IPR2018-00293
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`KVK-Tech, Inc.,
`Petitioner,
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`v.
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`Shire LLC,
`Patent Owner.
`____________
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`Case IPR2018-00293
`Patent 9,173,857
`____________
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`PATENT OWNER’S OPPOSITION TO
`PETITIONER’S MOTION TO EXCLUDE
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`KVK-Tech, Inc.,
`Petitioner,
`
`v.
`
`Shire LLC,
`Patent Owner.
`____________
`
`Case IPR2018-00293
`Patent 9,173,857
`____________
`
`PATENT OWNER’S OPPOSITION TO
`PETITIONER’S MOTION TO EXCLUDE
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`IPR2018-00293
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`Pursuant to the Scheduling Order (Paper 14, 4), Patent Owner Shire LLC
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`(“Shire”) submits this Opposition to Petitioner’s Motion to Exclude EX2083 and a
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`portion of EX2082. As set forth below, Petitioner’s motion should be denied for at
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`least two independent reasons. First, Petitioner failed to timely object to the disputed
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`evidence. Second, EX2082 and the disputed portion of EX2083 address the
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`credibility of Petitioner’s expert, Dr. McCracken.
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`I.
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`PETITIONER’S OBJECTIONS ARE WAIVED AS UNTIMELY
`EX2082 is the deposition transcript of Petitioner’s expert, Dr. McCracken,
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`and EX2083 was introduced during that deposition. EX2082, 184:4-174. Under 37
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`C.F.R. § 42.64(a), “[a]n objection to the admissibility of deposition evidence must
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`be made during the deposition.” See also 2012 Office Trial Practice Guide, 77 Fed.
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`Reg. at 48772 (“An objection at the time of the examination—whether to evidence,
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`to a party’s conduct, to the officer’s qualifications, to the manner of taking the
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`testimony, or any aspect of the testimony—must be noted on the record . . . .”).
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`Petitioner, however, failed to object to either EX2083 or the portion of 2082 it now
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`moves to exclude during the deposition. EX2082, 184:4-187:20. Tellingly,
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`Petitioner’s motion to exclude does not point out where any objection was made,
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`even though required by the Office’s Rules. See 37 CFR 42.64(c) (“The motion [to
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`exclude] must identify the objections in the record . . . .”). Accordingly, because
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`IPR2018-00293
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`Petitioner did not timely object to EX2082 or EX2083, those objections are waived.
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`Petitioner’s motion should be denied for this reason alone.
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`II.
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`EX2083 ADDRESSES THE CREDIBILITY OF PETITIONER’S
`EXPERT
`Petitioner incorrectly alleges that evidence of a witnesses’ credibility is
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`limited only to “evidence of the witnesses’ character or reputation (F.R.E. 608(a)),
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`the witnesses’ prior conduct (F.R.E. 608(b), or the witnesses’ prior inconsistent
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`statements (F.R.E. 613).” Paper 44, 2. The types of evidence set forth by Petitioner
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`do address credibility, but Petitioner’s list is not exclusive. As shown below, such
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`evidence is not limited to statements by the witness either.
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`Petitioner offers Dr. McCracken as an expert witness. Thus, there are many
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`factors that should be considered when addressing the credibility or reliability of Dr.
