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`IPR2016-01370
`U.S. Patent No. 8,664,231
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`KOIOS PHARMACEUTICALS LLC,
`Petitioner
`
`v.
`
`MEDAC GESELLSCHAFT FUER KLINISCHE
`SPEZIALPRÄPARATE MBH,
`Patent Owner
`____________
`
`Case No. IPR2016-01370
`Patent Number 8,664,231
`____________
`
`Before JACQUELINE WRIGHT BONILLA, TONI R. SCHEINER,
`and ERICA A. FRANKLIN, Administrative Patent Judges
`
`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
`UNDER 37 C.F.R. §§ 42.62 AND 42.64
`
`
`
`
`
`
`Pursuant to 37 C.F.R. §§ 42.62 and 42.64, Patent Owner medac Gesellschaft
`
`IPR2016-01370
`U.S. Patent No. 8,664,231
`
`
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`für Klinische Spezialpräparate mbH (“Medac”) moves to exclude certain of
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`Petitioner’s exhibits and cross-examination. This motion is timely filed under the
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`Board’s Scheduling Order. (Paper 14: Due Date 4). Medac requests that Exhibits
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`1041-45 and certain cross-examination testimony from Terri Shoemaker (Exhibit
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`1040) be excluded.
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`I.
`
`Legal Standards
`The Federal Rules of Evidence (“F.R.E.”) apply to inter partes review
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`proceedings. See 37 C.F.R. § 42.62(a); Office Patent Trial Practice Guide, 77 Fed.
`
`Reg. 48758. Under F.R.E. 402, “irrelevant evidence
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`is not admissible.”
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`Furthermore, an out-of-court statement used to prove the truth of the matter
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`asserted is inadmissible hearsay unless otherwise provided by a federal statute, the
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`Federal Rules of Evidence, or other rules prescribed by the Supreme Court. F.R.E.
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`801-05. Finally, “[t]o satisfy the requirement of authenticating or identifying an
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`item of evidence, the proponent must produce evidence sufficient to support a
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`finding that the item is what the proponent claims it is.” F.R.E. 901.
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`II. Exhibits 1041-45 Should be Excluded
`The Board should exclude Exhibits 1041-45 because those exhibits include
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`evidence that is irrelevant, inadmissible hearsay, and/or improperly authenticated.
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`Medac timely objected to these exhibits, stating the precise grounds why they are
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`1
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`
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`inadmissible.1 (Paper 38).
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`A. Exhibit 1041 Should be Excluded
`Exhibit 1041 is a copy of e-mail correspondence between counsel of record
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`concerning deposition scheduling for Petitioner’s expert witnesses. Medac timely
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`objected to Exhibit 1041 under F.R.E. 401, 402, 403, and 37 C.F.R. § 42.61.
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`(Paper 38 at 2).
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`Exhibit 1041 is irrelevant to this inter partes review and should not be
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`admitted under F.R.E. 401 and 402. E-mail between counsel about deposition
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`scheduling does not relate to the substance of any expert testimony, prior art
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`references, or any other patentability issue in this case. Moreover, admission of
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`the correspondence is entirely unnecessary because it is evident from the record
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`that Medac did not depose Petitioner’s experts. No transcripts of such depositions
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`were filed with the Board.
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`The issue, however, is that Petitioner relies on Exhibit 1041 to argue that
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`Medac “refused” to take the depositions of Petitioner’s experts (Drs. Schiff and
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`Miller) due to the “quality” of their opinions. Reply at 1, 3, 20. Such reliance is
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`misleading and unfairly prejudicial to Medac. There are many reasons for deciding
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`
`1
`In its objections to Petitioner’s Reply exhibits, Medac also objected to
`Petitioner’s incomplete and misleading citations of Dr. Thomas Zizic’s deposition
`testimony. Because the Board addressed those objections during a September 29,
`2017 conference call and allowed Medac to file a sur-reply with citations to
`additional testimony, Medac does not seek exclusion here.
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`2
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`not to depose an expert in an inter partes review aside from the alleged “quality”
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`of the opinion. Indeed, the deficiencies of a witness’s direct testimony may be
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`evident without cross-examination. Furthermore, here Medac addressed the
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`opinions of Petitioner’s experts in multiple expert declarations of its own. Given
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`Petitioner’s misleading statements about Exhibit 1041, and its lack of relevance to
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`any substantive issue in dispute, Exhibit 1041 should be excluded under F.R.E. 402
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`and 403.
`
`B.
`Exhibit 1042 Should be Excluded
`Exhibit 1042 purports to be a website copy of a non-U.S. court decision
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`regarding a U.K. patent that claims the same priority as the challenged patent.
