`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,
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`and for the reasons stated below, Petitioner respectfully requests that the Board
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`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
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`consists of the declaration testimony of Dr. Bruce Chabner. (Paper 35). Pursuant to
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`FRE 702, “the trial judge must ensure that any and all scientific testimony or
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`evidence admitted is not only relevant, but reliable.” Daubert v. Merrell Dow
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`Pharms., Inc., 509 U.S. 579, 589 (U.S. 1993). “Expert testimony is not admissible
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`if it includes unsubstantiated speculation and subjective beliefs.” Sport Dimension,
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`Inc. v. Coleman Co., 820 F.3d 1316, 1323 (Fed. Cir. 2016) (quotation omitted).
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`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.
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`Minn. 2010) (citing Hebert v. Lisle Corp., 99 F.3d 1109, 1117 (Fed. Cir. 1996)).
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`Dr. Chabner’s opinions are all of the above—unsubstantiated, and based on
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`subjective beliefs and incorrect legal standards.
`
`A. Dr. Chabner applies subjective beliefs and incorrect legal standards
`to reach his opinions.
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`When Dr. Chabner, was asked what methodology he used to distinguish
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`between his knowledge acquired over 50 years and a POSA’s knowledge in June
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`1
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`
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`1999, he testified that he “really can’t answer that question,” and admitted he did
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`not “employ methodologies” because he used “his own personal experience” and
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`did not conduct his analysis based on a POSA “less informed than myself.” (Ex.
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`1075- 233:15-234:12, 228:11-229:3.)
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`When asked how he applied the reasonable expectation of success standard
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`in his declaration, Dr. Chabner testified, “I looked at what I knew as of 1999, and
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`what the literature said and what was publicly available, and I concluded that it
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`was not obvious that – that using these vitamins would make a difference, would
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`improve therapy.” (Id. at 88:25-89:8.) When asked what criteria he employed, he
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`testified, “I think, you know, it’s like pornography. When it’s reasonable, you
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`understand it when you see it. Scientifically, I was skeptical about it.” (Id. at 1075-
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`89:20-25.)
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`When pressed to explain how reasonably successful the claimed
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`combination needed to be for obviousness, Dr. Chabner testified, “I think it would
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`need to be something that I could endorse”— admitting “my standard for saying
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`what’s obvious and reasonable is my personal standard. And that’s why I have 50
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`years in the field.” (Id. at 90:19-94:3 (emphasis added).)
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`Dr. Chabner’s failure to opine from a POSA’s perspective renders his
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`opinions unreliable and inadmissible. See Amazon.com, Inc. v.
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`Barnesandnoble.com, 239 F.3d 1343, 1364 (Fed. Cir. 2001) (what an expert “did
`
`
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`2
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`
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`or did not personally realize at the time based on his actual knowledge is
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`irrelevant”); Custom Accessories, Inc. v. Jeffrey-Allan Indus., 807 F.2d 955, 962
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`(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-
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`Star, Inc., 950 F.2d 714, 718 (Fed. Cir. 1991) (noting the “importance of resolving
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`the level of ordinary skill in the art lies in the necessity of maintaining objectivity
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`in the obviousness inquiry. Instead of ascertaining what was subjectively obvious
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`…, the court must ascertain what would have been objectively obvious...”).
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`Separately, Dr. Chabner admitted that his personal standard for a reasonable
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`expectation of success required “evidence that it worked in the clinical setting” and
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`that “what was really needed was clinical evidence” of success. (Ex. 1075-214:9-
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`215:4.) But “[c]onclusive proof of efficacy is not necessary to show obviousness.
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`All that is required is a reasonable expectation of success.” Hoffman-LaRoche Inc.
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`v. Apotex, Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014). Because Dr. Chabner did not
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`use the proper standard for determining whether a POSA would have a reasonable
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`expectation of success, his opinions should be excluded.
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`Dr. Chabner further opines that rather than administering folic acid and B12
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`to address pemetrexed’s known toxicity to patients with elevated homocysteine, a
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`POSA would have instead attempted alternative interventions to address toxicity.
