Case IPR 2016-00240
`Patent 7,772,209
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`NEPTUNE GENERICS, LLC,
`APOTEX INC., APOTEX CORP., TEVA PHARMACEUTICALS,
`FRESENIUS KABI USA, LLC, and WOCKHARDT BIO AG
`Petitioners,
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`v.
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`ELI LILLY & COMPANY,
`Patent Owner.
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`Case No. IPR2016-002401
`Patent No. 7,772,209
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`PATENT OWNER ELI LILLY AND COMPANY’S
`OPPOSITION TO MOTION TO EXCLUDE EVIDENCE
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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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`Case IPR 2016-00240
`Patent 7,772,209
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`TABLE OF CONTENTS
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`I. 
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`DR. CHABNER’S TESTIMONY SHOULD NOT BE EXCLUDED ........... 1 
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`A.  Dr. Chabner’s Application of Legal Standards Does Not
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`Warrant Exclusion of His Testimony .................................................... 2 
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`B.  Dr. Chabner’s Disagreement with Post-Priority Date
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`Characterizations of the Prior Art Do Not Warrant Exclusion ............. 6 
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`II.  DR. NIYIKIZA’S TRIAL TESTIMONY SHOULD NOT BE
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`EXCLUDED .................................................................................................... 9 
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`TABLE OF AUTHORITIES
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`Case IPR 2016-00240
`Patent 7,772,209
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`CASES
`Arceo v. City of Junction City, 182 F. Supp.2d 1062 (D. Kan. 2002) ..................... 13
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`Eli Lilly & Co. v. Teva Parenteral Medicines, et al., Case No. 1:10-
`cv-1376-TWP-DKL (S.D. Ind.) ...................................................................... 1, 14
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`Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342 (Fed.
`Cir. 2012) .............................................................................................................. 8
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`LG Chem, Ltd. v. Celgard, LLC, IPR2014-00692, Paper 76 (PTAB
`Oct. 5, 2015) ......................................................................................................... 4
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`Lupin Ltd. v. Senju Pharm. Co., Ltd., IPR2015-01099, Paper 69
`(PTAB Sept. 12, 2016) ............................................................................. 3, 5, 6, 9
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`Nutrition 21 v. United States, 930 F.2d 867 (Fed. Cir. 1991) ................................... 4
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`Petroleum Geo-Services, Inc. v. WesternGeco, LLC, IPR2014-01477,
`Paper 71 (PTAB July 11, 2016) .................................................................... 11, 13
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`SK Innovation Co. v. Celgard, LLC, IPR2014-00680, Paper 57 (PTAB
`Sept. 25, 2015) ...................................................................................................... 4
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`United States v. Inadi, 475 U.S. 387 (1986) ............................................................ 13
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`Valeo N.A., Inc., et al. v. Magna Elecs., Inc., IPR2014-00220, Paper
`59 (PTAB May 28, 2015) ..................................................................................... 6
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`OTHER AUTHORITIES
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`37 C.F.R. § 42.51 ............................................................................................... 10, 11
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`37 C.F.R. § 42.53 ............................................................................................... 10, 11
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`37 C.F.R. § 42.64 ................................................................................................. 6, 15
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`Federal Rule of Evidence 702 ................................................................................ 3, 9
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`Federal Rule of Evidence 801 .................................................................................... 6
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`Case IPR 2016-00240
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`Federal Rule of Evidence 804 .................................................................................. 14
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`McCormick on Evidence § 301 ............................................................................... 13
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`Patent Owner Eli Lilly and Company (“Lilly”) respectfully submits this
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`Case IPR 2016-00237
`Patent 7,772,209
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`Opposition to the Motion to Exclude (Paper 56, “Mot.”) filed by Petitioner
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`Neptune Generics, LLC (“Neptune”). Neptune’s motion is a transparent attempt to
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`garner additional pages within which to make merits arguments. Nothing it argues
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`justifies the exclusion of evidence, and its motion should be denied.
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`I.