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`Medac timely objected to Exhibit 1042 under F.R.E. 401, 402, 403, 802, 901, and
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`37 C.F.R. § 42.61. (Paper 38 at 3). Petitioner relies on Exhibit 1042 to imply that
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`because a foreign trial court rejected a U.K. patent with the same priority claim as
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`the ’231 patent, the challenged claims of the ’231 patent must also be invalid. See
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`Reply at 1. These statements and Exhibit 1042 should be excluded.
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`Exhibit 1042 is irrelevant and should not be admitted under F.R.E. 401, 402,
`
`and 403. The U.K. decision recited in Exhibit 1042 involved a different patent
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`with different claims, different parties, different facts and witnesses, and different
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`legal standards than those at issue here. Petitioner insinuates from Exhibit 1042
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`that the challenged claims of the ’231 patent must also be invalid, but there is no
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`3
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`legal or factual basis for this argument. Even if Exhibit 1042 had any probative
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`value here (which it does not), that value would be substantially outweighed by
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`unfair prejudice to Medac because the U.K. patent or its claims and the art relied
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`on in the U.K. decision are not in dispute or part of the record in this proceeding.
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`Exhibit 1042 should also be excluded as impermissible hearsay pursuant to
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`F.R.E. 802. Petitioner offers that exhibit for the truth of the matters asserted; i.e.,
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`the validity of the U.K. patent. No hearsay exception applies, however, to Exhibit
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`1042.
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`Exhibit 1042 should further be excluded due to lack of authentication under
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`F.R.E. 901. Exhibit 1042 appears to be a printout of a webpage.
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`For these reasons, Exhibit 1042 should be excluded.
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`C. Exhibit 1043 Should be Excluded
`Exhibit 1043 purports to be a copy of an online third-party news summary of
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`a non-U.S. court decision regarding a Netherlands patent that claims the same
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`priority as the challenged patent. Medac timely objected to Exhibit 1042 under
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`F.R.E. 401, 402, 403, 802, 901, and 37 C.F.R. § 42.61. (Paper 38 at 4-5). As with
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`Exhibit 1042, Petitioner improperly relies on Exhibit 1043 to imply that a foreign
`
`trial court’s decision in the context of a Netherlands patent and its claims somehow
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`makes it more likely than not that the challenged claims of the ’231 patent are
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`4
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`invalid. See Reply at 1. These arguments are improper, and Exhibit 1043 should
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`be excluded.
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`Exhibit 1043 is irrelevant and should not be admitted under F.R.E. 401, 402,
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`and 403 for at least the same reasons that apply to Exhibit 1042. The decision
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`summarized in Exhibit 1043 involved a different patent with different claims,
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`different facts and witnesses, different parties, and different legal standards than
`
`those at issue here. Furthermore, Medac has appealed the Netherlands decision, so
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`it is not final.
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`Exhibit 1043 should also be excluded as impermissible hearsay under F.R.E.
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`802 because Petitioner offers this exhibit for the truth of the matters asserted
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`regarding the foreign tribunal’s decision as reported in the news story. Petitioner,
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`however, has not provided the tribunal’s decision itself, but rather a third-party
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`summary of that decision, which is thus hearsay on hearsay. No hearsay exception
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`applies to either hearsay prong of Exhibit 1043.
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`Additionally, Exhibit 1043 should be excluded due to lack of authentication
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`under F.R.E. 901. Exhibit 1043 appears to be a printout of a webpage.
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`For these reasons, Exhibit 1043 should be excluded.
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`D. Exhibits 1044 and 1045 Should be Excluded
`Exhibits 1044 and 1045 are portions of the file history of U.S. Application
`
`No. 14/635,542, which is a continuation application that claims the same priority
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`5
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`
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`as the ’231 patent. Exhibit 1044 is said to be a copy of a November 14, 2016 Non-
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`Final Rejection, while Exhibit 1045 is said to be a copy of a June 6, 2017 Notice of
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`Abandonment. Medac timely objected to both exhibits under F.R.E. 401, 402, 403,
`
`and 37 C.F.R. § 42.61. (Paper 38 at 6-7). Petitioner cites these exhibits to imply
`
`that the PTO’s non-final rejection in a related child application, and applicant’s
`
`subsequent abandonment of that application, indicates that the challenged claims of
`
`the ’231 patent are invalid. This is an impermissible inference.
`
`Both exhibits are irrelevant to this case and should not be admitted under
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`F.R.E. 401, 402, and 403. Exhibit 1044 reflects a non-final rejection involving a
`
`continuation application with different claims than the ’231 patent and does not
`
`make it any more or less likely that the challenged claims of the ’231 patent are
`
`unpatentable. Indeed, the grounds for the rejection in that non-final action are not
`
`the grounds on which this inter partes review was instituted. Compare Ex. 1044 at
`
`4, 6, 7, 9, 10, with Decision Granting Institution (Paper 13) at 36.
