The latest installment in the cat-and-mouse game of deciding priority in Interference No 106,155 between Senior Party The Broad Institute, Harvard University, and the Massachusetts Institute of Technology (collectively, "Broad") and Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") is CVC's filing of its Miscellaneous Motion No. 2 to Exclude Evidence on April 2nd, and Broad's Opposition to this motion, filed on April 9th.

The interference rules (41 C.F.R. § 42 et seq.) provide that a party can object to an opponent's evidence including testimony.  Admissibility of evidence is governed by the Federal Rules of Evidence under 41 C.F.R. § 42.152; expert testimony is governed by the Federal Rules and Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579, 593-94 (1993).  Here, CVC argues in its brief in support of Miscellaneous Motion No. 2 that four prior art references should not be considered by the Board because they were not cited in any of Broad's papers; declarations from several individuals, including some of Broad's inventors, are inadmissible as hearsay because these individuals had not been made available for deposition; and certain expert testimony fails the Supreme Court's Daubert test for expert testimony admissibility.

The brief deals summarily with the uncited references, relying on Fed. R. Evid. 403 and 41 C.F.R. § 42.152.2.1 as being irrelevant for being uncited.  Turning to hearsay under Fed. R. Evid. 804, the brief identifies two categories of such inadmissible evidence:  declarations from prior proceedings (significantly, prior Interference No 106,048) that should be excluded according to CVC because the declarants were not made available for cross-examination.  The other category comprises "two expert declarations that recite these hearsay declarations for the truth of the matters asserted therein, and serve as further conduits for presenting the inadmissible hearsay in these declarations."

With regard to the first category, CVC argues that Broad submitted declarations of three fact witnesses (Drs. Sanjana, Lambowitz, and Zhang) for "the truth of the matter asserted" (specifically, timing and success of experiments by Broad inventors) that were submitted to the U.S. Patent and Trademark Office during prosecution of involved Broad patents (Sanjana, Zhang) or was a third-party declaration (Lambowitz).  CVC maintains that it objected to these declarations and Broad did not make these declarants available for cross-examination and thus their declarations constituted inadmissible hearsay, citing specifically Rose v. Frazer, Inf. No. 104,733 Paper 73 at 4 (B.P.A.I. Mar. 29, 2002), and 37 C.F.R. § 42.51(c).  The brief also cites 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), for the proposition that declaration evidence not subject to cross-examination (or an offer for cross-examination) should not be considered by the PTAB in contested cases.  The brief makes the appropriate representations that CVC requested these declarants be made available for deposition and Broad failed to make them available.  In addition, CVC suggests that the accuracy, if not the veracity, of Dr. Sanjana's declaration testimony was uncertain.

The second hearsay objection category involves expert testimony that CVC contends is merely a conduit for introducing (improperly) fact rather than opinion testimony.  CVC also argues that certain of the testimony (involving "state of mind" of inventors and others) violates "at least one of FRE 801, 802, and 804" as well as 41 C.F.R. § 42.152.2.1.  This type of testimony is particularly objectionable to CVC because it involved opinions on when Broad scientists possessed the invention and recognized that CRISPR could be performed using eukaryotic cells (certainly important if not dispositive factors involved in this interference).  Such testimony also violates Fed. R. Evid. 702 and 704 according to CVC's brief, which also cites In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d 164, 192 (S.D.N.Y. 2009); Lopez v. I-Flow Inc., No. CV 08-1063-PHX-SRB, 2011 WL 1897548 at *11 (E.D.N.Y. 2011); Fisher v. Halliburton, No. H-05-1731, 2009 WL 5216949 at *2 (S.D. Tex. Dec. 21, 2009); In re Heparin Prod. Liab. Litig., 803 F. Supp. 2d 712, at *8-9 (N.D. Ohio Mar. 21, 2011); and Hines v. Wyeth, No. 2:04-0690, 2011 WL 2680842 at *7 (S.D. W. Va. July 8, 2011).

With regard to its "conduit" theory, CVC cites Rule 703 for this principle, that "an expert is permitted to disclose hearsay for the limited purpose of explaining the basis for his expert opinion, but not as general proof of the truth of the underlying matter," citing Fox v. Taylor Diving & Salvage Co., 694 F. 2d 1349, 1356 (5th Cir. 1983), and United States v. Garcia, 793 F. 3d 1194, 1212 (10th Cir. 2015).  CVC specifically alleges that Drs. Seeger, Breaker, and Mirkin merely "[p]arrot[] extrajudicial information for the truth of the matter asserted" in certain portions of their declarations.  Moreover, CVC asserts that permitting Broad to introduce these factual assertions would permit Broad's scientists to enter "unchallengable statements" into the record, and "bootstrap untested evidence as proof of the underlying subject matter."