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`DR. CHABNER’S TESTIMONY SHOULD NOT BE EXCLUDED
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`Neptune seeks to exclude in its entirety the declaration of Dr. Bruce Chabner
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`(Ex. 2120), Lilly’s principal expert witness, on the grounds that his testimony is
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`“unreliable.” Mot. at 1-7. Dr. Chabner is the former Clinical Director of the
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`Massachusetts General Hospital Cancer Center, former Director of the Division of
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`Cancer Treatment at the National Cancer Institute at NIH, a Professor of Medicine
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`at Harvard Medical School, and a recognized expert in antifolates. Ex. 2120 ¶¶ 1,
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`10-20. During a two-week bench trial against Joinder-Petitioners Teva and
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`Fresenius, Dr. Chabner expressed substantially the same opinions about the same
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`issues about the same patent as are at issue here. Far from finding this testimony
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`so “unreliable” that it should be excluded wholesale, the district court expressly
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`relied on this testimony, and, moreover, expressly found Dr. Chabner to be “more
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`credible with respect to [his] opinions on how a POSA would view the teachings of
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`Worzalla and Hammond than Defendants’ experts.” Eli Lilly & Co. v. Teva
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`Parenteral Medicines, et al., Case No. 1:10-cv-1376-TWP-DKL, ECF No. 336 at
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`14 (S.D. Ind. Mar. 31, 2014), aff’d, 845 F.3d 1357 (Fed. Cir. 2017); Mot. at 4-7.
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`Petitioners’ experts here raise the same arguments about Hammond and Worzalla
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`that the district court rejected on the same subjects. The notion that the Board
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`should completely exclude as “unsubstantiated” the very opinions that the district
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`court has already found to be reliable and more credible than the opinions
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`Neptune’s experts are offering on the same topics belies comprehension.
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`A. Dr. Chabner’s Application of Legal Standards Does Not Warrant
`Exclusion of His Testimony
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`1. Neptune’s first set of complaints is that Dr. Chabner supposedly
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`“fail[ed] to opine from a POSA’s perspective” and failed to distinguish between
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`his own extensive knowledge of antifolate chemotherapy and that of a “POSA ‘less
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`informed than [him]self.’” Mot. at 1-3. As an initial matter, that is false, as the
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`entirety of Dr. Chabner’s testimony makes clear that he testified from the
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`perspective of the POSA. But more to the point, these are arguments about the
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`weight of Dr. Chabner’s testimony; they are not an argument for its exclusion.
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`Indeed, Neptune’s motion to exclude is a near-verbatim retread of arguments it
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`also raised in Reply (without mention of inadmissibility). E.g., Paper 47 at 2-3.
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`Neptune cites cases for the uncontroversial proposition that the obviousness
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`inquiry hinges on what would have been obvious to the POSA rather than to some
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`other individual. Mot. at 2-3. Dr. Chabner, however, testified that he was opining
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`from that perspective. Ex. 2120 ¶¶ 22-24, 26. When the Board considers Dr.
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`Chabner’s testimony as a whole, Lilly is confident it will find that he credibly
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`opined from the perspective he said he was applying. But there is no basis
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`whatsoever for evaluating whether he did so in the context of a motion to exclude;
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`the issues Neptune raises “go to the probative weight” of the testimony, “as
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`opposed to its admissibility,” and should be considered on the merits rather than as
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`part of the “gatekeeping” function of FRE 702. Lupin Ltd. v. Senju Pharm. Co.,
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`Ltd., IPR2015-01099, Paper 69 at 43-44 (PTAB Sept. 12, 2016).
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`And even on the merits, Neptune’s criticisms make no sense. Dr. Chabner
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`has opined that the challenged claims would not have been obvious. Neptune
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`appears to be saying that from the perspective of a POSA “less informed than” Dr.
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`Chabner, the invention would have been more obvious. Mot. at 2. That turns the
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`usual pattern on its head—Neptune is not challenging Dr. Chabner as unqualified,
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`they are challenging him as too qualified. The logical import of this position is
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`that while the invention would not be obvious to one who is knowledgeable about
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`the relevant issues, it would be obvious to one who is assumed not to understand
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`all of the relevant information. If Neptune needs the POSA to have blinders to
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`relevant knowledge in the field for the invention to appear obvious, that is hardly a
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`ringing endorsement of Neptune’s position on the merits. And it is certainly not a
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`basis to exclude the testimony of an expert testifying from the perspective of a
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`POSA who did consider the relevant knowledge and information.
