On May 12, the Federal Circuit issued its opinion in Regents of the University of California v. Broad Institute Inc., a case we have been following because it attracted an amicus brief. In this appeal, the Federal Circuit reviewed a judgment of the Patent Trial and Appeal Board in an interference proceeding concerning competing patent applications related to using the CRISPR-Cas9 gene-editing system in eukaryotic (e.g., plant or animal) cells. In a unanimous opinion authored by Judge Reyna and joined by Judges Hughes and Cunningham, the Federal Circuit vacated the Board’s decision, holding the Board incorrectly applied the legal standard for conception. The panel also affirmed the Board’s determination of compliance with the written requirement and dismissed a cross-appeal as moot. This is our opinion summary.
In this case, the Regents of the University of California, the University of Vienna, and Emmanuelle Charpentier (collectively “Regents”) appeal from the Board’s decision in the underlying interference proceeding, while the Broad Institute, Massachusetts Institute of Technology, and the President and Fellows of Harvard College (collectively “Broad”) cross-appeal.
As explained by Judge Reyna, the dispute between the parties arose because “[s]cientists at Regents claim they invented” the underlying technology while “[s]cientists at Broad argue they are the true inventors.” Therefore, he said, “this dispute centers on one of the oldest doctrines in U.S. patent law, conception.” Judge Reyna provided the relevant background:
Regents’ scientists claim that they further simplified CRISPR-based gene editing in 2012 by linking two RNA sequences in the CRISPR-Cas9 system into a single-molecule “chimeric” RNA, called a “single-guide” RNA (“sgRNA”) . . . They claim that they made a CRISPR-Cas 9 system from a sgRNA they designed, called “chimera A,” and Cas9 . . . They claim to have used this system to successfully target and edit DNA in a cell-free in vitro environment . . . [T]his system “simpl[ified]” gene editing by allowing the system to be “re-programmed by changing the crRNA” . . . Starting in March 2012, Regents’ scientists, directed by Charpentier, Jennifer Doudna, and Martin Jinek, planned experiments to show the single RNA CRISPR-Cas9 system could be used to edit eukaryotic DNA . . . After these initial plans, Regents filed its first provisional patent application, “P1” (U.S. Patent App. No. 61/652,086), on May 25, 2012 . . . Over the remainder of 2012, scientists from laboratories outside of Regents, including scientists at Broad, attempted to use the system to edit DNA in eukaryotic cells . . . One of these other laboratories was run by Feng Zhang, a scientist at Broad. Learning of the CRISPR-Cas9 system on June 26, 2012, Zhang immediately planned tests using the system to edit eukaryotic DNA . . . Zhang claims that, on July 20, 2012, he directed the implementation of his plan on mouse cells . . . He further claims that he soon recognized that the July 20, 2012 test showed that his Cas9 system successfully edited the mouse DNA . . . On October 5, 2012, Zhang submitted these results to Science, which published them on January 3, 2013 . . . From July through September 2012, Regents’ scientists conducted microinjection tests in fish embryos . . . Concurrently, from July to October 2012, Regents’ scientists conducted expression vector tests in human cells . . . On August 10, 2012, the student sent an email reporting the results of tests conducted on July 31 and August 9, 2012 . . . Doudna replied . . . that the results . . . . presented “very exciting” evidence of successful DNA editing . . . By August 13, 2012, Jinek replied, agreeing that the results were “really exciting” . . . On October 19, 2012, Regents filed a second provisional application “P2” (U.S. Patent App. No. 61/716,256) . . . Doudna claims that, on October 29, the second student reported evidence of successful editing, and, soon after, reported replication of this result . . . Regents and Broad filed patent applications related to the CRISPR technology. Both Regents and Broad claimed in those applications to be the inventor of the CRISPR technology as issue here, and, as a result, the Patent Trial and Appeal Board (“Board”) declared Interference No. 106,115 (“115 interference”), which is the subject of this appeal.
Judge Reyna began his analysis by addressing the standard of review. He explained that, while “[c]onception and inventorship are ultimately questions of law” review de novo,” they “are premised on underlying fact findings” reviewed for substantial evidence.” By contrast, he explained, “[w]ritten description is a question of fact” reviewed for substantial evidence.
