CRISPR Interference Parties File Motions to Exclude Evidence and for Oral Hearing

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Junior Party University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (hereinafter, "CVC") and Senior Party The Broad Institute, Massachusetts Institute of Technology, and Harvard University (hereinafter, "Broad") each filed Motions to Exclude Evidence and Requests for Oral Hearing in Interference No. 106,115.

CVC's motion to exclude is directed to "declarations of Benjamin Davies (Ex. 3435), Mark Kay (Ex. 3436), Alan Lambowith (Ex. 3437); Paul Simons (Exs. 3438 and 3440); Erez Lieberman Aidan (Ex. 3439), Greg Hannon (Ex. 3441 and 3442), Mark Isalan (Ex. 3443), Caixao Gao (Ex. 3446); Adam Bogdanove (Ex. 3449), Thierry VandenDriessche (Ex. 3450), Bryan Cullen (Ex. 3451), Paula Cannon (Ex. 3452), portions of the Third Declaration of Ronald Breaker (Ex. 3448)," and certain documentary exhibits.  The legal basis for the motion is that these exhibits and testimony "seeks to exclude violates the Federal Rules of Evidence, the Standing Order (Paper 2), and the Supreme Court's decision in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 593-94 (1993)."

With regard to CVC's arguments based on the Rules of Evidence, CVC objects to Broad being permitted to rely on testimony proffered in support of its motion that has not been offered for witness cross-examination by CVC.  This is prejudicial to CVC, the motion explains, because "it had no opportunity to confront and challenge these witnesses on their statements, including their purported recollections, proffered opinions, and potential biases."  This testimony is particularly relevant because Broad has relied on it to show whether a person of ordinary skill in the art would have expected CRISPR-Cas9 to work in eukaryotic cells in early 2012; this testimony thus involves "disputed facts at the heart of [Broad's] opposition" to CVC's priority position.  In addition, because "[m]any of these witness statements were submitted in foreign patent office proceedings" they were not sworn to under oath and also constitute hearsay and thus should not be entered into evidence.

In addition to CVC's objections based on the Federal Rules of Evidence, the motion asserts that this evidence is contrary to Standing Order (SO) ¶ 157.3, which provides that testimony not subject to cross-examination can be excluded.  Permitting Broad to rely on such unchallenged testimony is also contrary to relevant precedent, including Rose v. Frazer, Inf. No. 104,733 Paper 73 at 4 (B.P.A.I. Mar. 29, 2002); Praxair Distrib., Inc. v. INO Therapeutics LLC, IPR2015-00529, Paper 33 at 2 (PTAB Dec. 22, 2015); and Mexichem Amanco Holdings S.A. de C.V. v. Honeywell Int'l, Inc., Case IPR2013-00576, Paper 36 at 3 (PTAB Sept. 5, 2014), as well as 37 C.F.R. § 42.51(c).  This precedent stands against Broad's arguments that cross-examination is unnecessary because the statements contained therein are part of the "public record" according to CVC.

CVC points out for particular objection portions of Dr. Breaker's declaration as hearsay for relying on declarations of others he stated show that others in the field shared his opinions with regarding to eukaryotic CRISPR embodiments; to do so would contravene Federal Circuit precedent according to CVC, citing Wi-Lan Inc., v. Sharp Electronics Corp., 992 F.3d 1366 (Fed. Cir. 2021).  In addition to striking the specified portions of Dr. Breaker's testimony, CVC asks the Board to give no weight to citations of Dr. Breaker's opinion in Broad's priority motions, oppositions, and replies.  And because Dr. Breaker's reliance on unchallenged opinions of others is accordingly unreliable, those portions violate Daubert as well, according to CVC's brief.  To an anticipated response by Broad that an expert is entitled to rely on hearsay in forming their opinions, CVC argues that while true an expert cannot be used as a "conduit" for bringing hearsay to the factfinder for the truth of the matter asserted, citing the Federal Circuit's reliance on Marvel Characters, Inc. v. Kirby, 726 F.3d 119 (2d Cir. 2013), in its Wi-Lan Inc., v. Sharp Electronics Corp. decision.

With regard to certain exhibits, CVC objects as hearsay to recent books about CVC inventors including Walter Isaacson (The Code Breaker: Jennifer Doudna, Gene Editing, and the Future of the Human Race) and Kenneth (sic) Davies (Editing Humanity: The CRISPR Revolution and the New Era of Genome Editing) that CVC contends the Broad proffered as "purported evidence of the timing, difficulty, challenges, and the role different people played in the events leading up to the CVC inventors' fame and accolades."  Rather than providing admissible evidence, CVC contends that these books are the authors' words and interpretations of information they gathered and that the authors are without personal knowledge of the events they describe.  Nor have these authors submitted declarations under oath nor been made available for deposition.  And as "hearsay within hearsay" (as being the authors' hearsay statements regarding what others have said to them) these exhibits are inadmissible under FRE 805.  As stated by CVC in its motion, "[t]here is no hearsay exception for a published book, even a popular one."