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`(Ex. 1075-149:18-152:4.) Dr. Chabner testified that he would have been “very
`
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`3
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`
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`encouraged to undertake further investigation [of these alternatives].” (Ex. 1075-
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`136:2-6.) When asked, with respect to these alternatives, “[d]oes being encouraged
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`to undertake further investigation satisfy your understanding and application of a
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`reasonable expectation of success?”—Dr. Chabner answered “Yes.” (Id., 136:7-
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`13.) Dr. Chabner’s use of a lower standard (encouraged to undertake investigation)
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`for a reasonable expectation of success for his alternatives—and a heightened
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`standard (proof from clinical data) when evaluating reasonable expectation of
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`success for the claimed folic acid/B12 pretreatment—should result in the exclusion
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`of his opinions.
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`B. Dr. Chabner’s Opinions are Unsubstantiated.
`The Supreme Court has held that courts should not admit expert testimony
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`that “is connected to existing data only by the ipse dixit of the expert.” Gen. Elec.
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`v. Joiner, 522 US 136, 146 (1997). That is what Dr. Chabner’s opinions entail.
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`Three documents demonstrate that Dr. Chabner’s opinions are unsubstantiated and
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`so inadmissible, or at a minimum entitled to no weight. Lilly has produced two
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`documents it submitted to the FDA prior to the earliest effective filing date of the
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`’209 Patent. (Exs. 2103 and 2017.) These documents constitute party admissions
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`concerning the content of the prior art from a POSA’s perspective. Fed. R. Evid.
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`801(d)(2); In re Copaxone Consol. Cases, 2017 U.S. Dist. LEXIS 12168 at *78 (D.
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`Del. Jan. 30, 2017) (holding that non-prior art “statements that [Patent Owner]
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`4
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`
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`made to the FDA” “can properly be considered as an admission of a party
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`opponent,” and can inform the court’s “analysis of the motivations of those having
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`ordinary skill in the art at the time of the invention.”)
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`Lilly submitted a third document (Ex. 1047) to The Oncologist, of which Dr.
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`Chabner has always been Editor-in-Chief. (Ex. 1075 at 34:13-20). Although
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`Exhibit 1047 was submitted six months after the effective filing date, it is also
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`relevant to obviousness. See e.g., Ex Parte Raychem, 1992 Pat. App. LEXIS 21,
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`*10-11 & n. 4 (Bd. Pat. App. & Interferences June 30, 1992) (later-published
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`reference “relevant evidence” concerning a POSA’s knowledge about the prior art
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`reference’s teaching); Ex Parte Erlich, 1992 Pat. App. Lexis 2, *6 (Bd. Pat. App.
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`& Interferences Jan. 16 1992) (later-published reference citing many prior art
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`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-
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`published reference permissible evidence of art-related facts existing on the filing
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`date).
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`These documents cite the teachings of several prior art references at issue,
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`and uniformly contradict Dr. Chabner’s opinions of this prior art. During his
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`deposition, Dr. Chabner was shown Lilly’s admissions regarding the relevant prior
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`art cited in these three documents. Although Lilly’s admissions are consistent with
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`the references themselves, Dr. Chabner repeatedly rejected them.
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`
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`5
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`Specifically, Lilly admits in these references that Hammond taught a POSA
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`that the addition of folic acid supplementation permits pemetrexed dose escalation
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`and ameliorates toxicity. (Ex. 1077 ¶69.) Dr. Chabner’s declaration, in contrast,
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`states that Hammond teaches that folic acid undermines pemetrexed’s efficacy (Ex.
