Late last month, 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 in Interference No. 106,115.  Now Broad has filed its Opposition to CVC's motion and CVC has filed its responsive Reply.

CVC's motion was directed to testimonial declarations of several Broad witnesses, including Benjamin Davies, Mark Kay, Alan Lambowith, Paul Simons, Erez Lieberman Aidan, Greg Hannon, Mark Isalan, Caixao Gao, Adam Bogdanove, Thierry VandenDriessche, Bryan Cullen, Paula Cannon, and Ronald Breaker, as well as documentary evidence.  CVC's basis for its motion was that this witness testimony had not been subject to cross-examination, based on the Federal Rules of Evidence, Standing Order (SO) ¶ 157.3, 37 C.F.R. § 42.51(c), and precedent including Rose v. Frazer, Praxair Distrib., Inc. v. INO Therapeutics LLC, and Mexichem Amanco Holdings S.A. de C.V. v. Honeywell Int'l, Inc.  CVC also asserted that certain testimony, particularly that of Dr. Breaker, was hearsay.  CVC raised similar hearsay objections to Broad's proffer of two books about CRISPR, by 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).

Broad's opposition to this motion asserts existentially that CVC is attempting to avoid contemporaneous evidence regarding the inventors' appreciation that they had (or through the exercise of routine practice could) reduce eukaryotic embodiments to practice during the time from CVC's alleged conception date (March 3, 2012) to the constructive reduction to practice date, the filing of CVC's earliest priority document U.S. provisional application no. 61/757,640, filed January 28, 2013.  Reciting an argument made throughout this interference (and, indeed, in the earlier interference between the parties, No. 106,048), Broad asserts that the evidence it has adduced in this regard is admissible at least as an admission against interest.  And, Broad argues, its witness Dr. Breaker was entitled therefore to rely on them in support of his opinion that CVC has not shown that it was in possession of eukaryotic CRISPR earlier than Broad's dates of conception and actual reduction to practice.

In addition, Broad argues that much of the evidence objected to by CVC involves opinions from scientists regarding whether the person of ordinary skill would have considered eukaryotic embodiments of CRISPR to involve nothing more than the exercise of ordinary skill and to have been reasonably expected to succeed in view of CVC's evidence regarding in vitro experiments.

Broad's opposition also specifically addresses particular evidentiary items (e.g., Exhibit 3681, Issacson's Codebreaker) (conceding that should the Board consider CVC's objection to have any merit the issue is one of weight not admissibility).  Broad makes the equitable point that CVC should not "be allowed to tell science writers and the public about the difficulties and obstacles of their eukaryotic work so they can seek public acclaim" and then have the PTAB "ignore that those statements contradict CVC's arguments here, where CVC contends the same work actually required only 'routine techniques' and 'ordinary skill.'"  Broad then cites examples of inconsistencies between the statements CVC has made in this interference and what was said in the Exhibit regarding whether reducing eukaryotic CRISPR to practice was difficult or routine.

Broad's legal basis for its opposition to CVC's motion to exclude is that a party admission is not hearsay under Fed. R. Evid. 801(d)(2) and Rawlings v. Kentucky, 448 U.S. 98 (1980).  Even if not falling under this hearsay exception, Broad argues, Dr. Breaker as an expert is permitted to rely on these statements under Fed. R. Evid. 703.  As for reliability, Broad argues that the statements at issue are ones the PTAB relied upon in Decisions on Motions in this interference and the '048 Interference.  Broad argues "[t]hese statements are relevant and admissible as directly contradicting the inventors' present testimony" and Dr. Breaker was able to consider them in forming his opinions.  And the status of the statements in Issacson's book as "double hearsay"  under Fed. R. Evid. 805 is not to the contrary to Dr. Breaker's ability to consider and rely on them under Rule 703 and In re Biogen '755 6 Patent Litig., No. CV102734, 2018 WL 3613162, at *10 (D.N.J. July 26, 2018).

The Broad also argues that Dr. Breaker permissibly relied on admissible, contemporaneous, factual accounts of scientists' opinion regarding whether eukaryotic CRISPR would be reasonably expected to succeed in view of the in vitro experiments disclosed in the Jinek 2012 reference.  Broad bases these arguments on (what it characterizes as) both parties (and their experts) having relied on public statements from scientists in the field to assert evidence on "the state of the art, how POSAs reacted to historical research and developments in the gene editing and CRISPR fields, and how various scientists reacted to the disclosure of Jinek 2012's in vitro experiments," as well as the Board's reliance on this evidence.  This argument sets forth in parallel the equivalence of CVC's expert's reliance on such evidence and Broad's as well as correspondence between this evidence and publicly available records of these and other scientists' comments on the expectation of the skilled worker on reducing eukaryotic CRISPR to practice.

