’s hearsay testimony that a principal investigator allegedly “praised Dr.
`
`Niyikiza’s contribution to pemetrexed’s development. (Paper 32 at 56 (emphasis
`
`added).) Neptune was unable to explore whether the investigator’s reference was
`
`directed to all features of the claimed invention, which Lilly must establish in order
`
`to show the requisite “nexus” between the alleged “praise” and the claimed
`
`invention. Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318, 1327-28 (Fed. Cir.
`
`
`
`11
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`

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`2008). Neptune was further unable to explore with Dr. Niyikiza whether this so-
`
`called “praising” investigator was made aware of the relevant prior art at the time
`
`he allegedly gave such “praise.” Such prior art includes Exs. 1005; 1011;
`
`1013;1014; 1016; 1022; 2035) and both pemetrexed and other antifolates with
`
`vitamin B12 (Exs. 1013; 1014; 2042; 1064; 2043; 2079; 2055; 1020; 1010). If the
`
`investigator was not aware of such art, then Lilly’s assertions of praise must fail.
`
`See Bayer Healthcare Pharm., Inc. v. Watson Pharm., Inc., 713 F.3d 1369, 1377
`
`(Fed. Cir. 2013) (“industry praise of what was clearly rendered obvious by
`
`published references is not a persuasive secondary consideration”).
`
`2.
`
`The Board has repeatedly limited reliance on
`testimony that does not comply with its rules.
`
`Where, as here, a party relies on prior testimony but does not make a witness
`
`available for deposition as required by the Board’s rules, the Board has repeatedly
`
`held that the testimony is entitled to 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)); Altaire
`
`Pharm., Inc. v. Paragon Bioteck, Inc., PGR2015-00011, Paper 29 at 3 (P.T.A.B.
`
`Apr. 1, 2016) (same)
`
`
`
`12
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`

`

`In Organik Kimya AS v. Rohm & Haas Co., the petitioner submitted a
`
`declaration in the IPR that had been originally submitted in a prior trial at the
`
`International Trade Commission (“ITC”). 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. 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, Dr.
`
`Niyikiza’s trial testimony should be given no weight. Indeed, the facts are even
`
`more compelling here than Organik because Neptune has never had any
`
`opportunity to depose Dr. Niyikiza, unlike the Organik patent owner who had
`
`previously deposed the witness in the ITC proceeding.
`
`The fact that Dr. Niyikiza testified in a different proceeding, the Teva
`
`Litigation, does not make his testimony admissible in this IPR. Lilly previously
`
`relied on the regulatory history behind 37 C.F.R. § 42.51(b)(1) to argue that the Dr.
`
`Niyikiza’s deposition was not routine discovery – and thus excused from the
`
`Board’s rules requiring cross-examination – because his trial testimony was not
`
`“affidavit testimony prepared for the proceeding.” Paper 45 at 2 (emphasis in
`
`original). However, even after “prepared for the proceeding” was added to 37
`
`C.F.R. § 42.51(b)(1)(ii) in 2015, the Board has required cross-examination of
`
`declarants from prior proceedings where, as here, the testimony is “affirmatively
`
`
`
`13
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`

`

`relied upon by a patent owner” and thus interjected into the current IPR. Altaire
`
`Pharm., Inc. v. Paragon Bioteck, Inc., PGR2015-00011, Paper 29 at 2 (P.T.A.B.
`
`Apr. 1, 2016). Further, even in the decisions Lilly cited in its opposition to Dr.
`
`Niyikiza’s deposition where cross-examination was not ordered, the Board
`
`acknowledged either that the weight given to the testimony would be reduced in
`
`light of the lack of cross-examination in the IPR or did not rule on admissibility.
`
`See GEA Process Eng’g, Inc. v. Steuben Foods, Inc., IPR2014-00041, Paper No.
`
`41, at 3 (PTAB June 11, 2014) (“We will take into consideration that GEA did not
`
`have the opportunity to cross examine Mr. Taggart and Dr. Buchner and will give
`
`the declarations appropriate weight, if any, in our final decision.”); Maxliner, Inc.
`
`v. Cresta Tech. Corp., IPR2015-00594, at 2 (PTAB Jan. 15, 2016) (expunging a
`
`notice of deposition without assessing admissibility).
`
`Based on PTAB precedent, because Lilly heavily and affirmatively relied on
`
`Dr. Niyikiza’s trial testimony as if it were an affidavit, but opted not to make him
`
`available for deposition, Exhibit 2116 should be excluded, or at a minimum given
`
`no weight, due to Lilly’s violation of the Board’s rules.
`
`D. Exhibit 2116 is not a complete exhibit.
`Exhibit 2116 is a transcript of portions of the direct testimony of Dr.
`
`Niyikiza in a prior action, but it omits the cross-examination, redirect, and re-cross
`
`
`
`14
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`

`

`of Dr. Niyikiza, and thus violates the rule of completeness and should be excluded
`
`under Fed. R. Evid. 106.
`
`III. CONCLUSION
`For the foregoing reasons, Neptune respectfully requests that the Board
`
`exclude Exhibits 2120 and 2116, and strike all references thereof from Lilly’s
`
`Opposition and Sur-Reply and prohibit Lilly from making any references to these
`
`exhibits during oral argument.
`
`.
`
`
`
`
`
`15
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`