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`2120 ¶ 96), and he also disagreed with Lilly’s representations that Hammond
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`encouraged the use of folic acid for pemetrexed patients. (Ex. 1075-141:25-142:19,
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`146:11-148:14, 167:14-168:21, 180:13-184:15.) Dr. Chabner testified that he
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`“disagree[s] with everyone,” including Lilly scientists, who interpreted Hammond
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`as supporting the use of folic acid pretreatment with pemetrexed. (Ex. 1075-160:5-
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`20.) Not surprisingly, Dr. Chabner could not identify a single reference interpreting
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`Hammond the way he does. (Id., 160:22-161:12.)
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`Likewise, Lilly admitted Worzalla teaches that folic acid supplementation
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`reduced pemetrexed’s toxicities while maintaining antitumor efficacy. (Ex. 1077
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`¶70.) Dr. Chabner, in contrast, said Worzalla teaches that folic acid compromises
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`pemetrexed’s efficacy. (Ex. 2120 ¶ 157.) Dr. Chabner also disagreed with Lilly’s
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`interpretation of Worzalla evidencing that folic acid can ameliorate pemetrexed
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`toxicities without a reduction in antitumor efficacy. (Ex. 1075-157:5-159:20,
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`165:5-167:13, 219:23-221:5, 249:12-250:20, 269:3-277:2.) When asked “are you
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`aware of any publication that sides with your interpretation of Worzalla and not the
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`6
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`
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`one that is disclosed in The Oncologist article – or these reports?” He responded:
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`“No.” (Ex. 1075-251:19-24.) Again, Dr. Chabner’s opinions are unsubstantiated.
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`Lilly also admitted that Laohavinij teaches “it is possible to decrease the
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`toxicity [of lometrexol] to healthy tissue while maintaining antitumor effect
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`through careful adjustment of folic acid intake.” (Ex. 2107-10.) Dr. Chabner says
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`the opposite (Ex. 2120 ¶ 157) and disagrees with Lilly’s contemporaneous
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`understanding. (Ex. 1075-254:3-258:20.)
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`Dr. Chabner’s opinions regarding Hammond, Worzalla, and Laohavinij are
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`unsupported by any other reference and are inconsistent with contemporaneous
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`admissions made by Lilly to the FDA and a peer-reviewed journal. Because Dr.
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`Chabner’s opinions are unsubstantiated, they should not be admitted into evidence,
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`or at a minimum should be given no weight. See, e.g., Pharmastem Therapeutics,
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`Inc. v. Viacell, Inc., 491 F.3d 1342, 1361-63 (Fed. Cir. 2007); Ortho-McNeil
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`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
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`consists of 102 pages from the August 22, 2013 direct trial testimony of Dr. Clet
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`Niyikiza, the sole inventor listed on the face of the patent at issue in this IPR.
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`7
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`(Paper 36). This testimony was given in litigation, to which Neptune was not a
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`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
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`Owner Response, citing to the exhibit nine times. See Paper No. 32 at 11-13, 55-
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`56. As explained below, the testimony in Exhibit 2116 should be excluded as (1)
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`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)
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`incomplete under Fed. R. Evid. 106.
`
`A. Exhibit 2116 constitutes hearsay (and double hearsay) because the
`testimony was not given in this proceeding.
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`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
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`testifying at the current trial or hearing,” i.e., this IPR. See Fed. R. Evid. 801(c)(1).
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`In addition, much of Dr. Niyikiza’s trial testimony constitutes double
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`hearsay because the testimony as given in the district court was itself hearsay. For
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`example, Dr. Niyikiza testified about statements made by FDA officials during a
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`meeting in 1998. (Ex. 2116 at 787-88.) These alleged statements were made by
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`individuals other than Dr. Niyikiza. The same applies to Dr. Niyikiza testifying
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`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),
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`and comments made by an investigator at a conference (id. at 845).
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`Further, Lilly is offering Dr. Niyikiza’s testimony for the truth of the matters
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`asserted in the testimony. See Fed. R. Evid. 801(c)(2); Paper 32 at 11-13, 55-56
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`(citing Ex. 2116 at 733-34, 742-48, 750-58, 760-65, 771-75, 787-88, 798-99, 821-
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`22, 824).
