`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`KVK-Tech, Inc.,
`Petitioner,
`
`v.
`
`Shire LLC,
`Patent Owner.
`
`Case IPR2018-00293
`Patent 9,173,857
`
`PETITIONER’S REPLY IN SUPPRORT OF ITS
`OBJECTIONS AND MOTION TO EXCLUDE
`
`Patent Trial and Appeal Board
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`I.
`
`Petitioner Timely Objected
`
`Patent Owner argues Petitioner did not object to Exhibit 2083. That is untrue.
`
`This motion (Paper No. 44) is both an objection and a motion to exclude, as evident
`
`from its title and opening line, and, pursuant to 37 C.F.R. 42.64(b)(1), it was made
`
`within 5 business days (in fact the same day) of Patent Owner’s filing and service of
`
`Exhibit 2083 with its Sur-Reply, on March 7, 2019.
`
`II. Exhibit 2083 Should be Excluded
`
`During the February 22, 2019 conference call with the Board, Patent Owner
`
`represented that it only intended to present new evidence with its Sur-Reply if it
`
`related to the “impeachment” of Petitioner’s declarant, Dr. James McCracken.
`
`Petitioner agreed to these terms and, on February 25, 2019, the Board ruled that “any
`
`additional evidence submitted in connection with the briefing will be restricted to
`
`evidence related to the credibility of Petitioner’s additional declarant.” (Paper No.
`
`36, p. 4.) The Order reflected the parties’ agreement, as noted in the Order. Id.
`
`Patent Owner relies on this new reference on page 9 of its Sur-Reply as
`
`evidence of an alleged “consensus opinion” in 2009 concerning the issue of acute
`
`tolerance of amphetamines. Patent Owner argues that this reference was properly
`
`submitted to challenge the credibility of Dr. McCracken. Patent owner is wrong for
`
`several reasons.
`
`First, Patent Owner did not challenge Dr. McCracken’s credibility with this
`
`1
`
`
`
`reference during his deposition. Dr. McCracken is not an author of this reference, and
`
`testified that he had never seen this reference (McCracken Dep. EX. 2082 184:4-18).
`
`Patent Owner asked Dr. McCracken to read two passages from the reference into the
`
`record, without asking any substantive questions about those passages or any other
`
`passages. (Id. 184:23-186:24.)
`
`Now, without any substantive expert testimony concerning EX. 2083 – either
`
`from Patent Owner’s or Petitioner’s experts – Patent Owner seeks to introduce this
`
`article, and all its contents, into evidence under the pretext of attacking Dr.
`
`McCracken’s credibility.
`
`Second, Patent Owner grossly mischaracterizes this reference. It does not
`
`disclose a 2009 consensus opinion, nor does it implicate acute tolerance in
`
`amphetamines. Rather, it discusses an alleged “consensus opinion” from the 1980s
`
`that “stimulant drugs required bolus doses and a PK profile with peaks and valleys
`
`to produce and maintain clinical efficacy, which implied an inherent limitation on
`
`CR [controlled release] formulations.” (First full paragraph, EX. 2083 p. 3.)
`
`No expert in the case has or can provide an opinion on whether there was such
`
`a consensus opinion in the 1980s. There is no one to opine on this because Patent
`
`Owner did not introduce this exhibit with any of its experts, not did it ask for Dr.
`
`McCracken’s opinion.
`
`Even assuming there was such a consensus opinion in the 1980s, it’s not
`
`relevant to the opinions of Dr. McCracken on acute tolerance because his opinions
`2
`
`
`
`
`
`are largely based on his amphetamine study from 2003, EX.1037 (and additional
`
`studies in the 1990s, e.g., EX.1052 and 1053). Patent Owner’s new reference
`
`(EX.2083) even recognizes that opinions on acute tolerance have changed. Indeed,
`
`it states (on p. 11) that the “fundamental principle of acute tolerance is not
`
`understood or recognized by all, which is reflected in the second generation CR
`
`formulations (see the absence of acute tolerance in the reviews by Banaschewski et.
