`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`KVK-Tech, Inc.,
`Petitioner,
`
`v.
`
`Shire LLC,
`Patent Owner.
`____________
`
`Case IPR2018-00290
`Patent 8,846,100
`____________
`
`PATENT OWNER’S OPPOSITION TO
`PETITIONER’S MOTION TO EXCLUDE
`
`
`
`IPR2018-00290
`
`Pursuant to the Scheduling Order (Paper 16, 4), Patent Owner Shire LLC
`
`(“Shire”) submits this Opposition to Petitioner’s Motion to Exclude EX2083 and a
`
`portion of EX2082. As set forth below, Petitioner’s motion should be denied for at
`
`least two independent reasons. First, Petitioner failed to timely object to the disputed
`
`evidence. Second, EX2082 and the disputed portion of EX2083 address the
`
`credibility of Petitioner’s expert, Dr. McCracken.
`
`I.
`
`PETITIONER’S OBJECTIONS ARE WAIVED AS UNTIMELY
`EX2082 is the deposition transcript of Petitioner’s expert, Dr. McCracken,
`
`and EX2083 was introduced during that deposition. EX2082, 184:4-174. Under 37
`
`C.F.R. § 42.64(a), “[a]n objection to the admissibility of deposition evidence must
`
`be made during the deposition.” See also 2012 Office Trial Practice Guide, 77 Fed.
`
`Reg. at 48772 (“An objection at the time of the examination—whether to evidence,
`
`to a party’s conduct, to the officer’s qualifications, to the manner of taking the
`
`testimony, or any aspect of the testimony—must be noted on the record . . . .”).
`
`Petitioner, however, failed to object to either EX2083 or the portion of 2082 it now
`
`moves to exclude during the deposition. EX2082, 184:4-187:20. Tellingly,
`
`Petitioner’s motion to exclude does not point out where any objection was made,
`
`even though required by the Office’s Rules. See 37 CFR 42.64(c) (“The motion [to
`
`exclude] must identify the objections in the record . . . .”). Accordingly, because
`
`1
`
`
`
`IPR2018-00290
`
`Petitioner did not timely object to EX2082 or EX2083, those objections are waived.
`
`Petitioner’s motion should be denied for this reason alone.
`
`II.
`
`EX2083 ADDRESSES THE CREDIBILITY OF PETITIONER’S
`EXPERT
`Petitioner incorrectly alleges that evidence of a witnesses’ credibility is
`
`limited only to “evidence of the witnesses’ character or reputation (F.R.E. 608(a)),
`
`the witnesses’ prior conduct (F.R.E. 608(b), or the witnesses’ prior inconsistent
`
`statements (F.R.E. 613).” Paper 46, 2. The types of evidence set forth by Petitioner
`
`do address credibility, but Petitioner’s list is not exclusive. As shown below, such
`
`evidence is not limited to statements by the witness either.
`
`Petitioner offers Dr. McCracken as an expert witness. Thus, there are many
`
`factors that should be considered when addressing the credibility or reliability of Dr.
`
`McCracken’s testimony. For example, in Daubert v. Merrell Dow Pharmaceuticals,
`
`Inc., 509 U.S. 579, 593-94 (1993), the Supreme Court listed several factors that a
`
`court can consider when determining the reliability of an expert’s testimony under
`
`F.R.E. 702, including “whether the theory . . . has been subjected to peer review and
`
`publication” and whether the theory has “general acceptance” in the scientific
`
`community. See also Summit 6, LLC v. Samsung Elecs. Co., 802 F.3d 1283, 1297
`
`(Fed. Cir. 2015) (“In Daubert, The Supreme Court has delineated certain factors to
`
`assist courts in evaluating the foundation of a given expert's testimony, while
`
`carefully emphasizing the non-exhaustive nature of these factors. Suggested
`
`2
`
`
`
`IPR2018-00290
`
`considerations include whether the theory or technique the expert employs is
`
`generally accepted, whether the theory has been subjected to peer review and
`
`publication, whether the theory can and has been tested, whether the known or
`
`potential rate of error is acceptable, and whether there are standards controlling the
`
`technique's operation.”). But even Daubert recognized that there are many different
`
`factors to consider when assessing an expert’s testimony. Daubert, 509 U.S. at 593
`
`(“Many factors will bear on the inquiry, and we do not presume to set out a definitive
`
`checklist or test.”). Further, the Supreme Court and Federal Circuit have indicated
`
`that “the presentation of contrary evidence” is a proper means of attacking the
`
`credibility of expert testimony:
`
`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.