`
`No hearsay exception applies and thus Dr. Niyikiza’s testimony should be
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`excluded in its entirety. See Fed. R. Evid. 803, 804, 807. Lilly cannot rely on Fed.
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`R. Evid. 804(b)’s exception for former testimony because there is no indication
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`that Dr. Niyikiza “is unavailable as a witness” to testify in this proceeding. In
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`addition, even if Lilly could establish that a hearsay exception exists for Dr.
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`Niyikiza’s testimony generally, at least his double hearsay testimony about
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`statements made by other scientists and third parties over a decade earlier, as
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`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
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`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
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`Fed. R. Evid. 702. Dr. Niyikiza is not offered as an expert in this IPR and has
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`admitted he has no background in oncology, nutrition, or vitamins. (Ex. 2116 at
`9
`
`
`
`
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`717:15-20.) However, Dr. Niyikiza’s trial testimony includes repeated discussion
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`of these areas – topics over which he had no personal knowledge or expertise. For
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`example, Dr. Niyikiza testified regarding failures in programs that he did not
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`participate in, the interactions of folic acid and pemetrexed, cancer therapy
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`protocols, the folate pathway, and pemetrexed toxicity. (See id. at 733-34, 742-48,
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`824.) Dr. Niyikiza also provided, in effect, expert testimony regarding statistical
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`principles such as collinearity, but Dr. Niyikiza is not offered as an expert and was
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`not deposed in this IPR. (See id. at 733-37.) Accordingly, Exhibit 2116 should be
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`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
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`violation of the 37 C.F.R. § 42.51(b)(1)(ii) cannot be cured. With the Board’s
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`authorization (Ex. 1042, Tr. at 4:18-5:4, 16:12-18), Neptune filed a Motion to
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`
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`10
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`
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`Cross-Examine Dr. Niyikiza on November 9 (Paper 43), which Lilly opposed
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`(Paper 45). The Board has not ruled on Neptune’s motion and Lilly has not
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`provided Dr. Niyikiza for deposition. Thus, Neptune has had no opportunity to
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`depose Dr. Niyikiza in this IPR.
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`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
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`Neptune. By not making Dr. Niyijiza available for cross examination, Lilly has
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`denied Neptune the opportunity to explore other topics with him such as, for
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`example, the possibility that his allegation of “skepticism” was premised on
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`matters unrelated to the claimed invention, such as Dr. Niyikiza’s alleged ability to
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`design a study with sufficient statistical power to ensure FDA approval – not
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`skepticism that the claimed vitamin pretreatment regimen would reduce
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`pemetrexed related toxicities.
`
` Lilly has also prevented Neptune from probing Lilly’s reliance on Dr.
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`Niyikiza’s hearsay testimony that a principal investigator allegedly “praised Dr.
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`Niyikiza’s contribution to pemetrexed’s development. (Paper 32 at 56 (emphasis
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`added).) Neptune was unable to explore whether the investigator’s reference was
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`directed to all features of the claimed invention, which Lilly must establish in order
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`to show the requisite “nexus” between the alleged “praise” and the claimed
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`invention. Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318, 1327-28 (Fed. Cir.
`
`
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`11
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`
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`2008). Neptune was further unable to explore with Dr. Niyikiza whether this so-
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`called “praising” investigator was made aware of the relevant prior art at the time
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`he allegedly gave such “praise.” Such prior art includes Exs. 1005; 1011;
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`1013;1014; 1016; 1022; 2035) and both pemetrexed and other antifolates with
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`vitamin B12 (Exs. 1013; 1014; 2042; 1064; 2043; 2079; 2055; 1020; 1010). If the
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`investigator was not aware of such art, then Lilly’s assertions of praise must fail.
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`See Bayer Healthcare Pharm., Inc. v. Watson Pharm., Inc., 713 F.3d 1369, 1377
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`(Fed. Cir. 2013) (“industry praise of what was clearly rendered obvious by
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`published references is not a persuasive secondary consideration”).