`

`Respectfully Submitted,
`
`/Sarah E. Spires/
`Sarah E. Spires (Reg. No. 61,501)
`SKIERMONT DERBY LLP
`2200 Ross Ave., Ste. 4800W
`Dallas, Texas 75201
`P: 214-978-6600/F: 214-978-6601
`Lead Counsel for Petitioner
`
`Dr. Parvathi Kota (Reg. No. 65,122)
`Paul J. Skiermont (pro hac vice)
`SKIERMONT DERBY LLP
`2200 Ross Ave., Ste. 4800W
`Dallas, Texas 75201
`P: 214-978-6600/F: 214-978-6621
`
`Mieke K. Malmberg (pro hac vice
`requested)
`SKIERMONT DERBY LLP
`800 Wilshire Boulevard
`Los Angeles, CA 90017
`P: 213-788-4500/F: 213-788-4545
`Back-Up Counsel for Petitioner
`
`
`
`February 14, 2017
`
`
`
`
`
`16
`
`

`

`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served on the
`
`counsel for Patent Owner a true and correct copy of the foregoing Petitioner’s
`
`Motion to Exclude Patent Owner’s Evidence Pursuant to 37 C.F.R. § 42.64(c), by
`
`electronic means on February 14, 2017 at the following addresses of record:
`
`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
`Lead Counsel for Patent Owner
`
`Adam L. Perlman (pro hac vice)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth St. NW
`Washington, DC 20005
`Direct Phone: 202-434-5244
`Facsimile: 202-434-5029
`aperlman@wc.com
`Back-Up Counsel for Patent Owner
`
`John C. Demeter (Reg. No. 30,167)
`ELI LILLY AND COMPANY
`Lilly Corporate Center
`Indianapolis, IN 46285
`Direct Phone: 317-276-3785
`Facsimile: 317-276-3861
`demeter_john_c@lilly.com
`Back-Up Counsel for Patent Owner
`
`
`
`
`
`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
`Back-Up Counsel for Patent Owner
`
`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
`Back-Up Counsel for Patent Owner
`
`John D. Polivick (Reg. No. 57,926)
`RAKOCZY MOLINO
`MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Tel: 312-527-2157
`Fax: 312-527-4205
`jpolivick@rmmslegal.com
`Lead Counsel for Petitioner Apotex
`
`
`
`

`

`Patrick C. Kilgore (Reg. No. 69,131)
`RAKOCZY MOLINO
`MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Tel: 312-527-2157
`Fax: 312-527-4205
`pkilgore@rmmslegal.com
`Back-Up Counsel for Petitioner Apotex
`
`Mark D. Schuman (Reg. No. 31,197)
`CARLSON, CASPERS, VANDENBURGH,
`LINDQUIST AND SCHUMAN
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`Tel: 612-436-9600
`Fax: 612-436-9605
`mschuman@carlsoncaspers.com
`Back-Up Counsel for Petitioner Teva
`
`Patrick A. Doody
`(Reg. No. 35,002)
`PILLSBURY WINTHROP SHAW
`PITTMAN LLP
`1650 Tysons Boulevard
`McLean, Virginia 22102
`Tel: 703-770-7538
`Fax: 703-770-7901
`patrick.doody@pillsburylaw.com
`Lead Counsel for Wockhardt Bio AG
`
`Deanne M. Mazzochi (Reg. No. 50,158)
`RAKOCZY MOLINO
`MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Tel: 312-527-2157
`Fax: 312-527-4205
`dmazzochi@rmmslegal.com
`Back-Up Counsel for Petitioner Apotex
`
`Gary J. Speier (Reg. No. 45,458)
`CARLSON, CASPERS, VANDENBURGH,
`LINDQUIST AND SCHUMAN
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`Tel: 612-436-9600
`Fax: 612-436-9605
`gspeier@carlsoncaspers.com
`Lead Counsel for Petitioner Teva
`
`Cynthia Lambert Hardman
`(Reg. No. 45,458)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, New York 10018-1405
`Tel: 212-813-8800
`Fax: 212-355-3333
`chardman@goodwinprocter.com
`Back-Up Counsel for Petitioner Teva
`
`
`
`
`
`
`
`

`

`
`
`Respectfully Submitted,
`
`/Sarah E. Spires/
`Sarah E. Spires (Reg. No. 61,501)
`
`Lead Counsel for Petitioner
`
`
`
`Bryan P. Collins
`(Reg. No. 43,560)
`PILLSBURY WINTHROP SHAW
`PITTMAN LLP
`1650 Tysons Boulevard
`McLean, Virginia 22102
`Tel: 703-770-7755
`Fax: 703-770-7901
`bryan.collins@pillsburylaw.com
`Back-Up Counsel for Wockhardt Bio AG
`
`Dated: February 14, 2017
`
`
`
`
`
`
`
`
`
`

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