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`2.
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`Neptune next faults Dr. Chabner for supposedly applying an incorrect
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`legal standard for reasonable expectation of success. Mot. at 2-4. Neptune’s
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`argument is based on its counsel quizzing Dr. Chabner at his deposition about the
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`relevant legal standards. The full record will show that Dr. Chabner applied the
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`correct standards. But even if Dr. Chabner got his articulation of the law wrong in
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`some way, the Board has emphasized that “potential deficiencies in [an expert’s]
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`understanding of the legal concepts of unpatentability” do not warrant exclusion of
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`the testimony, because “[a]n expert’s opinion on the ultimate legal conclusion is
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`neither required nor indeed ‘evidence’ at all.” SK Innovation Co. v. Celgard, LLC,
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`IPR2014-00680, Paper 57 at 30-31 (PTAB Sept. 25, 2015) (quoting Nutrition 21 v.
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`United States, 930 F.2d 867, 871 n.2 (Fed. Cir. 1991)). Once again, any “alleged
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`deficiencies in [Dr. Chabner’s] analysis go to the weight to be accorded his
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`testimony rather than its admissibility.” LG Chem, Ltd. v. Celgard, LLC, IPR2014-
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`00692, Paper 76 at 47-48 (PTAB Oct. 5, 2015).
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`Neptune never articulates a standard that Dr. Chabner supposedly deviated
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`from; its primary complaint is that he was inconsistent in the standard he applied.
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`Mot. at 3-4. Neptune is mistaken. Dr. Chabner testified—in response to the very
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`question Neptune highlights—that his (and the POSA’s) background expectation
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`was that vitamin pretreatment “wasn’t going to work” and he “needed . . . clinical
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`evidence to change . . . my mindset about it.” Ex. 1075 at 214-15. In other words,
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`Dr. Chabner’s complete answer reveals that because the claimed pretreatment
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`regimen would have been expected to harm efficacy, the POSA would have
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`wanted to see clinical evidence that it did not. The alternative approaches Dr.
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`Chabner proposed, in contrast, would not have been expected to have the same
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`deleterious effects on efficacy. Ex. 2120 ¶¶ 56-60. Neptune’s assumption that
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`there is an inconsistency appears premised on the notion that the relevant
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`reasonable expectation of success was “in reducing pemetrexed toxicity.” Cf.
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`Paper 47 (Reply) at 23. But that is not the relevant standard, and more saliently
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`here, that does not appear to be what Dr. Chabner understood he was being asked
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`about. Ex. 1075 at 214-15. And even if he had been somehow inconsistent, that
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`too is an issue of weight, not admissibility. Lupin, IPR2015-01099, Paper 69 at
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`43-44. But there is no inconsistency in any event.
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`Finally, Neptune’s criticisms regarding reasonable expectation of success
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`provide no basis to exclude Dr. Chabner’s testimony on any other issue. The
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`majority of his testimony is addressed to a different flaw in Neptune’s obviousness
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`case: that the POSA would not have had reason to administer vitamin pretreatment
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`and in fact would have had reasons not to. Ex. 2120 ¶¶ 61-90. While Neptune’s
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`arguments do not warrant the exclusion of any of Dr. Chabner’s testimony, they
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`certainly cannot warrant wholesale exclusion of his entire declaration.
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`B. Dr. Chabner’s Disagreement with Post-Priority Date
`Characterizations of the Prior Art Do Not Warrant Exclusion
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`Neptune also raises a series of objections to Chabner’s testimony relating to
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`his disagreement with how certain post-priority date documents characterize the
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`prior art. Mot. at 4-7. Once again, the supposed inconsistencies Neptune
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`highlights are illusory, and its arguments are a flagrant repeat of arguments it made
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`in its Reply. Paper 47 at 6-11; see Paper 62 at 10-13 (responding to arguments).
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`These are questions for the Board to resolve after consideration of all of the
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`evidence, not in a motion to exclude. Lupin, IPR2015-01099, Paper 69 at 43-44;
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`Valeo N.A., Inc., et al. v. Magna Elecs., Inc., IPR2014-00220, Paper 59 at 10-11
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`(PTAB May 28, 2015). They do not go to the admissibility of the testimony.