`
`al., 2006 and Conner & Steingard, 2004) and by some investigators who have
`
`participated in the development of new CR formulations without an ascending drug
`
`profile ….” Id. p. 11.
`
`Third, evidence of impeachment or of a witnesses’ credibility is governed by
`
`the Federal Rules of Evidence, and consists 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). None of these categories are applicable here.
`
`Exhibit 2083 is not authored by Dr. McCracken, nor addressing Dr. McCracken’s
`
`conduct, character, or reputation. Nor can Patent Owner point to any inconsistent
`
`statement by Dr. McCracken in Exhibit 2083 as he is not quoted.
`
`Patent Owner argues that it should be allowed to introduce evidence that could
`
`be considered in a Daubert hearing. But Patent Owner did not request the right to
`
`introduce evidence that would be relevant in a Daubert hearing; it only requested
`
`the right to introduce impeachment evidence. Daubert factors are inapplicable as
`
`they relate to the of the admissibility of an expert’s testimony, not the credibility of
`3
`
`
`
`
`
`the expert. The inquiry in Daubert is whether the expert’s opinion is based on
`
`reliable scientific principles and methodology. See, Daubert v. Merrell Dow Pharm.,
`
`Inc., 509 U.S. 579, 592-594 (1993). “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.” Summit 6, LLC v. Samsung Electronics Co., Ltd., 802 F.3d 1283, 1295 (Fed.
`
`Cir. 2015).
`
` Patent Owner argues that whether acute tolerance is generally accepted is
`
`relevant to Daubert and therefore credibility. It’s not relevant to either. It’s the
`
`general acceptance of the expert’s methodology that is a factor in Daubert; not the
`
`expert’s conclusions. Daubert, at 595 (“The focus, of course, must be solely on the
`
`principles and methodology, not on the conclusions that they generate.”); Summit 6,
`
`at 1296 (“where the methodology is reasonable and its data or evidence are
`
`sufficiently tied to the facts of the case, the gatekeeping role of the court is satisfied,
`
`and the inquiry on the correctness of the methodology and of the results produced
`
`thereunder belongs to the factfinder.”)
`
` Patent Owner’s submission of Exhibit 2083 with Patent Owner’s Sur-Reply
`
`is contrary to the Board’s Order and agreement of the parties, is unrelated to
`
`impeachment (and even Daubert), and no expert has offered any opinion on it.
`
`Therefore, it should be excluded.
`
`III. Exhibit 2082
`
`For the same reasons, Petitioner objects and moves to exclude the portion of
`4
`
`
`
`
`
`the deposition transcript of Dr. McCracken (Exhibit 2082, p. 184 line 4 – p. 186,
`
`line 24) in which Patent Owner asked Dr. McCracken to read portions of Exhibit
`
`2083 into the record.
`
`Dated: March 21, 2019
`
`
`
`
`
`Respectfully submitted,
`
`/s/Steven Roth/
`Steven Roth, PTO Reg. No. 47,039
`Lucas & Mercanti, LLP
`
`5
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that, pursuant to 37 C.F.R. §§ 42.6(e) a
`
`copy of the foregoing PETITIONER’S REPLY IN SUPPORT OF ITS
`
`OBJECTIONS AND MOTION TO EXCLUDE as served electronically via email
`
`on March 21, 2019 on the following:
`
`Joseph R. Robinson
`Troutman Sanders LLP
`875 Third Avenue
`New York, NY 10022
`joseph.robinson@troutmansanders.com
`
`Dustin B. Weeks
`Troutman Sanders LLP
`Bank of America Plaza
`600 Peachtree Street NE, Suite 5200
`Atlanta, GA 30308-2231
`dustin.weeks@troutmansanders.com
`
`Robert Schaffer
`Troutman Sanders LLP
`875 Third Avenue New
`York, NY 10022
`robert.schaffer@troutmansanders.com
`Patent Owner has consented to electronic service.
`
`Date: March 21, 2019
`
`
`
`By:
`
`
`
`/Steven Roth/
`Steven Roth
`Reg. No. 47,039
`
`6
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