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`McCracken’s testimony. For example, in Daubert v. Merrell Dow Pharmaceuticals,
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`Inc., 509 U.S. 579, 593-94 (1993), the Supreme Court listed several factors that a
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`court can consider when determining the reliability of an expert’s testimony under
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`F.R.E. 702, including “whether the theory . . . has been subjected to peer review and
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`publication” and whether the theory has “general acceptance” in the scientific
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`community. See also Summit 6, LLC v. Samsung Elecs. Co., 802 F.3d 1283, 1297
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`(Fed. Cir. 2015) (“In Daubert, The Supreme Court has delineated certain factors to
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`assist courts in evaluating the foundation of a given expert's testimony, while
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`carefully emphasizing the non-exhaustive nature of these factors. Suggested
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`IPR2018-00293
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`considerations include whether the theory or technique the expert employs is
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`generally accepted, whether the theory has been subjected to peer review and
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`publication, whether the theory can and has been tested, whether the known or
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`potential rate of error is acceptable, and whether there are standards controlling the
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`technique's operation.”). But even Daubert recognized that there are many different
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`factors to consider when assessing an expert’s testimony. Daubert, 509 U.S. at 593
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`(“Many factors will bear on the inquiry, and we do not presume to set out a definitive
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`checklist or test.”). Further, the Supreme Court and Federal Circuit have indicated
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`that “the presentation of contrary evidence” is a proper means of attacking the
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`credibility of expert testimony:
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`But the question of whether the expert is credible or the opinion is
`correct is generally a question for the fact finder, not the court. Apple
`Inc. v. Motorola, Inc., 757 F.3d 1286, 1314 (Fed. Cir. 2014), overruled
`en banc in part not relevant here, Williamson v. Citrix Online, LLC, 792
`F.3d 1339, 1349 (Fed. Cir. 2015). Indeed, “[v]igorous cross-
`examination, presentation of contrary evidence, and careful instruction
`on the burden of proof are the traditional and appropriate means of
`attacking shaky but admissible evidence.” Daubert, 509 U.S. at 596.
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`Summit 6, 802 F.3d at 1296.; see also Moberly v. Sec'y of HHS, 592 F.3d 1315, 1325-
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`26 (Fed. Cir. 2010) (“Assessments as to the reliability of expert testimony often turn
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`on credibility determinations, particularly in cases such as this one where there is
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`little supporting evidence for the expert's opinion.”)
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`Patent Owner questioned Dr. McCracken on EX2083 (EX2082, 184:4-
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`187:20) and submitted EX2083 to show that Dr. McCracken is now providing expert
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`3
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`IPR2018-00293
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`testimony on a theory that is inconsistent with the “consensus opinion” of the
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`scientific community. Paper 40, 9 (quoting EX2083, 3). Briefly, Dr. McCracken
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`testified that acute tolerance is not an issue for amphetamines and ADHD, based on
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`certain of his work in 2003. See, e.g., EX1045, ¶¶ 31-39. Dr. McCracken conceded
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`that he is taking a position inconsistent with that of Dr. Swanson, a co-author of the
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`article he relies on in this case (EX1037) as well a companion article (EX1057).
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`EX2082, 187:3-5. Dr. Swanson is also an author of EX2083, a subsequent peer
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`review article that directly addresses the subject matter of Dr. McCracken’s
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`testimony. EX2082, 184:19-22, 187:3-20. Further, Dr. McCracken’s testimony
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`specifically criticized Dr. Swanson’s expertise. See, e.g., EX2082, 187:3-20.
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`Accordingly, EX2083 is highly probative of Dr. McCracken’s credibility, i.e.,
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`whether his testimony withstands “peer review” and has “general acceptance” in the
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`scientific community. See Daubert supra. Specifically, EX2083 establishes that Dr.
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`McCracken’s testimony regarding acute tolerance is not credible.
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`III. EX2082 ADDRESSES THE CREDIBILITY OF PETITIONER’S
`EXPERT
`Petitioner asks the Board to exclude portions of EX2082 (184:4-186:24) “[f]or
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`the same reason” as EX2083. Paper 44, 3. Accordingly, Patent Owner submits this
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`portion of EX2082 is admissible for the same reasons discussed above.
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`4
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`IPR2018-00293
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`IV. CONCLUSION
`For the foregoing reasons, Patent Owner respectfully requests that Petitioner’s
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`Motion to Exclude be denied.
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`Dated: March 15, 2019
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` Respectfully submitted,
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`/Joseph R. Robinson/
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`Joseph R. Robinson, PTO Reg. No. 33,448
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` Robert Schaffer, PTO Reg. No. 31,194
` Dustin B. Weeks, PTO Reg. No. 67,466
` Attorneys for Patent Owner
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`5
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`IPR2018-00293
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent Owner’s
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`Opposition to Petitioner’s Motion to Exclude has been served on attorneys for
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`Petitioner via electronic mail on March 15, 2019 on attorneys for Petitioner:
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`sroth@lmiplaw.com
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`tvetter@lmiplaw.com
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`djg@lmiplaw.com
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` Respectfully submitted,
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`/Dustin B. Weeks/
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` Dustin B. Weeks, PTO Reg. No. 67,466
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`Dated: March 15, 2019
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