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`To the extent a non-final rejection in a related application would have any
`
`probative value in this inter partes review (which it does not), it is substantially
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`outweighed by unfair prejudice to Medac from considering a non-final decision
`
`from an entirely different proceeding. Indeed, Petitioner uses Exhibit 1045
`
`improperly to contend that Medac “had no response” to the non-final rejection
`
`(Reply at 1). In fact, Medac filed a continuation application (15/592,882) with the
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`6
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`
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`same claims as in the direct parent application prior to allowing that parent
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`application to go abandoned and receiving the Petitioner-cited notice of
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`abandonment, a fact that Petitioner never mentions. Accordingly, Petitioner’s
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`reliance on Exhibit 1045 is misleading, inaccurate, and unfairly prejudicial.
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`For at least these reasons, both file history documents from the different,
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`still-pending application should be excluded.
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`III.
`
`Improper Cross-Examination Testimony Elicited from Ms. Shoemaker
`Should be Excluded
`The Board should also exclude specific cross-examination testimony from
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`Ms. Shoemaker (Ex. 1040). The cross-examination exceeds the permissible scope
`
`of cross-examination under the Board’s rules. Medac timely objected to that
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`testimony during the respective depositions.
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`Medac seeks exclusion of the cross-examination testimony at 34:9-16 and
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`34:21-35:13 of Ms. Shoemaker’s deposition transcript (Ex. 1040). Petitioner’s
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`counsel asked Ms. Shoemaker questions on topics that impermissibly exceeded the
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`scope of her direct declaration testimony. See 37 C.F.R. § 42.53(d)(5)(ii). Ms.
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`Shoemaker’s declaration addressed only the topic of a prior consulting relationship
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`between Medac and Dr. Schiff, one of Petitioner’s experts. See Ex. 2011.
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`However, during cross-examination, Petitioner’s counsel questioned Ms.
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`Shoemaker about Medac’s marketing and development of a commercial
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`7
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`embodiment of the ’231 patent, topics about which Ms. Shoemaker never testified
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`on direct (i.e., in her declaration). See Ex. 1040 at 34:9-16, 34:21-35:13.
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`Compounding the problem, in its Reply, Petitioner cited to that improper testimony
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`to make new arguments about supposed unpatentability. See Reply at 24 (“But
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`Medac’s own CEO, Terri Shoemaker, testified that Medac itself did not consider
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`developing and commercializing Rasuvo to be a low-risk undertaking. Ex. 1040 at
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`34:21-35:13.”). Petitioner’s attempt to introduce new arguments about Medac’s
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`products based on impermissible re-cross-examination should be excluded.
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`IV. Conclusion
`For the reasons above, the Board should exclude Exhibits 1041-45 and the
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`portions of deposition testimony from Ms. Shoemaker that exceeded the
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`permissible bounds of cross-examination.
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`8
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`IPR2016-01370
`U.S. Patent No. 8,664,231
`
`Dated: October 2, 2017
`
`
`
`Respectfully submitted,
`
`HALEY GUILIANO LLP
`
`/James F. Haley, Jr./
`
`James F. Haley, Jr. (Lead Counsel)
`75 Broad Street, Suite 1000
`New York, NY 10004
`T: 212-973-2502 / F: 646-219-6229
`james.haley@hglaw.com
`
`Attorneys/Agents For Patent Owner
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`9
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that the foregoing PATENT OWNER’S
`
`MOTION TO EXCLUDE EVIDENCE UNDER 37 C.F.R. §§ 42.62 AND 42.64
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`have been served in their entirety by filing this document through the Patent Trial
`
`and Appeal Board End to End (PTAB E2E), as well as providing courtesy copies
`
`via e-mail to the following attorneys of record for the Petitioners listed below:
`
`Lead Counsel:
`
`DeAnn F. Smith, Reg. No. 36,683
`Foley Hoag LLP
`155 Seaport Blvd.
`Boston MA 02210-2600
`T: 617-832-1230
`F: 617-832-7000
`dsmith@foleyhoag.com
`
`ipr2016-01370@foleyhoag.com
`Back-up Counsel: William Rothwell, Reg. No. 72,522
`Noroozi PC
`2245 Texas Dr. Suite 300
`Sugar Land, TX 77479
`T: 281-566-2685
`F: 844-975-7074
`william@noroozipc.com
`
`Kayvan B. Noroozi
`Noroozi PC
`1299 Ocean Ave., Suite 450
`Santa Monica, CA 90401
`kayvan@noroozipc.com
`T.: 1 (310) 975-7074
`
`
`Dated: October 2, 2017
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`
`
`
`By: /Crena Pacheco/
`Name: Crena Pacheco
`ROPES & GRAY LLP
`
`
`
`
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`10
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