`
`Summit 6, 802 F.3d at 1296.; see also Moberly v. Sec'y of HHS, 592 F.3d 1315, 1325-
`
`26 (Fed. Cir. 2010) (“Assessments as to the reliability of expert testimony often turn
`
`on credibility determinations, particularly in cases such as this one where there is
`
`little supporting evidence for the expert's opinion.”)
`
`Patent Owner questioned Dr. McCracken on EX2083 (EX2082, 184:4-
`
`187:20) and submitted EX2083 to show that Dr. McCracken is now providing expert
`
`3
`
`
`
`IPR2018-00290
`
`testimony on a theory that is inconsistent with the “consensus opinion” of the
`
`scientific community. Paper 42, 9 (quoting EX2083, 3). Briefly, Dr. McCracken
`
`testified that acute tolerance is not an issue for amphetamines and ADHD, based on
`
`certain of his work in 2003. See, e.g., EX1045, ¶¶ 31-39. Dr. McCracken conceded
`
`that he is taking a position inconsistent with that of Dr. Swanson, a co-author of the
`
`article he relies on in this case (EX1037) as well a companion article (EX1057).
`
`EX2082, 187:3-5. Dr. Swanson is also an author of EX2083, a subsequent peer
`
`review article that directly addresses the subject matter of Dr. McCracken’s
`
`testimony. EX2082, 184:19-22, 187:3-20. Further, Dr. McCracken’s testimony
`
`specifically criticized Dr. Swanson’s expertise. See, e.g., EX2082, 187:3-20.
`
`Accordingly, EX2083 is highly probative of Dr. McCracken’s credibility, i.e.,
`
`whether his testimony withstands “peer review” and has “general acceptance” in the
`
`scientific community. See Daubert supra. Specifically, EX2083 establishes that Dr.
`
`McCracken’s testimony regarding acute tolerance is not credible.
`
`III. EX2082 ADDRESSES THE CREDIBILITY OF PETITIONER’S
`EXPERT
`Petitioner asks the Board to exclude portions of EX2082 (184:4-186:24) “[f]or
`
`the same reason” as EX2083. Paper 46, 3. Accordingly, Patent Owner submits this
`
`portion of EX2082 is admissible for the same reasons discussed above.
`
`4
`
`
`
`IPR2018-00290
`
`IV. CONCLUSION
`For the foregoing reasons, Patent Owner respectfully requests that Petitioner’s
`
`Motion to Exclude be denied.
`
`
`
`
`
`
`
`
`
`
`
`
`
`Dated: March 15, 2019
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Respectfully submitted,
`
`/Joseph R. Robinson/
`
`Joseph R. Robinson, PTO Reg. No. 33,448
`
` Robert Schaffer, PTO Reg. No. 31,194
` Dustin B. Weeks, PTO Reg. No. 67,466
` Attorneys for Patent Owner
`
`5
`
`
`
`IPR2018-00290
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent Owner’s
`
`Opposition to Petitioner’s Motion to Exclude has been served on attorneys for
`
`Petitioner via electronic mail on March 15, 2019 on attorneys for Petitioner:
`
`sroth@lmiplaw.com
`
`tvetter@lmiplaw.com
`
`djg@lmiplaw.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Dated: March 15, 2019
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Respectfully submitted,
`
`/Dustin B. Weeks/
`
` Dustin B. Weeks, PTO Reg. No. 67,466
`
`