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`As an initial matter, Neptune repeats as a mantra that documents filed with
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`the FDA by Lilly, or by researchers who were somehow affiliated with Lilly,
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`constitute “party admissions.” Mot. at 4-5. Even assuming arguendo that Neptune
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`is right, all that means is that the documents are admissible in evidence. See FRE
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`801(d)(2). That is an irrelevant question; Lilly has not moved to exclude them. 37
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`C.F.R. § 42.64(c). It does not give them any special status that constrains Lilly’s
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`or Dr. Chabner’s ability to interpret them.
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`Dr. Chabner’s opinions about what Hammond, Worzalla, and Laohavinij
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`mean are anything but “unsubstantiated.” Dr. Chabner explained at great length,
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`and with reference to relevant literature in the field, why those references do not
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`render the claimed invention obvious, but instead confirm the POSA’s expectations
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`that administering folic acid and vitamin B12 pretreatment would undermine
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`pemetrexed’s efficacy. Ex. 2120 ¶¶ 49, 61-90, 96-103, 154-62. His extensive and
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`well-reasoned opinions do not magically become “unsubstantiated,” much less
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`inadmissible, just because Neptune argues that they disagree with conclusory
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`statements that it cherry-picks from documents that discuss the same references.
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`Neptune had the opportunity to cross-examine Dr. Chabner on these points, and the
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`Board will have the opportunity to weigh all of the evidence. There is no basis for
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`Neptune’s attempt to short-circuit that process through a motion to exclude.
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`Neptune’s attempts to use post-priority date references against Lilly (e.g.,
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`Mot. at 7) also fall flat because the characterizations to which they point occurred
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`after Lilly had come up with the invention and after severe toxicities had arisen in
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`clinical trials that meant that continuing to administer pemetrexed without vitamin
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`supplementation was no longer a realistic or ethical option. Exs. 2103, 2107, 2116
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`at 795-98. Lilly advocated the invention, following its conception, to a skeptical
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`FDA (Exs. 2100, 2103, and 2105), and the inventor, having already conceived the
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`invention, co-authored an article in The Oncologist in 2001 reflecting his own
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`thought processes (Ex. 1047). In other words, these publications reflect
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`characterizations of the invention by authors who knew of the invention. What they
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`say has no bearing on how the POSA, without hindsight knowledge of the
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`invention, would have interpreted those references. Kinetic Concepts, Inc. v. Smith
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`& Nephew, Inc., 688 F.3d 1342, 1369 (Fed. Cir. 2012). And they do not contradict,
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`much less render so unreliable as to preclude, Dr. Chabner’s testimony.
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`Finally, Neptune highlights the absence of references interpreting Hammond
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`and Worzalla the same way Dr. Chabner does. Mot. at 6-7. But that is hardly
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`surprising and not probative of anything. It is only natural that Lilly and the
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`inventor, after the priority date, described the claimed invention in glowing terms
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`and mined the prior art for statements that with hindsight knowledge of the
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`invention (which we now know actually works) they cast as supportive. But there
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`would have been no reason for anyone to publish an article disagreeing with those
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`same passing statements. The Hammond abstracts presented work in progress at a
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`conference. And Worzalla was the report of a pre-clinical study that is less
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`relevant than later data from human studies. Ex. 2120 ¶ 155; see Ex. 1077 ¶ 60.
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`Given that there is little reason to cite preclinical studies or abstracts once fulsome
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`clinical data are available, the fact that Hammond and Worzalla were not
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`disparaged by later references says nothing about whether their data or conclusions
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`are reliable or whether the POSA would have agreed with them.
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`In the final analysis, the admissibility of Dr. Chabner’s declaration is simply
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`not a close question. He is an undisputedly qualified expert in the relevant art. He
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`explained his views in a detailed declaration. And those views are the same
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`opinions that a district court expressly found credible having heard from Dr.
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`Chabner live on the witness stand. Neptune’s motion may reflect a hail-mary
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`attempt to exclude testimony fatal to their Petition, or simply a way to further brief
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`their positions on the merits. But it does not remotely meet the strict standards for
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`excluding testimony under FRE 702. Lupin, IPR2015-01099, Paper 69 at 44.