On the merits, Judge Reyna first addressed conception.
Judge Reyna explained that the Board legally erred in its analysis of conception for several reasons. The panel, for example, concluded “the Board legally erred by requiring Regents’ scientists to know their invention would work to prove conception.” The panel also determined that the “Board legally erred by focusing on Regents’ statements of uncertainty, without considering whether those statements led to modifications in their experiments that substantively changed their original idea.” Judge Reyna described how “[t]he key question here is ‘whether [Regents’ scientists] had formed the idea of [the invention’s] use for [its intended] purpose in sufficiently final form that only the exercise of ordinary skill remained to reduce it to practice’ ‘without extensive research or experimentation.'” It was, he said, “[a]lso relevant . . . whether an alleged inventor contemplated the use of routine skill or methods at an asserted conception date, or used such routine skill or methods during subsequent, successful experimentation conduct by the alleged inventor.” Judge Reyna and the panel concluded that “[t]he Board erred in its analysis by failing to consider routine methods or skill, and, instead focusing almost entirely on Regents’ scientists’ statements about perceived experimental difficulties and doubts about success.”
Next, Judge Reyna concluded, “[i]t was legal error for the Board to categorically disregard evidence of purported experimental success by others.” He noted how, “despite difficulties, ‘in the end only routine materials and techniques, as described by’ Regents’ scientists, ‘were required for a sgRNA CRISPR-Cas9 that can edit DNA in eukaryotic cells.'” According to Judge Reyna, “the Board legally erred by failing to consider whether Regents’ scientists described routine methods or skills in their disclosures at asserted conception dates, and whether they used routine methods or skill in subsequent, purportedly successful experiments.”
Summing up the panel’s analysis of conception, Judge Reyna explained that “the Board erred by failing to consider routine methods or skill, focusing almost entirely on Regents’ scientists perceived experimental difficulties and related statements of doubt.” As a result, the panel “vacate[d] the Board’s decisions on conception and remand[ed] for the Board to decide conception under the proper application of the legal framework.”
Judge Reyna next addressed the issue of written description. He first explained that the panel “disagree[d] with Regents that the Board legally erred” by “rejecting P1’s identification of the essential components of the CRISPR-Cas9 complex of Count 1, its explanation of why the complex works, and its explanation of how to use the complex in eukaryotes.” Judge Reyna explained that, “[c]ontrary to Regents’ arguments, the Board did not require P1 to convince a person of ordinary skill in the art of the success of Regents’ invention.” Instead, he said, the Board “correctly analyzed whether a person of ordinary skill in the art would understand that Regents had possession of the claimed subject matter.” As a result, he said, “in form and in substance, the Board correctly assessed possession and thus did not commit legal error.”
Next, Judge Reyna turned to Regents’ challenge to the Board’s written description under the Administrative Procedure Act. Judge Reyna rejected this challenge, indicating “[t]he Board’s written description satisfies the APA.” He explained there is “no indication that the Board limited its written description analysis to using expression vectors rather than microinjection,” and, “[i]n the absence of any such indication, we cannot say that the Board’s determinations are in fact limited to the use of expression vectors, nor can we say that the Board’s decision is arbitrary and capricious.”
Lastly, the Judge Reyna addressed Broad’s cross-appeal related to claim construction. He indicated “Broad’s cross-appeal is moot.” Citing the test of mootness, he stated that, “[e]ven if we agree with Broad that the Board’s claim construction analysis was erroneous, we could not grant Broad any effectual relief” because the “Board’s denial of Broad’s preliminary motions would remain intact.” Judge Reyna explained that, since “Broad chose to only apply the Board’s claim construction analysis,” the court was required to dismiss the cross-appeal because “the relief sought would not have an impact on the legal interests of the parties.”
In conclusion, Judge Reyna explained that, while the panel “affirm[ed] the Board’s written description decision and dismiss[ed] Broad’s cross-appeal as moot,” the panel also held that “the Board incorrectly applied the legal standard for conception.” As a result, the panel “vacate[d] the Board’s determination as to conception and remand[ed]” the case to the Board for it “to reconsider the issue of conception in a manner consistent with this opinion.”