Broad's motion to exclude is more limited, being specifically directed to testimony from Dr. Phillip Zamore regarding "how a person having ordinary skill in the art ("POSA") allegedly would have understood (1) the March 2011 Deltcheva et al. reference's disclosures regarding tracrRNA, (2) the RNAi, pre-mRNA, and DNA systems he alleges are relevant to Deltcheva et al.'s disclosures, and (3) Dr. Zhang's October 24, 2011 email regarding the role of tracrRNA in the CRISPR-Cas9 cutting complex."  According to Broad, what Dr. Zamore's declaration did not attest to was "(1) whether a 2012 POSA would have had a reasonable expectation of success of using CRISPR-Cas9 in eukaryotic cells; (2) the state of the art after the Jinek 2012 paper; or (3) relevant prokaryotic-based systems, such as Group II introns," all of which were issues upon which CVC Priority Motion.  But these issues were attested to not by Dr. Zamore in support of CVC's priority claims but by another witness, who did not opine on them.  Thus, CVC's proffer of Dr. Zamore's testimony on these matters is an attempt, in Broad's view, to "untimely seek[] to obtain expert testimony on these topics via improper re-direct testimony by Dr. Zamore" (i.e., during Broad's cross-examination of CVC's witness).  And Broad asserts that its cross-examination of Dr. Zamore was properly limited to "the actual opinions expressed in Dr. Zamore's declaration and his qualifications," and thus did not "open the door" to the testimony CVC elicited on redirect examination.

The brief recites specific portions of Dr. Zamore's redirect testimony to illustrate that Broad terms "an obviously rehearsed question and answer session that attempted to add to the record new testimony regarding reasonable expectation of success."  Broad's brief sets forth with specificity the testimony Broad asks the Board to exclude:

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Broad's basis for this relief is that the Board "allowing the challenged po1tions of Dr. Zamore's testimony into evidence here would prejudice Broad" because "Broad was denied a fair opportunity to prepare a full rebuttal to Dr. Zamore on topics such as prior art systems and reasonable expectation of success given such opinions were not in Dr. Zamore's declaration and only proffered for the first time on a purported re-direct, after Broad's opposition was filed."

Both Broad and CVC request oral hearing and present a list of issues for the Board to resolve.  For Broad, these issues include Broad's Motion No. 5 for judgment of priority, as well as CVC's Opposition Motion and Broad's Reply; Broad's motion No. 9 to exclude evidence (as well as any opposition by CVC and reply by Broad); CVC's Motion No. 2 for priority judgment, as well as Broad's Opposition and CVC's Reply; CVC's Motion No. 3 for misjoinder of inventorship, Broad's Opposition, and CVC's Reply; and Broad's Contingent Motion No. 6, CVC's Opposition, and Broad's Reply for Correction of Inventorship if the Board grants CVC's Motion No. 3 on misjoinder.  Broad also lists for the Board any motions to exclude by CVC and "any other issues that the PTAB would like Senior Party to address."

For CVC the issues on which CVC asks the Board to hear oral argument include CVC's Motion No. 2 for priority judgment, as well as Broad's Opposition and CVC's Reply; CVC's Motion No. 3 for misjoinder of inventorship, Broad's Opposition, and CVC's Reply; CVC's Motion No. 7 to exclude evidence, as well as any Broad Opposition and CVC Reply; Broad's Motion No. 5 for judgment of priority, as well as CVC's Opposition Motion and Broad's Reply; and Broad's Contingent Motion No. 6, CVC's Opposition, and Broad's Reply for Correction of Inventorship if the Board grants CVC's Motion No. 3 on misjoinder.  CVC also includes any other issues "raised by Broad during oral argument or issues the PTAB would like CVC to address."

The Board in its discretion will decide whether to grant these requests for oral hearing and set a hearing date in due course.

Finally, Broad has filed an unopposed Miscellaneous Motion (No. 8) pursuant to Standing Order ¶¶ 121 and 123 to seal redacted material under the protective order contained in portions of the deposition transcripts of two CVC witnesses, Erik Joseph Sontheimer (Ex. 6214) and Rodolphe Barrangou (Ex. 6212).  This testimony relates to financial disclosures and licensing information that, if disclosed, would "compromise privacy interests and competitively sensitive information about licensing held by non-parties to this proceeding."  Broad makes the case that the redactions are "narrowly tailored" to minimize negative impact on the public, and that the redacted information is not necessary for the public to understand the context or substantive merits in the interference.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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