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`II. DR. NIYIKIZA’S TRIAL TESTIMONY SHOULD NOT BE
`EXCLUDED
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`Neptune also challenges the admissibility of Exhibit 2116, which contains
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`trial testimony of the inventor, Dr. Clet Niyikiza, from the district court case
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`against Teva and Fresenius. Neptune advances a number of theories as to why Dr.
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`Niyikiza’s testimony should be excluded, but they all stem from the same
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`underlying complaint: that Dr. Niyikiza was not deposed in this proceeding.
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`Neptune’s arguments are without merit, and Exhibit 2116 should not be excluded.
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`A. Dr. Niyikiza was a Lilly employee when he conceived of the
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`invention, but today, he is the founder and CEO of L.E.A.F. Pharmaceuticals, an
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`independent pharmaceutical company not involved in this case. Paper 45 at 9; Ex.
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`2116 at 712. He is not under Lilly’s control.
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`Neptune itself put the district court’s findings of fact into evidence, and no
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`party has challenged their admissibility. Ex. 1028. With its POR, Lilly submitted
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`undisputedly relevant excerpts of Dr. Niyikiza’s testimony from the district court.
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`In addition to general background (to provide the Board with the same context the
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`district court had, see Ex. 1027 at 6-8; Paper 32 at 10-13), the principal subject of
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`this testimony was to describe how Dr. Niykiza’s “idea was met with consistent
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`skepticism, and was not adopted until after the priority date, when deaths occurred
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`in the Phase III clinical trials.” Paper 32 at 54-55. The same evidence and
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`arguments here were at issue in the district court, and Teva and Fresenius
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`thoroughly examined Dr. Niyikiza by deposition and at trial. Neptune’s expert, Dr.
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`Feigal, has also analyzed many of the documents and testified that in 1998, “FDA
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`noted the risk of decreasing pemetrexed’s efficacy” if vitamin pretreatment was
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`administered. Ex. 1080 ¶ 35; Ex. 2100 at ELAP00008719; cf. Ex. 2116 at 790-92.
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`After Lilly submitted its POR, Neptune and Sandoz jointly sought and
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`received permission to file a motion to obtain Dr. Niykiza’s deposition. Paper 43.
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`The Board has not ruled on Petitioners’ motion.
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`B.
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`In its motion to exclude, Neptune reiterates the procedural arguments
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`from its motion seeking Dr. Niyikiza’s deposition and accuses Lilly of violating
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`the Board’s procedural regulations. Mot. at 10-15. Neptune is mistaken.
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`The lynchpins of Neptune’s arguments are 37 C.F.R. §§ 42.51 and 42.53.
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`Section 42.53 states that “[u]ncompelled direct testimony must be submitted in the
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`form of an affidavit.” Section 42.51(b)(1)(ii) permits cross-examination by
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`deposition of “affidavit testimony prepared for the proceeding.” 37 C.F.R.
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`§ 42.51(b)(1)(ii) (emphasis added). Based on these two regulations, Neptune
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`argues that the submission of testimony in other forms, from other proceedings, is
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`forbidden; in Neptune’s view, the only testimony that can be considered is affidavit
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`testimony, and all affidavit testimony must be subject to cross-examination. But
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`that is plainly wrong. Neptune’s reading would mean that the “prepared for the
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`proceeding” language of 37 C.F.R. § 42.51(b)(1)(ii) is surplusage, as under that
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`reading, all affidavits, prepared for any proceeding, would have to be followed by
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`cross-examination. Alternatively, if affidavits were permitted without cross-
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`examination but 37 C.F.R. § 42.53 were read as a blanket prohibition on prior
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`testimony in other forms, affidavit testimony from other proceedings without
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`cross-examination would be favored over transcripts of trials and hearings that did
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`feature cross-examination. Neither possibility makes any sense.
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`In fact, the regulations, taken together, have a different, internally consistent
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`reading. When uncompelled testimony is “prepared for the proceeding,” it must be
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`submitted in the form of an affidavit, and the other party is then entitled to cross-
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`examine the affiant. Neither regulation has any bearing on whether or when
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`testimony prepared for other proceedings—in whatever form—can be submitted.
