Regents of The University of California, University of Vienna, Emmanuelle Charpentier (“UC”) v. Broad Institute, Inc., Mass. Inst. Tech., Fellows of Harvard College (“Broad”)

Docket No. 2017-1907

September 10, 2018

Brief summary: FC panel affirmed the Board’s judgment of no interference-in-fact between UC’s and Broad’s claims, also stating that this “is not a ruling on the validity of either set of claims.”

Summary: UC appealed PTAB (“Board”) decision finding no interference between UC’s Appln. No. 13/842,859 (the ‘859 application claiming priority to May 25, 2012) and the claims of twelve patents owned by Broad Inst., MIT, and Harvard (collectively “Broad”). The claims at issue relate to the use of a “Clustered Regularly Interspaced Short Palindromic Repeats” (CRISPR) system for targeted cutting of DNA involving three main components: 1) an RNA molecule with a variable portion that complements a target DNA sequence (“crRNA”); 2) “tracrRNA” to which the crRNA also binds; and 3) the Cas9 protein which interacts with the crRNA and tracrRNA to cut both strands of DNA at the target site. The FC panel opinion explains that UC researchers published an article in 2012 showing that the CRISPR-Cas9 system, which naturally occurs in prokaryotes (e.g., bacteria) “but have not been shown to naturally exist in eukaryotes, such as plants and animals”, could be used in vitro without reporting results from eukaryotic cells, and that “the claims in UC’s ‘859 application do not refer to a particular cell type or environment”. The FC panel also explained that “[t]he claims in Broad’s patents and application are limited to use in eurkaryotic cells” (e.g., representative claim 1 of US 8,697,359 claiming priority to December 12, 2012 (e.g., “method…comprising introducing into a eukaryotic cell”, first and second “regulatory element(s) operable in a eukaryotic cell”)). The Board instituted an interference which Broad sought to terminate because “it claims are patentably distinct from UC’s claims because a person of ordinary skill in the art would not have had a reasonable expectation that the CRISPR-Cas9 system would work successfully in a eukaryotic cell.” The Board agreed with Broad, finding no interference-in-fact and “that UC’s claims…did not render obvious Broad’s claims to its use in eukaryotes”.

The FC panel explained that 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 CFR § 41.203(a); Noelle, FC 2004; Medichem, FC 2003 (“the standard of review mirrors that in an obviousness review”; FN2 pointing out that “[t]he AIA replaced the first-to-invent rule with a first-inventor-to-file rule” but that “the prior rule continues to apply in this interference”). UC argued the Board’s erred by improperly adopting “a rigid test for obviousness that required the prior art contain specific instructions” and “dismissing evidence of simultaneous invention as irrelevant.” The FC panel concluded that the Board’s fact-finding as to a lack of a reasonable expectation of success is supported by substantial evidence” including “expert testimony, contemporaneous statements made by skilled artisans, statements by the UC inventors themselves, and prior art failures” supported the Board’s decision of no obviousness. The FC panel did note that “UC expended substantial time and effort to convince this court that substantial evidence supports the view it would like us to adopt”, and acknowledged “[t]here is certainly evidence in the record that could support this position”, but explained it does “not reweigh evidence” and its role is to ask whether the “evidence supports the findings that were in fact made.”

UC argued that the Board erred because “instead of asking whether the claimed invention is ‘the product not of innovation but of ordinary skill and common sense,’ the Board adopted a rigid test for obviousness that formalistically looked for specific instructions in the prior art while ignoring ‘the inferences and creative steps that a person of ordinary skill in the art would employ’ without the need for specific guidance” (citing KSR, FC 2007). But the FC panel disagreed, finding the Board “acknowledged that certainty in the art is not required”, “performed a factual analysis based on the correct legal standard”, and “made clear that the determination ‘depends on the specific nature of what was known from the prior art about closely related subject matter’” (“At no point did the Board suggest it found there would not have been a reasonable expectation of success solely because there were not specific instructions….”)

UC also argued “the Board erred in dismissing evidence of simultaneous invention as irrelevant” but the FC panel disagreed, finding “the Board expressly recognized the relevance of simultaneous invention to the question of obviousness” (Linemann, FC 1984; Monarch Knitting, FC 1998). The FC panel found, for instance, that “[t]he Board expressly recognized UC’s evidence” that “within a short time” after the 2012 paper (describing “a breakthrough in the art”) was published, “six research groups succeeded in applying this technology in eukaryotic cells” and that “this is certainly strong evidence that there was a motivation to combine the prior art in this manner.” But the FC panel also explained that the Board need not have inferred that because “that approach was ultimately successful”, the research teams “must have expected that approach to work.” The FC panel concluded the Board did not err in its analysis and its finding to be supported by substantial evidence.

Thus, the FC panel affirmed the Board’s judgment of no interference-in-fact, also stating that this “is not a ruling on the validity of either set of claims.”

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