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`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
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`held that the testimony is entitled to no weight. See Coalition for Affordable Drugs
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`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
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`Pharm., Inc. v. Paragon Bioteck, Inc., PGR2015-00011, Paper 29 at 3 (P.T.A.B.
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`Apr. 1, 2016) (same)
`
`
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`12
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`
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`In Organik Kimya AS v. Rohm & Haas Co., the petitioner submitted a
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`declaration in the IPR that had been originally submitted in a prior trial at the
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`International Trade Commission (“ITC”). IPR2014-00185, Paper 42 at 2 (P.T.A.B.
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`Dec. 18, 2014). The patent owner had deposed the declarant in the ITC proceeding
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`but still sought a deposition in the IPR. Id. The Board held that the declaration
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`would be “entitled to little or no weight, as it has not been subject to cross-
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`examination as it pertains to the instant proceeding.” Id. at 3. Similarly, Dr.
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`Niyikiza’s trial testimony should be given no weight. Indeed, the facts are even
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`more compelling here than Organik because Neptune has never had any
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`opportunity to depose Dr. Niyikiza, unlike the Organik patent owner who had
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`previously deposed the witness in the ITC proceeding.
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`The fact that Dr. Niyikiza testified in a different proceeding, the Teva
`
`Litigation, does not make his testimony admissible in this IPR. Lilly previously
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`relied on the regulatory history behind 37 C.F.R. § 42.51(b)(1) to argue that the Dr.
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`Niyikiza’s deposition was not routine discovery – and thus excused from the
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`Board’s rules requiring cross-examination – because his trial testimony was not
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`“affidavit testimony prepared for the proceeding.” Paper 45 at 2 (emphasis in
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`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
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`declarants from prior proceedings where, as here, the testimony is “affirmatively
`
`
`
`13
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`
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`relied upon by a patent owner” and thus interjected into the current IPR. Altaire
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`Pharm., Inc. v. Paragon Bioteck, Inc., PGR2015-00011, Paper 29 at 2 (P.T.A.B.
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`Apr. 1, 2016). Further, even in the decisions Lilly cited in its opposition to Dr.
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`Niyikiza’s deposition where cross-examination was not ordered, the Board
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`acknowledged either that the weight given to the testimony would be reduced in
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`light of the lack of cross-examination in the IPR or did not rule on admissibility.
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`See GEA Process Eng’g, Inc. v. Steuben Foods, Inc., IPR2014-00041, Paper No.
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`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
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`the declarations appropriate weight, if any, in our final decision.”); Maxliner, Inc.
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`v. Cresta Tech. Corp., IPR2015-00594, at 2 (PTAB Jan. 15, 2016) (expunging a
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`notice of deposition without assessing admissibility).
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`Based on PTAB precedent, because Lilly heavily and affirmatively relied on
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`Dr. Niyikiza’s trial testimony as if it were an affidavit, but opted not to make him
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`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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`
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`of Dr. Niyikiza, and thus violates the rule of completeness and should be excluded
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`under Fed. R. Evid. 106.
`
`III. CONCLUSION
`For the foregoing reasons, Neptune respectfully requests that the Board
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`exclude Exhibits 2120 and 2116, and strike all references thereof from Lilly’s
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`Opposition and Sur-Reply and prohibit Lilly from making any references to these
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`exhibits during oral argument.
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`.
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`15
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`
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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
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`February 14, 2017
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`16
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served on the
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`counsel for Patent Owner a true and correct copy of the foregoing Petitioner’s
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`Motion to Exclude Patent Owner’s Evidence Pursuant to 37 C.F.R. § 42.64(c), by
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`electronic means on February 14, 2017 at the following addresses of record:
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`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
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`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
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`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
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`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
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`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
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`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
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`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
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`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
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`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
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`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
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`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
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`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
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`Respectfully Submitted,
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`/Sarah E. Spires/
`Sarah E. Spires (Reg. No. 61,501)
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`Lead Counsel for Petitioner
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`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
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`Dated: February 14, 2017
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