The opposition (under PTAB rules in interferences) then sets forth a line-by-line rebuttal of the legal bases of the assertions in CVC's motion to exclude.  And Broad addresses what it describes as "similar but slightly different issues" regarding CVC's objections to the Lambowith declaration specifically related to "trying (and failing to adapt Group II introns for use in eukaryotic cells."

Finally, Broad sets forth its rebuttal to CVC's objections to specific Exhibits comprising figures relied upon by Dr. Breaker in his expert testimony.

CVC in its Reply sets forth its grounds for the Board to grant its motion.  Most of these arguments reiterate arguments made in its motion, focusing on the statements by the authors (Issacson and Davies) as "double hearsay" in violation of Fed. R. Evid. 805 and re-emphasizing violation of the rule set forth in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 593-94 (1993) (an argument Broad does not address in their Opposition).  CVC disputes Broad's assertions that as publicly available statements much of what CVC has objected to should be allowed (saying that Broad has cited no authority for this proposition), characterizing Broad's use of this hearsay as "unapologetic" and that Broad should not be permitted to "cure its defiance of the Rules [of Evidence] through further defiance."  CVC also emphasizes Broad's failure to provide CVC with an opportunity to challenge these witnesses over this evidence (which even though being a practical impossibility might not excuse it).  CVC makes a distinction between relying on "scholarly journal articles, written by scientists for the scientific community and subject to rigorous peer-review" with what they characterize as "statements prepared for advocacy purposes during adversarial proceedings or ex parte prosecution, and not subject to any review (by cross-examination or otherwise)."

Next, CVC argues that Broad's purpose for submitting this evidence can be distinguished from the purpose to which CVC and the Board have relied upon public statements.  That distinction is that the Board and CVC have cited such statements "as examples of information on which a hypothetical person of ordinary skill in the art might base his or her expectations of success—something that does not turn on whether the statements are true or reliable."  In contrast, CVC argues, Broad is submitting these statements for the truth of the matter asserted (as an example, "whether the witness believed the CVC inventor's CRISPR-Cas9 system would work in eukaryotes, and what obstacles they expected to encounter"), where "[m]ost of these witnesses do not appear to have sworn any oath, nor have any of them been offered for cross-examination in any forum."  Asserting that "[i]f ever there were a model situation to exclude declaration testimony, this is it," CVC asks the Board to exclude the specific Exhibits set forth in its Motion to Exclude.

CVC's Reply then turns to portions of Dr. Breaker's Declaration.  These portions are merely an attempt for Broad to "backdoor so-called 'factual accounts'" and deny CVC the opportunity for cross-examination, CVC argues.  In addition, CVC notes that Dr. Breaker is being advanced as a scientific expert and "witness declarations from adversarial proceedings are not the type of documents that experts in Dr. Breaker's field reasonably rely upon to draw scientific conclusions," citing United States v. Tran Trong Cuong, 18 F.3d 1132, 1143 (4th Cir. 1994), authority supported by similar statements by the Federal Circuit (see Wi-Lan Inc., v. Sharp Electronics Corp., 992 F.3d 1366 (Fed. Cir. 2021)).  Accordingly, CVC argues that Broad has "not met its burden of establishing that these declarations fall within the scope of Rule 703," that these portions of Dr. Breaker's declaration violate Daubert and the Standing Order, and that the Board should grant CVC's Motion that this portion of his testimony is inadmissible.

Finally, turning to the Issacson book, CVC characterizes this as "media coverage" which is inadmissible "to prove sequences of events or an inventor's mental state," citing New England Mut. Life Ins. Co., v. Anderson, 888 F.2d 646, 650 (10th Cir. 1989), and Horta v. Sullivan, 4 F.3d 2, 8 (1st Cir. 1993).  In addition, CVC's Reply makes a distinction between the Board's citation of a book written by one of the inventors and this book written by a third party, reiterating its allegations that this evidence is inadmissible double hearsay.  (CVC also notes that Broad did not oppose CVC's motion to exclude Exhibits 6107 and 6116.)

CVC's Opposition to Broad's Motion to Exclude portions of its evidence and Broad's Reply will be the subject of a later post.