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`In fact, the Board routinely considers such testimony. See, e.g., Petroleum Geo-
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`Services, Inc. v. WesternGeco, LLC, IPR2014-01477, Paper 71, at 54-55 (PTAB
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`July 11, 2016) (analyzing testimony from district-court trial involving same patent
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`as evidence of praise).
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`C. Neptune also asserts that unless Dr. Niyikiza is shown to be
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`“unavailable,” his trial testimony is hearsay because it is not “at the current trial or
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`hearing.” Mot. at 8-9. Its position is curious, given its prior arguments that Dr.
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`Niyikiza’s testimony should be given no weight “if he cannot be cross-examined.”
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`Paper 43 at 10 (emphasis added). If Neptune were correct that testimony from
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`other proceedings must be treated as hearsay here unless the witness is unavailable,
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`the ability to depose Dr. Niyikiza would not have made his trial testimony
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`admissible, and its original position would have made no sense. Neptune was right
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`the first time; the relevant question is one of weight. Neptune cites a number of
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`cases for the proposition that when testimony is submitted as a declaration from
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`another proceeding the declarations should be given little weight. Mot. at 12-14
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`(collecting cases). Those cases are inapplicable here because the testimony is from
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`a trial where, unlike a declaration from a prior proceeding, full cross-examination
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`occurred. But if Neptune were correct that prior testimony must be treated as
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`hearsay in PTAB proceedings absent a showing of unavailability, the declarations
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`would not have been admissible in those cases, and there would have been no
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`question in the cases it cites about how much weight to give them.
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`In fact, the Board has rejected hearsay challenges like Neptune’s on the
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`ground that “prior trial testimony” is “similar to a declaration in this proceeding for
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`which Petitioner had the opportunity to conduct cross-examinations and thus is not
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`inadmissible.” PGS, IPR2014-01477, Paper 71 at 75-76. This approach is
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`consistent with that taken in other contexts, such as consideration of summary
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`judgment in district court, where live testimony is unavailable and prior testimony
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`is not disfavored over written testimony from the same proceeding. E.g., Arceo v.
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`City of Junction City, 182 F. Supp.2d 1062, 1080-81 (D. Kan. 2002).
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`At a trial or hearing in open court, transcripts of prior proceedings are not
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`admissible evidence if the witness is available to testify live, but the reasons for
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`that are inapplicable to PTAB proceedings that are decided on the papers. As the
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`Supreme Court has observed, “[i]f the declarant is available and the same
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`information can be presented to the trier of fact in the form of live testimony, with
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`full cross-examination and the opportunity to view the demeanor of the declarant,
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`there is little justification for relying on” prior testimony. United States v. Inadi,
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`475 U.S. 387, 394 (1986); see McCormick on Evidence § 301 (the rationale behind
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`the hearsay treatment of prior testimony is “the strong preference to have available
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`witnesses testify in open court”). These principles offer no justification for
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`excluding Dr. Niyikiza’s testimony, as he was cross-examined in court, and where
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`Neptune’s proffered alternative—an affidavit followed by cross-examination by
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`deposition—would not provide any opportunity to view his demeanor.
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`Neptune’s only response is to argue that only Joinder-Petitioners, not
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`Neptune itself, got to cross-examine Dr. Niyikiza at trial. Mot. at 11-12. But those
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`Joinder-Petitioners who did examine Dr. Niyikiza at deposition and trial had
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`exactly the same incentive to cross-examine Dr. Niyikiza as Neptune does here—
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`they had even more than the “an opportunity and similar motive to develop” cross-
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`examination testimony that the evidence rules recite. FRE 804(b)(1)(B). The
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`invention about which others expressed skepticism is the same in both proceedings
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`and the skepticism has no relationship to the precise invalidity theory being
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`advanced (which is, in any event, largely the same here as in the district court).
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`And the sole issue relating to skepticism about which Neptune says it would have
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`examined Dr. Niyikiza—“the possibility that his allegation of ‘skepticism’ was
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`premised on matters unrelated to the claimed invention”—was an issue argued at
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`trial. Eli Lilly & Co. v. Teva Parenteral Medicines, et al., Case No. 1:10-cv-1376-
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`TWP-DKL, ECF No. 331 at 40-41 (S.D. Ind. Oct. 11, 2013).