As it has in its Replies to Broad's Opposition to CVC's Motions No. 1 and No. 2 for benefit of priority, CVC takes particular issue with the testimony of Dr. Chad Mirkin.  As in those Replies, CVC argues that Dr. Mirkin is not an expert in genetic engineering (CVC asserts his expertise is in nanoparticles) and thus "his opinions are therefore irrelevant and unreliable" and the PTAB should discount his testimony under Daubert.  CVC states that it would be an abuse of discretion for the PTAB to permit Dr. Mirkin's testimony to be considered admissible in this interference, and that the status of an interference as being more in the nature of a bench trial instead of a jury trial does not change these considerations nor abrogate the Board's gatekeeping function.  CVC also contends that Dr. Mirkin's testimony is merely an "improper narrative based on no personal knowledge nor expertise" and hence inadmissible under FRE 602, 701-703, 801, and 802.  Nor should an expert be "an advocate or storyteller" without relevant expertise (which CVC argues Dr. Mirkin does not have), citing In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 551 (S.D.N.Y. 2004), and In re Prempro Prods. Liab. Litig., 554 F. Supp. 2d 871, 886 (E.D. Ark. 2008).  "In other words, an expert who merely reads or summarizes documents for the factfinder is not providing helpful testimony because the factfinder is capable of reading and reaching conclusions on its own," according to CVC's brief.  In this case and this witness, according to CVC, "Dr. Mirkin understands the relevant technology only well enough to serve as Broad's mouthpiece, and was unable to answer even the most basic questions about the technology or the evidence that was not part of his prepared statement."  For these reasons, CVC argues that the Board should rule the identified portions of Dr. Mirkin's testimony inadmissible.

Broad disagrees, and its brief in opposition makes two broad points.  First, Broad characterizes the evidence objected to as hearsay was submitted merely as a "proffer" to the Board that set forth Broad's arguments to be submitted during the Priority Phase, citing Byrn v. Aronhime, Patent Inf. 105,384 (McK), Paper 64 at 12:17-20 (PTAB Sept. 20, 2006).  Second, Broad asserts that CVC made similar proffers relying on purported hearsay during the '048 Interference; albeit not citing any precedent for such a "tit-for-tat" principle or evidentiary standard, but does use the argument to allege that CVC is being "disingenuous" (as well as being incorrect) for presumably trying to impose a stricter standard on Broad in this interference than was applied to CVC in the earlier '048 interference.

With regard to the availability vel non of Broad's declarants as a basis for considering their testimony to be hearsay, Broad in its turn dismisses these objection summarily by asserting that CVC never requested depositions of these witnesses.

Broad asserts it proffer exception to the hearsay rule for the Sanjana, Lambowitz, and Zhang declarations, as well as the Cong 2013 reference.  Broad argues that CVC's hearsay objections "are, at best, premature."  The brief asserts instances in the '048 Interference where CVC made a proffer based on the type of evidence that CVC now objects to as hearsay.  Broad also makes "policy" arguments, citing the impracticality of subjecting to cross-examination "the authors of any exhibit used in a proffer, and even the lawyer explaining the import of those exhibits" which supposedly would be occasioned by CVC's interpretation of admissibility of this evidence.  More persuasively, Broad's brief notes that in the cases CVC cited in support of its objections the PTAB admitted the objected-to evidence but retained the ability to take those objections into consideration when deciding the weight to give to the evidence.  With regard to the Cong reference, Broad makes a related argument, that as a reference the Board is capable of considering it for what it says, citing Rozbicki v. Chiang, Inf. 105,898, Paper 154 at 25 (PTAB June 26, 2013) 10 (explaining that a document is always "admissible as proof of what it says"), as well as falling within the hearsay rule exception set forth in FRE 807 (which, as a reminder, is the "residuary" rule permitting evidence to be considered if (1) the statement is supported by sufficient guarantees of trustworthiness—after considering the totality of circumstances under which it was made and evidence, if any, corroborating the statement; and (2) it is more probative on the point for which it is offered than any other evidence that the proponent can obtain through reasonable efforts).

