Federal Circuit Affirms Board’s Determination of No Interference in CRISPR-Cas9 Technology

In Regents of the University of California v. Broad Institute, Inc., [2017-1907](September 10, 2018), the Federal Circuit affirmed the PTAB’s determination that there was no interference-in-fact between the University of California’s Application No. 13/842,859, and the claims of twelve patents and one application owned by the Broad Institute,
Inc., Massachusetts Institute of Technology, and the President and Fellows of Harvard College.  The involved claims relate to the use of a CRISPR-Cas9 system for the targeted cutting of DNA molecules.

The Board applies a two-way test to determine whether the claims are patentably distinct, asking whether “the subject matter of a claim of one party would, if prior art, have anticipated or rendered obvious the subject matter of a claim of the opposing party and vice versa.” 37 C.F.R. § 41.203(a). If the two-way test is not met, no interference-in-fact exists.

This Federal Circuit said that the case turns in its entirety on the substantial evidence
standard. It noted that the Board found a person of ordinary skill in the art would not have had a reasonable expectation of success in applying the CRISPR-Cas9 system in
eukaryotic cells. Given the mixture of evidence in the record, the Federal Circuit found that substantial evidence supports the Board’s finding that there was not a reasonable
expectation of success, and affirmed.

UC argued that the Board: (1) improperly adopted a rigid test for obviousness that required the prior art contain specific instructions, and (2) erred in dismissing evidence of simultaneous invention as irrelevant. However the Federal Circuit found no error in the Board’s analysis. After a detailed review of the evidence, the Federal Circuit concluded that in light of the record evidence, which includes expert testimony, contemporaneous statements made by skilled artisans, statements by the UC inventors themselves, and prior art failures, the Board’s fact finding as to a lack of reasonable expectation of success is supported by substantial evidence.  The Federal Circuit said that the Board did not adopt a test requiring there be specific instructions in the art in order to make a finding of a reasonable expectation of success, and thus found no error in the Board’s analysis.

On the issue of simultaneous invention, the Federal Circuit acknowledged that simultaneous invention may serve as evidence of obviousness when considered in light of all of the circumstances.  First, it is evidence of the level of skill in the art, and second it constitutes objective evidence that persons of ordinary skill in the art understood the problem and a solution to that problem. However in the context of interferences, evidence of simultaneous invention cannot alone show obviousness, otherwise any claims involved in an interference would be unpatentable for  obviousness. Thus, the Federal Circuit instructed, the weight of evidence of simultaneous invention must, therefore, be carefully considered in light of all the circumstances.  Noting that the Board explained that each case must be decided in its particular context, including the characteristics of the science or technology, its state of advance, the nature of the known choices, the specificity or generality of the prior art, and the predictability of results in the area of interest, the Federal Circuit found no error in the Board’s analysis.