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`Finally, Neptune argues that Dr. Niyikiza’s testimony is double hearsay to
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`the extent he testified about the statements made by others. Mot. at 8-9. But as the
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`district court correctly ruled at trial, these statements are not being offered for their
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`truth; what matters to skepticism is that they were said. Ex. 2116 at 748-49, 763-
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`64, 788. They are therefore not double hearsay. (Lilly does not ask the Board to
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`consider the one answer in the pages Neptune cites that was excluded as hearsay
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`by the district court. Ex. 2116 at 747-48; see Mot. at 10.)
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`D. Neptune also complains that Dr. Niyikiza is not an expert. Mot. at 9.
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`But he is not being offered to provide expert testimony, as the district court
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`recognized in overruling identical objections, but merely explained his own use of
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`terminology and thought processes. Ex. 2116 at 734-737. Neptune also complains
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`that Dr. Niyikiza testified about matters about which he had no personal
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`knowledge, but with regard to the history of the Lilly antifolate program, Neptune
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`has not established (or even articulated) what information Dr. Niyikiza supposedly
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`testified about without adequate foundation or why this issue, too, does not go to
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`the testimony’s weight rather than admissibility. Mot. at 10. These arguments do
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`not provide a basis to exclude any of Dr. Niyikiza’s testimony, much less all of it.
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`E.
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`Finally, Neptune faults Lilly for omitting the remainder of Dr.
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`Niyikiza’s testimony. Lilly served the entirety of Dr. Niyikiza’s trial testimony as
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`supplemental evidence under 37 C.F.R. § 42.64(b)(2). Neptune had every
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`opportunity to submit any other portions it desired to submit or to submit the
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`testimony in its entirety. It did not, and then amazingly seeks to use that as a basis
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`for exclusion. In any event, this issue is easily resolved. Lilly is filing with this
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`paper the entirety of Dr. Niyikiza’s testimony as Exhibit 2125, Ex. A.
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`Dated: February 21, 2017
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`Respectfully submitted,
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`Case IPR 2016-00240
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`/David M. Krinsky/
`David M. Krinsky
`Reg. No. 72,339
`Williams & Connolly, LLP
`725 12th St., NW
`Washington, DC 20005
`Telephone: 202-434-5338
`Facsimile: 202-434-5029
`Email: dkrinsky@wc.com
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`Back-up Counsel for
`Patent Owner
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`Case IPR 2016-00240
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`CERTIFICATE OF SERVICE
`(37 C.F.R. §§ 42.6(e))
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`The undersigned hereby certifies that the document above was served on
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`this 21st day of February, 2017, on the Petitioners by delivering a copy via
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`electronic mail to the following individuals at the email addresses below:
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`Sarah E. Spires
`Reg. No. 61,501
`240Neptune@skiermontderby.com
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`Skiermont Derby LLP
`2200 Ross Ave., Ste. 4800W
`Dallas, Texas 75201
`P: 214-978-6600/F: 214-978-6601
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`Attorneys for Neptune Generics, LLC
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`John D. Polivick
`Reg. No. 57,926
`jpolivick@rmmslegal.com
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`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
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`Attorneys for Apotex Inc. and Apotex
`Corp.
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`Gary J. Speier
`Reg. No. 45,458
`gspeier@carlsoncaspers.com
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`Dr. Parvathi Kota
`Reg. No. 65,122
`240Neptune@skiermontderby.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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`Mark D. Schuman
`Reg. No. 31,197
`mschuman@carlsoncaspers.com
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`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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`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
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`Patrick A. Doody
`Reg. No. 35,022
`patrick.doody@pillsburylaw.com
`
`Pillsbury Winthrop Shaw Pittman LLP
`1650 Tysons Boulevard
`McLean, VA 22102
`P: 703-770-7755/F: 703-770-7901
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`Counsel for Wockhardt Bio AG
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`Case IPR 2016-00240
`Patent 7,772,209
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`Bryan P. Collins
`Reg. No. 43,560
`bryan.collins@pillsburylaw.com
`
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`/David M. Krinsky/
`David M. Krinsky
`Attorney for Patent Owner
`Registration No. 72,339
`Back-up Counsel for
`Patent Owner
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`Case IPR 2016-00240
`Patent 7,772,209
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`Date: February 21, 2017
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