One drawback to the proffer argument, and its application to the Priority Phase, is that any such proffer is not being made in the Priority Phase but in the Motions Phase, and particularly with regard to Broad's Motions No. 2 (to substitute the Count), No. 3 (to designate certain claims as not corresponding to the Count), and No. 4 (for priority benefit of U.S. Provisional Application No. 61/736,527).

Regarding CVC's "conduit for hearsay" argument, Broad relies on its "non-hearsay" distinction based on its proffer argument, and buttresses this argument by the general proposition that an expert can rely on hearsay "[i]f experts in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject" under Fed. R. Evid. 703, citing In re Biogen '755 Patent Litig., No. CV102734CCCJBC, 2018 WL 3613162, at *10 (D.N.J. 6 July 26, 2018).  Regarding CVC's objection to one expert's testimony, Broad asserts that these "ring hollow" because CVC purportedly relied on "similar expert testimony" in the '048 Interference (calling this "a double standard").  The brief also cites as "baseless" CVC's "storyteller" objection, because according to Broad their expert simply relied on "evidence going to key issues."

Not surprisingly, Broad defends the competence of its expert Dr. Mirkin, noting that his expertise is relevant to eukaryotic applications of CRISPR technology, specifically having to do with technology for introducing proteins and nucleic acids into eukaryotic cells ("Dr. Mirkin is . . . one of the world's foremost experts in the chemistry and use of nanostructures for delivery of proteins and nucleic acids to eukaryotic cells") (although without establishing that such methods were methods used to introduce protein and nucleic acid components of CRISPR into eukaryotic cells).  And the brief reminds the Board of Dr. Mirkin's bona fides, including that "[h]e has published over 740 manuscripts, has been issued over 330 patents, and has been the recipient of over 100 national and international awards for his work in the above-mentioned areas" and that he "is one of very few scientists to be elected to all three US National Academies: the National Academy of Medicine, the National Academy of Sciences, and the National Academy of Engineering."  The brief then goes on to cite case law regarding the (relatively) permissive standards of expert testimony under FRE 702 ("a broad range of knowledge, skill, experience, training, and education [is sufficient] to qualify an expert as such), citing Pineda v. Ford Motor Co., 520 F.3d 237, 244 (3d Cir. 2008); Carnegie Mellon Univ. v. Marvell Tech. Grp., Ltd., 807 F.3d 1283, 1303 (Fed. Cir. 2015); and SEB S.A. v. Montgomery Ward & Co., 18 594 F.3d 1360, 1373 (Fed. Cir. 2010) ("Where an expert's testimony "establishe[s] an adequate relationship between his experience and the claimed invention," the expert will generally be qualified.).

More specifically and relevant to the question of Dr. Mirkin's competency to testify as an expert in this interference, Broad argues that he was "exceedingly well-qualified" to speak to the question of the difficulties and challenges in adapting CRISPR to eukaryotic cells (a theme Broad developed successfully to convince the Board in the '048 Interference that there was no interference-in-fact).  Dr. Mirkin testified on this point expressly in his deposition, reproduced in the brief:

I think ultimately the basis of my expertise is the work that I do generally in the development of nucleic acid and protein-based medicines and an understanding,  perhaps a unique understanding, of the challenges associated with taking those types of constructs into cells and getting them to function properly.

(put more succinctly, testifying that his lab had developed over "decades" "a series of platforms . . . that are extremely good at moving nucleic acids and proteins into cells").  Because the ability to introduce the components of CRISPR-Cas 9 were "some of the greatest challenges with respect to [eukaryotic applications of] CRISPR" this expertise qualified him "to opine on whether a POSA would have understood CVC to have had possession in 2012 of a CRISPR-Cas9 system engineered to perform effectively in the complex environment of a eukaryotic cell."

Broad addressed directly the "storytelling" argument regarding Dr. Mirkin asserted by CVC in its brief, contending that his "application of his experience to an extensive review of the relevant scientific facts and data" was permissible for expert testimony.  And as for the specific deficiencies CVC asserts Dr. Mirkin demonstrated on particular questions relating to CRISPR technology in his deposition, Broad argues that this is a mischaracterization of his testimony and/or takes his testimony out of context (issues the Board will be able to determine for itself).

On balance, Broad set forth a robust defense of the qualifications of its expert witness, and it seems unlikely that the Board will rule his testimony inadmissible.  What remains unclear is the extent to which CVC's disparagements of Dr. Mirkin's general competence in CRISPR technology and deficiencies on specific points will cause the Board to diminish the weight it gives to his testimony.